You are on page 1of 89

6890 Federal Register / Vol. 82, No.

12 / Thursday, January 19, 2017 / Rules and Regulations

DEPARTMENT OF HEALTH AND public health orders and medical f. Medical Examinations
HUMAN SERVICES reviews as needed. In implementing g. Requirements Relating to Issuance of a
quarantine, isolation, or other public Federal Order for Quarantine, Isolation,
42 CFR Parts 70 and 71 or Conditional Release
health measures under this Final Rule,
h. Mandatory Reassessment of a Federal
HHS/CDC will seek to use the least Order for Quarantine, Isolation, or
[CDC Docket No. CDC–2016–0068]
restrictive means necessary to prevent Conditional Release
RIN 0920–AA63 the spread of communicable disease. i. Medical Review of a Federal Order for
Quarantine, Isolation, or Conditional
Control of Communicable Diseases Table of Contents Release
I. Executive Summary j. Administrative Records Relating to a
AGENCY: Centers for Disease Control and A. Purpose of the Action Federal Order for Quarantine, Isolation,
Prevention (CDC), Department of Health B. Summary of Major Provisions or Conditional Release
and Human Services (HHS). C. Summary of Costs and Benefits k. Other Due Process Concerns
ACTION: Final rule. II. Public Participation l. Privacy
III. Background m. Payment for Care and Treatment
SUMMARY: The Centers for Disease A. Legal Authority n. Agreements
Control and Prevention (CDC), within B. Regulatory History o. Penalties
IV. Summary of the Final Rule p. Economic Impact
the Department of Health and Human A. General References to ‘‘CDC’’ and q. Paperwork Reduction Act
Services (HHS), is issuing this final rule ‘‘Director’’ in Parts 70 and 71 B. Provisions Applicable to Part 70 Only
(FR) to amend its regulations governing B. Definitions (§§ 70.1 and 71.1(b)) (Domestic)
its domestic (interstate) and foreign C. Apprehension and Detention of Persons a. General
quarantine regulations to best protect With Quarantinable Communicable b. Requirements Relating to Travelers
the public health of the United States. Diseases (70.6) Under a Federal Order of Isolation,
These amendments have been made to D. Medical Examinations (§§ 70.12 and Quarantine, or Conditional Release
71.36) c. Report of Death or Illness Onboard
aid public health responses to outbreaks E. Requirements Relating to the Issuance of Aircraft Operated by an Airline
of new or re-emerging communicable a Federal Order for Quarantine, Isolation, C. Provisions Applicable to Part 71 Only
diseases and to accord due process to or Conditional Release (§§ 70.14 and (Foreign)
individuals subject to Federal public 71.37) a. Requirements Relating to Transmission
health orders. In response to public F. Mandatory Reassessment of a Federal of Airline and Vessel Passenger, Crew,
comment received, the updated Order for Quarantine, Isolation, or and Flight Information for Public Health
provisions in this final rule clarify Conditional Release (§§ 70.15 and 71.38) Purposes
G. Medical Review of a Federal Order for b. Suspension of Entry of Animals,
various safeguards to prevent the
Quarantine, Isolation, or Conditional Articles, or Things From Designated
importation and spread of Release (§§ 70.16 and 71.39)
communicable diseases affecting human Foreign Countries and Places Into the
H. Administrative Records Relating to a United States
health into the United States and Federal Order for Quarantine, Isolation, VI. Alternatives Considered
interstate. or Conditional Release (§§ 70.17 and VII. Required Regulatory Analyses
71.29)
DATES: This rule is effective February A. Executive Orders 12866 and 13563
I. Payment for Care and Treatment (70.13
21, 2017. B. The Regulatory Flexibility Act
and 71.30)
C. The Paperwork Reduction Act
FOR FURTHER INFORMATION CONTACT: J. Agreements (§§ 70.18 and 71.40)
D. National Environmental Policy Act
Director, Division of Global Migration K. Penalties (§§ 70.18 and 71.2)
L. Public Health Prevention Measures To (NEPA)
and Quarantine, Centers for Disease E. Executive Order 12988: Civil Justice
Detect Communicable Disease (§§ 70.10
Control and Prevention, 1600 Clifton and 71.20) Reform
Road NE., MS–E03, Atlanta, GA 30329, M. Requirements Relating to Travelers F. Executive Order 13132: Federalism
or email dgmqpolicyoffice@cdc.gov. Under a Federal Order of Isolation, G. The Plain Language Act of 2010
SUPPLEMENTARY INFORMATION: Based on Quarantine, or Conditional Release I. Executive Summary
public comment received to the Notice (§ 70.5)
of Proposed Rulemaking (NPRM) (81 FR N. Report of Death or Illness Onboard A. Purpose of the Action
Aircraft Operated by an Airline (§ 70.11)
54230) this final rule, among other O. Requirements Relating to Collection,
HHS/CDC has statutory authority (42
things: Withdraws a provision regarding Storage, and Transmission of Airline and U.S.C. 264, 265) to promulgate
‘‘Agreements’’ as proposed in the Vessel Passenger, Crew, and Flight and regulations that protect U.S. public
NPRM, requires CDC to issue a federal Voyage Information for Public Health health from communicable diseases,
order within 72 hours after Purposes (§§ 71.4 and 71.5) including quarantinable communicable
apprehending an individual, increases P. Requirements Relating to Collection, diseases as specified in an Executive
the threshold for those who may be Storage, and Transmission of Airline and Order of the President. See Executive
considered ‘‘indigent’’ to 200% of the Vessel Passenger, Crew, and Flight and Order 13295 (April 4, 2003), as
Voyage Information for Public Health
applicable poverty guideline, adds a Purposes (§§ 71.4 and 71.5)
amended by Executive Order 13375
definition for ‘‘Secretary,’’ adds a Q. Report of Death or Illness (§ 71.21) (April 1, 2005) and Executive Order
requirement for CDC to provide legal V. Overview of Public Comment to the 2016 13674 (July 31, 2014). The need for this
counsel for isolated or quarantined NPRM rulemaking was reinforced during HHS/
individuals qualifying as indigent who A. Provisions Applicable to Both Parts 70 CDC’s response to the largest outbreak
request a medical review, modifies the and 71 of Ebola virus disease (Ebola) on record,
mstockstill on DSK3G9T082PROD with RULES3

definition of ‘‘non-invasive,’’ includes a. General Comments followed by the recent outbreak of


‘‘known or possible exposure’’ in the list b. Scope and Authority Middle East Respiratory Syndrome
c. Definitions
of information that may be collected d. Public Health Prevention Measures To
(MERS), both quarantinable
during a public health risk assessment, Detect Communicable Disease communicable diseases, and repeated
and strengthens due process protections e. Apprehension and Detention of Persons outbreaks and responses to measles, a
by ensuring that CDC will arrange for With Quarantinable Communicable non-quarantinable communicable
translation or interpretation services for Diseases disease of public health concern. This

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6891

final rule will enhance HHS/CDC’s infected with a quarantinable HHS/CDC traveler data orders may
ability to prevent the introduction, communicable disease. This would result from the implementation of the
transmission, and spread of include communication through email provisions in this final rule, HHS/CDC
communicable diseases into the United and webcam application tools. Finally, may become better able to respond to
States and interstate by clarifying and while neither modifying nor authorizing infectious diseases threats and (1)
providing greater transparency additional criminal penalties for reduce case-loads during infectious
regarding its response capabilities and violations of quarantine rules and disease outbreaks, (2) reduce public
practices. regulations, this final rule updates anxiety during disease outbreaks, (3)
regulatory language to align with mitigate economic impacts on
B. Summary of Major Provisions
existing criminal penalties set forth in businesses as a consequence of reduced
Both the domestic and foreign statute. public anxiety associated with
portions of this regulation include new quarantinable communicable disease
proposed public health definitions; new C. Summary of Costs and Benefits
outbreaks initiated by international
regulatory language implementing HHS/ The regulatory impact analysis travelers (such as have been observed
CDC’s activities concerning non- quantitatively addresses the costs and during outbreak of severe acute
invasive public health prevention benefits associated with this final rule. respiratory syndrome in Canada or
measures (i.e., traveler health screening) The economic impact analysis of this Middle East respiratory syndrome in
at U.S. ports of entry and other U.S. final rule is subdivided into two South Korea), and (4) reduce the amount
locations (i.e., railway stations, bus sections. of personnel labor time to conduct large-
terminals); and provisions affording due The first analysis summarizes the scale contact investigations in response
process to persons served with a Federal economic impact of changes to 42 CFR to a new infectious disease or one with
public health order (e.g., isolation, 70.1, 42 CFR 71.1/71.4/71.5 for which larger scale public health and medical
quarantine), including requiring that the primary costs for submitting consequences like Ebola.
HHS/CDC explain the reasons for passenger and crew information to The second analysis in this final rule
issuing the order, administrative HHS/CDC are incurred by airlines and is of a number of provisions that aim to
processes for appealing the order, and a vessel operators and the primary benefit improve transparency of how HHS/CDC
mandatory reassessment of the order. is improved public health uses its regulatory authorities to protect
The domestic portion of this final rule responsiveness to assess and offer post- public health. HHS/CDC believes that
includes a requirement that commercial exposure prophylaxis to travelers improving the quality of its regulations
passenger flights report deaths or potentially exposed to communicable by providing clearer explanations of its
illnesses to the CDC. It also includes a diseases of public health concern. The policies and procedures is an important
provision requiring that individuals most likely estimates of annual costs to public benefit. However, HHS/CDC is
apply for a travel permit if they are airlines, vessel operators, the United not able to attach a dollar value to this
under a Federal quarantine, isolation, or States government, and public health added benefit in a significant way.
conditional release order (unless the departments are low ($32,622, range
specific travel is authorized by the $10,959 to $430,839) because the final II. Public Participation
Federal conditional release order) or if rule primarily codifies existing practice On August 15, 2016, HHS/CDC
a State or local public health or improves alignment between existing published a notice of proposed
department requests CDC assistance in regulatory text and the International rulemaking (NPRM) (81 FR 54299) to
enforcing a State or local quarantine or Civil Aviation Organization (ICAO)’s amend 42 CFR part 70 (interstate) and
isolation order. Additionally, the guidelines for symptoms to report. The 42 CFR part 71 (foreign) quarantine
domestic portion of this final rule cost estimates in this final rule are based regulations. The public was invited to
includes new regulatory language on (1) an anticipated small increase in comment on these amendments. The
clarifying when an individual who is the number of illness reports delivered comment period ended October 14,
moving between U.S. states is by airlines and processed by HHS/CDC 2016. In the NPRM, HHS/CDC
‘‘reasonably believed to be infected’’ and (2) increased costs for airlines and specifically requested public comment
with a quarantinable communicable vessel operators to comply with HHS/ on the following:
disease in a ‘‘qualifying stage.’’ These CDC orders for traveler and crew contact • Whether the use of the standard
determinations are made when the CDC data, to the extent that such information definition of ‘‘indigent’’ is an
considers the need to apprehend or is readily available and already appropriate threshold to determine
examine an individual for potential maintained, and not already transmitted whether an individual cannot afford
infection with a quarantinable to the U.S. Customs and Border representation and therefore should be
communicable disease. The foreign Protection (CBP). The cost estimate also appointed a medical representative at
portion of this final rule includes new includes an increase in costs for public the government’s expense and whether
regulatory authority permitting the CDC health departments to contact more the public believes that there may be
Director to prohibit the importation of exposed travelers due to the availability non-indigent individuals, as defined in
animals or products that pose a threat to of improved contact data. the NPRM, who may have difficulty
public health. The best estimate of the annual affording a representative;
HHS/CDC has also changed the text of quantified benefits of the final rule are • The definition of public health
the regulation to reflect modern $110,045 (range $26,337 to $297,393) emergency and its utility in identifying
terminology, technology, and plain and mostly result from increased communicable diseases that ‘‘would be
language used by private industry, efficiencies for HHS/CDC and State and likely to cause a public health
mstockstill on DSK3G9T082PROD with RULES3

public health partners, and the public. local public health departments to emergency if transmitted to other
The final rule also authorizes public conduct contact investigations among individuals’’ under 42 U.S.C.
health monitoring through electronic or travelers on an aircraft exposed to 264(d)(2)(B);
internet-based means of communication communicable diseases of public health • Requirements relating to travelers
for individuals under a Federal concern, especially for measles and under a Federal order of isolation,
conditional release order who are tuberculosis. To the extent that quarantine, or conditional release;
reasonably believed to be exposed to or improved responsiveness of airlines to specifically, on whether stakeholders

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6892 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

have concerns regarding the of airlines sufficient time for operators potential for spread, particularly during
requirement imposed on conveyance to respond to manifests orders; travel, may require a public health
operators to not ‘‘knowingly’’ transport • The likelihood that the passenger intervention. The provisions contained
individuals under a Federal order and and crew data elements requested are within the proposal were designed to
the feasibility of this requirement and already collected and maintained by enhance HHS/CDC’s ability to prevent
the application of this provision to airline operators for transmission to the further importation and spread of
individuals under State/local order as CDC; communicable diseases into the United
well as individuals traveling entirely • Any industry concerns regarding States and interstate by clarifying HHS/
within a State. whether proposed section 71.63 CDC’s response capabilities, practices,
• Public health prevention measures sufficiently details the circumstances and making them more transparent.
and whether the public has any under which HHS/CDC may impose an
embargo on the importation of animals, III. Summary of the Final Rule
concerns regarding the mandatory
health screening of passengers using articles, or things, including how such Upon consideration of public
non-invasive means as defined in the an embargo would be implemented, as comment, the following is a section-by-
proposal or the collection of personal well as any concerns regarding section summary of the changes from
information from screened individuals coordination with other Federal the proposed text that HHS/CDC made
for the purposes of contact tracing; agencies. to parts 70 and 71:
• Payment for care and treatment, and The public comment period for the
A. General References to ‘‘CDC’’ and
whether there are any concerns that all proposed rule ended on October 14,
‘‘Director’’ in Parts 70 and 71
third party payments be exhausted prior 2016 and HHS/CDC received 15,800
to the Federal reimbursement of medical comments from individuals, Throughout the regulatory text in
care or treatment for individuals placed stakeholders, and groups. A summary of parts 70 and 71, references to ‘‘CDC’’ or
under a Federal order for quarantine, those comments and responses to those ‘‘HHS/CDC’’ have been replaced with
isolation, or conditional surveillance; comments are found at Section IV, ‘‘Director.’’ This is in keeping with the
common practice that federal agencies
• The application of requirements below.
act through employees and officials to
relating to issuance of a Federal order II. Background whom the authority involved has been
for quarantine, isolation or conditional
A. Legal Authority delegated. Director is currently defined
release as it applies to groups and
in sections 70.1 and 71.1 to mean ‘‘the
whether this provision sufficiently The primary legal authorities Director, Centers for Disease Control
informs the public of the important supporting this rulemaking are sections and Prevention, Department of Health
details concerning circumstances during 361 and 362 1 of the Public Health and Human Services, or another
which HHS/CDC would issue to groups Service Act (42 U.S.C. 264, 265). HHS/ authorized representative as approved
or individuals Federal orders for CDC also believes that the following by the CDC Director or the Secretary of
quarantine, isolation, and conditional Public Health Service Act sections are HHS.’’ Where it is necessary to exclude
release and the duration and conditions relevant with respect to this rulemaking: CDC employees or officials from
of such orders; section 311 (42 U.S.C. 243), section 321 undertaking certain functions this has
• Whether 72 hours is the necessary (42 U.S.C. 248), section 322 (42 U.S.C. been indicated by use of parenthesis,
amount of time to conduct a 249), section 365 (42 U.S.C. 268), and e.g., ‘‘Director (excluding the CDC
reassessment after a Federal order is sections 367–69 (42 U.S.C. 270–72). A official who issued the quarantine,
first issued, or if the reassessment detailed explanation of these legal isolation, or conditional release order).’’
should take place earlier or later; authorities was provided in the NPRM This is a stylistic change from the
• Whether or not the public sees a published at 81 FR 54230 (Aug. 15, NPRM, but does not result in a
role for the Federal government to 2016). substantive change in the final rule.
ensure that basic living conditions,
amenities, and standards are satisfactory B. Regulatory History B. Definitions (Sections 70.1 and
when placing individuals under Federal On August 15, 2016, HHS/CDC 71.1(b))
orders; published a Notice of Proposed • The definition of Agreements has
• Whether the definition of ‘‘non- Rulemaking to update 42 CFR 70 been removed.
invasive’’ aligns with common (domestic) and 42 CFR 71 (foreign) • The definition of Electronic or
perceptions of what constitutes non- quarantine regulations. These internet-based monitoring has been
invasive procedures that may be amendments were proposed to aid modified to include ‘‘communication
conducted outside of a traditional public health responses to outbreaks of through’’ these means and ‘‘audio’’
clinical setting; communicable disease, such as the conference.
• Whether the penalties proposed, largest outbreak of Ebola virus disease • The definition of Indigent has been
and the circumstances under which (Ebola) on record, Middle East modified to increase the threshold to
such penalties may be imposed, were Respiratory Syndrome (MERS), both 200% of the applicable poverty
clearly explained; quarantinable communicable diseases, guidelines.
• The applicability of the December and repeated outbreaks of measles in the • The definition of Ill person under
13, 2007 system of records notice United States, a non-quarantinable section 71.1 has been modified to
(SORN) to the activities proposed (72 FR communicable disease of public health include a person who ‘‘Has a fever that
70867), and whether the SORN concern. (81 FR 54299). Communicable has persisted for more than 48 hours’’ or
mstockstill on DSK3G9T082PROD with RULES3

sufficiently addresses the public’s diseases of public health concern are ‘‘Has acute gastroenteritis, which means
concerns related to maintenance and those diseases that because of their either diarrhea, defined as three or more
protection of the data elements episodes of loose stools in a 24-hour
1 Section 3 of Executive Order 13295 (April 4,
proposed; period or what is above normal for the
2003) states that the functions of the President
• The request for a passenger and under sections 362 and 364(a) of the Public Health
individual, or vomiting accompanied by
crew manifest within 24 hours and Service Act (42 U.S.C. 265 and 267(a) are assigned one or more of the following: One or
whether the provision grants operators to the HHS Secretary. more episodes of loose stools in a 24-

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6893

hour period, abdominal cramps, that the Director, as part of the Federal quarantine, isolation, or conditional
headache, muscle aches, or fever order, advise the individual that the release to participate in the medical
(temperature of 100.4 °F [38°C] or medical examination shall be conducted review.’’ These provisions have also
greater).’’ This language was quoted by an authorized and licensed health been modified to include paragraph (q)
verbatim in the preamble of the NPRM worker with prior informed consent. which states that the Director shall
at 81 FR 54305 but was inadvertently arrange for translation or interpretation
E. Requirements Relating to the
omitted from the proposed regulatory services as needed for purposes of this
Issuance of a Federal Order for
text. section. References to CDC have been
• The definition of Medical Quarantine, Isolation, or Conditional
Release (§§ 70.14 and 71.37) replaced with Director throughout this
Examination has been modified to section.
indicate that the health worker Paragraphs (a)(5) and (a)(4) of these
conducting the assessment must be provisions have been modified, H. Administrative Records Relating to a
‘‘licensed.’’ respectively, to require that the Federal Federal Order for Quarantine, Isolation,
• The definition of Medical order include an explanation that the or Conditional Release (§§ 70.17 and
Representative has been changed to Federal order will be reassessed no later 71.29)
Representatives and now includes for an than 72 hours after it has been served These sections have been modified to
indigent individual the additional and an explanation of the right to remove paragraphs (5) regarding
appointment of ‘‘an attorney who is request a medical review, present agreements between CDC and the
knowledgeable of public health witnesses and testimony at the medical individual.
practices’’ if the indigent individual review, and to be represented at the
requests a medical review. medical review by either an advocate I. Payment for Care and Treatment
• The definition of Non-invasive has (e.g., an attorney, family member, or (§§ 70.13 and 71.30)
been modified to: (1) Replace ‘‘physical physician) at the individual’s own These provisions have been finalized
examination’’ with ‘‘visual expense, or, if indigent, to have as proposed, with the exception that
examination;’’ (2) specify that the representatives appointed at the references to CDC have been replaced
individual performing the assessment government’s expense. Paragraph (b) of with Director throughout this section.
must be a ‘‘public health worker (i.e., an these provisions has been modified to
require that a Federal public health J. Agreements (§§ 70.18 and 71.40)
individual with education and training
in the field of public health)’’; and (3) order be served within 72 hours of an These provisions have been removed.
remove ‘‘auscultation, external individual’s apprehension. Paragraph
K. Penalties (§§ 70.18 and 71.2)
palpation, external measurement of (c) has been modified to require that the
blood pressure.’’ Director arrange for translation or The content of these provisions has
• A definition for Secretary has been interpretation services of the Federal been finalized as proposed. Proposed
added. Secretary means the Secretary of order as needed. References to CDC § 70.19 Penalties has been moved to
Health and Human Services (HHS) or have been replaced with Director § 70.18, since proposed § 70.18
any other officer or employee of that throughout this section. Agreements has been removed from this
Department to whom the authority final rule.
F. Mandatory Reassessment of a Federal
involved has been delegated. We note L. Public Health Prevention Measures
Order for Quarantine, Isolation, or
that while the NPRM did not propose To Detect Communicable Disease
Conditional Release (§§ 70.15 and
this definition, the NPRM referenced the (§§ 70.10 and 71.20)
71.38)
Secretary in defining Public Health
Emergency. Thus, HHS/CDC considers it These provisions have been modified Paragraph (b) has been modified to
useful to also define the term Secretary. to include paragraph (g) which states include ‘‘known or possible exposure’’
that the Director shall arrange for information to the list of information
C. Apprehension and Detention of translation or interpretation services of that may be collected. References to
Persons With Quarantinable the Federal order as needed. References CDC have been replaced with Director
Communicable Diseases (Section 70.6) to CDC have been replaced with throughout this section.
This provision is has been finalized as Director throughout this section. M. Requirements Relating to Travelers
proposed, with the exception that Under a Federal Order of Isolation,
G. Medical Review of a Federal Order
references to CDC have been replaced Quarantine, or Conditional Release
for Quarantine, Isolation, or Conditional
with Director throughout this section. (Section 70.5)
Release (§§ 70.16 and 71.39)
HHS/CDC has also added a requirement
that the Director arrange for adequate Paragraph (f) of these provisions has Paragraph (a), (a)(4), (b)(1), (b)(2), and
food and water, appropriate been modified to reference (c) of this provision have been modified
accommodation, appropriate medical ‘‘Representatives,’’ consistent with the to remove ‘‘agreements.’’ Paragraph (d)
treatment, and means of necessary change in definition. Paragraph (f) of has been modified to add ‘‘to
communication, for individuals who are these provisions has also been modified individuals traveling entirely intrastate
apprehended or held in quarantine or to remove, ‘‘and cannot afford a medical and to conveyances that may transport
isolation. Similar language has been representative’’ because this language is such individuals.’’ The language in
added to an analogous provision at duplicative and unnecessary if the paragraph (d) was discussed in the
Section 71.33(a). individual has already qualified as NPRM at 81 FR 54243 and public
indigent. Paragraph (k) of these comment concerning intrastate
mstockstill on DSK3G9T082PROD with RULES3

D. Medical Examinations (Sections provisions has been modified to state: application of this provision was
70.12 and 71.36) ‘‘The medical review shall be conducted explicitly solicited. The language,
These provisions are finalized as by telephone, audio or video however, was inadvertently omitted
proposed, with the exception that conference, or through other means that from the regulatory text. References to
references to CDC have been replaced the medical reviewer determines in his/ CDC have also been replaced with
with Director throughout this section. her discretion are practicable for Director throughout this section. In
HHS/CDC has also added a requirement allowing the individual under response to public comments, HHS/CDC

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6894 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

has included a requirement that the medical treatment. In keeping with A. Provisions Applicable to Both Parts
Director respond to a request for a travel current practice, HHS/CDC will 70 and 71
permit within five (5) business days and continue to recommend care and a. General Comments
to an appeal under this section within treatment, including post-exposure
three (3) business days. Public prophylaxis when indicated, to Since posting the proposed regulation
comments concerning this provision are individuals who are either sick with or on August 15, 2016, HHS/CDC received
addressed below. 15,800 public comments. HHS/CDC
at risk of disease following exposure to
received several comments from
N. Report of Death or Illness Onboard a communicable disease of public individuals, groups, or industry
Aircraft Operated by an Airline (§ 70.11) health concern. requesting to extend the 60-day
This provision has been finalized as HHS/CDC also received comments comment period. In light of the number
proposed, with the exception that relating to immigration policy and of comments submitted, HHS/CDC has
references to CDC have been replaced regulations, issues of citizenship, border determined that a 60-day comment
with Director throughout this section. security, religion, personal testimony period was both fair and sufficient to
regarding adverse vaccine events, and adequately inform the public of the
O. Requirements Relating to contents of this rulemaking, allow the
requests to apply these regulations only
Transmission of Airline and Vessel public to carefully consider the
to individuals who are not citizens of
Passenger, Crew, and Flight and Voyage rulemaking, and receive informed
the United States. These comments are
Information for Public Health Purposes public feedback. Thus, HHS/CDC
(§ 71.4 and 71.5) beyond the scope of this final rule and
have not been included in this declines to reopen the comment period.
These provisions have been finalized discussion. However, HHS/CDC notes Several commenters requested that
as proposed, with the exception that the HHS/CDC withdraw the NPRM in its
that it will continue to apply
title has been modified to remove entirety. A non-profit organization
communicable disease control and
references to collection and storage of stated that the ‘‘NPRM would be, if
prevention measures uniformly to all adopted, a direct and onerous
information to more accurately reflect individuals in the United States,
the requirements under this section and infringement of the personal liberties of
regardless of citizenship, religion, race, Americans and an unnecessary
references to CDC have been replaced
or country of residency. aggressive method of assisting in the
with Director throughout this section.
HHS/CDC also received public control of communicable disease.’’
P. Suspension of Entry of Animals, comment regarding disinsection (i.e., Another commenter said that the
Articles, or Things From Designated measures to control or kill insect vectors ‘‘NPRM is premature.’’ HHS/CDC
Foreign Countries and Places Into the of disease) and fumigation procedures, disagrees and declines to withdraw the
United States (§ 71.63) citing HHS/CDC’s statutory authorities proposal in its entirety because it
This provision has been finalized as relating to inspection, fumigation, and contains important measures that will
proposed with the exception that pest extermination. We note that while aid the public health response to
references to CDC have been replaced HHS/CDC maintains regulations at 42 prevent the introduction, transmission,
with Director throughout this section. CFR 70.2 and 71.32(b) implementing and spread of communicable diseases
this statutory authority, such comments into and within the United States.
Q. Report of Death or Illness (§ 71.21) Moreover, in the spirit of transparency,
are outside of the scope of this final
The title of this provision has been rule, which did not include proposed these measures, which are largely
finalized as proposed, to remove the current practice, are being published
changes to these regulatory provisions.
word ‘‘Radio.’’ and codified to make the public aware
The following is a discussion of of their use.
V. Overview of Public Comments to the public comments received that are HHS/CDC received a comment from a
2016 NPRM applicable and within the scope of the partnership of public health legal
On August 15, 2016 HHS/CDC regulation. Topics including: scholars and organizations stating that it
published a Notice of Proposed Accountability, Administrative Records, should promulgate a separate rule
Rulemaking proposing to amend the Agreements, Apprehension, Authority guaranteeing humane conditions of
current interstate (domestic) and foreign (including Scope), Conditional Release, confinement. HHS/CDC disagrees that
quarantine regulations for the control of Constitutional Issues (including such a separate rule is needed and
communicable diseases. The NPRM Amendments, Court Cases, and Habeas believes that the current final rule
included a 60-day public comment Corpus), Data Collection, Definitions, adequately addresses these concerns, as
period and during this time, HHS/CDC Detention, Due Process, Economic discussed in detail below.
received 15,800 comments from Impact, Electronic Monitoring, HHS/CDC received a comment that
individuals, groups, organizations, Exposure, Informed Consent, Least the proposed rule does not comply with
industry, and unions. Comments were Restrictive Means, Minors, Medical Executive Order 12866 because there is
both in support of and in opposition to Assessments, Examination, Notice, no public need for the rule and it did
the regulation. Many public comments Penalties, Privacy, Qualifying Stage, not adequately assess the costs and
expressed concern that these updated Quarantine, Quarantinable benefits of the rule, including the
regulations sought to compel medical alternative of not regulating. HHS/CDC
Communicable Diseases List, and others
treatment or vaccination without patient disagrees. As discussed in detail below,
are discussed.
consent. One association stated its this rule describes the public health
mstockstill on DSK3G9T082PROD with RULES3

strong objection ‘‘to the coercive A summary of comments and a measures that may be used in response
imposition of treatment, including response to those comments are found to outbreaks of communicable diseases,
vaccination, without the genuine below, organized by general and specific such as the recent largest recorded
consent of the patient.’’ comments that apply to both parts 70 outbreak of Ebola. The economic impact
HHS/CDC begins this section by and 71, comments that only apply to analysis has been clarified to more
stating that these regulations do not part 70 (interstate), and comments that clearly differentiate quarantinable and
compel vaccination or involuntary only apply to part 71 (foreign). non-quarantinable diseases. The

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6895

economic impact analysis also examines disease. This case demonstrated that the • The risk assessment at the limited
the costs and benefits of the Final Rule processes then in place to prevent ports of entry provided an important
measured against current practices (i.e., departure of individuals exposed to or opportunity for HHS/CDC to stratify the
a status quo baseline). Both the costs infected with Ebola in affected West risk of developing Ebola for every
and benefits of this Final Rule are small African countries could not detect individual who entered from the
because the provisions set forth are persons who were exposed but were affected countries. It allowed HHS/CDC
primarily a codification of current unaware of or denied such exposure and to work with State and local health
practices, based on existing regulatory were potentially incubating the departments in implementing the least
authorities. infection. To further reduce the risk of restrictive means of monitoring
A public health research center introduction and spread, HHS/CDC individuals for development of
commented that there is no evidence recommended monitoring of all symptoms. HHS/CDC notes that there
that measures employed at points of potentially exposed individuals by a were no Federal quarantine orders
entry were effective during the response public health authority through the 21- issued because of the availability of
to the 2014–2016 Ebola outbreak and day risk period after potential exposure, monitoring options provided by State
that HHS/CDC is attempting to codify rather than relying on previously and local authorities under the Interim
these ineffective practices for use in recommended self-monitoring. U.S. Guidance for Monitoring and
future disease outbreaks. They further Monitoring was viewed as the least Movement of Persons with Potential
noted that despite greater than 99% restrictive alternative to widespread Ebola Virus Exposure.
complete monitoring, zero cases of quarantine and travel bans demanded • The encounter also provided an
Ebola were detected among those by some members of the public that opportunity to provide travelers with
monitored. HHS/CDC appreciates this would ultimately have hampered the educational materials, orientate them to
comment and recognizes the challenges response efforts in West Africa and the monitoring program (Check and
presented by measuring the benefits of domestically. HHS/CDC, along with its Report Ebola (CARE)), and facilitate
prevention in public health. Federal and State partners, reporting of the traveler’s health status
HHS/CDC disagrees that the measures implemented an entry process by which to State and local health departments.
employed in response to the 2014–16 individuals identified as having recently The enhanced entry risk assessment
Ebola outbreak were ineffective and that traveled to, from, or through an affected and monitoring process described above
it is seeking to codify ineffective country entered through five ports of was developed in response to the
measures. HHS/CDC considers more entry where public health staff and epidemiological profile of Ebola and the
than 99% complete monitoring a partners were stationed, submitted complexities of a 21-day incubation
successful effort in State and Federal accurate and complete contact period. However, in the event of an
cooperation in response to an outbreak of a different communicable
information, were checked for
unprecedented outbreak of Ebola. disease requiring enhanced assessment
symptoms, and were provided answers
Second, rather than the number of cases or monitoring of travelers (whether
to Ebola risk assessment questions.
detected, HHS/CDC considers the key quarantinable or non-quarantinable),
metrics of effectiveness to be the This was done for several reasons: HHS/CDC, in concert with Federal and
number of people who were able to • To ensure that any individual State partners, may implement a
continue to travel safely without fear of entering the United States who could different system of risk assessment and
disease spread and the ability to have been exposed to or infected with monitoring. HHS/CDC would tailor the
facilitate rapid isolation and evaluation Ebola in a country experiencing an program in accordance with the
of the approximately 1400 individuals Ebola outbreak was identified and scientific evidence of the situation and
who developed illness compatible with reported to the State and local health the utility and feasibility of the program
Ebola during the 21-day monitoring department of final destination so that, given the availability of resources.
period. Finally, we note that this if the individual became ill, State or The same public health research
commenter limited his or her statement local health departments could rapidly center commented that employing non-
to HHS/CDC measures put into place at notify healthcare providers prior to the evidence-based measures is contrary to
U.S. ports of entry during the Ebola individual’s arriving at a hospital. This the United States’ international legal
response. process was designed specifically to agreements, specifically mentioning the
The enhanced public health risk prevent unknowing individuals from public health measures implemented
assessment protocol put into place at exposing others such as occurred in during the response to Ebola as they
U.S. ports of entry in response to the Texas when a patient exposed two pertain to the International Health
Ebola outbreak was one part of a layered healthcare workers. Regulations (IHR 2005). The commenter
risk mitigation program to prevent the • While HHS/CDC acknowledges that further stated that given the absence of
importation and spread of Ebola within a public health worker may be unlikely evidence to support the use of travel
the United States, which included exit to encounter someone with symptoms at monitoring and quarantine, HHS/CDC
screening in the affected countries as the moment of entry because of the 21- should proceed cautiously before
recommended by the World Health day incubation period, individuals employing these measures in the future.
Organization (WHO) (see Statement on coming from the outbreak countries Having addressed the commenter’s
the 1st meeting of the International frequently traveled for well over 24 concern regarding the evidence of the
Health Regulations [IHR] Emergency hours and in many cases had itineraries effectiveness of public health measures
Committee on the 2014 Ebola outbreak that involved interstate movement at ports of entry above, HHS/CDC
in West Africa 8/8/2014) and a reliance within the United States. The odds of concurs with the commenter that the
mstockstill on DSK3G9T082PROD with RULES3

on air industry partners for detection developing symptoms during that travel, use of quarantine and travel restrictions,
and reporting of potentially ill travelers and potential onward travel, were in the absence of evidence of their
prior to arrival. considered non-trivial, and public utility, is detrimental to efforts to
The enhanced entry risk assessment health measures to detect symptoms combat the spread of communicable
process was instituted after an upon entry were considered warranted disease. However, HHS/CDC disagrees
individual infected with Ebola entered given the serious morbidity and costs that it used non-evidence based
the United States and transmitted the associated with Ebola. measures in contravention of the IHR.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6896 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

To the contrary, HHS/CDC used the best places the onus on those considering a regulations were not more widely
available science and risk assessment potentially harmful action, such as disseminated through media outlets. In
procedures in designing a port of entry drilling or mining near a watershed, to response, HHS/CDC notes that Federal
risk assessment and management prove its safety in advance. The courts have long recognized that
program that took into account available principle may be used by policy makers publication in the Federal Register is
resources, circumstances in the to justify discretionary decisions in legally sufficient for giving affected
countries with Ebola outbreaks, and situations where there is the possibility persons notice of proposed rulemaking.
principles of least restrictive means to of harm from making a certain decision See Federal Crop Ins. Corp. v. Merrill,
successfully ensure that measures to ban (e.g. taking a particular course of action) 332 U.S. 380, 385 (1947) (‘‘Congress has
travel between the United States and the when extensive scientific knowledge on provided that the appearance of rules
affected countries were unnecessary. the matter is lacking. and regulations in the Federal Register
These measures would have negatively HHS/CDC disagrees that this gives legal notice of their contents.’’).
impacted the efforts to combat Ebola in regulation will have harmful effect or The Federal Register, within the
the region and would have had dramatic that these measures lack a scientific National Archives and Records
negative implications for travelers and basis for protecting public health. In Administration, is the official
industry. fact, as described above regarding the publication for all Federal agency rules,
Furthermore, the measures did not response efforts to the 2014–2016 Ebola proposed rules, and notices of Federal
unduly affect travel or trade beyond the response, HHS/CDC has successfully agencies and organizations, as well as
voluntary changes made by industry employed the measures outlined in this for Executive Orders and certain other
and travelers. HHS/CDC believes that regulation for many years. Again, the presidential documents. Individuals
CDC’s entry risk assessment and provisions outlined through this interested in obtaining more
management program was appropriate, regulation are not new practices, nor information regarding HHS/CDC’s
commensurate with the risk, and new authorities, but a codification of regulatory processes, including input
consistent with the following WHO HHS/CDC practice to protect public provided by persons and organizations,
recommendation: ‘‘[Member] States health. may examine the regulatory docket or
should be prepared to detect, One commenter suggested that submit a request through the Freedom of
investigate, and manage Ebola cases; education on healthy practices would be Information Act.
this should include assured access to a more effective than regulatory
provisions. Another commenter stated HHS/CDC received a comment stating
qualified diagnostic laboratory for Ebola
and, where appropriate, the capacity to that our immune systems would ward that HHS/CDC should, by regulation,
manage travelers originating from off communicable disease if we provide sufficient public health
known Ebola-infected areas who arrive encourage clean water, adequate shelter, justification for screening practices to
at international airports or major land effective sewage treatment, and support its proposed public health
crossing points with unexplained febrile nutritious food. HHS/CDC agrees that prevention measures at ports of entry.
illness.’’ WHO Statement on the 1st these necessities are important to public While HHS/CDC agrees that it should
meeting of the IHR Emergency health, and we rely on health provide sufficient public health
Committee on the 2014 Ebola outbreak communication often to educate the justification for large-scale screening
in West Africa (Aug. 8, 2014). Travelers public on how to protect themselves practices, HHS/CDC disagrees that this
were assessed for risk on an individual and others from certain communicable justification should be formalized in
basis upon entry; and any individual diseases. For example, HHS/CDC regulations. During the 2014–2016 Ebola
who met the pre-defined symptom routinely advises people with seasonal epidemic, HHS/CDC issued Interim U.S.
threshold (based on exposure level) was influenza to stay home from work and Guidance for Monitoring and Movement
medically evaluated and referred to care school, to cover their coughs and of Persons with Potential Ebola Virus
as needed. No Federal quarantine orders sneezes, and to wash their hands. HHS/ Exposure to assist HHS/CDC staff and
were issued for the duration of the CDC also works with State, local, and public health partners engaged in the
response because HHS/CDC in airport authorities in posting health response. The guidance provided public
coordination with State and local public education materials for the public. health authorities and partners with
health authorities was able to tailor its However, in certain circumstances, recommendations for monitoring people
interventions to allow onward travel. when a communicable disease poses a potentially exposed to Ebola and for
Future outbreaks may necessitate a severe health threat to others, additional evaluating their intended travel,
different combination of public health measures may be needed to protect the including the application of movement
measures at ports of entry. In those public’s health. This is particularly restrictions when necessary. From
circumstances, HHS/CDC will use the important in situations when the August 2014–December 2015, the
best available science to assess the risk infectious individual has disregarded guidance was accessed online
of importation and spread within the public health recommendations by, for approximately 334,000 times, with more
United States. example, refusing to take prescribed than 88,000 views during the first 4
One commenter suggested that if medications to treat infectious days after the October 2014 update that
HHS/CDC were to apply the tuberculosis or traveling while added recommendations for active
‘‘Precautionary Principle,’’ it would not infectious. In such situations, it may be monitoring and clarified travel and
promulgate these regulations. HHS/CDC necessary to use public health movement restriction recommendations.
notes first that the ‘‘precautionary authorities to require the individual to Updates to the guidance to
principle,’’ often described as the remain in isolation or to prevent travel accommodate new information and
mstockstill on DSK3G9T082PROD with RULES3

avoidance of harm when there is to protect the public’s health. changes in the outbreak situation
scientific uncertainty about risks, HHS/CDC received a few comments continued through 2015. The guidance
originated in environmental contexts suggesting that publication of the NPRM was retired on February 19, 2016, when
and remains largely associated with in the Federal Register was not more than 45 days had passed since
environmental issues. Invoking the sufficient to inform the public of these Guinea was declared free of Ebola virus
precautionary principle in an proposed updates. One comment transmission, signaling widespread
environmental context, for instance, questioned why the proposed human-to-human transmission in the

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6897

affected countries was at an end. ensure infected U.S. citizens seeking to counsel hired by the minor’s parent or
Formalizing this guidance in regulation return to the U.S. do so in a manner that legal guardian. As explained further
would have deprived HHS/CDC of the does not place the public at risk. below, HHS/CDC will appoint
needed flexibility to respond to public A few commenters expressed concern, representatives, including a medical
health events as they occurred, would as parents or guardians, about their representative and an attorney, if the
have proved administratively rights with respect to children or individual (including a minor’s parent
burdensome and unnecessary, and minors. Specifically, these commenters or legal guardian) is indigent and
would have potentially delayed wondered whether children/minors requests a medical review. HHS/CDC
prevention measures therefore resulting would be separated from parents/ clarifies, however, that the public health
in a less effective response. HHS/CDC guardians during a public health risk measures included in this final rule,
will consider the need for similar assessment. HHS/CDC thanks the including apprehension, examination,
guidance during future outbreaks taking commenters for these questions and quarantine, and isolation, do not require
into account the extent of the outbreak appreciates the opportunity to respond. a parent or legal guardian’s consent as
and the risk of importation and spread In response, HHS/CDC notes that these a prerequisite to their application.
of disease into the United States. regulations do not limit the rights that However, in response to concerns about
HHS/CDC received several comments parents or guardians may have over informed consent, HHS/CDC has added
suggesting that the proposed regulations minor children, including the right to regulatory language requiring that the
were not written in plain language and make medical decisions. Director advise the individual that if a
were therefore difficult to understand. Notwithstanding, children are included medical examination is required as part
One commenter also noted errors in the in the definition of ‘‘individuals’’ as of a Federal order that the examination
document such as hyperlinks, used in these regulations and thus will be conducted by an authorized and
references, and footnotes. This minor children may be subject to licensed health worker with prior
commenter also reviewed the NPRM for apprehension, detention, examination, informed consent.
inconsistencies, conflicts, missing and conditional release for
definitions, misleading language, and quarantinable communicable diseases to b. Scope and Authority
ambiguities. HHS/CDC thanks these the same extent as adults. In such rare HHS/CDC received comments from
commenters for the input. We have circumstances, HHS/CDC will work the public questioning whether HHS/
developed communication materials with the child’s parent or guardian to CDC is a part of the Federal government
and published them to our Web site to ensure that the rights accorded to any and has the authority to propose and
help facilitate the review and individual subject to Federal isolation promulgate regulations, or whether the
comprehension of these documents. or quarantine, such as the opportunity Agency is a private entity. The
Interested persons should see http:// for an administrative medical review, ‘‘Communicable Disease Center’’
www.cdc.gov/quarantine/notice- are adequately protected. became part of the U.S. Public Health
proposed-rulemaking-control- In addition, and in keeping with Service on July 1, 1946 and is an
communicable-diseases.html. standard public health practice, parents Agency within the U.S. Department of
One commenter opposed the rule or guardians while in the presence of Health and Human Services. For more
because of a perceived negative social infected minor children may be required information on the history of CDC,
impact upon individuals placed under a to adhere to infection control please see http://www.cdc.gov/museum/
public health order. We respond that precautions for their own protection. timeline/index.html.
one compelling reason for the Such protections may include wearing HHS/CDC received numerous
publication of this final rule is to make personal protective equipment (such as comments from the public seeking
the public aware of these measures so a mask) while in close proximity to the clarity on the scope of authority the
that the words, purposes, and meanings child/minor to avoid further Agency has to take actions described in
of ‘‘quarantine’’ and ‘‘isolation’’ become transmission of the illness. In extremely this regulation. Specifically, HHS/CDC
more familiar and less likely to cause rare circumstances, such as a child received comments questioning whether
public anxiety and stigmatization. infected with Ebola, the risk may be too the authority to detain an individual
HHS/CDC received comments great to allow a parent to remain with may be exercised by a Federal agency of
suggesting that, to best prevent the a child; however, every effort will be government, instead of the U.S.
introduction of communicable diseases made to facilitate communication President or Congress. Several
into the U.S., individuals who travel to between a parent and a minor child commenters specifically questioned
or originate in countries with high risk through the least restrictive means, for whether the wording of the regulation
of communicable disease should not be example, through the use of technology. was too ‘‘general’’ and expressed
allowed to enter (or return to) the One commenter asked about HHS/ concern over its potential for abuse. A
United States. On March 27, 2015, HHS/ CDC obtaining the consent of a parent public health organization
CDC published a Notice in the Federal or legal guardian prior to the medical recommended that HHS/CDC’s
Register titled Criteria for examination, quarantine, or treatment of authority should be limited only to
Recommending Federal Travel minors. We respond that HHS/CDC will those diseases listed by Executive Order
Restrictions for Public Health Purposes, adhere to all applicable laws regarding as quarantinable communicable
Including for Viral Hemorrhagic Fevers. the medical examination or treatment of diseases. An association suggested that
See 80 FR 16400 (Mar. 27, 2015). The minors. If minors are traveling the proposed rule would vastly increase
Notice describes the tools the Federal unaccompanied by a parent or legal the authority of HHS/CDC. One
government has to ensure that people guardian and are believed to be infected individual stated that this regulation is
mstockstill on DSK3G9T082PROD with RULES3

who pose a public health risk do not with or exposed to a quarantinable an attempt by HHS/CDC to evade
board flights or enter the United States communicable disease, HHS/CDC will Congress. One organization speculated
without a public health evaluation. See use its best efforts to contact a parent or that HHS/CDC plans to request that the
80 FR 16400 (Mar. 27, 2015). It is the guardian to obtain consent prior to list of quarantinable communicable
policy of HHS/CDC to work with the medical examination. In addition, HHS/ diseases be expanded ‘‘to include
Department of State, and any other CDC will not restrict a minor’s ability to measles and other vaccine targeted
relevant Federal and State agencies to communicate with family or legal diseases for the purpose of

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6898 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

apprehending and quarantining from other countries as well as spread consideration of the proposal as well as
travelers entering the US or traveling of communicable disease between States the input provided.
between States, who have not been and between States and territories. First, we note that HHS/CDC only has
vaccinated with MMR (measles-mumps- Thus, HHS/CDC’s and States’ authority to quarantine or isolate
rubella vaccine) and other Federally authorities together create a individuals who have illnesses that are
recommended vaccines.’’ comprehensive system to protect the listed by Executive Order of the
In response, HHS/CDC first notes that public from communicable disease President as quarantinable
it cannot—and will not—act beyond the threats including in situations such as communicable diseases. HHS/CDC does
scope of authority granted by Congress interstate travel when a single State’s not have the ability or authority to
in statute; HHS/CDC offers the following authorities may be inadequate to unilaterally modify the list of
clarifications. Under section 361(a) of address the communicable disease quarantinable communicable diseases.
the Public Health Service Act (42 U.S.C. threat. Second, because HHS/CDC also has
264(a)), the HHS Secretary is authorized Several commenters suggested that statutory authority to prevent the
to make and enforce regulations as in HHS/CDC has the authority to ‘‘introduction, transmission, and
the Secretary’s judgment are necessary unilaterally change or update the list of spread’’ of communicable diseases,
to prevent the introduction, quarantinable communicable diseases. HHS/CDC may take actions other than
transmission, or spread of all Other commenters requested that the quarantine or isolation to protect the
communicable diseases from foreign list be narrowed to only those diseases public’s health. These other actions may
countries into the States or possessions with a ‘‘high mortality rate.’’ HHS/CDC include contact tracing investigations to
of the United States and from one State reemphasizes that, as prescribed by notify individuals to seek proper
or possession into any other State or statute, the list of quarantinable treatment if they have been exposed to
possession. Under section 361(b)(42 communicable diseases may only be a communicable disease, even if the
U.S.C. 264(b)), the authority to issue changed by Executive Order of the disease is not listed by Executive Order
regulations authorizing the President and that such suggestions are as quarantinable. HHS/CDC does not
apprehension, examination, detention, beyond the scope of this final rule. seek to compel vaccination or medical
and conditional release of individuals is HHS/CDC received several comments treatment. In keeping with current
limited to those communicable diseases on the Agency’s accountability system, practice, HHS/CDC recommends certain
specified in an Executive Order of the encouraging that a ‘‘strong system of vaccines for post-exposure prophylaxis
President, i.e., ‘‘quarantinable and individuals may choose to follow
checks and balances’’ should be in place
communicable diseases.’’ The authority these recommendations as they deem
for this regulation to be implemented.
for carrying out these regulations has appropriate.
HHS/CDC agrees that there should be Other commenters questioned why
been delegated from the HHS Secretary
accountability and oversight regarding diseases such as Ebola, measles, and
to the CDC Director, who in turn
the agency’s activities. We note that Zika—three very different diseases with
delegated these authorities to HHS/
these regulations do not affect the three very different effects on
CDC’s Division of Global Migration &
ability of Congress to conduct its individuals—are used to support the
Quarantine (DGMQ). These
oversight activities or affect the same regulatory provisions. One
quarantinable communicable diseases
jurisdiction of federal courts to review organization quoted the NPRM, citing
are currently limited to cholera,
federal agency actions under the correctly that while measles is not a
diphtheria, infectious tuberculosis (TB),
plague, smallpox, yellow fever, and Administrative Procedure Act (5 U.S.C. quarantinable communicable disease, it
viral hemorrhagic fevers (such as 704). was used in the NPRM to support the
Marburg, Ebola, Lassa fever, and HHS/CDC received a comment that need for this updated regulation. HHS/
Crimean-Congo), severe acute there is no court supervision of HHS/ CDC welcomes the opportunity to
respiratory syndromes, and influenza CDC activities. We disagree. These provide further clarification.
caused by novel or re-emergent regulations do not affect the jurisdiction The proposed rule provides HHS/CDC
influenza viruses that are causing or of the Federal courts or the statutory with a number of options for public
have the potential to cause a pandemic. rights of individuals to obtain judicial health interventions based on a public
See Executive Order 13295 (April 4, review of CDC’s actions and decisions health risk assessment of the
2003), as amended by Executive Order through appropriate mechanisms such communicable disease in question and
13375 (April 1, 2005) and Executive as the habeas corpus statute (28 U.S.C. the situation at hand. These
Order 13674 (July 31, 2014). Changes to 2241) or the Administrative Procedure interventions could include conducting
the list of quarantinable communicable Act (5 U.S.C. 704). a contact investigation on an airplane or
diseases are beyond the scope of this Some commenters questioned the vessel if a person with a serious
regulation. And again, we reemphasize need for HHS/CDC to use its authorities communicable disease was known to
that HHS/CDC does not intend, through if the threat of death is minimal have traveled on the airplane or vessel.
these regulations, to mandate compared with the size of the These contact investigations are similar
vaccination or compulsory medical population, listing illnesses such as to those conducted by health
treatment of individuals. chickenpox, pertussis, Zika, the departments in community settings. In
One commenter supported the common cold and flu, and leprosy. One addition to these interventions, for the
international proposals (part 71), but organization suggested that, through the nine communicable diseases currently
urged HHS/CDC to remove the domestic language of the NPRM, HHS/CDC was designated by Executive Order as
portion (part 70) of this regulation. We ‘‘equating’’ non-quarantinable diseases quarantinable communicable diseases,
mstockstill on DSK3G9T082PROD with RULES3

disagree. HHS/CDC’s authorities apply with quarantinable diseases. Another HHS/CDC may apprehend, detain,
to all travelers in the United States, commenter suggested that HHS/CDC’s examine, quarantine, isolate, or
regardless of citizenship or residency, authority to act should be based on the conditionally release individuals for
and are intended to complement State mortality of the illness, rather than purposes of preventing communicable
authorities within their jurisdictions by whether or not it appears on the list of disease spread. Ebola and infectious
providing a mechanism to prevent quarantinable communicable diseases. tuberculosis are examples of
importation of communicable disease HHS/CDC thanks the commenters for quarantinable communicable diseases.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6899

HHS/CDC also provides the public 80 FR 16,400 (Mar. 27, 2015)(describing procedures, these regulations improve
with recommendations to address other air travel restrictions that may be the public’s awareness and
communicable diseases of public health applicable to a passenger who would understanding of HHS/CDC’s activities
concern. Zika is a good example of a represent a threat to public health). to protect the public’s health.
disease of public health concern HHS/CDC believes that requesting One commenter expressed concerns
because of the ways it can be spread, that DHS restrict the air travel of about religious exemptions for
e.g., through mosquitoes, sexual persons with measles is warranted mandatory vaccination or treatment. In
transmission, and maternal-fetal because measles is a serious and highly response, HHS/CDC notes that these
transmission. Therefore, HHS/CDC has contagious communicable disease that regulations do not authorize compulsory
recommended avoiding mosquito bites, would pose a public health threat vaccinations or medical treatment.
protecting against sexual transmission, during travel. People exposed to While HHS/CDC will implement these
and for pregnant women to avoid travel measles who are not immune to the regulations in a manner consistent with
to areas where Zika is spreading. infection and have not been vaccinated respecting the religious rights of
Another example is seasonal influenza, following the exposure are advised to individuals, religion is not a basis for
which is very contagious but also very delay their travel voluntarily until they exempting individuals from the
common; therefore, HHS/CDC makes are no longer at risk of becoming provisions of these regulations,
recommendations for people sick with infectious. including those provisions relating to
flu-like symptoms to stay home from A number of commenters suggested quarantine and isolation.
work or school and take basic that the proposed regulations are One commenter raised similar
precautions such as covering their unconstitutional or in violation of the concerns that the regulations may lead
coughs and sneezes and washing their ‘‘Nuremberg Code,’’ the United Nations to apprehensions based on factors
hands. In all situations, HHS/CDC Educational, Scientific and Cultural unrelated to public health such as
considers how common and severe the Organization (UNESCO), the Universal wearing of religious garb or reading of
communicable disease is, how it is Declaration on Bioethics and Human certain newspapers. HHS/CDC agrees
transmitted, and what interventions are Rights, the Geneva Convention, human that public health actions should not be
available and appropriate before making rights in general, and/or civil liberties in taken based on factors unrelated to
recommendations or taking action to general because they ostensibly protecting the public’s health and these
protect the health of the public. authorize compulsory medical treatment regulations do not authorize such
One commenter questioned why without informed consent. Commenters actions. Additionally, these regulations
HHS/CDC was not able to currently also cited numerous Supreme Court strike the appropriate balance between
control all communicable diseases, cases purportedly in support of these individual liberties and public health
specifically leprosy. While HHS/CDC claims, such as Mills v. Rogers, 457 U.S. protection.
works regularly and continuously with 291 (1982), (curtailing the involuntary Several commenters questioned
other Federal, State, local and tribal administration of anti-psychotic drugs whether quarantine and isolation may
health departments to eliminate the to mental patients); Vacco v. Quill, 521 be carried out consistent with the
introduction, transmission and spread U.S. 793 (1997) (constitutionality of an Fourth Amendment to the U.S.
of all communicable disease, outbreaks assisted suicide ban); Washington v. Constitution. One commenter also
can and do still occur. HHS/CDC staff Harper, 494 U.S. 210 (1990) suggested that implementation of public
have experienced first-hand the impact (involuntary administration of anti- health prevention measures at airports
of globalization on public health. The psychotic drugs to prison inmates); Sell would lead to ‘‘unreasonable searches
rapid speed and tremendous volume of v. United States, 539 U.S. 166 and seizures’’ under the Fourth
international and transcontinental (2003)(upholding certain strict due Amendment. HHS/CDC disagrees with
travel, commerce, and human migration process protections before any these assertions. The Fourth
enable microbial threats to disperse involuntary administration of anti- Amendment protects the rights of
worldwide in 24 hours—less time than psychotic drugs to incarcerated persons to be free in their persons,
the incubation period of most prisoners can be made); and Canterbury houses, papers, and effects, against
communicable diseases. These and v. Spence, 409 U.S. 1064 (1972)(duty of unreasonable government searches and
other forces intrinsic to modern doctors to obtain informed consent). seizures. HHS/CDC notes that at ports of
technology and ways of life favor the HHS/CDC disagrees and re-asserts that entry, routine apprehensions and
emergence of new communicable this final rule does not authorize examinations related to quarantine and
diseases and the reemergence or compulsory medical treatment, isolation may fall under the border-
increased transmission of known including compulsory vaccination, search doctrine, which provides that, in
communicable diseases. without informed consent. general, searches conducted by CBP
HHS/CDC received many comments These regulations do not violate or officers at the border are not subject to
regarding measles and the need to apply take away any recognized rights the requirements of first establishing
public health measures to prevent the guaranteed by the U.S. Constitution or probable cause or obtaining a warrant.
transmission and spread of the disease. applicable international agreements. See United States v. Roberts, 274 F.3d
We note also that while measles may be While HHS/CDC has successfully 1007, 1011 (5th Cir. 2001); see also
transmissible during travel, it is not one responded to outbreaks of United States v. Bravo, 295 F.3d 1002,
of the quarantinable communicable communicable diseases, such as Ebola, 1006 (9th Cir. 2002) (noting that only in
diseases listed by Executive Order of the these regulations will improve HHS/ circumstances involving extended
President. Therefore, while HHS/CDC CDC’s future ability to prevent the detentions or intrusive medical
mstockstill on DSK3G9T082PROD with RULES3

may recommend post-exposure introduction, transmission, and spread examinations have courts required that
prophylaxis, or other ways to manage of communicable diseases, through such border searches be premised upon
and prevent spread, we do not have the mechanisms as improved reporting of reasonable suspicion). Similarly,
authority to apprehend, examine, illnesses and public health prevention apprehensions and examination of
detain, or conditionally release measures at airports. While many of persons traveling interstate under this
individuals who may have measles, nor these activities have been carried out in rule are authorized under the special-
those who may have been exposed. See the past through internal operating needs doctrine articulated by the

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6900 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

Supreme Court in Skinner v. Railway in the Fifth Amendment to the U.S. primary authority for quarantine and
Labor Executives’ Ass’n, 489 U.S. 602 Constitution. Specifically, procedural isolation within their borders, the
(1989) because of the ‘‘special need’’ in safeguards contained in the final rule Federal government has an important
preventing communicable disease include: (1) A requirement for written and longstanding role in preventing
spread. Furthermore, to the extent that orders of quarantine, isolation, or communicable disease spread at ports of
‘‘probable cause,’’ rather than ‘‘special conditional release, including entry and interstate. This authority is
needs,’’ would be the applicable Fourth translation or interpretation services as reflected in 42 U.S.C. 264 and consistent
Amendment standard, HHS/CDC needed; (2) mandatory review of the with principles of Federalism.
contends that meeting the requirements Federal order after the first 72 hours; (3) HHS/CDC received one comment
of 42 U.S.C. 264 satisfies this standard. notifying individuals through the stating that it should conduct a
See Villanova v. Abrams, 972 F.2d 792, written order of their right to request a Federalism analysis because
795 (7th Cir.1992)(noting that probable medical review; (4) an opportunity at implementing the rule will require
cause for emergency civil commitment the medical review for the detained working with State health officials and
exists where ‘‘there are reasonable individual to be heard through an resources. Under Executive Order
grounds for believing that the person attorney or other advocate hired at their 13132, a Federalism analysis is required
seized is subject to the governing legal own expense, present experts or other if a rulemaking has federalism
standard.’’). HHS/CDC further witnesses, submit documentary or other implications, would limit or preempt
acknowledges that any searches and evidence; and confront and cross- State or local law, or imposes
seizures of individuals must be examine any government witnesses; (5) substantial direct compliance costs on
reasonable under the circumstances. a decision-maker independent of those State or local governments. Under such
HHS/CDC reiterates that this final rule who authorized the original isolation, circumstances, a Federal agency must
does not authorize compulsory medical quarantine, or conditional release; (6) a consult with State and local officials.
treatment, including vaccination, written statement by the fact-finder of Federalism implications is defined as
without informed consent. the evidence relied upon and the having substantial direct effects on State
HHS/CDC received a comment citing reasons for the decision; (7) or local governments, on the
Missouri v. McNeely, where the U.S. appointment of representatives, relationship between the national
Supreme Court ruled that police must including a medical representative and government and the States, or on the
generally obtain a warrant before an attorney, if the individual is indigent distribution of power and
subjecting a drunken-driving suspect to and requests a medical review; and (8) responsibilities among the various
a blood test, and that the natural timely notice of the preceding rights. levels of government. Under 42 U.S.C.
metabolism of blood alcohol does not See Vitek v. Jones, 445 U.S. 480 (1980); 264(e), Federal public health regulations
establish a per se exigency that would Matthews v. Eldridge, 424 U.S. 319 do not preempt State or local public
justify a blood draw without consent. In (1976). health regulations, except in the event
response, HHS/CDC notes that courts HHS/CDC also received a comment of a conflict with the exercise of Federal
have recognized that while the that quarantine violates the guarantees authority. Other than to restate this
requirements for probable cause and a of substantive due process under the 5th statutory provision, this rulemaking
warrant generally apply in a criminal Amendment to the U.S. Constitution. does not alter the relationship between
context, these standards do not apply HHS/CDC disagrees. In addition to a the Federal government and State/local
when the government is conducting a guarantee of fair procedures, the U.S. governments as set forth in 42 U.S.C.
non-law enforcement related activity. Supreme Court has interpreted the Fifth 264. While HHS/CDC acknowledges that
See Nat’l Treasury Employees Union v. Amendment’s Due Process Clause as portions of this rule may involve HHS/
Von Raab, 489 U.S. 665 (1989) containing a substantive component CDC ‘‘working with State health
(reaffirming the general principle that a barring certain arbitrary, wrongful officials’’ to better coordinate public
government search may be conducted government actions regardless of the health responses, the rule is consistent
without probable cause and a warrant fairness of the procedures used to with 42 U.S.C. 264(e) and there are no
when there is a special governmental implement them. See Zinermon v. provisions that impose direct
need, beyond the normal need for law Burch, 494 U.S. 113, 125 (1990). HHS/ compliance costs on State and local
enforcement). HHS/CDC reiterates that CDC notes that the quarantine of governments. The longstanding
the special-needs doctrine articulated by individuals who have been exposed to provision on preemption in the event of
the Supreme Court in Skinner v. a communicable disease, but are not yet a conflict with Federal authority (42
Railway Labor Executives’ Ass’n., 489 capable of transmission is a well-known CFR 70.2) is left unchanged by this
U.S. 602 (1989) provides the appropriate and accepted public health strategy of rulemaking. Therefore, HHS/CDC
legal standard under the Fourth long standing. See Jacobson v. believes that the rule does not warrant
Amendment for apprehensions and Massachusetts, 197 U.S. 11, 25 (1905) additional consultation under Executive
detentions under this final rule. (recognizing the power of States to issue Order 13132.
Several commenters also questioned ‘‘quarantine laws and health laws of HHS/CDC received several questions
whether the regulations are consistent every description’’); Compagnie asking who would be responsible for the
with the requirements of the Fifth and Francaise de Navigation a Vapeur v. enforcement of these regulations. One
Sixth Amendments to the U.S. State Bd. of Health, Louisiana, 186 U.S. commenter questioned whether HHS/
Constitution. We note at the outset that 380, 396 (1902) (discussing the 1893 CDC would use ‘‘militarized police or
the Sixth Amendment only applies to Federal quarantine statute). The create [an] armed Federal police force to
criminal proceedings and thus would be restrictions on individuals authorized carry out these actions.’’ As explained
mstockstill on DSK3G9T082PROD with RULES3

inapplicable to isolation and quarantine under this regulation are justified by the elsewhere, in keeping with current
decisions which are public health benefits to the public health. practice and existing law, law
protection measures unrelated to the HHS/CDC received a comment that enforcement support for quarantine or
normal needs of law enforcement. quarantine and isolation are State police isolation orders will generally be
Furthermore, HHS/CDC asserts that this powers that should not be exercised at provided by U.S. Customs and Border
final rule is consistent with the the Federal level. While HHS/CDC Protection, U.S. Coast Guard, or other
requirements of due process embodied acknowledges that the States have Federal law enforcement programs, but

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6901

HHS/CDC may also accept voluntary an infected individual to another SMS texts, video or audio conference,
State and local assistance in enforcing individual.’’ Thus, HHS/CDC clarifies webcam technologies, integrated voice-
its Federal orders. HHS/CDC will also that indirect transmission of an response systems, or entry of
continue to enforce its regulations in a infectious agent may include information into a web-based forum;
manner consistent with the Fourth transmission via an insect vector as wearable tracking technologies; and
Amendment and other provisions of the described by the commenter. This other mechanisms or technologies as
U.S. Constitution. definition is finalized as proposed. determined by the Director or
supervising State or local health
c. Definitions Conditional Release authority.’’
Agreements HHS/CDC received many comments Several commenters expressed
HHS/CDC received many comments on the proposed definition and privacy concerns because conditional
on the definition of Agreement, largely provision regarding Conditional release of exposed or ill individuals may
expressing confusion and concern that Release; a substantive discussion of be accomplished over the internet or
such agreements would not be truly these comments is presented in the through electronic monitoring. Other
voluntary. The intent of this provision section below titled Requirements commenters expressed concerns about
was to provide HHS/CDC with an Relating to Issuance of a Federal Order privacy, having misunderstood the
additional tool to facilitate cooperation for Quarantine, Isolation, or Conditional proposed rule as authorizing HHS/CDC
from individuals in regard to Release. to conduct invasive surveillance of
recommended public health actions. In HHS/CDC is modifying the definition personal communications such as
response to public comments, however, of Conditional Release under section emails, text messages, and telephone
HHS/CDC has withdrawn this definition 70.1 to remove the cross-reference to the calls. Commenters also expressed
and will not issue the proposed definition of surveillance as that term concerns related to the use of webcams
provisions on ‘‘Agreements.’’ appears in current section 71.1. The and wearable tracking technologies as
definition of Conditional Release under an option for monitoring of exposed
Airline section 70.1 tracks the definition of people. One association viewed this
HHS/CDC did not receive public surveillance under section 71.1 and proposed provision as an expansion of
comment on the proposed definition of means ‘‘the temporary supervision by a CDC’s ‘‘electronic monitoring of
Airline. However, consistent with HHS/ public health official (or designee) of an personal information, under the guise of
CDC’s intent that this definition apply individual or group, who may have been protecting the public against rare,
to common air carriers, to improve exposed to a quarantinable isolated outbreaks of disease.’’
clarity, we have removed the phrase communicable disease to determine the HHS/CDC appreciates the opportunity
‘‘including scheduled or public charter risk of disease spread and includes to address these concerns. CDC’s intent
passenger operations operating in air public health supervision through in- was to describe mechanisms that HHS/
commerce within the United States’’ person visits, telephone, or through CDC or other public health authorities
and removed the reference to 49 U.S.C. electronic or internet-based can use to communicate with
40102(a)(3). monitoring.’’ HHS/CDC is making this individuals for the purpose of
change to improve clarity and remove conducting monitoring following
Apprehension exposure to a quarantinable
the need for the public to cross-
HHS/CDC received many comments reference the definition of surveillance communicable disease. These
on the proposed definition and to understand the definition of mechanisms are intended as alternatives
provision regarding Apprehension; a Conditional Release as used in section to in-person interviews because of the
discussion of these comments is in the 70.1. inconvenience and logistical problems
section below titled, ‘‘Apprehension This definition of Conditional Release that may arise when meeting in-person.
and Detention of Persons with under section 71.1 is finalized as During the 2014–2016 Ebola response,
Quarantinable Communicable proposed. HHS/CDC recommended ‘‘active
Diseases.’’ The definition is finalized as monitoring’’ defined as daily
proposed. Contaminated Environment communication between public health
HHS/CDC did not receive public authorities and the individuals being
Commander comment on the proposed definition of monitored. HHS/CDC did not specify
HHS/CDC did not receive public Contaminated Environment. Therefore, how this communication should occur,
comment on the proposed definition of this definition is finalized as proposed. and health departments used a variety
Commander. Therefore, this definition of electronic technologies for this
is finalized as proposed. Conveyance purpose including those listed in the
HHS/CDC did not receive public regulation. HHS/CDC also
Communicable Stage recommended ‘‘direct active
comment on the proposed definition of
HHS/CDC received a comment Conveyance. Therefore, this definition monitoring’’ for people with certain
seeking clarity regarding the definition is finalized as proposed. higher levels of exposure. This involved
of Communicable Stage. The having a public health official check in
commenter stated that the definition for Electronic or Internet-Based Monitoring with the person through direct
communicable stage may unnecessarily HHS/CDC received many comments observation rather than relying on
restrict social distancing powers on the proposed definition and phone calls or electronic
because it appears limited to human-to- provision regarding Electronic or communications. Webcams were used
mstockstill on DSK3G9T082PROD with RULES3

human transmission and does not Internet-based monitoring. We have by some health departments as an
include human transmission via an modified this definition as follows: alternative to in-person visits to observe
intermediate vector, such as mosquitoes ‘‘mechanisms or technologies allowing the person taking his or her
or flea bites. HHS/CDC disagrees. The for the temporary public health temperature. The webcam was only
definition of communicable stage supervision of an individual under operational during this scheduled
includes transmission of an infectious conditional release and may include public health ‘‘visit.’’ The use of
agent either ‘‘directly or indirectly from communication through electronic mail, webcams proved convenient for both

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6902 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

the health departments and the people Under this system of records, CDC HHS/CDC clarifies that the purpose of
being monitored, especially if the will only release data collected under the ill person definition is to align with
people lived in remote areas. Webcams this rule and subject to the Privacy Act current global and accepted detection
are also used routinely by health to authorized users as legally permitted. and reporting practices so that onboard
departments for ‘‘directly observed HHS/CDC will take precautionary deaths and illnesses are reported by
therapy’’ for diseases like tuberculosis measures including implementing the airlines and, where necessary,
(TB), in order to watch patients take necessary administrative, technical and investigated by HHS/CDC. We note that
their TB medications. HHS/CDC has physical controls to minimize the risks the ill person definition in this final rule
clarified the regulatory text to state that of unauthorized access to medical and is consistent with the internationally
these technologies will be used for other private records. In addition, HHS/ recognized and accepted illness
communicating with the individual and CDC will make disclosures from the reporting guidelines published by the
not as a means of monitoring the system only with the consent of the International Civil Aviation
individual’s personal communications. subject individual or, in accordance Organization (ICAO). This practice is
One commenter asked whether HHS/ with the routine uses published at 72 FR not new, but has been used successfully
CDC would ‘‘assist with payment for 70867, or as allowed under an exception for many years by aircraft and vessel
internet services’’ if webcam to the Privacy Act. Furthermore, HHS/ crews to assist public health officials in
communications was required. In CDC will apply the protections of the preventing further transmission and
keeping with current practice, if an SORN to all travelers regardless of spread of communicable disease.
individual does not have access to citizenship or nationality. Finally, such HHS/CDC also does not intend to
internet services, HHS/CDC may use records will be stored and maintained in apprehend individuals based solely on
alternative methods to assist with keeping with the official Records their meeting the definition of an ill
communication, such as the issuance of Control Schedule as set forth by the person. The purpose of an illness report
a cellular phone. Some organizations National Archives and Records is to allow trained HHS/CDC public
also expressed concerns about the use of Administration. For more information, health and medical officers to determine
technologies such as cellular phones or please see https://www.archives.gov/ whether an illness occurring onboard a
wearable tracking technologies for the records-mgmt/rcs. flight or voyage necessitates a public
purpose of electronic monitoring. HHS/ health response. In contrast, an
Ill Person apprehension of an individual is based
CDC acknowledges that the use of
We have modified the definition of Ill on a variety of criteria in addition to an
wearable tracking technology may be
person under 71.1 to include a person illness report including: Clinical
necessary in rare situations when a
who ‘‘(b)(2) Has a fever that has manifestations, contact or suspected
person does not comply with the
persisted for more than 48 hours; or contact with infected individuals, host
required monitoring or when it is
(b)(3) Has acute gastroenteritis, which susceptibility, travel to affected
necessary to know the physical
countries or places, or other evidence of
whereabouts of the person to ensure that means either diarrhea, defined as three
exposure to or infection with a
they are not in a public place. While or more episodes of loose stools in a 24-
quarantinable communicable disease.
HHS/CDC acknowledges that public hour period or what is above normal for
Thus, HHS/CDC disagrees that the ill
health surveillance of ill or exposed the individual, or vomiting
person definition will lead to
individuals through electronic accompanied by one or more of the
unnecessary apprehensions of
monitoring may raise some privacy following: One or more episodes of
individuals.
concerns, HHS/CDC believes that loose stools in a 24-hour period, Several commenters noted that the
protecting the public’s health outweighs abdominal cramps, headache, muscle symptoms listed in HHS/CDC’s
these concerns. aches, or fever (temperature of 100.4 °F definition of an ill person are common
HHS/CDC is committed to protecting [38 °C] or greater).’’ This language was symptoms of many non-threatening
the privacy of personally identifiable quoted verbatim in the preamble of the conditions, and thus questioned their
information collected and maintained NPRM at 81 FR 54305 but was inclusion in the definition. HHS/CDC
under the Privacy Act of 1974. As inadvertently omitted from the appreciates the opportunity to respond
detailed in the preamble of the proposed proposed regulatory text. to these concerns. The symptoms listed
rule, on December 13, 2007, HHS/CDC HHS/CDC received comments in HHS/CDC’s ill person definition are
published a notice of a new system of regarding the updated definition of Ill provided for airlines and vessels to
records under the Privacy Act of 1974 person which flight crews use to report report to HHS/CDC so that HHS/CDC
for its conduct of activities under this to the CDC occurrences of illnesses in can make a public health risk
final rule (72 FR 70867). HHS/CDC passengers or crew during travel. assessment; the symptoms alone would
accepted public comment on its Specifically, commenters expressed not result in issuance of a public health
proposed new system of records at that concern that ‘‘non-medical personnel’’ order. In making such an assessment,
time. As required under the Privacy Act, such as flight attendants would report HHS/CDC medical and public health
HHS/CDC described in its notice the such observations; others questioned officers consider the symptoms as well
proposed system of records, the purpose whether the definition is too broad and as the medical history of the person and
for the collection of the system data, the may result in over-reporting of non- any possible exposures that could
proposed routine uses (i.e., disclosures threatening illnesses; others worried indicate that the person may be infected
of system data that are compatible to the that it could lead to unnecessary with a quarantinable communicable
purpose for the data collection), the apprehensions of individuals. One disease.
mstockstill on DSK3G9T082PROD with RULES3

benefits and need for the routine use of commenter claimed to be ‘‘chemical A few commenters stated that the
this data, our agency’s policies, sensitive,’’ and worried that he or she definition of ill person appears to
procedures, and restrictions on the may be penalized for having a reaction expand the scope of HHS/CDC’s
routine use disclosure of this from sitting next to someone on a plane authority beyond the list of
information, and, most importantly, our wearing a ‘‘strong fragrance.’’ HHS/CDC quarantinable communicable diseases
safeguards to prevent its unauthorized thanks the commenters for considering specified through an Executive Order of
use. the proposal and providing feedback. the President. HHS/CDC disagrees. The

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6903

purpose of the ill person definition is to plus headache, fever plus cough, fever communicable disease, whereas the
help facilitate the identification, plus persistent vomiting, fever plus definition on vessels includes diarrheal
particularly by flight crews, of persistent diarrhea, etc. These illness without fever to allow for the
communicable diseases of public health symptoms combined with fever are reporting of viral gastrointestinal
concern. Thus, HHS/CDC has defined ill frequently seen in communicable illnesses that typically do not cause
person in such a way that the term may diseases that could pose a public health fever but have been known to cause
be understood by non-medically trained risk to others during travel. Because a large outbreaks on cruise vessels. The
crewmembers. While the reporting of an person with fever who also appears third difference is the presence onboard
ill person onboard a flight may trigger obviously unwell could have a serious cruise vessels of medical facilities
a public health evaluation by a trained communicable disease, HHS/CDC feels capable of making a diagnosis of
quarantine officer in consultation with it is appropriate to retain this symptom, pneumonia which allows the inclusion
an HHS/CDC medical officer, such and further notes that its inclusion of pneumonia in the vessel definition.
reporting does not expand the basis better aligns with Note 1 to the In all other respects, the definitions are
upon which an ill person may be subject guidelines set forth by the International the same. HHS/CDC adds that
to apprehension, detention, or Civil Aviation Organization in combining the definitions would be
conditional release. As noted by the paragraph 8.15 of Annex 9 to the confusing to industry professionals
commenter, such public health actions Convention on International Civil responsible for conducting this
are limited to those quarantinable Aviation. reporting.
communicable diseases specified One public health organization One public health organization
through an Executive Order of the commented that the definition of ill provided a recommendation to modify
President (e.g., cholera, diphtheria, person was broad and would be better the description of the ‘‘rash’’ component
infectious tuberculosis, yellow fever, issued through agency guidance rather in the definition of ill person to ensure
viral hemorrhagic fevers, Severe Acute than a rule. In response, HHS/CDC notes that the term fully encompassed the
Respiratory Syndromes, and pandemic that the existing regulation contains an range of potential skin rash symptoms.
influenza). outdated and overly narrow definition The organization’s recommendation for
A public health association suggested of ill person that does not reflect current revisions was as follows: ‘‘The
that any changes to the list of signs and knowledge of communicable diseases, individual has areas on the skin that are
symptoms within the definition of ill and that the reporting of ill travelers has red or purple, flat or bumps; with
person should be made available for been managed through a combination of multiple red bumps; red, flat spots; or
public comment. HHS/CDC assumes regulation and agency guidance. This blister-like bumps filled with fluid or
this comment is in reference to section combination of ‘‘required’’ and pus that are intact, draining, or partly
(3) of the definition which provides for ‘‘requested’’ reporting has proven crusted over; or dry and scaling patches.
reporting of ‘‘symptoms or other confusing to some airline and vessel The rash may be discrete or run
indications of communicable disease, as employees and this rule seeks to together, and may include one area of
the HHS/CDC may announce through mitigate such confusion by including all the body, such as the face, or more than
posting of a notice in the Federal relevant symptom clusters in the rule. one area.’’
Register.’’ HHS/CDC appreciates the Further, HHS/CDC notes that the change HHS/CDC responds that it will not
opportunity to clarify the purpose of in the ill person definition better aligns change the regulatory text of the ill
this section. Section (3) of the ill person with guidelines set forth by the person definition with this language
definition is intended to apply only to International Civil Aviation because we are concerned that this
new, emerging, and imminent threats to Organization and is supported in might add too much complexity to the
public health. We expect it will only be comments received from the airline regulatory definition. However,
relied on in emergency situations where industry. consistent with the regulatory definition
a quick response is required to protect One public health organization of ‘‘ill person,’’ HHS/CDC will update
the public. Other circumstances, where commented on the different definitions its reporting guidance for aircraft and
the list of signs and symptoms may of ill person for aircraft and vessels and vessels to include this revised
change due to evolving science or recommended that the definitions be description. Current guidance may be
technology, will be made available for combined and not depend on the mode found at: http://www.cdc.gov/
public comment, through a similar of transport. In response, HHS/CDC quarantine/air/reporting-deaths-illness/
process as this rulemaking—Notices in wishes to point out three crucial guidance-reporting-onboard-deaths-
the Federal Register—and may also differences between aircraft and vessels illnesses.html.
request input from the public. which HHS/CDC feels justify the An air industry commenter suggested
A number of commenters noted that different definitions. One difference, another change to the ill person
symptoms listed in HHS/CDC’s additionally noted by the commenting definition. The proposed definition
definition of an ill person are common organization, is the difference in time included ‘‘headache with stiff neck,’’
symptoms of many conditions, that a traveler spends on an aircraft and and the commenter suggested that this
particularly ‘‘appears obviously unwell’’ a vessel which makes the time frame (24 be modified to ‘‘severe headache of
which many commenters requested be hours) specified in the definition of recent onset with stiff neck.’’ While
removed from the definition. HHS/CDC acute gastroenteritis for vessels relevant HHS/CDC will not change the regulatory
appreciates the opportunity to clarify and minimizes the reporting of travelers definition of ill person to accommodate
that, with the exception of acute with a single episode of loose stool that this change, HHS/CDC believes this is a
gastroenteritis on vessels, HHS/CDC subsequently resolves, a common useful modification to make in ill
mstockstill on DSK3G9T082PROD with RULES3

only requires reporting of an ill traveler occurrence. The second is the high risk person reporting guidance to aircraft
on an aircraft or vessel if fever of spread of gastrointestinal infections and vessels.
‘‘accompanied by one or more of the onboard vessels that is unlikely to occur
following’’ other symptoms listed are on aircraft; for this reason, reporting of Incubation Period
present. Therefore, as an example, diarrheal illnesses on aircraft includes HHS/CDC did not receive any
headache alone would not be sufficient the presence of fever which is more comments on the proposed definition of
to require reporting, but rather fever likely to indicate a serious Incubation period. However, upon a

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6904 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

review of the definition, we have health assessment because a mental Non-Invasive


decided that the definition should more health condition may impact an HHS/CDC received several comments
closely track the definition of individual’s appreciation of his or her concerning the definition of Non-
Precommunicable stage. For public health risk to others. While HHS/ invasive, including support from a
quarantinable communicable diseases, CDC acknowledges that a mental health public health association regarding the
the Incubation period is defined as the assessment may be useful as part of an definition. However, several individuals
Precommunicable stage of the disease. individual’s medical care and treatment disagreed with the proposed definition.
Thus, we have determined that the two and that such an assessment may be In response to public comment that the
definitions should more closely align. A ordered as needed by a treating definition of ‘‘non-invasive’’ allowed
substantive discussion of comments clinician, HHS/CDC declines to make too much physical contact between the
received concerning the definition of such assessments a formal part of the individual and public health officer,
Precommunicable stage appears below. medical examination process. HHS/CDC has replaced ‘‘physical’’ with
Accordingly, we have modified the Specifically, because a mental health ‘‘visual’’ and removed ‘‘auscultation;
definition of Incubation period to add assessment is not generally needed to external palpation; external
‘‘or, if signs and symptoms do not diagnose or confirm the presence or measurement of blood pressure’’ from
appear, the latest date signs and extent of infection with a quarantinable the definition. While HHS/CDC
symptoms could reasonably be expected communicable disease, HHS/CDC continues to believe that these
to appear.’’ Other aspects of this disagrees that it is necessary or procedures qualify as Non-invasive
definition are finalized as proposed. appropriate to require such an under the definition, after considering
Indigent assessment as part of a Federal public public comment and a review of
health order. standard operating procedures, HHS/
HHS/CDC received comments relating
Medical Representative CDC finds such procedures to be
to the proposed definition of Indigent
unlikely to be conducted during a
which is used to determine whether a HHS/CDC received several comments public health risk assessment. Such
detained individual qualifies for relating to the proposed definitions of procedures may be conducted at a port
appointment at government expense of Medical Representative and Medical of entry by emergency medical service
representatives to assist him/her during Reviewer as well as the potential use of personnel as part of a medical
a medical review. One comment from a HHS/CDC employees as representatives assessment to determine the need for
public health department suggested or medical reviewers. One commenter emergency medical care. We also
raising the threshold for indigent status suggested that it would be less modified the definition to clarify that
to at least 200% of the applicable problematic for HHS/CDC to allow and the individual conducting the public
poverty guideline. HHS/CDC agrees and pay for outside participants to serve in health risk assessment will be a ‘‘public
has made this change in the final these capacities. First, HHS/CDC notes health worker.’’ Public health workers
regulation. that the definition of Medical
One commenter opposed including a are individuals who have education and
representative has been changed to training in the field of public health.
definition for indigents and indicated Representatives and revised as detailed One commenter mentioned that the
that HHS/CDC should assume all costs below. HHS/CDC disagrees with this new definition of Non-invasive states
whenever an individual is placed into comment and notes that the definition that the HHS/CDC could order
Federal isolation or quarantine. HHS/ of both Representatives and Medical laboratory testing under certain
CDC disagrees that assuming such costs reviewer would in fact allow for the conditions. The commenter further
without regard to indigence is necessary appointment of non-HHS/CDC asserted that forced laboratory testing,
or appropriate. employees in these capacities as
Other substantive comments relating without the option of quarantine
suggested by the commenter. For this instead, is an invasive measure, and
to the appointment at government reason, both Representatives and
expense of representatives to assist questioned how this could be in line
Medical reviewer are broadly defined in with the concept of non-invasive. HHS/
detained indigent individuals during a terms of the occupational qualifications
medical review are discussed below. CDC responds that the definition of non-
of these individuals. HHS/CDC also invasive applies to procedures
Master or Operator does not consider it problematic to rely conducted during a public health risk
HHS/CDC did not receive any on internal reviewers and notes that it assessment at a port of entry and that
comments on the definition of Master or is not unusual, for instance, for this definition does not authorize
operator. Accordingly, this definition is hospitals to rely on internal decision- forcible or invasive procedures to
finalized as proposed. makers when determining whether to extract human biological samples for
commit a mental health patient on an laboratory testing. Should laboratory
Medical Examination emergency basis. testing be needed for a person
In response to comments received HHS/CDC received a comment that reasonably believed to be infected with
regarding medical examinations under the ‘‘definition of medical exemption is a quarantinable communicable disease,
sections 70.12 and 71.36, we have not apparent.’’ In response, HHS/CDC such testing would be done as part of a
modified the definition of Medical notes that no clarification of what is medical examination conducted at a
Examination to indicate that the health meant by ‘‘medical exemption’’ is healthcare facility and performed with
worker conducting the assessment must provided by the commenter and that the patient’s informed consent. HHS/
be ‘‘licensed.’’ Comments regarding HHS/CDC did not propose adding such CDC has added language to the
mstockstill on DSK3G9T082PROD with RULES3

sections 70.12 and 71.36 are addressed a definition. While these regulations do regulatory text requiring that the
below. not authorize compulsory vaccination or Director advise individuals of their right
HHS/CDC received a comment medical treatment, there is no to have medical testing and examination
regarding the definition of Medical recognized ‘‘medical exemption’’ from conducted by an authorized and
Examination. The commenter stated quarantine, isolation, or conditional licensed health worker and with prior
that the definition of medical release and HHS/CDC declines to create informed consent. While this regulation
examination should include a mental one. does not authorize forcible testing,

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6905

HHS/CDC may require laboratory test individual who displays no symptoms long-term disability.’’ HHS/CDC
results demonstrating that a of a communicable illness. In response, disagrees because the definition
symptomatic individual is no longer HHS/CDC states that it has defined includes infectious diseases that are
infectious prior to rescinding a Federal Precommunicable stage consistent with highly likely to cause ‘‘serious illness’’
isolation order. the public health practice of quarantine. if not properly controlled. HHS/CDC
Quarantine refers to the public health clarifies that ‘‘short- or long-term
Precommunicable Stage
practice of separating and restricting the disability’’ caused by an infectious agent
HHS/CDC received comments relating movement of individuals who are would be considered a ‘‘serious illness.’’
to the definition of Precommunicable reasonably believed to have been This commenter further suggested
stage. One commenter suggested that exposed to a communicable disease, but that in addition to referencing a public
persons in the ‘‘precommunicable are not yet ill. In contrast, isolation health emergency declaration by the
stage’’ of a quarantinable communicable refers to the public health practice of HHS Secretary, the definition should
disease pose no direct threat to the separating and restricting the movement also include similar declarations by the
public’s health. A public health of individuals who have been exposed President under the Stafford Act or
organization also stated that this to a communicable disease and are under the National Emergencies Act.
definition should not apply to non- symptomatic from those who are not HHS/CDC disagrees. We note first that
symptomatic people who have been sick. the definition of public health
exposed to Ebola. HHS/CDC disagrees The definition of Precommunicable emergency is not limited to those
with both comments. For instance, a stage is finalized as proposed. emergencies declared by the HHS
patient diagnosed with multidrug- Secretary. Second, in the event of a
resistant or extensively drug-resistant Public Health Emergency
man-made or natural disaster that also
tuberculosis who is not currently HHS/CDC received several comments affects public health, the HHS Secretary
infectious, but who has not been relating to the definition of Public may issue a separate declaration under
adequately treated and is thus at high health emergency. One commenter the Public Health Service Act as was
risk for relapse would be considered to stated that use of the term is duplicative done in response to the terrorist attacks
be in the ‘‘precommunicable stage’’ of and unnecessary because the term is of September 11, 2001 and in response
the disease and pose a direct threat to used elsewhere in the Public Health to Hurricane Katrina. Thus, HHS/CDC
the public’s health. Similarly, an Service Act (42 U.S.C. 247d) and does not see a need to also reference
individual who is reasonably believed appears in State-based legislation based Presidential declarations as suggested
to have been exposed to Ebola poses a on the Model State Emergency Health by the commenter.
direct threat. Powers Act. This commenter suggested This commenter also requested
Several public health organizations that to avoid confusion the term should clarification concerning whether the
additionally expressed concerns be renamed ‘‘Public Health Exigency.’’ World Health Organization’s (WHO)
regarding the use of the HHS/CDC disagrees. Section 361(d) of declaration of a Public Health
‘‘precommunicable stage’’ definition to the Public Health Service Act (42 U.S.C. Emergency of International Concern
justify quarantine of healthcare workers 264(d)(1)) authorizes the apprehension (PHEIC) could continue to serve as the
caring for patients with quarantinable and examination of individuals basis for a ‘‘public health emergency’’ if
communicable diseases such as Ebola or traveling interstate who are in the the President or HHS Secretary
severe acute respiratory syndromes, ‘‘precommunicable stage’’ of a disagreed with the declaration of a
including healthcare workers providing quarantinable communicable disease, PHEIC on legal, epidemiologic, or policy
care in the United States or in other but only if the disease ‘‘would be likely grounds. In response, HHS/CDC notes
countries. One such organization further to cause a public health emergency if that the scenario proposed by the
requested clarification of whether the transmitted to other individuals.’’ Thus, commenter is unlikely, but that CDC
rule provides for the needs and section 361(d) is unique and differs remains a component of HHS, subject to
protection of healthcare workers who from how the term public health the authority and supervision of the
voluntarily self-quarantine while emergency is used in other statutes or HHS Secretary and President of the
providing care for patients with the provisions of the Public Health Service United States.
quarantinable communicable diseases Act because it authorizes application of HHS/CDC also received a comment
noted above. specific public health measures objecting to referencing the WHO’s
In response, HHS/CDC states that it (apprehension and examination) to declaration of a Public Health
does not recommend quarantine or specific individuals (those in the Emergency of International Concern
occupational restrictions of healthcare precommunicable stage of a (PHEIC) in the definition of ‘‘public
workers who follow recommended quarantinable communicable disease), health emergency’’ because this
infection control precautions while but only if the disease would be likely ostensibly relinquishes U.S. sovereignty.
providing care for patients with to cause a public health emergency. HHS/CDC disagrees. By including
quarantinable communicable diseases. Thus, HHS/CDC considers it essential to references to a PHEIC, HHS/CDC is not
Healthcare workers who do not follow define public health emergency because constraining its actions or makings its
infection control precautions or who the existence of such an emergency is a actions subject to the dictates of the
have had unprotected exposures to necessary prerequisite to the WHO. Rather, the declaration or
patients with a quarantinable apprehension and examination of notification of a PHEIC is only one way
communicable disease may be subject to individuals in the precommunicable for HHS/CDC to define when the
quarantine or occupational restrictions; stage of a quarantinable communicable precommunicable stage of a
mstockstill on DSK3G9T082PROD with RULES3

these individuals would be afforded the disease. quarantinable communicable disease


same due process protections as other This commenter also suggested that may be likely to cause a public health
exposed individuals. the definition of public health emergency if transmitted to other
Several commenters also questioned emergency contains an oversight individuals. While HHS/CDC will give
CDC’s proposed definition for because it does not mention the consideration to the WHO’s declaration
Precommunicable stage stating that it potential for an infectious condition of a PHEIC or the circumstances under
may result in an apprehension of an being highly likely to cause ‘‘short- or which a PHEIC may be notified to the

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6906 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

WHO, HHS/CDC will continue to make provisions, is discussed in the section State and local public health officials to
its own independent decisions below titled Public Health Prevention ensure that any restrictions imposed on
regarding when a quarantinable Measures to Detect Communicable an individual are commensurate with
communicable disease may be likely to Disease. The definition is finalized as the degree of risk and using the least
cause a public health emergency if proposed. restrictive means available.
transmitted to other individuals. Thus, The definition of Qualifying stage is
Qualifying Stage finalized as proposed.
HHS/CDC disagrees that referencing the
WHO determination of a PHEIC results HHS/CDC received several comments
relating to Qualifying stage. Several Reasonably Believed To Be Infected, as
in any relinquishment of U.S. Applied to Individuals
sovereignty. commenters, including one public
The International Health Regulations health organization, expressed concern HHS/CDC received several comments
are an international legal instrument that the definition was either too vague, regarding the definition of Reasonably
that sets out the roles of WHO and State too broad, or too confusing. One believed to be infected, as applied to an
parties in identifying, responding to, commenter suggested that the definition individual. Several public health
and sharing information about public for Qualifying stage is confusing organizations expressed concern there
health emergencies of international because it splits communicable diseases could be undue burden placed on
concern. HHS/CDC believes that it into a ‘‘precommunicable stage’’ and a healthcare facilities or health
would be unlikely for the United States ‘‘communicable stage’’ and that a departments by greatly expanding the
to formally object to the WHO’s communicable disease would not be on number of individuals requiring health
declaration of a PHEIC, but that CDC the list of Federal quarantinable screening, medical examination and
remains a component of HHS, subject to communicable diseases if its spread did testing, or placed under Federal
the authority and supervision of the not already have some potential to cause isolation of quarantine orders. HHS/
HHS Secretary and President of the a public health emergency. In response, CDC disagrees. This rule represents a
United States. HHS/CDC notes that the term codification of current practice and
Also regarding the definition of ‘‘qualifying stage’’ is defined under 42 decisions regarding the need for medical
‘‘public health emergency,’’ one public U.S.C. 264(d)(2) to include both a examination of individuals suspected of
health association expressed concern ‘‘precommunicable stage’’ and a being infected with a quarantinable
that any disease considered to be a ‘‘communicable stage’’ and that this communicable disease, including
public health emergency may qualify it definition explicitly references diseases during an outbreak or public health
as quarantinable. Another commenter ‘‘likely to cause a public health emergency, will generally be based on
noted that some PHEICs ‘‘most certainly emergency.’’ Thus, while HHS/CDC may published disease-specific case
do not qualify as public health clarify and explain statutory terms definitions for PUIs (persons under
emergencies’’ under the proposed through regulation, it has no authority investigation) that incorporate clinical
definition. HHS/CDC appreciates the to change the language of the statute. and epidemiologic factors. Furthermore,
opportunity to clarify. Only those One public health organization decisions regarding the issuance of
communicable diseases listed by recommended that HHS/CDC policy Federal public health orders or medical
Executive Order of the President may implementing the Qualifying stage examination for a suspected
qualify as quarantinable communicable definition acknowledge that a one-size quarantinable communicable disease
diseases. For example, Zika virus fits all protocol is not appropriate would typically be made in
infection, which although the current because different diseases have different coordination with a State or local health
epidemic was declared a PHEIC by transmission patterns and the need for department of jurisdiction. Therefore,
WHO, is not a quarantinable isolation and quarantine may differ. HHS/CDC does not anticipate placing an
communicable disease. The definition HHS/CDC agrees that the need for undue burden on healthcare facilities or
of Public health emergency is finalized isolation and quarantine may differ health departments as a result of these
as proposed. based on the disease and adds that it definitions.
conducts a public health risk One commenter stated that the
Public Health Prevention Measures assessment before issuing Federal Reasonably believed to be infected, as
HHS/CDC received one comment public health orders. For example, HHS/ applied to an individual definition
relating to the definition of Public CDC does not typically issue Federal allows for apprehension, quarantine, or
health prevention measures. The public health orders for cholera, a isolation based solely on reasonable
commenter stated that the second use of quarantinable communicable disease as inferences that the person was exposed
‘‘and other non-invasive means’’ should defined by Executive Order because the somehow or in some way to infectious
be deleted from the definition of public sanitation infrastructure in the United agents. HHS/CDC disagrees because as
health prevention measures as States makes cholera transmission stated in the definition reasonable
redundant. HHS/CDC disagrees because unlikely. HHS/CDC further notes that it inferences may only be drawn from
‘‘observation, questioning, review of typically conducts the public health risk ‘‘specific articulable facts’’ that an
travel documents, and records review’’ assessment in coordination with the individual has been exposed to an
as cited in the definition appears to State or local health department of infectious agent such as through
materially differ from ‘‘other non- jurisdiction before issuing a Federal ‘‘contact with an infected person or an
invasive means’’ that may be used as a public health order. infected person’s bodily fluids, a
part of public health prevention Public health organizations and other contaminated environment, or through
measures such as temperature checks, commenters cautioned against an intermediate host or vector.’’ Thus,
mstockstill on DSK3G9T082PROD with RULES3

visual observation, or visual apprehending individuals or issuing HHS/CDC disagrees that this standard
examination of the ear, nose, or mouth. public health orders when the risk of does not comport with standard public
Accordingly, HHS/CDC believes that the communicable disease spread during health practice.
updated definition provides greater the precommunicable period is low. HHS/CDC received a comment from a
clarity as written. Further information, HHS/CDC agrees and further adds that public health agency expressing concern
including a discussion regarding it will typically conduct a public health that travel to other countries where
comments received on these proposed risk assessment in coordination with transmission of a quarantinable

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6907

communicable disease has likely aligns the definition with the and/or public health authorities having
occurred would be the sole basis upon Precommunicable stage definition. notified HHS/CDC that the individual is
which HHS/CDC would form a • The definition of Indigent has been known or suspected to be infected with
reasonable belief that an individual may modified to increase the threshold to a quarantinable communicable disease
be infected with a quarantinable 200% of the applicable poverty and likely non-adherent with public
communicable disease. In response, guidelines. health recommendations.
HHS/CDC clarifies that travel to other • The definition of Medical HHS/CDC has modified paragraph (b)
countries was simply used as an Examination has been modified to of the provisions relating to public
illustrative example. The decision to indicate that the health worker health prevention measures to detect
place an individual into isolation or conducting the assessment must be communicable disease (§§ 70.10 and
quarantine will ordinarily be based on ‘‘licensed.’’ 71.20) to include information about
several factors, including travel, contact • The definition of Medical ‘‘known or possible exposure,’’ in
with an infected person or an infected Representative has been changed to response to comments requesting
person’s bodily fluids, host Representatives and now includes in further clarity of CDC’s criteria.
susceptibility, and clinical addition to the appointment of a One organization from the airline
manifestations. HHS/CDC believes that medical professional, the appointment industry was generally supportive of
this definition is clear and that no of ‘‘an attorney who is knowledgeable of 70.10 and 71.20, public health
further changes are necessary. public health practices.’’ prevention measures to detect
The definition of Reasonably believed • The definition of Non-invasive has communicable disease, and requested
to be infected as applied to an been modified to (1) replace ‘‘physical that any measures, such as screening,
individual is finalized as proposed. examination’’ with ‘‘visual occur prior to individuals boarding an
examination,’’ (2) specify that the aircraft, and preferably prior to arrival at
Secretary individual performing the assessment the gate. HHS/CDC thanks these
HHS/CDC has added a definition for must be a ‘‘public health worker (i.e., an commenters for their support. In
Secretary meaning the Secretary of individual with education and training response, while an operational plan for
Health and Human Services (HHS) or in the field of public health)’’ and (3) each location has not yet been finalized,
any other officer or employee of that remove ‘‘auscultation, external HHS/CDC expects such measures to
Department to whom the authority palpation, external measurement of occur prior to the boarding of an
involved has been delegated. We note blood pressure.’’ aircraft, and to the extent possible, prior
that while the NPRM did not propose • A definition for Secretary has been to arrival at the gate. One airline
this definition, the NPRM referenced the added and means ‘‘the Secretary of organization insisted that airline
Secretary in defining Public Health Health and Human Services (HHS) or operators should not be financially
Emergency. Thus, HHS/CDC considers it any other officer or employee of that responsible for any costs associated
useful to also define the term Secretary. Department to whom the authority with screening. HHS/CDC responds that
After consideration of comments involved has been delegated.’’ it does not expect airlines and airline
regarding Definitions, HHS/CDC has operators to assume direct costs
d. Public Health Prevention Measures
made the following changes in the final associated with public health screening,
To Detect Communicable Disease
rule: such as providing additional personnel
• The definition of Agreements has HHS/CDC received support from to conduct the screening. However,
been withdrawn. commenters on screening individuals indirect costs such as missed flights of
• The definition of Conditional entering the U.S. from parts of the world passengers who are detained may occur.
Release under section 70.1 has been where highly infectious diseases are Another airline organization
modified to remove the internal cross- common. One such commenter requested that HHS/CDC ensure wait-
reference to the definition of requested to know the criteria HHS/CDC times in lines are not impacted by
surveillance under section 71.1. The uses when deciding whether to detain screening, and encouraged HHS/CDC to
definition of Conditional Release under an individual. Another commenter take into account the needs of all
section 70.1 has been further modified stated that travel history ‘‘should be a stakeholders. HHS/CDC feels strongly
to align with the definition of prerequisite for Federal orders to that in these rare circumstances, which
surveillance under section 71.1 and quarantine’’ and ‘‘medical exam should would only occur should a threat to
means ‘‘the temporary supervision by a be a prerequisite for Federal orders to public health exist, preventing airline
public health official (or designee) of an isolate.’’ HHS/CDC thanks these employees and other passengers from
individual or group, who may have been commenters and welcomes the being exposed to a detained or delayed
exposed to a quarantinable opportunity to explain this process. individual provides a greater benefit
communicable disease to determine the HHS/CDC’s decision to detain an than the monetary loss of airfare. In
risk of disease spread and includes individual is based on several criteria, keeping with current practice, HHS/
public health supervision through in- including: Clinical manifestations: Signs CDC will work together with public
person visits, telephone, or through and symptoms consistent with those of health partners, carriers, and all who
electronic or internet-based a quarantinable communicable disease; have equities, to ensure insofar as
monitoring.’’ known or suspected contact with cases, possible that the least restrictive and
• The definition of Electronic or i.e., patients either confirmed or time-consuming measures are
internet-based monitoring has been suspected to be infected with a implemented. Finally, commenters
modified to indicate ‘‘communication quarantinable communicable disease; requested that individuals who refuse to
mstockstill on DSK3G9T082PROD with RULES3

through’’ such means, and include epidemiologic information/evidence undergo a public health risk assessment
‘‘audio’’ conference. (travel history, exposure to animals); prior to travel be denied boarding of an
• The definition of Incubation period other documentary or physical evidence aircraft. In response, HHS/CDC notes
has been modified to add ‘‘or, if signs in the individual’s possession, such as that individuals may be denied boarding
and symptoms do not appear, the latest a physician’s note documenting for public health reasons pursuant to the
date signs and symptoms could infection with or medication for criteria published at 80 FR 16,400 (Mar.
reasonably be expected to appear.’’ This treatment of a quarantinable disease; 27, 2015) titled Criteria for Requesting

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6908 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

Federal Travel Restrictions for Public were performed in areas of the airport ‘‘known or possible exposure’’ in the list
Health Purposes, Including for Viral that are not considered private, these of information that may be collected.
Hemorrhagic Fevers. were limited to collection of contact
HHS/CDC received a comment e. Apprehension and Detention of
information, noncontact temperature
expressing concern about conducting Persons With Quarantinable
measurement, observation for visible
public health prevention measures at Communicable Diseases
signs of illness, and superficial
‘‘other locations’’ besides U.S. ports of screening questions that did not collect HHS/CDC received several comments
entry because the commenter found this sensitive information. Any more relating to the ‘‘apprehension’’ of an
language vague. HHS/CDC clarifies that detailed public health assessment individual. One public health
this term is meant to include all would be done in a private area. association and a public health
locations where individuals may enter HHS/CDC is bound by the Privacy Act department suggested that HHS/CDC
the United States from a foreign country to protect personally identifiable data not use the term ‘‘apprehension’’
(i.e., border crossings) or gather for the collected and maintained in accordance because this may create social stigma.
purposes of engaging in interstate travel with that Act. Furthermore, HHS/CDC HHS/CDC uses this term in these
(e.g., airports, seaports, railway stations, will apply the protections of the SORN regulations to align with the statutory
bus terminals), regardless of whether to all travelers regardless of citizenship terminology used in 42 U.S.C. 264(b)
such places are formally designated as or nationality. Personally identifiable which authorizes the ‘‘apprehension,
such. data collected by HHS/CDC at airports detention, or conditional release’’ of
One public health organization are maintained in a secure database and individuals coming into a State or
requested clarification regarding what shared only for official purposes on a possession from a foreign country or
information or event would justify need to know basis using secure possession for purposes of preventing
triggering the screening of travelers. methods as described in CDC’s System the introduction, transmission, and
CDC’s response is that, while specific of Records Notice published at 72 FR spread of quarantinable diseases.
triggers cannot be defined at this time, 70867. HHS is also a hybrid entity Similarly, 42 U.S.C. 264(d) authorizes
screening of travelers may generally be under HIPAA, but only those parts of the ‘‘apprehension and examination’’ of
conducted during a public health HHS that have been determined to be any individual in the qualifying stage of
emergency if HHS/CDC determined that health care components are subject to a quarantinable communicable disease
monitoring of potentially exposed the HIPAA Privacy Rule. CDC is who is moving or about to move
travelers was needed to protect the generally not a health care component between States or constitutes a probable
public’s health. treated as a ‘‘covered entity’’ under the source of infection to individuals
One public health organization and HIPAA Privacy Rule. However, certain moving between States. While HHS/
many individual commenters asserted specific offices of HHS, CDC, and the CDC can clarify and explain this term,
that people exposed to measles should National Institute for Occupational only Congress has the authority to
not be ‘‘tracked’’ through the use of Safety and Health (NIOSH) performing change statutory language. In addition
Federal public health orders. First, we activities related to the World Trade to being a term specifically used in
reiterate that because measles is not a Center Health Program are considered statute under 42 U.S.C. 264, HHS/CDC
quarantinable communicable disease, health care components of HHS and has determined that this term best
HHS/CDC does not have the authority to must comply with HIPAA and the conveys that HHS/CDC may, based on
issue a public health order for this Privacy Rule. public health grounds, assume physical
illness. Second, it is not HHS/CDC’s One public health organization custody of individuals. Furthermore,
policy to monitor people following recommended that the rulemaking using alternative terminology, may
measles exposures. Rather, HHS/CDC specify that individuals undergoing a reduce public understanding and
notifies State or local health public health risk assessment only be transparency regarding HHS/CDC’s legal
departments regarding people in their asked to provide contact tracing authorities.
jurisdictions who may have been information if the risk assessment leads One commenter stated that not every
exposed to measles. The State or local to a reasonable belief that the individual social distancing technique needs to
health departments, in turn, choose to may become infected. It is CDC’s policy involve taking physical custody of
notify people regarding their measles to conduct conveyance-related contact individuals and that using more
exposure, assess their immunity to investigations for confirmed cases of voluntary-based options would be
measles and, if they are not immune, communicable diseases. In instances advisable. HHS/CDC agrees that
offer vaccination with MMR vaccine to when confirmation cannot be obtained, attempting to obtain voluntary
prevent infection. State or local health HHS/CDC may investigate contacts compliance with public health measures
authorities may choose to monitor based on reasonable belief of infection is more advisable than assuming legal
people following exposures to measles following a public health risk custody, but believes that maintaining
based on their own criteria. assessment which is typically the authority to apprehend individuals
One commenter asked whether conducted in coordination with the who may pose a public health risk is a
mandatory health screenings at airports State or local health department of necessary tool to protect the public’s
would be conducted privately, whether jurisdiction. Such operational details health. HHS/CDC received a comment
processes would comply with HIPAA, are generally defined in internal regarding the ‘‘burden of proof’’ for an
and how data would be protected at protocols. State or local authorities may apprehension. In response, HHS/CDC
airports. In response, HHS/CDC states conduct community-based contact notes that the applicable standard for an
that, in all situations, HHS/CDC strives investigations within their jurisdictions apprehension of an interstate traveler is
mstockstill on DSK3G9T082PROD with RULES3

to protect the privacy of individuals based on their own criteria. ‘‘reason to believe’’ that the individual
subject to screening, collection of After consideration of these is in the qualifying stage of a
information, or the issuance of Federal comments, HHS/CDC has modified quarantinable communicable disease.
public health orders under HHS/CDC’s paragraph (b) the provisions relating to HHS/CDC notes that Reasonably
authority. While some aspects of the Public Health Prevention Measures to believed to be infected as applied to an
entry risk assessment process conducted Detect Communicable Disease (§§ 70.10 individual is defined under this final
during the 2014–2016 Ebola epidemic and 71.20) to include information about rule.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6909

Several commenters expressed President as quarantinable. Accordingly, measures (such as ensuring phone
concern that because the HHS/CDC does not foresee sufficient access) to allow apprehended
‘‘apprehension’’ period is not explicitly ‘‘non-exigent’’ circumstances where it individuals to have contact with family
time-limited, that HHS/CDC may would be necessary for it to issue a or legal counsel whom they hire at their
‘‘apprehend’’ an individual indefinitely Federal isolation or quarantine order own expense. As explained further
without providing the individual with a and thus declines to establish the below, HHS/CDC will also appoint
written public health order or a medical suggested alternative framework on this representatives, including a medical
review. One commenter noted that basis. representative and an attorney, if the
HHS/CDC used the term ‘‘generally’’ in The circumstances under which HHS/ individual is indigent and requests a
the preamble of the NPRM and felt it CDC may apprehend and detain medical review. Individuals who do not
was too vague, stating ‘‘setting a firm individuals is limited by the terms of 42 qualify as indigent may also choose to
timeframe is vital.’’ A partnership of U.S.C. 264. HHS/CDC may only isolate, be represented at the medical review by
public health legal scholars and quarantine, or conditionally release an an advocate (e.g., an attorney, physician,
organizations stated that because HHS/ individual if it reasonably believes that family member) and present a
CDC did not explicitly limit how long the individual is infected with a reasonable number of medical experts,
an individual could remain quarantinable communicable disease of their own choosing and at their own
apprehended that such apprehensions and the individual is either arriving into expense. HHS/CDC, however, rejects as
could turn into the functional the U.S. from a foreign country, moving impractical the notion that indigent
equivalent of a quarantine thus between States, or constitutes a probable individuals should have representatives
potentially raising Fourth and Fifth source of infection to others who may appointed to them at the moment of
Amendment concerns. In response to then move between States. apprehension because most illnesses of
these concerns, HHS/CDC has added Accordingly, the circumstances under public health concern can be ruled out
language requiring that it serve an which CDC is would issue a quarantine based on a short interview with a
apprehended individual with a public or isolation order are ‘‘exigent’’ because quarantine officer involving an
health order within 72 hours of that the individual constitutes a assessment of symptoms and travel
individual’s apprehension. communicable disease risk and is history. Thus, the expected length of an
actively engaged in travel or constitutes apprehension will be very short and not
HHS/CDC received several other a source of infection to others engaged justify the appointment of
comments relating to the sections in travel. It is thus unnecessary and representatives.
authorizing the apprehension and impractical to provide a ‘‘pre- This commenter also requested clarity
detention of persons with quarantinable deprivation’’ hearing prior to on what legal recourse may be available
communicable diseases. A partnership quarantining or isolating the individual to apprehended individuals. While
of public health legal scholars and because he/she if released from custody HHS/CDC does not express an opinion
organizations suggested two public may be lost to public health follow-up regarding what form of legal action an
health frameworks for apprehension and and may expose others. HHS/CDC aggrieved individual should pursue, we
detention, one for implementation would not quarantine or isolate an note that these regulations do not
during non-exigent circumstances and a arriving traveler from a foreign country impact the constitutional or statutory
second for exigent circumstances. As where a single case of a communicable rights of individuals to seek judicial
described, the primary distinction disease such as Ebola exists unless it redress for detention.
between the non-exigent and exigent reasonably believes that the traveler HHS/CDC received comments from
framework, is that in the former HHS/ arriving into the U.S. is infected with a the public regarding HHS/CDC’s
CDC would be required to hold a due quarantinable communicable disease. authority to ‘‘arrest’’ individuals. One
process hearing prior to the imposition Commenters stated that individuals commenter stated that individuals
of an isolation or quarantine, while in must receive notice of their suspected should only be detained when a crime
the latter HHS/CDC may briefly detain exposure and be permitted to speak has been committed. One association
the individual prior to holding a with legal counsel or have legal counsel objected to HHS/CDC’s ‘‘power to detain
hearing. While HHS/CDC appreciates appointed to them. HHS/CDC agrees an individual for 72 hours and longer
the input provided by this partnership, that individuals should be adequately without any Federal court order.’’ Some
HHS/CDC declines to adopt this notified of the basis for their detention commenters also worried that any
suggestion. Importantly, unlike State and directs this commenter to sections person showing signs of a ‘‘common
and local public health authorities who 70.14 and 71.37, which detail the cold’’ may be held. To be clear, HHS/
have primary responsibility for the specific factual content that must be CDC is not a law enforcement agency, it
imposition of public health measures included in a Federal order for has no legal authority to ‘‘arrest’’
occurring within their jurisdictions, quarantine, isolation, or conditional individuals, but rather has been granted
HHS/CDC acts in time-sensitive release. We have also modified these the authority by Congress to ‘‘apprehend
circumstances to prevent communicable sections to explicitly require that the and detain’’ individuals for the
disease spread, such as at ports of entry, federal order include an explanation of purposes of preventing the introduction,
upon the request of a State or local the right to request a medical review, transmission and spread of
public health authority of jurisdiction, present witnesses and testimony at the quarantinable communicable disease as
or when State or local control is medical review, and to be represented at specified in an Executive Order of the
inadequate. Furthermore, unlike State the medical review by either an President. 42 U.S.C. 264(b). This
and local public health authorities who advocate (e.g., family member, provision further provides that
mstockstill on DSK3G9T082PROD with RULES3

generally have broad police-power physician, or attorney) at the ‘‘regulations may provide that if upon
authority to protect the public’s health, individual’s own expense, or, if examination any such individual is
HHS/CDC’s statutory authority with indigent, to have representatives found to be infected, he may be
respect to isolation and quarantine is appointed at the government’s expense. detained for such time and in such
limited to only those small, subset of As previously stated, consistent with manner as may be reasonably
communicable diseases specified principles of preventing communicable necessary.’’ 42 U.S.C. 264(d)(1). HHS/
through an Executive Order of the disease spread, HHS/CDC will also take CDC strongly believes that these

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6910 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

authorities may be implemented in a Executive Order 13674 (July 31, 2014), provided by the examining health care
manner consistent with the U.S. explicitly excludes ‘‘influenza’’ from the provider in coordination with the health
Constitution. Furthermore, during the definition of severe acute respiratory department of jurisdiction.
period of apprehension, HHS/CDC will syndrome. After consideration of these
arrange for adequate food and water, HHS/CDC received several comments comments, HHS/CDC has finalized the
appropriate accommodation, from a flight attendant union relating to Apprehension and Detention of Persons
appropriate medical treatment, and apprehension and detention of a flight With Quarantinable Communicable
means of necessary communication. crew. These comments include that the Diseases (§ 70.6) provision as proposed,
HHS/CDC received comments from flight attendant’s employer should be with the exception that Federal public
the public inquiring about the criteria made aware of the apprehension, that health orders must be served on the
that HHS/CDC uses to determine HHS/CDC should limit the personal individual within 72 hours of an
whether an individual should be health information that is shared with apprehension. As further detailed
detained and assessed. As provided for the employer, that the employer should below, the 72-hour period was
in the regulation, HHS/CDC may treat this information as confidential, determined based on public comment
apprehend, examine, isolate, and and that those apprehended should be from health departments familiar with
quarantine such individuals to protect able to notify families and their union. the process, as well as CDC’s previous
the public’s health. In determining In response, HHS/CDC notes that it experience of the time necessary to
whether an individual poses a threat to works closely with the airline industry conduct a medical examination, collect
public health, HHS/CDC has developed regarding potential occupational and package laboratory specimens,
and uses the following criteria: Clinical exposures to communicable diseases. transport the specimens to an
manifestations: Signs and symptoms Furthermore, HHS/CDC notes that appropriate laboratory (when
consistent with those of a quarantinable personally identifiable health necessary), and conduct the testing.
disease; known or suspected contact information collected and maintained
f. Medical Examinations
with a case, i.e., patients either under the Privacy Act will be disclosed
confirmed or suspected to be infected only with the consent of the subject HHS/CDC received several comments
with a quarantinable disease; individual, in accordance with the relating to medical examinations. HHS/
epidemiologic information/evidence routine uses published in HHS/CDC’s CDC received a comment from a public
(travel history, exposure to animals); system of records notice (72 FR 70867), health agency stating that when an
other documentary or physical evidence or under an applicable exception to the individual agrees to submit to a medical
in the individual’s possession, such as Privacy Act. While these regulations do examination, it may be more
a physician’s note documenting not mandate how employers should appropriate to medically examine the
infection with or medication for treat the personal health information of patient during the ‘‘apprehension’’
treatment of a quarantinable their employees, HHS/CDC agrees that period. In response, HHS/CDC notes
communicable disease; and/or public such information should be treated as that these regulations do not prohibit
health authorities have notified HHS/ confidential. Lastly, consistent with voluntary compliance with public
CDC that the individual is known or principles of preventing communicable health recommendations in the absence
suspected to be infected with a disease spread, HHS/CDC will allow of a public health order.
quarantinable communicable disease persons detained in accordance with Notwithstanding, HHS/CDC believes
and non-adherent with public health these regulations to communicate with that the ability to order a medical
recommendations. This determination is family, union representatives, legal examination as part of an order for
typically made in consultation and counsel whom they hire at their own isolation, quarantine, or conditional
coordination with State and local public expense, and others of their choosing. release is an important tool to protect
health authorities, as well as the treating HHS/CDC will also appoint the public’s health. This agency also
health care physician (when available). representatives, including a medical stated that the definitions of ‘‘health
One public health association agreed representative and an attorney, if the status’’ and ‘‘public health risk’’ should
that travel history (entering the U.S. individual is indigent and requests a be modified to ensure that the medical
from a country where quarantinable medical review. examination contains the minimum
diseases occur) made sense for One commenter asked about requirements needed to assess the
screening, but not for a quarantine or provisions for people detained under communicable disease of public health
isolation order. HHS/CDC responds that HHS/CDC’s authority who require concern. In response, HHS/CDC clarifies
the criteria listed above, as well as those emergency medical care, and whether that its sole purpose in ordering a
within the NPRM, are examples of the need to conduct a public health medical examination would be to
factors that HHS/CDC takes into assessment could impede such care determine the presence, absence, or
consideration when determining the resulting in harm to the individual. In extent of infection with a quarantinable
totality of the circumstances—not one response, HHS/CDC states that public communicable disease. HHS/CDC notes,
criterion does, should, or will, decide if health officers at ports of entry work however, that the medical examination
the individual requires a public health closely with emergency medical service is conducted by clinical staff who have
order. (EMS) personnel and that emergency primary responsibility for the patient’s
One commenter questioned whether, medical care takes precedence over the medical care and treatment and that a
regarding the list of quarantinable public health risk assessment. When an medical examination would thus
communicable diseases listed by individual suspected of being infected ordinarily include the taking of a
Executive Order of the President, a with a quarantinable communicable medical history and physical
mstockstill on DSK3G9T082PROD with RULES3

‘‘common cold’’ would qualify as a disease requires emergency care, the examination. HHS/CDC believes that
‘‘severe acute respiratory syndrome’’ individual would be transported this definition is clear and that no
and therefore subject the ill individual immediately by EMS to a medical further modifications are needed.
to a public health order. In response, we facility, using appropriate infection HHS/CDC received a comment
note that Executive Order 13295 (April control precautions. The public health expressing concern that an individual
4, 2003), as amended by Executive risk assessment would be completed would not be able to choose his or her
Order 13375 (April 1, 2005) and subsequently using information own clinical healthcare provider if

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6911

ordered to undergo a medical the patient’s informed consent that such orders had been used
examination. One commenter raised consistent with established standards of effectively in the past to facilitate timely
concerns about the possibility of medical practice. examination.
medical examinations being conducted Public health organizations provided One public health organization
by ‘‘unqualified’’ or ‘‘non-medical several comments regarding medical requested that language be added to the
personnel.’’ In response, HHS/CDC examinations, including that they be rule stating that medical examinations
clarifies that, in keeping with current performed promptly so as not to curtail will be performed with proper
practice, any medical evaluation liberty, include only minimal adherence to worker safety and health
required by HHS/CDC would be components necessary to establish the policies and protocols. HHS/CDC
conducted at a healthcare facility by a diagnosis of or rule out the responds that such occupational health
licensed healthcare practitioner. quarantinable communicable disease of protections are beyond the scope of this
Furthermore, HHS/CDC has determined concern, and that specimens obtained regulation and are covered by
that it would be impractical to allow during such examinations not be used regulations of the Occupational Safety
individuals to choose their own medical for purposes other than diagnostic and Health Administration (OSHA).
examiners. HHS/CDC notes that among testing without informed consent. In HHS/CDC received several comments
other considerations, it must ensure that response, HHS/CDC states that it agrees from a flight attendant union relating to
the healthcare facility where the with all of these points and that CDC, medical examinations. This
medical examination will be conducted in keeping with current practice, has a organization stated that the regulations
has appropriate containment facilities, commitment to upholding the highest should mandate that an employer pay a
that necessary laboratory samples will ethical standards for both medical care flight attendant’s salary and per diem
be properly collected, and that it is and research. and that no flight attendant should
HHS/CDC’s practice to coordinate One public health organization asked incur discipline as a result of being
closely with State and local public for clarification of whether hospital staff absent from work. This organization
health authorities in the choosing of would be involved in obtaining consent further commented that any changes in
clinical healthcare providers. for medical examinations authorized the employer-employee relationship
Accordingly, we have concluded that under this rule. In response, HHS/CDC should be addressed through joint
the public interest is best served by states that, while a public health order guidance between government and
having HHS/CDC, in coordination with authorizes that a medical examination industry groups. This group also
the local health authority and EMS, be conducted, should any invasive commented that ‘‘promptly’’ should be
choose the healthcare facility where the procedures be determined by the defined in terms of the length of time
medical examination will be conducted treating clinician to be necessary for that may be needed to arrange for a
and not the detained individual. diagnostic or treatment purposes, medical exam and that no more than
One commenter expressed concern consent for such procedures should be five hours would be reasonable. This
that nonmedical personnel may be obtained by medical staff in accordance group further stated that ‘‘reasonably
allowed to make a determination of with established standards. believed’’ should be defined to require
illness resulting in actions being taken One organization asked for specific, articulable facts that a trained
based on potential misdiagnosis. HHS/ clarification of the location where medical professional can articulate.
CDC appreciates the opportunity to medical examinations would be HHS/CDC responds that these
clarify this point. Decisions to issue conducted, including whether inpatient regulations do not alter, define, or
Federal public health orders are based or ambulatory-care facilities would be mandate the employer-employee
on the assessment of qualified and included. HHS/CDC responds that it relationship between flight attendants
licensed physicians. These decisions are will coordinate with State or local and their employers. In regard to the
based on all available evidence, health departments of jurisdiction timeframe for arranging a medical
including clinical presentation, medical concerning such operational details as examination, HHS/CDC rejects a
and exposure history, and the results of the exact locations where medical specific 5-hour timeframe as too
medical evaluation and laboratory examinations may be conducted. prescriptive, but agrees that the medical
testing. Treatment decisions are made Several public health organizations examination should be arranged as
by the individual’s treating physician commented on whether the issuance of quickly as possible based on the
with guidance from public health public health orders is needed prior to circumstances of the event. HHS/CDC
subject-matter experts. medical examination if individuals further notes that the definition of
One commenter suggested that agree voluntarily to such examinations, ‘‘reasonably believed to be infected’’
medical examinations should be noting that a requirement for the already requires the existence of
conducted only with the informed issuance of orders could impede or ‘‘specific articulable facts’’ articulated
consent of the individual and should delay the medical examination and that by a public health officer. Such specific,
not ‘‘forcibly’’ be required. HHS/CDC the examination, itself, could determine articulable facts would, for instance,
clarifies that it may require a medical whether such orders are needed. In include ‘‘contact with an infected
examination under 42 U.S.C. 264(d) response, HHS/CDC notes that it may person or an infected person’s bodily
because this section, among other choose not to exercise its authority to fluids, a contaminated environment, or
things, authorizes the ‘‘apprehension issue public health orders if an through an intermediate host or vector.’’
and examination’’ of individuals individual complies voluntarily with HHS/CDC received a comment from a
reasonably believed to be infected with HHS/CDC’s requirements, including the partnership of public health legal
quarantinable communicable diseases in requirement of a medical examination. scholars and organizations expressing
mstockstill on DSK3G9T082PROD with RULES3

a qualifying stage. CDC, however, agrees However, HHS/CDC retains the right to concern that the regulations do not
that medical examinations may not be issue an order requiring a medical appear to limit the invasiveness of a
conducted ‘‘forcibly.’’ Furthermore, examination should an individual not medical examination, so long as the
because medical examinations will comply voluntarily. Of note, one public examination itself is needed to diagnose
typically occur in a hospital setting and health organization supported the use of or determine the presence or extent of
be performed by clinical staff, it will be Federal public health orders in infection with a quarantinable
incumbent upon clinical staff to obtain requiring medical examinations, stating communicable disease. HHS/CDC

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6912 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

welcomes this opportunity to provide expect to publish the names of unusual for the Federal government to
further clarifications. HHS/CDC notes individual passengers or crew as part of exercise jurisdiction concurrently with
that because medical examinations will a publicly posted quarantine order. State and local governments.
occur in a hospital setting and be Furthermore, while HHS/CDC agrees One public health organization noted
performed by the hospital’s clinical that flight attendants provide an the longstanding difficulties faced by
staff, it will be incumbent upon clinical important public health and safety role, Federal, State and local authorities in
staff to obtain the patient’s informed HHS/CDC disagrees that acknowledging identifying suitable facilities for
consent consistent with established this role requires the issuance of quarantining of large groups of people
standards of medical practice prior to different public health orders than those (approximately 350, representing the
any examination occurring and that issued to other affected persons. potential complement of travelers
such examinations may not be forcibly HHS/CDC received several comments onboard an international flight),
conducted. HHS/CDC has also added a requesting the ‘‘least restrictive’’ means including the immediate availability of
requirement that the Director, as part of with respect to quarantine and isolation. such facilities in the event of an
the Federal order, the individual that HHS/CDC agrees and clarifies that in all emergency. HHS/CDC acknowledges
the medical examination shall be situations involving quarantine, these difficulties and affirms that it is
conducted by an authorized and isolation, or other public health actively working with Federal partners
licensed health worker with prior measures, it seeks to use the least to identify suitable locations to
informed consent. Furthermore, HHS/ restrictive means necessary to prevent accommodate large groups of people
CDC will implement this provision spread of disease. Regarding quarantine, while under a Federal public health
consistent with U.S. constitutional as an example, during the 2014–2016 order.
requirements and Articles 23 and 31 of Ebola epidemic, HHS/CDC One commenter stated, ‘‘If this is
the International Health Regulations, recommended monitoring of potentially enacted . . . everyone who works with
which requires that parties apply ‘‘the exposed individuals rather than diseases . . . CDC, WHO, Labs, Drs.,
least intrusive and invasive medical quarantine. Most of these people were nurses etc. would have to be arrested as
examination that would achieve the free to travel and move about the potential carriers.’’ HHS/CDC disagrees
public health objective.’’ community, as long as they maintained with this assertion. HHS/CDC is not a
After consideration of these daily contact with their health law enforcement agency and does not
comments, HHS/CDC has finalized the department. For some individuals with have authority to arrest individuals.
provisions relating to Medical higher levels of exposure, HHS/CDC HHS/CDC’s authority to issue Federal
Examination (§§ 70.12 and 71.36) as recommended enhanced monitoring public health orders is limited to those
proposed, with the exception that the (involving direct observation) and, in diseases defined by Executive Order as
Director as part of the Federal order some cases restrictions on travel and quarantinable communicable diseases.
must advise the individual that the being in crowded places, but did not Furthermore, HHS/CDC does not
medical examination will be conducted recommend quarantine. HHS/CDC has recommend restriction of movement for
by an authorized and licensed health the option of ‘‘conditional release’’ as a healthcare workers, laboratory workers,
worker with prior informed consent. less restrictive alternative to issuance of or others whose occupations involve
an order of quarantine or isolation. working with infectious pathogens as
g. Requirements Relating to Issuance of long as the recommended infection
Under a conditional release order, the
a Federal Order for Quarantine, control precautions are followed.
person would not be confined as long as
Isolation, or Conditional Release Workers who do not take the necessary
the terms of the order were followed.
HHS/CDC received several comments Should a quarantine or isolation order precautions or have unprotected
relating to the issuance of Federal orders be deemed necessary, home quarantine exposures to a quarantinable
for isolation or quarantine. A flight or isolation would be considered as a communicable disease may be subject to
attendant union commented that crew less restrictive option to confinement in restrictions if they meet the
lists should not be published as part of a guarded facility as long as this was requirements for issuance of Federal
a quarantine order posted in a determined to be safe for other public health orders.
conspicuous location. This group household members, appropriate based Some commenters indicated that
further stated that quarantine orders for on the individual’s ability and vaccination or treatment should not be
flight attendants should be treated willingness to follow all necessary ‘‘conditions’’ under ‘‘conditional
differently than those applicable to precautions, and based on the release.’’ HHS/CDC confirms that this
passengers or other airline personnel individual’s history of compliance with final rule does not compel mandatory
because flight attendants are health and public health recommendations. vaccination or medical treatment of
safety personnel trained in how to One public health organization individuals. HHS/CDC clarifies that
perform CPR and operate defibrillators. requested that HHS/CDC specify the when medically appropriate,
In response, HHS/CDC notes that if a types of locations of Federal quarantine vaccination or treatment, may be
public health order is publicly posted, and asked clarification of whether this ‘‘conditions’’ of an individual’s release
the order will be written to refer to a would occur on lands or property under from quarantine or isolation.
group of individuals, such as all Federal jurisdiction, and whether Individuals consent to these conditions.
individuals onboard a particular Federal or State standards would apply A public health agency commented
affected interstate or international flight. to an individual quarantined on lands or that HHS/CDC should consider the
Under such circumstances, HHS/CDC property not under Federal control. In conditions of confinement to ensure that
expects that all members of the group response, HHS/CDC notes that certain minimum requirements, such as
mstockstill on DSK3G9T082PROD with RULES3

will receive individual copies of the operational issues such as the exact access to telephones, and reasonable
public health order. In some location of a quarantine and whether accommodation of dietary restrictions,
circumstances, CDC anticipates that Federal, State, and local orders would are observed. Specifically, such
issuance of a group federal order to an be issued separately or concurrently conditions should be considered at
individual may not be feasible—such as would depend on individual facts and different stages including as part of the
when the location of the individual is circumstances unique to each case. issuance of an order, during the
unknown. Thus, HHS/CDC does not HHS/CDC notes, however, that it is not mandatory reassessment, and as a part

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6913

of the medical review. In response, through posting or publication, but only CDC is committed to performing a
HHS/CDC notes that in addition to when individual service is reassessment within 72 hours of the
implementing these regulations ‘‘impracticable.’’ federal public health order being served
consistent with U.S. constitutional After consideration of these on the individual. If, at that time, HHS/
requirements, CDC’s implementation comments, HHS/CDC has modified the CDC determines that the order was
will also be consistent with Article 32 provisions regarding requirements properly issued and that a public health
of the International Health Regulations relating to issuance of a Federal order risk continues to exist, the order would
which, among other things, requires that for quarantine, isolation, or conditional either be continued or HHS/CDC would
in implementing health measures under release (§§ 70.14 and 71.37). Paragraphs work with the State and local health
the IHR the gender, sociocultural, ethnic (a)(5) and (4) of these provisions have department to transfer custody. In the
and religious concerns of the traveler be been modified, respectively, to require event that HHS/CDC continues the
taken into consideration. Furthermore, that the federal order include an order, the individual may request a
Article 32 requires arranging for explanation of the right to request a medical review at that time.
adequate food and water, protection for medical review, present witnesses and A few commenters stated that the
baggage and other possessions, testimony at the medical review, and to reassessment of HHS/CDC’s orders
appropriate accommodation, be represented at the medical review by should be conducted in a shorter time
appropriate medical treatment, and either an advocate (e.g., family member, period than 72 hours such as within 12
means of necessary communication for physician, or attorney) at the hours, performed electronically and
those subject to public health orders. individual’s own expense, or, if conducted by a 3rd party. While HHS/
Furthermore, as stated in the indigent, to have representatives CDC appreciates the input provided by
regulations, as part of a mandatory appointed at the government’s expense. these commenters, HHS/CDC finds
reassessment and medical review, HHS/ Paragraph (b) of these provisions has these suggestions impractical. Medical
CDC will consider whether the least been modified to require that a Federal examination to confirm or rule out
restrictive means are being used to public health order be served within 72 infection with a quarantinable
protect the public health. HHS/CDC, hours of an individual’s apprehension. communicable disease may require up
however, does not believe that it is A new provision, paragraph (c), has to 72 hours to allow for laboratory
necessary for ‘‘conditions of been added requiring that the Director testing. While some communicable
confinement’’ to be formally considered arrange for translation and diseases (typically viral infections) may
as part of an administrative review interpretation services of the Federal be diagnosed using molecular tests such
because many conditions of order as needed. as polymerase chain reaction (PCR) that
confinement, such as availability of take several hours to perform, others
h. Mandatory Reassessment of a Federal
entertainment or other amenities, may require that the organism be cultured to
Order for Quarantine, Isolation, or
be raised through informal means such make a confirmed diagnosis or to
Conditional Release
as making one’s concern known to the conduct antimicrobial sensitivity testing
facility where the individual is being A number of commenters were in order to provide appropriate
housed. confused regarding the 72-hour period, treatment. This is typically needed for
HHS/CDC received a comment from a believing this period referred to the bacterial infections, such as diphtheria
public health agency noting that it period of apprehension pending the or plague, and may take 48–72 hours (or
should assume the responsibility of issuance of a Federal public health longer) to complete. For some infectious
providing translation and interpretation order and asked why 72 hours were tuberculosis cases, laboratory
services when issuing an order for needed. The 72-hour period proposed confirmation may take several weeks
quarantine, isolation, or conditional referred to the timeframe in which HHS/ although preliminary molecular testing
release, or when conducting a medical CDC must conduct a mandatory may assist in conducting an assessment
review. HHS/CDC agrees and has reassessment of the continued need for of risk sufficient to continue or rescind
incorporated these changes into the isolating or quarantining an individual the order. Specimen transportation time
regulatory text. following the service of a Federal public may also need to be factored in as
HHS/CDC received a comment from a health order. However, in response to testing for certain diseases is only
partnership of public health legal public comments HHS/CDC has also available at state public health
scholars and organizations requesting added in sections 70.14(b) and 71.37(b) laboratories or CDC.
clarification as to whether personal a requirement that it serve the While HHS/CDC is required by this
service will occur when a quarantine individual with a Federal public health provision to reassess the need for a
order is issued on a group basis and order within 72 hours of that Federal public health order within 72
posted in a conspicuous location. In individual’s apprehension. hours, HHS/CDC will immediately
response, HHS/CDC notes that if a Some commenters, including a public release individuals from detention if at
public health order is publicly posted, health association, supported the any time it receives information
the order will be written to refer to a mandatory 72-hour reassessment confirming the absence of infection with
group of individuals, such as all provision guaranteed by these a quarantinable communicable disease.
individuals onboard a particular regulations. One of these commenters We note that while the medical
affected interstate or international flight. also suggested the time be re-evaluated assessment is intended primarily as a
Under such circumstances, HHS/CDC periodically in the event that technology review of available medical records and
expects that all members of the group provides a way of speeding up the other relevant information, these
will receive individual copies of the diagnosis process; another suggested the regulations do not prohibit HHS/CDC
mstockstill on DSK3G9T082PROD with RULES3

public health order, thus addressing any time frame be expanded to five days to from conducting the review
concerns about adequacy of notice. account for weekends; one more electronically, for instance by relying on
Because HHS/CDC, however, cannot commenter noted that circumstances electronic medical records.
foresee all of the circumstances that may may arise where an additional 72 hours Furthermore, HHS/CDC disagrees that
arise in an emergency situation, HHS/ may be needed; and another commenter relying on internal decision-makers for
CDC believes that it is appropriate for stated that a second 72-hour the reassessment is inappropriate or
these regulations to authorize service reassessment should be required. HHS/ undesirable and thus does not consider

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6914 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

it necessary to rely on a ‘‘3rd party.’’ reasonable under all of the communicability, appropriateness of the
However, the CDC official or employee circumstances). home environment, and the individual
conducts the reassessment will not be After consideration of these patient’s understanding, ability, and
the same person who issued the comments, HHS/CDC has finalized the willingness to comply with less
quarantine, isolation, or conditional provisions relating to mandatory restrictive alternatives. For this reason,
release order. Following the reassessment of a Federal order for HHS/CDC has made consideration of
reassessment, the detained individual quarantine, isolation, or conditional less restrictive alternatives a part of the
may also request a medical review as release (§§ 70.15 and 71.38) as medical review proceeding where
described in these regulations. proposed. evidence may be submitted into the
HHS/CDC received a comment from a record, testimony obtained, and a
i. Medical Review of a Federal Order for
public health agency requesting recommendation provided by the
Quarantine, Isolation, or Conditional
clarification as to whether all medical reviewer. As a general matter,
Release
individuals within a group will receive however, HHS/CDC clarifies that less
individual due process when a group HHS/CDC received several comments restrictive alternatives would refer to
order is issued. This agency also arguing that its proposed medical reasonable and available alternatives
questioned the feasibility of providing a review procedures are deficient. that are adequate to protect the public’s
mandatory reassessment and medical Specifically, one commenter stated that health other than confinement in a
review for large groups. In response, assessment procedures should be clearly guarded facility, such as home
HHS/CDC confirms that if a group order communicated to all affected persons; quarantine, directly observed therapy,
is issued, all individuals within that that HHS/CDC should more clearly or other forms of supervised release.
group will be accorded due process. delineate ‘‘less restrictive alternatives;’’ In response to concerns about legal
Furthermore, HHS/CDC has provided that affected individuals should have a representation, HHS/CDC has amended
flexibility in the regulations to allow for right to legal representation; and that the definition of ‘‘Medical
a mandatory reassessment of the group access to independent judicial review is representative’’ to ‘‘Representatives’’
order and consolidation of medical essential. and will now appoint ‘‘an attorney
reviews where appropriate. HHS/CDC agrees that it should clearly knowledgeable of public health
HHS/CDC received a comment from a communicate review procedures to practices’’ in addition to a ‘‘physician,
partnership of public health legal individuals subject to Federal isolation, nurse practitioner, or similar medical
scholars and organizations stating that quarantine, or conditional release. We professional qualified in the diagnosis
while the rule requires consideration of note that sections 70.14 and 71.37 have and treatment of infectious diseases.’’
least restrictive means upon been modified to require that the federal HHS/CDC hopes that by appointing both
reassessment of an order and as part of order authorizing isolation, quarantine, an attorney and a qualified medical
the medical review, HHS/CDC must also or conditional release include an professional for indigent individuals it
consider least restrictive means prior to explanation that the federal order will will alleviate concerns expressed by the
the issuance of a quarantine or isolation be reassessed 72 hours after it is served public regarding the medical review
order. HHS/CDC agrees that all means on the individual and of the right to process. We note that an attorney may
short of assuming legal custody of the request a medical review, present become ‘‘knowledgeable of public
individual including attempting to witnesses and testimony at the medical health practices’’ in a number of ways,
obtain voluntary compliance with review, and to be represented at the for instance, through prior
public health measures should be medical review by either an advocate representation of a public health agency
explored. HHS/CDC notes, however, (e.g., family member, physician, or or advocacy organization, training
that an isolation or quarantine order is attorney) at the individual’s own provided by a public health or advocacy
typically issued in time-sensitive expense, or, if indigent, to have organization or other training that
situations where because of the exigent representatives appointed at the would ordinarily occur through a
circumstances surrounding the risk of government’s expense. We further note Continuing Legal Education (CLE)
communicable disease spread it is not that the provisions relating to medical event, law school coursework, or
immediately possible to explore all reviews, sections 70.16 and 71.39 have through independent study. We further
available less restrictive means, been revised to include new paragraphs note that for individuals qualifying as
including the appropriateness of a home (q) which states that ‘‘The Director shall indigent, HHS/CDC intends to provide
environment, instead of a hospital. For arrange for translation or interpretation independent legal counsel from outside
this reason, HHS/CDC has chosen the services as needed for purposes of this of the agency. In doing so, HHS/CDC
mandatory reassessment and medical section.’’ may employ a variety of mechanisms,
review as the appropriate time to Similarly, in regard to minor children such as through agreements or
conduct a formal assessment of least or adults with a cognitive disability, memorandums of understanding with
restrictive means. To the extent that the HHS/CDC will work with a competent law school legal clinics, State or local
commenters suggest that due process guardian to ensure that procedures are bar associations, or public interest
requires more, we disagree. See Yin v. clearly communicated. In regard to less groups representing indigent clients.
California, 95 F.3d 864, 870 (9th Cir. restrictive alternatives, HHS/CDC Individuals who do not qualify as
1996) (recognizing that in searches and believes that it is not possible to indigent may choose to be represented
seizures justified by special needs, the delineate with specificity all of the less at the medical review by an advocate
government does not have to use the restrictive options that may be available (e.g., an attorney, physician, family
least restrictive means to further its because such determinations will member) and present a reasonable
mstockstill on DSK3G9T082PROD with RULES3

interests); Stockton v. City of Freeport, inevitably be based on the individual number of medical experts, of their own
Texas, 147 F.Supp.2d 642, 647 (S.D. circumstances of each case, including choosing and at their own expense.
Tex. 2001) (recognizing that the Fourth the severity of the particular disease- HHS/CDC also agrees that access to
Amendment does not require that a causing agent, availability of treatment independent judicial review is essential
search or seizure be conducted through options should the disease not be and assures the public that this final
the least restrictive means, but rather adequately contained, the patient’s rule does not affect the constitutional or
that the alleged personal invasion be particular level of infectivity or statutory rights of individual to seek

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00026 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6915

judicial review through such traditional consolidated, HHS/CDC believes that nevertheless make reasonable efforts to
mechanisms as a petition for a writ of the circumstances giving rise to the produce any HHS/CDC employees that
habeas corpus under 28 U.S.C. 2241. As need for consolidation will be would be critical to a detained
a Federal agency, however, HHS/CDC exceedingly rare and that medical individual’s presentation of evidence
would lack the legal authority through reviews will generally be conducted on during a medical review.
regulation to grant Federal courts with an individual basis. HHS/CDC also disagrees that there is
jurisdiction that they would not HHS/CDC also disagrees that there is no judicial review and notes that these
otherwise possess because only no access to legal counsel because HHS/ regulations do not impact an
Congress may expand a Federal court’s CDC will, consistent with principles of individual’s constitutional or statutory
jurisdiction. preventing communicable disease rights to contest their Federal detention
HHS/CDC received a comment from a spread, allow persons subject to public through such traditional mechanisms as
partnership of public health legal health orders to communicate with a petition for a writ of habeas corpus
scholars and organizations stating that family and legal counsel whom they under 28 U.S.C. 2241. To the extent,
the CDC Director should not have hire at their own expense. Furthermore, however, that the commenter contends
unfettered discretion to accept or reject as described above, the regulations have that HHS/CDC should follow legal
the medical reviewer’s decision, but been amended to require the procedures other than those set forth
rather should only be allowed to reject appointment of both an attorney and a through the Federal quarantine statute
a decision based on lack of substantial medical professional if the detained at 42 U.S.C. 264, we disagree. HHS/CDC
evidence. HHS/CDC believes that it individual qualifies as an indigent and notes that as a Federal agency it lacks
would be inappropriate to mandate requests a medical review. Individuals the ability to rewrite Federal statutes or
through regulation that the decision of who do not qualify as indigent may also grant Federal courts with legal
a medical reviewer (which may include choose to be represented at the medical jurisdiction that they do not already
an HHS or CDC employee) should review by an advocate (e.g., an attorney, possess. HHS/CDC also rejects as
displace the decision of the CDC physician, family member) and present impractical and as insufficient to protect
Director, particularly where the statute a reasonable number of medical experts, public health, the notion that isolation
and delegation of authority have of their own choosing and at their own or quarantine should only occur based
provided otherwise. expense. upon the consent of the subject
HHS/CDC received several comments HHS/CDC further believes that individual.
stating that a medical representative reliance on internal reviewers does not HHS/CDC received a comment from a
should be appointed to anyone violate due process and notes that it is flight attendant union that as an
regardless of their ability to pay. HHS/ not unusual, for instance, for hospitals important ‘‘safety net’’ HHS/CDC should
CDC disagrees and notes that to rely on internal decision-makers pay for ‘‘second medical opinions.’’
appointment of a representative at the when determining whether to commit a HHS/CDC declines to extend payment
government’s expense without regard to mental health patient on an emergency to medical examinations beyond those
the patient’s indigence is not required. basis. The regulations, moreover, required as part of a public health order,
The status of ‘‘indigent’’ is self-reported explicitly state that the medical but notes that as part of a medical
as HHS/CDC will not require access to reviewer will not be the same individual review individuals may submit
an individual’s financial records. Those who initially authorized the quarantine additional evidence into the record
who self-identify as indigent may be or isolation order. We note further that concerning their health status and
required to sign an affidavit or the definition of both ‘‘representatives’’ potential public health risk to others.
declaration under penalty of perjury and ‘‘medical reviewer’’ would in fact One commenter noted language in the
stating they meet the threshold of at allow for the appointment of non-HHS/ NPRM stating that the ‘‘medical review
least 200% of the applicable poverty CDC employees in these capacities is not intended to address the concerns
guidelines. because both terms are broadly defined of individuals who take issue with
HHS/CDC received a comment from a in terms of the professional amenities of their confinement . . .,’’
non-profit organization contending that qualifications and not employment interpreting this to mean that ‘‘no
the medical review does not comport status of these individuals. Thus, these provision is made for those who must
with due process because there is no regulations do not prohibit the CDC use a CPAP (continuous positive airway
limit on the number of reviews that may Director from appointing personnel pressure) at night or who need
be consolidated into a single from outside of the agency to assist in orthopedic appliances, or who have
proceeding, no access to legal counsel, conducting a medical review. For food allergies, to name a few.’’ In
no independence of the reviewer from individuals qualifying as indigent, HHS/ response, HHS/CDC states that, when
the initial decision-maker, no CDC intends, generally, to provide confinement of an individual under
confrontation or cross-examination of independent legal counsel from outside Federal public health authorities is
witnesses, no compulsory process for of the agency. needed, HHS/CDC will ensure that such
obtaining evidence or testimony, and no HHS/CDC also clarifies that during confinement will occur in a location
judicial review. This group contends the course of a medical review, a and with necessary amenities to ensure
that any detention that is non-exigent detained individual will be permitted to the health and safety of the individual,
should occur only based on the present witnesses and question any including provision for medical or
‘‘informed explicit written consent’’ of witnesses offered by HHS/CDC. Any dietary requirements. Issues related to
the patient or ‘‘utilize the existing legal ‘‘confrontation’’ of witnesses, however, health and safety will be addressed at
procedures for involuntary commitment will be conducted in a manner the time of the issuance of the order, or
mstockstill on DSK3G9T082PROD with RULES3

of persons.’’ consistent with principles of preventing as soon as HHS/CDC is made aware of


HHS/CDC disagrees that the medical communicable disease spread. HHS/ them, but are beyond the scope of the
review as described and set forth in the CDC, as a Federal agency, however lacks medical review which is intended to re-
regulations does not comport with due the legal authority to allow a detained evaluate the continued need for the
process. While HHS/CDC acknowledges individual to use compulsory processes, Federal public health order based on a
that there is no numerical limit to the such as a subpoena, to compel the review of the medical and other
number of medical reviews that may be presence of witnesses. HHS/CDC will evidence submitted into the record.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6916 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

HHS/CDC received a comment from a j. Administrative Records Relating to a rights guaranteed by the U.S.
partnership of public health legal Federal Order for Quarantine, Isolation, Constitution, such as Due Process and
scholars and organizations stating that it or Conditional Release specifically during the medical review
should provide for an oral hearing HHS/CDC received a comment from a process. HHS/CDC disagrees that the
whenever practical. HHS/CDC agrees flight attendant union concerning regulations are insufficient to protect
that an oral hearing is appropriate and whether an overlap existed between the constitutional rights of individuals.
has modified the language to state: ‘‘The CDC’s maintenance of administrative In regard to medical reviews, HHS/CDC
medical review shall be conducted by asserts that allowing individuals to
records relating to the issuance of
telephone, audio or video conference, or choose at the government’s expense
Federal public health orders and an
through other means that the medical who will conduct the medical review is
employee’s access to exposure and
not required by due process and that
reviewer determines in his/her medical records under OSHA (29 CFR
there is no conflict of interest in
discretion are practicable for allowing 1910.1020). We note that since HHS/
allowing the CDC Director to appoint
the individual under quarantine, CDC is not a flight attendant’s employer,
who will conduct the medical review on
isolation, or conditional release to HHS/CDC would not be covered by this
the agency’s behalf. HHS/CDC asserts,
participate in the medical review.’’ particular OSHA standard under these
however, that individuals will be
circumstances. Furthermore, because
HHS/CDC received a comment from a allowed to submit relevant information,
these regulations do not alter, define, or including information provided by
partnership of public health legal
mandate the employer-employee outside doctors or other medical
scholars and organizations that the CDC relationship between flight attendants
Director’s written order, which specialists during the medical review.
and their employers, to the extent that HHS/CDC will further preserve relevant
constitutes final agency action, must this question seeks input regarding an
advise individuals of their rights to agency documents for purposes of
employer’s obligations under OSHA, ensuring a competent legal review in the
appeal to Federal court. We note that HHS/CDC views the question as outside
the commenters specifically cite the event that the individual seeks judicial
the scope of the rulemaking. redress of their quarantine or isolation.
Administrative Procedures Act (APA, 5 HHS/CDC received a comment from a As explained elsewhere, law
U.S.C. 704), which provides that ‘‘final partnership of public health legal enforcement support for quarantine or
agency action for which there is no scholars and organizations stating that isolation orders will generally be
other adequate remedy in a court are the regulations should require quarterly provided by U.S. Customs and Border
subject to judicial review.’’ While HHS/ reporting to Congress to facilitate Protection, U.S. Coast Guard, or other
CDC agrees that independent judicial transparency and oversight. While CDC Federal law enforcement programs, but
review of agency decisions is available, recognizes the additional transparency HHS/CDC may also accept voluntary
it takes no position as to whether such that direct reporting of details related to state and local assistance in enforcing
reviews should occur under the APA (as quarantine activities may provide to the its Federal orders.
suggested by the commenters) or public, CDC notes that historically, the HHS/CDC received public comment
through other traditional mechanisms as issuance of Federal orders is rare (i.e., expressing concern with regard to
a petition for a writ of habeas corpus one to two orders issued per year). potential language barriers experienced
under 28 U.S.C. 2241. For this reason, Thus, publication of the specifics by foreign nationals during travel. HHS/
HHS/CDC believes that due process is surrounding individual quarantine cases CDC responds that it has revised those
satisfied by designating the Director’s may raise significant privacy concerns sections of the regulations dealing with
written order as ‘‘final agency action’’ related to the individuals placed under issuance of Federal orders to require
federal orders. that HHS/CDC arrange for translation or
without further speculation as to the
CDC does routinely describe its interpretation services of the Federal
exact form of further legal review.
practices in published Morbidity and order as needed. In circumstances
However, to clarify HHS/CDC’s Mortality Weekly Reports (MMWR) where it would be impractical to
intended we have added the following when new methods, technologies, or provide a line-by-line translation of the
language to the regulatory text: other changes make it possible to revise order, HHS/CDC may take other steps to
‘‘Nothing in these regulations shall and improve programs (e.g. DNB, M&M reasonably apprise individuals of the
affect the constitutional or statutory guidance, change in air contact contents of the order, for example, by
rights of individuals to obtain judicial investigation algorithms), which all arranging for oral translation services.
review of their federal detention.’’ serve to enhance transparency. Such One public health organization
Accordingly, after consideration of information is also found on CDC’s Web questioned the feasibility of CDC’s
these comments, HHS/CDC has site and publicly available standard conducting the mandatory reassessment
modified paragraph (f) of the provisions operating procedures. or medical review of a group quarantine
regarding medical review of a Federal After consideration of comments order within the specified time frame. In
order for quarantine, isolation, or received and as further explained response, HHS/CDC states that a group
conditional release (§§ 70.16 and 71.39) below, HHS/CDC has modified the quarantine order would be issued on the
to include the revised definition of provisions regarding Administrative basis of a shared exposure for all
Records relating to a Federal order for individuals in the group; therefore, the
‘‘Representatives,’’ which now requires
quarantine, isolation, or conditional mandatory reassessment or medical
HHS/CDC to appoint both a medical
release (§§ 70.17 and 71.29) to remove review could be conducted based on the
professional and an attorney ‘‘to assist shared exposure, unless certain
paragraphs (5) regarding agreements
mstockstill on DSK3G9T082PROD with RULES3

the individual for purposes of the entered into between HHS/CDC and the individuals in the group were
medical review upon a request and individual. determined to be immune to the
certification, under penalty of perjury, quarantinable communicable disease in
by that individual that he or she is k. Other Due Process Concerns question. Part of the reassessment
indigent and cannot afford a HHS/CDC received many additional would include a determination of
representative.’’ comments from the public concerned whether the group order should be
over whether this regulation violates revised as individual orders.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00028 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6917

HHS/CDC also received a comment One public health organization manifestations of physical illness or
that the duration of a quarantine, recommended that HHS/CDC include laboratory test results. Thus, weighing
isolation, or conditional release period written notification to individuals under these factors, HHS/CDC disagrees that
is not adequately defined. HHS/CDC public health orders of the duration that due process requires it to adopt a system
disagrees because the regulations limit the order will be in effect. HHS/CDC of mandatory administrative hearings in
these actions to only those who would responds that it will provide the absence of the individual requesting
pose a public health threat, for instance, information on the incubation and a medical review.
by being in the ‘‘qualifying stage’’ or a communicability period of the Regarding the use of a ‘‘neutral’’
quarantinable communicable disease. quarantinable communicable disease, if decision maker, HHS/CDC restates that
The ‘‘qualifying stage’’ of the disease is known, but that the duration of the the definition of both ‘‘representatives’’
defined as a communicable stage of the public health order may depend on a and ‘‘medical reviewer’’ would in fact
disease or a precommunicable stage, but variety of factors, such as demonstration allow for the appointment of non-HHS/
only if the disease would be likely to of non-infectiousness through repeated CDC employees in these capacities. The
cause a public health emergency if laboratory testing. Thus, HHS/CDC is regulations, moreover, explicitly state
transmitted to other individuals. We unable to provide an exact numerical that the medical reviewer will not be the
note that HHS/CDC’s ‘‘Health limit (in terms of days or hours) that a same individual who initially
Information for International Travel’’ public health order will remain in authorized the quarantine or isolation
(also known as the Yellow Book) effect. order. Accordingly, HHS/CDC has
provides the public with general determined that the procedures it has
HHS/CDC received a comment from a
guidance regarding the expected length adopted for medical reviews comport
partnership of public health legal
of communicability for many with due process.
scholars and organizations stating that
quarantinable communicable diseases. in exigent circumstances HHS/CDC may l. Privacy
For more information, please see http:// isolate or quarantine an individual, but
wwwnc.cdc.gov/travel/yellowbook/ Several people commented on the
should then be required to hold a private nature of the doctor-patient
2016/table-of-contents. mandatory due process hearing within
HHS/CDC received a comment that relationship. HHS/CDC appreciates the
48 hours before a neutral decision- opportunity to respond to this concern.
the qualifications of who may issue a
maker. At the outset, HHS/CDC agrees HHS/CDC is charged with protecting the
quarantine or isolation order are not
with the commenters that the health of the public. At times, this
defined leading to concerns that such
orders will be issued by non-medically appropriate framework for determining requires obtaining private information
trained personnel. In regard to the the adequacy of due process procedures about people’s health or exposure
qualifications of who may issue a are the factors articulated by the history and taking certain actions to
Federal public health order, HHS/CDC Supreme Court in Matthews v. Eldridge, protect others from becoming sick with
notes that all orders are issued under 424 U.S. 319 (1976). These factors a communicable disease. HHS/CDC
the authority of the CDC Director, but include: (1) The private interest affected works closely with State and local
that in practice such determinations are by the government’s actions; (2) the risk health departments to ensure that ill
made only by personnel trained in of erroneous deprivation of such private people detained or isolated under
public health and licensed to practice interest through the procedures used Federal orders receive appropriate care
medicine in the United States. and the probable value, if any, of and treatment. HHS/CDC is also bound
One organization requested that HHS/ additional or substitute procedures; and by the Privacy Act to protect personally
CDC provide notification to the (3) the government’s interest, including identifiable information collected and
appropriate embassy if a foreign the function involved and the fiscal and maintained under that Act. For a more
national is placed under a Federal order. administrative burden of proposed detailed explanation of how such
In regard to non-resident foreign additional or substitute procedures. information is protected, please see
nationals, HHS/CDC clarifies that it will Concerning the private interest at stake, http://www.cdc.gov/sornnotice/09-20-
coordinate closely with the U.S. HHS/CDC disagrees that this interest 0171.htm. For information on the
Department of State to ensure that all should be measured solely in terms of retention and maintenance of such
rights and obligations under the Vienna the physical liberty of the individual, records, please see https://
Convention on Consular Relations and but notes that the private interest also www.archives.gov/records-mgmt/rcs.
bilateral agreements will be observed. includes an interest in receiving HHS/CDC received a comment from a
Because of the complexity of this issue, medical treatment and in not harming professor of public health law and
including reliance on the interpretation others, as would occur if the individual ethics stating that HHS/CDC should
of treaties and bilateral agreements, was communicable. The Federal address how the HIPAA Privacy Rule,
HHS/CDC believes that it is best to government’s interest, moreover, is Americans with Disabilities Act (ADA),
ensure compliance through operational particularly strong because it is not and Administrative Procedure Act
procedures, rather than to formalize simply guarding the welfare of a single (APA) counterbalance the powers set
such obligations through regulatory text. individual or even a small group of forth in the proposal and reflect
One commenter requested that HHS/ individuals, but rather protecting the ‘‘appropriate social distancing
CDC clarify its handling of issues public at large against the spread of a practices.’’ The commenter did not
relating to diplomatic immunity. HHS/ quarantinable communicable disease. highlight which specific provisions of
CDC recognizes that under the Vienna Most importantly, HHS/CDC believes these laws HHS/CDC should address or
Convention on Diplomatic Relations, that mandatory administrative hearings the relationship that these laws have to
mstockstill on DSK3G9T082PROD with RULES3

diplomats are not liable to any form of are unlikely to significantly guard social distancing. Notwithstanding,
‘‘detention.’’ It is HHS/CDC’s policy to against erroneous deprivations. Unlike HHS/CDC may generally state that these
coordinate closely with the U.S. subjective determinations of behavior regulations will be carried out
Department of State regarding any which typically form the basis of a consistent with Federal law.
public health issues arising in regards to mental health ‘‘civil commitment,’’ We note that HHS is a hybrid entity
diplomats and HHS/CDC will continue isolation and quarantine decisions are under HIPAA, but only those parts of
to do so under these regulations. based on objective criteria such as the Department that have been

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00029 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6918 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

determined to be health care all related medical expenses, housing individuals with the costs of their own
components are subject to the HIPAA costs, and other necessities for isolation or quarantine, payment for
Privacy Rule. CDC is generally not a individuals or groups subject to expenses will be made consistent with
health care component treated as a deprivations of liberty and that it is constitutional and ethical obligations to
‘‘covered entity’’ under the HIPAA ‘‘ethically unfair’’ for HHS/CDC to be provide for the basic necessities, e.g.,
Privacy Rule. However, certain specific the ‘‘payer of last resort.’’ Another food, medical treatment, for those
offices of HHS, CDC, and the National commenter stated that ‘‘CDC must subject to such public health orders.
Institute for Occupational Safety and guarantee financial help after third party Furthermore, these regulations do not
Health (NIOSH) performing activities payments are exhausted.’’ While HHS/ alter, define, or modify the contractual
related to the World Trade Center CDC acknowledges that it has an ethical, relationship between insurance
Health Program are considered health moral, and legal obligation to provide companies and the insured.
care components of HHS and must care and treatment for individuals under After consideration of these
comply with HIPAA and the Privacy a Federal quarantine or isolation order, comments, HHS/CDC has finalized the
Rule. HHS/CDC disagrees that it is ‘‘ethically provisions relating to payment for care
CDC most often acts as a public health unfair’’ to excuse a medical insurer or and treatment (§§ 70.13 and 71.30) as
authority under the HIPAA Privacy other entity with a contractual proposed.
Rule. During the course of a public obligation from paying for medical n. Agreements
health investigation it may seek the expenses. Accordingly, HHS/CDC has
support of a covered entity, such as a determined that it is appropriate for it HHS/CDC received comments relating
hospital or private physician. The to maintain and affirm its status as a to the intention and use of agreements.
HIPAA Privacy Rule permits the ‘‘payer of last resort.’’ Commenters worried that such
disclosure of public health information Two public health organizations ‘‘agreements’’ may be coerced, and
to public health authorities, such as the asked whether nonmedical costs such as individuals would be compelled to
CDC, and their authorized agents for training of staff, replenishing of submit to involuntary testing or
public health purposes including but personal protective equipment, ‘‘research projects.’’ One commenter
not limited to public health managing and disposing of biological stated that the definition of agreement is
surveillance, investigations, and waste and contaminated supplies, etc., circular and confusing because the word
interventions. More information are also subject to HHS/CDC payment ‘‘agreement’’ appears in the definition.
concerning the HIPAA Privacy Rule authorization. While the costs of care This commenter also suggested that
may be found here: http://www.cdc.gov/ and treatment of individual patients what HHS/CDC proposes should more
mmwr/preview/mmwrhtml/ under Federal public health orders are aptly be labeled as an ‘‘Affidavit’’ or
m2e411a1.htm. authorized by this rule, these additional ‘‘Affirmation’’ because the definition as
Similarly, we note that this final rule costs to the extent that they are proposed by HHS/CDC lacks bilateral
while formalizing administrative unrelated to the individual patient’s obligations on both parties.
policies and practices, does not affect treatment and care would not be Due to the number of public
the rights of individuals under the ADA covered by this rule. comments received expressing
or APA, which are statutes enacted by HHS/CDC received a comment confusion over this public health
Congress. One commenter opined that suggesting that the regulations allow for measure, HHS/CDC has removed the
collection of contact information as part charging detainees the medical and provisions on Agreements (70.18 and
of public health prevention measures hospital costs of nonconsensual 71.40), and modified other provisions of
and maintenance of administrative treatment. HHS/CDC disagrees and first, the final rule (70.1, 71.1(b), and 70.5) to
records raise privacy concerns and that clarifies that these regulations do not remove references to ‘‘agreements.’’
HHS/CDC should consider ‘‘super- authorize compulsory medical
o. Penalties
enhanced privacy protections’’ treatment. HHS/CDC further
consistent with the Model State Public acknowledges that constitutional Many commenters expressed concern
Health Privacy Act of 1999. HHS/CDC principles and medical ethics require over the penalties provisions contained
disagrees. As a Federal agency, HHS/ that those detained under isolation or within the proposed regulation.
CDC must abide by the laws established quarantine have access to adequate Specifically, one association objected to
by Congress for the protection of nourishment, appropriate ‘‘CDC’s proposed increase in penalties.’’
records, specifically the Privacy Act of accommodation, and medical treatment. Another stated that ‘‘CDC is not
1974, 5 U.S.C. 552. On December 13, However, HHS/CDC has determined qualified to decide upon the
2007, HHS/CDC published a system of that its obligation to pay for medical punishment.’’ HHS/CDC takes this time
records notice (72 FR 70867) under the care and treatment should be secondary to better explain that the penalties listed
Privacy Act describing, among other to the obligation of any third party, such in today’s final rule, which have been
things, safeguards for preventing the as a medical insurer that may have a codified as proposed, are set forth by
unauthorized use of information pre-existing contractual obligation with Congress via statutory language and
collected from travelers. HHS/CDC will the patient to pay for hospital expenses. codified into regulation to reflect
make disclosures from this system only Accordingly, HHS/CDC declines to current practice. This regulation serves
with the consent of the subject make any changes to the provisions to notify the public of the existing
individual, in accordance with routine authorizing payment for medical care statutory penalties for violation of
uses published in its system notice, or and treatment. quarantine regulations, which HHS/CDC
in accordance with an applicable A flight attendant union commented has no authority to change.
mstockstill on DSK3G9T082PROD with RULES3

exception under the Privacy Act. that HHS/CDC should pay for any One organization requested that
outside costs that the flight attendant language be added to rules regarding the
m. Payment for Care and Treatment would normally incur relating to issuance of penalties if an employer
HHS/CDC received several comments medical treatment, e.g., copayments, provides an ‘‘unsafe work or
relating to payment for medical deductibles. HHS/CDC declines this unhealthful working condition.’’ HHS/
expenses. One commenter stated that suggestion and notes that while it is not CDC responds that such penalties are
HHS/CDC should assume payment for HHS/CDC’s intent to unduly burden beyond the scope of this rule and refers

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00030 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6919

the commenter to regulations of the than the $1,000 set forth under 42 been revised to note that delays in
Occupational Safety and Health U.S.C. 271 (which sets a maximum compliance with manifest order
Administration. penalty of not more than $1,000 or one requirements may result from HHS/CDC
HHS/CDC received a comment from a year of jail, or both for violation of having incorrect traveler information in
flight attendant union regarding quarantine laws), and because 42 U.S.C. the manifest order.
criminal penalties stating that HHS/CDC 271 does not exempt its lower penalties The same industry organization also
should provide further clarification as to from 18 U.S.C. 3571(e), HHS/CDC has reports that all of the data available to
what constitutes a violation and clarify chosen to codify the greater penalties of them related to passengers are currently
that flight attendants who act in 18 U.S.C. 3571(b)(5) and (c)(5) and to transmitted as Advance Passenger
accordance with their company’s remove the lower penalties as stated in Information System (APIS), and
practices, policies, or procedures should 42 CFR 71.2 from the regulation. potentially under Passenger Name
not be held criminally liable. In After consideration of these Record (PNR), data to the Department of
response, HHS/CDC notes that while the comments, HHS/CDC has finalized the Homeland Security (DHS) and that there
text of the regulation is being updated, provisions relating to Penalties (70.18 is no reason to burden airlines with an
these regulations do not increase the and 71.2) as proposed. Penalties has order for passenger data. HHS/CDC
criminal penalties that may be imposed been moved to section 70.18, since recognizes that industry does submit
for violations of quarantine regulations proposed 70.18 Agreements has been certain passenger data to DHS and it is
or alter the manner in which liability removed from this final rule. not our intent to burden industry with
may be assessed. Rather, these duplicative requirements, but rather to
p. Economic Impact
regulations serve to inform the public of effectively and efficiently protect public
the criminal penalties that currently Within the analysis published with health. In the experience of the HHS/
exist in statute (42 U.S.C. 271 and 18 the NPRM, HHS/CDC solicited public CDC, queries from APIS/PNR rarely
U.S.C. 3571). Furthermore, HHS/CDC comment regarding the cost and benefit result in full sets of contact information
clarifies that criminal penalties, if any, estimates for airlines and vessel (i.e. the record includes all five
would be assessed by a court of law operators associated with improved additional data fields as outlined in the
based on an indictment or information provision of traveler contact data. While final rule). The data fields that are most
filed by an Assistant U.S. Attorney HHS/CDC received support for the data commonly missing from the records are
based on individualized facts and collection from two public health email addresses (missing 90 percent of
circumstances, and would not be associations, HHS/CDC received a the time), secondary phone number
determined administratively by the comment from industry who misread (missing 90 percent of the time), and
CDC. the proposals to mean that aircraft street addresses (missing or insufficient
HHS/CDC offers the following operators would be required to develop for public health contact tracing up to
explanation to inform the public new capacity and processes to capture 50 percent of the time). These data
regarding this section. As prescribed in and store a comprehensive set of elements are vital to a contact tracing
section 368 (42 U.S.C. 271) and under sensitive data, archive this data, and investigation. In looking at a random
18 U.S.C. 3559 and 3571(c), criminal then provide it to CDC. sample of 20% of the compiled
sanctions exist for violating regulations HHS/CDC restates and clarifies that international air travel manifests for
enacted under sections 361 and 362 (42 today’s final rule does not impose any 2015, those including a compiled data
U.S.C. 264 and 265). 18 U.S.C. 3559 new burdens upon the airline industry set from NTC and the airlines, 100%
defines an offense (not otherwise but rather, codifies the current practice were missing at least one of the 5 data
classified by letter grade) as a ‘‘Class A of receiving a passenger manifest order fields. Email address and secondary
misdemeanor’’ if the maximum term of (if needed, as CDC currently collects phone number were among those most
imprisonment is ‘‘one year or less but passenger information from CBP via frequently missing. For context, there
more than six months.’’ 18 U.S.C. 3571 APIS and PNR) and providing HHS/CDC were approximately 760,000 scheduled
provides that individuals found guilty with any data in an airline’s possession. flights that arrived into the United
of an offense may be sentenced to a fine. This regulatory impact analysis has States in 2015. In 2015, CDC issued
Specifically, an individual may be fined been revised to clarify that the rule does passenger manifest requests for 64
‘‘not more than the greatest of’’—(1) the not require an airline to solicit or store international flights arriving into the
amount specified in the law setting forth additional data. Therefore, HHS/CDC United States. As noted in the RIA of
the offense; or (2) for a misdemeanor does not expect that formalizing its the final rule, from 2010 to 2015, CDC
resulting in death, not more than current data collection practices will conducted an average of 77 contact
$250,000; or (3) for a Class A increase costs. Neither airlines nor U.S. investigations per year involving
misdemeanor that does not result in Customs and Border Protection (CBP) arriving international flights.
death, not more than $100,000. will need to develop new data systems Airlines are contacted for the majority
Similarly, an organization, found guilty nor will travelers need to provide data of contact investigations using a
of an offense may be fined ‘‘not more as part of the ‘‘check in process.’’ manifest order document. At a
than the greatest of’’—(1) the amount The same industry organization also minimum, CDC needs to confirm the ill
specified in the law setting forth the commented that they have been traveler was on the flight and where the
offense; or (2) for a misdemeanor complying effectively with the existing individual sat in relation to other
resulting in a death, not more than requirements, but have, on occasion travelers to determine risk of exposure.
$500,000; or (3) for a Class A found it difficult to locate, extract, In CDC’s experience the following has
misdemeanor that does not result in compile, format and transmit available been true:
mstockstill on DSK3G9T082PROD with RULES3

death, not more than $200,000. 42 information within the timeframe • Only airlines can quickly and
U.S.C. 271 sets forth statutory penalties specified in orders from HHS/CDC. efficiently produce a partial manifest
of up to 1 year in jail and a fine of They note that delays sometimes arise targeting affected rows;
$1,000. Therefore, it is classified as a because the manifest order may contain • only airlines can confirm identity of
Class A misdemeanor under 18 U.S.C. incorrect flight or passenger ‘‘babes in arms’’ and their co-travelers
3559. Because the alternate fines set information. The discussion in the (Parent); this is important for measles
forth under 18 U.S.C. 3571 are greater regulatory impact analysis section has cases;

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00031 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6920 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

• only airlines can quickly confirm industry did not provide any new requested that DHS/TSA restrict
whether an individual actually flew (in information regarding costs to search for interstate or international air travel for
instances where individuals deplane responsive data when receiving people known to be infectious with
and do not re-board during a layover); manifest orders. The benefit estimate measles who were noncompliant with
and has been revised and is lower than the public health recommendations not to
• only airlines can confirm a plane’s estimate for the NPRM to indicate that travel. However, HHS/CDC does not
configuration if there is a question with the airlines may not have any more recommend restricting the air travel of
the provided row numbers. Different contact data than is already provided in persons who have not received the
aircraft have different seating APIS or PNR data submitted to DHS. measles vaccine.
arrangements depending on carrier and HHS/CDC received a number of One commenter questioned whether
layout. It is important to know if a comments from the general public that the estimated value of statistical life
certain seat is separated by a bulkhead compared the relatively small number of ($9.4 million) should be multiplied by
or is a window seat. measles cases in any given year to the the total number of measles vaccine-
In addition, HHS/CDC only requires a total numbers of vaccine-associated associated adverse events in the United
partial manifest, e.g. 5 rows for travelers adverse events and health department States. HHS/CDC appreciates this
with infectious tuberculosis, so that spending to contain measles outbreaks. thoughtful comment. This would result
NTC and HHS/CDC staff can limit the Based on this comparison, commenters in a larger estimate in the cost of
investigation to only those passengers at believed that HHS/CDC and health measles vaccine-associated adverse
risk and supplement/cross reference departments spend too much money on events. However, this is not a correct
with APIS and PNR data. If a partial communicable disease control and that usage of the value of statistical life,
manifest is not available from the resources would be better allocated to which should only be multiplied by an
airlines, then each passenger record other activities. Some commenters estimated number of deaths. The
must be researched individually to find suggested that the costs of these adverse regulatory impact analysis has been
a seat number, and then the events should be included in a Small revised to better explain this distinction.
configuration of an entire plane must be Business Regulatory Enforcement Another commenter suggested that
populated to determine where the index Fairness Act analysis. In general, this public health department measles
case sat in relation to other at-risk type of analysis is outside the scope of response costs were overestimated by
passengers. For large flights from Asia, this regulatory impact analysis because using a model-based approach rather
this can pose a tremendous burden to this final rule does not require measles than estimating the cost of hiring of
NTC and CDC staff while slowing the vaccination. HHS/CDC’s recommended additional staff to deal with measles
ability of CDC to provide important vaccine schedule will not be affected by outbreaks. HHS/CDC addressed the
contact information to state and local this final rule. Although HHS/CDC comment in the regulatory impact
health departments. Manually recommends that health departments analysis by clarifying that the analysis is
populating multiple 300+ person flights offer measles vaccine to non-immune a published model-based analysis and
is not feasible in a timely manner. individuals exposed during travel, that the cost estimate is based on the
As part of its plan for retrospective measles is not a quarantinable opportunity cost of public health
analysis under E.O. 13563, HHS/CDC communicable disease and this final personnel and is not based on the cost
intends to synthesize, analyze, and rule does not require any individual to of hiring additional staff.
report within the next two years on receive a measles vaccine. Because HHS/CDC received comments from
strategies to reduce duplication of the health departments offer measles the airline industry indicating that the
collection of passenger/crew manifest vaccines to exposed, non-immune definition of ill person under 71.1 does
information in coordination with DHS/ travelers, HHS/CDC estimates that the align with Note 1 to Standard 8.15 of
CBP. The report will include any final rule will only result in a small ICAO’s Annex 9 to the Convention on
recommendations (e.g., IT systems number (6) of additional measles International Civil Aviation. HHS/CDC
improvements to facilitate enhanced vaccines. The costs of procuring and also received comments from the airline
search capabilities of passenger data, administering these vaccines is industry regarding the change to the
increased efficiency to relay passenger included in the analysis. definition of ill person under 70.1 for
data, improvements to the existing As noted in the regulatory impact interstate flights contending that these
CDC–CBP MOU) to ensure that the analysis, there are only 564 travelers changes would increase costs.
collection of passenger or crew manifest exposed to measles during international Specifically, the airline industry
information do not unduly burden travel in a given year. Most of these reported that not only does the
airlines, vessels, and other affected travelers will already have immunity to expansion of the definition of ill person
entities. HHS/CDC intends to seek measles and the final rule is only place a greater burden on airline staff,
public comment on the report and any expected to have a small impact on the the ambiguity of that definition
recommendations regarding the costs ability of health departments to contact amplifies the burden or at least raises
and benefits of activities implemented travelers. The total costs of all measles questions as to the particular obligations
in 42 CFR parts 71.4 and 71.5. Estimates vaccine-associated adverse events is of the flight crew to determine if
of both costs and benefits in the NPRM outside the scope of the analysis for this someone is an ‘‘ill person.’’ Moreover,
regulatory impact analysis were not very final rule as mentioned above. the airline industry wanted to know
large because HHS/CDC is not One commenter suggested that the whether flight crews have an obligation
implementing a new data collection cost estimates for the NPRM were too to conduct a physical examination of
requirement. The regulatory impact low because the analysis did not the passenger to determine fever. The
mstockstill on DSK3G9T082PROD with RULES3

analysis for the final rule has been account for reduced willingness to airline industry also noted that under
revised to reflect that HHS/CDC will travel if vaccines against measles and the OSHA blood borne pathogens
work with CBP to search for responsive other communicable diseases are standard, employers are prohibited from
data to avoid duplicative data required to travel. HHS/CDC disagrees exposing crewmembers to blood or
requirements. Estimates of costs in the with this suggestion because other potentially infectious materials.
revised regulatory impact analysis have vaccination is not a requirement in this The airline industry also questioned
not been revised because the airline final rule. HHS/CDC has on occasion whether the fever-related illness

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00032 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6921

reporting in the proposal would require upper bound analysis finds that a 100% limited number of instances in which it
that all carriers have the equipment increase in info-only reports and 50% would be advantageous to follow up
(thermometers) onboard to determine increase in reports requiring response with ill travelers for an assessment upon
fever. The proposal, as noted, has two would result in a marginal cost of disembarkation. The current numbers of
other ways to identify fever (warm to $20,573 for airlines and vessel illness reports received are summarized
touch or history of fever) which the operators. This cost is negligible in the regulatory impact analysis and
airline industry wanted to ensure would compared to the annual revenue of the the number of reports is not expected to
remain viable options within the final international air and maritime travel increase significantly because the
rule. markets. HHS/CDC also received a regulatory text will better align with
HHS/CDC notes that there is no comment to include the cost of training publically available HHS/CDC guidance.
expectation that flight crews should for illness reporting in the regulatory A number of comments from the
perform physical examinations as part impact analysis. HHS/CDC notes that public questioned whether there would
of illness reporting. HHS/CDC also notes illness reporting is already required be a huge cost resulting from the broad
that the non-thermometer (warm to under existing regulations and the definition of ill person. These
touch or history of fever) remain in the changes in this final rule more closely commenters expressed concern that
final rule. Regarding the potential for align with ICAO guidance for illness misdiagnosis by non-medically trained
increased costs associated with the reporting for international flights and personnel would lead to reduced travel
change in illness reporting for interstate represent a reduction in burden for based on the public’s fear of being
flights, HHS/CDC notes that the current interstate flights, where reporting of all wrongly detained by public health
illness reporting requirements for cases or suspected cases of officials. HHS/CDC notes that illness
interstate travel appear in 42 CFR 70.4 communicable diseases is required. reporting is already required for both
and state that ‘‘The master of any vessel HHS/CDC added an estimate of training interstate and international travel. We
or person in charge of any conveyance costs to the upper bound cost analysis note that travelers are not placed under
engaged in interstate traffic, on which a for airlines (an annualized $356,000 per public health orders simply as a result
case or suspected case of a year). of an illness report. Rather, orders are
communicable disease develops shall, HHS/CDC received a comment from a issued only if a licensed medical officer
as soon as practicable, notify the local local health department concerning the based on a public health risk assessment
health authority at the next port of call, rationale for reporting all illnesses and has sufficient reason to believe that the
station, or stop, and shall take such deaths that occur on interstate flights. individual is infected with a
measures to prevent the spread of the This health department asked whether
quarantinable communicable disease. In
disease as the local health authority evaluating illnesses and deaths that
addition, the new definition is
directs.’’ Communicable disease is occur on interstate flights may lead to
consistent with existing international
defined in current 42 CFR 70.1 as an increase in costs for State and local
guidelines and HHS/CDC guidance.
‘‘illnesses due to infectious agents or health departments. HHS/CDC does not
Thus, HHS/CDC does not believe the
their toxic products, which may be anticipate an increase in costs for State
changes to illness reporting will result
transmitted from a reservoir to a and local health departments because
in a large burden to the general public.
susceptible host either directly as from evaluating illnesses and deaths
The cost analysis in the regulatory
an infected person or animal or occurring on interstate flights is
impact analysis has been updated to
indirectly through an intermediate plant consistent with existing HHS/CDC
or animal host, vector, or the inanimate guidance and represents a less include the cost to travelers involved in
environment.’’ restrictive alternative compared to the public health follow-up after an illness
The changes in this final rule will not existing reporting requirement in 42 report.
result in substantially increased costs CFR 70.4. Furthermore, the costs to One commenter opposed the rule
because airlines would either: (1) Be State and local health departments may because of a perceived negative
complying with the current regulatory decrease if HHS/CDC is able to filter out economic and/or social impact upon
requirement and report all cases or reports that do not require a public individuals placed under a public
suspected cases of communicable health response, which airlines would health order. Regarding the social
disease to local health departments; or have previously reported directly to the impact of the individual who may be
(2) report illnesses according to HHS/ health departments under 42 CFR 70.4. ostracized, HHS/CDC notes that public
CDC guidance available at http:// If there is an increase in the number of health measures such as quarantine and
www.cdc.gov/quarantine/air/reporting- illness reports requiring a public health isolation are not new concepts or
deaths-illness/guidance-reporting- response, HHS/CDC believes the costs to practices, HHS/CDC has been
onboard-deaths-illnesses.html, which is health departments may decrease if the implementing these measures to protect
codified in this final rule. HHS/CDC health department is notified earlier. public health for many years. We
notes that changes in this final rule A public health research center reemphasize that one compelling reason
align the symptoms requested for questioned the value of nonmedical for the publication of this final rule is
international and interstate illness personnel being able to differentiate to make ‘‘quarantine’’ and ‘‘isolation’’
reporting. In addition, according to Ebola, Middle East respiratory better understood by the public so that
guidance, reports received by HHS/CDC syndrome (MERS) or measles from other these terms, its purposes, and meanings
would be considered sufficient to satisfy medical issues. HHS/CDC appreciates become more familiar and thereby
the requirement to report to local health the concern and notes that the final rule decrease public anxiety over these
departments because HHS/CDC will aligns the illness reporting requirement important protections. For the same
mstockstill on DSK3G9T082PROD with RULES3

coordinate response activities with the with international guidelines and reason, HHS/CDC does not believe the
local health department after receiving represents a reduced burden for illness provisions in the final rule will increase
an illness report. In response to these reporting on interstate flights compared or decrease the cost of isolation or
comments, HHS/CDC increased the to current regulatory language as quarantine. HHS/CDC does provide an
expected number of illness reports in mentioned above. The intent of illness estimate of traveler cost in the sections
the upper bound analysis regulatory reporting is not to diagnose disease describing Ebola entry enhanced risk
impact analysis for the final rule. This during flight, but rather to identify a assessment and management and illness

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00033 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6922 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

reports in the regulatory impact regarding public willingness to pay in the cost of active monitoring would
analysis. the regulatory impact analysis. likely exceed the costs incurred at the
One commenter suggested that the HHS/CDC also received comments airports. However, HHS/CDC did
costs incurred by airlines would be from several individuals regarding the provide an estimate of total Federal
passed along to the general U.S. high cost of the measures taken to spending for both domestic and
population purchasing tickets for air reduce the risk of Ebola transmission in international efforts to attempt to
travel. HHS/CDC concurs and mentions the United States during the 2014–2016 quantify the cost of these efforts. Federal
this possibility in the regulatory impact Ebola epidemic in West Africa. Several money was used to support State/local
analysis. However, changes included in of these commenters indicated they had surveillance efforts. Federal money was
this final rule are a codification of a zero willingness to pay for future public also used to support improvements in
current practice and estimated total health measures in the event of a large laboratory capacity by States and
costs are only $11,000 to $431,000 per Ebola outbreak. hospital infection control efforts, which
year. Thus, significant changes in ticket Many commenters stressed the need should have benefits beyond the 2014–
prices are not expected. to reassess whether to implement such 2016 Ebola epidemic. In addition,
One commenter suggested that activities in the event of a future Ebola Federal funding supported research into
changes in infectious disease caseloads outbreak. An example of such potential Ebola vaccines and medicines.
would not result in cost savings to comments is provided by a research The cost for the Ebola enhanced entry
public health agencies or individuals center studying international response risk assessment program was just a
because there is already a public health efforts to emerging infectious disease portion of these costs and HHS/CDC
workforce in place. HHS/CDC calculates threats, who noted that despite 99% acknowledges that risk assessment
such costs based on the opportunity cost complete active monitoring by health program at airports by itself would have
of public health staff under the departments, there was no evidence of limited potential to reduce risk.
presumption that such staff would be incident Ebola cases among individuals However, HHS/CDC also notes that the
involved in other productive activities if traveling from Ebola-affected countries. costs of Ebola entry risk assessment at
not spending time addressing outbreaks. This does not include the two incident points of entry included efforts to (1)
HHS/CDC solicited comment from the cases that preceded active monitoring. stratify travelers by risk level so that
public regarding potential public The commenters state that given this health departments could focus more
willingness to pay to be contacted in the evidence it is not advisable for HHS/ intense monitoring efforts on travelers at
event of an exposure to a communicable CDC to recommend active monitoring in higher risk and (2) educate travelers on
disease during travel. This was done to the event of future Ebola outbreaks. Ebola risk factors and symptoms and
help estimate the potential benefit to the In addition, a public health research provide informational materials, a
public of HHS/CDC’s efforts to work center cautioned against extrapolating thermometer, and a telephone to all
with health departments to contact costs and benefits calculation methods travelers to improve compliance with
travelers exposed to meningococcal for measles and tuberculosis to Ebola, active monitoring efforts. This led to a
disease, viral hemorrhagic fevers, MERS MERS, and other rare diseases. The higher cost, but more effective program
or other severe acute respiratory research center further noted that relative to an alternative in which
syndromes, measles, and tuberculosis, countermeasures for Ebola and MERS travelers would only be screened once
among other diseases. HHS/CDC do not exist (other than isolation and at the airport, such as occurred in other
received a number of comments from quarantine). They suggest that this countries implementing screening
several individuals that they believe would limit the effectiveness of point of programs during the 2003 Severe Acute
public health measures to mitigate entry measures. These researchers also Respiratory Syndrome (SARS)
measles transmission are unnecessary. point to the fact that transmission of epidemic.
Some individuals also noted that Ebola Ebola and MERS has not occurred HHS/CDC believes that the risk of
and MERS cases in the United States during air travel. They noted that point Ebola infection in the U.S. population
have not led to widespread of entry risk assessment programs may was potentially reduced because of the
transmission. These commenters either increase anxiety (and costs) if cases are combination of measures to protect
indicated or inferred that they would be detected in the community after the against Ebola transmission in the United
unwilling to pay to be informed of implementation of point of entry States, including risk assessment at
potential communicable disease measures. Finally, the research center ports of entry. HHS/CDC acknowledges
exposures during travel. The discussion noted that the costs for State and local the risk was probably very low in the
in the regulatory impact analysis has health departments to actively monitor absence of domestic activities.
been updated to incorporate this all arriving travelers for 21 days were HHS/CDC further notes that it
feedback. not included in the analysis. recommended active monitoring of
HHS/CDC solicited public comment In response to these comments, HHS/ travelers as a less restrictive alternative
on willingness to pay to reduce Ebola CDC concurs that it would not be wise to more stringent measures such as
risk in the United States to near zero if to directly extrapolate approaches for quarantines that were being demanded
another international outbreak of Ebola measles and tuberculosis to rare by some members of the public.
with widespread transmission occurs in diseases and has tried to provide as Widespread implementation of
the future. HHS/CDC received much information as possible around quarantine, particularly for healthcare
comments from an organization the decision to implement the Ebola risk workers crucial to the response efforts
representing flight attendants indicating assessment program and in West Africa and the United States,
that they believe it is in the public recommendations for active monitoring. would have greatly hampered outbreak
mstockstill on DSK3G9T082PROD with RULES3

interest to reduce Ebola risk in the HHS/CDC did not simply extrapolate control measures by providing a strong
United States to near zero in the event the analysis for measles and disincentive to healthcare workers
of a future outbreak. They indicated that tuberculosis to Ebola. participating in the response.
there is no reason to believe that HHS/CDC does not have data on State To estimate the potential benefits of
achieving this objective would require and local spending to achieve the the Ebola risk assessment program at
unsustainable levels of funding. HHS/ objective of the 21-day active ports of entry, HHS/CDC provided a cost
CDC incorporated this comment monitoring program and concedes that comparison of the incident Ebola cases

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00034 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6923

that occurred in Texas compared to New existing authorities, this analysis has practice. Thus, where possible, HHS/
York to estimate the difference in costs been moved to a separate appendix after CDC tried to provide data on the current
between an Ebola case that was detected incorporating public feedback. burden of the provisions that are being
quickly and treated in a pre-selected A number of commenters suggested updated in this final rule. HHS/CDC
hospital identified to be capable of that HHS/CDC did not include the cost does not expect any major changes in
Ebola treatment in comparison to an for people participating in the Ebola practice as a result of this final rule.
Ebola infection that was not initially enhanced risk assessment program. One commenter suggests that the cost/
suspected to be Ebola leading to However, HHS/CDC did provide such benefit analyses was confusing because
community exposures and hospital an analysis of these costs. One public quarantinable and non-quarantinable
exposures in a hospital that was not a commenter suggested that the diseases were not clearly identified.
pre-selected hospital capable of Ebola psychological cost of quarantine should HHS/CDC appreciates this feedback and
treatment. be considered in the economic impact has updated the analyses to more clearly
HHS/CDC also examined the recent analysis. Although HHS/CDC generally differentiate quarantinable and non-
MERS outbreak in South Korea to concurs with the idea of accounting for quarantinable diseases.
demonstrate that even relatively small all of the costs associated with time One commenter suggested that HHS/
outbreaks of rare diseases such as MERS spent in quarantine, HHS/CDC’s CDC took an unnecessarily extreme
and Ebola can have large economic costs authority to issue quarantine orders will position in analyzing an alternative of
despite a relatively small number of not change with the publication of this removing all enforcement of current
cases and deaths. HHS/CDC found that final rule. Thus, this final rule does not regulations. HHS/CDC used this as an
the number of international travelers incur new psychological costs for alternative because this final rule is a
(non-Korean citizens traveling to South persons under quarantine orders. codification of current practice and does
Korea) decreased by 40–50% during the HHS/CDC notes the opportunity costs not impose new regulatory burdens.
peak months of the 2015 MERS for persons undergoing risk assessment
outbreak. HHS/CDC further notes that at airports and/or evaluation at hospitals q. Paperwork Reduction Act
these declines in travel occurred in the during the 2014–16 Ebola entry risk HHS/CDC published notices related to
absence of widespread travel assessment and management program. modifications and a new information
restrictions. The costs incurred by South HHS/CDC estimates their opportunity collection in the Notice of Proposed
Korea during the outbreak were used to costs based on average wage rates, but Rulemaking. Those information
demonstrate the potential costs of a did not have additional data to estimate collections are as follows:
larger Ebola outbreak in the United a marginal psychological cost. (1) Foreign Quarantine Regulations
States. Opportunity costs were also estimated (42 CFR part 71) (OMB Control No.
Given the evidence from the programs for a more restrictive option compared 0920–0134)—Nonmaterial/non-
implemented to mitigate risk during the to the Ebola entry risk assessment and substantive change—National Center for
2014–16 Ebola epidemic, i.e., the small management program, i.e. a suspension Emerging, and Zoonotic Infectious
number of international air travelers of entry for 21 days after having been in Diseases (NCEZID), Centers for Disease
from countries with widespread Ebola an Ebola-affected country. Control and Prevention (CDC).
transmission that later developed Ebola One commenter suggested that this (2) Restrictions on Interstate Travel of
and the very limited risk of transmission rulemaking does not represent the ‘‘least Persons (42 CFR part 70) (OMB Control
by asymptomatic individuals with Ebola burden on society’’ because HHS/CDC No. 0920–0488)—Nonmaterial/non-
infection, HHS/CDC may not elect to has failed to clearly identify a substantive change—National Center for
implement an Ebola entry risk ‘‘compelling public need’’ for the rule. Emerging, and Zoonotic Infectious
assessment program in the event of a HHS/CDC appreciates the comment and Diseases (NCEZID), Centers for Disease
future outbreak or to recommend 21-day responds that the regulatory impact Control and Prevention (CDC).
active monitoring of travelers from analysis cites a specific market failure (3) Airline and Vessel and Traveler
countries with widespread addressed by this final rule. The market Information Collection (42 CFR part
transmission. failure is that the costs associated with 71)—New Information Collection
HHS/CDC emphasizes that it will the spread of communicable diseases Request—National Center for Emerging,
continue to consider cost and work with impacts the entire U.S. population, not and Zoonotic Infectious Diseases
multiple U.S. government agencies, as just the group of persons currently (NCEZID), Centers for Disease Control
well as with airport authorities and infected with communicable diseases. and Prevention (CDC).
health departments in U.S. States and Since this final rule is primarily One commenter stated that there are
territories, to apply the latest evidence implementing current practice, HHS/ no estimates of additional information
to future decision-making. In addition, CDC does not anticipate major new collection requirements resulting in a
HHS/CDC will try to employ the least benefits or costs. clear violation of the Paperwork
restrictive measures to achieve public One commenter stated that the cost/ Reduction Act. The commenter further
health objectives. HHS/CDC notes that, benefit analyses was very vague, stated that requesting information when
during the period that the Ebola entry meaning that there is no accountability HHS/CDC has no idea of the impact is
risk assessment and monitoring program or way to measure whether or not the not a well thought out or planned
was in effect, only 0.08% (29/38,344) of final rule will achieve its intended rulemaking. This commenter further
travelers assessed at U.S. airports were result of preventing the spread of questioned the value of providing
recommended for medical evaluation at quarantinable communicable diseases comment when the agency purportedly
hospitals and that no Federal quarantine via travel, which the commenter stated has no idea what additional burden it is
mstockstill on DSK3G9T082PROD with RULES3

or isolation orders were issued during was already an extremely low risk. imposing on the public. HHS/CDC
the epidemic, although some States did HHS/CDC concurs that there is disagrees with these assessments.
issue such orders under their own uncertainty in the regulatory impact The focus of the final rule is to codify
authorities. These considerations have analysis. However, HHS/CDC has tried current practices and to update
been added to the regulatory impact to indicate that one of the reasons for currently approved information
analysis in the final rule. Since this this uncertainty is that this final rule is collections to better align with
analysis concerns a codification of primarily implementing current operational procedures and other

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00035 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6924 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

industry guidance related to illness 54305 but was inadvertently omitted make take action to prevent the
reporting on aircraft and vessels. Those from the proposed regulatory text. interstate spread of communicable
information collections are currently diseases in the event that the CDC
B. Provisions Applicable Only to Part 70
approved under OMB control numbers Director determines that inadequate
Only (Domestic)
0920–0134 (Foreign Quarantine local control exists. This longstanding
Regulations), 0920–0488 (Restrictions a. General provision on preemption in the event of
on Interstate Travel of Persons), and the HHS/CDC received comments from a conflict with Federal authority is left
new information collection request the public asserting that State and local unchanged by this rulemaking.
Airline and Vessel and Traveler public health regulations already in One public health organization
Information Collection (42 CFR part 71), place are sufficient to protect requested clarification of the process to
which is currently pending OMB transfer an individual from Federal to
individuals without the need for Federal
approval. The estimates of the burden State custody and further stipulated that
involvement. HHS/CDC agrees that State
provided in the Paperwork Reduction the State authority should require an
and local authorities play an integral
Act section of the NPRM were based on independent State assessment of risk
role in protecting public health, but
previous experience with particular under State law. In response, HHS/CDC
disagrees that there is no Federal role.
information collections solicited or notes that the issuance of Federal public
HHS/CDC’s DGMQ maintains
required from the public or industry in health orders is coordinated with State
quarantine stations at major U.S. ports
the past. In some cases, larger estimates and, when appropriate, local public
of entry that fulfill a primary purpose in
of the burden to account for an health authorities. Transfer of an
preventing the introduction of
increased number of reports to HHS/ individual from Federal to State custody
communicable diseases into the United would be similarly coordinated such
CDC during disease outbreaks or public States, but also play an important role
health emergencies were included. that the State would need to agree to
in containing the interstate spread of assume custody and the State’s order
There are no information collections communicable disease. There are
requirements that are wholly new, would need to be in place prior to HHS/
several broad areas of cooperation CDC’s rescinding the Federal order.
unreasonably burdensome, or outside between quarantine field staff and State
the scope of historical HHS/CDC When custody of an individual is
and local health agencies, such as transferred to a State authority, the State
practices implemented to prevent the contact tracing, which provide a
introduction or spread of communicable may choose, but would not be under a
framework for responding to Federal mandate, to conduct an
disease into or within the United States. communicable disease threats arising independent assessment of risk
Another commenter suggested that from interstate travel and at the local pursuant to its own policies and
training in recognizing ill travelers is a level. It is through these networks and procedures. Furthermore, once the
burden that was not adequately established partnerships, in keeping transfer of custody has occurred, the
considered. HHS/CDC disagrees because with current practice, that the State’s laws and standards for due
it does not mandate specific training for provisions of the final rule will be process would apply.
recognition of ill travelers. HHS/CDC is successfully implemented. Another public health authority asked
seeking to better align the ill person HHS/CDC received a comment to the for clarification of how jurisdictional
definition with the ICAO standard and effect that quarantine specifically issues regarding transfers of authority
thus is not the only organization that should be left to the States. HHS/CDC affecting more than one State would be
has this requirement. HHS/CDC received another comment stating that handled for individuals under Federal
provides specific guidance for how to Federal authority should not take quarantine. HHS/CDC responds that if
recognize ill travelers and report to precedence over State authority. In more than one State is affected by the
HHS/CDC on its Web site. HHS/CDC contrast, a public health association transfer of authority, HHS/CDC will
also believes this training is most likely suggested that these regulations should work with all relevant States to
already part of the training process for indicate that Federal public health determine the most appropriate State or
flight crews. An analysis of potential measures ‘‘supersede activities taken by local jurisdiction to accept custody of
training costs has been added to the States.’’ We respond that while HHS/ the individual. If it is necessary to
upper bound cost analysis in the CDC works closely with State and local transport the individual to another
Regulatory Impact Analysis. The upper public health authorities, the Federal State, for example to the individual’s
bound annualized costs for additional government has a traditional role in State of residence, HHS/CDC will work
training are estimated at $356,000. preventing introductions and spread of with the affected States to facilitate such
Finally, HHS/CDC is re-inserting ‘‘Has communicable diseases at ports of entry a transfer under Federal orders.
a fever that has persisted for more than and interstate. HHS/CDC also disagrees One public health organization
48 hours’’ as a component in the with the suggestion that it should not requested clarification of the procedures
definition of Ill person in § 70.1 General intervene in the event of inadequate HHS/CDC would use to rescind a public
definitions and ‘‘Has acute local control or lacks authority to health order. HHS/CDC responds that it
gastroenteritis, which means either protect the public’s health within the would issue the detained individual a
diarrhea, defined as three or more authority granted to it by Congress. written order rescinding the isolation,
episodes of loose stools in a 24-hour Under 42 U.S.C. 264(e), Federal public quarantine, or conditional release. This
period or what is above normal for the health regulations do not preempt State would be based on either one of two
individual, or vomiting accompanied by or local public health regulations, criteria: The individual is determined to
one or more of the following: One or except in the event of a conflict with the no longer pose a public health threat or
mstockstill on DSK3G9T082PROD with RULES3

more episodes of loose stools in a 24- exercise of Federal authority. Other than custody of the individual has been
hour period, abdominal cramps, to restate this statutory provision, this transferred to a State or local public
headache, muscle aches, or fever rulemaking does not alter the health authority.
(temperature of 100.4 °F [38 °C] or relationship between the Federal HHS/CDC received a comment from a
greater)’’ in § 71.1 General definitions. government and State/local public health department stating that
This language was quoted verbatim in governments as set forth in 42 U.S.C. the regulations should include language
the preamble of the NPRM at 81 FR 264. Under, 42 CFR 70.2, HHS/CDC that HHS/CDC will coordinate with

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00036 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6925

State and local public health authorities vaccine is available, but only with or there is inadequate local control. In
and law enforcement regarding any informed consent. further response, HHS/CDC notes that
intended surveillance and enforcement One commenter noted that the the restriction would remain in place so
activities. HHS/CDC strongly believes regulation allows HHS/CDC to issue long as the individual is infected or
that coordination with State and local interstate travel permits to an infected capable of infecting others. This
public health authorities, as well as individual conditioned upon the commenter further requested
relevant law enforcement entities, is individual taking ‘‘precautionary clarification of the impact of a
essential to the public health response measures’’ as prescribed by HHS/CDC. disagreement between HHS/CDC and
to individual cases as well as outbreaks This commenter requested that HHS/ State or local public health authorities.
of communicable disease. On the few CDC clarify what precautionary We note that by the terms of 42 U.S.C.
occasions that HHS/CDC has issued measures may be prescribed and stated 264(e), Federal public health regulations
Federal isolation orders for travelers that such conditions should not be do not preempt State or local public
with infectious tuberculosis, HHS/CDC based on factors unrelated to the health regulations except in the event of
has worked closely with State and local individual’s health condition, e.g., a conflict with the exercise of Federal
health departments to coordinate socio-economic, ethnic status. While authority. Moreover, per the terms of 42
transportation, medical evaluation, and HHS/CDC agrees that the issuance of a CFR 70.2, HHS/CDC may take action to
treatment of the ill traveler, including travel permit should not be based on prevent the interstate spread of
law enforcement when needed. During such factors as race, gender, ethnicity, communicable diseases in the event that
the 2014–2016 Ebola epidemic, HHS/ or socio-economic status, we note that the CDC Director determines that
CDC issued guidance and alerted health the issuance of a travel permit may be inadequate local control exists.
care and EMS workers to consider a conditioned on such factors as the HHS/CDC received a comment from a
diagnosis of Ebola if patients had individual’s ability and willingness to flight attendant union requesting
compatible symptoms and had visited comply with the terms of the permit. clarification as to whether an employee
an affected country within the previous Furthermore, while the exact could be held criminally liable for
three weeks. HHS/CDC and State and precautionary measures prescribed may knowingly transporting someone in
local health departments worked closely vary based on the infectious agent, such violation of the terms of a travel permit
to assess any potentially exposed measures, for instance, may include: as specified under section 70.5. In
individuals with symptoms compatible Agreeing to minimize time in congregate response, HHS/CDC clarifies that the
with Ebola to determine whether settings while traveling; avoiding eating term ‘‘operator’’ is defined under 70.1
medical evaluation was needed and, if in restaurants or other enclosed public consistent with 14 CFR 1.1 and with
so, to ensure safe transportation to a places; traveling with no other people in respect to an aircraft means, ‘‘any
medical facility designated by the health the vehicle or, if other people are person who uses, causes to use or
department. In light of HHS/CDC’s needed to safely operate the vehicle, authorizes to use an aircraft, with or
history of close coordination with State agreeing to wear a mask and ensure without the right of legal control (as
and local public health authorities, good ventilation; and reporting to the owner, lessee, or otherwise).’’ We
including cooperating law enforcement local health department upon arrival or further note that criminal liability, if
entities when needed, HHS/CDC has on route as needed. any, will be determined by a court of
determined that specific regulatory This commenter also requested law and not administratively by HHS/
language is unnecessary. clarification of the legal impact of a CDC. Accordingly, we decline to
person who is denied a permit or has speculate as to whether employees who
b. Requirements Relating to Travelers had a permit revoked. We note that per knowingly violate the terms of a travel
Under a Federal Order of Isolation, the terms of the regulation persons permit may be held criminally liable.
Quarantine, or Conditional Release denied a travel permit or who have had One public health organization asked
Some commenters questioned HHS/ a travel permit revoked may submit a for clarification of how local health
CDC’s authority, as well as the need, to written appeal. The right to a written departments would be engaged in
restrict the movement of individuals appeal, as well as the means by which conducting communicable disease
who are not ill but have been exposed. an appeal may be requested, will be screening activities or enforcing Federal
HHS/CDC thanks these commenters for addressed in the written order denying public health travel restrictions for
their review and input. Some the request for a travel permit or individuals traveling interstate, given
quarantinable communicable diseases, revoking an existing permit. The appeal that HHS/CDC staff are not present at
such as novel pandemic influenza will be decided by an HHS/CDC official many points of interstate travel. HHS/
strains, may be contagious before the who is senior to the employee who CDC acknowledges this limitation in
infected person becomes symptomatic. denied or revoked the permit. HHS/CDC their presence at some ports of entry
Therefore, in these situations, it may be declines to speculate as to what else this and in regard to interstate travel and
necessary to restrict the movement of commenter may be referring to by the intends to address this through future
asymptomatic exposed people to make term ‘‘legal impact,’’ but notes that the guidance and discussion with
sure they do not expose others regulation does not impair the ability of stakeholders.
inadvertently while they are not aware persons to seek judicial review of final In regard to interstate air travel, HHS/
that they are contagious. It may also be agency actions through the CDC clarifies that the Federal public
necessary to restrict movement of an Administrative Procedure Act. health Do Not Board tool will deny
exposed person if public health This commenter also requested boarding of persons known to pose a
authorities are unable to ensure clarification of how long an individual public health risk to other air travelers.
mstockstill on DSK3G9T082PROD with RULES3

appropriate monitoring of the person, may be restricted in his or her travel This tool is applicable to persons
for example, if an individual is known under a Federal travel permit. We note boarding a commercial aircraft with an
to have a history of noncompliance with first that the restriction only applies to origin or destination in the United
public health recommendations. those under a Federal public health States, including interstate travel. See
Exposed people whose movement is order or under a State or local order if 80 FR 16400 (Mar. 27, 2015).
restricted through quarantine or other the State or local health department of For other modes of travel, HHS/CDC
means may be offered vaccination, if a jurisdiction requests Federal assistance does not have a systematic mechanism

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00037 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6926 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

of denying boarding and these situations order itself would include authorization appeal may involve coordination with
may need to be addressed on a case-by- for these individuals to continue travel affected state or local jurisdictions.
case basis, either through direct to their home State of residence After consideration of comments
communication with a conveyance provided that they subsequently report received, HHS/CDC has modified
operator or through application of other to public health authorities as needed. paragraphs (a), (b)(1), (b)(2), and (c) of
movement restrictions such as the For example, during the response to the provision concerning Requirements
issuance of State or Federal public Ebola, CDC worked with state public Relating to Travelers Under a Federal
health orders. Such situations will health authorities to allow certain Order of Isolation, Quarantine, or
likely require the participation of State individuals who met certain risk Conditional Release (§ 70.5) to remove
or local public health authorities; thresholds to travel in private vehicles ‘‘agreements,’’ referring to agreements
however, as noted by the commenting to their place of residence while entered into by the CDC. We have also
organization, the Federal and State/local maintaining a focus on protecting public modified paragraph (a)(5) to require that
costs and resources required during health. This was done on a case by case HHS/CDC must issue a written response
such operations are not known. The basis, depending on distance of travel to an appeal within three (3) business
specific roles of State or local health and risk of exposure, and distance from days. Other provisions of this section
departments will be addressed through a health care facility with adequate are finalized as proposed.
future guidance or stakeholder capacity to treat and contain Ebola. CDC c. Report of Death or Illness Onboard
discussion. would make similar assessments in the Aircraft Operated by an Airline
HHS/CDC received a comment event that conditional release orders are
contending that the extension of travel needed for other quarantinable Several commenters expressed
permits to intrastate travel is in communicable diseases. We note that concern that the new regulations
violation of the Commerce Clause. HHS/ remove the requirement for a local
the conditional release order itself
CDC disagrees. We note that HHS/CDC health authority to be notified when a
would provide permission to travel and
will only require intrastate travel passengers falls ill or dies on board a
have added clarifying language to the
permits when a State or local health flight. The commenters insisted that this
text.
authority of jurisdiction requests federal could interfere with effective local
HHS/CDC clarifies, however, that response to important communicable
assistance or in the event that State and after arriving in their home State,
local actions are inadequate to prevent disease threats. They propose that local
should the individuals wish to engage authorities should be notified in a
interstate communicable disease spread. in further travel, a travel permit may be
Under 42 U.S.C. 264, Congress acting timely manner, such as within one hour
needed at that time. In response to of initial reporting, and that HHS/CDC
pursuant to its Commerce Clause
comments from this partnership should consult with local health
jurisdiction, has authorized HHS/CDC
organization, HHS/CDC also clarifies authorities on the necessary steps to
to take measures to prevent the foreign
that the travel permit, as provided for in contain the spread of communicable
introduction and interstate spread of
the regulations, will only be required diseases. In contrast, one airline
communicable diseases. It is well
under circumstances where the supported the direct reporting to HHS/
established that the Federal government
individual is already under a Federal, CDC.
may act to protect interstate commerce,
State or local order of quarantine, HHS/CDC carefully considered these
even though the threat may come
isolation, or conditional release. comments and responds that it will
entirely from intrastate activities. See
United States v. Lopez, 514 U.S. 549, Because the travel permit requirement is continue its long standing partnership
558–559 (1995). only applicable to individuals who are with local authorities. The rationale
One commenter requested that HHS/ already under a Federal, State, or local behind asking airlines to submit reports
CDC replace the word ‘‘traveler’’ with public health order, HHS/CDC believes of deaths or reportable illnesses directly
‘‘passenger’’ with respect to mandatory that this provision does not to HHS/CDC as opposed to local
public health assessments, as a traveler impermissibly restrict an individual’s authorities is to simplify and streamline
could be taken to mean ‘‘anybody in a right to travel. the reporting process for these airlines.
private vehicle lined up at a toll booth.’’ In response to comments regarding Under the final rule, airlines will not be
In response, HHS/CDC states that the the time with which CDC may consider required to know the current points of
use of the word ‘‘traveler’’ with respect a travel permit request, the CDC Director contact for multiple local jurisdictions,
to conveyances is intended to include shall respond to a request for a travel but rather may report to HHS/CDC as a
both passengers and crew. Furthermore, permit within 5 business days Likewise, single point of contact. HHS/CDC will
HHS/CDC states that its authority one public health association suggested continue to share public health
extends to all individuals engaging in that, in the event a travel permit is information with State and local health
interstate travel including those denied, these regulations should state departments through approved
traveling by private vehicle, particularly the timeframe that HHS/CDC will issue electronic disease reporting networks
if they are in the ‘‘qualifying stage’’ of a response to the appeal; another such as the Epidemic Information
a quarantinable communicable disease. proposed the time period for CDC’s Exchange (Epi-X), HHS/CDC’s secure,
HHS/CDC received a comment from a response to be 72 hours. In response to Web-based system. HHS/CDC may also
partnership of public health legal these comments, HHS/CDC has added a notify State or local authorities via
scholars and organizations expressing requirement in the regulation that in the phone calls.
concern that requiring application for a event that a request for a travel permit Some commenters questioned
travel permit may be unduly is denied, it must decide an appeal from whether HHS/CDC has adequate
mstockstill on DSK3G9T082PROD with RULES3

burdensome because individuals who that denial within three (3) business resources to be the first responder at the
are served with a conditional release days. HHS/CDC believes that this local level. HHS/CDC responds that it
order at an airport would then need to timeframe is appropriate because this regularly coordinates with Federal, State
apply for a separate travel permit to provision only applies to individuals and local agencies and other partners in
travel to their home State of residence. who already have had their travel the airport environment. HHS/CDC
HHS/CDC disagrees because under such restricted through the issuance of a intends to continue working closely
circumstances the conditional release public health order and deciding an with Federal, State, and local partners,

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00038 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6927

including first responders such as EMS clarify first that this domestic provision disagrees. In keeping with current
and State and local health agencies, was proposed to mirror the current practice, HHS/CDC will continue to
when assistance is needed. foreign provision under 42 CFR require and receive the reports of all
One commenter suggested that the 71.21(b)—which HHS/CDC did not deaths that occur on board a carrier,
reporting of ill travelers ‘‘would be an propose to change—and which states regardless of the suspected cause, to
invasion of our liberty and privacy.’’ ‘‘the commander of an aircraft destined allow a public health official to conduct
HHS/CDC disagrees. The report of for a U.S. airport shall report an assessment.
illness or death on board a carrier is a immediately . . . any death or ill person One public health organization raised
longstanding regulatory provision and among passengers or crew.’’ While we concerns about replacing reporting to
practice. This final rule only changes to acknowledge the many duties of the local health authorities with reporting to
whom the report is made (directly to pilot in command, because this HHS/CDC. In response, HHS/CDC notes
HHS/CDC), rather than to the local individual is directly responsible and that extensive input was sought in 2012
health department of destination. We has final authority over the operation of from the Association of State and
further note that personally identifiable the aircraft, in keeping with the practice Territorial Health officers (ASTHO) and
information collected and maintained already established through regulation National Association of County and City
under the Privacy Act will be handled under 42 CFR 71.21(b), we believe that Health Officials (NACCHO).
in accordance with that Act and CDC’s the responsibility for reporting ill Representatives from those
system of records notice published at 72 persons onboard should ultimately rest organizations recommended that
FR 70867. with the pilot in command as stated in requirements and protocols should be
Another commenter worried that the regulation. Thus, the text of the the same for international and interstate
‘‘having flight reservations require regulation has not changed from the flights and procedures should be
health reports will significantly impede proposal. outlined describing how this would
air travel.’’ It is not HHS/CDC practice, One industry group commented that occur. These representatives
nor a requirement under this regulation, the role of flight attendants in recommended that airlines should
for individuals to submit health reports identifying sick travelers on board report ill persons on domestic flights to
prior to or after making a flight or vessel should be addressed through guidance HHS/CDC and that HHS/CDC should
reservation. The only instance when developed in conjunction with HHS/ subsequently notify State or local health
health documents may be required prior CDC and industry. HHS/CDC responds departments. Subsequently, HHS/CDC
to travel, is if a person is known to be that it routinely issues guidance for posted guidance to this effect on its Web
infectious with a communicable disease flight crews, including standard site and has continued response
that could spread during travel and has guidance for the recognition and planning and development of standard
been placed on the Federal Public reporting of ill travelers and disease- or operating procedures to implement
Health Do Not Board described in 80 FR situation-specific guidance during these recommendations. Thus, this
16400 (Mar. 27, 2015). Because this outbreaks. Such guidance is published rulemaking codifies the current practice
practice is not new, HHS/CDC believes on HHS/CDC’s Web site and and is consistent with recommendations
it will not impede air travel. disseminated through established list provided by ASTHO and NACCHO.
A flight attendant association serves, industry associations, and any One commenter stated that it appears
suggested that HHS/CDC should adopt other available means. HHS/CDC will HHS/CDC is ‘‘attempting to move
training and awareness requirements for coordinate with industry partners to towards mandatory reporting by carriers
airline employers to provide to flight determine whether additional guidance and border personnel, requiring
attendants concerning ‘‘what entails a may be needed and, if necessary, work reporting of persons with signs of illness
qualifying stage.’’ Industry also with these partners to develop such as they cross borders, as opposed to
expressed concern that flight crews may guidance. having to do large-scale individual
be held responsible and penalized for One industry organization contact interviews and investigations
missed illness identification. HHS/CDC commented that the proposed rule after an outbreak occurs.’’ In response,
understands that the statutory definition failed to recognize that airlines employ HHS/CDC states that reporting by
of ‘‘qualifying stage’’ may be confusing intermediary professional medical carriers is already required under the
to lay persons and does not expect air personnel. HHS/CDC responds that it existing regulations and that this
or vessel crewmembers to be trained in recognizes the role of intermediary regulation only codifies current practice
the nuances of such language. Instead, professional medical personnel in and guidance. In addition, DHS notifies
we have crafted a definition of ill person assisting flight crews in managing an ill HHS/CDC of ill travelers detected by
to focus, in plain language, on the signs traveler onboard and references such border personnel. HHS/CDC and DHS
and symptoms of communicable personnel in industry guidance issued agreed to this notification process in a
diseases of public health concern and at http://www.cdc.gov/quarantine/air/ memorandum of understanding and
quarantinable communicable diseases, index.html. therefore changes to this regulation are
while taking into account the medical It is not HHS/CDC’s intent for the unnecessary. HHS/CDC additionally
resources available to aircrew. HHS/ public health assessment conducted by coordinates notification and
CDC intends to enforce this provision HHS/CDC public health officers to investigation of contacts during
consistent with how reports of deaths replace this role in medical exposure or outbreak situations when
and illnesses are currently handled in management. However, HHS/CDC necessary based on a public health risk
regard to foreign arrivals. We note that restates that the reporting of ill travelers assessment. Such investigations are
flight crews have not been penalized in to HHS/CDC is the ultimate standard public health practice and not
mstockstill on DSK3G9T082PROD with RULES3

the past for missed reports of illness. responsibility of the pilot in command mutually exclusive of reporting by
HHS/CDC received comments from as noted above. carriers or notifications by border
industry that the report of death or One association requested that the personnel.
illness should not be limited only to the report of deaths on board a carrier be After consideration of these
pilot in command, given the many modified and limited to those deaths comments, the title of the Radio Report
duties already under his/her which resulted from a possible of Death or Illness (71.21) in the
responsibility. HHS/CDC disagrees. We communicable disease. HHS/CDC provision has been finalized as

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00039 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6928 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

proposed to remove the word ‘‘Radio,’’ PNR as a result of normal operating exposed contacts are defined following
and now reads Report of Death or procedures. We also take this time to exposures to measles or varicella on
Illness. emphasize two important points. First, aircraft or vessels. HHS/CDC appreciates
passengers are not required by HHS/ the comment but seeks to clarify that
C. Provisions Applicable to Part 71 Only
CDC to submit specific data elements these protocols were mentioned in the
(Foreign)
provided by passengers. Second, HHS/ NPRM solely for the purposes of
One commenter questioned the CDC will only seek this information providing context for the economic
seriousness of communicable disease from CBP or the airline in the event of analysis and that the content of the
spread on aircraft and vessels. Another a confirmed or suspected communicable protocols themselves is beyond the
commenter noted an ‘‘extreme disease on board a carrier which scope of this rulemaking.
unlikeliness of contracting any requires contacting fellow passengers to One public health organization
communicable disease while traveling’’ inform them of possible exposure. commented on the fact that buses and
and that, therefore, HHS/CDC failed to While HHS/CDC received support for trains typically do not maintain or have
prove a ‘‘compelling need’’ for the the data collection from two public access to passenger manifests that
proposed regulations. HHS/CDC health associations, a commenter would allow for the collection of
appreciates the opportunity to respond misread the proposals to mean that information by HHS/CDC for the
to these comments. The spread of aircraft operators would be required to purpose of contact tracing. HHS/CDC
communicable diseases on aircraft and develop new capacity and processes to agrees with this comment and notes that
vessels is well documented. There are capture and store a comprehensive set these regulations do not require
numerous reports in the medical and of sensitive data, archive this data, and operators of buses or trains to maintain
public health literature of spread of then provide it to HHS/CDC. HHS/CDC passenger manifests for purposes of
measles, tuberculosis, SARS- takes this opportunity to restate and contact tracing. The organization also
coronavirus, and influenza virus on clarify that these final regulations do not commented on the utility of the
aircraft. Outbreaks of varicella impose any new burdens upon the requirement that operators of buses or
(chickenpox), influenza, and airline industry but rather, codify the trains not knowingly transport
gastrointestinal viruses such as current practice of receiving a passenger individuals subject to a Federal public
norovirus are common on cruise ships, manifest order (as needed) and health order. In response, HHS/CDC
and spread of other diseases such as providing HHS/CDC with any data in an notes that it is useful to prohibit
measles, rubella (German measles), airline’s possession. This rule places no conveyance operators from knowingly
tuberculosis, and other gastrointestinal requirement on the airline to solicit or transporting someone under a Federal
diseases has also been reported. Aircraft store additional data than current public health order without a travel
and vessels have people together in practices allow. Therefore, HHS/CDC permit or in violation of the terms of a
confined spaces for prolonged periods does not expect this formalization of permit because this may limit
of time. Therefore, conducting contact current practice to have an impact on communicable disease spread. This
investigations for certain communicable operations, including ‘‘check-in prohibition, however, would only apply
diseases identified on aircraft or vessels process.’’ If an airline does not have in in circumstances where the operator
is standard public health practice, both its possession the five additional data would know or have reason to know
in the United States and internationally, elements, it is not required to collect or that a travel permit is required, for
similar to public health practice in submit them to CDC. instance, if the conveyance operator has
community settings. One airline industry group been directly informed by the HHS/CDC
HHS/CDC received comments from commented that the collection of or another cooperating Federal, State, or
industry regarding ongoing efforts with information from screened individuals local agency.
DHS/CBP to improve passenger data for the purpose of contact tracing should A non-profit organization also
collection, as announced in the NPRM. apply only to passengers because commented that requiring airlines to
Several commenters stated that HHS/ crewmember information would be disclose passenger information, upon
CDC should delay this final rule until provided by the employer. HHS/CDC request, but without a warrant, for
DHS/CBP has published a regulation to responds that this may be the case purposes of notifying passengers of their
ensure that a coordinated system is put operationally; however, HHS/CDC potential exposure to a communicable
in place. HHS/CDC thanks these reserves the right to collect information disease violates the Fourth Amendment
commenters for their input but disagrees directly from crew members if to the U.S. Constitution. This
that this final rule should be delayed. necessary. organization also contends that HHS/
This comprehensive regulation seeks to HHS/CDC received a comment CDC lacks the legal authority to require
protect public health, by implementing, expressing concern that individuals may that travelers provide certain contact
among other things, current passenger provide false contact information, e.g. information, such as information
and crew data collection practices. emails and telephone numbers, to concerning their intended destination,
One commenter objected to the airlines, and thus that HHS/CDC would health status, and travel history as part
collection of health information prior to lack the means of contacting of a public health investigation.
using public transportation. Another individuals. In response, HHS/CDC Specifically, this group contends that
commenter opposed the idea of carriers notes that airlines are not required to ‘‘examination’’ as used in 42 U.S.C.
being ‘‘forced to collect and report 17 verify the accuracy of information 264(d)(1) should be understood as
data elements on American travelers.’’ A collected and HHS/CDC takes no referring only to an ‘‘inspection’’ not an
public health association also insisted position on what consequences the ‘‘interrogation.’’ This group further
mstockstill on DSK3G9T082PROD with RULES3

that data elements should only be airline may impose if a traveler refuses contends that because HHS/CDC lacks
collected from people if there is a to provide information or provides the legal authority to collect information
reasonable belief that the person is inaccurate information. under 42 U.S.C. 264 it also lacks the
infected. This final rule does not require One public health organization authority to collect information under
carriers to collect or transmit any data commented on the scope of HHS/CDC’s the Privacy Act of 1974. Lastly, this
elements that are not currently collected protocols for when contact group contends that any compulsory
and transmitted to CBP via APIS and investigations are conducted and how questioning of travelers about ‘‘acts of

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00040 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6929

assembly or association’’ violates the disease during travel may be contacted, foreign country is unduly vague. In
First Amendment to the U.S. informed, and provided with response, we explain that HHS/CDC
Constitution. appropriate public health follow-up. may take public health measures in
HHS/CDC disagrees with these HHS/CDC measures to prevent the regard to animals, articles, or things, to
comments. HHS/CDC notes that the introduction, transmission, or spread of prevent the introduction, transmission,
requirement of a judicial warrant is not communicable diseases do not implicate and spread of communicable diseases
applicable to requiring passenger and any of these constitutionally-protected into the United States and interstate.
crew information from air carriers. areas. ‘‘Article’’ generally refers to an article of
Rather, this activity is permitted HHS/CDC further notes that its commerce, such as a specific product
without a warrant under the special- purpose in collecting passenger that someone wishes to import into the
needs doctrine articulated by the information is to notify passengers who United States or move between States
Supreme Court in Skinner v. Railway have been potentially exposed to that poses a public health risk. In
Labor Executives’ Ass’n, 489 U.S. 602 communicable diseases of public health contrast, a ‘‘thing’’ simply refers to a
(1989) because of the ‘‘special need’’ in concern. For some of these diseases,
material object that poses a public
preventing communicable disease there are preventive medications or
health risk regardless of whether there
spread. Furthermore, requiring vaccines that the individual may be
is a specific intent to import or move
passenger information from airlines and made aware of and wish to obtain to
questioning travelers is authorized keep from becoming sick. Therefore, between States. For instance, on July 10,
under 42 U.S.C. 264(a), which allows for HHS/CDC considers the collection of 2001, CDC issued an order under the
the promulgation of regulations passenger locating information to be of authority of section 71.32(b) requiring
necessary for preventing the spread of benefit to these passengers and in that imports of ‘‘lucky bamboo’’ (a
communicable diseases from foreign keeping with standard public health decorative plant) shipped in standing
countries into the United States and practice to prevent further water be prohibited from entering the
interstate. In carrying out and enforcing communicable disease transmission. United States because the water (i.e., the
these regulations, 42 U.S.C. 264(a), After considering these comments, method of packing the lucky bamboo)
authorizes ‘‘inspection’’ and ‘‘other HHS/CDC has finalized these provisions constituted a potential vector for
measures’’ as may be necessary which (71.4 and 71.5) as proposed, with the mosquito-borne illnesses. See 66 FR
allows for inspection of airline records exception that the title has been 35984 (July 10, 2001). In contrast,
and questioning of travelers regarding modified to remove references to shipments of ‘‘lucky bamboo’’ that were
their health status and travel history. ‘‘collection’’ and ‘‘storage’’ of packed dry (not in standing water) were
While 42 U.S.C. 264(d)(1) is not directly information to more accurately reflect permitted entry into the United States.
implicated in questioning of travelers the requirements under this section. In this case, ‘‘lucky bamboo’’ (the
because such questioning may occur References to the CDC have also been decorative plant) would constitute the
without a specific reason to believe that replaced with Director throughout these ‘‘article’’ and the standing water would
the individual traveler may be infected sections. constitute the ‘‘thing.’’
with a quarantinable communicable a. Suspension of Entry of Animals, HHS/CDC received a question
disease, we note that the commenter’s Articles, or Things From Designated regarding the fate of animals or articles
suggestion that an ‘‘examination’’ Foreign Countries and Places Into the denied entry under this regulation,
excludes ‘‘interrogation’’ is not United States stating that ‘‘articles might presumably
supported by common understanding or be forfeited and pets will be executed,’’
language usage. We note that Merriam Regarding provision 71.63 Suspension
of entry of animals, articles, or things and questioning whether this provision
Webster defines ‘‘examination’’ among aligns with due process, particularly
other things as ‘‘a formal interrogation.’’ from designated foreign countries and
places into the United States, one public with respect to the right to appeal. In
Thus, this commenter’s suggestion that response, HHS/CDC states that the
because HHS/CDC purportedly lacks the health association proposed that the
restriction of animals should include an provision authorizing temporary
legal authority to collect traveler
exception for ports of entry that could suspension of entry of certain animals,
information under 42 U.S.C. 264 it also
provide for physical inspection. In articles and things based on the
lacks authority to collect information
response, HHS/CDC clarifies that if the existence of a communicable disease in
under the Privacy Act is without merit.
HHS/CDC also rejects the suggestion CDC Director determines an imported a foreign country and to protect the
that questioning of travelers violates animal (or product) poses a significant public’s health is intended to prevent
their rights to free association under the public health threat, this provision the arrival of these items at a U.S. port
First Amendment. The U.S. Supreme requires the Director to designate the of entry. Therefore, HHS/CDC will seek
Court has recognized a ‘‘freedom of period of time and conditions under to ensure travelers are informed of the
association’’ in only two distinct areas: which entry into the United States shall restriction and will also work with
(1) Choices to enter into and maintain be suspended, which may include carriers to prevent these animals or
certain personal human relationships limiting entries to certain ports where items from being loaded onto aircraft or
(as an element of personal liberty); and physical inspections are available. In vessels traveling to the United States. If
(2) a right to associate for the purpose keeping with current practice, HHS/ such animals or items do arrive at a U.S.
of engaging in other activities protected CDC will implement public health port of entry, HHS/CDC will take
by the First Amendment, i.e., speech, protection measures that strike the measures as needed to protect the
assembly, petition for redress of appropriate balance between protecting public’s health. Such measures will be
mstockstill on DSK3G9T082PROD with RULES3

grievances, exercise of religious the public’s health and continued determined on a case-by-case basis and
freedom. City of Dallas v. Stanglin, 490 importation and trade. may include, at the owner’s expense,
U.S. 19, 23–24 (1989). The purpose of HHS/CDC received a comment that confinement, re-exportation, or
this proposed requirement is to protect the term ‘‘thing’’ as used in 71.63 destruction. Re-exportation may be
the vital health interests of passengers authorizing the suspension of ‘‘animals, considered if there is no public health
and crew so that individuals who have articles, or things,’’ based on the risk during travel. HHS/CDC would also
been exposed to a communicable existence of communicable disease in a consider euthanasia of animals if there

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00041 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6930 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

are no other reasonable alternatives to embargos (less restrictive) or does not annualized costs and benefits are
protect the public’s health. allow importation of animals under estimated to be much less than $100
In response to the concern expressed temporary embargos for science, million in any given year.
about an ‘‘appeal,’’ HHS/CDC notes that education, and exhibition when However, there is uncertainty about
the Director’s suspension order would accompanied by a special permit. the appropriate analytic baseline, and
ordinarily constitute ‘‘final agency We believe the regulations described relative to some possible baselines, the
action’’ under the Administrative above and set forth below in text offer effects of the rule are non-negligible. For
Procedure Act, 5 U.S.C. 704. However, the best solutions for protecting U.S. example, if in the absence this rule,
HHS/CDC will consider the public health while allowing for some aspects of future HHS/CDC
appropriateness of offering an continued travel. HHS/CDC believes screening or risk assessment activities
administrative appeal as it develops the that this rulemaking complies with are found to be legally impermissible,
relevant suspension order. Executive Order 13563; all of these then the status quo baseline would not
After considering these comments, changes provide good alternatives to the represent a reasonable approximation of
HHS/CDC has finalized the Suspension current baseline. the state of the world without the rule.
of Entry of Animals, Articles, or Things Relative to a non-status quo baseline,
From Designated Foreign Countries and VII. Required Regulatory Analyses the rule would lead to activities (e.g.,
Places Into the United States (71.63) A. Executive Orders 12866 and 13563 the 2014–16 Ebola risk assessment and
provision as proposed. management program) that have both
HHS/CDC has examined the impacts
VI. Alternatives Considered substantial costs and substantial
of the final rule under Executive Order
benefits. Analyses relative to this non-
Under Executive Order 13563 12866, Regulatory Planning and Review
status quo baseline are presented in a
agencies are asked to consider all (58 FR 51735, October 4, 1993) 2 and
separate appendix.
feasible alternatives to current practice Executive Order 13563, Improving This Regulatory Impact Analysis
and the rulemaking as drafted. One less Regulation and Regulatory Review, (76 (RIA) section presents the anticipated
restrictive alternative would be for FR 3821, January 21, 2011).3 Both costs and benefits that are quantified
HHS/CDC to stop enforcing its Executive Orders direct agencies to where possible are relative to the status
regulations and make compliance with evaluate any rule prior to promulgation quo baseline. Where quantification is
current regulations voluntary. Under to determine the regulatory impact in not possible, a qualitative discussion is
this scenario, HHS/CDC would not terms of costs and benefits to United provided of the costs and/or benefits
obtain contact data from airlines or States populations and businesses. that HHS/CDC anticipates from issuing
provide such data to health departments Further, together, the two Executive these regulations.
in order to conduct contact Orders set the following requirements:
investigations. HHS/CDC would not Quantify costs and benefits where the Need for Rule
require illness and death reports on new regulation creates a change in The 2014–2016 Ebola response
aircraft or vessels, but would still current practice; define qualitative costs highlights the inadequacies and
follow-up with airlines and vessel and benefits; choose approaches that limitations of the current regulatory
operators upon request. This alternative maximize net benefits including provisions on the traveler data
would put travelers at greater risk of potential economic, environmental, collection process in which CDC must
becoming infected with communicable public health and safety, and other request traveler manifests from airlines
diseases, reduce the ability of public advantages; support regulations that and manually search for contact data in
health departments to offer post- protect public health and safety; and order to know who enters the United
exposure prophylaxis or other measures minimize the adverse impact of States, where they go, and how to
to prevent communicable disease spread regulation. HHS/CDC has analyzed the contact them.
from travelers known to have been final rule as required by these Executive Airlines have been slow to respond to
exposed, and generally increase the risk Orders and has determined that it is HHS/CDC requests for traveler
of communicable disease transmission consistent with the principles set forth manifests:
in the United States. in the Executive Orders and the Æ 30% arrive more than three days
Another alternative, is to extend the Regulatory Flexibility Act,4 as amended after a request,
scope of the regulations by closing U.S. by the Small Business Regulatory Æ 15% arrive more than six days late.
borders and ports of entry to incoming Enforcement Fairness Act (SBREFA) 5 In addition, available locating
traffic from countries experiencing and that, relative to the status quo, the information is usually incomplete:
widespread transmission of final rule will not be economically HHS/CDC receives only the name and
quarantinable communicable diseases to significant because the sum of seat number for 61% of travelers, and
protect public health is also analyzed one or more additional pieces of
based on the 2014–16 Ebola outbreak in 2 Executive Order 12866 of September 30, 1993: information for 39% of travelers. This
West Africa as well as recent Regulatory Planning and Review. Federal Register. final rule clarifies HHS/CDC’s existing
Monday, October 4, 1993; 58(190). http://
importations of Middle East respiratory www.archives.gov/federal-register/executive-orders/
authority to request any available
syndrome. HHS/CDC believes this pdf/12866.pdf. Accessed January 2016. contact data from airlines and vessel
approach is neither practicable nor is it 3 Executive Order 13563 of January 18, 2011: operators, which may improve the
desirable. Improving Regulation and Regulatory Review. timeliness and completeness of future
In a separate appendix, alternatives Federal Register. Friday, January 21, 2011; 76(14). requests from airlines or vessel
http://www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/
are considered to increase or decrease operators for data not already submitted
mstockstill on DSK3G9T082PROD with RULES3

2011-1385.pdf. Accessed January 2016.


HHS/CDC’s required payments for care 4 U.S. Small Business Administration. Regulatory to the Department of Homeland
and treatment for individuals under Flexibility Act. http://www.sba.gov/advocacy/823. Security.
Federal orders as specified in 42 CFR Accessed January 2016. Some traveler contact data is available
5 Summary of the Unfunded Mandates Reform
70.13 and 42 CFR 71.30. Also in a in the APIS/PNR dataset already
Act. 2 U.S.C. 1501 et seq. (1995). http://
separate appendix, alternatives are also www2.epa.gov/laws-regulations/summary-
submitted by airlines to CBP. In the
considered in which HHS/CDC does not unfunded-mandates-reform-act. Accessed January experience of the HHS/CDC, queries
implement temporary animal import 2016. from APIS/PNR rarely result in full sets

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00042 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6931

of contact information (i.e. the record populated to determine where the index international travel to persons or
includes all five additional data fields as case sat in relation to other at-risk animals infected with communicable
outlined in the final rule). The data passengers. For large flights from Asia, diseases.
fields that are most commonly missing this can pose a tremendous burden to The economic impact analysis of this
from the records are email addresses NTC and CDC staff while slowing the final rule is subdivided into four
(missing 90 percent of the time), ability of CDC to provide important sections:
secondary phone number (missing 90 contact information to state and local 1. An analysis of 42 CFR 70.1, 42 CFR
percent of the time), and street health departments. Manually 71.1/71.4/71.5, for which the primary
addresses (missing or insufficient for populating multiple 300+ person flights costs may be incurred by aircraft and
public health contact tracing up to 50 is not feasible in a timely manner. vessel operators and the primary benefit
percent of the time). These data Finally, CDC wishes to reiterate its is improved public health
elements are vital to a contact tracing desire for the above-described responsiveness to assess and provide
investigation. In looking at a random operations to be published in regulation post-exposure prophylaxis to travelers
sample of 20% of the compiled to provide the public, as well as exposed to communicable diseases of
international air travel manifests for industry, with understanding of the public health concern.
2015, those including a compiled data efforts made by CDC to protect public 2. An analysis of a number of
set from NTC and the airlines, 100% health. provisions that aim to improve
were missing at least one of the 5 data The other change to the economic transparency of how HHS/CDC uses
fields. Email address and secondary baseline that may result from this final regulatory authorities to protect public
phone number were among those most rule was the need to change the health. These changes are not intended
frequently missing. For context, there definition of an ‘‘ill person’’ to better to provide HHS/CDC with new
were approximately 760,000 scheduled match HHS/CDC guidance and the regulatory authorities, but rather to
flights that arrived into the United guidelines contained in Note 1 to clarify the agency’s standard operating
States in 2015. In 2015, HHS/CDC paragraph 8.15 of Annex 9 to the procedures and policies, and due
issued passenger manifest requests for Convention on International Civil process rights for individuals. HHS/CDC
64 international flights arriving into the Aviation. Where possible, the marginal believes that improving the quality of its
United States. As noted in the RIA of costs and benefits of these changes regulations by providing clearer
the final rule, from 2010 to 2015, HHS/ relative to the status quo baseline are explanations of its policies and
CDC conducted an average of 77 contact monetized. procedures is an important public
investigations per year involving In addition, HHS/CDC believes that benefit. However, HHS/CDC is not able
arriving international flights. there is a need to better communicate to to attach a dollar value to this added
Airlines are contacted for the majority the public the actions that it has taken benefit in a significant way. In a
of contact investigations using a in accordance with its regulatory separate appendix, HHS/CDC analyzes
manifest order document. At a authority under 42 CFR 70.6 the costs and benefits associated with
minimum, HHS/CDC needs to confirm Apprehension and detention of persons the 2014–2016 Ebola enhanced risk
the ill traveler was on the flight and with specific diseases, 42 CFR 71.32 assessment and management program
where the individual sat in relation to Persons, carriers, and things, and are used to illustrate the costs and
other travelers to determine risk of § 71.33—Persons: Isolation and benefits of implementation of some of
exposure. Further, in HHS/CDC’s surveillance. HHS/CDC believes it is these authorities, and are especially
experience, only airlines can: necessary for the public to better relevant when analyzing the effects of
• Quickly and efficiently produce a understand actions that may be taken to the rule relative to a non-status quo
partial manifest targeting affected rows prevent the importation of baseline.
• confirm identity of ‘‘babes in arms’’ communicable diseases and to explain 3. In a separate appendix, HHS/CDC
and their co-travelers (Parent); this is the due process available to individuals provides an analysis of the revisions to
important for measles cases; under Federal orders for isolation, 42 CFR 70.13/71.30: Payment for care
• quickly confirm whether an quarantine, or conditional release. HHS/ and treatment, which are not expected
individual actually flew (in instances CDC also believes it is important to to lead to a change in HHS/CDC policy
where individuals deplane and do not explain when HHS/CDC may authorize under which HHS/CDC may act as the
re-board during a layover); and payment for the care and treatment of payer of last resort for individuals
• confirm a plane’s configuration if individuals subject to medical subject to medical examination,
there is a question with the provided examination, quarantine, isolation and quarantine, isolation, and conditional
row numbers. Different aircraft have conditional release. release under Federal orders. The
different seating arrangements Finally, HHS/CDC believes it is primary benefit of codification is
depending on carrier and layout. It is important to explain its regulatory increased transparency around HHS/
important to know if a certain seat is authority to suspend entry of animals, CDC policies to assist in paying for
separated by a bulkhead or is a window articles or things from designated treatment or transportation for
seat. foreign countries and places into the individuals under Federal orders. The
In addition, HHS/CDC only requires a United States when importation analysis for these provisions is an
partial manifest, e.g. 5 rows for travelers increases the risk of the introduction examination in potential transfer
with infectious tuberculosis, so that and/or transmission of a communicable payments between HHS/CDC and
NTC and HHS/CDC staff can limit the disease within the United States. healthcare facilities that provide
investigation to only those passengers at The specific market failure addressed treatment to individuals under Federal
mstockstill on DSK3G9T082PROD with RULES3

risk and supplement/cross reference by these regulations is that the costs orders or to other payers.
with APIS and PNR data. If a partial associated with the spread of 4. In a separate appendix, HHS/CDC
manifest is not available from the communicable diseases impacts the provides an analysis of 42 CFR 71.63:
airlines, then each passenger record entire U.S. population, not just the Suspension of entry of animals, articles,
must be researched individually to find group of persons currently infected with or things from designated foreign
a seat number, and then the communicable diseases or with business countries and places into the United
configuration of an entire plane must be interests in providing interstate or States. In this final rule, HHS/CDC is

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00043 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6932 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

explaining its existing regulatory of all rodents from Africa (order purpose of the analysis is to
authority. HHS/CDC cannot predict how Rodentia).6 A simple economic impact demonstrate potential costs and benefits
often such authority may be used in the analysis of this embargo is performed to using a realistic example.
future or for what purpose. HHS/CDC demonstrate the costs and benefits of Table 1 provides a summary of
previously exercised this authority on one example, but HHS/CDC does not
whether quantitative or qualitative
June 11, 2003, when under 42 CFR anticipate an increase in frequency of
analyses were performed for each of the
71.32(b), HHS/CDC implemented an such actions based on the provisions
immediate embargo on the importation included in this final rule. The primary provisions in the final rule.

TABLE 1—SUMMARY OF PROVISIONS INCLUDED IN THIS FINAL RULE


Codification
Qualitative
Provision of existing
impacts only authority

§ 70.1/§ 71.1 General Definitions .......................................................................................................................... No a ................ Yes (except


definition of
‘‘ill person’’).
§ 70.5 Requirements relating to travelers under a federal order of isolation, quarantine, or conditional release Yes ................. Yes.
§ 70.6 Apprehension and detention of persons with specific diseases; § 71.32 Persons, carriers, and things Yes ................. Yes.
(no change to title).
§ 70.10/§ 71.20 Public health prevention measures to detect communicable disease ........................................ Yes b .............. Yes.
§ 70.11 Report of death or illness onboard aircraft operated by an airline ......................................................... Yes ................. Yes.
§ 70.12/§ 71.36 Medical examinations .................................................................................................................. Yes ................. Yes.
§ 70.13/§ 71.30 Payment for Care and Treatment ............................................................................................... Yes c ............... Yes.
§ 70.14/§ 71.37 Requirements relating to the issuance of a Federal order for quarantine, isolation, or condi- Yes ................. Yes.
tional release.
§ 70.15/§ 71.38 Mandatory reassessment of a federal order for quarantine, isolation, or conditional release ... Yes ................. Yes.
§ 70.16/§ 71.39 Medical review of a federal order for quarantine, isolation, or conditional release .................... Yes ................. Yes.
§ 70.17/§ 71.29 Administrative records relating to federal quarantine, isolation, or conditional release ............. Yes ................. Yes.
§ 70.18/§ 71.2 Penalties ........................................................................................................................................ Yes ................. Yes.
§ 71.4 Requirements relating to collection, storage and transmission of airline passenger, crew and flight in- No a ................ Yes.
formation for public health purposes.
§ 71.5 Requirements relating to collection, storage and transmission of vessel passenger, crew, and voyage No a ................ Yes.
information for public health purposes.
§ 71.33 Persons: Isolation and surveillance ......................................................................................................... Yes ................. Yes.
§ 71.63 Suspension of entry of animals, articles, or things from designated foreign countries and places into Yes d .............. Yes.
the United States.
a Analyzed in RIA.
b The costs and benefits associated with the 2014–2016 Ebola enhanced risk assessment and management program are used to illustrate the
costs and benefits in a separate appendix.
c In a separate appendix, an analysis of previous HHS/CDC payments for care and treatment is provided. However, the provisions in the Final
Rule are not expected to lead to a change in HHS/CDC policy under which HHS/CDC may act as the payer of last resort for individuals subject
to medical examination, quarantine, isolation, and conditional release under Federal orders.
d In a separate appendix, HHS/CDC provides an analysis of this provision based on past experience when HHS/CDC implemented an imme-
diate embargo on the importation of all rodents from Africa.

Executive Summary of the Costs and cost estimates are based on an increase Estimated Benefits
Benefits of 42 CFR 70.1, 42 CFR 71.1/ in:
71.4/71.5 • The number of illness reports The best estimate of quantified
delivered by airlines and vessel benefits of the final rule is also
Estimated Costs operators to CDC, relay of air illness relatively small $110,045 (range $26,337
reports to CDC by the Federal Aviation to $297,393). This estimate is based on
The quantified costs and benefits of expected improvements in illness
the final rule are estimated for the Administration (FAA) when such
reports are received by FAA air traffic reporting and in the timeliness,
following stakeholders: Air and completeness, and accuracy of contact
maritime conveyance operators, State service units, illness reports processed
by HHS/CDC and time for travelers; data. These improvements should result
and local public health departments in increased efficiencies for HHS/CDC
• increased costs for airlines and
(PHDs), individuals exposed to and State and local public health
vessel operators to comply with HHS/
communicable diseases during travel CDC requests for traveler contact data; departments in conducting contact
and United States Government (USG). • increased costs for State and local investigations among travelers exposed
The most likely estimates of primary public health departments to follow up to communicable diseases on aircraft
costs are low ($32,622, range $10,959 to with a larger number of travelers and vessels and reduced illness costs
$430,839) because the final rule exposed to communicable diseases associated with the reduced risk of
primarily codifies existing practice or during travel; measles and tuberculosis morbidity and
mstockstill on DSK3G9T082PROD with RULES3

improves alignment between regulatory • The upper bound cost estimate also mortality in exposed travelers.
text and the symptoms reporting includes a substantial increase in Other potential but non-quantified
guidelines provided by the International training costs for the changes to illness benefits of the final rule would be
Civil Aviation Organization (ICAO). The reporting. associated with future outbreaks of

6 Federal Register 62353 Vol. 68, No. 213

Tuesday, November 4, 2003. P. 62353–69.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00044 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6933

infectious disease cases for which effectively able to contact persons without accurate and timely contact
improved compliance by airlines and potentially exposed to the index case on data, it is frequently difficult to
vessel operators to provide available an aircraft or vessel. These increased intervene within these timelines. A
traveler contact data would reduce efficiencies should lead to smaller recent analysis showed that 9 cases
onward spread of disease in the infectious disease outbreaks and fewer likely occurred as a result of exposure
destination communities of exposed public health resources needed to during 108 flights with 74 case-travelers
travelers. In addition, the change to the control an outbreak. over 3 years. Although there was no
definition of ‘‘ill person’’ may also There are multiple communicable onward transmission from these 9
increase reporting of communicable diseases including quarantinable (e.g., cases,11 future cases may lead to larger
diseases of public health concern tuberculosis, MERS, and Ebola) and outbreaks.
onboard conveyances. Reduction in non-quarantinable (e.g., measles, Measles outbreaks can have
onward spread would also lead to the varicella, pertussis, rabies, substantial associated costs. One model-
ability of the public health meningococcal, and rubella) diseases based analysis showed that 16 outbreaks
establishment to reduce effects of that may necessitate a contact with 107 confirmed measles cases cost
disease outbreaks, e.g., delay the spread investigation to prevent spread of an estimated $2.7 million to $5.3
of disease until a vaccine is available or disease in the community. HHS/CDC million U.S. dollars for public health
limit the numbers of outbreaks and notes that for non-quarantinable departments to contain.12 The estimate
cases or reduce public anxiety diseases, HHS/CDC efforts would is based on outbreak-specific travel
associated with the risk of transmission. primarily be limited to assisting health expenses and the opportunity cost of
There may also be a reduction in the departments to notify individuals of diverting public health staff to outbreak
economic costs of many business sectors their potential exposures. HHS/CDC was response activities and is not based on
such as avoidance of costs to the travel unable to quantify the benefits of the cost of hiring additional staff. This
and tourism industry 7 8 when a disease preventing the spread of all diseases as corresponds to an average cost per
is contained in its early stages. a group because of differences in the outbreak of about $250,000 in 2015
Section 202(a) of the Unfunded characteristics of each disease. The USD. In comparison, a total of 125 cases
Mandates Reform Act of 1995 requires differences with respect to potential occurring in 8 States and three countries
that agencies prepare a written spread and impact make it difficult to were associated with a single measles
statement, which includes an assess the benefits that may accrue from outbreak that originated in late
assessment of anticipated costs and reduced spread of all diseases. The December 2014 in amusement theme
benefits, before proposing ‘‘any rule that quantified analysis focuses on the two parks in Orange County, California.13
includes any Federal mandate that may diseases that generate the greatest Thus, the number of cases in this one
result in the expenditure by State, local, number of contacts to follow up: outbreak exceeded the total number of
and tribal governments, in the aggregate, Measles and tuberculosis. outbreak-associated cases identified in
or by the private sector, of The ongoing persistence of measles in 16 outbreaks during 2011. The source of
[$146,000,000 in 2015 USD] or more.’’ the United States provides a good the initial exposure has not been
Not only will this final rule not cost example of the need for this final rule. identified so it is not possible to
State, local and tribal governments any In 2000, measles was declared no longer determine where this index case was
expenditure, it is possible that these endemic in the United States due to exposed. However, this example
stakeholders who might be engaged in high vaccination rates. Cases and demonstrates the speed with which
contact tracing may see a reduction in outbreaks of measles continue to occur, communicable diseases can be
costs if the final rule is implemented however, as a result of importation from transmitted and the importance of
and there is an improvement in airline other countries and lack of adherence to quickly identifying persons that may
compliance with HHS/CDC requests to the recommendation for measles have been exposed during air or
provide traveler data. vaccination (http://www.cdc.gov/ maritime travel. It is possible that the
The Final Rule vaccines/hcp/acip-recs/vacc-specific/ costs of this one outbreak, which spread
mmr.html). The United States is across 8 States, exceeded the total costs
Traveler contact information will only currently discovering the greatest of all 16 outbreaks that occurred in 2011
be requested by HHS/CDC after a case number of measles cases that have been and were estimated to cost public health
of serious communicable disease (index identified since the declaration of departments a total of $2.7 million to
case) is reported in a person who measles elimination; 97% of recent $5.4 million dollars.14
traveled on a commercial airline or cases were associated with importations In the absence of interventions by
vessel while contagious. Examples of from other countries. Of 45 direct public health departments, travelers
serious communicable diseases include importations, 40 occurred in U.S.
measles, novel influenzas, and viral citizens after traveling abroad.9 11 Nelson, K., Marienau, K.J., Schembri, C. and

hemorrhagic fevers such as Ebola among Among air travelers exposed to Redd, S. (2013). ‘‘Measles transmission during air
others. This type of situation travel, United States.’’ Travel Medicine and
measles during flights, post-exposure Infectious Disease (2013) 11, 81e89 11: 81–89.
necessitates identifying and locating prophylaxis (PEP) with measles- 12 Ortega-Sanchez, I.R., M. Vijayaraghavan, A.E.
passengers seated near the index case in containing vaccine (within 72 hours) or Barskey and G.S. Wallace (2012). ‘‘The economic
order to conduct a contact investigation immune globulin (within 6 days) can burden of sixteen measles outbreaks on United
(CI). This final rule would lead to better States public health departments in 2011.’’ Vaccine
prevent onset of disease,10 halting 32(11).
health outcomes if public health outbreaks before they begin. However, 13 Jennifer Zipprich, Kathleen Winter, Jill Hacker,
departments are more quickly and
mstockstill on DSK3G9T082PROD with RULES3

Dongxiang Xia, James Watt, Kathleen Harriman.


9 Gastañaduy, P.A., S.B. Redd, A.P. Fiebelkorn, (2015) Measles Outbreak—California, December
7 Rassy D, Smith RD. The economic impact of J.S. Rota, P.A. Rota, W.J. Bellini, J.F. Seward and 2014–February 2015. MMWR/February 20, 2015/
H1N1 on Mexico’s tourist and pork sectors. Health G.S. Wallace (2014). ‘‘Measles—United States, Vol. 64/No. 6: 153–154.
Econ. 2013;22(7):824–34. doi: 10.1002/hec.2862. January 1–May 23, 2014.’’ MMWR 63(22): 496–499. 14 Ortega-Sanchez, I.R., M. Vijayaraghavan, A.E.
PubMed PMID: 23744805. 10 Nelson, K., Marienau, K.J., Schembri, C. and Barskey and G.S. Wallace (2012). ‘‘The economic
8 Keogh-Brown MR, Smith RD. The economic Redd, S. (2013). ‘‘Measles transmission during air burden of sixteen measles outbreaks on United
impact of SARS: How does the reality match the travel, United States.’’ Travel Medicine and States public health departments in 2011.’’ Vaccine
predictions? Health Policy. 2008;88(1):110–20. Infectious Disease (2013) 11, 81e89 11: 81–89. 32(11).

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00045 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6934 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

infected with measles during $430,839 and the upper bound For example, in 2014, two international
international travel would be as likely quantified benefits are $297,393. Lower travelers on commercial flights from the
as any other individuals to initiate a bound quantified costs are $10,959 and Middle East arrived in the United States
measles outbreak. In the absence of benefits are $26,337. while infected with MERS and two
HHS/CDC efforts to retrieve and The measles and tuberculosis international travelers on commercial
transmit contact data, public health examples should not be considered a flights from West Africa arrived while
departments would not be able to infected with Ebola. Regardless of the
complete estimate of non-quantified
contact travelers to offer post-exposure infectious disease scenarios faced by
benefits associated with this final rule,
prophylaxis and to recommend self- HHS/CDC in a given year, this final rule
because the impact of this final rule to
monitoring for potential measles should improve HHS/CDC’s ability to
mitigate many different types of
symptoms. mitigate infectious diseases in the
infectious disease outbreaks cannot be
Summary of Quantifiable and quantified. It just provides examples future. To the extent that the final rule
Qualitative Results of the Regulatory based on the two diseases for which would lead to improved responsiveness
Impact Analysis contact investigations are most of airlines and vessel operators to HHS/
The Summary Table provides frequently undertaken. Besides CDC traveler data requests via manifest
estimated total monetary results for communicable diseases commonly orders, HHS/CDC may become better
stakeholders’ costs and benefits of reported in the United States (e.g., able to respond to infectious diseases
implementing the final rule. The measles, tuberculosis), this final rule threats and (1) reduce case-loads during
Summary Table (Table 2) includes may also improve HHS/CDC’s ability to infectious disease outbreaks, (2) reduce
estimates associated with changes to the respond to diseases that are infrequently public anxiety during disease outbreaks,
definition of ‘ill person’ in 42 CFR 70.1/ diagnosed in the United States (e.g., (3) mitigate economic impacts on
71.1 and the codification of Ebola, novel influenza, Middle East businesses as a consequence of reduced
international traveler data collection Respiratory Syndrome). For example, it public anxiety, and (4) reduce the
processes of aircraft and vessel contact is possible that HHS/CDC may need to amount of personnel labor time to
investigations under 42 CFR 71.4/71.5. prepare to address both Ebola and conduct large-scale contact
The best estimates of annual costs are another disease such as novel influenza investigations in response to a new
$32,622 compared to the best estimate or Middle East Respiratory Syndrome infectious disease or one with serious
of annual benefits at $110,045. The (MERS) occurring in two separate public health and medical consequences
upper bound annual quantified costs are countries or regions during a given year. like Ebola.

TABLE 2—SUMMARY OF MONETIZED AND QUALITATIVE BENEFITS AND COSTS OF THE FINAL RULE
[2015 USD]

Source citation
Most likely Lower bound Upper bound
Category (RIA,
estimate estimate estimate preamble, etc.)

BENEFITS

Annual monetized routine benefits from reduced effort by CDC and health $12,218 $0 $12,218 RIA.
department to search for exposed contacts (0% discount rate).
Annual monetized routine benefits from reduced illness (0% discount rate) $97,828 $26,337 $272,958 RIA.
Total annual monetized routine benefits (0% discount rate) .......................... $110,045 $26,337 $285,175 RIA.

Qualitative (unquantified benefits) ................................................................... To the extent that airlines or vessel operators RIA.
have data available and improve responsive-
ness of airlines and vessel operators to HHS/
CDC traveler data requests results from the
implementation of the provisions in this final
rule, HHS/CDC may become better able to re-
spond to infectious diseases threats and (1) re-
duce case-loads during infectious disease out-
breaks, (2) reduce public anxiety during dis-
ease outbreaks, (3) mitigate economic impacts
on businesses as a consequence of reduced
public anxiety, and (4) reduce the amount of
personnel labor time to conduct large-scale CIs
in response to a new infectious disease or one
with serious public health and medical con-
sequences like Ebola.

COSTS

Annual monetized costs for changes to illness reporting (airlines and vessel $0 $0 $376,554 RIA.
mstockstill on DSK3G9T082PROD with RULES3

operators, 0% discount rate) *.


Annual monetized costs for changes to codification of manifest order proc- $12,654 $0 $25,308 RIA.
ess (airlines and vessel operators), 0% discount rate) *.
Annual monetized costs for additional activities by health department con- $19,968 $10,959 $28,977 RIA.
tacting individuals exposed to communicable diseases during inter-
national travel (0% discount rate).
Total annual monetized routine costs (0% discount rate) .............................. $32,622 $10,959 $430,839 RIA.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00046 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6935

TABLE 2—SUMMARY OF MONETIZED AND QUALITATIVE BENEFITS AND COSTS OF THE FINAL RULE—Continued
[2015 USD]

Source citation
Most likely Lower bound Upper bound
Category (RIA,
estimate estimate estimate preamble, etc.)

Annual quantified, but unmonetized, costs ..................................................... None RIA.

Qualitative (unquantified) costs ....................................................................... None RIA.

The second analysis in this final rule procedures is an important public final rule primarily updates regulatory
is of a number of provisions that aim to benefit. However, HHS/CDC is not able requirements to better match current
improve transparency of how HHS/CDC to attach a dollar value to this added practice, the economic impacts are
uses its regulatory authorities to protect benefit in a significant way. marginal changes to current practice
public health. These changes are not that result from codification of current
Economic Baseline
intended to provide HHS/CDC with new practices.
regulatory authorities, but rather to Regulated Entities: Airlines and Vessel The North American Industry
clarify the agency’s standard operating Operators Classification System (NAICS) is used
procedures and policies with regard to The group of entities that may be by Federal statistical agencies in
pre-existing regulations in 42 CFR parts affected by this final rule would include classifying business establishments for
70 and 71 including due process rights international and interstate aircraft the purpose of collecting, analyzing, and
for individuals under Federal orders. operators, vessel operators, travelers, publishing statistical data related to the
HHS/CDC believes that improving the State or local health departments and U.S. business economy. A summary of
quality of its regulations by providing the Federal government agencies that the total numbers of each entity is
clearer explanations of its policies and interact with these groups. Since this summarized in Table 3.

TABLE 3—SUMMARY OF THE NUMBER OF FIRMS ENGAGED IN INTERSTATE AND INTERNATIONAL AIR AND MARITIME TRAVEL
Number of
NAICS codes NAICS description firms in
industry

481111 ............... Scheduled Passenger Air Transportation ............................................................................................................ 264


481112 ............... Scheduled Freight Air Transportation .................................................................................................................. 212
481219 ............... Other Nonscheduled Air Transportation .............................................................................................................. 516
483111 ............... Deep Sea Freight Transportation ........................................................................................................................ 191
483112 ............... Deep Sea Passenger Transportation .................................................................................................................. 54
483113 ............... Coastal and Great Lakes Freight Transportation ................................................................................................ 337
483114 ............... Coastal and Great Lakes Passenger Transportation .......................................................................................... 110
483211 ............... Inland Water Freight Transportation .................................................................................................................... 318
483212 ............... Inland Water Passenger Transportation .............................................................................................................. 193
Statistics of U.S. Businesses, 2013 U.S. all industries.15
2012 North American Industry Classification System (NAICS).16

According to a report by the Federal In 2011, there were approximately 11 landscape. Both U.S. and foreign
Aviation Administration, in 2012, U.S. million North American cruise ship airlines engage in ‘‘code-sharing’’
civil aviation-related economic activity passengers spending 71.8 million arrangements, whereby the marketing
generated $1.5 trillion and supported passenger nights on board vessels. The carrier places its call sign (or code) on
11.8 million jobs with $459.4 billion in cruise ship market was highly the operating carrier’s flight. For
earnings.17 In 2015, the domestic U.S. concentrated with four firms accounting purposes of this rule, reporting duty
market for air travel included 696 for 98% of the total market.19 In total, would require the operating carrier to
million passengers and the international approximately 18 million travelers enter report on all passengers and
market included another 198 million the United States each year via cruise or crewmembers, whether traveling on the
cargo ships.20
travelers.18 operator’s code or another carrier’s.
The domestic/international air carrier
market is an ever-shifting corporate The complexity of the domestic/
15 http://www.census.gov/econ/susb/.
foreign airline-corporations’ legal and
16 https://www.census.gov/cgi-bin/sssd/naics/
19 U.S. Department of Transportation Maritime financial arrangements makes it very
naicsrch. Administration (March 2012) North American
17 U.S. Department of Transportation, Federal
difficult to ascertain exactly how each
Cruise Statistical Snapshot, 2011 http://
Aviation Administration (January 2015) The www.marad.dot.gov/wp-content/uploads/pdf/ and every domestic and foreign airline
mstockstill on DSK3G9T082PROD with RULES3

Economic Impact of Civil Aviation on the U.S. North_American_Cruise_Statistics_Quarterly_ would be affected by the
Economy: Economic Impact of Civil Aviation by Snapshot.pdf (Accessed 5/2/2016). implementation costs associated with
20 According to the U.S. Department of Homeland
State. http://www.faa.gov/air_traffic/publications/ this final rule; presumably, some of the
media/2015-economic-impact-report.pdf (Accessed Security, 54,236 passengers and crew arrive via
vessel each day, which correspond to costs might be passed along to the
5/2/2016).
approximately 18 million per year. https:// carrier putting its code on the operating
18 Bureau of Transportation Statistics T–100
www.transportation.gov/policy/aviation-policy/us-
Market data. http://www.transtats.bts.gov/Data_ international-air-passenger-and-freight-statistics- carrier, pursuant to the particular terms
Elements.aspx?Data=1 (Accessed 5/2/2016). report Accessed on 5/2/2106. of each applicable contract.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00047 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6936 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

Under this final rule, the operator of quarantinable diseases, efforts could airline or vessel operator staff and
any airline operating a flight arriving include issuance of Federal orders for would require a medical assessment by
into the United States must make quarantine, isolation, or conditional a public health professional.
certain contact information described release of exposed/infected individuals.
Contact Investigations and Diseases—
below available within 24 hours of a
Interstate and International
request by HHS/CDC, to the extent that TABLE 4—DISEASES ANALYZED
such data are available to the operator. The number of travelers exposed to an
This requirement also applies to the Non-quarantinable Quarantinable index case that are subject to a contact
operator of any vessel carrying 13 or investigation (CI) varies by disease and
more passengers (excluding crew) and, Measles Tuberculosis. may include only the two passengers
Pertussis Viral Hemorrhagic Fe-
which is not a ferry as defined in under sitting adjacent to the index case
Rabies vers.
46 U.S.C. 2101 and U.S. Coast Guard Meningococcal dis- Middle East Res- (meningococcal disease or pertussis) or
(USCG) regulations (46 CFR 2.10–25). ease piratory Syndrome as much as the entire aircraft (e.g.,
This requirement is a codification of Varicella Coronavirus initial investigations of cases of MERS
current practice, and applies to any of Rubella (MERS). or Ebola) (Table 5). The entire aircraft or
the data elements that the airline or vessel may be subject to CI if the disease
vessel operator may have available and In addition, these diseases for which is new and transmission patterns are not
authorizes the airline or vessel operator HHS/CDC currently issues manifest well understood (e.g., MERS) or if the
to transmit the contact information in orders and conducts contact disease is felt to have serious medical or
any format and through any system investigations can also be subdivided to public health consequences (e.g., Ebola).
available and acceptable to both the identify those encountered with some Some CIs are only initiated for long-
airline and HHS/CDC. Again, because frequency (routine diseases): duration travel (e.g., tuberculosis for
this is a codification of current Tuberculosis, measles, meningococcal flights of 8 hours or longer). For other
practices, HHS/CDC assumes airlines disease, pertussis and rubella. Among diseases (e.g., measles, MERS), CIs are
and vessel operators will continue to these diseases, only tuberculosis is a undertaken regardless of duration.
submit data through current quarantinable disease. The second class The table also includes criteria to be
mechanisms, although HHS/CDC will is a group of new or emerging diseases, considered a contact for persons
accept others that are mutually or diseases with serious public health exposed on vessels. In contrast to air
acceptable. and medical consequences, that are not contact investigations, most maritime
To simplify the analysis and to currently prevalent, but are foreseeable contact investigations are undertaken
develop conservative cost estimates, as a future threat, e.g., severe acute before travelers disembark from vessels.
HHS/CDC assumed that all costs to respiratory syndromes (including SARS Another difference between air and
airlines and vessel operators would be and MERS), Ebola. This second group maritime contact investigations is that
passed along to U.S.-based airlines, only includes quarantinable diseases, varicella contact investigations are
vessel operators, or U.S. consumers. which may be updated in the future by frequently undertaken among maritime
Executive Order, but which are not travelers on vessels, but are not pursued
Diseases Affected by the Rule being updated as a part of the final rule. for air travelers. In addition, HHS/CDC
HHS/CDC has gathered statistics, or Although HHS/CDC may help identify has not yet had to conduct a contact
reported information on, a number of travelers ill with or exposed to measles, investigation for Middle East
notifiable and quarantinable diseases meningococcal disease, pertussis, Respiratory Syndrome or viral
(Table 4) that form the basis for rubella, rabies, and varicella, HHS/CDC hemorrhagic fever for travelers exposed
estimates of quantitative and qualitative does not have the authority to place any on vessels. The criteria listed in Table
benefits. The final rule provides CDC travelers with such illnesses or 5 are current as of October 2016, but
with the authority to take certain actions exposures under Federal orders. For may be updated in the future based on
with regard to both quarantinable and quarantinable diseases, illness reporting reviews of the effectiveness of contact
non-quarantinable diseases. For non- could lead to issuance of Federal orders investigations. For example, HHS/CDC
quarantinable diseases, efforts would be if travelers are reasonably believed to be stopped providing contact data to health
primarily limited to early identification infected with a quarantinable departments for mumps investigations
and notification of exposed individuals communicable disease in a qualifying after reviewing evidence of the
and transmission of contact data to local stage. Such restrictions would not occur effectiveness of mumps contact
and State health departments. For based simply on an illness report by investigations.

TABLE 5—CONTACT INVESTIGATION CRITERIA BY DISEASE, PHD FOLLOW UP


Disease CI initiated if Persons contacted, aircraft Persons contacted, vessels Recommended activities

Ebola (Quar- All cases ................................ All passengers and crew as Cruise vessel—any pas- Monitoring for 21 days after
antinable). of April 2016. In the future, senger or crew who made last potential exposure.
the recommendation may have come into contact with
change to include fewer the index case’s body fluids
passengers and crew. while the index case was
symptomatic.
mstockstill on DSK3G9T082PROD with RULES3

Cargo vessel—all on board


the vessel while the index
case was symptomatic.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00048 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6937

TABLE 5—CONTACT INVESTIGATION CRITERIA BY DISEASE, PHD FOLLOW UP—Continued


Disease CI initiated if Persons contacted, aircraft Persons contacted, vessels Recommended activities

Measles (Non- All cases if notification re- Passengers seated within 2 Direct face-to-face contact or Offer MMR vaccination if non-
quarantin- ceived within 21 days of rows either direction of the shared confined space >1 immune and <72 hrs. since
able). flight. index case, all babies-in- hour with symptomatic exposure; immune globulin
arms, crew in same cabin. case-patient. if indicated and within 6
All passengers and crew on days of exposure.
flights with <50 seats.
Meningo-coc- Case meets the definition of Passengers or crew sitting di- Cruise vessels—Cabin mates Post-exposure
cal disease meningococcal disease rectly to the left and right of of or potential for direct chemoprophylaxis.
(Non-quar- within 14 days of travel. the index case or with po- contact with oral or res-
antinable). For air travel: Flight >8 hrs. tential for direct contact piratory secretions of case-
(or shorter flights if direct with oral or respiratory se- patient during the 7 days
exposure reported). cretions. prior to symptom onset until
24 hours after implementa-
tion of effective anti-
microbial therapy.
Cargo vessels—All on board
the vessel during the 7
days prior to symptom
onset of case-patient until
24 hours after implementa-
tion of effective anti-
microbial therapy.
New or re- All cases during early stages All passengers and crew ....... All crew and passengers ....... Monitoring for 10 days after
emerging in- of international spread. last potential exposure;
fluenza vi- possible serologic testing.
ruses (Quar-
antinable).
Pertussis All cases if notification is re- Passengers sitting next to Direct face-to-face contact or Post-exposure
(Non-quar- ceived within 21 days of index case. shared confined space >1 chemoprophylaxis.
antinable). travel. hour with symptomatic
case-patient.
Rubella (Non- All cases if notification is re- Passengers seated within 2 Direct face-to-face contact or Serologic testing and guid-
quarantin- ceived within 60 days of rows + crew in same cabin. shared confined space >1 ance for pregnant women.
able). travel. All passengers and crew on hour with symptomatic
flights with <50 seats. case-patient.
Severe Acute All cases ................................ SARS-Coronavirus: All pas- Cruise vessel—any pas- Monitoring for 10–14 days
Respiratory sengers and crew. senger or crew who had di- after last potential expo-
Syndromes MERS: All passengers and rect face-to-face contact or sure; potential serologic
(Quarantin- crew contacted during 2014 shared confined space >1 testing.
able). CIs. Future CIs will include hour with symptomatic
passengers seated within 2 case-patient.
rows of index case. Cargo vessel—all on board
the vessel while the index
case was symptomatic.
TB (Quarantin- Notification received within 3 Passengers seated within 2 Cargo vessel: All crew mem- Aircraft: Testing for latent TB
able). months of travel, clinical cri- rows. bers within 3 months of di- infection; chest radiograph
teria met For air travel: agnosis who worked with if the LTBI test is positive.
Flight >8 hrs. case-patient. Vessels: Clinical assessment
Cruise vessel: Passenger for symptoms and chest
travel companions or crew radiograph.
working in close proximity/
sharing living quarters.
Varicella (Non- All cases on vessels .............. NA .......................................... Any person who has had ≥5 Varicella vaccination if
quarantin- minutes of direct face-to- unvaccinated/non-immune
able). face contact with a varicella and <3 days since expo-
case during the infectious sure (possibly up to 5
period. days). High-risk contacts
evaluated Varicella Zoster
immune globulin if <10
days after exposure.

The Quarantine Activity Reporting flights and vessels and at land border CIs for international flights from
mstockstill on DSK3G9T082PROD with RULES3

System (QARS), which contains, among crossings; infectious disease threats, and January 2010 through December 2015
other data, information collected under follow-up actions. Currently, HHS/CDC are summarized in Table 6. More than
OMB Control Numbers 0920–0134, Quarantine Stations at U.S. ports of half (73.2%) were initiated as a result of
0920–0488, 0920–0821, and 0920–0900, entry are using the system to record tuberculosis cases. Measles is the next
is a web-based and secure electronic their daily activities. All CIs undertaken most common disease (20.8%). The
system that supports collection of data by HHS/CDC are documented in QARS. remaining 6% are subdivided across
for ill persons on inbound or interstate rubella, pertussis, meningococcal

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00049 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6938 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

disease and other diseases. This table


also includes CIs undertaken for MERS.

TABLE 6—INTERNATIONAL AIR CONTACT INVESTIGATIONS, AVERAGE NUMBER OF ANNUAL INVESTIGATIONS AND CONTACTS
BY DISEASE, JAN 2010 THROUGH DEC 2015
[QARS data] a

Average Average
Total Percent of
Disease Total contacts investigations contacts
investigations total contacts
per year per year

Influenza, avian ................................................................ 0 0 0.0 0.0 0.0


MERS Coronavirus b ........................................................ 2 270 0.3 45.0 1.7
Measles ............................................................................ 94 3,381 15.7 563.5 20.8
Meningococcal disease .................................................... 8 9 1.3 1.5 0.1
Other ................................................................................ 3 97 0.5 16.2 0.6
Pertussis .......................................................................... 11 18 1.8 3.0 0.1
Rabies .............................................................................. 3 4 0.5 0.7 0.0
Rubella ............................................................................. 17 532 2.8 88.7 3.3
TB (clinically active) ......................................................... 318 11,928 53.0 1,988.0 73.2
Viral hemorrhagic fever .................................................... 7 53 1.2 8.8 0.3

Total .......................................................................... 463 16,292 77.2 2,715 ........................


a In May 2011, CIs were discontinued for international outbound flights. To give a better picture of what CIs will look like under this new pro-
tocol, flights from January 2010 to May 2011 have been excluded from the above-reported counts. In addition, CIs for mumps have been discon-
tinued. Prior to discontinuation, there were approximately 25 contacts per year investigated for mumps.
b For these CIs, contact information for the entire flight was required.
In rare instances, a disease is ruled out after a CI has happened.

HHS/CDC also requests traveler summarized in Table 7. In contrast to tuberculosis contact investigations
contact data to support contact international flights, very few contact (Table 5). The majority of contacts were
investigations for travelers exposed to investigations for tuberculosis were investigated after exposure to measles
infectious diseases on interstate flights. undertaken on interstate flights, because cases (76%) followed by MERS (8.4%)
The numbers of investigations and most interstate flights do not meet the and viral hemorrhagic fevers including
contacts during 2010–15 are 8-hour time requirement for Ebola (8.0%).

TABLE 7—INTERSTATE AIR CONTACT INVESTIGATIONS, AVERAGE NUMBER OF ANNUAL INVESTIGATIONS AND CONTACTS BY
DISEASE, JANUARY 2010 THROUGH DECEMBER 2015
[QARS data]

Average Average
Total number of number of Percent of
Disease Total contacts
investigations investigations contacts total contacts
per year per year

Measles ............................................................................ 72 3033 12.0 505.5 76.1


Meningococcal disease .................................................... 1 1 0.2 0.2 0.0
MERS Coronavirus a ........................................................ 2 334 0.3 55.7 8.4
Other ................................................................................ 0 0 0.0 0.0 0.0
Pertussis .......................................................................... 43 83 7.2 13.8 2.1
Rabies .............................................................................. 3 3 0.5 0.5 0.1
Rubella ............................................................................. 8 172 1.3 28.7 4.3
TB (clinically active) ......................................................... 2 40 0.3 6.7 1.0
Viral hemorrhagic fever .................................................... 4 319 0.7 53.2 8.0

Total .......................................................................... 135 3,985 22.5 664.2


Notes:
a For these CIs, contact information for the entire flight was required.
In rare instances, a disease is ruled out after a CI has happened.

The numbers of contacts for maritime measles (∼6%). Most of the varicella and passengers are reported to HHS/CDC’s
contact investigations are summarized measles contact investigations were Vessel Sanitation Program and cases of
in Table 8. For maritime investigations, initiated while travelers were still on Legionnaires’ disease are reported
the majority of contacts were vessels. Besides the investigations listed
mstockstill on DSK3G9T082PROD with RULES3

directly to HHS/CDC’s Respiratory


investigated for varicella (∼79%) in Table 8, gastrointestinal illness cases Diseases Branch.
followed by tuberculosis (∼13%) and on cruise vessels carrying 13 or more

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00050 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6939

TABLE 8—MARITIME PASSENGER DATA COLLECTION, AVERAGE NUMBER OF ANNUAL CONTACTS BY DISEASE
[January 2010–December 2015]

Average Average
Total number of number of Percent of
Passengers per voyage Total contacts
investigations investigations contacts total contacts
per year per year

Measles ............................................................................ 5 288 0.83 48 6.3


Meningococcal disease .................................................... 3 22 0.5 3.67 0.5
MERS Coronavirus ** ....................................................... 0 0 0 0 0.0
Other ................................................................................ 1 9 0.17 1.5 0.2
Pertussis .......................................................................... 3 14 0.5 2.33 0.3
Rabies .............................................................................. 0 0 0 0 0.0
Rubella ............................................................................. 2 26 0.33 4.33 0.6
TB (clinically active) ......................................................... 50 585 8.3 97.5 12.8
Viral hemorrhagic fever .................................................... 0 0 0 0 0.0
Varicella (chickenpox) a .................................................... 206 3,627 34.3 604.5 79.3

Total .......................................................................... 270 4,571 45 761.8 100.0


a One CI for varicella involved entire crew of the vessel (1224).

Traveler Manifest Orders for Airlines ‘‘urgent’’ manifest requests. In current Considering all requests from 2014, at
Contact tracing is most effective at practice, requests for contact data are least one additional piece of contact
reducing cases of communicable disease only considered ‘‘non-urgent’’ for information was provided for only about
at the early stages of a potential contact investigations in which travelers 39% of passengers. If the sample were
outbreak as soon after initial exposure had rubella (for which there is no restricted to only flights for which any
as possible. Therefore, if an efficient available prophylaxis) or tuberculosis or contact information was provided (1,270
contact system is not in place when the for situations in which HHS/CDC is not out of 2,411 total passengers), the
first ill travelers arrive, the benefits of notified of travelers diagnosed with fraction of passengers with at least one
contact tracing are greatly diminished. some communicable diseases until after piece of contact information beyond
Contact data requests only occur after a certain amount of time during which name and seat number increased from
a case of serious communicable disease prophylaxis would be effective (e.g., for 39% to 73.9%. This contact information
(index case) is reported in a person who measles: 6 days). If the analysis is would include U.S. address for 41.7% of
traveled on a commercial airline or limited to diseases where requests for passengers and one phone number for
vessel while contagious. This type of traveler contact data are marked 45% of passengers. As a result of HHS/
situation necessitates identifying and ‘‘urgent’’ by HHS/CDC (measles, CDC’s use of available information and
locating travelers seated near the index meningococcal disease, MERS, viral technology and its partnerships with
case in order to conduct a CI. hemorrhagic fevers, and rabies), other Federal agencies, contact tracing
At present, HHS/CDC uses a multi- performance improved such that 51% of exposed travelers can now be
step process to obtain traveler contact arrived within 24 hours of a request, accomplished more rapidly than would
information from airlines. HHS/CDC 33% arrived between 1–3 days after a be possible if only the contact data
issues a written order to the airline that request, 13% between 3–6 days and provided by airlines were used.
requires the airline to provide HHS/CDC only 3% arrived after 6 days. HHS/CDC However, if airlines or vessel operators
with contact information about the notes that there may be instances where have additional data relative to what is
index case and traveler contacts. The CDC may not have included the correct currently provided to DHS, the
order cites current regulatory language information in a manifest order (e.g., efficiency of contact investigations
in 42 CFR 71.32(b), as authorized by 42 flight number or port of entry). The could improve.
U.S.C. 264. HHS/CDC requires that the provision of incorrect flight information
airline provide it with the traveler’s first may have caused delay submission in Change to Definition of an ‘‘Ill Person’’
and last name, seat number, two phone some of the instances cited above. HHS/CDC is updating the definition
numbers and email address. HHS/CDC While HHS/CDC requires that all of ‘‘ill person’’ in 42 CFR 70.1 and 71.1
instructs airlines and vessel operators to information be provided upon first to better facilitate identification of
provide data when available or to report order for information, HHS/CDC has communicable diseases of public health
when data are unavailable. The time it consistently seen that the information concern aboard flights and voyages.
takes for HHS/CDC to obtain the provided by a majority of airlines However, HHS/CDC currently requests
available traveler contact data can range appears limited to frequent flyer that aircraft and vessels report several of
from a few hours to a few days. From information, or other limited contact the symptoms included in the revised
2010 through May 2015, about 70% of information. Overall, the completeness definition of ill person. Besides aircraft
manifests from airlines arrived within 3 of data provided by airlines varied such and vessel operators, quarantine stations
days of the request, 15% arrived that airlines generally fell into two also receive illness reports from U.S.
between 3 and 6 days after a request, categories. Some airlines always Customs and Border Protection, U.S.
mstockstill on DSK3G9T082PROD with RULES3

15% arrived after more than six days, provided only the passenger name and Coast Guard, State and local health
and nine requests took more than a seat number. Other airlines would departments, and health facilities. These
month or were never received by HHS/ provide some additional contact reports are not included in this analysis,
CDC. information for passengers. However, which focuses on reporting during
At present, HHS/CDC requests that even among these airlines, contact data travel.
airlines and vessels provide available for some of the passengers only HHS/CDC has crafted the definition of
traveler contact data within 24 hours for included names and seat numbers. ‘‘ill person’’ in such a way that it should

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00051 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6940 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

be understood by non-medically trained indirectly through the agency of an For aircraft, the updated definition
crewmembers and used to discern intermediate plant or animal host, better aligns with symptoms reporting
illnesses of public health interest that vector, or the inanimate environment.’’ guidelines published by ICAO in Note 1
HHS/CDC would like to be made aware Thus, the changes in this final rule to paragraph 8.15 of Annex 9 to the
of according to 42 CFR 70.4 from those would amount to fewer illness reports Convention on International Civil
that it does not (e.g., common cold), than may be anticipated under the Aviation. Therefore, HHS/CDC does not
while more closely aligning the current regulation. However, in practice, anticipate much additional burden on
definition with the symptoms reporting according to CDC guidance available at airlines and vessel operators to report ill
guidelines published by ICAO in Note 1 http://www.cdc.gov/quarantine/air/ travelers during travel.
to paragraph 8.15 of Annex 9 to the reporting-deaths-illness/guidance-
reporting-onboard-deaths- Although HHS/CDC estimates the net
Convention on International Civil change will be no cost to airline or
Aviation. To further assist flight illnesses.html, the symptoms requested
for international and interstate illness vessel operators, it may be possible to
crewmembers (and vessel crewmembers examine the potential increase using
under part 71) in identifying individuals reporting are the same subset. In
addition, according to guidance, reports simple assumptions. Table 9 shows the
with a reportable illness, HHS/CDC number of reports by pilots in command
provides the following in-depth received by HHS/CDC would be
considered sufficient to satisfy the during flights and recorded in HHS/
explanations and examples of the CDC’s Quarantine Activity Reporting
communicable diseases that such signs requirement to report to local health
departments since HHS/CDC would System (QARS). These include reports
and symptoms might indicate. Note that of illness that fit the illness definition
these explanations also apply to the coordinate any response activities with
the local health department after receipt specified in current 42 CFR 71.1, reports
definition of ‘‘ill person’’ under part 71 based on HHS/CDC’s guidance for
and are discussed in the preamble of of the illness report.
This final rule would align the airlines and vessel operators, reports
this final rule. made based on the guidelines in Note 1
definition from CDC guidance with
The current illness reporting regulatory text by requiring reports of ill to paragraph 8.15 of Annex 9 to the
requirements for interstate travel are travelers with fever and persistent Convention on International Civil
summarized in 42 CFR 70.4 and state cough, persistent vomiting, difficulty Aviation, or illness reports unrelated to
that ‘‘The master of any vessel or person breathing, headache with stiff neck, current regulation or guidance. Such
in charge of any conveyance engaged in decreased consciousness, travelers reports can also be subdivided into
interstate traffic, on which a case or appearing obviously unwell, or reports requiring HHS/CDC response
suspected case of a communicable unexplained bleeding. In practice, the (‘‘response reports’’) and reports that
disease develops shall, as soon as codification of such guidance may HHS/CDC receives, but which do not
practicable, notify the local health increase costs to some or all airlines and require an HHS/CDC response (‘‘info-
authority at the next port of call, station, vessel operators who submit illness only reports’’). Info-only reports may
or stop, and shall take such measures to reports based only upon symptoms include symptoms included in HHS/
prevent the spread of the disease as the currently identified in 42 CFR 71.1 and CDC guidance, but for which the
local health authority directs.’’ not based on HHS/CDC guidance. For underlying condition can easily be
Communicable disease is defined in 42 illness reports from aircraft, DOT/FAA diagnosed not to be a communicable
CFR 70.1 as ‘‘illnesses due to infectious may also incur additional costs if the disease of public health concern (e.g.,
agents or their toxic products, which number of illness reports made by influenza-like illness on an aircraft).
may be transmitted from a reservoir to aircraft pilots in command to air traffic Info-only reports can also be based on
a susceptible host either directly as from control and reported to HHS/CDC via illnesses not requested by HHS/CDC
an infected person or animal or the Domestic Events Network increases. guidance (e.g., motion sickness).

TABLE 9—TOTAL NUMBERS OF REPORTS MADE DURING FLIGHT BY AIRCRAFT OPERATORS, 2011 TO 2015
[HHS/CDC QARS data]

Reports not
Based on based on
Based on
symptoms symptoms
symptoms
Year Category included included in Total
included
in current either current
in final rule
regulation regulation or
final rule

2015 .............................. Info-only .............................................................. 30 55 43 128


Response ............................................................ 33 22 15 70
2014 .............................. Info-only .............................................................. 33 61 42 136
Response ............................................................ 19 36 12 67
2013 .............................. Info-only .............................................................. 31 46 29 106
Response ............................................................ 21 25 4 50
2012 .............................. Info-only .............................................................. 34 58 38 130
Response ............................................................ 12 18 2 32
2011 .............................. Info-only .............................................................. 27 39 25 91
mstockstill on DSK3G9T082PROD with RULES3

Response ............................................................ 25 29 13 67

Average, Info-only .......................................................................................... 31 51.8 35.4 118.2


Average Response ........................................................................................ 22 26 9.2 57.2
Average, total ................................................................................................. 53 77.8 44.6 175.4
In addition to illness reports, HHS/CDC receives an average of 10 death reports during air travel each year. Since death reporting require-
ments are not changing, these are not analyzed.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00052 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6941

Table 9 shows that HHS/CDC already symptoms not included either in current follow-up and 10.6 info-only reports
receives a number of reports based on regulatory text or in this final rule. each year. In contrast to reports from
symptoms included in HHS/CDC The number of illness reports from aircraft, most of the reporting for vessels
guidance that will be codified with this master of vessels during voyages is pertains to symptoms included in the
final rule. On average, among the total summarized in Table 10. Compared to current regulation (175 per year) as
175 illness reports per year, about 78 the breakdown in reports for aircraft, the opposed to those specified in this final
annual reports are based on symptoms vast majority of illness reports during rule (32 per year). Very few reports from
included in the final rule, but not in voyages are for response as opposed to vessels (3.4 per year) were based on
current regulations compared to 53 info-only. There may be greater fever only or based on symptoms not
reports based on symptoms already specificity in reports from cruise vessels
included in either current regulation or
listed in current regulations. The because of the presence of medical
specified in this final rule.
remaining 45 reports would include officers onboard vessels. On average,
those based on fever alone or based on there were about 208 reports requiring

TABLE 10—TOTAL NUMBERS OF ILLNESS REPORTS (EXCLUDING INFLUENZA-LIKE ILLNESS) MADE DURING VOYAGE BY
MASTERS OF VESSELS, 2011 TO 2015
[HHS/CDC QARS data]

Reports not
Based on based on
Based on
symptoms symptoms
symptoms
Year Type of report included included in Total
included
in current either current
in final rule
regulation regulation or
final rule

2015 ....... Info-only ..................................................................................... 5 4 4 13


Response ................................................................................... 179 21 1 201
2014 ....... Info-only ..................................................................................... 6 3 3 12
Response ................................................................................... 168 21 12 201
2013 ....... Info-only ..................................................................................... 1 1 3 5
Response ................................................................................... 145 48 11 204
2012 ....... Info-only ..................................................................................... 5 7 3 15
Response ................................................................................... 167 19 1 187
2011 ....... Info-only ..................................................................................... 1 3 4 8
Response ................................................................................... 196 32 19 247

Average, Info-only .......................................................................................... 3.6 3.6 3.4 10.6


Average Response ........................................................................................ 171 28.2 8.8 208
Average, total ................................................................................................. 174.6 31.8 12.2 218.6
In addition to the illness reports reported in the table, HHS/CDC receives about 115 reports of death during maritime travel each year. In addi-
tion, HHS/CDC requests, but not require reporting of influenza-like-illness from cruise vessels (also not included in above table).

Baseline Contact Investigation Process D If data are not available in DHS could have improved success contacting
for Routinely Imported Diseases databases, HHS/CDC will require (as passengers with more accurate or
This section reports the primary steps part of the manifest order) for the timelier data.
of CIs for routine diseases: airlines to provide any available traveler The model for estimating the benefits
• A traveler (the index case) is contact information. The number of of CIs is: Current number of CIs ×
identified as ill either during the flight travelers for which contact data will be (reduction in HHS/CDC and health
or voyage with a reportable illness or requested is based on the disease- department staff time/resources per
after with a notifiable disease. The specific criteria listed in Table 5. contact) × value of staff time.
aircraft pilot in command or master of Once HHS/CDC has the traveler The rest of this section reports both
vessel may report the illness directly to contact information and flight-seating the quantifiable benefits arising from
HHS/CDC. Illnesses on aircraft may also chart, the CI begins. Current CI streamlining the CI process and a
be reported indirectly to HHS/CDC via procedures are cumbersome, in part discussion of health benefits. The
air traffic control. The FAA then passes because of the difficulties associated differential impacts of the various
the report to CDC through the Domestic with obtaining traveler contact diseases make it hard to summarize the
Event Network. If the report occurs after information. HHS/CDC staff may contact final rule’s effects given uncertainty
travel, a healthcare facility would then airlines more than once to obtain around future probabilities of case(s) of
report the illness either to HHS/CDC or traveler contact data including email multiple such notifiable disease(s). The
public health departments (PHDs). address, one or two phone numbers, and timeliness of contact investigations
• If CI criteria are met, HHS/CDC address in the United States for U.S. could also be improved if improvements
contacts the airlines for citizens and permanent residents. in illness reporting led to earlier
mstockstill on DSK3G9T082PROD with RULES3

Æ a manifest to determine where the When passenger contact information diagnoses of communicable diseases.
index case was seated in relation to is delayed or partial, State/local public
Estimating the Number of Infected
other passengers or crew members, health departments are delayed in
Travelers
D HHS/CDC then requests information starting CIs and, depending on the
available from DHS’ databases to verify disease, this delay could make it Most air travelers with illness are not
or obtain passenger contact information impossible to prevent illness and/or the identified in flight, but rather seek
not included in the manifest. transmission of disease. Further, PHDs medical care and are identified as an

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00053 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6942 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

index case after their travel is of intermediate steps between either an local level within a State. A couple of
completed. Compared to air travelers, illness report or receiving more examples:
maritime travelers spend more time on complete or timelier traveler data and • One State assigns 2 registered
vessels during voyages and medical stopping an infectious disease outbreak. nurses (RNs) who perform 5 CIs or fewer
officers may be employed on cruise For example, the travelers exposed to per year for the entire State another
vessels. the infectious disease would have to be State assigns 3 RNs, a Public Health
When communicable diseases are contacted by health departments and Service Medical Officer, a physician,
diagnosed after travel, the medical comply with recommended public and a data analyst and conducts about
practitioner should notify HHS/CDC or health measures, which could include 25 CIs a year.23
a PHD if the diagnosed disease is on some form of public health or medical • When one State receives
either the list of quarantinable follow up to mitigate their risk of information about passenger contacts
communicable diseases or the list of becoming ill, or self-monitoring/ from HHS/CDC, the State
notifiable diseases. If HHS/CDC can quarantine to mitigate the risk of epidemiologist creates several
draw upon improved contact transmitting that disease to other documents to fax to the relevant county
information based on the codification of individuals. health departments, a team of an
requests for traveler contact data to The amount of time HHS/CDC staff epidemiologist and RNs at the county
aircraft and vessel operators as set forth spend per air or maritime contact varies then either call or visit the contacts if
in this final rule, the risk of onward with the size of the CI because some there is an address. But the State
disease transmission can be reduced. By tasks are CI-specific, such as filling out epidemiologist will make every effort to
contacting ill travelers more quickly, reports or obtaining manifests, and some locate travelers even if their final
HHS/CDC may slow the spread and the are contact-specific such as determining destination is unclear.24
severity of the outbreak. The benefits a specific traveler’s contact information. Finally, different diseases may elicit
therefore depend on: The CI-specific labor time costs less per different levels of response at the PHD
• How many infected travelers are contact when an investigation includes level, with a more rapid response for
expected to enter the United States; more contacts, e.g., a manifest that takes highly infectious diseases like measles
• How many quarantinable or 60 minutes of HHS/CDC staff time to that can be prevented with timely post-
notifiable diseases are detected either obtain for 2 contacts is the equivalent of exposure prophylaxis and a more
on-board the aircraft/vessel or reported 30 minutes-staff-time-per-contact while measured response for less infectious
to HHS/CDC by PHDs; the same manifest listing 30 contacts is diseases like TB. By using the same cost
• How many exposed travelers will the equivalent of 2 minutes-staff-time- for HHS/CDC and for PHDs, HHS/CDC
become ill as a result of exposure during per-contact. On the other hand, the believes the potential reductions in cost
travel; traveler-specific time tends to increase- from reduced effort for PHDs to locate
• How the infection will be per-contact with less information and infectious disease contacts are
transmitted within the U.S. population; decrease-per-contact with more conservatively estimated.
• How effective public health agency
information.21 Further, the QARS
contact tracing will be with and without TABLE 11—COST-PER-CONTACT
system used to document and follow up
the final rule.
In addition to improved efficiencies on CIs requires full-time personnel to
CDC PHD
associated with more timely or more maintain the system, pull regular
complete provision of traveler contact reports, and monitor follow-up of $180 ...................................... $180
data by airlines and vessel operators, travelers contacted during CIs. Finally,
there may also be an increase in the HHS/CDC has two full-time persons Infectious Disease Transmission During
number of reports of ill travelers during regularly assigned as liaisons to DHS International Travel
travel that require HHS/CDC follow-up. whose duties include gathering contact
information from DHS systems. For some diseases, there is empirical
Under the most likely scenario, there data from which onboard transmission
will not be a change in these reports, Therefore, for HHS/CDC staff time to
initiate and follow up on different sized can be estimated. According to a
since the new definition better published analysis of the outcomes of
corresponds to reporting guidelines CIs, to track down traveler contact
information from multiple sources, to measles contact investigations (74 case-
published by ICAO in Note 1 to travelers on 108 flights resulting in
paragraph 8.15 of Annex 9 to the work with PHDs, document and report
on CIs, update and train in systems, and 3,399 contacts) in the United States
Convention on International Civil between December 2008 and December
Aviation and current HHS/CDC manage the staff involved in CIs, a cost
of $180 per contact is estimated. This is 2011, HHS/CDC could not assign 9% of
guidance. However, there may be an measles contacts (322) to a health
increase in illness reports depending on the equivalent of 2 hours of a HHS/CDC
staff person’s being paid the salary of a department due to insufficient contact
whether airlines and vessel operators data. Another 12% of these contacts
increase reporting for required rather GS–13, step 4 plus 100% for benefits
and employee overhead costs (Table 11). (397) were believed to be outside the
than recommended symptoms. United States.25 After HHS/CDC
For PHD resources, HHS/CDC also
Contact Investigations Supported by estimated a cost-per-contact of $180, provides contact data to State health
CDC and Undertaken by Partners at which is consistent with HHS/CDC departments, HHS/CDC requests, but
State and Local Health Departments costs and a recent publication adjusted does not require health departments to
The change to the definition of an ‘‘ill to 2015 dollars.22 PHD processes vary
mstockstill on DSK3G9T082PROD with RULES3

23 Personal communication from states to Dr.


person’’ for the purposes of illness greatly from State to State and at the Margaret S. Coleman 2010.
reporting and the codification of HHS/ 24 Discussion between Dr. Brian Maskery, Dr.

CDC requests from airlines and vessel 21 Margaret S. Coleman, unpublished data. Margaret S. Coleman and State and County Health
operators for traveler contact data may 22 Coleman, M.S., Marienau, K.J., Marano, N., Department contacts 11/21/2014.
Marks, S.M., Cetron, M.S. (2014). ‘‘Economics of 25 Nelson, K., Marienau, K.J., Schembri, C. and
improve HHS/CDC’s ability to respond United States tuberculosis airline contact Redd, S. (2013). ‘‘Measles transmission during air
effectively and mitigate infectious investigation policies: a return on investment travel, United States.’’ Travel Medicine and
disease outbreaks. There are a number analysis.’’ TMAID 12(1):63–71. Infectious Disease (2013) 11, 81e89 11: 81–89.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00054 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6943

provide data on the outcomes of their travelers with no history of measles passenger-contacts whose information
attempts to follow-up with travelers. immunization or infection). Second, was provided to health departments,
Among the 2,673 contacts assigned to exposed travelers would be counseled HHS/CDC received results for 861
U.S. public health departments in 2008– by health departments to self-isolate and (26%). HHS/CDC found that 103/861
11, HHS/CDC only received outcome seek treatment if they started to (12%) had a previous history of a
data for 1,177 out of the 2,673 assigned experience symptoms consistent with positive TB screening test result or
contacts. This outcome data included measles onset. For example infants treatment for latent tuberculosis or
reports from State health departments exposed during travel and too young to active disease and were not re-tested. Of
that 225 out of the 1,177 assigned be vaccinated could arrange for special the remaining 758 passenger contacts,
contacts could not be located (19%). precautions if they visit a pediatrician 182 (24%) tested positive. The majority
Among the 952 contacts for which HHS/ after becoming ill with measles-like of travelers with data about TB risk
CDC received measles outcome data symptoms to minimize the transmission factors (other than exposure to cases
from health departments, there were 9 to other unvaccinated infants. Both during air travel) had at least one risk
lab-confirmed measles cases (1%). Since activities will limit the possibility of factor (130/142 or 92%). Risk factors
there may be reporting bias from health measles transmission to family members included having been born or lived in
departments (i.e. health departments or others in the community. The attack a country with high TB prevalence
would be more likely to report outcome rate for measles is estimated to be 90%, (prevalence >100 per 100,000
data for contacts that developed measles but the high background immunization population). Although passenger-
than for other exposed travelers that did rate and high efficacy of measles contacts with risk factors were more
not develop measles, HHS/CDC vaccine attenuates the burden of likely to have pre-existing latent
considers a range of measles incidence measles outbreaks in the United States. tuberculosis infection, the authors could
rates among exposed travelers from 9 In summary, the potential size of a not exclude the possibility that infection
cases/2,673 contacts assigned to health measles outbreak occurring depends on: was acquired during the flights when
departments (0.34%) to 9 cases/952 • The number of persons contacted the travelers were exposed.
exposed contacts with outcome data by the infectious measles patient Furthermore, because outcomes data
reported to HHS/CDC (0.95%). This • Background immunity among were reported for only 26% of passenger
probability could overstate or understate persons contacted contacts forwarded to U.S. health
the true transmission rate depending on Æ Survey estimates have shown
departments (19% of all passenger
the length of the flight and seating considerable heterogeneity in
contacts) the precise determination of
configuration. On the other hand, it may background vaccination rates such that
in-flight transmission risk of M.
understate the probability if cases were 80% of unvaccinated children live in
tuberculosis was not feasible.32
not reported or occurred overseas. counties comprising 40% of the total
The results from this investigation
The majority of travelers exposed to population.28
For tuberculosis, it is difficult to were used in a cost-effectiveness study
measles on aircraft (∼74%) had pre- to estimate the return on investment for
existing immunity based on past estimate the transmission rate on an
aircraft or vessel. A modeling study tuberculosis CIs. The authors examined
measles immunization, past measles a range of latent tuberculosis prevalence
illness, or being born prior to 1957 and suggests that the risk of infection is
about 1/1000 on an 8.7 hour flight and rates among exposed travelers that
thus likely to have measles immunity varied between 19% and 24% for two
even if they do not recall experiencing that persons seated closer to the index
case are at greater risk of infection.29 different HHS/CDC CI protocols for
the disease.26 Among the 952 exposed flight-related TB investigations. The
travelers, 8 cases occurred in the 247 Only 5–10% of persons infected with
the bacteria Mycobacterium tuberculosis return on investment was calculated
contacts (3.2%) without known pre- based on the likelihood that travelers
existing immunity compared to 1 case will go on to develop active, infectious
disease and the risk of progression is with latent tuberculosis infection would
in the 705 contacts with past history of initiate and complete a treatment
vaccination or measles illness (0.1%). greatest within the first two years after
infection.30 regimen to clear the infection, the
The median age of measles cases in average cost of tuberculosis treatment, a
exposed air traveler contacts was 1.6 An analysis of the epidemiology and
outcomes of HHS/CDC-led flight-related tuberculosis case fatality rate of 5% and
years. a conservative value of statistical life
Intervention by public health tuberculosis contact investigations
conducted in the United States from estimate of $4.2 million (in 2009 USD)
departments mitigates the risk of to account for the value of mortality risk
measles transmission in two ways. First, January 2007 to June 2008 examined
131 case-travelers and 4,550 passenger- reduction from avoided tuberculosis
exposed travelers without measles disease. The return on investment
immunity may be offered voluntary contacts.31 Among 3,375 (74%)
depended on the probability assumed
post-exposure prophylaxis with for persons with latent TB infection to
28 Smith P, Marcuse E, Seward J, Zhao Z, WA O.
measles-containing vaccine (within 72 develop active disease (5–10%) and
Children and Adolescents Unvaccinated Against
hours) or immune globulin (within 6 Measles: Geographic Clustering, Parents’ Beliefs, variation in the costs to health
days),27 which can prevent onset of and Missed Opportunities. Public Health Rep. departments to locate exposed travelers
disease, halting outbreaks before they 2015;5:485–504.
($28 to $164). Using the expected latent
29 Ko G, Thompson KM, Nardell EA. Estimation
begin. Under the status quo, relatively tuberculosis prevalence rate of 19% in
of tuberculosis risk on a commercial airliner. Risk
few exposed travelers receive post- Anal 2004;24:379e88. travelers identified for contact
exposure prophylaxis (just 11 out of 248 30 Marienau KJ, Cramer EH, Coleman MS, Marano
investigations on flights and a health
mstockstill on DSK3G9T082PROD with RULES3

N, Cetron MS. Flight related tuberculosis contact department cost per contact of $164, the
26 Nelson, K., Marienau, K.J., Schembri, C. and investigations in the United States: comparative risk
Redd, S. (2013). ‘‘Measles transmission during air and economic analysis of alternate protocols. Travel return on investment was estimated to
travel, United States.’’ Travel Medicine and Med Infect Dis. 2014;12(1):54–62.
Infectious Disease (2013) 11, 81e89 11: 81–89. 31 Marienau KJ, Burgess GW, Cramer E, et al. 32 Marienau KJ, Burgess GW, Cramer E, et al.
27 Nelson, K., Marienau, K.J., Schembri, C. and Tuberculosis investigations associated with air Tuberculosis investigations associated with air
Redd, S. (2013). ‘‘Measles transmission during air travel: US Centers for Disease Control and travel: US Centers for Disease Control and
travel, United States.’’ Travel Medicine and Prevention, January 2007–June 2008. Travel Med Prevention, January 2007–June 2008. Travel Med
Infectious Disease (2013) 11, 81e89 11: 81–89. Infect Dis 2010;8:104e12. Infect Dis 2010;8:104e12.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00055 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6944 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

vary between $1.01 and $3.20. The viral hemorrhagic fevers during travel multiplied (0.0034 to 0.0095) by the
return on investment formula was on aircraft or vessels. However, there ratio of the average basic reproductive
calculated based on (Expected have not been enough observations to numbers (9.5/16) to arrive at a
benefits¥Expected costs)/Expected determine that there is no risk. transmission rate (0.002 to 0.006) for
costs. Thus, for each $1 in Federal and For the remainder of the diseases, rubella on airplanes. This rate is
State resources spent on contact empirical data does not exist. Like approximately 60% of the rate for
investigations and offering treatment to measles, immunizations are measles. The estimated transmission
persons infected with latent recommended to prevent pertussis, rates for some diseases are reported in
tuberculosis infections would result in rubella, and meningococcal disease. Table 12. The exceptions are for
benefits in excess of costs equal to $1.01 Since meningococcal conjugate vaccine meningococcal disease and tuberculosis.
to $3.20 33 34 on average. At the upper was more recently added to the United
For meningococcal disease, the risk of
bound latent tuberculosis prevalence States vaccination schedule, it is likely
transmission in household contacts
estimate (24%), the return on that background immunity is much
lower relative to measles, rubella or 0.002 to 0.004 37 is used in the absence
investment was estimated to vary
pertussis. of other data and taking account that CIs
between $1.35 and $3.92.
There is also empirical data for SARS In the absence of data for some are only performed for travelers sitting
infections occurring on an aircraft. A diseases, the infection rate of measles is adjacent to the index case or in the
study reported that 37 infections used to estimate the infection rates by event of other known exposures. For
resulted from 40 flights with infectious using the ratio of basic reproduction tuberculosis, the probability that
passengers on board. Of the 40 flights, numbers (R0). The basic reproduction exposed travelers have latent
four have documented aircraft sizes. number is a measure of disease tuberculosis 38 (19%–24%) is used,
They average 127 passengers per infectiousness. Specifically, it is an although infection may have occurred
plane.35 Therefore the on board estimate of new infections in a prior to air travel. For the purposes of
transmission rate could be estimated to completely susceptible population. For evaluating the economic impact of
be 0.73% among all travelers. In example, rubella has an R0 of 9 to 10 tuberculosis investigations, it does not
comparison, there is no evidence of while measles has an R0 of 15 to 17.36 matter if travelers were infected during
transmission of MERS Coronavirus or The infection rate of measles is travel or before.

TABLE 12—ESTIMATED TRANSMISSION RATE ON PLANE FOR EXPOSED TRAVELERS


Estimated transmission rate on
aircraft to exposed passengers
Disease R0
Lower bound Upper bound

Diphtheria (quarantinable) ........................................................................................................ 11 to 14 ............ 0.0026 0.0074


Measles (non-quarantinable) .................................................................................................... 15 to 17 ............ 0.0034 0.0095
Meningococcal Disease (non-quarantinable) ........................................................................... NA ..................... <2/1000 <4/1000
Pertussis (non-quarantinable) ................................................................................................... 4 to 5 ................ 0.001 0.003
Rubella (non-quarantinable) ..................................................................................................... 9 to 10 .............. 0.002 0.006
TB (quarantinable) .................................................................................................................... NA .................... 0.19 0.24

Estimated Number of Cases in Traveler respectively. Contact investigations on much more uncertain for other diseases.
Contacts vessels are excluded for this analysis. The number of tuberculosis cases are
Based on this analysis, tuberculosis (19 adjusted from the number of contacts
The number of potential contacts for to 48) and measles cases (3.6 to 10.1) are with tuberculosis by assuming that only
each disease can be multiplied by the the most likely diseases that will be 5% (lower bound) to 10% (upper
estimated transmission rate by disease diagnosed among contacts exposed bound) of infected contacts will go on
in Table 12 to generate a rough estimate during travel (Table 13). Tuberculosis to develop clinical disease.39
of the annual number of cases among contact investigations only occur for
traveler contacts. These numbers of international flights with the very rare For viral hemorrhagic fevers and
contacts for each disease are exception of a domestic flight with a MERS, there is no evidence of
summarized in Tables 6 and 7 for duration greater than 8 hours. The transmission, but there have not been
interstate and international CIs numbers of contacts and outcomes are very many observations.

33 Coleman M, Marienau K, Marano N, Marks S, 35 Mangili A, Gendreau MA. Transmission of 38 Marienau KJ, Burgess GW, Cramer E, et al.
mstockstill on DSK3G9T082PROD with RULES3

Cetron M, Dis TMI. Economics of United States infectious diseases during commercial air travel. Tuberculosis investigations associated with air
Tuberculosis Airline Contact Investigation Policies. Lancet. 2005;365:989–96. travel: US Centers for Disease Control and
Travel Medicine and Infectious Disease. 36 Anderson RM. The concept of herd immunity Prevention, January 2007–June 2008. Travel Med
2014;12:63–71. Infect Dis 2010;8:104e12.
34 Marienau KJ, Burgess GW, Cramer E, et al.
and the design of community-based immunization 39 Coleman M, Marienau K, Marano N, Marks S,
programmes. Vaccine. 1992;10(13):928–35.
Tuberculosis investigations associated with air Cetron M, Dis TMI. Economics of United States
37 Chapter 14. Meningococcal Disease, The Pink
travel: US Centers for Disease Control and Tuberculosis Airline Contact Investigation Policies.
Prevention, January 2007–June 2008. Travel Med Book, CDC http://www.cdc.gov/vaccines/pubs/ Travel Medicine and Infectious Disease.
Infect Dis 2010;8:104e12. pinkbook/mening.html Accessed 5/2/2016. 2014;12:63–71.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00056 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6945

TABLE 13—ANNUAL ESTIMATED NUMBER OF CASES AMONG INTERNATIONAL PASSENGER CONTACTS BY DISEASE
Expected Expected Expected Expected
incidence incidence
Number of number of number of
Passengers per flight among among
contacts new cases new cases
contacts contacts (lower bound) (upper bound)
(lower bound) (upper bound)

MERS Coronavirus (quarantinable) ......................................... 101 Insufficient data

Measles (non-quarantinable) ................................................... 1,069 0.0034 0.0095 3.6 10.1


Meningococcal Disease (non-quarantinable) .......................... 1.7 0.00200 0.00400 0.0033 0.0067
Pertussis (non-quarantinable) .................................................. 16.8 0.001 0.003 0.02 0.04
Rubella (non-quarantinable) .................................................... 117 0.002 0.006 0.2 0.7
TB a (quarantinable) ................................................................. 1,995 b 0.19 b 0.24 c 18.9 c 47.90

Viral Hemorrhagic Fever (quarantinable) ................................ 62.0 Insufficient data

Total .................................................................................. 3,362 ........................ ........................ 22.8 58.7


a For tuberculosis, travelers contacts are typically found to test positive for infection, but do not have active disease.
b These probabilities indicate the likelihood that a contact will test positive for infection.
c The expected numbers of cases adjust for the finding that only 5–10% of individuals that test positive for infection will go on to develop clin-
ical disease.

These estimates of cases may be a average, HHS/CDC acted upon 77 number of contact investigations among
lower bound, because potential cases requests per year to airlines for exposed air or maritime travelers. HHS/
resulting from flights in which contact international traveler contact data CDC notes the manifest order process
investigations were not performed are between 2010 and 2015 (Table 6). In for interstate flights is not codified in
not included. Especially for tuberculosis addition, HHS/CDC made 22.5 requests the final rule. The data is provided here
cases, many international travelers may per year for interstate traveler data for completeness.
return to their home countries before (Table 7) over the same period. There The average wages for computer and
seeking treatment and such cases may were 45 contact investigations per year information systems managers
not lead to contact investigations if among travelers on vessels (Table 8); (occupation code 11–3021) reported in
HHS/CDC is not informed. however, most of these were undertaken the Bureau of Labor Statistics, May 2015
Marginal Costs of Final Rule before travelers disembarked vessels in Occupational Employment Statistics 40
which case contact data could be were $63.27 per hour. On average,
Data Collection collected directly from exposed under the baseline, HHS/CDC assumes
Since the final rule does not change travelers as part of the investigation. that it would require 6 hours of work by
the timeframe or amount of data The number of maritime contact airlines to search databases and provide
requested from airlines or vessel investigations requiring manifest data. For the final rule, HHS/CDC
operators, the most likely economic requests after disembarkation is assumes that a management-level
impact is a small change in the amount estimated to be less than 10 per year. computer specialist will spend
of effort for airlines to provide more Overall, including international air additional time to provide the best
complete and timely information. To the and maritime activities, the estimated possible contact data for potentially
extent that airlines would respond more number of contact data requests after exposed travelers. The base salary is
quickly or with additional data, it disembarkation was estimated at 100 to multiplied by an overhead multiplier of
would require some airline information account for the fact that HHS/CDC 100% to account for non-wage benefits
technology staff to expedite requests or sometimes requests traveler contact data and other overhead costs for supporting
to search in more depth for available for infectious disease events prior to each employee (Table 14). The lower
data. HHS/CDC estimates this may confirmed diagnoses. On occasion, it bound estimate ($0) is no change from
require one hour of staff time per turns out that travelers are not infected current practice, while the upper bound
request. HHS/CDC has no way to predict with diseases that require a public estimate assumes 2 hours of time
how much more complete, timely, or health response. This rounding up instead of one ($25,308). These costs are
accurate contact from airlines would should also account for a year in which applied to an estimated 100 manifest
become as a result of this final rule. On there is a significant increase in the requests per year.

TABLE 14—ESTIMATE OF COSTS FOR AIRLINES AND VESSEL OPERATORS TO IMPROVE COMPLIANCE WITH HHS/CDC
REQUESTS FOR TRAVELER CONTACT DATA, 2015 USD
Increased
effort to
Average provide more Average hourly
number of Overhead
complete or wage rate
manifest multiplier Total cost
timelier of IT staff
mstockstill on DSK3G9T082PROD with RULES3

requests (%)
passenger (2015 USD)
per year contact data
(hrs.)

Baseline ........................................................................... 100 6 $63.27 100 $75,924


Best estimate ................................................................... 100 1 63.27 100 12,654

40 http://www.bls.gov/oes/current/oes_nat.htm.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00057 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6946 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

TABLE 14—ESTIMATE OF COSTS FOR AIRLINES AND VESSEL OPERATORS TO IMPROVE COMPLIANCE WITH HHS/CDC
REQUESTS FOR TRAVELER CONTACT DATA, 2015 USD—Continued
Increased
effort to
Average provide more Average hourly
number of Overhead
complete or wage rate
manifest multiplier Total cost
timelier of IT staff
requests (%)
passenger (2015 USD)
per year contact data
(hrs.)

Lower bound .................................................................... 100 0 63.27 100 0


Upper bound .................................................................... 100 2 63.27 100 25,308

Illness Reporting Costs public health officer, and 60 minutes for Washington Operations Center Complex
When reports are received, public HHS/CDC to document the info-only (6 minutes).41
health officers at Quarantine Stations report, the estimated cost of the For aircraft pilots in command or
perform case assessments, may request additional reports can be estimated masters of vessels (occupation codes
follow-up information, and may consult based on the opportunity cost of time 53–2011 and 53–5021) and travelers
with HHS/CDC medical officers to for each type of personnel. In addition (average across all occupations code 00–
determine if additional action such as a to the time required for aircraft pilots in 0000), their opportunity cost is
contact investigation, onboard response, command and masters of vessels to estimated from Bureau of Labor
or notification to State and local health make reports, the personnel in the Statistics, May 2015 Occupational
departments is warranted. Under one Department of Transportation’s Federal Employment Statistics 42 based on the
assumed upper bound scenario, the Aviation Administration (DOT/FAA) average salary of aircraft pilots or
change in the definition of ‘‘ill person’’ may incur additional costs to relay copilots ($57.35 per hour), traveler
included in the final rule could result in reports of suspected cases of ($23.23 per hour) or vessel captain,
a 100% increase in the number of info- communicable disease received by air mate, or pilot ($39.95 per hour). For
only reports from airlines and a 25% traffic control to CDC through the HHS/CDC employees, the average wage
increase from vessels. On average, there Domestic Events Network. The amount rate is based on the Federal
are 129 info-only reports for aircraft and of DOT/FAA staff time is estimated at government’s general salary scale for a
vessels each year and these increases 26 minutes for a government employee GS–12, step 5 employee based in
would correspond to an annual increase at GS-level 15, step 6 based in Atlanta, GA). Base salaries are
of 119 info-only reports on aircraft and Washington, DC. In reality, there would multiplied by an overhead multiplier of
3 info-only reports on vessels (Table 15). be three DOT/FAA employees involved 100% to account for non-wage benefits
If the average time for each report is including 1 GS–15/16 level employee at and other overhead costs for supporting
estimated to be 2 minutes for aircraft air traffic control (10 minutes), 1 GS–15 each employee. Travelers do not have
pilots in command or masters of vessels level employee at the Domestic Events overhead costs. The annual quantified
to make the report, 10 minutes for a Network (10 minutes), and 1 GS–14 costs of 122 additional info-only reports
traveler to discuss the illness with level employee at DOT/FAA’s would be $17,471.

TABLE 15—CHANGES IN NUMBERS OF INFO-ONLY REPORTS AND ASSOCIATED COSTS FOR THE FINAL RULE UPPER
BOUND, 2015 USD
Amount
Change in Estimated
of time Overhead
number wage rate Estimated
Employee type required multiplier
of info-only (2015 USD cost
per report (%)
reports per hr.)
(min)

Aircraft:
Aircraft Pilots or Copilots .............................................. 119 2 $57.35 100 $455
CDC employee ............................................................. 119 60 39.83 100 9,480
DOT/FAA employees .................................................... 119 26 70.57 100 7,278
Traveler ......................................................................... 119 10 23.23 0 461
Air total .................................................................. ........................ ........................ ........................ ........................ 17,213
Vessels:
Air or maritime conveyance officer ............................... ........................ ........................ ........................ ........................ ........................
Captains, Mates, and Pilots of Water Vessels ............. 3 2 39.95 100 8
CDC employee ............................................................. 3 60 439.83 100 239
Traveler ......................................................................... 3 10 23.23 0 12
Maritime total ......................................................... ........................ ........................ ........................ ........................ 259
mstockstill on DSK3G9T082PROD with RULES3

Total costs, aircraft and vessels ................................... ........................ ........................ ........................ ........................ 17,471
Notes: Assumes 100% increase in info-only reports from airlines and 25% from vessel operators.

41 Personal communication between Dr. Brian 42 http://www.bls.gov/oes/current/oes_nat.htm.

Maskery and DOT/FAA.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00058 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6947

Besides the possible change in costs reports): 29 reports per year on aircraft not reported during travel, but instead
of info-only reports, the other potential and 21 reports per year on vessels. HHS/ was later reported by a public health
change would be an increase in the CDC assumes that the time required to department to HHS/CDC. In addition,
number of reports that require HHS/ submit illness reports and for DOT/FAA the public health response to the illness
CDC follow-up. Under the most likely staff to relay reports requiring responses would likely be more efficient because
scenario, there will not be a change in is the same as for info-only reports (2 exposed travelers could be contacted
these reports since the new definition minutes for pilots in command and earlier. In rare situations, such travelers
better corresponds to HHS/CDC masters of vessels and 26 minutes for may potentially be informed of their
guidance and to reporting guidelines DOT/FAA to relay reports, Table 16). potential exposure at the gate after
published by ICAO in Note 1 to Further, HHS/CDC assumes that disembarking the aircraft or vessel. Such
paragraph 8.15 of Annex 9 to the travelers could spend up to 60 minutes actions should not result in significant
Convention on International Civil talking to HHS/CDC and/or State and delays by holding travelers on board.
Aviation. However, there may be an local public health officers for reports
increase in the number of reports requiring response. The upper bound HHS/CDC did not include any
requiring a response. Under this estimate of total costs associated with training costs because the change in the
scenario, there may be an increase in the increase in the number of illness ‘‘ill person’’ definition in this final rule
costs for air or masters of vessels to reports requiring response is estimated is consistent with the internationally
report illnesses. The upper bound to be $3,102. recognized and accepted illness
increase in reports requiring response is There would likely be no change or a reporting guidelines published by ICAO
assumed to be 50% of the average decrease in HHS/CDC costs because for international travelers and
annual illness reports from airlines and earlier reporting would lead to a more represents a reduced burden compared
a 10% increase from vessels (refer to efficient HHS/CDC response relative to to the previous illness reporting
Tables 10 and 11 for baseline number of an alternative in which the illness was regulations for interstate travelers.

TABLE 16—CHANGES IN ANNUAL NUMBERS OF REPORTS REQUIRING RESPONSE AND ASSOCIATED COSTS FOR THE FINAL
RULE UPPER BOUND, 2015 USD
Amount Estimated
Change of time Overhead Estimated
wage rate
Employee type in number required multiplier cost
(2015 USD
of reports per report (%) (2015 USD)
per hr.)
(min)

Aircraft:
Aircraft Pilots or Copilots .............................................. 29 2 $57.35 100 $111
CDC employee ............................................................. 29 0 39.83 100 0
DOT/FAA employee ...................................................... 29 26 70.57 100 1,774
Traveler ......................................................................... 29 60 23.23 0 674

Total ....................................................................... ........................ ........................ ........................ ........................ 2,558


Vessels:
Captains, Mates, and Pilots of Water Vessels ............. 21 2 39.95 100 56
CDC employee ............................................................. 21 0 39.83 100 0
Traveler ......................................................................... 21 60 23.23 0 488

Total ....................................................................... ........................ ........................ ........................ ........................ 544

Total .............................................................................. ........................ ........................ ........................ ........................ 3,102


Notes: Assume 50% increase in air illness and a 10% increase in maritime illness reports requiring response (international and interstate).

There may also be a one-time cost vessel operators, it may be necessary to with existing HHS/CDC and ICAO
associated with updating training to revise training materials. guidance documents, this change may
reflect the new regulatory text. As noted The cost of training was estimated not result in a new training requirement
above, HHS/CDC reiterates that the based on the number of pilots and flight for all airlines since some presumably
change to regulatory text is a attendants and their average wage rates already use HHS/CDC guidance in
codification of HHS/CDC guidance and as reported in the Bureau of Labor training. This 10 minute estimate does
better aligns with international guidance Statistics, May 2015 Occupational not necessarily mean all 230,000 pilots
(Note 1 to paragraph 8.15 of Annex 9 to Employment Statistics.43 HHS/CDC and flight attendants each require 10
the Convention on International Civil assumes that the opportunity cost of minutes of training. For example, 50%
Aviation). Further for interstate travel, employee time spent in training would of each could require 20 minutes of
these changes result in relaxed illness be the primary cost as opposed to the training, while the other 50% may
reporting compared to status quo cost of developing training materials. As already conduct training in accordance
regulatory text. Thus any airlines using an upper bound, HHS/CDC assumed the with either CDC or ICAO guidance. The
mstockstill on DSK3G9T082PROD with RULES3

either ICAO or HHS/CDC guidance to cost of training could be estimated total cost of the one-time change in
support training efforts for illness based on assuming that all employees training is about $3.1 million. If this
reporting should not need to change would require 10 minutes of training to cost is annualized over 10 years, the
training materials. At most, it may be summarize the changes. As noted above, average annual cost depends on the
necessary to clarify that some symptoms since this change aligns regulatory text discount rate assumed and varies from
that were previously requested are now $313,000 per year (7% discount rate) to
required. However, for some airlines or 43 http://www.bls.gov/oes/current/oes_nat.htm. $416,000 (0% discount rate). These

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00059 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6948 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

results are summarized in Table 17. for illness reporting. The lower bound changes to the definition better align
These costs (3% discount rate) are and best estimates are $0 since the with existing CDC and ICAO guidance.
added to the upper bound cost estimate

TABLE 17—ESTIMATED COSTS FOR ONE-TIME TRAINING ABOUT CHANGES IN ILLNESS REPORTING FOR AIRLINES, 2015
USD
Amount of Estimated Estimated
time required Overhead
Number of wage rate cost or
Employee type for training multiplier
employees (2015 USD benefit
per employee (%)
per hr.) (2015 USD)
(minutes)

Aircraft Pilots or Copilots ..................................................... 121,110 10 57.35 100 2,315,220


Flight attendants .................................................................. 108,510 10 22.46 100 812,465

Total .............................................................................. ........................ ........................ ........................ ........................ 3,127,685

Annualized cost over 10-year time horizon 3% discount rate ... $355,981 0% discount rate ... $416,179 7% discount rate ... $312,768

The monetized annual costs resulting person’’ are summarized in Table 18. communicable disease transmission are
from the change in the definition of ‘‘ill The benefits in regard to reductions in summarized in a subsequent section.

TABLE 18—BEST ESTIMATE, LOWER BOUND AND UPPER BOUND OF THE CHANGES IN ANNUAL MONETIZED BENEFITS AND
COSTS AS A RESULT OF THE CHANGE TO THE REPORTABLE ILLNESS DEFINITION, 2015 USD
Best Lower Upper
estimate bound bound

Costs

Final Rule:
Aircraft .................................................................................................................................. $0 $0 $375,751
Vessels ................................................................................................................................. 0 0 802

Total ............................................................................................................................... 0 0 376,554

The total costs of the final rule are costs of the change to the definition of the requirement for airlines to provide
summarized in Table 19 and include the an ‘‘ill person’’ and the codification of passenger contact data for the final rule.

TABLE 19—TOTAL COSTS AND BENEFITS RESULTING FROM CODIFICATION OF TRAVELER DATA COLLECTION (71.4 AND
71.5) AND CHANGE TO DEFINITION OF ‘‘ILL PERSON’’ (70.1 AND 71.1)
Best Lower Upper
estimate bound bound

Costs

Final Rule:
71.4 and 71.5 Passenger data collection ............................................................................. $12,654 $0 $25,308
70.1 and 71.1 Change in definition of an ‘‘ill person’’ .......................................................... 0 0 376,554

Total costs ..................................................................................................................... 12,654 0 401,862

Benefits From Streamlining the CI 6) for all diseases reported on disembark vessels. By limiting the
Process for Routinely Imported Diseases international flights. International flight analysis to contacts on international
data were extracted for this analysis flights, HHS/CDC conservatively
This section reports the benefits that because the codification of the estimates the potential benefits
HHS/CDC anticipates from requirements to provide timelier and associated with this final rule. HHS/
implementation of the final rule in more complete contact data is limited to CDC multiplied the average annual
avoiding the costs incurred annually for international arrivals. In comparison, number of contacts on international
CIs of infectious diseases. The model for HHS/CDC requests contact information flights by the cost-per-contact for HHS/
mstockstill on DSK3G9T082PROD with RULES3

estimating the benefits of CIs is: Current for approximately 664 contacts per year CDC and PHDs (Table 11) to estimate
number of CIs × (reduction in HHS/CDC on interstate flights (Table 7). HHS/CDC the costs of CIs under the current
and health department staff time/ also supports contact investigations baseline.
resources per contact) × value of staff affecting an average of 762 contacts per To estimate the benefits (Tables 20
time. year for illnesses on board vessels and 21), HHS/CDC assumed a percent
HHS/CDC obtained the total number (Table 8); however, many of these reduction in staff time for CIs at HHS/
of contacts traced (2,715 per year, Table investigations occur before travelers CDC (0–3%) and PHD levels (0–2%)

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00060 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6949

based on internal conversations with or vaccines in a more timely fashion or regulatory requirement. In addition, the
personnel directly involved in the CI to recommend self-monitoring to change to the definition of ‘‘ill person’’
process. The reduction in staff time that mitigate onward transmission. In may lead to the earlier diagnoses of
would result from implementation of addition, it would be less likely that some travelers with communicable
this final rule would arise from the HHS/CDC would send incorrect contact disease, which may lead to earlier and
ability of HHS/CDC to have a better data to States. With all of the preceding more efficient public health responses.
starting point with which to provide factors in mind, HHS/CDC estimated
HHS/CDC annual costs to engage in
traveler contact data to State and local that the final rule would reduce labor
health departments as a result of the time by between 0% to 3% at HHS/CDC, international air, interstate air, and
receipt of more complete and timely and 0% to 2% at PHDs. The higher maritime CIs are about $745,000 or
traveler contact data from airlines. The percentage of avoided costs at HHS/CDC roughly the equivalent of 3.8 HHS/CDC
impact of codification is expected to be reflect reduced efforts by HHS/CDC to full-time employees (FTEs) at the wage
limited and would depend on instances search for accurate contact data for level of GS–13, step 4 plus benefits and
in which airlines have more data than travelers due to untimely or inaccurate overhead (Table 21). The final rule
what is currently provided to DHS. data. The lower percentage of avoided should have the greatest effect on the
Better data would improve HHS/CDC’s costs at PHDs reflects a more diffuse international air CIs. The annual
ability to transmit information to (e.g., multiple local PHDs in a State) reduction in contact tracing costs from
destination States more quickly and for infrastructure and the more labor- implementing the final rule (Table 22)
States to contact exposed travelers intensive tasks of following up on for HHS/CDC ranged from $0 to $14,661
earlier. This would allow States to start individuals. These estimates are small based on a 0–3% reduction in effort on
their investigations more quickly, because the change is a clarification and international CIs. For PHDs, the
contact more travelers faster to conduct codification of a current practice reduction in costs ranged from $0 at the
public health assessments and authorized under broad statutory and lower bound to $9,774 at the upper
potentially offer preventive medications regulatory authority rather than a new bound (Table 22).

TABLE 20—ANNUALLY FOR HHS/CDC AND PHD: BASELINE COSTS


Annual num- HHS/CDC PHD costs Total costs
ber contacts

HHS/CDC and PHD Baseline Costs (Current Practice)

International air contacts ................................................................................. 2,715 $488,700 $488,700 $977,400


Interstate air contacts ...................................................................................... 664 119,520 119,520 239,040
Maritime contacts ............................................................................................. 762 137,160 137,160 274,320

Total baseline costs .................................................................................. 4,141 745,380 745,380 1,490,760


Viral hemorrhagic fever, MERS, and SARS contacts ..................................... 163 29,340 29,340 58,680

TABLE 21—ANNUAL FOR HHS/CDC AND PHDS: BASELINE COSTS, FINAL RULE COSTS, BENEFITS WITH THE FINAL RULE
(NUMBER CONTACTS ANNUALIZED FROM JANUARY 2010 TO DECEMBER 2015), 2015 USD

HHS/CDC and PHD Baseline Costs (Current Practice)

Annual number HHS/CDC PHD


contacts

International contacts ....................................................................... 2,715 $488,700 $488,700

HHS/CDC and PHD Costs With the Final Rule

Estimated Costs for HHS/CDC After Estimated Costs for PHDs After Effi-
Efficiency Improvement with Final ciency Improvement with Final
Rule Rule

0%, Lower 3%, Upper 0%, Lower 2%, Upper


bound bound bound bound

International contacts costs assuming reduction in time (2,715) .... $488,700 $474,039 $488,700 $478,926

Benefits From Implementing the Final Rule

HHS/CDC 0% and 3% Reduction in PHD (0% and 2% Reduction in


effort effort)
mstockstill on DSK3G9T082PROD with RULES3

Benefits (Reduced costs) ................................................................ $0 $14,661 $0 $9,774

The best estimate of benefits are the PHDs ($12,218). The lower bound ($0) both entities are also reported in Table
midpoint of the lower bound and upper and upper bound estimates ($24,435) for 22.
bound estimates for both HHS/CDC and

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00061 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6950 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

TABLE 22—BEST ESTIMATE, LOWER BOUND AND UPPER BOUND OF BENEFITS FROM INCREASED EFFICIENCIES FOR HHS/
CDC AND PHDS TO CONDUCT CONTACT INVESTIGATIONS WITH PROVISION OF BETTER DATA FROM AIRLINES (FINAL
RULE), 2015 USD
HHS/CDC PHD benefits Total
benefits

Best estimate ............................................................................................................................... $7,331 $4,887 $12,218


Lower bound ................................................................................................................................ 0 0 0
Upper bound ................................................................................................................................ 14,661 9,774 24,435

The total annual monetized benefits reduced effort for contact investigations
by stakeholder from the potential are summarized in Table 23.

TABLE 23—BEST ESTIMATE, LOWER BOUND AND UPPER BOUND OF BENEFITS FROM INCREASED EFFICIENCIES FOR HHS/
CDC AND PHDS TO CONDUCT CONTACT INVESTIGATIONS WITH PROVISION OF BETTER DATA FROM AIRLINES, 2015 USD
HHS/CDC PHD benefits, Airlines, USD Total
benefits, USD USD

Best estimate ................................................................................................... $7,331 $4,887 $0 $12,218


Lower bound .................................................................................................... 0 0 0 0
Upper bound .................................................................................................... 14,661 9,774 0 24,435

Marginal Impact of Final Rule—Measles which measles vaccination would public health departments (Table 24),
Health Outcome Benefits reduce their risk of developing either because HHS/CDC cannot assign
On average, HHS/CDC identified 564 symptomatic measles. At present, very the contacts to health departments or
travelers exposed to measles cases on few travelers receive post-exposure because the information provided by
international flights during 2010–2015 prophylaxis, 11/248 or 4.4%.44 In HHS/CDC is not sufficient to enable
(Table 6). The final rule may affect the addition, health departments have health departments to locate contacts
cost for health departments to implemented quarantine (usually after assignment from HHS/CDC.
implement public health measures in voluntary) for unvaccinated, high risk Among these contacts, HHS/CDC
two ways: (1) Health departments may measles exposures.45 HHS/CDC notes assumes that 10% of all contacts (56) are
contact exposed travelers more quickly that measles is not a quarantinable not located because HHS/CDC cannot
and (2) health departments may be able communicable disease under Federal assign contacts to State health
to contact a higher percentage of regulations, but may be quarantinable departments due to insufficient data.
exposed travelers. For the first set of under a State’s authorities. HHS/CDC
For these contacts, health departments
travelers that are contacted earlier with also notes that measles vaccine is
would not incur any contact tracing
the final rule than under the status quo, recommended for all persons lacking
immunity. Thus, the costs of costs because such contacts would not
the cost to both the contacted travelers be assigned. HHS/CDC assumes a 15%
and to health departments should be vaccination for exposed travelers as part
of the contact investigation may have improvement from baseline as a result
less than under the status quo. For
been incurred at a later date if travelers’ of this final rule (Table 24). This would
measles contacts, earlier follow-up with
public health departments should lead health care providers recommended result in 8.5 additional contacts per year
to more travelers being offered measles vaccination at a more routine assigned to health departments for
voluntary measles vaccines within 72 health care visit in the future.46 contact tracing. As shown in Table 11,
hours. This would potentially reduce However, to be conservative, HHS/CDC HHS/CDC estimates that health
the cost of following up with exposed includes the full additional cost to departments incur an estimated cost of
travelers at which time health administer such vaccines to persons $180 per contact. The marginal cost
departments could offer to administer contacted. incurred from this final rule for
immune globulin or health departments Among the contacts, HHS/CDC additional measles contacts assigned to
may monitor travelers that have been estimates that approximately 25% (141 health departments would be $180 × 8.5
located after the 72-hour window in contacts per year) cannot be located by = $1,530 per year (Table 25).

TABLE 24—ESTIMATED MARGINAL IMPROVEMENT IN THE NUMBERS OF MEASLES CONTACTS WHO COULD BE TREATED
WITH FINAL RULE
Description n Reference

Average contacts per year for measles, (a) ........................................................................................ 564 Table 6.
mstockstill on DSK3G9T082PROD with RULES3

Estimated number of contacts for which HHS/CDC cannot assign to a health department, (b) = 56 Nelson et al. 2013.47
10% × (a).

44 Nelson K, Marienau K, Schembri C, Redd S. 45 P Kutty, J Rota, W Bellini, SB Redd, A Barskey, 46 CDC (2015) Epidemiology and Prevention of

Measles transmission during air travel, United G Wallace. (2014) Manual for the Surveillance of Vaccine-Preventable Diseases: Measles. http://
States. Travel Medicine and Infectious Disease Vaccine-Preventable Diseases: Chapter 7 Measles. www.cdc.gov/vaccines/pubs/pinkbook/meas.html
(2013) 11, 81e89. 2013;11:81–9. http://www.cdc.gov/vaccines/pubs/surv-manual/ Accessed 5/8/2016.
chpt07-measles.html Accessed 5/8/2016.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00062 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6951

TABLE 24—ESTIMATED MARGINAL IMPROVEMENT IN THE NUMBERS OF MEASLES CONTACTS WHO COULD BE TREATED
WITH FINAL RULE—Continued
Description n Reference

Estimated improvement in HHS/CDC’s ability to assign contacts to health department (c) = 15% × 8.5 Assumption.
(b).
Numbers of people who are not currently contacted due to lack of contact information, (d) = (a) × 141 Nelson et al. 2013.
25%.
Expected numbers of people who could be contacted with final rule, (e) = (d) × 15% ..................... 21 Assumption.
Among those contacted, 70% would have evidence of measles immunity (f) = (e) × 70% ............... 15 Nelson et al. 2013 (Table 2).
Among those contacted, 30% may be susceptible to measles (g) = (e) × 30% ................................ 6 Nelson et al. 2013 (Table 2).
47 Nelson, K., Marienau, K.J., Schembri, C. and Redd, S. (2013). ‘‘Measles transmission during air travel, United States.’’ Travel Medicine and
Infectious Disease (2013) 11, 81e89 11: 81–89.

TABLE 25—ESTIMATED MARGINAL COSTS FOR HEALTH DEPARTMENTS TO CONTACT EXPOSED TRAVELERS AND OFFER
MEASLES POST-EXPOSURE PROPHYLAXIS (VACCINATION), 2015 USD
Number of additional names sent to health department, (c) .............................................................................................................. 8.5
Additional cost per contact to health department to search for and examine contacts (USD per contact) (h) ................................. $180
Additional cost to health department to search for contacts, total (USD), (i) = (c) × (h) .................................................................... $1,530
MMR vaccine price per dose (USD) (j) ............................................................................................................................................... $39
Vaccine administration (k) ................................................................................................................................................................... $31
Estimated cost prophylactic measles vaccine per person (USD), (l) = (j) + (k) ................................................................................. $70
Number of individuals who may receive measles vaccine, (g) ........................................................................................................... 6
Cost of measles vaccination, total (USD) (m) = (g) × (l) .................................................................................................................... $420
Total additional annual cost to follow up with more contacts (USD), (i) + (m) ................................................................................... $1,950

In addition, HHS/CDC assumes that be very little improvement. Among the would be adults and would be
the final rule could improve health 21 additional exposed travelers that vaccinated with the measles-mumps-
departments’ abilities to contact 15% of would be contacted, 70% of them (15 rubella (MMR) vaccine. The vaccine
those who could not be currently per year) are expected to have measles price for adults is estimated from the
contacted because of insufficient contact immunity because they were born Vaccines for Children vaccine price
information (21 contacts per year). HHS/ before 1957, had history of measles, or archives (July 2014 and July 2015) 48
CDC does not have any data to measure received one or more doses of measles based on the public sector price for the
the magnitude of improvement and vaccine. The remaining 6 travelers per vaccine. Vaccine administration costs
applies a range of 10% to 20% to year without proven measles immunity are estimated from Healthcare
calculate lower and upper bounds. If would incur additional costs if they are Solutions’ 2015 Physicians’ Fee &
vaccinated (vaccine costs + vaccine
airlines and vessel operators do not Coding Guide (CPT 90471).49 Total costs
administration, Table 25).
have any additional data besides what is To be conservative, HHS/CDC resulting from the final rule are
already transmitted to DHS, there will assumes that all 6 exposed travelers summarized in Table 26.

TABLE 26—MARGINAL IMPACT OF FINAL RULE TO IMPROVE CONTACT INVESTIGATIONS


Additional Addition contacts Number of Average prob-
Number of
Marginal cost for measles in- names provided to reached by travelers provided ability
travelers identified
vestigations health health depart- post-exposure that contact
earlier
departments ments prophylaxis is infected

$1,950 ................................... 8.5 21 6 Unknown ............................... 0.0035–0.0095

In the absence of interventions by monitoring for potential measles (16+57) = 20.1%. The lower bound
public health departments, travelers symptoms. represents an assumption that all of the
infected with measles during For measles in 2011, 16 outbreaks 113 cases unassociated with outbreaks
international travel would be as likely occurred leading to 107 cases. An of 3 or more cases occurred in clusters
as any other individuals to spark a outbreak was defined based on 3 or with just one case each. The upper
measles outbreak. In the absence of more cases in a cluster.50 The remaining bound represents a scenario with 56
HHS/CDC efforts to retrieve and 113 cases reported in 2011 resulted in clusters of two cases each with one
transmit contact data, public health one or two cases per cluster. Thus, the cluster with one case. Thus, the
departments would not be able contact probability that any individual measles
mstockstill on DSK3G9T082PROD with RULES3

probability that any individual measles


travelers to offer post-exposure index case leads to an outbreak was case could spark an outbreak of 3 or
prophylaxis and/or to recommend self- between 16/(16+113) = 12.4% and 16/ more cases is 12.4% to 20.1%. The

48 http://www.cdc.gov/vaccines/programs/vfc/ 49 InGauge Healthcare Solutions. 2015 Physicians’ measles outbreaks on United States public health
awardees/vaccine-management/price-list/ Fee & Coding Guide. Atlanta GA2013. departments in 2011. Vaccine. 2012;32(11).
50 Ortega-Sanchez IR, Vijayaraghavan M, Barskey
archive.html Accessed 5/2/2016.
AE, Wallace GS. The economic burden of sixteen

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00063 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6952 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

average cost to public health The estimated illness costs for person’s life. For example if 1,000
departments per measles outbreak is measles are $300 ($86–$515) for people were willing to pay $1,000 each
$250,000 and the upper bound cost is $1 outpatient cases and $24,500 ($3,900– to reduce their risk of death by 1/1,000,
million.51 $45,052) for inpatient cases.52 The the value of statistical life would be
HHS/CDC assumes that the probability of hospitalization is equal to $1,000/0.001 change in risk of
probability that a measles case resulting estimated to be 44.3%.53 A range of death = $1 million. Alternatively 1,000
from exposure during travel and that is hospitalization rates is estimated based people each experiencing a mortality
not contacted by a public health on 50% to 150% of this base case risk reduction of 0.001 would
department is as likely as any other estimate (22%–66%). The measles case correspond to 1,000 people × 0.001
measles case to initiate a measles fatality rate has been estimated to be mortality risk reduction = 1 statistical
outbreak of 3 or more cases, which 0.2%.54 HHS/CDC assumes that the
life; 1,000 people each willing to pay
occurs at an approximate probability of value of statistical life is $9.4 million
$1,000 = 1,000 × $1,000 = $1 million to
12.4% to 21.9%. The average cost to (range $4.3 million to $14.2 million).
health departments is $250,000 for each This value is an estimate of the average avert that one statistical death. Using
of these outbreaks and the average willingness to pay to reduce one’s these estimates, the average illness costs
outbreak size is about 7 cases (107 mortality risk by a small increment not associated with a measles case (Table
cases/16 outbreaks). an estimate of the value of any specific 27) is about $30,000 ($9,500 to $58,000).

TABLE 27—ESTIMATED ILLNESS AND MORTALITY COSTS PER MEASLES CASE


Best estimate Lower bound Upper bound

Outpatient cost, a ...................................................................................................... $300 $86 $515


Inpatient cost, b ......................................................................................................... $24,500 $3,943 $45,052
Hospitalization rate, c ................................................................................................ 44.30% 22.0% 66.0%
Case fatality rate, d ................................................................................................... 0.2% 0.2% 0.2%
VSL, e ........................................................................................................................ $9,400,000 $4,300,000 $14,200,000
Total cost per case (b × c + a × (1¥c) + d × e) ....................................................... $29,821 $9,535 $58,309

The estimated number of measles of outbreaks in the absence of public costs. The estimated costs of measles
cases that will occur in contacts health intervention to conduct contact outbreaks in the absence of contact
exposed during travel (3.6 to 10.1) can investigations in exposed travelers. For investigations for exposed travelers is
be multiplied by the probability of an each outbreak, HHS/CDC assumes that presented in Table 28.
outbreak with 3 or more cases (12.4% to an average of 6 additional cases occur
21.7%) to estimate the expected number with associated morbidity and mortality

TABLE 28—ESTIMATED ILLNESS, MORTALITY, PUBLIC HEALTH RESPONSE COSTS ASSOCIATED WITH MEASLES OUTBREAKS
Best estimate Lower bound Upper bound

Estimated number of measles cases among contacts, a ......................................... 6.85 3.6 10.1
Probability of measles outbreak, b ............................................................................ 17 12.4 21.9
Number of additional cases per outbreak, c ............................................................. 6 6 6
Estimated number of outbreaks, d = a × b ............................................................... 1.18 0.45 2.22
Estimated number of outbreak cases, e = a × b × c ................................................ 7.06 2.68 13.29
Estimated health department costs per outbreak, f .................................................. 250,000 250,000 250,000
Estimated health department costs, g = f × d ........................................................... 293,989 111,607 553,758
Average cost per case, h .......................................................................................... 29,821 9,535 58,309
Estimated illness costs, I = h × e .............................................................................. 210,406 25,539 774,944
Estimated total costs, g + i ........................................................................................ 504,395 137,146 1,328,703

HHS/CDC has not received any outbreak is significantly mitigated by the provisions in the final rule further
reports of large measles outbreaks pre-warning of exposure before disease improve health departments’ ability to
associated with measles cases in outset. Given that HHS/CDC estimates prevent measles outbreaks in cases that
patients exposed during travel and that health departments are able to occur among travelers exposed during
contacted by State or local public health reach approximately 75% of contacts flights. A modest improvement of 15%
departments. As a result, HHS/CDC under the status quo, HHS/CDC assumes is assumed (range 10%–20%) resulting
believes that when measles cases occur that the risk of an outbreak has been in estimated benefits of about $45,000
in contacts reached by health reduced by at least 60% under the status ($8,000 to $159,000) in Table 29.
departments, the probability of an quo. Further, HHS/CDC assumes that
mstockstill on DSK3G9T082PROD with RULES3

51 Ortega-Sanchez IR, Vijayaraghavan M, Barskey the United States, 2009. Pediatrics. 2014;133:577– 54 Centers for Disease Control and Prevention.

AE, Wallace GS. The economic burden of sixteen 85. Epidemiology and Prevention of Vaccine-
measles outbreaks on United States public health 53 Mason WH, Ross LA, Lanson J, Wright HT.
Preventable Diseases, 13th Edition—Measles April
departments in 2011. Vaccine. 2012;32(11). Epidemic measles in the postvaccine era: evaluation 2015 http://www.cdc.gov/vaccines/pubs/pinkbook/
52 Zhou F, Shefer A, Wenger J, Messonnier M, of epidemiology, clinical presentation, and downloads/meas.pdf. Accessed 6/13/2016.
Wang LY, Lopez A, et al. Economic Evaluation of complications during an urban outbreak. Pediatr
the Routine Childhood Immunization Program in Infect Dis J. 1993;12:42–8.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00064 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6953

TABLE 29—ESTIMATED BENEFITS ASSOCIATED WITH IMPROVEMENT OF MEASLES CONTACT INVESTIGATIONS AS A RESULT
OF THIS FINAL RULE

Best estimate Lower bound Upper bound

Estimated total costs without intervention, j = g + i .................................................. $504,395 $137,146 $1,328,703


Estimated effectiveness of outbreak prevention baseline, k ..................................... 60% 60% 60%
Estimated cost of measles outbreaks under baseline, j × (1¥k) ............................. $201,758 $54,858 $531,481
Estimated effectiveness of outbreak prevention with final rule, l .............................. 69% 66% 72%
Estimated cost of measles outbreaks with final rule, m = j × (1¥l) ......................... $156,363 $46,630 $372,037
Estimated benefit associated with final rule, n = j¥m .............................................. $45,396 $8,229 $159,444

Marginal Impact on Tuberculosis have latent tuberculosis infection.55 The treatment and the remaining 26% start,
Investigations contact rate for exposed tuberculosis but do not complete treatment. The
Although measles is not a contacts is probably higher than for authors estimated that the risk of
quarantinable disease and tuberculosis measles because the vast majority of progression to active tuberculosis is
is a quarantinable disease, HHS/CDC’s tuberculosis contacts are exposed reduced by 80% for those that complete
and health departments’ approaches to during international travel as exposed to treatment. The authors assumed that
contact investigations are relatively measles contacts, which are there is no effect for individuals that
similar. However, HHS/CDC may issue approximately evenly divided between start, but do not complete treatment.
isolation orders for individuals with interstate and international travel. HHS/CDC assumes that under the status
active tuberculosis in some situations, The estimated costs to provide testing quo that health departments are able to
but would not have authority to issue and treatment to contacts that test contact 75% of exposed travelers (based
isolation (or quarantine orders) for positive for latent tuberculosis infection on the reported outcomes from measles
individuals with measles. The expected are estimated to be $1,044 for infected contact investigations).57
benefits associated with reduced contacts that complete a full course of The costs to provide treatment for
tuberculosis morbidity and mortality of treatment and $591 for infected contacts latent tuberculosis infections under the
contact investigations for exposed that discontinue treatment after 30 status quo are summarized in Table 30.
travelers are based on a previous days.56 Following the assumptions in In total, the costs are almost $900,000
analysis, which estimated a return on the article, an estimated 28% of persons including about $720,000 to locate
investment of $1.01 to $3.20 for the who test positive for latent tuberculosis contacts and about $180,000 to provide
baseline situation in which an estimated infection do not start treatment. An treatment to individuals with latent
19% of exposed contacts are found to estimated 46% start and complete tuberculosis infection.

TABLE 30—BASELINE ESTIMATED COSTS TO CONDUCT TUBERCULOSIS CONTACT INVESTIGATIONS AND TO PROVIDE
TREATMENT
Number of Estimated cost Estimated cost Notes
contacts per contact

Estimated cost of contact investigations ........ 1,995 $360 $718,092 Number of contacts from Table 13 and cost
per contact from Table 11.
Estimated number of contacts reached by 1,496 NA ........................ Estimated at 75% similar to measles from
health departments (75%). Table 24.
Estimated number of contacts reached by 284 NA ........................ Estimated 19% of contacts have LTBI (Table
health departments and have latent TB in- 13).
fection (19% of 75%).
Number of contacts that never start treatment 79.6 0 0 28% of 284 contacts with LTBI.
(28%).
Number of contacts that complete treatment 130.8 1,044 136,506 46% of 284 contacts with LTBI.
(46%).
Number of contacts that start, but not com- 73.9 591 43,677 26% of 284 contacts with LTBI.
pete treatment, (26%).

Total cost ................................................. ........................ ........................ 898,275

The benefits associated with transmission of tuberculosis among Estimated Costs × ROI + Estimated
tuberculosis contact investigations are averted cases, potentially resulting in a Costs. The estimated benefits are $2.6
estimated from a published article, conservative estimate of the return on million and are shown in Table 31
which reported a range of $1.01 to investment. The formula used to derive (range: $1.8 million to $3.8 million).
$3.20. This analysis did not include the estimated benefits from the return on
mstockstill on DSK3G9T082PROD with RULES3

potential benefits from reduced onward investment (ROI) is Estimated Benefits =

55 Coleman M, Marienau K, Marano N, Marks S, 56 Coleman M, Marienau K, Marano N, Marks S, 57 Nelson K, Marienau K, Schembri C, Redd S.

Cetron M, Dis TMI. Economics of United States Cetron M, Dis TMI. Economics of United States Measles transmission during air travel, United
Tuberculosis Airline Contact Investigation Policies. Tuberculosis Airline Contact Investigation Policies. States, December 1, 2008–December 31, 2011.
Travel Medicine and Infectious Disease. Travel Medicine and Infectious Disease. Travel Med Infect Dis. 2013;11(2):81–9.
2014;12:63–71. 2014;12:63–71.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00065 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6954 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

TABLE 31—BASELINE ESTIMATED COSTS AND BENEFITS FOR TUBERCULOSIS CONTACT INVESTIGATIONS, 2015 USD
Best estimate Lower bound Upper bound Notes

Estimate costs for contact investigations and $898,260 $898,260 $898,260 Table 30.
treatment.
Return on investment from tuberculosis con- 1.91 1.01 3.20 Coleman et al.
tact investigations.
Estimated benefits .......................................... 2,613,936 1,805,502 3,772,691 = Cost × ROI + Costs.

The provisions in the final rule much longer period of latent infection by this range of improvement (5%–15%)
should result in a small increase prior to active disease; thus, as shown in Table 32. This results in
(assumed baseline of 10%, range: 5– tuberculosis contact investigations are marginal increased costs associated with
15%) in the number of contacts reached less time sensitive relative to measles the final rule of $18,000 (range: $9,000
by health departments and offered contact investigations. The estimated to $27,000). The estimated benefits
treatment for latent tuberculosis costs associated with this marginal (Table 32) associated with the final rule
infection. This estimated improvement improvement to reach more contacts can are $52,000 (range: $18,000 to
is less than that assumed for measles be estimated by multiplying the costs of $114,000).
because tuberculosis usually involves a providing latent tuberculosis ($180,000)

TABLE 32—ESTIMATED COSTS AND BENEFITS FOR TUBERCULOSIS CONTACT INVESTIGATIONS ASSOCIATED WITH THIS
FINAL RULE, 2015 USD
Best estimate Lower bound Upper bound Notes

Baseline contact investigation costs ............... $718,080 $718,080 $718,080


Baseline latent tuberculosis treatment costs .. $180,180 $180,180 $180,180 Table 30 costs for latent tuberculosis treat-
ment and testing.
Estimated improvement in health depart- 10% 5% 15% Assumed.
ments’ abilities to contact exposed trav-
elers.
Estimated increased cost for latent tuber- $18,018 $9,009 $27,027 Estimated cost for improvement in contact
culosis treatment under final rule. rate as result of final rule.
Estimated costs under final rule ..................... $916,278 $907,269 $925,287 Estimated baseline cost + increased cost as
result of final rule.
Estimated ROI ................................................. $1.91 $1.01 $3.20 Table 30.
Estimated benefits for final rule ...................... $2,666,368 $1,823,610 $3,886,204 = Cost × ROI + Costs.
.
Estimated costs associated with final rule ...... $18,018 $9,009 $27,027. Calculated from the difference in costs for
the final rule—Baseline costs.
Estimated benefits associated with final rule $52,432 $18,108 $113,513 Calculated from the difference in benefits for
the final rule—Baseline benefits.

Total Costs and Benefits for Measles and activities are estimated by summing the (Table 32). The results are summarized
Tuberculosis Contact Investigations costs and benefits of measles contact in Table 33.
The total costs for measles and investigations (Table 29) and
tuberculosis contact investigation tuberculosis contact investigations

TABLE 33—CHANGES IN MEASLES AND TUBERCULOSIS CONTACT INVESTIGATIONS COSTS AND BENEFITS RELATIVE TO
BASELINE, 2015 USD
Best estimate Lower bound Upper bound

Final rule benefits ...................................................................................................... $97,828 $26,337 $272,958


Final rule costs .......................................................................................................... 19,968 10,959 28,977
Note: This table includes the sum of results in Tables 29 and 32.

Total Annual Benefits Resulting From the quality and timeliness of traveler and tuberculosis morbidity and
Codification of Traveler Data Collection contact data or the improvement of mortality (Table 33).
(71.4 and 71.5) and Change to Definition illness reporting is summarized by
mstockstill on DSK3G9T082PROD with RULES3

of ‘‘Ill Person’’ (70.1 and 71.1) Leading summing the improved efficiency for
to Improved Contact Investigations and HHS/CDC to provide contact data to
Health Outcomes for Measles and health departments and improved
Tuberculosis efficiency for health departments to
The total quantified benefits (Table contact exposed travelers (Table 23) and
34) resulting from the improvement of the reductions associated with measles

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00066 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6955

TABLE 34—TOTAL ANNUAL COSTS AND BENEFITS ASSOCIATED WITH IMPROVED EFFICIENCY PUBLIC HEALTH RESPONSE
ACTIVITIES, 2015 USD
Best estimate Lower bound Upper bound

Final rule benefits ...................................................................................................... $110,045 $26,337 $297,393


Final rule costs .......................................................................................................... 19,968 10,959 28,977

The benefits and costs associated with airlines, vessel operators, DOT/FAA, manifest requests (Table 19) to estimate
improved effectiveness of contact and HHS/CDC to submit and respond to the total annual costs and benefits of the
investigations (Table 34) can be illness reports or to provide more timely final rule (Table 35).
combined with the increased costs to and complete traveler contact data for

TABLE 35—TOTAL ANNUAL COSTS AND BENEFITS OF THE FINAL RULE, 2015 USD
Best estimate Lower bound Upper bound

Final rule benefits ...................................................................................................... $110,045 $26,337 $297,393


Final rule costs .......................................................................................................... 32,622 10,959 430,839

Other Diseases (Besides Measles and contact the Agency created a level of search and obtain data collected from
Tuberculosis) fear in the general population that may their APIS and PNR data sets prior to
HHS/CDC does not have sufficient not have been necessary if better contact contacting airlines or vessel operators
data to quantify the health impact of data were available. In addition, this with duplicate data requests.
contact investigations for pertussis, fear may have led to non-health costs
Analysis of Alternatives
rubella, varicella (vessels only), viral (such as fear of airplane travel) that
would have been mitigated if the Traveler Contact Data Alternatives
hemorrhagic fevers (including Ebola),
MERS, or SARS. HHS/CDC attempts to Agency were able to contact all
For the less restrictive alternative,
passengers without the media request.
continuously update its contact HHS/CDC assumes that the process of
However, when HHS/CDC solicited
investigation protocols based on requesting contact data from airlines
public comment about perceived
available evidence. In the past few and vessel operators would be
willingness to pay to be contacted in the
years, HHS/CDC has stopped requesting discontinued. Thus, the cost to provide
event of an exposure to a communicable
data to conduct mumps contact such data can be modeled as a benefit
disease during, HHS/CDC only received
investigations 58 and has modified its to airlines and vessel operators equal to
a few public comments, all of which
protocol to reduce the number of their costs under the baseline. For the
indicated that they had zero willingness
tuberculosis contacts investigated.59 more restrictive alternative, HHS/CDC
to pay in the event of an exposure to a
Experience from interstate flight assumes that suspension of entry may
communicable disease.
contact investigations suggest that In summary, improved alignment be implemented for travelers from
travelers may want to know when they between regulatory text and HHS/CDC’s countries experiencing widespread
have been exposed to communicable publicly available guidance should transmission of quarantinable
diseases during flights. The first Ebola reduce compliance costs for airlines and communicable diseases. HHS/CDC
contact investigation conducted in the vessel operators while improving HHS/ notes that suspension of entry would
United States occurred in October, 2014, CDC’s ability to respond to public not be considered for non-quarantinable
and found that 60 travelers out of 164 health threats associated with diseases (refer to Table 4). Specifically,
had no contact information on the international and interstate travel. To HHS/CDC assumes that persons
manifest that was provided by the the extent that airlines and vessel traveling from affected countries are not
airline. A second request was made to operators improve responsiveness to permitted entry to the United States
the airline after it was announced to the HHS/CDC traveler data requests, HHS/ unless such persons spend an amount of
media that the airline had contacted CDC may become better able to respond time equivalent to the incubation period
over 800 travelers, including travelers to infectious diseases threats and (1) for the target disease at a location where
who had flown on the same plane reduce case-loads during infectious they are not at risk of exposure and are
subsequent to the flight with the Ebola. disease outbreaks, (2) reduce public also screened for symptoms of the
At that time the airline was able to anxiety during disease outbreaks, (3) disease prior to travel to the United
provide HHS/CDC more complete mitigate economic impacts on States. During the 2014–2016 Ebola
information for all travelers. businesses as a consequence of reduced epidemic, travelers from Liberia, Sierra
It is likely that the need for CDC to public anxiety, and (4) reduce the Leone or Guinea would not be able to
put out media requests for travelers to amount of personnel labor time to enter until 21 days in another country
conduct large-scale CIs in response to a or within the affected country but
58 Nelson KR, Marienau KJ, Barskey AE, Schembri
new infectious disease or one with separated from others in a manner that
mstockstill on DSK3G9T082PROD with RULES3

C. No evidence of mumps transmission during air


travel, United States, November 1, 2006–October serious public health and medical excludes the possibility of interaction
31, 2010. Travel Medicine and Infectious Disease. consequences like Ebola. HHS/CDC will with potentially infected individuals.
2012;10:165–71. make all reasonable efforts to work with On average, HHS/CDC has conducted
59 Marienau KJ, Cramer EH, Coleman MS, Marano
DHS/CBP via CDC’s liaison located at about 2.5 contact investigations for viral
N, Cetron MS. Flight related tuberculosis contact
investigations in the United States: comparative risk
the National Targeting Center, as hemorrhagic fevers and MERS
and economic analysis of alternate protocols. Travel provided through internal coronavirus over the past six years.
Med Infect Dis. 2014;12(1):54–62. Memorandum of Understanding, to HHS/CDC assumes that if suspensions

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00067 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6956 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

of entry may be in place, some fraction restrictive alternative resulting in for 2.5 investigations ($12,338 vs.
of these contact investigations may not estimated benefits of $75,924. For the $12,654) and calculating the cost
be conducted. more restrictive scenario, the costs are reduction of doing 2.5 fewer contact
Thus, the cost to airlines and vessel relatively similar as for the final rule investigations each year ($1,898) (Table
operators to provide traveler contact except for the reduction in cost 36).
data would decrease for the less associated with providing contact data

TABLE 36—ESTIMATE OF THE COSTS AND BENEFITS TO AIRLINES AND VESSEL OPERATORS TO PROVIDE TRAVELER
CONTACT DATA, 2015 USD
Less More
Baseline Final rule restrictive restrictive
alternative a alternative b

Baseline number of contact investigations ...................................................... 100 100 0 97.5

Costs

Best estimate ................................................................................................... NA $12,654 $0 $12,338


Lower bound .................................................................................................... NA 0 0 0
Upper bound .................................................................................................... NA 25,308 0 24,802

Benefits

Best estimate ................................................................................................... NA $0 $75,924 $1,898


Lower bound .................................................................................................... NA 0 75,924 1,898
Upper bound .................................................................................................... NA 0 75,924 1,898
a The less restrictive alternative is less expensive than the status quo, because HHS/CDC does not request data from airlines and attempt to
provide data to health departments to follow up with exposed travelers.
b The more restrictive alternative also could potentially reduce costs to airlines and vessel operators because HHS/CDC would restrict travel to
countries undergoing widespread transmission of quarantinable communicable diseases such as viral hemorrhagic fevers, MERS or SARS.

Illness Reporting Alternatives reports are based on symptoms the magnitude of decrease in reporting.
HHS/CDC examines two alternatives: currently requested by HHS/CDC, but HHS/CDC believes that both HHS/CDC
A less restrictive alternative in which not required. In addition, only 67% of and DOT/FAA would continue to
HHS/CDC relaxes its regulatory illness reports during air travel require maintain their current infrastructure to
authorities to make illness reporting HHS/CDC response and follow-up. In effectively respond to public health
compliance voluntary rather than comparison, illness reports from vessels emergencies either on aircraft or vessels.
compulsory. Under the more restrictive are much more likely to be based on the Thus, relative to the status quo, the
alternative HHS/CDC may enforce the definition of ill person as defined in primary impact of voluntary reporting
current requirement that airlines report current 71.1 (174.6/218.6 or 80%). In would be reduced incremental time
all persons with communicable diseases addition, a much greater proportion of costs for pilots in command and masters
to local health departments in addition reports require an HHS/CDC follow-up of vessels, travelers, DOT/FAA, and
to reporting to HHS/CDC. (>95%). This may result from HHS/CDC, especially for info-only
The current status quo for illness differences in the types of illnesses illness reports. This 50% reduction in
reporting is summarized in Tables 9 and observed on vessels relative to aircraft illness reporting would generate
10. Reports can be subdivided by or because of the presence of medical benefits from cost reductions for airlines
illnesses that fit (1) the ill person officers on cruise vessels, who may be and vessel operators, HHS/CDC,
definition specified in current 42 CFR better able to identify communicable travelers, and DOT/FAA of
71.1, (2) reports based on HHS/CDC’s diseases of public health concern during approximately $14,700 (Tables 37 and
guidance for airlines and vessel travel relative to aircraft personnel. 38).
operators, or (3) illness reports If illness reporting were entirely The adverse impact for the less
unrelated to current regulation or voluntary, HHS/CDC assumes the restrictive alternative relative to the
guidance. As shown in Table 9, only number of reports (both info-only and baseline would be reduced capacity for
about 53 out of 175.4 (30%) illness reports requiring response) would HHS/CDC to respond quickly to
reports during air travel appear to be decrease by 50% from both airlines and communicable disease threats occurring
based on symptoms included in the vessel operators (refer to Tables 9 and during travel. This is analyzed in a
current definition of an ill person in 10) from the current status quo. HHS/ subsequent section on the health impact
existing 71.1. The remaining 70% of CDC does not have any data to estimate of regulated activities.

TABLE 37—LESS RESTRICTIVE ALTERNATIVE FOR ILLNESS REPORTING


[Effect on info-only reports, 2015 USD]
mstockstill on DSK3G9T082PROD with RULES3

Amount
Change in of time Estimated Overhead Estimated
number of
Employee type required wage rate multiplier benefit
info-only per report (per hr.) (%) (cost reduction)
reports (min)

Aircraft:
Aircraft Pilots or Copilots .......................................... 60 2 $57.35 100 $229

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00068 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6957

TABLE 37—LESS RESTRICTIVE ALTERNATIVE FOR ILLNESS REPORTING—Continued


[Effect on info-only reports, 2015 USD]

Amount
Change in of time Estimated Overhead Estimated
number of
Employee type required wage rate multiplier benefit
info-only per report (per hr.) (%) (cost reduction)
reports (min)

CDC employee ......................................................... 60 60 39.83 100 4,780


DOT/FAA employees ................................................ 60 26 70.57 100 3,670
Traveler ..................................................................... 60 10 23.23 0 232

Air total .............................................................. ........................ ........................ ........................ ........................ 8,911


Vessels:
Captains, Mates, and Pilots of Water Vessels ......... 6 2 39.95 100 16
CDC employee ......................................................... 6 60 39.83 100 478
Traveler ..................................................................... 6 10 23.23 0 23

Maritime total ..................................................... ........................ ........................ ........................ ........................ 517

Total (Air + Maritime) ................................. ........................ ........................ ........................ ........................ 9,428


Assume 50% reduction in reports.

TABLE 38—LESS RESTRICTIVE ALTERNATIVE FOR ILLNESS REPORTING


[Effect on reports requiring response, 2015 USD]

Amount
Change in of time Estimated Overhead Estimated
number of
Employee type required wage rate multiplier benefit
info-only per report (per hr.) (%) (cost reduction)
reports (min)

Aircraft:
Aircraft pilots or copilots ........................................... 29 2 $57.35 100 $111
CDC employee ......................................................... 29 0 39.83 100
DOT/FAA employee .................................................. 29 26 70.57 100 1,774
Traveler ..................................................................... 29 60 23.23 0 674

Total ................................................................... ........................ ........................ ........................ ........................ 2,558


Vessels:
Captains, mates, and pilots (masters) of vessels .... 104 2 39.95 100 277
CDC employee ......................................................... 104 0 39.83 100
Traveler ..................................................................... 104 60 23.23 0 2,416

Total ................................................................... ........................ ........................ ........................ ........................ 2,693

Total (Air + Maritime) ................................. ........................ ........................ ........................ ........................ 5,251


Notes: Assume 50% reduction in air illness reports and 15% of maritime illness reports (response, international and interstate).

Under the more restrictive alternative, reports occur during interstate travel. illness reports than HHS/CDC. The costs
HHS/CDC would require duplicate The time required for pilots in to airlines and vessel operators is
illness reporting both to HHS/CDC and command and masters of vessels is estimated to be $848 per year (Table 39).
to local health departments with assumed to be about 4 minutes. This Since HHS/CDC would coordinate
jurisdiction upon arrival for interstate duration is greater than the amount of responses to illness reports with local
flights and voyages. This alternative is time estimate for reporting to HHS/CDC health departments under the status
based upon the existing regulatory text because pilots in command and masters quo, there are no additional costs or
under 42 CFR 70.4. HHS/CDC assumes of vessels may have to search for contact benefits to requiring duplicative reports
that 50% of illness reports occur during information for local health departments to local health departments. These costs
interstate (relative to international) air and because local health departments would be added to the costs of the
travel and that 15% of maritime illness may have less experience dealing with changes resulting from the final rule.

TABLE 39—MORE RESTRICTIVE ALTERNATIVE (ILLNESS REPORTING IN DUPLICATE TO HHS/CDC AND TO LOCAL HEALTH
DEPARTMENTS), 2015 USD
mstockstill on DSK3G9T082PROD with RULES3

Amount
Change in Estimated
of time Overhead Estimated
number of wage rate
Employee type required multiplier cost
info-only (2015 USD
per report (%) ($2015 USD)
reports per hr.)
(min)

Aircraft pilots or copilots ...................................................... 88 4 $57.35 100 $673

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00069 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6958 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

TABLE 39—MORE RESTRICTIVE ALTERNATIVE (ILLNESS REPORTING IN DUPLICATE TO HHS/CDC AND TO LOCAL HEALTH
DEPARTMENTS), 2015 USD—Continued
Amount
Change in Estimated
of time Overhead Estimated
number of wage rate
Employee type required multiplier cost
info-only (2015 USD
per report (%) ($2015 USD)
reports per hr.)
(min)

Captains, mates, and pilots (masters) of vessels ............... 33 4 39.83 100 175

Total .............................................................................. ........................ ........................ ........................ ........................ 848

The total costs and benefits associated reporting scenarios as compared to the
with the more and less restrictive illness final rule are summarized in Table 40.

TABLE 40—BEST ESTIMATE, LOWER BOUND AND UPPER BOUND OF THE CHANGES IN ANNUAL MONETIZED BENEFITS AND
COSTS AS A RESULT OF THE CHANGE TO THE REPORTABLE ILLNESS DEFINITION, 2015 USD
Best estimate Lower bound Upper bound

Costs

Final Rule:
Aircraft .................................................................................................................................. $0 $0 $375,751
Vessels ................................................................................................................................. 0 0 802

Total ............................................................................................................................... 0 0 376,554


Less Restrictive Alternative: a
Aircraft .................................................................................................................................. 0 0 0
Vessels ................................................................................................................................. 0 0 0

Total ............................................................................................................................... 0 0 0
More Restrictive Alternative:
Aircraft .................................................................................................................................. 673 673 376,424
Vessels ................................................................................................................................. 175 175 978

Total ............................................................................................................................... 848 848 377,402

Benefits

Final Rule:
Aircraft .................................................................................................................................. 0 0 0
Vessels ................................................................................................................................. 0 0 0

Total ............................................................................................................................... 0 0 0
Less Restrictive Alternative: a
Aircraft .................................................................................................................................. 11,469 11,469 11,469
Vessels ................................................................................................................................. 3,210 3,210 3,210

Total ............................................................................................................................... 14,679 14,679 14,679


More Restrictive Alternative:
Aircraft .................................................................................................................................. 0 0 0
Vessels ................................................................................................................................. 0 0 0

Total ............................................................................................................................... 0 0 0
a For the less restrictive scenario, the current reporting requirement is relaxed leading to a reduction in costs.

The total costs of the alternatives costs of the change to the definition of passenger contact data for the final rule,
compared to the final rule are an ‘‘ill person’’ and the codification of the less restrictive alternative, and the
summarized in Table 41 and include the the requirement for airlines to provide more restrictive alternative.

TABLE 41—TOTAL COSTS AND BENEFITS RESULTING FROM CODIFICATION OF TRAVELER DATA COLLECTION (71.4 AND
71.5) AND CHANGE TO DEFINITION OF ‘‘ILL PERSON’’ (70.1 AND 71.1)
mstockstill on DSK3G9T082PROD with RULES3

Best estimate Lower bound Upper bound

Costs

Final Rule:
71.4 and 71.5 Passenger data collection ............................................................................. $12,654 $0 $25,308

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00070 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6959

TABLE 41—TOTAL COSTS AND BENEFITS RESULTING FROM CODIFICATION OF TRAVELER DATA COLLECTION (71.4 AND
71.5) AND CHANGE TO DEFINITION OF ‘‘ILL PERSON’’ (70.1 AND 71.1)—Continued
Best estimate Lower bound Upper bound

70.1 and 71.1 Change in definition of an ‘‘ill person’’ .......................................................... 0 0 376,554

Total costs ..................................................................................................................... 12,654 0 401,862


Less Restrictive Alternative:
71.4 and 71.5 Passenger data collection ............................................................................. 0 0 0
70.1 and 71.1 Change in definition of an ‘‘ill person’’ .......................................................... 0 0 0

Total costs ..................................................................................................................... 0 0 0


More Restrictive Alternative:
71.4 and 71.5 Passenger data collection ............................................................................. 12,338 0 24,802
70.1 and 71.1 Change in definition of an ‘‘ill person’’ .......................................................... 848 848 377,402

Total costs ..................................................................................................................... 13,186 848 402,204

Benefits

Final Rule:
71.4 and 71.5 Passenger data collection ............................................................................. 0 0 0
70.1 and 71.1 Change in definition of an ‘‘ill person’’ .......................................................... 0 0 0

Total benefits ................................................................................................................. 0 0 0


Less Restrictive Alternative:
71.4 and 71.5 Passenger data collection ............................................................................. 75,924 75,924 75,924
70.1 and 71.1 Change in definition of an ‘‘ill person’’ .......................................................... 14,679 14,679 14,679

Total benefits ................................................................................................................. 90,603 90,603 90,603


More Restrictive Alternative:
71.4 and 71.5 Passenger data collection ............................................................................. 1,898 1,898 1,898
70.1 and 71.1 Change in definition of an ‘‘ill person’’ .......................................................... 0 0 0

Total benefits ................................................................................................................. 1,898 1,898 1,898

Staff Time for Contact Investigations more restrictive alternative (i.e. HHS/CDC and health departments or
For the less restrictive alternative, the implementing travel restrictions $58,000 in total). The benefits of the
change relative to baseline is equal to immediately upon evidence of avoided contacted investigations are
the current cost of performing Cis for widespread transmission of viral then added to the cost savings for the
travelers exposed on international hemorrhagic fevers, SARS or MERS, the remaining contacts assuming a 0–3%
flights ($745,000 each for HHS/CDC and costs of these contact investigations are improvement in HHS/CDC efficiency
local health departments or a total of assumed to be avoided (potential cost and a 0–2% improvement in PHD
about $1.5 million, Table 20). Under the reductions of about $29,000 each to efficiency as for the final rule (Table 42).

TABLE 42—ESTIMATED BENEFITS ASSOCIATED WITH REDUCED COSTS TO CONDUCT CONTACT INVESTIGATIONS
HHS/CDC PHD Total
benefits benefits

Final Rule:
Best estimate ........................................................................................................................ $7,331 $4,887 $12,218
Lower bound ......................................................................................................................... 0 0 0
Upper bound ......................................................................................................................... 14,661 9,774 24,435
Less Restrictive Alternative:
Best estimate ........................................................................................................................ 745,380 745,380 1,490,760
Lower bound ......................................................................................................................... 745,380 745,380 1,490,760
Upper bound ......................................................................................................................... 745,380 745,380 1,490,760
More Restrictive Alternative:
Best estimate ........................................................................................................................ 36,671 34,227 70,898
Lower bound ......................................................................................................................... 29,340 29,340 58,680
Upper bound ......................................................................................................................... 44,001 39,114 83,115
mstockstill on DSK3G9T082PROD with RULES3

Measles Contact Investigation Health the probability of onward transmission $137,000 to $1.3 million) (Table 28).
Outcomes—Alternatives from 3.6 to 10.1 measles patients Measles outcomes for the more
exposed each year during travel greatly restrictive alternative are the same as
For this analysis, under the less increases and is modeled based on the estimated for the final rule since there
restrictive alternative, HHS/CDC estimated costs of measles in the is no difference in measles efforts
assumes that no contact investigations absence of intervention $504,000 (range: between the final rule and the more
are performed for measles. As a result,

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00071 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6960 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

restrictive alternative because measles is status quo baseline are shown in Table in measles outbreak costs relative to the
not a quarantinable disease. The 43. For the less restrictive alternative, baseline.
comparative benefits relative to the costs are estimated based on an increase

TABLE 43—ESTIMATED BENEFITS ASSOCIATED WITH AVERTED COSTS FROM MEASLES OUTBREAKS RELATIVE TO
BASELINE, 2015 USD
Best estimate Lower bound Upper bound

Benefits

Final Rule ..................................................................................................................................... $45,396 $8,229 $159,444


Less Restrictive Alternative ......................................................................................................... 0 0 0
More Restrictive Alternative ......................................................................................................... 45,396 8,229 159,444

Costs

Final Rule ..................................................................................................................................... 1,950 1,950 1,950


Less Restrictive Alternative a ....................................................................................................... 201,758 54,858 531,481
More Restrictive Alternative ......................................................................................................... 1,950 1,950 1,950
a For the less restrictive alternative, contact investigations are not performed so the cost can be estimated based on the estimated public
health benefit of contact investigations performed under the baseline (Table 29).

Tuberculosis Contact Investigations about $180,000 to forego providing alternative in which suspension of entry
Health Outcomes—Alternatives treatment for latent tuberculosis is enforced in response to quarantinable
treatment) or benefits associated with communicable disease outbreaks, there
Under the less restrictive alternative, reduced tuberculosis morbidity and is no change relative to the final rule
tuberculosis contact investigation are no mortality. Relative to the baseline, the results because it is unlikely that a
longer conducted for persons exposed estimated cost of increased tuberculosis tuberculosis outbreak would cause
during travel. Relative to the baseline, morbidity and mortality is estimated to suspension of entry. Results are
there are neither costs to conduct such be $2.6 million (range: $1.8 million to summarized in Table 44.
investigations (resulting in benefits of $3.8 million). Under the more restrictive

TABLE 44—CHANGES IN TUBERCULOSIS CONTACT INVESTIGATIONS COSTS AND BENEFITS RELATIVE TO BASELINE, 2015
USD
Best estimate Lower bound Upper bound Notes

Benefits

Final Rule ........................................................ $52,432 18,108 113,513 Table 32.


Less Restrictive Alternative ............................ 180,180 180,180 180,180 Assumed to be the cost to provide LTBI
treatment under the baseline (Table 32).
More Restrictive Alternative ............................ 52,432 18,108 113,513 The more restrictive alternative has the
same effect on TB contact investigations
as the final rule.

Costs

Final Rule ........................................................ 18,018 9,009 27,027 Table 32.


Less Restrictive Alternative ............................ $2,613,936 $1,805,502 $3,772,691 Estimated based on the benefits of avoided
TB morbidity and mortality resulting from
contact investigations under the baseline.
More Restrictive Alternative ............................ 18,018 9,009 27,027 The more restrictive alternative has the
same effect on TB contact investigations
as final rule.

The total costs and benefits of changes which contact investigations are no costs. The more restrictive alternative
in health outcomes associated with the longer pursued shows a large increase in does not change health outcomes for
more and less restrictive alternatives costs relative to the baseline and in tuberculosis and measles in comparison
compared to the provisions included in comparison to the provisions in the to the final rule.
the Final Rule are summarized in Table final rule. In addition, there are some
45. The less restrictive alternative in benefits, but not enough to offset the
mstockstill on DSK3G9T082PROD with RULES3

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00072 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6961

TABLE 45—CHANGES IN MEASLES AND TUBERCULOSIS CONTACT INVESTIGATIONS COSTS AND BENEFITS RELATIVE TO
BASELINE, 2015 USD
Best estimate Lower bound Upper bound

Benefits

Final Rule ..................................................................................................................................... $97,828 $26,337 $272,958


Less Restrictive Alternative ......................................................................................................... 180,180 180,180 180,180.
More Restrictive Alternative ......................................................................................................... 97,828 26,337 272,958

Costs

Final Rule ..................................................................................................................................... 19,968 10,959 28,977


Less Restrictive Alternative ......................................................................................................... 2,815,694 1,860,360 4,304,172
More Restrictive Alternative ......................................................................................................... 19,968 10,959 28,977
Note: This table includes the sum of results in Tables 43 and 44.

The total quantified costs and benefits provisions included in the final rule is departments to contact exposed
(Table 46) resulting from the additional summarized by summing the improved travelers (Table 42) and the reductions
data provision and timeliness of traveler efficiency for HHS/CDC to provide associated with measles and
contact data or the improvement of contact data to health departments and tuberculosis morbidity and mortality
illness reporting for alternatives to the improved efficiency for health (Table 45).

TABLE 46—TOTAL ANNUAL COSTS AND BENEFITS ASSOCIATED WITH IMPROVED EFFICIENCY PUBLIC HEALTH RESPONSE
ACTIVITIES, 2015 USD
Best Lower Upper
estimate bound bound

Benefits

FR ................................................................................................................................................ $110,045 $26,337 $297,393


Less Restrictive Alternative ......................................................................................................... 1,670,940 1,670,940 1,670,940
More Restrictive Alternative ......................................................................................................... 168,725 85,017 356,073

Costs

FR ................................................................................................................................................ 19,968 10,959 28,977


Less Restrictive Alternative ......................................................................................................... 2,815,694 1,860,360 4,304,172
More Restrictive Alternative ......................................................................................................... 19,968 10,959 28,977

The total annual costs and benefits for final rule, the costs are underestimated. investigations for quarantinable diseases
the alternatives compared to the final HHS/CDC does not have sufficient data such as Ebola and MERS. Refer to the
rule are summarized in Table 47. to quantify the long term costs of appendix for some details of potential
Although the benefits for the more implementing suspensions of entry for costs associated with hypothetical
restrictive alternative in which countries experiencing outbreaks of suspensions of entry for the countries
suspensions of entry would be quarantinable diseases; however, such with widespread Ebola transmission
implemented for countries experiencing costs would probably exceed the during the 2014–2016 global Ebola
outbreaks of quarantinable $100,000 in estimated benefits epidemic.
communicable diseases are greater than associated with suspensions of entry
the quantified annual benefits of the that may result in fewer contact

TABLE 47—TOTAL ANNUAL COSTS AND BENEFITS OF THE FINAL RULE, LESS RESTRICTIVE AND MORE RESTRICTIVE
ALTERNATIVES, 2015 USD
Best estimate Lower bound Upper bound

Benefits

Final Rule ..................................................................................................................................... $110,045 $26,337 $297,393


Less Restrictive Alternative ......................................................................................................... 1,780,524 1,780,524 1,780,524
mstockstill on DSK3G9T082PROD with RULES3

More Restrictive Alternative ......................................................................................................... 170,623 86,915 357,971

Costs

Final Rule ..................................................................................................................................... 32,622 10,959 430,839


Less Restrictive Alternative ......................................................................................................... 2,815,694 1,860,360 4,304,172
More Restrictive Alternative ......................................................................................................... 33,154 11,807 431,181

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00073 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6962 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

Codification of Current Practice Federal orders to issue travel permits to transparent regulatory authority to
(Multiple Provisions in Final Rule) allow individuals to travel (interstate). require such measures, travelers may be
HHS/CDC does not expect that most HHS/CDC may allow persons under less likely to comply, either by refusing
of the provisions included in the final Federal orders to travel interstate for to answer risk assessment questions or
rule will result in measurable changes whom there is greater uncertainty providing false information. This lack of
relative to the economic baseline. The regarding HHS/CDC restricting their compliance may require that HHS/CDC,
primary purpose of the provisions travel. if it reasonably believes that the
summarized in list below is to explain Æ Monetized benefit/cost of final rule individual is infected with or has been
how HHS/CDC interprets its current D Increased clarity around due exposed to a quarantinable
statutory and regulatory authority under process may result in fewer resources communicable disease, to quarantine,
the Public Health Service Act (42 U.S.C. and time expended by individuals isolate, or place the individual under
264, 265) and regulations at 42 CFR under orders and HHS/CDC in surveillance under 42 CFR 70.6 or 71.32
parts 70 and 71. HHS/CDC is grouping disagreements over HHS/CDC’s and 71.33. HHS/CDC has not
the complementary provisions in part authority to issue Federal public health implemented public health measures at
70 and part 71 in the list below, when orders that limit an individual’s locations where individuals may
they align, to facilitate public review of movement. This includes the potential congregate for the purposes of interstate
the current provisions as well as those costs of litigation and associated travel in at least 50 years and cannot
included in the final rule. These activities. predict if or how often it may
changes are intended to clarify the • New provisions: § 70.6 implement measures in the future.
agency’s standard operating procedures Apprehension and detention of persons Æ Change relative to baseline as result
and policies, and due process rights for with specific diseases; § 71.32 Persons, of final rule
individuals. HHS/CDC believes that carriers, and things (no change to title) D Improved transparency and
such clarity is an important qualitative Æ Baseline and Current Regulatory potentially improved compliance in the
benefit of the provisions in this final Provision: event that HHS/CDC implements such
rule, but is not able to monetize this D Under current 42 CFR 70.6 and measures in the future.
impact in a significant way. § 71.32, HHS/CDC has regulatory Æ Qualitative benefit/cost of final rule
• New Provisions: § 70.5 authority to apprehend and detain D Improved transparency and public
Requirements relating to travelers under individuals with quarantinable understanding of HHS/CDC’s rationale
a Federal order of isolation, quarantine, communicable diseases. and authority to conduct such measures
or conditional release. Æ Change relative to baseline as result and require individuals to comply.
Æ Baseline and Current Regulatory of final rule Æ Monetized benefit/cost of final rule
Provision: § 70.5 Certain communicable D As a result of these new provisions, D Increased clarity around due
disease; special requirements. the major change would be improved process procedures may result in fewer
D Without the final rule, HHS/CDC transparency of HHS/CDC’s regulatory resources and time expended by
may issue Federal orders to restrict authority with regard to the issuance of individuals under orders and HHS/CDC
travel for persons infected or exposed to Federal quarantine, isolation, or in disagreements over HHS/CDC’s
quarantinable communicable diseases. conditional release orders of individuals authority to issue Federal public health
However, this process is less transparent traveling interstate. orders that limit an individual’s
and efficient than allowing travel (i.e. Æ Qualitative benefit/cost of final rule movement. This includes the potential
issue travel permits to allow interstate D ;Improved transparency and costs of litigation and associated
travel to persons under Federal orders compliance with Federal orders. activities.
for diseases not currently identified Æ Monetized benefit/cost of final rule • New Provisions: § 70.12 Medical
under existing 42 CFR 70.5.) Under D Increased clarity around due examinations; § 71.36 Medical
current practice, HHS/CDC issues process may result in fewer resources Examinations
approximately one Federal order per and time expended by individuals Æ Baseline and Current Regulatory
year, most frequently for tuberculosis, under orders, cooperating entities, and Provisions: 71.33 Persons: Isolation and
which is a disease not included in the CDC in disagreements over HHS/CDC’s Surveillance.
current 70.5. authority to issue Federal public health D This is carried out under statutory
Æ Change relative to baseline as result orders that limit an individual’s authority and under the regulatory
of final rule movement. This includes the potential authorities in 42 CFR 70.6 and 71.32(a),
D With the final rule, HHS/CDC is costs of litigation and associated 71.33, which would allow for medical
aligning the list of diseases for which activities. examinations of individuals under
individuals under Federal orders may • New Provisions: § 70.10 Public Federal orders.
be allowed to travel with the health prevention measures to detect Æ Change to baseline as result of final
quarantinable communicable diseases communicable disease; § 71.20 Public rule
specified in Executive Order. A health prevention measures to detect D With the final rule, the major
potential future qualitative benefit communicable disease. change would be an alignment between
would be to reduce uncertainty by the Æ Baseline and Current Regulatory the statutory language in the Public
individual subject to the order, carrier Provisions: No explicit regulatory Health Service Act and improved
operators, and cooperating health and provision. transparency of HHS/CDC’s regulatory
law enforcement entities about whether D In the absence of the final rule and authority.
HHS/CDC could issue a travel permit to under existing statutory authority Æ Qualitative benefit/cost of final rule
mstockstill on DSK3G9T082PROD with RULES3

an individual under a Federal order and provided in the Public Health Service D Improved transparency and public
quantifiable benefit would be the Act and regulatory authority provided understanding of HHS/CDC’s rationale
avoided cost of potential legal by 42 CFR 70.2 and 71.32(b), HHS/CDC and authority to conduct such measures
challenge. could still implement public health and require individuals to comply.
Æ Qualitative benefit/cost of final rule measures at locations where individuals Æ Monetized benefit/cost of final rule
D Improved transparency for HHS/ may gather for interstate travel or at U.S. D Increased clarity around due
CDC’s ability to allow individuals under ports of entry. However, without more process procedures may result in fewer

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00074 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6963

resources and time expended by individuals besides for those under issue Federal quarantine, isolation, or
individuals under orders, cooperating Federal isolation orders. conditional release orders. However, the
entities, and HHS/CDC in disagreements Æ Change to baseline as result of final process for reassessing a Federal order
over HHS/CDC’s authority to issue rule is implemented through internal policy
Federal public health orders that limit D Improved transparency around and standard operating procedures that
an individual’s movement. This HHS/CDC’s authority for, and are not as transparent to the public as
includes the potential costs of litigation requirements and processes related to detailed regulations outlining
and associated activities. payment for care and treatment. requirements.
• New Provisions: § 70.13 Payment Æ Qualitative benefit/cost of final rule Æ Change to baseline as result of final
for Care and Treatment; § 71.30 Payment D Improved transparency and public rule:
for Care and Treatment knowledge of HHS/CDC’s procedures D With the final rule, individuals
Æ Baseline and Current Regulatory and regulatory requirements. under Federal order may be more aware
Provisions: No current explicit Æ Monetized benefit/cost of final rule of the mandatory reassessment of a
regulatory provision. D None. This is a clarification of HHS/ Federal quarantine, isolation, or
D This addition is not expected to CDC’s current practice. (For more conditional release order.
lead to a change in HHS/CDC policy details, please refer to separate RIA Æ Qualitative benefit/cost of final rule
under which HHS/CDC may act as the Appendix) D Improved transparency and
payer of last resort for individuals • New Provisions: § 70.14 understanding of due process
subject to medical examination, Requirements relating to the issuance of protections under a Federal public
quarantine, isolation, and conditional a Federal order for quarantine, isolation, health order.
release under Federal orders. The or conditional release; § 71.37 Æ Monetized benefit/cost of final rule
provisions included in the final rule are Requirements relating to the issuance of D Increased clarity around due
similar to a Memorandum of Agreement a Federal order for quarantine, isolation, process protections may result in fewer
between a number of hospitals and or conditional release resources and time expended by
HHS/CDC. Under the terms of the Æ Baseline and Current Regulatory individuals under orders and HHS/CDC
Memorandum of Agreement, the Provisions: No current explicit in disagreements over HHS/CDC’s
hospital can be reimbursed for incurred regulatory provision authority to issue Federal public health
medical expenses subject to HHS/CDC’s D Without the final rule, HHS/CDC orders that limit an individual’s
discretion, availability of can under current statutory provided by movement. This includes the potential
appropriations, and limited to what a the Public Health Service Act and costs of litigation and associated
hospital would bill Medicare. The regulatory authority under 42 CFR 70.6 activities.
Memorandum of Agreement also and 71.32(a), 71.33 continue to issue • New Provisions: § 70.16 Medical
indicates that HHS/CDC should be the Federal quarantine, isolation, or review of a Federal order for quarantine,
payer of last resort. condition release orders. However, the isolation, or conditional release; § 71.39
D HHS/CDC issued 12 isolation orders issuance of federal orders is Medical review of a Federal order for
between Jan 1, 2005 and May 10, 2016, implemented through internal policies quarantine, isolation, or conditional
which would correspond to an average and standard operating procedures that release
of about 1 order per year over the past are not as transparent to the public as Æ Baseline and Current Regulatory
11.3 years. HHS/CDC has information detailed regulations outlining Provisions: No current explicit
on payments made for 3 of the 12 cases. requirements. regulatory provision.
In most cases, HHS/CDC makes Æ Change to baseline as result of final D Without the final rule, HHS/CDC
payment directly to healthcare facilities, rule can under current statutory authority
sometimes in lieu of payments that D Improved transparency around provided by the Public Health Service
would be made by State or local health HHS/CDC’s authority for, and Act and regulatory authority under 42
departments. Among the three instances requirements and processes related to, CFR 70.6 and 71.32, 71.33 continue to
for which HHS/CDC has some data on the issuance of Federal quarantine, issue Federal quarantine, isolation, or
payments for treatment, care, and isolation, and conditional release conditional release orders. However, the
transportation of individuals under orders. process for a medical review of a
Federal orders: Æ Qualitative benefit/cost of final rule Federal order is outlined in internal
D HHS/CDC’s expected annual D Improved transparency and public policy and standard operating
payments for care and treatment are knowledge of HHS/CDC’s procedures procedures that are not as transparent to
estimated to be between $0 and and regulatory requirements. the public as detailed regulations
$1,000,000 in any given year under the Æ Monetized benefit/cost of final rule outlining requirements.
current baseline. This upper bound cost D None. This is a clarification of HHS/ Æ Change to baseline as result of final
would correspond to a year in which CDC’s current practice. rule:
HHS/CDC would have to incur the costs • New Provisions: § 70.15 Mandatory D With the final rule, individuals
of two patients at $500,000 per patient. reassessment of a Federal order for under Federal order may become aware
This roughly corresponds to the average quarantine, isolation, or conditional of their right to a medical review, and
cost to treat an extremely drug-resistant release; § 71.38 Mandatory reassessment exercise that right, under this due
tuberculosis case (XDR–TB). of a Federal order for quarantine, process provision.
Alternatively, this could represent a isolation, or conditional release Æ Qualitative benefit/cost of final rule
situation in which HHS/CDC may have Æ Baseline and Current Regulatory D Improved transparency and
mstockstill on DSK3G9T082PROD with RULES3

to pay a significant fraction of the total Provisions: No current explicit understanding of due process afforded
costs for one very complicated illness regulatory provision. to individuals under a Federal order
associated with a quarantinable D Without the final rule, HHS/CDC Æ Monetized benefit/cost of final rule
communicable disease not endemic to can under current statutory authority D Increased clarity around due process
the United States (e.g., Ebola). provided by the Public Health Service protections may result in fewer
D HHS/CDC has not incurred any Act and regulatory authority under 42 resources and time expended by
costs for the care and treatment of any CFR 70.6 and 71.32(a), 71.33 continue to individuals under orders and HHS/CDC

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00075 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6964 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

in disagreements over HHS/CDC’s issue Federal quarantine, isolation, or of animals, articles or things from
authority to issue Federal public health conditional release orders. However, the designated foreign countries and places
orders that limit an individual’s process for documenting the into the United States based on existing
movement. This includes the potential administrative record is implemented 42 CFR 71.32(b).
costs of litigation and associated internal policy and standard operating Æ Change to baseline as result of final
activities. procedures that are not as transparent to rule
D One potential change that could the public as a detailed regulation D With the NRPM, there will be less
have an economic effect is the outlining this requirement. confusion about HHS/CDC’s ability to
requirements to appoint medical and Æ Change to baseline as result of final temporarily restrict importations
legal representatives for individuals that rule associated with communicable disease
qualify as ‘‘indigent’’. The status of D The requirement, with which HHS/ risks.
‘‘indigent’’ is self-reported as HHS/CDC CDC is already complying, will clarify Æ Qualitative benefit/cost of final rule
will not require access to an for the public that certain documents D Improved transparency.
individual’s financial records. Those must be retained for the administrative Æ Monetized benefit/cost of final rule
who self-identify as indigent may be record. D Refer to the appendix for an
required to sign an affidavit or Æ Qualitative benefit/cost of final rule analysis of the temporary embargo of
declaration under penalty of perjury D Improved transparency African rodents implemented in 2003.
stating they meet the threshold of at Æ Monetized benefit/cost of final rule
least 200% of the applicable poverty D Not applicable. This is a B. Regulatory Flexibility Act
guidelines. HHS/CDC notes that in codification of an administrative
Under the Regulatory Flexibility Act,
practice it has never denied a request for activity within HHS/CDC.
as amended by the Small Business
a representative. HHS/CDC estimates • New Provisions: § 70.18 Penalties/
Regulatory Enforcement Fairness Act
the cost of providing one medical § 71.2 Penalties
Æ Baseline and Current Regulatory (SBREFA), agencies are required to
representative and one legal
Provision: § 71.2 Penalties. Part 70 analyze regulatory options to minimize
representative based on the average
currently has no penalties provision. significant economic impact of a rule on
hourly wage for physicians and
D Without the final rule, individuals small businesses, small governmental
surgeons ($97.33, occupation code 29–
may not be aware that 18 U.S.C. 3559 units, and small not-for-profit
1060) and lawyers ($65.51, occupation
and 3571 increased the maximum organizations. We have analyzed the
code 23–1011) as reported from the
penalties for violations of regulations costs and benefits of the final rule, as
Bureau of Labor Statistics’ May 2015
under 42 CFR part 70 and part 71. And required by Executive Order 12866, and
National Occupational Employment and
Wage Estimates. Assuming that it takes it may not be clear to individuals that a preliminary regulatory flexibility
about 40 hours of physician time and 40 violating quarantine regulation under 42 analysis that examines the potential
hours of lawyer time per review and an CFR part 70 may result in criminal economic effects of this rule on small
overhead cost multiplier of 100%, the penalties. entities, as required by the Regulatory
expected cost is about $13,000 per Æ Change to baseline as result of final Flexibility Act. Based on the cost benefit
review. HHS/CDC notes that public rule analysis, we expect the rule to have
health orders are issued on average once D With the NRPM, there will be less little or no economic impact on small
per year. The need for HHS/CDC to pay confusion about the maximum criminal entities.
for medical and legal representatives penalties for a violation of regulations C. The Paperwork Reduction Act
will depend on the income level for under 42 CFR 70 and 71.
persons placed under federal orders, but Æ Qualitative benefit/cost of final rule HHS/CDC has determined that this
should not exceed this $13,000 estimate D Improved transparency and final rule contains proposed information
in most years and will be $0 in many alignment with current law under 18 collections that are subject to review by
years. Without the new regulatory U.S.C. 3559 and 3571. the Office of Management and Budget
provision, as part of current practice, Æ Monetized benefit/cost of final rule (OMB) under the Paperwork Reduction
HHS/CDC would still attempt to appoint • No individual or organization has Act of 1995 (PRA) (44 U.S.C. 3501–
legal and medical representatives if been assessed criminal penalties for 3520). A description of these proposed
requested for the medical review by violating these regulations, so provisions is given below with an
individuals unable to afford the cost of monetizing this benefit or cost is not estimate of the annual reporting and
such representation. Thus, relative to feasible. This is simply an effort to align recordkeeping burden. Included in the
current practice, there should be the domestic and foreign quarantine estimate is the time for reviewing
minimal costs associated with this penalties provisions, and updates instructions, searching existing data
provision. outdated regulatory language so that it sources, gathering and maintaining the
• New Provisions: § 70.17 reflects current statutory language data needed, and completing and
Administrative records relating to concerning criminal penalties. reviewing each collection of
Federal quarantine, isolation, or • New Provisions: § 71.63 Suspension information. Comments are invited on
conditional release; § 71.29 of entry of animals, articles, or things the following subjects.
Administrative records relating to from designated foreign countries and • Whether the proposed collection of
Federal quarantine, isolation, or places into the United States information is necessary for the proper
conditional release Æ Baseline and Current Regulatory performance of the functions of HHS/
Æ Baseline and Current Regulatory Provision: § 71.32(b) has previously CDC, including whether the information
mstockstill on DSK3G9T082PROD with RULES3

Provisions: No current explicit been used to justify the temporary will have practical utility.
regulatory provision. embargo of imported African rodents • The accuracy of HHS/CDC’s
D Without the final rule, HHS/CDC prior to the codification of this as a estimate of the burden of the collection
can issue under current statutory requirement in existing 42 CFR 71.56. of information.
provided by the Public Health Service D Without the final rule, individuals • Ways to enhance the quality, utility,
Act and regulatory authority under 42 may not be aware that HHS/CDC’s and clarity of the information to be
CFR 70.6 and 71.32(a), 71.33 continue to authority to temporarily suspend entry collected.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00076 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6965

• Ways to minimize the burden of the interstate quarantine activities (42 CFR In this final rule, CDC is requesting
collection of information on parts 70 and 71) authorize quarantine approval from OMB for 4 non-
respondents, including by using officers and other personnel to inspect substantive changes to OMB Control
information technology. and undertake necessary control Number 0920–0134 Foreign Quarantine
While HHS/CDC currently has measures in order to protect the public Regulations (42 CFR part 71):
approval to collect certain information health. Currently, with the exception of (1) Updating the definition of ‘‘ill
concerning illnesses and travelers under the CDC’s Vessel Sanitation Program, person,’’ which relates to the illness
OMB Control Numbers 0920–0134 inspections are performed only on those reporting requirements under 42 CFR
(Foreign Quarantine Regulations, vessels and aircraft that report illness 71.21(a), (b), and (c) for airlines and
expiration date 05/31/2019) and 0920– before arriving or when illness is vessels arriving into the United States.
0488 (Restrictions on Interstate Travel of discovered upon arrival. Other CDC is updating the definition of ‘‘ill
Persons, expiration date 05/31/2019), inspection agencies assist quarantine person’’ by implementing current
CDC is requesting updates to certain officers in public health risk assessment practice with the anticipated effect of
information collections within these and management of persons, pets, and better facilitating identification of
control numbers. other importations of public health communicable diseases of concern and
In another information collection importance. These practices and quarantinable communicable diseases
request associated with this final rule, procedures ensure protection against the aboard flights and maritime voyages to
CDC is also requesting approval to introduction and spread of the United States, diseases such as
require that airlines and vessels provide communicable diseases into the United measles, viral hemorrhagic fevers, active
certain data elements to CDC, as States with a minimum of tuberculosis, and influenza caused by
described in proposed 71.4 and 71.5, for recordkeeping and reporting as well as novel or re-emergent influenza viruses
the purposes of contact tracing. This a minimum of interference with trade that are causing or have the potential to
information is used to locate and travel. The information collection cause a pandemic. CDC is also including
individuals, both passengers and burden is associated with these a provision to allow the Director to add
crewmembers, who may have been recordkeeping and reporting new symptoms to the definition of ill
exposed to a communicable disease requirements. person to respond to unknown
during travel and to provide them with At present, HHS/CDC has approval communicable diseases that may emerge
appropriate public health follow-up. from OMB to collect certain information as future concerns.
Written comments should be received The final rule updates the current
and impose recordkeeping requirements
within 30 days of the publication of this definition of ill person to better focus on
related to foreign quarantine
final rule. Please send written the signs and symptoms of
responsibilities under OMB Control
comments to CDC Desk Officer, Office of communicable diseases of public health
Number 0920–0134 (expiration 05/31/
Management and Budget, Washington, concern and quarantinable
2019). The specific provisions within 42
DC 20503 or by fax to (202) 395–5806. communicable diseases. The changes
CFR part 71 that include information
define an ill person in the context of the
Proposed Projects collection under are as follows:
medical resources available to the
42 CFR 71.21(a), (b), and (c) Report of operator of an airline or vessel.
(1) Foreign Quarantine Regulations
death and illness. CDC already requests from pilots in
(42 CFR part 71) (OMB Control No.
42 CFR 71.33(c) Report of persons command of aircraft and commanders of
0920–0134)—Nonmaterial/non-
held in isolation or surveillance. vessels several of the symptoms
substantive change—National Center for
42 CFR 71.35 Report of death or included in the revised definition of ill
Emerging, and Zoonotic Infectious
illness on carrier during stay in port. person through publicly available
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC). 42 CFR 71.51 Dogs and cats. guidance to airlines and vessels.
(2) Restrictions on Interstate Travel of 42 CFR 71.52 Turtles, terrapins, Moreover, for airlines, the updated
Persons (42 CFR part 70) (OMB Control tortoises. definition also better aligns with
No. 0920–0488)—Nonmaterial/non- 42. CFR 71.56 African Rodents symptoms reporting guidelines
substantive change—National Center for HHS/CDC has also used its authority published by ICAO in Note 1 to
Emerging, and Zoonotic Infectious under 42 CFR 71.32 to require importers paragraph 8.15 of Annex 9 to the
Diseases (NCEZID), Centers for Disease to submit statements or documentation Convention on International Civil
Control and Prevention (CDC) of non-infectiousness for those items Aviation, and the definition of ‘‘acute
(3) Airline and Vessel and Traveler that may constitute a public health risk gastroenteritis’’ is used by the WHO and
Information Collection (42 CFR and if not rendered non-infectious. is currently included in reporting
71)—New Information Collection Finally, HHS/CDC has approval from guidance from CDC’s Vessel Sanitation
Request—National Center for Emerging, OMB to collect from importers/filers Program. Therefore, CDC does not
and Zoonotic Infectious Diseases certain documents and data elements to anticipate additional burden on airlines
(NCEZID), Centers for Disease Control identify and clear HHS/CDC regulated or vessel operators to respond to these
and Prevention (CDC). imports via the Automated Commercial information collections.
Environment and the International (2) CDC is requesting a change in the
Description Trade Data System using the Document title of the information collection
Section 361 of the Public Health Imaging System and Partner pertaining to reports of death and illness
Service (PHS) Act (42 U.S.C. 264) Government Agency Message Sets. from vessels to CDC. The former title is
authorizes the Secretary of Health and These CDC Partner Government Agency Radio Report of death or illness—illness
mstockstill on DSK3G9T082PROD with RULES3

Human Services to make and enforce Message Sets are currently limited to: reports from ships. CDC sought a change
regulations necessary to prevent the CDC PGA Message Set for Importing to remove ‘‘Radio’’ from the title. This
introduction, transmission, or spread of Cats and Dogs, CDC PGA Message Set change reflects the fact that reports to
communicable diseases from foreign for Importing African Rodents, CDC CDC primarily via means other than
countries into the United States and PGA Message Set for Importing African radio, such as the Maritime Illness and
interstate. Legislation and existing Rodent and All Family Viverridae Death Reporting System, managed by
regulations governing foreign and Products. CDC’s Vessel Sanitation Program. CDC

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00077 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6966 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

did not receive any public comments to Commander or Operator’’ to ‘‘Pilot in There is no burden to respondents
this change, and it is therefore finalized Command.’’ other than the time taken to complete
as proposed. Table 1 below presents estimates of the reports to CDC, maintain
(3) CDC is seeking a change in the title annual burden (in hours) associated recordkeeping of illness aboard vessels
with each reporting and recordkeeping and records of sickness or death in
of a specific information collection
requirement under this OMB control imported cats and dogs, as outlined in
pertaining to reports of gastro-intestinal
number, accounting for the rule the table below. If a cat or dog is ill
illness to CDC. CDC is updating the
changes. upon arrival, or dies prior to arrival, an
definition of ill person and is replacing Description of Respondents.
the term ‘‘gastro-intestinal’’ with ‘‘acute Respondents to this data collection exam is required, the initial exam fee
gastroenteritis’’; therefore, the title include pilots in command of aircraft, may be between $100 and $200. Rabies
change is requested to align with the maritime vessel operators, importers/ testing on a dog that dies may be
definition. filers, and travelers/general public. The between $50 and $100. The expected
(4) CDC is seeking a change in title of nature of the response to HHS/CDC number of ill or dead dogs arriving into
respondents from ‘‘Maritime dictates which forms are completed and the United States for which CDC may
Conveyance Operator’’ to ‘‘Maritime by whom. The total requested burden require an examination is estimated at
Vessel Operator’’ and from ‘‘Airline hours are 82,779. less than 30 per year.

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 0920–0134


Average
No. of burden Total
No. of responses
Type of respondent Regulatory provision or form name per burden
respondents per response hours
respondent (in hours)

Maritime Vessel Operators ......... 42 CFR 71.21(a) Report of illness or death from 2,000 1 2/60 67
ships—Maritime Vessel Illness or Death Investiga-
tion Form/Cumulative Influenza/Influenza-Like Illness
(ILI) Form/Radio report or transcribed email.
Pilot in Command ....................... 42 CFR 71.21 (b) Death/Illness reports from aircraft .... 1,700 1 2/60 57
Maritime Vessel Operators ......... 42 CFR 71.21(c) (MIDRS) Acute Gastro-Enteritis re- 17,000 1 3/60 850
ports (24 and 4 hours before arrival).
Maritime Vessel Operators ......... 42 CFR 71.21 (c) Recordkeeping-Medical logs ............. 17,000 1 3/60 850
Isolated or Quarantined individ- 42 CFR 71.33 Report by persons in isolation or sur- 11 1 3/60 1
uals. veillance.
Maritime Vessel Operators ......... 42 CFR 71.35 Report of death/illness during stay in 5 1 30/60 3
port.
Importer ....................................... 42 CFR 71.51(c)(1), (d)—Valid Rabies Vaccination 245,310 1 15/60 61,328
Certificates.
Importer ....................................... CDC Form 75.37 Notice To Owners And Importers Of 1,400 1 10/60 233
Dogs: Requirement for Dog Confinement.
Importer ....................................... 42 CFR 71.51(c)(i), (ii), and (iii) exemption criteria for 43,290 1 15/60 10,823
the importation of a dog without a rabies vaccination
certificate.
Importer ....................................... 42 CFR 71.51(c)(2), (d) Application for a Permit to Im- 1,400 1 15/60 350
port A Dog Inadequately Immunized Against Rabies.
Importer ....................................... 42 CFR 71.51(b) (3) Dogs/cats: Record of sickness or 20 1 15/60 5
deaths.
Importer/Filer ............................... 42 CFR 71.51_CDC Requested Data on Regulated Im- 30,000 1 15/60 7,500
ports: Domestic Dogs and Cats (PGA Message Set).
Importer ....................................... 42 CFR 71.52(d) Turtle Importation Permits ................. 5 1 30/60 3
Importers ..................................... 42 CFR 71.55, 42 CFR 71.32 Dead Bodies—Death 5 1 1 5
certificates.
Importer ....................................... 42 CFR 71.56 (a)(2) African Rodents—Request for ex- 20 1 1 20
emption.
Importer ....................................... 42 CFR 71.56(a)(iii) Appeal ........................................... 2 1 1 2
Importer/Filer ............................... 42 CFR 71.56 CDC Requested Data on Regulation Im- 60 1 15/60 15
ports: Live African Rodents (PGA Message Set).
Importer/Filer ............................... 42 CFR 71.32 Statements or documentation of non-in- 2,000 1 5/60 167
fectiousness.
Importer/Filer ............................... 42 CFR 71.56, 42 CFR 71.32 CDC Requested Data 2,000 1 15/60 500
on Regulated Imports: Products of African Rodents;
Products of all Family Viverridae (PGA Message
Set).

Total ..................................... ......................................................................................... .................... .................... ................ 82,779


mstockstill on DSK3G9T082PROD with RULES3

The estimates are based on experience account for the potential for increased been missed by airlines or vessels and
to date with current recordkeeping and reports of illness during an outbreak and are reported to CDC after travel.
reporting requirements of 42 CFR part for reports of disease that may have Under this final rule, CDC is also
71, with additional burden included to requesting a nonmaterial/non-

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00078 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6967

substantive change to Restrictions on on which a case or suspected case of in interstate travel, in the event that
Interstate Travel of Persons (42 CFR part communicable disease develops shall, some reports are still made to State
70) (OMB Control No. 0920–0488). The as soon as practicable, notify the local health authorities.
regulations at 42 CFR part 70 are health authority. In addition to the requirement to
intended to prevent the interstate spread Under the final rule, pilots in
report directly to HHS/CDC, HHS/CDC
of disease, and include a requirement command of an aircraft, operating on
behalf of an airline, that submit the ill is updating the definition of ‘‘ill person’’
that the master of vessel or person in
person or death report to HHS/CDC for the purposes of illness reports to
charge of conveyance to report the
under new 70.11 will not be required to HHS/CDC in 42 CFR part 70. HHS/CDC
occurrence on board of communicable
disease. Under this regulation and also submit a report to the local health has, as a matter of agency guidance,
control number, CDC has approval to authority under current 70.4. HHS/CDC communicated with airlines that the
collect the following information: will continue to share public health same current set of required and
• 42 CFR 70.4 Report by the master of information with State and local health requested signs and symptoms of
a vessel or person in charge of departments through electronic disease disease, as well as any death, apply to
conveyance of the incidence of a reporting networks. It is unlikely that domestic as well as international flights.
communicable disease occurring while HHS/CDC would request follow-up This guidance is similar to that of the
in interstate travel. reports of illnesses that are reported to guidelines issued by ICAO under Note
Through this final rule, CDC is adding the local health authorities, unless there 1 to paragraph 8.15 of Annex 9 to the
the provision 70.11 Report of death or was an urgent public health need. Convention on International Civil
illness onboard aircraft operated by Therefore, CDC does not anticipate any Aviation. Therefore, the new proposed
airline, which specifies that the pilot in additional burden to the respondents; definition of ill person should not affect
command of an aircraft operating on however, the accounting for burden in standard practice, and no change in
behalf of an airline who conducts a Table 2 will add 70.11 Report of death burden is anticipated.
commercial passenger flight in interstate or illness onboard aircraft operated by Table 2 below presents estimates of
traffic under a regular schedule shall airline. annual burden (in hours) associated
report as soon as practicable to HHS/ As a result of this final rule, CDC does
with each reporting and recordkeeping
CDC the occurrence onboard of any not anticipate a change in total burden.
requirement under this OMB control
deaths or ill persons among passengers CDC is instead allocating 95% of the
or crew and take such measures as HHS/ reports of illness or death within the number, accounting for the rule
CDC may direct to prevent the potential proposed 70.11 Report of death or changes.
spread of the communicable disease. illness onboard aircraft operated by Description of Respondents
HHS/CDC notes that it is changing the airline. The remains 5% will remain
existing regulatory requirement at 42 within 70.4 Report by the master of a Respondents to this data collection
CFR 70.4, which states that the master vessel or person in charge of include masters of vessels or persons in
of a vessel or person in charge of any conveyance of the incidence of a charge of conveyance and pilots in
conveyance engaged in interstate traffic communicable disease occurring while command of aircraft.

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 0920–0488


Average
No. of burden Total
No. of responses
Type of respondent Form name per burden
respondents per response (in hours)
respondent (in hours)

Pilot in command ........................ 42 CFR 70.11 Report of death or illness onboard air- 190 1 7/60 22
craft operated by airline.
Master of vessel or person in 42 CFR 70.4 Report by the master of a vessel or per- 10 1 7/60 1
charge of conveyance. son in charge of conveyance of the incidence of a
communicable disease occurring while in interstate
travel.

Total ..................................... ......................................................................................... 200 .................... ................ 23

The total requested burden hours are Finally, under this final rule HHS/ communicable disease of public health
23. There is no burden to respondents CDC is requesting approval for a new concern, occurs during travel to the
other than the time taken to complete information collection, Airline and United States and public health follow-
the reports. The estimates are based on Vessel and Traveler Information up is warranted. These proposed
experience to date with current Collection (42 CFR part 71). This provisions are found in 42 CFR 71.4 for
recordkeeping and reporting information collection request airlines and 71.5 for vessels.
requirements of 42 CFR part 70, and accompanies the codification of issuing The ordering of manifests from
take into account the potential for orders to airlines and vessel operators airlines and vessel operators arriving
mstockstill on DSK3G9T082PROD with RULES3

additional burden from increased for the provision to CDC of airline and into the United States is an ongoing
reports of illness during an outbreak and vessel and traveler information (aka activity executed under CDC’s broad
for reports of disease that may have manifests) in the event that a regulatory authority found at 42 CFR
been missed by respondents during quarantinable communicable disease or 71.32 Persons, carriers, and things. To
travel and are reported to CDC by other a communicable disease of public increase transparency with regard to
means. health concern, or a death caused by a CDC’s authorities and manifest order
quarantinable communicable disease or process, CDC is proposing specific

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00079 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6968 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

regulatory provisions that outline the possession, they must be provided to Description of Respondents
particular data elements CDC requires to CDC within 24 hours.
perform contact tracing investigations. Table 3 below presents estimates of Respondents to this data collection
As stated in the final rule, CDC is not annual burden (in hours) associated include the Airline Medical Officer or
mandating the collection of additional with each reporting and recordkeeping Equivalent and a Computer and
data. Only that if the airlines or requirement under this OMB control Information Systems Manager.
maritime operators have the data number, accounting for the final rule
elements listed in 71.4 and 71.5 in their changes.

TABLE 3—ESTIMATE OF ANNUAL BURDEN AIRLINE AND VESSEL MANIFEST ORDERS


Average
No. of burden Total
No. of responses
Type of respondent Form name per burden
respondents per response (in hours)
respondent (in hours)

Airline Medical Officer or Equiva- International TB Manifest Template ............................... 67 1 360/60 402
lent/Computer and Information
Systems Manager.
Airline Medical Officer or Equiva- International Non-TB Manifest Template. ...................... 29 1 360/60 174
lent/Computer and Information
Systems Manager.

Total ..................................... ......................................................................................... 96 .................... ................ 576

The total requested burden hours health regulations, except in the event Quarantine, Quarantinable
included in this final rule is 576. There of a conflict with the exercise of Federal Communicable Disease.
is no burden to respondents other than authority. Other than to restate this For the reasons discussed in the
the time taken to complete the manifest statutory provision, this rulemaking preamble, we amend 42 CFR parts 70
information and send to CDC. The does not alter the relationship between and 71 as follows:
estimates are based on experience to the Federal government and State/local
date with current manifest order governments as set forth in 42 U.S.C. PART 70—INTERSTATE QUARANTINE
process. 264. The longstanding provision on
preemption in the event of a conflict ■ 1. The authority citation for part 70
D. National Environmental Policy Act continues to read as follows:
(NEPA) with Federal authority (42 CFR 70.2) is
left unchanged by this rulemaking. Authority: Secs. 215 and 311 of the Public
HHS/CDC has determined that the Additionally, there are no provisions in Health Service (PHS) Act, as amended (42
amendments to 42 CFR parts 70 and 71 these regulations that impose direct U.S.C. 216, 243) section 361–369, PHS Act,
will not have a significant impact on the compliance costs on State and local as amended (42 U.S.C. 264–272); 31 U.S.C.
human environment. governments. Therefore, HHS/CDC 9701.
E. Executive Order 12988: Civil Justice believes that the rule does not warrant ■ 2. Amend § 70.1 by—
Reform additional consultation under Executive ■ a. Adding in alphabetical order
Order 13132. definitions for ‘‘Airline’’,
HHS/CDC has reviewed this rule
under Executive Order 12988 on Civil G. The Plain Language Act of 2010 ‘‘Apprehension’’, and ‘‘Communicable
Justice Reform and determines that this stage’’;
final rule meets the standard in the Under 63 FR 31883 (June 10, 1998), ■ b. Revising the definition of
Executive Order. Executive Departments and Agencies ‘‘Conditional release’’;
are required to use plain language in all ■ c. Adding in alphabetical order a
F. Executive Order 13132: Federalism proposed and final rules. HHS/CDC definitions for ‘‘Contaminated
Under Executive Order 13132, a received several comments suggesting environment;’’
Federalism analysis is required if a that the proposed regulation was not ■ d. Revising the definition of
rulemaking has Federalism written in plain language and was ‘‘Conveyance’’;
implications, would limit or preempt therefore difficult to understand. Prior ■ e. Adding in alphabetical order
State or local law, or impose substantial to publication, this final rule was definitions for ‘‘Electronic or Internet-
direct compliance costs on State or local reviewed by specialists in health based monitoring’’ and ‘‘Ill person’’;
governments. Under such communication and education to ensure ■ f. Revising the definition of
circumstances, a Federal agency must the content and intention, as well as ‘‘Incubation period’’;
consult with State and local officials. substance, were clear and accurate. ■ g. Adding in alphabetical order a
Federalism implications is defined as definition for ‘‘Indigent’’;
List of Subjects in 70.1, 70.5, 70.6,
having substantial direct effects on State ■ h. Revising the definition of
70.10–70.18, 71.1, 71.2, 71.4, 71.5,
or local governments, on the ‘‘Interstate traffic’’;
mstockstill on DSK3G9T082PROD with RULES3

71.12, 71.20, 71.29, 71.30, 71.36–71.39,


relationship between the national ■ i. Revising the definition of ‘‘Master or
71.63
government and the States, or on the operator’’;
distribution of power and Apprehension, Communicable ■ j. Adding in alphabetical order
responsibilities among the various diseases, Conditional release, CDC, Ill definitions for ‘‘Medical examination’’,
levels of government. Under 42 U.S.C. person, Isolation, Non-invasive, Public ‘‘Medical reviewer’’, ‘‘Non-invasive’’,
264(e), Federal public health regulations health emergency, Public health ‘‘Precommunicable stage’’, ‘‘Public
do not preempt State or local public prevention measures, Qualifying stage, health emergency’’, ‘‘Public health

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00080 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6969

prevention measures’’, ‘‘Qualifying persistent diarrhea, persistent vomiting purpose (except as provided in 14 CFR
stage’’, ‘‘Reasonably believed to be (other than air sickness), headache with 91.13) of air navigation including the
infected, as applied to an individual’’, stiff neck, appears obviously unwell; or piloting of an aircraft, with or without
and ‘‘Representatives’’. (2) Has a fever that has persisted for the right of legal control (as owner,
The additions and revisions read as more than 48 hours; or lessee, or otherwise).
follows: (3) Has symptoms or other indications Medical examination means the
of communicable disease, as the CDC assessment of an individual by an
§ 70.1 General definitions. may announce through posting of a authorized and licensed health worker
Airline means any air carrier or notice in the Federal Register. to determine the individual’s health
foreign air carrier providing air Incubation period means the time status and potential public health risk to
transportation as that term is defined in from the moment of exposure to an others and may include the taking of a
49 U.S.C. 40102(a)(2), (a)(5), and (a)(21). infectious agent that causes a medical history, a physical examination,
Apprehension means the temporary communicable disease until signs and and collection of human biological
taking into custody of an individual or symptoms of the communicable disease samples for laboratory testing as may be
group for purposes of determining appear in the individual or, if signs and needed to diagnose or confirm the
whether Federal quarantine, isolation, symptoms do not appear, the latest date presence or extent of infection with a
or conditional release is warranted. signs and symptoms could reasonably quarantinable communicable disease.
* * * * * be expected to appear. For a Medical reviewer means a physician,
Communicable stage means the stage quarantinable communicable disease, nurse practitioner, or similar medical
during which an infectious agent may incubation period means the professional qualified in the diagnosis
be transmitted either directly or precommunicable stage. and treatment of infectious diseases
indirectly from an infected individual to Indigent means an individual whose who is appointed by the Secretary or
another individual. annual family income is below 200% of Director to conduct medical reviews
Conditional release means the the applicable poverty guidelines under this part and may include an HHS
temporary supervision by a public updated periodically in the Federal or CDC employee, provided that the
health official (or designee) of an Register by the U.S. Department of employee differs from the CDC official
individual or group, who may have been Health and Human Services under the who issued the Federal order for
exposed to a quarantinable authority of 42 U.S.C. 9902(2) or, if no quarantine, isolation, or conditional
communicable disease to determine the income is earned, liquid assets totaling release.
Non-invasive means procedures
risk of disease spread and includes less than 15% of the applicable poverty
conducted by an authorized public
public health supervision through in- guidelines.
health worker (i.e., an individual with
person visits, telephone, or through Interstate traffic (1) Means:
education and training in the field of
electronic or Internet-based monitoring. (i) The movement of any conveyance
public health) or another individual
Contaminated environment means the or the transportation of persons or with suitable public health training and
presence of an infectious agent on a property, including any portion of such includes the visual examination of the
surface, including on inanimate articles, movement or transportation that is ear, nose, and mouth; temperature
or in a substance, including food, water, entirely within a State or possession— assessments using an ear, oral,
or in the air. (ii) From a point of origin in any State cutaneous, or noncontact thermometer,
Conveyance means an aircraft, train, or possession to a point of destination or thermal imaging; and other
road vehicle, vessel (as defined in this in any other State or possession; or procedures not involving the puncture
section) or other means of transport, (iii) Between a point of origin and a or incision of the skin or insertion of an
including military. point of destination in the same State or instrument or foreign material into the
* * * * * possession but through any other State, body or a body cavity excluding the ear,
Electronic or Internet-based possession, or contiguous foreign nose, and mouth.
monitoring means mechanisms or country.
* * * * *
technologies allowing for the temporary (2) Interstate traffic does not include Precommunicable stage means the
public health supervision of an the following: stage beginning upon an individual’s
individual under conditional release (i) The movement of any conveyance earliest opportunity for exposure to an
and may include communication which is solely for the purpose of infectious agent and ending upon the
through electronic mail, SMS texts, unloading persons or property individual entering or reentering the
video or audio conference, webcam transported from a foreign country, or communicable stage of the disease or, if
technologies, integrated voice-response loading persons or property for the individual does not enter the
systems, entry of information into a transportation to a foreign country. communicable stage, the latest date at
Web-based forum, wearable tracking (ii) The movement of any conveyance which the individual could reasonably
technologies, and other mechanisms or which is solely for the purpose of be expected to have the potential to
technologies as determined by the effecting its repair, reconstruction, enter or reenter the communicable stage.
Director or supervising health authority. rehabilitation, or storage. Public health emergency as used in
Ill person means an individual who: * * * * * this part means:
(1) Has a fever (a measured Master or operator with respect to a (1) Any communicable disease event
temperature of 100.4 °F [38 °C] or vessel, means the sea crew member with as determined by the Director with
greater, or feels warm to the touch, or responsibility for vessel operation and either documented or significant
mstockstill on DSK3G9T082PROD with RULES3

gives a history of feeling feverish) navigation, or a similar individual with potential for regional, national, or
accompanied by one or more of the responsibility for a conveyance. international communicable disease
following: Skin rash, difficulty Consistent with the definition of spread or that is highly likely to cause
breathing, persistent cough, decreased ‘‘operate’’ in 14 CFR 1.1, ‘‘operator’’ death or serious illness if not properly
consciousness or confusion of recent means, with respect to aircraft, any controlled; or
onset, new unexplained bruising or person who uses, causes to use, or (2) Any communicable disease event
bleeding (without previous injury), authorizes to use an aircraft, for the described in a declaration by the

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00081 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6970 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

Secretary pursuant to 319(a) of the and an attorney who is knowledgeable revoked, may submit a written appeal to
Public Health Service Act (42 U.S.C. of public health practices, who are the Director (excluding the CDC official
247d (a)); or appointed by the Secretary or Director who denied, suspended, or revoked the
(3) Any communicable disease event and may include HHS or CDC permit). The appeal must be in writing,
the occurrence of which is notified to employees, to assist an indigent state the factual basis for the appeal, and
the World Health Organization, in individual under Federal quarantine, be submitted to the Director (excluding
accordance with Articles 6 and 7 of the isolation, or conditional release with a the CDC official who denied,
International Health Regulations, as one medical review under this part. suspended, or revoked the permit)
that may constitute a Public Health * * * * * within 10 calendar days of the denial,
Emergency of International Concern; or Secretary means the Secretary of suspension, or revocation of the permit.
(4) Any communicable disease event Health and Human Services (HHS) or The Director (excluding the CDC official
the occurrence of which is determined any other officer or employee of that who denied, suspended, or revoked the
by the Director-General of the World Department to whom the authority permit) will issue a written response to
Health Organization, in accordance with involved has been delegated. the appeal within 3 business days,
Article 12 of the International Health which shall constitute final agency
* * * * *
Regulations, to constitute a Public action.
■ 3. Revise § 70.5 to read as follows: (b) The operator of any conveyance
Health Emergency of International
Concern; or § 70.5 Requirements relating to travelers
operating in interstate traffic shall not:
(5) Any communicable disease event under a Federal order of isolation,
(1) Accept for transportation any
for which the Director-General of the quarantine, or conditional release. individual whom the operator knows, or
World Health Organization, in reasonably should know, to be under a
(a) The following provisions are Federal order of isolation, quarantine, or
accordance with Articles 15 or 16 of the applicable to any individual under a
International Health Regulations, has conditional release, unless such an
Federal order of isolation, quarantine, or individual presents a permit issued by
issued temporary or standing conditional release with regard to a
recommendations for purposes of the Director or a copy of the Federal
quarantinable communicable disease or conditional release order authorizing
preventing or promptly detecting the to any individual meeting the
occurrence or reoccurrence of the such travel;
requirements of paragraph (d), (e), or (f) (2) Transport any individual whom
communicable disease. of this section: the operator knows, or reasonably
Public health prevention measures (1) Except as specified under the should know, to be under a Federal
means the assessment of an individual terms of a Federal conditional release order of isolation, quarantine, or
through non-invasive procedures and order, no such individual shall travel in conditional release in violation of any of
other means, such as observation, interstate traffic or from one State or the terms or conditions prescribed in
questioning, review of travel U.S. territory to another without a the travel permit or conditional release
documents, records review, and other written travel permit issued by the order issued by the Director.
non-invasive means, to determine the Director. (c) Whenever a conveyance operating
individual’s health status and potential (2) Requests for a travel permit must in interstate traffic transports an
public health risk to others. state the reasons why the travel is being individual under a Federal order or
Qualifying stage is statutorily defined requested, mode of transportation, the travel permit, the Director may require
(42 U.S.C. 264(d)(2)) to mean: places or individuals to be visited, the that the operator of the conveyance
(1) The communicable stage of a precautions, if any, to be taken to submit the conveyance to inspection,
quarantinable communicable disease; or prevent the potential transmission or sanitary measures, and other measures,
(2) The precommunicable stage of the spread of the communicable disease, as the Director deems necessary to
quarantinable communicable disease, and other information as determined prevent the possible spread of
but only if the quarantinable necessary by the Director to assess the communicable disease.
communicable disease would be likely individual’s health condition and (d) The Director may additionally
to cause a public health emergency if potential for communicable disease apply the provisions in paragraphs (a)
transmitted to other individuals. spread to others. through (c) of this section to individuals
* * * * * (3) The Director will consider all traveling entirely intrastate and to
Reasonably believed to be infected, as requests for a permit and, taking into conveyances that transport such
applied to an individual, means specific consideration the risk of introduction, individuals upon the request of a State
articulable facts upon which a public transmission, or spread of the or local health authority of jurisdiction.
health officer could reasonably draw the communicable disease, may condition The Director shall consider the State or
inference that an individual has been the permit upon compliance with such local health authority’s request for
exposed, either directly or indirectly, to precautionary measures as the Director assistance and taking into consideration
the infectious agent that causes a shall prescribe. The Director shall the risk of introduction, transmission, or
quarantinable communicable disease, as respond to a request for a permit within spread of the communicable disease,
through contact with an infected person 5 business days. grant or deny, in his/her discretion, the
or an infected person’s bodily fluids, a (4) An individual to whom a permit request for assistance.
contaminated environment, or through has been issued shall retain it in his/her (e) The Director may additionally
an intermediate host or vector, and that possession throughout the course of his/ apply the provisions in paragraphs (a)
as a consequence of the exposure, the her authorized travel and comply with through of this section (c) to individuals
mstockstill on DSK3G9T082PROD with RULES3

individual is or may be harboring in the all conditions prescribed therein, traveling interstate or entirely intrastate
body the infectious agent of that including presentation of the permit to and to conveyances that transport such
quarantinable communicable disease. the operators of conveyances, as individuals whenever the Director
Representatives means a physician, required by its terms. makes a determination under 42 CFR
nurse practitioner, or similar medical (5) An individual who has had his/her 70.2 that based on the existence of
professional qualified in the diagnosis request for a permit denied, or who has inadequate local control such measures
and treatment of infectious diseases, had a travel permit suspended or are needed to prevent the spread of any

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00082 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6971

of the communicable diseases from such 70.12 Medical examinations. be conducted when one is required
State or U.S. territory to any other State 70.13 Payment for care and treatment. under this section and shall as part of
or U.S. territory. 70.14 Requirements relating to the issuance the Federal order advise the individual
(f) The Director may additionally of a Federal order for quarantine,
that the medical examination shall be
isolation, or conditional release.
apply the provisions in paragraphs (a) 70.15 Mandatory reassessment of a Federal conducted by an authorized and
through (c) of this section to individuals order for quarantine, isolation, or licensed health worker, and with prior
under a State or local order, or written conditional release. informed consent.
agreement, for quarantine, isolation, or 70.16 Medical review of a Federal order for (c) As part of the medical
conditional release and to conveyances quarantine, isolation, or conditional examination, the Director may require
that may transport such individuals, release. an individual to provide information
upon the request of a State or local 70.17 Administrative records relating to and undergo such testing as may be
health authority of jurisdiction or Federal quarantine, isolation, or reasonably necessary to diagnose or
whenever the Director makes a conditional release. confirm the presence or extent of
70.18 Penalties.
determination of inadequate local infection with a quarantinable
control under 42 CFR 70.2. The Director § 70.10 Public health prevention measures communicable disease.
shall consider the State or local health to detect communicable disease. (d) Individuals reasonably believed to
authority’s request for assistance and (a) The Director may conduct public be infected based on the results of a
taking into consideration the risk of health prevention measures at U.S. medical examination may be isolated, or
introduction, transmission, or spread of airports, seaports, railway stations, bus if such results are inconclusive or
the communicable disease, grant or terminals, and other locations where unavailable, individuals may be
deny, in his/her discretion, the request individuals may gather to engage in quarantined or conditionally released in
for assistance. interstate travel, through non-invasive accordance with this part.
(g) The Director may exempt procedures determined appropriate by § 70.13 Payment for care and treatment.
individuals and non-public the Director to detect the presence of
conveyances, such as ambulances, air (a) The Director may authorize
communicable diseases.
ambulance flights, or private vehicles, payment for the care and treatment of
(b) As part of the public health
from the requirements of this section. individuals subject to medical
prevention measures, the Director may
■ 4. Revise § 70.6 to read as follows:
examination, quarantine, isolation, and
require individuals to provide contact
conditional release, subject to
information such as U.S. and foreign
§ 70.6 Apprehension and detention of paragraphs (b) through (h) of this
addresses, telephone numbers, email
persons with quarantinable communicable section.
addresses, and other contact
diseases. (b) Payment for care and treatment
information, as well as information
(a) The Director may authorize the shall be in the CDC’s sole discretion and
concerning their intended destination,
apprehension, medical examination, subject to the availability of
health status, known or possible
quarantine, isolation, or conditional appropriations.
exposure history, and travel history. (c) Payment shall be secondary to the
release of any individual for the purpose
of preventing the introduction, § 70.11 Report of death or illness onboard obligation of the United States or any
transmission, and spread of aircraft operated by an airline. third-party (i.e., any State or local
quarantinable communicable diseases, (a) The pilot in command of an governmental entity, private insurance
as specified by Executive Order, based aircraft operated by an airline who is carrier, or employer), under any other
upon a finding that: conducting a commercial passenger law or contractual agreement, to pay for
(1) The individual is reasonably flight in interstate traffic under a regular such care and treatment, and shall be
believed to be infected with a schedule shall report as soon as paid by the Director only after all third-
quarantinable communicable disease in practicable to the Director the party payers have made payment in
a qualifying stage and is moving or occurrence onboard of any deaths or the satisfaction of their obligations.
about to move from a State into another presence of ill persons among (d) Payment may include costs for
State; or passengers or crew and take such providing ambulance or other medical
(2) The individual is reasonably measures as the Director may direct to transportation when such services are
believed to be infected with a prevent the potential spread of the deemed necessary by the Director for
quarantinable communicable disease in communicable disease, provided that the individual’s care and treatment.
a qualifying stage and constitutes a such measures do not affect the (e) Payment shall be limited to those
probable source of infection to other airworthiness of the aircraft or the safety amounts the hospital, medical facility,
individuals who may be moving from a of flight operations. or medical transportation service would
State into another State. (b) The pilot in command of an customarily bill the Medicare system
(b) The Director will arrange for aircraft operated by an airline who using the International Classification of
adequate food and water, appropriate reports in accordance with paragraph (a) Diseases, Clinical Modification (ICD–
accommodation, appropriate medical of this section shall be deemed to satisfy CM), and relevant regulations
treatment, and means of necessary the reporting obligation under 42 CFR promulgated by the Centers for
communication for individuals who are 70.4. Medicare and Medicaid Services in
apprehended or held in quarantine or existence at the time of billing.
isolation under this part. § 70.12 Medical examinations. (f) For quarantinable communicable
■ 5. Add §§ 70.10 through 70.18 to read (a) The Director may require an diseases, payment shall be limited to
mstockstill on DSK3G9T082PROD with RULES3

as follows: individual to undergo a medical costs for services and items reasonable
Sec. examination as part of a Federal order and necessary for the care and treatment
* * * * * for quarantine, isolation, or conditional of the individual or group for the time
70.10 Public health prevention measures to release for a quarantinable period beginning when the Director
detect communicable disease. communicable disease. refers the individual or group to the
70.11 Report of death or illness onboard (b) The Director shall promptly hospital or medical facility and ends
aircraft operated by an airline. arrange for the medical examination to when, as determined by the Director,

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00083 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6972 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

the period of apprehension, quarantine, be conducted by an authorized and individual, except that the Federal order
isolation, or conditional release expires. licensed health worker, and with prior may be served by publication or by
(g) For diseases other than those informed consent. posting in a conspicuous location if the
described in paragraph (f) of this (b) A Federal order authorizing Federal order is applicable to a group of
section, such payment shall be limited quarantine, isolation, or conditional individuals and individual service
to costs for services and items release shall be served on the individual would be impracticable.
reasonable and necessary for care and no later than 72 hours after the (g) The Director shall arrange for
treatment of the individual for the time individual has been apprehended, translation or interpretation services of
period that begins when the Director except that the Federal order may be the Federal order as needed.
refers the individual to the hospital or published or posted in a conspicuous
location if the Federal order is § 70.16 Medical review of a Federal order
medical facility and ends when the
for quarantine, isolation, or conditional
individual’s condition is diagnosed, as applicable to a group of individuals and release.
determined by the Director, as an illness individual service would be
impracticable. (a) The Director shall, as soon as
other than a quarantinable
(c) The Director shall arrange for practicable, arrange for a medical review
communicable disease.
(h) For ambulance or other medical translation or interpretation services of upon a request by an individual under
transportation, payment shall be limited the Federal order as needed. Federal quarantine, isolation, or
to the costs for such services and other (d) Nothing in this section shall affect conditional release.
the constitutional or statutory rights of (b) A request for a medical review
items reasonable and necessary for the
individuals to obtain judicial review of may only occur after the Director’s
individual’s safe medical transport.
their Federal detention. mandatory reassessment under section
§ 70.14 Requirements relating to the 70.15 and following the service of a
issuance of a Federal order for quarantine, § 70.15 Mandatory reassessment of a Federal order continuing or modifying
isolation, or conditional release. Federal order for quarantine, isolation, or the quarantine, isolation, or conditional
(a) A Federal order authorizing conditional release. release.
quarantine, isolation, or conditional (a) The Director (excluding the CDC (c) The medical review shall be for the
release shall be in writing, signed by the official who issued the quarantine, purpose of ascertaining whether the
Director, and contain the following isolation, or conditional release order) Director has a reasonable belief that the
information: shall reassess the need to continue the individual is infected with a
(1) The identity of the individual or quarantine, isolation, or conditional quarantinable communicable disease in
group subject to the order; release of an individual no later than 72 a qualifying stage.
(2) The location of the quarantine or hours after the service of the Federal (d) The Director shall notify the
isolation or, in the case of conditional order. individual in writing of the time and
release, the entity to who and means by (b) As part of the reassessment, the place of the medical review.
which the individual shall report for Director (excluding the CDC official (e) The Director (excluding the CDC
public health supervision; who issued the quarantine, isolation, or official who issued the quarantine,
(3) An explanation of the factual basis conditional release order) shall review isolation, or conditional release order)
underlying the Director’s reasonable all records considered in issuing the shall designate a medical reviewer to
belief that the individual is in the Federal order, including travel records, review the medical or other evidence
qualifying stage of a quarantinable records evidencing exposure or presented at the review, make medical
communicable disease; infection with a quarantinable or other findings of fact, and issue a
(4) An explanation of the factual basis communicable disease, as well as any recommendation concerning whether
underlying the Director’s reasonable relevant new information. the Federal order for quarantine,
belief that the individual is moving or (c) As part of the reassessment, and isolation, or conditional release should
about to move from one State into where applicable, the Director be rescinded, continued, or modified.
another or constitutes a probable source (excluding the CDC official who issued (f) The individual under Federal
of infection to others who may be the quarantine, isolation, or conditional quarantine, isolation, or conditional
moving from one State into another; release order) shall consider and make release may authorize an advocate (e.g.,
(5) An explanation that the Federal a determination regarding whether less an attorney, family member, or
order will be reassessed no later than 72 restrictive alternatives would physician) at his or her own expense to
hours after it has been served and an adequately serve to protect the public submit medical or other evidence and,
explanation of the medical review of the health. in the medical reviewer’s discretion, be
Federal order pursuant to this part, (d) At the conclusion of the allowed to present a reasonable number
including the right to request a medical reassessment, the Director (excluding of medical experts. The Director
review, present witnesses and testimony the CDC official who issued the (excluding the CDC official who issued
at the medical review, and to be quarantine, isolation, or conditional the quarantine, isolation, or conditional
represented at the medical review by release order) shall promptly issue and release order) shall appoint
either an advocate (e.g., an attorney, serve a written Federal order directing representatives at government expense
family member, or physician) at the that the quarantine, isolation, or to assist the individual for purposes of
individual’s own expense, or, if conditional release be continued, the medical review upon a request and
indigent, to have representatives modified, or rescinded. certification, under penalty of perjury,
appointed at the government’s expense; (e) In the event that the Director by that individual that he or she is
mstockstill on DSK3G9T082PROD with RULES3

(6) An explanation of the criminal orders that the quarantine, isolation, or indigent.
penalties for violating a Federal order of conditional release be continued or (g) Prior to the convening of the
quarantine, isolation, or conditional modified, the written Federal order review, the individual or his/her
release; and shall explain the process for requesting authorized advocate or representatives
(7) An explanation that if a medical a medical review under this part. shall be provided a reasonable
examination is required as part of the (f) The Director’s written Federal opportunity to examine the available
Federal order that the examination will order shall be promptly served on the medical and other records involved in

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00084 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6973

the medical review that pertain to that release be continued, modified, or isolation, or conditional release order,
individual. rescinded. In the event that the Director or any subsequent Federal orders;
(h) The Director shall take such (excluding the CDC official who issued (3) Records submitted by the
measures that he/she determines to be the quarantine, isolation, or conditional individual under quarantine, isolation,
reasonably necessary to allow an release order) continues or modifies the or conditional release, or by an
individual under Federal quarantine or Federal quarantine, isolation, or authorized advocate or representatives,
isolation to communicate with any conditional release, the Director’s as part of a request for rescission of the
authorized advocate or representatives written order shall include a statement Federal quarantine, isolation, or
in such a manner as to prevent the that the individual may request that the conditional release or as part of a
possible spread of the quarantinable Director rescind the Federal quarantine, medical review;
communicable disease. isolation, or conditional release, but (4) The written findings and report of
(i) The medical reviewer may order a based only on a showing of significant, the medical reviewer, including any
medical examination of an individual new or changed facts or medical transcripts of the medical review and
when, in the medical reviewer’s evidence that raise a genuine issue as to any written objections submitted by the
professional judgment, such an whether the individual should continue individual under Federal quarantine,
examination would assist in assessing to be subject to Federal quarantine, isolation, or conditional release, or by
the individual’s medical condition. isolation, or conditional release. The any authorized advocate or
(j) As part of the review, and where written Federal order shall be promptly representatives;
applicable, the medical reviewer shall served on the individual and the (b) An individual subject to a Federal
consider and accept into the record individual’s authorized advocate or public health order shall upon request
evidence concerning whether less representatives, except that the Federal be served with a copy of his or her own
restrictive alternatives would order may be served by publication or administrative record in its entirety.
adequately serve to protect public by posting in a conspicuous location if
health. § 70.18 Penalties.
applicable to a group of individuals and (a) Persons in violation of this part are
(k) The medical review shall be
individual service would be subject to a fine of no more than
conducted by telephone, audio or video
impracticable. $100,000 if the violation does not result
conference, or through other means that
(n) The Director’s written order shall in a death or one year in jail, or both,
the medical reviewer determines in his/
not constitute final agency action until or a fine of no more than $250,000 if the
her discretion are practicable for
it has been served on the individual and violation results in a death or one year
allowing the individual under
the individual’s authorized advocate or in jail, or both, or as otherwise provided
quarantine, isolation, or conditional
representatives, or alternatively, if by law.
release to participate in the medical
applicable to a group of individuals and (b) Violations by organizations are
review.
(l) At the conclusion of the review, individual service would be subject to a fine of no more than
the medical reviewer shall, based upon impracticable, it is published or posted. $200,000 per event if the violation does
his or her review of the facts and other (o) The Director (excluding the CDC not result in a death or $500,000 per
evidence made available during the official who issued the quarantine, event if the violation results in a death
medical review, issue a written report to isolation, or conditional release order) or as otherwise provided by law.
the Director (excluding the CDC official may order the consolidation of one or
who issued the quarantine, isolation, or more medical reviews if the number of PART 71—FOREIGN QUARANTINE
conditional release order) concerning individuals or other factors makes the
holding of individual medical reviews ■ 6. The authority citation for part 71
whether, in the medical reviewer’s continues to read as follows:
professional judgment, the Federal impracticable.
(p) The Director may issue additional Authority: Secs. 215 and 311 of the Public
quarantine, isolation, or conditional
instructions as may be necessary or Health Service (PHS) Act, as amended (42
release should be rescinded, continued, U.S.C. 216, 243) section 361–369, PHS Act,
desirable governing the conduct of
or modified. The written report shall as amended (42 U.S.C. 264–272).
medical reviews.
include a determination regarding
(q) The Director shall arrange for ■ 7. Amend § 71.1, paragraph (b), by—
whether less restrictive alternatives
translation or interpretation services as ■ a. Adding in alphabetical order
would adequately serve to protect definitions for ‘‘Airline’’ and
needed for purposes of this section.
public health. The written report shall ‘‘Apprehension’’;
be served on the individual and the § 70.17 Administrative records relating to ■ b. Revising the definition of
individual’s authorized advocate or Federal quarantine, isolation, or conditional ‘‘Commander’’;
representatives. release. ■ c. Adding in alphabetical order
(m) The Director (excluding the CDC (a) The administrative record of an definitions for ‘‘Conditional release’’,
official who issued the quarantine, individual under Federal quarantine, ‘‘Contaminated environment’’, and
isolation, or conditional release order) isolation, or conditional release shall, ‘‘Electronic or Internet-based
shall, as soon as practicable, review the where applicable, consist of the monitoring’’;
written report and any objections that following: ■ d. Revising the definition of ‘‘Ill
may be submitted by the individual or (1) The Federal order authorizing person’’;
the individual’s authorized advocate or quarantine, isolation, or conditional ■ e. Adding in alphabetical order a
representatives that contest the findings release, including any subsequent definition for ‘‘Indigent’’;
and recommendation contained in the Federal orders continuing or modifying ■ f. Revising the definition of
mstockstill on DSK3G9T082PROD with RULES3

medical reviewer’s written report. Upon the quarantine, isolation or conditional ‘‘International voyage’’;
conclusion of the review, the Director release; ■ g. Adding in alphabetical order
(excluding the CDC official who issued (2) Records of any available medical, definitions for ‘‘Master or operator’’,
the quarantine, isolation, or conditional laboratory, or other epidemiologic ‘‘Medical examination’’, ‘‘Medical
release order) shall promptly issue a information that are in the agency’s reviewer’’, ‘‘Non-invasive’’, ‘‘Public
written Federal order directing that the possession and that were considered in health prevention measures’’,
quarantine, isolation, or conditional issuing the Federal quarantine, ‘‘Representatives’’, and ‘‘Secretary’’.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00085 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6974 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

The additions and revisions read as (ii) Who if onboard a vessel: the right of legal control (as owner,
follows: (A) Has a fever (a measured lessee, or otherwise).
temperature of 100.4 °F [38 °C] or Medical examination means the
§ 71.1 General definitions. greater; or feels warm to the touch; or assessment of an individual by an
* * * * * gives a history of feeling feverish) authorized and licensed health worker
(b) * * * accompanied by one or more of the to determine the individual’s health
Airline means any air carrier or following: Skin rash, difficulty status and potential public health risk to
foreign air carrier providing air breathing or suspected or confirmed others and may include the taking of a
transportation, as that term is defined in pneumonia, persistent cough or cough medical history, a physical examination,
49 U.S.C. 40102(a)(2), (a)(5), and (a)(21). with bloody sputum, decreased and collection of human biological
Apprehension means the temporary consciousness or confusion of recent samples for laboratory testing as may be
taking into custody of an individual or onset, new unexplained bruising or needed to diagnose or confirm the
group for purposes of determining bleeding (without previous injury), presence or extent of infection with a
whether quarantine, isolation, or persistent vomiting (other than sea quarantinable communicable disease.
conditional release is warranted. sickness), headache with stiff neck; or Medical reviewer means a physician,
* * * * * (B) Has a fever that has persisted for nurse practitioner, or similar medical
Commander means the pilot in more than 48 hours; or professional qualified in the diagnosis
command of an aircraft as defined in 14 (C) Has acute gastroenteritis, which and treatment of infectious diseases
CFR 1.1. means either diarrhea, defined as three who is appointed by the Secretary or
* * * * * or more episodes of loose stools in a 24- Director to conduct medical reviews
Conditional release means hour period or what is above normal for under this part and may include an HHS
surveillance as defined under this part the individual, or vomiting or CDC employee, provided that the
and includes public health supervision accompanied by one or more of the employee differs from the CDC official
through in-person visits by a health following: One or more episodes of who issued the Federal order for
official or designee, telephone, or loose stools in a 24-hour period, quarantine, isolation, or conditional
through any electronic or internet-based abdominal cramps, headache, muscle release.
means as determined by the Director. aches, or fever (temperature of 100.4 °F * * * * *
Contaminated environment means the [38 °C] or greater); or Non-invasive means procedures
presence of an infectious agent on a (D) Has symptoms or other conducted by an authorized public
surface, including on inanimate articles, indications of communicable disease, as health worker (i.e., an individual with
or in a substance, including food, water, the Director may announce through education and training in the field of
or in the air. posting of a notice in the Federal public health) or another individual
* * * * * Register. with suitable public health training and
Electronic or internet-based Indigent means an individual whose includes the visual examination of the
monitoring means mechanisms or annual family income is below 200% of ear, nose, and mouth; temperature
technologies allowing for the temporary the applicable poverty guidelines assessments using an ear, oral,
public health supervision of an updated periodically in the Federal cutaneous, or noncontact thermometer,
individual under conditional release Register by the U.S. Department of or thermal imaging; and other
and may include communication Health and Human Services under the procedures not involving the puncture
through electronic mail, SMS texts, authority of 42 U.S.C. 9902(2) or, if no or incision of the skin or insertion of an
video or audio conference, webcam income is earned, liquid assets totaling instrument or foreign material into the
technologies, integrated voice-response less than 15% of the applicable poverty body or a body cavity excluding the ear,
systems, entry of information into a guidelines. nose, and mouth.
web-based forum, wearable tracking * * * * * * * * * *
technologies, and other mechanisms or International voyage means: Public health prevention measures
technologies as determined by the (i) In the case of a carrier, a voyage means the assessment of an individual
Director. between ports or airports of more than through non-invasive procedures and
Ill person means an individual: one country, or a voyage between ports other means, such as observation,
(i) Who if onboard an aircraft: or airports of the same country if the questioning, review of travel
(A) Has a fever (a measured ship or aircraft stopped in any other documents, records review, and other
temperature of 100.4 °F [38 °C] or country on its voyage; or non-invasive means, to determine the
greater, or feels warm to the touch, or (ii) In the case of a person, a voyage individual’s health status and potential
gives a history of feeling feverish) involving entry into a country other public health risk to others.
accompanied by one or more of the than the country in which that person Representatives means a physician,
following: Skin rash, difficulty begins his/her voyage. nurse practitioner, or similar medical
breathing, persistent cough, decreased * * * * * professional qualified in the diagnosis
consciousness or confusion of recent Master or operator with respect to a and treatment of infectious diseases,
onset, new unexplained bruising or vessel, means the sea crew member with and an attorney who is knowledgeable
bleeding (without previous injury), responsibility for vessel operation and of public health practices, who are
persistent diarrhea, persistent vomiting navigation, or a similar individual with appointed by the Secretary or Director
(other than air sickness), headache with responsibility for a carrier. Consistent and may include HHS or CDC
mstockstill on DSK3G9T082PROD with RULES3

stiff neck, appears obviously unwell; or with the definition of ‘‘operate’’ in 14 employees, to assist an indigent
(B) Has a fever that has persisted for CFR 1.1, ‘‘operator’’ means, with respect individual under Federal quarantine,
more than 48 hours; or to aircraft, any person who uses, causes isolation, or conditional release with a
(C) Has symptoms or other indications to use or authorizes to use aircraft, for medical review under this part.
of communicable disease, as the the purpose (except as provided in 14 * * * * *
Director may announce through posting CFR 91.13) of air navigation including Secretary means the Secretary of
of a notice in the Federal Register. the piloting of aircraft, with or without Health and Human Services (HHS) or

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00086 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6975

any other officer or employee of that (12) Flight number; (14) Embarkation port and date;
Department to whom the authority (13) City of departure; (15) Disembarkation port and date;
involved has been delegated. (14) Departure date and time; (16) All port stops; and
* * * * * (15) City of arrival; (17) Cabin number.
(16) Arrival date and time; and (c) No later than February 21, 2019,
■ 8. Revise § 71.2 to read as follows:
(17) Seat number. the Secretary or Director will publish
§ 71.2 Penalties. (c) No later than February 18, 2019, and seek comment on a report
(a) Persons in violation of this part are the Secretary or Director will publish evaluating the burden of this section on
subject to a fine of no more than and seek comment on a report affected entities and duplication of
$100,000 if the violation does not result evaluating the burden of this section on activities in relation to mandatory
in a death or one year in jail, or both, affected entities and duplication of passenger data submissions to DHS/
or a fine of no more than $250,000 if the activities in relation to mandatory CBP. The report will specifically
violation results in a death or one year passenger data submissions to DHS/ recommend actions that streamline and
in jail, or both, or as otherwise provided CBP. The report will specifically facilitate use and transmission of any
by law. (b) Violations by organizations recommend actions that streamline and duplicate information collected.
are subject to a fine of no more than facilitate use and transmission of any ■ 11. Add § 71.20 to subpart C to read
$200,000 per event if the violation does duplicate information collected. as follows:
not result in a death or $500,000 per ■ 10. Add § 71.5 to subpart A to read as
§ 71.20 Public health prevention measures
event if the violation results in a death follows:
to detect communicable disease.
or as otherwise provided by law.
§ 71.5 Requirements relating transmission (a) The Director may conduct public
■ 9. Add 71.4 to subpart A to read as of vessel passenger, crew, and voyage health prevention measures, at U.S.
follows: information for public health purposes. ports of entry or other locations, through
§ 71.4 Requirements relating transmission (a) The operator of any vessel carrying non-invasive procedures as defined in
of airline passenger, crew and flight 13 or more passengers (excluding crew) section 71.1 to detect the potential
information for public health purposes. and, which is not a ferry as defined presence of communicable diseases.
(a) Any airline with a flight arriving under 46 U.S.C. 2101 and U.S. Coast (b) As part of the public health
into the United States, including any Guard (USCG) regulations (46 CFR 2.10– prevention measures, the Director may
intermediate stops between the flight’s 25), shall make the data elements in require individuals to provide contact
origin and final destination, shall make paragraph (b) of this section available to information such as U.S. and foreign
the data elements in paragraph (b) of the Director for passengers or crew who, addresses, telephone numbers, email
this section available to the Director for as determined by the Director, may be addresses, and other contact
passengers or crew who, as determined at risk of exposure to a communicable information, as well as information
by the Director, may be at risk of disease, to the extent that such data are concerning their intended destination,
exposure to a communicable disease, to already in the operator’s possession, health status, known or possible
the extent that such data are already within 24 hours of an order by the exposure history, and travel history.
available and maintained by the airline, Director and in a format available and ■ 12. Add §§ 71.29 and 71.30 to subpart
within 24 hours of an order by the acceptable to both the operator and the D to read as follows:
Director and in a format available and Director.
(b) The data elements referred to in § 71.29 Administrative records relating to
acceptable to both the airline and the quarantine, isolation, or conditional release.
Director. paragraph (a) of this section include:
(b) The data elements referred to in (1) Full name (last, first, and, if (a) The administrative record of an
paragraph (a) of this section include: available middle or others); individual under quarantine, isolation,
(1) Full name (last, first, and, if (2) Date of birth; or conditional release shall, where
available, middle or others); (3) Sex; applicable, consist of the following:
(2) Date of birth; (4) Country of residence; (1) The Federal order authorizing
(3) Sex; (5) If a passport is required: Passport quarantine, isolation, or conditional
(4) Country of residence; number, passport country of issuance, release, including any subsequent
(5) If a passport is required: Passport and passport expiration date; Federal orders continuing or modifying
number, passport country of issuance, (6) If a travel document other than a the quarantine, isolation or conditional
and passport expiration date; passport is required: Travel document release;
(6) If a travel document other than a type, travel document number, travel (2) Records of any available medical,
passport is required: Travel document document country of issuance and laboratory, or other epidemiologic
type, travel document number, travel travel document expiration date; information that are in the agency’s
document country of issuance and (7) Address while in the United States possession and that were considered in
travel document expiration date; (number and street, city, State, and zip issuing the Federal quarantine,
(7) Address while in the United States code), except that U.S. citizens and isolation, or conditional release order,
(number and street, city, State, and zip lawful permanent residents will provide or any subsequent Federal orders;
code), except that U.S. citizens and address of permanent residence in the (3) Records submitted by the
lawful permanent residents will provide United States (number and street, city, individual under quarantine, isolation,
address of permanent residence in the State, and zip code; as applicable); or conditional release, or by an
U.S. (number and street, city, State, and (8) Primary contact phone number to authorized advocate or representatives,
mstockstill on DSK3G9T082PROD with RULES3

zip code); include country code; as part of a request for rescission of the
(8) Primary contact phone number to (9) Secondary contact phone number quarantine, isolation, or conditional
include country code; to include country code; release or as part of a medical review;
(9) Secondary contact phone number (10) Email address; (4) The written findings and report of
to include country code; (11) Vessel operator; the medical reviewer, including any
(10) Email address; (12) Vessel name; transcripts of the medical review and
(11) Airline name; (13) Voyage number; any written objections submitted by the

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00087 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6976 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

individual under Federal quarantine, other than a quarantinable that an individual provide information
isolation, or conditional release, or by communicable disease. and undergo such testing, as may be
an authorized advocate or (h) For ambulance or other medical reasonably necessary, to diagnose or
representatives; transportation, payment shall be limited confirm the presence, absence, or extent
(b) An individual subject to a Federal to the costs for such services and other of infection with a quarantinable
public health order shall, upon request, items reasonable and necessary for the communicable disease.
be served with a copy of his or her own safe medical transport of the individual. (d) Individuals reasonably believed to
administrative record in its entirety. ■ 13. Amend § 71.33 by revising be infected, based on the results of a
paragraphs (a) and (c) to read as follows: medical examination, may be isolated,
§ 71.30 Payment for care and treatment.
or if such results are inconclusive or
(a) The Director may authorize § 71.33 Persons: Isolation and
surveillance. unavailable, individuals may be
payment for the care and treatment of quarantined or conditionally released in
individuals subject to medical (a) The Director will arrange for
accordance with this part.
examination, quarantine, isolation, and adequate food and water, appropriate
conditional release, subject to accommodation, appropriate medical § 71.37 Requirements relating to the
paragraphs (b) through (h) of this treatment, and means of necessary issuance of a Federal order for quarantine,
section. communication for persons who are isolation, or conditional release.
(b) Payment for care and treatment apprehended or held in isolation or (a) A Federal order authorizing
shall be in the Director’s sole discretion quarantine under this subpart. quarantine, isolation, or conditional
and subject to the availability of * * * * * release shall be in writing, signed by the
appropriations. (c) Every person who is placed under Director, and contain the following
(c) Payment shall be secondary to the surveillance by authority of this subpart information:
obligation of the United States or any shall, during the period of surveillance: (1) The identity of the individual or
third-party (including any State or local (1) Give information relative to his/ group subject to the order;
governmental entity, private insurance her health and his/her intended (2) The location of the quarantine or
carrier, or employer), under any other destination and submit to surveillance, isolation or, in the case of conditional
law or contractual agreement, to pay for including electronic and internet-based release, the entity to who and means by
such care and treatment, and shall be monitoring as required by the Director which the individual shall report for
paid by the Director only after all third- or by the State or local health public health supervision;
party payers have made payment in department having jurisdiction over the (3) An explanation of the factual basis
satisfaction of their obligations. areas to be visited, and report for such underlying the Director’s reasonable
medical examinations as may be belief that the individual is exposed to
(d) Payment may include costs for
required. or infected with a quarantinable
providing ambulance or other medical (2) Inform the Director prior to
transportation when such services are communicable disease;
departing the United States or prior to
deemed necessary by the Director for (4) An explanation that the Federal
traveling to any address other than that
the individual’s care and treatment. order will be reassessed no later than 72
stated as the intended destination.
(e) Payment shall be limited to those hours after it has been served and an
amounts the hospital, medical facility, * * * * * explanation of the medical review of the
or medical transportation service would ■ 14. Add §§ 71.36 through 71.39 to Federal order pursuant to this part,
customarily bill the Medicare system subpart D to read as follows: including the right to request a medical
Sec. review, present witnesses and testimony
using the International Classification of
Diseases, Clinical Modification (ICD– * * * * * at the medical review, and to be
CM), and relevant regulations 71.36 Medical examinations. represented at the medical review by
71.37 Requirements relating to the issuance either an advocate (e.g., an attorney,
promulgated by the Centers for of a Federal order for quarantine,
Medicare and Medicaid Services in isolation, or conditional release. family member, or physician) at the
existence at the time of billing. 71.38 Mandatory reassessment of a Federal individual’s own expense, or, if
(f) For quarantinable communicable order for quarantine, isolation, or indigent, to have representatives
diseases, payment shall be limited to conditional release (surveillance). appointed at the government’s expense;
costs for services and items reasonable 71.39 Medical review of a Federal order for (5) An explanation of the criminal
and necessary for the care and treatment quarantine, isolation, or conditional penalties for violating a Federal order of
release.
of the individual for the time period quarantine, isolation, or conditional
beginning when the Director refers the § 71.36 Medical examinations. release; and
individual to the hospital or medical (a) The Director may require that an (6) An explanation that if a medical
facility and ends when, as determined individual arriving into the United examination is required as part of the
by the Director, the period of States undergo a medical examination Federal order that the examination will
apprehension, quarantine, isolation, or as part of a Federal order for quarantine, be conducted by an authorized and
conditional release expires. isolation, or conditional release. licensed health worker, and with prior
(g) For diseases other than those (b) The Director shall promptly informed consent.
described in paragraph (f) of this arrange for the medical examination to (b) A Federal order authorizing
section, such payment shall be limited be conducted when one is required quarantine, isolation, or conditional
to costs for services and items under this section and shall as part of release shall be served on the individual
mstockstill on DSK3G9T082PROD with RULES3

reasonable and necessary for care and the Federal order advise the individual no later than 72 hours after the
treatment of the individual for the time that the medical examination shall be individual has been apprehended,
period that begins when the Director conducted by an authorized and except that the Federal order may be
refers the individual to the hospital or licensed health worker, and with prior published or posted in a conspicuous
medical facility and ends when the informed consent. location if applicable to a group of
individual’s condition is diagnosed, as (c) As part of the medical individuals and individual service
determined by the Director, as an illness examination, the Director may require would be impracticable.

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00088 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations 6977

(c) The Director shall arrange for upon a request by an individual under consider and accept into the record
translation or interpretation services of Federal quarantine, isolation, or evidence concerning whether less
the Federal order as needed. conditional release. restrictive alternatives would
(d) Nothing in these regulations shall (b) A request for a medical review adequately serve to protect public
affect the constitutional or statutory may only occur after the Director’s health.
rights of individuals to obtain judicial mandatory reassessment under 71.38 (k) The medical review shall be
review of their federal detention. and following the issuance and service conducted by telephone, audio or video
of a Federal order continuing or conference, or through other means that
§ 71.38 Mandatory reassessment of a modifying the quarantine, isolation, or the medical reviewer determines in his/
Federal order for quarantine, isolation, or
conditional release (surveillance). conditional release. her discretion are practicable for
(c) The medical review shall be for the allowing the individual under
(a) The Director (excluding the CDC purpose of ascertaining whether the quarantine, isolation, or conditional
official who issued the quarantine, Director has a reasonable belief that the release to participate in the medical
isolation, or conditional release order) individual is infected with a review.
shall reassess the need to continue the quarantinable communicable disease. (l) At the conclusion of the review,
quarantine, isolation, or conditional (d) The Director shall notify the the medical reviewer shall, based upon
release of an individual no later than 72 individual in writing of the time and his or her review of the facts and other
hours after the service of the Federal place of the medical review. evidence made available during the
order. (e) The Director (excluding the CDC medical review, issue a written report to
(b) As part of the reassessment, the official who issued the quarantine, the Director (excluding the CDC official
Director (excluding the CDC official isolation, or conditional release order) who issued the quarantine, isolation, or
who issued the quarantine, isolation, or shall designate a medical reviewer to conditional release order) concerning
conditional release order) shall review review the medical or other evidence whether, in the medical reviewer’s
all records considered in issuing the presented at the review, make medical professional judgment, the Federal
Federal order, including travel records, or other findings of fact, and issue a quarantine, isolation, or conditional
records evidencing exposure or
recommendation concerning whether release should continue. The written
infection with a quarantinable
the Federal order for quarantine, report shall include a determination
communicable disease, as well as any
isolation, or conditional release should regarding whether less restrictive
relevant new information.
be rescinded, continued, or modified. alternatives would adequately serve to
(c) As part of the reassessment, and
(f) The individual subject to Federal protect public health. The written report
where applicable, the Director
quarantine, isolation, or conditional shall be served on the individual and
(excluding the CDC official who issued
release may authorize an advocate (e.g., the individual’s authorized advocate or
the quarantine, isolation, or conditional
an attorney, family member, or representatives.
release order) shall consider and make (m) The Director (excluding the CDC
physician) at his or her own expense to
a determination regarding whether less official who issued the quarantine,
submit medical or other evidence and,
restrictive alternatives would isolation, or conditional release order)
in the medical reviewer’s discretion, be
adequately serve to protect the public shall, as soon as practicable, review the
allowed to present a reasonable number
health. written report and any objections that
(d) At the conclusion of the of medical experts. The Director shall
appoint representatives at government may be submitted by the individual or
reassessment, the Director (excluding
expense to assist the individual for the individual’s advocate or
the CDC official who issued the representatives that contest the findings
quarantine, isolation, or conditional purposes of the medical review upon a
request and certification, under penalty and recommendation contained in the
release order) shall promptly issue a medical reviewer’s written report. Upon
written Federal order directing that the of perjury, by that individual that he/
she is indigent. conclusion of the review, the Director
quarantine, isolation, or conditional (excluding the CDC official who issued
(g) Prior to the convening of the
release be continued, modified, or the quarantine, isolation, or conditional
review, the individual or his/her
rescinded. release order) shall promptly issue a
(e) In the event that the Director authorized advocate or representatives
shall be provided a reasonable written Federal order directing that the
orders that the quarantine, isolation, or quarantine, isolation, or conditional
conditional release be continued or opportunity to examine the available
medical and other records involved in release be continued, modified, or
modified, the written Federal order rescinded. In the event that the Director
shall explain the process for requesting the medical review pertaining to that
individual. (excluding the CDC official who issued
a medical review under this part. the quarantine, isolation, or conditional
(f) The Director’s written Federal (h) The Director shall take such
measures that he/she determines to be release order) continues or modifies the
order shall be promptly served on the
reasonably necessary to allow an Federal quarantine, isolation, or
individual, except that the Federal order
individual under Federal quarantine or conditional release, the Director’s
may be served by publication or by written order shall include a statement
posting in a conspicuous location if isolation to communicate with any
authorized advocate or representatives that the individual may request that the
applicable to a group of individuals and Director rescind the Federal quarantine,
individual service would be in such a manner as to prevent the
possible spread of the quarantinable isolation, or conditional release, but
impracticable. based only on a showing of significant,
(g) The Director shall arrange for communicable disease.
(i) The medical reviewer may order a new or changed facts or medical
mstockstill on DSK3G9T082PROD with RULES3

translation or interpretation services of


medical examination of an individual evidence that raise a genuine issue as to
the Federal order as needed.
when, in the medical reviewer’s whether the individual should continue
§ 71.39 Medical review of a Federal order professional judgment, such an to be subject to Federal quarantine,
for quarantine, isolation, or conditional examination would assist in assessing isolation, or conditional release. The
release. the individual’s medical condition. written Federal order shall be promptly
(a) The Director shall, as soon as (j) As part of the review, and where served on the individual and the
practicable, arrange for a medical review applicable, the medical reviewer shall individual’s authorized advocate or

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00089 Fmt 4701 Sfmt 4700 E:\FR\FM\19JAR3.SGM 19JAR3
6978 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

representatives, except that the Federal desirable governing the conduct of which would threaten the public health
order may be served by publication or medical reviews. of the United States; and
by posting in a conspicuous location if (q) The Director shall arrange for (2) The entry of imports from that
applicable to a group of individual’s and translation or interpretation services as country or place increases the risk that
individual service would be needed for purposes of this section. the communicable disease may be
impracticable. ■ 15. Add § 71.63 to subpart F to read introduced, transmitted, or spread into
(n) The Director’s written order shall as follows: the United States.
not constitute final agency action until (b) The Director shall designate the
§ 71.63 Suspension of entry of animals, foreign countries or places and the
it has been served on the individual or articles, or things from designated foreign
the individual’s authorized advocate or period of time or conditions under
countries and places into the United States.
representatives, or alternatively, if which the introduction of imports into
(a) The Director may suspend the the United States shall be suspended.
applicable to a group of individuals and
entry into the United States of animals, The Secretary or Director will
individual service would be
articles, or things from designated coordinate in advance with other
impracticable, it is published or posted.
foreign countries (including political Federal agencies that have overlapping
(o) The Director (excluding the CDC subdivisions and regions thereof) or authority in the regulation of entry of
official who issued the quarantine, places whenever the Director animals, articles, or other things, as may
isolation, or conditional release order) determines that such an action is be necessary to implement and enforce
may order the consolidation of one or necessary to protect the public health this provision.
more medical reviews if the number of and upon a finding that:
individuals or other factors makes the (1) There exists in a foreign country Dated: January 9, 2017.
holding of individual medical reviews (including one or more political Sylvia M. Burwell,
impracticable. subdivisions and regions thereof) or Secretary.
(p) The Director may issue additional place a communicable disease the [FR Doc. 2017–00615 Filed 1–12–17; 4:15 pm]
instructions as may be necessary or introduction, transmission, or spread of BILLING CODE 4163–18–P
mstockstill on DSK3G9T082PROD with RULES3

VerDate Sep<11>2014 23:46 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00090 Fmt 4701 Sfmt 9990 E:\FR\FM\19JAR3.SGM 19JAR3

You might also like