Authorizing Legislation 42 CFR Part 71

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public health orders and medical
reviews as needed. In implementing
quarantine, isolation, or other public
health measures under this Final Rule,
HHS/CDC will seek to use the least
restrictive means necessary to prevent
the spread of communicable disease.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Parts 70 and 71
[CDC Docket No. CDC–2016–0068]
RIN 0920–AA63

Table of Contents

Control of Communicable Diseases
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Final rule.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), within
the Department of Health and Human
Services (HHS), is issuing this final rule
(FR) to amend its regulations governing
its domestic (interstate) and foreign
quarantine regulations to best protect
the public health of the United States.
These amendments have been made to
aid public health responses to outbreaks
of new or re-emerging communicable
diseases and to accord due process to
individuals subject to Federal public
health orders. In response to public
comment received, the updated
provisions in this final rule clarify
various safeguards to prevent the
importation and spread of
communicable diseases affecting human
health into the United States and
interstate.

SUMMARY:

This rule is effective February
21, 2017.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Global Migration
and Quarantine, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE., MS–E03, Atlanta, GA 30329,
or email [email protected].
SUPPLEMENTARY INFORMATION: Based on
public comment received to the Notice
of Proposed Rulemaking (NPRM) (81 FR
54230) this final rule, among other
things: Withdraws a provision regarding
‘‘Agreements’’ as proposed in the
NPRM, requires CDC to issue a federal
order within 72 hours after
apprehending an individual, increases
the threshold for those who may be
considered ‘‘indigent’’ to 200% of the
applicable poverty guideline, adds a
definition for ‘‘Secretary,’’ adds a
requirement for CDC to provide legal
counsel for isolated or quarantined
individuals qualifying as indigent who
request a medical review, modifies the
definition of ‘‘non-invasive,’’ includes
‘‘known or possible exposure’’ in the list
of information that may be collected
during a public health risk assessment,
and strengthens due process protections
by ensuring that CDC will arrange for
translation or interpretation services for

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I. Executive Summary
A. Purpose of the Action
B. Summary of Major Provisions
C. Summary of Costs and Benefits
II. Public Participation
III. Background
A. Legal Authority
B. Regulatory History
IV. Summary of the Final Rule
A. General References to ‘‘CDC’’ and
‘‘Director’’ in Parts 70 and 71
B. Definitions (§§ 70.1 and 71.1(b))
C. Apprehension and Detention of Persons
With Quarantinable Communicable
Diseases (70.6)
D. Medical Examinations (§§ 70.12 and
71.36)
E. Requirements Relating to the Issuance of
a Federal Order for Quarantine, Isolation,
or Conditional Release (§§ 70.14 and
71.37)
F. Mandatory Reassessment of a Federal
Order for Quarantine, Isolation, or
Conditional Release (§§ 70.15 and 71.38)
G. Medical Review of a Federal Order for
Quarantine, Isolation, or Conditional
Release (§§ 70.16 and 71.39)
H. Administrative Records Relating to a
Federal Order for Quarantine, Isolation,
or Conditional Release (§§ 70.17 and
71.29)
I. Payment for Care and Treatment (70.13
and 71.30)
J. Agreements (§§ 70.18 and 71.40)
K. Penalties (§§ 70.18 and 71.2)
L. Public Health Prevention Measures To
Detect Communicable Disease (§§ 70.10
and 71.20)
M. Requirements Relating to Travelers
Under a Federal Order of Isolation,
Quarantine, or Conditional Release
(§ 70.5)
N. Report of Death or Illness Onboard
Aircraft Operated by an Airline (§ 70.11)
O. Requirements Relating to Collection,
Storage, and Transmission of Airline and
Vessel Passenger, Crew, and Flight and
Voyage Information for Public Health
Purposes (§§ 71.4 and 71.5)
P. Requirements Relating to Collection,
Storage, and Transmission of Airline and
Vessel Passenger, Crew, and Flight and
Voyage Information for Public Health
Purposes (§§ 71.4 and 71.5)
Q. Report of Death or Illness (§ 71.21)
V. Overview of Public Comment to the 2016
NPRM
A. Provisions Applicable to Both Parts 70
and 71
a. General Comments
b. Scope and Authority
c. Definitions
d. Public Health Prevention Measures To
Detect Communicable Disease
e. Apprehension and Detention of Persons
With Quarantinable Communicable
Diseases

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f. Medical Examinations
g. Requirements Relating to Issuance of a
Federal Order for Quarantine, Isolation,
or Conditional Release
h. Mandatory Reassessment of a Federal
Order for Quarantine, Isolation, or
Conditional Release
i. Medical Review of a Federal Order for
Quarantine, Isolation, or Conditional
Release
j. Administrative Records Relating to a
Federal Order for Quarantine, Isolation,
or Conditional Release
k. Other Due Process Concerns
l. Privacy
m. Payment for Care and Treatment
n. Agreements
o. Penalties
p. Economic Impact
q. Paperwork Reduction Act
B. Provisions Applicable to Part 70 Only
(Domestic)
a. General
b. Requirements Relating to Travelers
Under a Federal Order of Isolation,
Quarantine, or Conditional Release
c. Report of Death or Illness Onboard
Aircraft Operated by an Airline
C. Provisions Applicable to Part 71 Only
(Foreign)
a. Requirements Relating to Transmission
of Airline and Vessel Passenger, Crew,
and Flight Information for Public Health
Purposes
b. Suspension of Entry of Animals,
Articles, or Things From Designated
Foreign Countries and Places Into the
United States
VI. Alternatives Considered
VII. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
B. The Regulatory Flexibility Act
C. The Paperwork Reduction Act
D. National Environmental Policy Act
(NEPA)
E. Executive Order 12988: Civil Justice
Reform
F. Executive Order 13132: Federalism
G. The Plain Language Act of 2010

I. Executive Summary
A. Purpose of the Action
HHS/CDC has statutory authority (42
U.S.C. 264, 265) to promulgate
regulations that protect U.S. public
health from communicable diseases,
including quarantinable communicable
diseases as specified in an Executive
Order of the President. See Executive
Order 13295 (April 4, 2003), as
amended by Executive Order 13375
(April 1, 2005) and Executive Order
13674 (July 31, 2014). The need for this
rulemaking was reinforced during HHS/
CDC’s response to the largest outbreak
of Ebola virus disease (Ebola) on record,
followed by the recent outbreak of
Middle East Respiratory Syndrome
(MERS), both quarantinable
communicable diseases, and repeated
outbreaks and responses to measles, a
non-quarantinable communicable
disease of public health concern. This

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final rule will enhance HHS/CDC’s
ability to prevent the introduction,
transmission, and spread of
communicable diseases into the United
States and interstate by clarifying and
providing greater transparency
regarding its response capabilities and
practices.
B. Summary of Major Provisions
Both the domestic and foreign
portions of this regulation include new
proposed public health definitions; new
regulatory language implementing HHS/
CDC’s activities concerning noninvasive public health prevention
measures (i.e., traveler health screening)
at U.S. ports of entry and other U.S.
locations (i.e., railway stations, bus
terminals); and provisions affording due
process to persons served with a Federal
public health order (e.g., isolation,
quarantine), including requiring that
HHS/CDC explain the reasons for
issuing the order, administrative
processes for appealing the order, and a
mandatory reassessment of the order.
The domestic portion of this final rule
includes a requirement that commercial
passenger flights report deaths or
illnesses to the CDC. It also includes a
provision requiring that individuals
apply for a travel permit if they are
under a Federal quarantine, isolation, or
conditional release order (unless the
specific travel is authorized by the
Federal conditional release order) or if
a State or local public health
department requests CDC assistance in
enforcing a State or local quarantine or
isolation order. Additionally, the
domestic portion of this final rule
includes new regulatory language
clarifying when an individual who is
moving between U.S. states is
‘‘reasonably believed to be infected’’
with a quarantinable communicable
disease in a ‘‘qualifying stage.’’ These
determinations are made when the CDC
considers the need to apprehend or
examine an individual for potential
infection with a quarantinable
communicable disease. The foreign
portion of this final rule includes new
regulatory authority permitting the CDC
Director to prohibit the importation of
animals or products that pose a threat to
public health.
HHS/CDC has also changed the text of
the regulation to reflect modern
terminology, technology, and plain
language used by private industry,
public health partners, and the public.
The final rule also authorizes public
health monitoring through electronic or
internet-based means of communication
for individuals under a Federal
conditional release order who are
reasonably believed to be exposed to or

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infected with a quarantinable
communicable disease. This would
include communication through email
and webcam application tools. Finally,
while neither modifying nor authorizing
additional criminal penalties for
violations of quarantine rules and
regulations, this final rule updates
regulatory language to align with
existing criminal penalties set forth in
statute.
C. Summary of Costs and Benefits
The regulatory impact analysis
quantitatively addresses the costs and
benefits associated with this final rule.
The economic impact analysis of this
final rule is subdivided into two
sections.
The first analysis summarizes the
economic impact of changes to 42 CFR
70.1, 42 CFR 71.1/71.4/71.5 for which
the primary costs for submitting
passenger and crew information to
HHS/CDC are incurred by airlines and
vessel operators and the primary benefit
is improved public health
responsiveness to assess and offer postexposure prophylaxis to travelers
potentially exposed to communicable
diseases of public health concern. The
most likely estimates of annual costs to
airlines, vessel operators, the United
States government, and public health
departments are low ($32,622, range
$10,959 to $430,839) because the final
rule primarily codifies existing practice
or improves alignment between existing
regulatory text and the International
Civil Aviation Organization (ICAO)’s
guidelines for symptoms to report. The
cost estimates in this final rule are based
on (1) an anticipated small increase in
the number of illness reports delivered
by airlines and processed by HHS/CDC
and (2) increased costs for airlines and
vessel operators to comply with HHS/
CDC orders for traveler and crew contact
data, to the extent that such information
is readily available and already
maintained, and not already transmitted
to the U.S. Customs and Border
Protection (CBP). The cost estimate also
includes an increase in costs for public
health departments to contact more
exposed travelers due to the availability
of improved contact data.
The best estimate of the annual
quantified benefits of the final rule are
$110,045 (range $26,337 to $297,393)
and mostly result from increased
efficiencies for HHS/CDC and State and
local public health departments to
conduct contact investigations among
travelers on an aircraft exposed to
communicable diseases of public health
concern, especially for measles and
tuberculosis. To the extent that
improved responsiveness of airlines to

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HHS/CDC traveler data orders may
result from the implementation of the
provisions in this final rule, HHS/CDC
may become better able to respond to
infectious diseases threats and (1)
reduce case-loads during infectious
disease outbreaks, (2) reduce public
anxiety during disease outbreaks, (3)
mitigate economic impacts on
businesses as a consequence of reduced
public anxiety associated with
quarantinable communicable disease
outbreaks initiated by international
travelers (such as have been observed
during outbreak of severe acute
respiratory syndrome in Canada or
Middle East respiratory syndrome in
South Korea), and (4) reduce the amount
of personnel labor time to conduct largescale contact investigations in response
to a new infectious disease or one with
larger scale public health and medical
consequences like Ebola.
The second analysis in this final rule
is of a number of provisions that aim to
improve transparency of how HHS/CDC
uses its regulatory authorities to protect
public health. HHS/CDC believes that
improving the quality of its regulations
by providing clearer explanations of its
policies and procedures is an important
public benefit. However, HHS/CDC is
not able to attach a dollar value to this
added benefit in a significant way.
II. Public Participation
On August 15, 2016, HHS/CDC
published a notice of proposed
rulemaking (NPRM) (81 FR 54299) to
amend 42 CFR part 70 (interstate) and
42 CFR part 71 (foreign) quarantine
regulations. The public was invited to
comment on these amendments. The
comment period ended October 14,
2016. In the NPRM, HHS/CDC
specifically requested public comment
on the following:
• Whether the use of the standard
definition of ‘‘indigent’’ is an
appropriate threshold to determine
whether an individual cannot afford
representation and therefore should be
appointed a medical representative at
the government’s expense and whether
the public believes that there may be
non-indigent individuals, as defined in
the NPRM, who may have difficulty
affording a representative;
• The definition of public health
emergency and its utility in identifying
communicable diseases that ‘‘would be
likely to cause a public health
emergency if transmitted to other
individuals’’ under 42 U.S.C.
264(d)(2)(B);
• Requirements relating to travelers
under a Federal order of isolation,
quarantine, or conditional release;
specifically, on whether stakeholders

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have concerns regarding the
requirement imposed on conveyance
operators to not ‘‘knowingly’’ transport
individuals under a Federal order and
the feasibility of this requirement and
the application of this provision to
individuals under State/local order as
well as individuals traveling entirely
within a State.
• Public health prevention measures
and whether the public has any
concerns regarding the mandatory
health screening of passengers using
non-invasive means as defined in the
proposal or the collection of personal
information from screened individuals
for the purposes of contact tracing;
• Payment for care and treatment, and
whether there are any concerns that all
third party payments be exhausted prior
to the Federal reimbursement of medical
care or treatment for individuals placed
under a Federal order for quarantine,
isolation, or conditional surveillance;
• The application of requirements
relating to issuance of a Federal order
for quarantine, isolation or conditional
release as it applies to groups and
whether this provision sufficiently
informs the public of the important
details concerning circumstances during
which HHS/CDC would issue to groups
or individuals Federal orders for
quarantine, isolation, and conditional
release and the duration and conditions
of such orders;
• Whether 72 hours is the necessary
amount of time to conduct a
reassessment after a Federal order is
first issued, or if the reassessment
should take place earlier or later;
• Whether or not the public sees a
role for the Federal government to
ensure that basic living conditions,
amenities, and standards are satisfactory
when placing individuals under Federal
orders;
• Whether the definition of ‘‘noninvasive’’ aligns with common
perceptions of what constitutes noninvasive procedures that may be
conducted outside of a traditional
clinical setting;
• Whether the penalties proposed,
and the circumstances under which
such penalties may be imposed, were
clearly explained;
• The applicability of the December
13, 2007 system of records notice
(SORN) to the activities proposed (72 FR
70867), and whether the SORN
sufficiently addresses the public’s
concerns related to maintenance and
protection of the data elements
proposed;
• The request for a passenger and
crew manifest within 24 hours and
whether the provision grants operators

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of airlines sufficient time for operators
to respond to manifests orders;
• The likelihood that the passenger
and crew data elements requested are
already collected and maintained by
airline operators for transmission to
CDC;
• Any industry concerns regarding
whether proposed section 71.63
sufficiently details the circumstances
under which HHS/CDC may impose an
embargo on the importation of animals,
articles, or things, including how such
an embargo would be implemented, as
well as any concerns regarding
coordination with other Federal
agencies.
The public comment period for the
proposed rule ended on October 14,
2016 and HHS/CDC received 15,800
comments from individuals,
stakeholders, and groups. A summary of
those comments and responses to those
comments are found at Section IV,
below.
II. Background
A. Legal Authority
The primary legal authorities
supporting this rulemaking are sections
361 and 362 1 of the Public Health
Service Act (42 U.S.C. 264, 265). HHS/
CDC also believes that the following
Public Health Service Act sections are
relevant with respect to this rulemaking:
section 311 (42 U.S.C. 243), section 321
(42 U.S.C. 248), section 322 (42 U.S.C.
249), section 365 (42 U.S.C. 268), and
sections 367–69 (42 U.S.C. 270–72). A
detailed explanation of these legal
authorities was provided in the NPRM
published at 81 FR 54230 (Aug. 15,
2016).
B. Regulatory History
On August 15, 2016, HHS/CDC
published a Notice of Proposed
Rulemaking to update 42 CFR 70
(domestic) and 42 CFR 71 (foreign)
quarantine regulations. These
amendments were proposed to aid
public health responses to outbreaks of
communicable disease, such as the
largest outbreak of Ebola virus disease
(Ebola) on record, Middle East
Respiratory Syndrome (MERS), both
quarantinable communicable diseases,
and repeated outbreaks of measles in the
United States, a non-quarantinable
communicable disease of public health
concern. (81 FR 54299). Communicable
diseases of public health concern are
those diseases that because of their
1 Section 3 of Executive Order 13295 (April 4,
2003) states that the functions of the President
under sections 362 and 364(a) of the Public Health
Service Act (42 U.S.C. 265 and 267(a) are assigned
to the HHS Secretary.

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potential for spread, particularly during
travel, may require a public health
intervention. The provisions contained
within the proposal were designed to
enhance HHS/CDC’s ability to prevent
the further importation and spread of
communicable diseases into the United
States and interstate by clarifying HHS/
CDC’s response capabilities, practices,
and making them more transparent.
III. Summary of the Final Rule
Upon consideration of public
comment, the following is a section-bysection summary of the changes from
the proposed text that HHS/CDC made
to parts 70 and 71:
A. General References to ‘‘CDC’’ and
‘‘Director’’ in Parts 70 and 71
Throughout the regulatory text in
parts 70 and 71, references to ‘‘CDC’’ or
‘‘HHS/CDC’’ have been replaced with
‘‘Director.’’ This is in keeping with the
common practice that federal agencies
act through employees and officials to
whom the authority involved has been
delegated. Director is currently defined
in sections 70.1 and 71.1 to mean ‘‘the
Director, Centers for Disease Control
and Prevention, Department of Health
and Human Services, or another
authorized representative as approved
by the CDC Director or the Secretary of
HHS.’’ Where it is necessary to exclude
CDC employees or officials from
undertaking certain functions this has
been indicated by use of parenthesis,
e.g., ‘‘Director (excluding the CDC
official who issued the quarantine,
isolation, or conditional release order).’’
This is a stylistic change from the
NPRM, but does not result in a
substantive change in the final rule.
B. Definitions (Sections 70.1 and
71.1(b))
• The definition of Agreements has
been removed.
• The definition of Electronic or
internet-based monitoring has been
modified to include ‘‘communication
through’’ these means and ‘‘audio’’
conference.
• The definition of Indigent has been
modified to increase the threshold to
200% of the applicable poverty
guidelines.
• The definition of Ill person under
section 71.1 has been modified to
include a person who ‘‘Has a fever that
has persisted for more than 48 hours’’ or
‘‘Has acute gastroenteritis, which means
either diarrhea, defined as three or more
episodes of loose stools in a 24-hour
period or what is above normal for the
individual, or vomiting accompanied by
one or more of the following: One or
more episodes of loose stools in a 24-

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hour period, abdominal cramps,
headache, muscle aches, or fever
(temperature of 100.4 °F [38°C] or
greater).’’ This language was quoted
verbatim in the preamble of the NPRM
at 81 FR 54305 but was inadvertently
omitted from the proposed regulatory
text.
• The definition of Medical
Examination has been modified to
indicate that the health worker
conducting the assessment must be
‘‘licensed.’’
• The definition of Medical
Representative has been changed to
Representatives and now includes for an
indigent individual the additional
appointment of ‘‘an attorney who is
knowledgeable of public health
practices’’ if the indigent individual
requests a medical review.
• The definition of Non-invasive has
been modified to: (1) Replace ‘‘physical
examination’’ with ‘‘visual
examination;’’ (2) specify that the
individual performing the assessment
must be a ‘‘public health worker (i.e., an
individual with education and training
in the field of public health)’’; and (3)
remove ‘‘auscultation, external
palpation, external measurement of
blood pressure.’’
• A definition for Secretary has been
added. Secretary means the Secretary of
Health and Human Services (HHS) or
any other officer or employee of that
Department to whom the authority
involved has been delegated. We note
that while the NPRM did not propose
this definition, the NPRM referenced the
Secretary in defining Public Health
Emergency. Thus, HHS/CDC considers it
useful to also define the term Secretary.

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C. Apprehension and Detention of
Persons With Quarantinable
Communicable Diseases (Section 70.6)
This provision is has been finalized as
proposed, with the exception that
references to CDC have been replaced
with Director throughout this section.
HHS/CDC has also added a requirement
that the Director arrange for adequate
food and water, appropriate
accommodation, appropriate medical
treatment, and means of necessary
communication, for individuals who are
apprehended or held in quarantine or
isolation. Similar language has been
added to an analogous provision at
Section 71.33(a).
D. Medical Examinations (Sections
70.12 and 71.36)
These provisions are finalized as
proposed, with the exception that
references to CDC have been replaced
with Director throughout this section.
HHS/CDC has also added a requirement

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that the Director, as part of the Federal
order, advise the individual that the
medical examination shall be conducted
by an authorized and licensed health
worker with prior informed consent.
E. Requirements Relating to the
Issuance of a Federal Order for
Quarantine, Isolation, or Conditional
Release (§§ 70.14 and 71.37)
Paragraphs (a)(5) and (a)(4) of these
provisions have been modified,
respectively, to require that the Federal
order include an explanation that the
Federal order will be reassessed no later
than 72 hours after it has been served
and an explanation of the right to
request a medical review, present
witnesses and testimony at the medical
review, and to be represented at the
medical review by either an advocate
(e.g., an attorney, family member, or
physician) at the individual’s own
expense, or, if indigent, to have
representatives appointed at the
government’s expense. Paragraph (b) of
these provisions has been modified to
require that a Federal public health
order be served within 72 hours of an
individual’s apprehension. Paragraph
(c) has been modified to require that the
Director arrange for translation or
interpretation services of the Federal
order as needed. References to CDC
have been replaced with Director
throughout this section.
F. Mandatory Reassessment of a Federal
Order for Quarantine, Isolation, or
Conditional Release (§§ 70.15 and
71.38)
These provisions have been modified
to include paragraph (g) which states
that the Director shall arrange for
translation or interpretation services of
the Federal order as needed. References
to CDC have been replaced with
Director throughout this section.
G. Medical Review of a Federal Order
for Quarantine, Isolation, or Conditional
Release (§§ 70.16 and 71.39)
Paragraph (f) of these provisions has
been modified to reference
‘‘Representatives,’’ consistent with the
change in definition. Paragraph (f) of
these provisions has also been modified
to remove, ‘‘and cannot afford a medical
representative’’ because this language is
duplicative and unnecessary if the
individual has already qualified as
indigent. Paragraph (k) of these
provisions has been modified to state:
‘‘The medical review shall be conducted
by telephone, audio or video
conference, or through other means that
the medical reviewer determines in his/
her discretion are practicable for
allowing the individual under

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quarantine, isolation, or conditional
release to participate in the medical
review.’’ These provisions have also
been modified to include paragraph (q)
which states that the Director shall
arrange for translation or interpretation
services as needed for purposes of this
section. References to CDC have been
replaced with Director throughout this
section.
H. Administrative Records Relating to a
Federal Order for Quarantine, Isolation,
or Conditional Release (§§ 70.17 and
71.29)
These sections have been modified to
remove paragraphs (5) regarding
agreements between CDC and the
individual.
I. Payment for Care and Treatment
(§§ 70.13 and 71.30)
These provisions have been finalized
as proposed, with the exception that
references to CDC have been replaced
with Director throughout this section.
J. Agreements (§§ 70.18 and 71.40)
These provisions have been removed.
K. Penalties (§§ 70.18 and 71.2)
The content of these provisions has
been finalized as proposed. Proposed
§ 70.19 Penalties has been moved to
§ 70.18, since proposed § 70.18
Agreements has been removed from this
final rule.
L. Public Health Prevention Measures
To Detect Communicable Disease
(§§ 70.10 and 71.20)
Paragraph (b) has been modified to
include ‘‘known or possible exposure’’
information to the list of information
that may be collected. References to
CDC have been replaced with Director
throughout this section.
M. Requirements Relating to Travelers
Under a Federal Order of Isolation,
Quarantine, or Conditional Release
(Section 70.5)
Paragraph (a), (a)(4), (b)(1), (b)(2), and
(c) of this provision have been modified
to remove ‘‘agreements.’’ Paragraph (d)
has been modified to add ‘‘to
individuals traveling entirely intrastate
and to conveyances that may transport
such individuals.’’ The language in
paragraph (d) was discussed in the
NPRM at 81 FR 54243 and public
comment concerning intrastate
application of this provision was
explicitly solicited. The language,
however, was inadvertently omitted
from the regulatory text. References to
CDC have also been replaced with
Director throughout this section. In
response to public comments, HHS/CDC

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has included a requirement that the
Director respond to a request for a travel
permit within five (5) business days and
to an appeal under this section within
three (3) business days. Public
comments concerning this provision are
addressed below.
N. Report of Death or Illness Onboard
Aircraft Operated by an Airline (§ 70.11)
This provision has been finalized as
proposed, with the exception that
references to CDC have been replaced
with Director throughout this section.
O. Requirements Relating to
Transmission of Airline and Vessel
Passenger, Crew, and Flight and Voyage
Information for Public Health Purposes
(§ 71.4 and 71.5)
These provisions have been finalized
as proposed, with the exception that the
title has been modified to remove
references to collection and storage of
information to more accurately reflect
the requirements under this section and
references to CDC have been replaced
with Director throughout this section.
P. Suspension of Entry of Animals,
Articles, or Things From Designated
Foreign Countries and Places Into the
United States (§ 71.63)
This provision has been finalized as
proposed with the exception that
references to CDC have been replaced
with Director throughout this section.

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Q. Report of Death or Illness (§ 71.21)
The title of this provision has been
finalized as proposed, to remove the
word ‘‘Radio.’’
V. Overview of Public Comments to the
2016 NPRM
On August 15, 2016 HHS/CDC
published a Notice of Proposed
Rulemaking proposing to amend the
current interstate (domestic) and foreign
quarantine regulations for the control of
communicable diseases. The NPRM
included a 60-day public comment
period and during this time, HHS/CDC
received 15,800 comments from
individuals, groups, organizations,
industry, and unions. Comments were
both in support of and in opposition to
the regulation. Many public comments
expressed concern that these updated
regulations sought to compel medical
treatment or vaccination without patient
consent. One association stated its
strong objection ‘‘to the coercive
imposition of treatment, including
vaccination, without the genuine
consent of the patient.’’
HHS/CDC begins this section by
stating that these regulations do not
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medical treatment. In keeping with
current practice, HHS/CDC will
continue to recommend care and
treatment, including post-exposure
prophylaxis when indicated, to
individuals who are either sick with or
at risk of disease following exposure to
a communicable disease of public
health concern.
HHS/CDC also received comments
relating to immigration policy and
regulations, issues of citizenship, border
security, religion, personal testimony
regarding adverse vaccine events, and
requests to apply these regulations only
to individuals who are not citizens of
the United States. These comments are
beyond the scope of this final rule and
have not been included in this
discussion. However, HHS/CDC notes
that it will continue to apply
communicable disease control and
prevention measures uniformly to all
individuals in the United States,
regardless of citizenship, religion, race,
or country of residency.
HHS/CDC also received public
comment regarding disinsection (i.e.,
measures to control or kill insect vectors
of disease) and fumigation procedures,
citing HHS/CDC’s statutory authorities
relating to inspection, fumigation, and
pest extermination. We note that while
HHS/CDC maintains regulations at 42
CFR 70.2 and 71.32(b) implementing
this statutory authority, such comments
are outside of the scope of this final
rule, which did not include proposed
changes to these regulatory provisions.
The following is a discussion of
public comments received that are
applicable and within the scope of the
regulation. Topics including:
Accountability, Administrative Records,
Agreements, Apprehension, Authority
(including Scope), Conditional Release,
Constitutional Issues (including
Amendments, Court Cases, and Habeas
Corpus), Data Collection, Definitions,
Detention, Due Process, Economic
Impact, Electronic Monitoring,
Exposure, Informed Consent, Least
Restrictive Means, Minors, Medical
Assessments, Examination, Notice,
Penalties, Privacy, Qualifying Stage,
Quarantine, Quarantinable
Communicable Diseases List, and others
are discussed.
A summary of comments and a
response to those comments are found
below, organized by general and specific
comments that apply to both parts 70
and 71, comments that only apply to
part 70 (interstate), and comments that
only apply to part 71 (foreign).

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A. Provisions Applicable to Both Parts
70 and 71
a. General Comments
Since posting the proposed regulation
on August 15, 2016, HHS/CDC received
15,800 public comments. HHS/CDC
received several comments from
individuals, groups, or industry
requesting to extend the 60-day
comment period. In light of the number
of comments submitted, HHS/CDC has
determined that a 60-day comment
period was both fair and sufficient to
adequately inform the public of the
contents of this rulemaking, allow the
public to carefully consider the
rulemaking, and receive informed
public feedback. Thus, HHS/CDC
declines to reopen the comment period.
Several commenters requested that
HHS/CDC withdraw the NPRM in its
entirety. A non-profit organization
stated that the ‘‘NPRM would be, if
adopted, a direct and onerous
infringement of the personal liberties of
Americans and an unnecessary
aggressive method of assisting in the
control of communicable disease.’’
Another commenter said that the
‘‘NPRM is premature.’’ HHS/CDC
disagrees and declines to withdraw the
proposal in its entirety because it
contains important measures that will
aid the public health response to
prevent the introduction, transmission,
and spread of communicable diseases
into and within the United States.
Moreover, in the spirit of transparency,
these measures, which are largely
current practice, are being published
and codified to make the public aware
of their use.
HHS/CDC received a comment from a
partnership of public health legal
scholars and organizations stating that it
should promulgate a separate rule
guaranteeing humane conditions of
confinement. HHS/CDC disagrees that
such a separate rule is needed and
believes that the current final rule
adequately addresses these concerns, as
discussed in detail below.
HHS/CDC received a comment that
the proposed rule does not comply with
Executive Order 12866 because there is
no public need for the rule and it did
not adequately assess the costs and
benefits of the rule, including the
alternative of not regulating. HHS/CDC
disagrees. As discussed in detail below,
this rule describes the public health
measures that may be used in response
to outbreaks of communicable diseases,
such as the recent largest recorded
outbreak of Ebola. The economic impact
analysis has been clarified to more
clearly differentiate quarantinable and
non-quarantinable diseases. The

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economic impact analysis also examines
the costs and benefits of the Final Rule
measured against current practices (i.e.,
a status quo baseline). Both the costs
and benefits of this Final Rule are small
because the provisions set forth are
primarily a codification of current
practices, based on existing regulatory
authorities.
A public health research center
commented that there is no evidence
that measures employed at points of
entry were effective during the response
to the 2014–2016 Ebola outbreak and
that HHS/CDC is attempting to codify
these ineffective practices for use in
future disease outbreaks. They further
noted that despite greater than 99%
complete monitoring, zero cases of
Ebola were detected among those
monitored. HHS/CDC appreciates this
comment and recognizes the challenges
presented by measuring the benefits of
prevention in public health.
HHS/CDC disagrees that the measures
employed in response to the 2014–16
Ebola outbreak were ineffective and that
it is seeking to codify ineffective
measures. HHS/CDC considers more
than 99% complete monitoring a
successful effort in State and Federal
cooperation in response to an
unprecedented outbreak of Ebola.
Second, rather than the number of cases
detected, HHS/CDC considers the key
metrics of effectiveness to be the
number of people who were able to
continue to travel safely without fear of
disease spread and the ability to
facilitate rapid isolation and evaluation
of the approximately 1400 individuals
who developed illness compatible with
Ebola during the 21-day monitoring
period. Finally, we note that this
commenter limited his or her statement
to HHS/CDC measures put into place at
U.S. ports of entry during the Ebola
response.
The enhanced public health risk
assessment protocol put into place at
U.S. ports of entry in response to the
Ebola outbreak was one part of a layered
risk mitigation program to prevent the
importation and spread of Ebola within
the United States, which included exit
screening in the affected countries as
recommended by the World Health
Organization (WHO) (see Statement on
the 1st meeting of the International
Health Regulations [IHR] Emergency
Committee on the 2014 Ebola outbreak
in West Africa 8/8/2014) and a reliance
on air industry partners for detection
and reporting of potentially ill travelers
prior to arrival.
The enhanced entry risk assessment
process was instituted after an
individual infected with Ebola entered
the United States and transmitted the

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disease. This case demonstrated that the
processes then in place to prevent
departure of individuals exposed to or
infected with Ebola in affected West
African countries could not detect
persons who were exposed but were
unaware of or denied such exposure and
were potentially incubating the
infection. To further reduce the risk of
introduction and spread, HHS/CDC
recommended monitoring of all
potentially exposed individuals by a
public health authority through the 21day risk period after potential exposure,
rather than relying on previously
recommended self-monitoring.
Monitoring was viewed as the least
restrictive alternative to widespread
quarantine and travel bans demanded
by some members of the public that
would ultimately have hampered the
response efforts in West Africa and
domestically. HHS/CDC, along with its
Federal and State partners,
implemented an entry process by which
individuals identified as having recently
traveled to, from, or through an affected
country entered through five ports of
entry where public health staff and
partners were stationed, submitted
accurate and complete contact
information, were checked for
symptoms, and were provided answers
to Ebola risk assessment questions.
This was done for several reasons:
• To ensure that any individual
entering the United States who could
have been exposed to or infected with
Ebola in a country experiencing an
Ebola outbreak was identified and
reported to the State and local health
department of final destination so that,
if the individual became ill, State or
local health departments could rapidly
notify healthcare providers prior to the
individual’s arriving at a hospital. This
process was designed specifically to
prevent unknowing individuals from
exposing others such as occurred in
Texas when a patient exposed two
healthcare workers.
• While HHS/CDC acknowledges that
a public health worker may be unlikely
to encounter someone with symptoms at
the moment of entry because of the 21day incubation period, individuals
coming from the outbreak countries
frequently traveled for well over 24
hours and in many cases had itineraries
that involved interstate movement
within the United States. The odds of
developing symptoms during that travel,
and potential onward travel, were
considered non-trivial, and public
health measures to detect symptoms
upon entry were considered warranted
given the serious morbidity and costs
associated with Ebola.

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• The risk assessment at the limited
ports of entry provided an important
opportunity for HHS/CDC to stratify the
risk of developing Ebola for every
individual who entered from the
affected countries. It allowed HHS/CDC
to work with State and local health
departments in implementing the least
restrictive means of monitoring
individuals for development of
symptoms. HHS/CDC notes that there
were no Federal quarantine orders
issued because of the availability of
monitoring options provided by State
and local authorities under the Interim
U.S. Guidance for Monitoring and
Movement of Persons with Potential
Ebola Virus Exposure.
• The encounter also provided an
opportunity to provide travelers with
educational materials, orientate them to
the monitoring program (Check and
Report Ebola (CARE)), and facilitate
reporting of the traveler’s health status
to State and local health departments.
The enhanced entry risk assessment
and monitoring process described above
was developed in response to the
epidemiological profile of Ebola and the
complexities of a 21-day incubation
period. However, in the event of an
outbreak of a different communicable
disease requiring enhanced assessment
or monitoring of travelers (whether
quarantinable or non-quarantinable),
HHS/CDC, in concert with Federal and
State partners, may implement a
different system of risk assessment and
monitoring. HHS/CDC would tailor the
program in accordance with the
scientific evidence of the situation and
the utility and feasibility of the program
given the availability of resources.
The same public health research
center commented that employing nonevidence-based measures is contrary to
the United States’ international legal
agreements, specifically mentioning the
public health measures implemented
during the response to Ebola as they
pertain to the International Health
Regulations (IHR 2005). The commenter
further stated that given the absence of
evidence to support the use of travel
monitoring and quarantine, HHS/CDC
should proceed cautiously before
employing these measures in the future.
Having addressed the commenter’s
concern regarding the evidence of the
effectiveness of public health measures
at ports of entry above, HHS/CDC
concurs with the commenter that the
use of quarantine and travel restrictions,
in the absence of evidence of their
utility, is detrimental to efforts to
combat the spread of communicable
disease. However, HHS/CDC disagrees
that it used non-evidence based
measures in contravention of the IHR.

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To the contrary, HHS/CDC used the best
available science and risk assessment
procedures in designing a port of entry
risk assessment and management
program that took into account available
resources, circumstances in the
countries with Ebola outbreaks, and
principles of least restrictive means to
successfully ensure that measures to ban
travel between the United States and the
affected countries were unnecessary.
These measures would have negatively
impacted the efforts to combat Ebola in
the region and would have had dramatic
negative implications for travelers and
industry.
Furthermore, the measures did not
unduly affect travel or trade beyond the
voluntary changes made by industry
and travelers. HHS/CDC believes that
CDC’s entry risk assessment and
management program was appropriate,
commensurate with the risk, and
consistent with the following WHO
recommendation: ‘‘[Member] States
should be prepared to detect,
investigate, and manage Ebola cases;
this should include assured access to a
qualified diagnostic laboratory for Ebola
and, where appropriate, the capacity to
manage travelers originating from
known Ebola-infected areas who arrive
at international airports or major land
crossing points with unexplained febrile
illness.’’ WHO Statement on the 1st
meeting of the IHR Emergency
Committee on the 2014 Ebola outbreak
in West Africa (Aug. 8, 2014). Travelers
were assessed for risk on an individual
basis upon entry; and any individual
who met the pre-defined symptom
threshold (based on exposure level) was
medically evaluated and referred to care
as needed. No Federal quarantine orders
were issued for the duration of the
response because HHS/CDC in
coordination with State and local public
health authorities was able to tailor its
interventions to allow onward travel.
Future outbreaks may necessitate a
different combination of public health
measures at ports of entry. In those
circumstances, HHS/CDC will use the
best available science to assess the risk
of importation and spread within the
United States.
One commenter suggested that if
HHS/CDC were to apply the
‘‘Precautionary Principle,’’ it would not
promulgate these regulations. HHS/CDC
notes first that the ‘‘precautionary
principle,’’ often described as the
avoidance of harm when there is
scientific uncertainty about risks,
originated in environmental contexts
and remains largely associated with
environmental issues. Invoking the
precautionary principle in an
environmental context, for instance,

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places the onus on those considering a
potentially harmful action, such as
drilling or mining near a watershed, to
prove its safety in advance. The
principle may be used by policy makers
to justify discretionary decisions in
situations where there is the possibility
of harm from making a certain decision
(e.g. taking a particular course of action)
when extensive scientific knowledge on
the matter is lacking.
HHS/CDC disagrees that this
regulation will have harmful effect or
that these measures lack a scientific
basis for protecting public health. In
fact, as described above regarding the
response efforts to the 2014–2016 Ebola
response, HHS/CDC has successfully
employed the measures outlined in this
regulation for many years. Again, the
provisions outlined through this
regulation are not new practices, nor
new authorities, but a codification of
HHS/CDC practice to protect public
health.
One commenter suggested that
education on healthy practices would be
more effective than regulatory
provisions. Another commenter stated
that our immune systems would ward
off communicable disease if we
encourage clean water, adequate shelter,
effective sewage treatment, and
nutritious food. HHS/CDC agrees that
these necessities are important to public
health, and we rely on health
communication often to educate the
public on how to protect themselves
and others from certain communicable
diseases. For example, HHS/CDC
routinely advises people with seasonal
influenza to stay home from work and
school, to cover their coughs and
sneezes, and to wash their hands. HHS/
CDC also works with State, local, and
airport authorities in posting health
education materials for the public.
However, in certain circumstances,
when a communicable disease poses a
severe health threat to others, additional
measures may be needed to protect the
public’s health. This is particularly
important in situations when the
infectious individual has disregarded
public health recommendations by, for
example, refusing to take prescribed
medications to treat infectious
tuberculosis or traveling while
infectious. In such situations, it may be
necessary to use public health
authorities to require the individual to
remain in isolation or to prevent travel
to protect the public’s health.
HHS/CDC received a few comments
suggesting that publication of the NPRM
in the Federal Register was not
sufficient to inform the public of these
proposed updates. One comment
questioned why the proposed

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regulations were not more widely
disseminated through media outlets. In
response, HHS/CDC notes that Federal
courts have long recognized that
publication in the Federal Register is
legally sufficient for giving affected
persons notice of proposed rulemaking.
See Federal Crop Ins. Corp. v. Merrill,
332 U.S. 380, 385 (1947) (‘‘Congress has
provided that the appearance of rules
and regulations in the Federal Register
gives legal notice of their contents.’’).
The Federal Register, within the
National Archives and Records
Administration, is the official
publication for all Federal agency rules,
proposed rules, and notices of Federal
agencies and organizations, as well as
for Executive Orders and certain other
presidential documents. Individuals
interested in obtaining more
information regarding HHS/CDC’s
regulatory processes, including input
provided by persons and organizations,
may examine the regulatory docket or
submit a request through the Freedom of
Information Act.
HHS/CDC received a comment stating
that HHS/CDC should, by regulation,
provide sufficient public health
justification for screening practices to
support its proposed public health
prevention measures at ports of entry.
While HHS/CDC agrees that it should
provide sufficient public health
justification for large-scale screening
practices, HHS/CDC disagrees that this
justification should be formalized in
regulations. During the 2014–2016 Ebola
epidemic, HHS/CDC issued Interim U.S.
Guidance for Monitoring and Movement
of Persons with Potential Ebola Virus
Exposure to assist HHS/CDC staff and
public health partners engaged in the
response. The guidance provided public
health authorities and partners with
recommendations for monitoring people
potentially exposed to Ebola and for
evaluating their intended travel,
including the application of movement
restrictions when necessary. From
August 2014–December 2015, the
guidance was accessed online
approximately 334,000 times, with more
than 88,000 views during the first 4
days after the October 2014 update that
added recommendations for active
monitoring and clarified travel and
movement restriction recommendations.
Updates to the guidance to
accommodate new information and
changes in the outbreak situation
continued through 2015. The guidance
was retired on February 19, 2016, when
more than 45 days had passed since
Guinea was declared free of Ebola virus
transmission, signaling widespread
human-to-human transmission in the

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affected countries was at an end.
Formalizing this guidance in regulation
would have deprived HHS/CDC of the
needed flexibility to respond to public
health events as they occurred, would
have proved administratively
burdensome and unnecessary, and
would have potentially delayed
prevention measures therefore resulting
in a less effective response. HHS/CDC
will consider the need for similar
guidance during future outbreaks taking
into account the extent of the outbreak
and the risk of importation and spread
of disease into the United States.
HHS/CDC received several comments
suggesting that the proposed regulations
were not written in plain language and
were therefore difficult to understand.
One commenter also noted errors in the
document such as hyperlinks,
references, and footnotes. This
commenter also reviewed the NPRM for
inconsistencies, conflicts, missing
definitions, misleading language, and
ambiguities. HHS/CDC thanks these
commenters for the input. We have
developed communication materials
and published them to our Web site to
help facilitate the review and
comprehension of these documents.
Interested persons should see http://
www.cdc.gov/quarantine/noticeproposed-rulemaking-controlcommunicable-diseases.html.
One commenter opposed the rule
because of a perceived negative social
impact upon individuals placed under a
public health order. We respond that
one compelling reason for the
publication of this final rule is to make
the public aware of these measures so
that the words, purposes, and meanings
of ‘‘quarantine’’ and ‘‘isolation’’ become
more familiar and less likely to cause
public anxiety and stigmatization.
HHS/CDC received comments
suggesting that, to best prevent the
introduction of communicable diseases
into the U.S., individuals who travel to
or originate in countries with high risk
of communicable disease should not be
allowed to enter (or return to) the
United States. On March 27, 2015, HHS/
CDC published a Notice in the Federal
Register titled Criteria for
Recommending Federal Travel
Restrictions for Public Health Purposes,
Including for Viral Hemorrhagic Fevers.
See 80 FR 16400 (Mar. 27, 2015). The
Notice describes the tools the Federal
government has to ensure that people
who pose a public health risk do not
board flights or enter the United States
without a public health evaluation. See
80 FR 16400 (Mar. 27, 2015). It is the
policy of HHS/CDC to work with the
Department of State, and any other
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ensure infected U.S. citizens seeking to
return to the U.S. do so in a manner that
does not place the public at risk.
A few commenters expressed concern,
as parents or guardians, about their
rights with respect to children or
minors. Specifically, these commenters
wondered whether children/minors
would be separated from parents/
guardians during a public health risk
assessment. HHS/CDC thanks the
commenters for these questions and
appreciates the opportunity to respond.
In response, HHS/CDC notes that these
regulations do not limit the rights that
parents or guardians may have over
minor children, including the right to
make medical decisions.
Notwithstanding, children are included
in the definition of ‘‘individuals’’ as
used in these regulations and thus
minor children may be subject to
apprehension, detention, examination,
and conditional release for
quarantinable communicable diseases to
the same extent as adults. In such rare
circumstances, HHS/CDC will work
with the child’s parent or guardian to
ensure that the rights accorded to any
individual subject to Federal isolation
or quarantine, such as the opportunity
for an administrative medical review,
are adequately protected.
In addition, and in keeping with
standard public health practice, parents
or guardians while in the presence of
infected minor children may be required
to adhere to infection control
precautions for their own protection.
Such protections may include wearing
personal protective equipment (such as
a mask) while in close proximity to the
child/minor to avoid further
transmission of the illness. In extremely
rare circumstances, such as a child
infected with Ebola, the risk may be too
great to allow a parent to remain with
a child; however, every effort will be
made to facilitate communication
between a parent and a minor child
through the least restrictive means, for
example, through the use of technology.
One commenter asked about HHS/
CDC obtaining the consent of a parent
or legal guardian prior to the medical
examination, quarantine, or treatment of
minors. We respond that HHS/CDC will
adhere to all applicable laws regarding
the medical examination or treatment of
minors. If minors are traveling
unaccompanied by a parent or legal
guardian and are believed to be infected
with or exposed to a quarantinable
communicable disease, HHS/CDC will
use its best efforts to contact a parent or
guardian to obtain consent prior to
medical examination. In addition, HHS/
CDC will not restrict a minor’s ability to
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counsel hired by the minor’s parent or
legal guardian. As explained further
below, HHS/CDC will appoint
representatives, including a medical
representative and an attorney, if the
individual (including a minor’s parent
or legal guardian) is indigent and
requests a medical review. HHS/CDC
clarifies, however, that the public health
measures included in this final rule,
including apprehension, examination,
quarantine, and isolation, do not require
a parent or legal guardian’s consent as
a prerequisite to their application.
However, in response to concerns about
informed consent, HHS/CDC has added
regulatory language requiring that the
Director advise the individual that if a
medical examination is required as part
of a Federal order that the examination
will be conducted by an authorized and
licensed health worker with prior
informed consent.
b. Scope and Authority
HHS/CDC received comments from
the public questioning whether HHS/
CDC is a part of the Federal government
and has the authority to propose and
promulgate regulations, or whether the
Agency is a private entity. The
‘‘Communicable Disease Center’’
became part of the U.S. Public Health
Service on July 1, 1946 and is an
Agency within the U.S. Department of
Health and Human Services. For more
information on the history of CDC,
please see http://www.cdc.gov/museum/
timeline/index.html.
HHS/CDC received numerous
comments from the public seeking
clarity on the scope of authority the
Agency has to take actions described in
this regulation. Specifically, HHS/CDC
received comments questioning whether
the authority to detain an individual
may be exercised by a Federal agency of
government, instead of the U.S.
President or Congress. Several
commenters specifically questioned
whether the wording of the regulation
was too ‘‘general’’ and expressed
concern over its potential for abuse. A
public health organization
recommended that HHS/CDC’s
authority should be limited only to
those diseases listed by Executive Order
as quarantinable communicable
diseases. An association suggested that
the proposed rule would vastly increase
the authority of HHS/CDC. One
individual stated that this regulation is
an attempt by HHS/CDC to evade
Congress. One organization speculated
that HHS/CDC plans to request that the
list of quarantinable communicable
diseases be expanded ‘‘to include
measles and other vaccine targeted
diseases for the purpose of

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apprehending and quarantining
travelers entering the US or traveling
between States, who have not been
vaccinated with MMR (measles-mumpsrubella vaccine) and other Federally
recommended vaccines.’’
In response, HHS/CDC first notes that
it cannot—and will not—act beyond the
scope of authority granted by Congress
in statute; HHS/CDC offers the following
clarifications. Under section 361(a) of
the Public Health Service Act (42 U.S.C.
264(a)), the HHS Secretary is authorized
to make and enforce regulations as in
the Secretary’s judgment are necessary
to prevent the introduction,
transmission, or spread of all
communicable diseases from foreign
countries into the States or possessions
of the United States and from one State
or possession into any other State or
possession. Under section 361(b)(42
U.S.C. 264(b)), the authority to issue
regulations authorizing the
apprehension, examination, detention,
and conditional release of individuals is
limited to those communicable diseases
specified in an Executive Order of the
President, i.e., ‘‘quarantinable
communicable diseases.’’ The authority
for carrying out these regulations has
been delegated from the HHS Secretary
to the CDC Director, who in turn
delegated these authorities to HHS/
CDC’s Division of Global Migration &
Quarantine (DGMQ). These
quarantinable communicable diseases
are currently limited to cholera,
diphtheria, infectious tuberculosis (TB),
plague, smallpox, yellow fever, and
viral hemorrhagic fevers (such as
Marburg, Ebola, Lassa fever, and
Crimean-Congo), severe acute
respiratory syndromes, and influenza
caused by novel or re-emergent
influenza viruses that are causing or
have the potential to cause a pandemic.
See Executive Order 13295 (April 4,
2003), as amended by Executive Order
13375 (April 1, 2005) and Executive
Order 13674 (July 31, 2014). Changes to
the list of quarantinable communicable
diseases are beyond the scope of this
regulation. And again, we reemphasize
that HHS/CDC does not intend, through
these regulations, to mandate
vaccination or compulsory medical
treatment of individuals.
One commenter supported the
international proposals (part 71), but
urged HHS/CDC to remove the domestic
portion (part 70) of this regulation. We
disagree. HHS/CDC’s authorities apply
to all travelers in the United States,
regardless of citizenship or residency,
and are intended to complement State
authorities within their jurisdictions by
providing a mechanism to prevent
importation of communicable disease

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from other countries as well as spread
of communicable disease between States
and between States and territories.
Thus, HHS/CDC’s and States’
authorities together create a
comprehensive system to protect the
public from communicable disease
threats including in situations such as
interstate travel when a single State’s
authorities may be inadequate to
address the communicable disease
threat.
Several commenters suggested that
HHS/CDC has the authority to
unilaterally change or update the list of
quarantinable communicable diseases.
Other commenters requested that the
list be narrowed to only those diseases
with a ‘‘high mortality rate.’’ HHS/CDC
reemphasizes that, as prescribed by
statute, the list of quarantinable
communicable diseases may only be
changed by Executive Order of the
President and that such suggestions are
beyond the scope of this final rule.
HHS/CDC received several comments
on the Agency’s accountability system,
encouraging that a ‘‘strong system of
checks and balances’’ should be in place
for this regulation to be implemented.
HHS/CDC agrees that there should be
accountability and oversight regarding
the agency’s activities. We note that
these regulations do not affect the
ability of Congress to conduct its
oversight activities or affect the
jurisdiction of federal courts to review
federal agency actions under the
Administrative Procedure Act (5 U.S.C.
704).
HHS/CDC received a comment that
there is no court supervision of HHS/
CDC activities. We disagree. These
regulations do not affect the jurisdiction
of the Federal courts or the statutory
rights of individuals to obtain judicial
review of CDC’s actions and decisions
through appropriate mechanisms such
as the habeas corpus statute (28 U.S.C.
2241) or the Administrative Procedure
Act (5 U.S.C. 704).
Some commenters questioned the
need for HHS/CDC to use its authorities
if the threat of death is minimal
compared with the size of the
population, listing illnesses such as
chickenpox, pertussis, Zika, the
common cold and flu, and leprosy. One
organization suggested that, through the
language of the NPRM, HHS/CDC was
‘‘equating’’ non-quarantinable diseases
with quarantinable diseases. Another
commenter suggested that HHS/CDC’s
authority to act should be based on the
mortality of the illness, rather than
whether or not it appears on the list of
quarantinable communicable diseases.
HHS/CDC thanks the commenters for

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consideration of the proposal as well as
the input provided.
First, we note that HHS/CDC only has
authority to quarantine or isolate
individuals who have illnesses that are
listed by Executive Order of the
President as quarantinable
communicable diseases. HHS/CDC does
not have the ability or authority to
unilaterally modify the list of
quarantinable communicable diseases.
Second, because HHS/CDC also has
statutory authority to prevent the
‘‘introduction, transmission, and
spread’’ of communicable diseases,
HHS/CDC may take actions other than
quarantine or isolation to protect the
public’s health. These other actions may
include contact tracing investigations to
notify individuals to seek proper
treatment if they have been exposed to
a communicable disease, even if the
disease is not listed by Executive Order
as quarantinable. HHS/CDC does not
seek to compel vaccination or medical
treatment. In keeping with current
practice, HHS/CDC recommends certain
vaccines for post-exposure prophylaxis
and individuals may choose to follow
these recommendations as they deem
appropriate.
Other commenters questioned why
diseases such as Ebola, measles, and
Zika—three very different diseases with
three very different effects on
individuals—are used to support the
same regulatory provisions. One
organization quoted the NPRM, citing
correctly that while measles is not a
quarantinable communicable disease, it
was used in the NPRM to support the
need for this updated regulation. HHS/
CDC welcomes the opportunity to
provide further clarification.
The proposed rule provides HHS/CDC
with a number of options for public
health interventions based on a public
health risk assessment of the
communicable disease in question and
the situation at hand. These
interventions could include conducting
a contact investigation on an airplane or
vessel if a person with a serious
communicable disease was known to
have traveled on the airplane or vessel.
These contact investigations are similar
to those conducted by health
departments in community settings. In
addition to these interventions, for the
nine communicable diseases currently
designated by Executive Order as
quarantinable communicable diseases,
HHS/CDC may apprehend, detain,
examine, quarantine, isolate, or
conditionally release individuals for
purposes of preventing communicable
disease spread. Ebola and infectious
tuberculosis are examples of
quarantinable communicable diseases.

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HHS/CDC also provides the public
with recommendations to address other
communicable diseases of public health
concern. Zika is a good example of a
disease of public health concern
because of the ways it can be spread,
e.g., through mosquitoes, sexual
transmission, and maternal-fetal
transmission. Therefore, HHS/CDC has
recommended avoiding mosquito bites,
protecting against sexual transmission,
and for pregnant women to avoid travel
to areas where Zika is spreading.
Another example is seasonal influenza,
which is very contagious but also very
common; therefore, HHS/CDC makes
recommendations for people sick with
flu-like symptoms to stay home from
work or school and take basic
precautions such as covering their
coughs and sneezes and washing their
hands. In all situations, HHS/CDC
considers how common and severe the
communicable disease is, how it is
transmitted, and what interventions are
available and appropriate before making
recommendations or taking action to
protect the health of the public.
One commenter questioned why
HHS/CDC was not able to currently
control all communicable diseases,
specifically leprosy. While HHS/CDC
works regularly and continuously with
other Federal, State, local and tribal
health departments to eliminate the
introduction, transmission and spread
of all communicable disease, outbreaks
can and do still occur. HHS/CDC staff
have experienced first-hand the impact
of globalization on public health. The
rapid speed and tremendous volume of
international and transcontinental
travel, commerce, and human migration
enable microbial threats to disperse
worldwide in 24 hours—less time than
the incubation period of most
communicable diseases. These and
other forces intrinsic to modern
technology and ways of life favor the
emergence of new communicable
diseases and the reemergence or
increased transmission of known
communicable diseases.
HHS/CDC received many comments
regarding measles and the need to apply
public health measures to prevent the
transmission and spread of the disease.
We note also that while measles may be
transmissible during travel, it is not one
of the quarantinable communicable
diseases listed by Executive Order of the
President. Therefore, while HHS/CDC
may recommend post-exposure
prophylaxis, or other ways to manage
and prevent spread, we do not have the
authority to apprehend, examine,
detain, or conditionally release
individuals who may have measles, nor
those who may have been exposed. See

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80 FR 16,400 (Mar. 27, 2015)(describing
air travel restrictions that may be
applicable to a passenger who would
represent a threat to public health).
HHS/CDC believes that requesting
that DHS restrict the air travel of
persons with measles is warranted
because measles is a serious and highly
contagious communicable disease that
would pose a public health threat
during travel. People exposed to
measles who are not immune to the
infection and have not been vaccinated
following the exposure are advised to
delay their travel voluntarily until they
are no longer at risk of becoming
infectious.
A number of commenters suggested
that the proposed regulations are
unconstitutional or in violation of the
‘‘Nuremberg Code,’’ the United Nations
Educational, Scientific and Cultural
Organization (UNESCO), the Universal
Declaration on Bioethics and Human
Rights, the Geneva Convention, human
rights in general, and/or civil liberties in
general because they ostensibly
authorize compulsory medical treatment
without informed consent. Commenters
also cited numerous Supreme Court
cases purportedly in support of these
claims, such as Mills v. Rogers, 457 U.S.
291 (1982), (curtailing the involuntary
administration of anti-psychotic drugs
to mental patients); Vacco v. Quill, 521
U.S. 793 (1997) (constitutionality of an
assisted suicide ban); Washington v.
Harper, 494 U.S. 210 (1990)
(involuntary administration of antipsychotic drugs to prison inmates); Sell
v. United States, 539 U.S. 166
(2003)(upholding certain strict due
process protections before any
involuntary administration of antipsychotic drugs to incarcerated
prisoners can be made); and Canterbury
v. Spence, 409 U.S. 1064 (1972)(duty of
doctors to obtain informed consent).
HHS/CDC disagrees and re-asserts that
this final rule does not authorize
compulsory medical treatment,
including compulsory vaccination,
without informed consent.
These regulations do not violate or
take away any recognized rights
guaranteed by the U.S. Constitution or
applicable international agreements.
While HHS/CDC has successfully
responded to outbreaks of
communicable diseases, such as Ebola,
these regulations will improve HHS/
CDC’s future ability to prevent the
introduction, transmission, and spread
of communicable diseases, through such
mechanisms as improved reporting of
illnesses and public health prevention
measures at airports. While many of
these activities have been carried out in
the past through internal operating

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procedures, these regulations improve
the public’s awareness and
understanding of HHS/CDC’s activities
to protect the public’s health.
One commenter expressed concerns
about religious exemptions for
mandatory vaccination or treatment. In
response, HHS/CDC notes that these
regulations do not authorize compulsory
vaccinations or medical treatment.
While HHS/CDC will implement these
regulations in a manner consistent with
respecting the religious rights of
individuals, religion is not a basis for
exempting individuals from the
provisions of these regulations,
including those provisions relating to
quarantine and isolation.
One commenter raised similar
concerns that the regulations may lead
to apprehensions based on factors
unrelated to public health such as
wearing of religious garb or reading of
certain newspapers. HHS/CDC agrees
that public health actions should not be
taken based on factors unrelated to
protecting the public’s health and these
regulations do not authorize such
actions. Additionally, these regulations
strike the appropriate balance between
individual liberties and public health
protection.
Several commenters questioned
whether quarantine and isolation may
be carried out consistent with the
Fourth Amendment to the U.S.
Constitution. One commenter also
suggested that implementation of public
health prevention measures at airports
would lead to ‘‘unreasonable searches
and seizures’’ under the Fourth
Amendment. HHS/CDC disagrees with
these assertions. The Fourth
Amendment protects the rights of
persons to be free in their persons,
houses, papers, and effects, against
unreasonable government searches and
seizures. HHS/CDC notes that at ports of
entry, routine apprehensions and
examinations related to quarantine and
isolation may fall under the bordersearch doctrine, which provides that, in
general, searches conducted by CBP
officers at the border are not subject to
the requirements of first establishing
probable cause or obtaining a warrant.
See United States v. Roberts, 274 F.3d
1007, 1011 (5th Cir. 2001); see also
United States v. Bravo, 295 F.3d 1002,
1006 (9th Cir. 2002) (noting that only in
circumstances involving extended
detentions or intrusive medical
examinations have courts required that
border searches be premised upon
reasonable suspicion). Similarly,
apprehensions and examination of
persons traveling interstate under this
rule are authorized under the specialneeds doctrine articulated by the

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Supreme Court in Skinner v. Railway
Labor Executives’ Ass’n, 489 U.S. 602
(1989) because of the ‘‘special need’’ in
preventing communicable disease
spread. Furthermore, to the extent that
‘‘probable cause,’’ rather than ‘‘special
needs,’’ would be the applicable Fourth
Amendment standard, HHS/CDC
contends that meeting the requirements
of 42 U.S.C. 264 satisfies this standard.
See Villanova v. Abrams, 972 F.2d 792,
795 (7th Cir.1992)(noting that probable
cause for emergency civil commitment
exists where ‘‘there are reasonable
grounds for believing that the person
seized is subject to the governing legal
standard.’’). HHS/CDC further
acknowledges that any searches and
seizures of individuals must be
reasonable under the circumstances.
HHS/CDC reiterates that this final rule
does not authorize compulsory medical
treatment, including vaccination,
without informed consent.
HHS/CDC received a comment citing
Missouri v. McNeely, where the U.S.
Supreme Court ruled that police must
generally obtain a warrant before
subjecting a drunken-driving suspect to
a blood test, and that the natural
metabolism of blood alcohol does not
establish a per se exigency that would
justify a blood draw without consent. In
response, HHS/CDC notes that courts
have recognized that while the
requirements for probable cause and a
warrant generally apply in a criminal
context, these standards do not apply
when the government is conducting a
non-law enforcement related activity.
See Nat’l Treasury Employees Union v.
Von Raab, 489 U.S. 665 (1989)
(reaffirming the general principle that a
government search may be conducted
without probable cause and a warrant
when there is a special governmental
need, beyond the normal need for law
enforcement). HHS/CDC reiterates that
the special-needs doctrine articulated by
the Supreme Court in Skinner v.
Railway Labor Executives’ Ass’n., 489
U.S. 602 (1989) provides the appropriate
legal standard under the Fourth
Amendment for apprehensions and
detentions under this final rule.
Several commenters also questioned
whether the regulations are consistent
with the requirements of the Fifth and
Sixth Amendments to the U.S.
Constitution. We note at the outset that
the Sixth Amendment only applies to
criminal proceedings and thus would be
inapplicable to isolation and quarantine
decisions which are public health
protection measures unrelated to the
normal needs of law enforcement.
Furthermore, HHS/CDC asserts that this
final rule is consistent with the
requirements of due process embodied

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in the Fifth Amendment to the U.S.
Constitution. Specifically, procedural
safeguards contained in the final rule
include: (1) A requirement for written
orders of quarantine, isolation, or
conditional release, including
translation or interpretation services as
needed; (2) mandatory review of the
Federal order after the first 72 hours; (3)
notifying individuals through the
written order of their right to request a
medical review; (4) an opportunity at
the medical review for the detained
individual to be heard through an
attorney or other advocate hired at their
own expense, present experts or other
witnesses, submit documentary or other
evidence; and confront and crossexamine any government witnesses; (5)
a decision-maker independent of those
who authorized the original isolation,
quarantine, or conditional release; (6) a
written statement by the fact-finder of
the evidence relied upon and the
reasons for the decision; (7)
appointment of representatives,
including a medical representative and
an attorney, if the individual is indigent
and requests a medical review; and (8)
timely notice of the preceding rights.
See Vitek v. Jones, 445 U.S. 480 (1980);
Matthews v. Eldridge, 424 U.S. 319
(1976).
HHS/CDC also received a comment
that quarantine violates the guarantees
of substantive due process under the 5th
Amendment to the U.S. Constitution.
HHS/CDC disagrees. In addition to a
guarantee of fair procedures, the U.S.
Supreme Court has interpreted the Fifth
Amendment’s Due Process Clause as
containing a substantive component
barring certain arbitrary, wrongful
government actions regardless of the
fairness of the procedures used to
implement them. See Zinermon v.
Burch, 494 U.S. 113, 125 (1990). HHS/
CDC notes that the quarantine of
individuals who have been exposed to
a communicable disease, but are not yet
capable of transmission is a well-known
and accepted public health strategy of
long standing. See Jacobson v.
Massachusetts, 197 U.S. 11, 25 (1905)
(recognizing the power of States to issue
‘‘quarantine laws and health laws of
every description’’); Compagnie
Francaise de Navigation a Vapeur v.
State Bd. of Health, Louisiana, 186 U.S.
380, 396 (1902) (discussing the 1893
Federal quarantine statute). The
restrictions on individuals authorized
under this regulation are justified by the
benefits to the public health.
HHS/CDC received a comment that
quarantine and isolation are State police
powers that should not be exercised at
the Federal level. While HHS/CDC
acknowledges that the States have

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primary authority for quarantine and
isolation within their borders, the
Federal government has an important
and longstanding role in preventing
communicable disease spread at ports of
entry and interstate. This authority is
reflected in 42 U.S.C. 264 and consistent
with principles of Federalism.
HHS/CDC received one comment
stating that it should conduct a
Federalism analysis because
implementing the rule will require
working with State health officials and
resources. Under Executive Order
13132, a Federalism analysis is required
if a rulemaking has federalism
implications, would limit or preempt
State or local law, or imposes
substantial direct compliance costs on
State or local governments. Under such
circumstances, a Federal agency must
consult with State and local officials.
Federalism implications is defined as
having substantial direct effects on State
or local governments, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Under 42 U.S.C.
264(e), Federal public health regulations
do not preempt State or local public
health regulations, except in the event
of a conflict with the exercise of Federal
authority. Other than to restate this
statutory provision, this rulemaking
does not alter the relationship between
the Federal government and State/local
governments as set forth in 42 U.S.C.
264. While HHS/CDC acknowledges that
portions of this rule may involve HHS/
CDC ‘‘working with State health
officials’’ to better coordinate public
health responses, the rule is consistent
with 42 U.S.C. 264(e) and there are no
provisions that impose direct
compliance costs on State and local
governments. The longstanding
provision on preemption in the event of
a conflict with Federal authority (42
CFR 70.2) is left unchanged by this
rulemaking. Therefore, HHS/CDC
believes that the rule does not warrant
additional consultation under Executive
Order 13132.
HHS/CDC received several questions
asking who would be responsible for the
enforcement of these regulations. One
commenter questioned whether HHS/
CDC would use ‘‘militarized police or
create [an] armed Federal police force to
carry out these actions.’’ As explained
elsewhere, in keeping with current
practice and existing law, law
enforcement support for quarantine or
isolation orders will generally be
provided by U.S. Customs and Border
Protection, U.S. Coast Guard, or other
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HHS/CDC may also accept voluntary
State and local assistance in enforcing
its Federal orders. HHS/CDC will also
continue to enforce its regulations in a
manner consistent with the Fourth
Amendment and other provisions of the
U.S. Constitution.

an infected individual to another
individual.’’ Thus, HHS/CDC clarifies
that indirect transmission of an
infectious agent may include
transmission via an insect vector as
described by the commenter. This
definition is finalized as proposed.

c. Definitions

Conditional Release
HHS/CDC received many comments
on the proposed definition and
provision regarding Conditional
Release; a substantive discussion of
these comments is presented in the
section below titled Requirements
Relating to Issuance of a Federal Order
for Quarantine, Isolation, or Conditional
Release.
HHS/CDC is modifying the definition
of Conditional Release under section
70.1 to remove the cross-reference to the
definition of surveillance as that term
appears in current section 71.1. The
definition of Conditional Release under
section 70.1 tracks the definition of
surveillance under section 71.1 and
means ‘‘the temporary supervision by a
public health official (or designee) of an
individual or group, who may have been
exposed to a quarantinable
communicable disease to determine the
risk of disease spread and includes
public health supervision through inperson visits, telephone, or through
electronic or internet-based
monitoring.’’ HHS/CDC is making this
change to improve clarity and remove
the need for the public to crossreference the definition of surveillance
to understand the definition of
Conditional Release as used in section
70.1.
This definition of Conditional Release
under section 71.1 is finalized as
proposed.

Agreements
HHS/CDC received many comments
on the definition of Agreement, largely
expressing confusion and concern that
such agreements would not be truly
voluntary. The intent of this provision
was to provide HHS/CDC with an
additional tool to facilitate cooperation
from individuals in regard to
recommended public health actions. In
response to public comments, however,
HHS/CDC has withdrawn this definition
and will not issue the proposed
provisions on ‘‘Agreements.’’
Airline
HHS/CDC did not receive public
comment on the proposed definition of
Airline. However, consistent with HHS/
CDC’s intent that this definition apply
to common air carriers, to improve
clarity, we have removed the phrase
‘‘including scheduled or public charter
passenger operations operating in air
commerce within the United States’’
and removed the reference to 49 U.S.C.
40102(a)(3).
Apprehension
HHS/CDC received many comments
on the proposed definition and
provision regarding Apprehension; a
discussion of these comments is in the
section below titled, ‘‘Apprehension
and Detention of Persons with
Quarantinable Communicable
Diseases.’’ The definition is finalized as
proposed.

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Commander
HHS/CDC did not receive public
comment on the proposed definition of
Commander. Therefore, this definition
is finalized as proposed.
Communicable Stage
HHS/CDC received a comment
seeking clarity regarding the definition
of Communicable Stage. The
commenter stated that the definition for
communicable stage may unnecessarily
restrict social distancing powers
because it appears limited to human-tohuman transmission and does not
include human transmission via an
intermediate vector, such as mosquitoes
or flea bites. HHS/CDC disagrees. The
definition of communicable stage
includes transmission of an infectious
agent either ‘‘directly or indirectly from

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Contaminated Environment
HHS/CDC did not receive public
comment on the proposed definition of
Contaminated Environment. Therefore,
this definition is finalized as proposed.
Conveyance
HHS/CDC did not receive public
comment on the proposed definition of
Conveyance. Therefore, this definition
is finalized as proposed.
Electronic or Internet-Based Monitoring
HHS/CDC received many comments
on the proposed definition and
provision regarding Electronic or
Internet-based monitoring. We have
modified this definition as follows:
‘‘mechanisms or technologies allowing
for the temporary public health
supervision of an individual under
conditional release and may include
communication through electronic mail,

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SMS texts, video or audio conference,
webcam technologies, integrated voiceresponse systems, or entry of
information into a web-based forum;
wearable tracking technologies; and
other mechanisms or technologies as
determined by the Director or
supervising State or local health
authority.’’
Several commenters expressed
privacy concerns because conditional
release of exposed or ill individuals may
be accomplished over the internet or
through electronic monitoring. Other
commenters expressed concerns about
privacy, having misunderstood the
proposed rule as authorizing HHS/CDC
to conduct invasive surveillance of
personal communications such as
emails, text messages, and telephone
calls. Commenters also expressed
concerns related to the use of webcams
and wearable tracking technologies as
an option for monitoring of exposed
people. One association viewed this
proposed provision as an expansion of
CDC’s ‘‘electronic monitoring of
personal information, under the guise of
protecting the public against rare,
isolated outbreaks of disease.’’
HHS/CDC appreciates the opportunity
to address these concerns. CDC’s intent
was to describe mechanisms that HHS/
CDC or other public health authorities
can use to communicate with
individuals for the purpose of
conducting monitoring following
exposure to a quarantinable
communicable disease. These
mechanisms are intended as alternatives
to in-person interviews because of the
inconvenience and logistical problems
that may arise when meeting in-person.
During the 2014–2016 Ebola response,
HHS/CDC recommended ‘‘active
monitoring’’ defined as daily
communication between public health
authorities and the individuals being
monitored. HHS/CDC did not specify
how this communication should occur,
and health departments used a variety
of electronic technologies for this
purpose including those listed in the
regulation. HHS/CDC also
recommended ‘‘direct active
monitoring’’ for people with certain
higher levels of exposure. This involved
having a public health official check in
with the person through direct
observation rather than relying on
phone calls or electronic
communications. Webcams were used
by some health departments as an
alternative to in-person visits to observe
the person taking his or her
temperature. The webcam was only
operational during this scheduled
public health ‘‘visit.’’ The use of
webcams proved convenient for both

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the health departments and the people
being monitored, especially if the
people lived in remote areas. Webcams
are also used routinely by health
departments for ‘‘directly observed
therapy’’ for diseases like tuberculosis
(TB), in order to watch patients take
their TB medications. HHS/CDC has
clarified the regulatory text to state that
these technologies will be used for
communicating with the individual and
not as a means of monitoring the
individual’s personal communications.
One commenter asked whether HHS/
CDC would ‘‘assist with payment for
internet services’’ if webcam
communications was required. In
keeping with current practice, if an
individual does not have access to
internet services, HHS/CDC may use
alternative methods to assist with
communication, such as the issuance of
a cellular phone. Some organizations
also expressed concerns about the use of
technologies such as cellular phones or
wearable tracking technologies for the
purpose of electronic monitoring. HHS/
CDC acknowledges that the use of
wearable tracking technology may be
necessary in rare situations when a
person does not comply with the
required monitoring or when it is
necessary to know the physical
whereabouts of the person to ensure that
they are not in a public place. While
HHS/CDC acknowledges that public
health surveillance of ill or exposed
individuals through electronic
monitoring may raise some privacy
concerns, HHS/CDC believes that
protecting the public’s health outweighs
these concerns.
HHS/CDC is committed to protecting
the privacy of personally identifiable
information collected and maintained
under the Privacy Act of 1974. As
detailed in the preamble of the proposed
rule, on December 13, 2007, HHS/CDC
published a notice of a new system of
records under the Privacy Act of 1974
for its conduct of activities under this
final rule (72 FR 70867). HHS/CDC
accepted public comment on its
proposed new system of records at that
time. As required under the Privacy Act,
HHS/CDC described in its notice the
proposed system of records, the purpose
for the collection of the system data, the
proposed routine uses (i.e., disclosures
of system data that are compatible to the
purpose for the data collection), the
benefits and need for the routine use of
this data, our agency’s policies,
procedures, and restrictions on the
routine use disclosure of this
information, and, most importantly, our
safeguards to prevent its unauthorized
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Under this system of records, CDC
will only release data collected under
this rule and subject to the Privacy Act
to authorized users as legally permitted.
HHS/CDC will take precautionary
measures including implementing the
necessary administrative, technical and
physical controls to minimize the risks
of unauthorized access to medical and
other private records. In addition, HHS/
CDC will make disclosures from the
system only with the consent of the
subject individual or, in accordance
with the routine uses published at 72 FR
70867, or as allowed under an exception
to the Privacy Act. Furthermore, HHS/
CDC will apply the protections of the
SORN to all travelers regardless of
citizenship or nationality. Finally, such
records will be stored and maintained in
keeping with the official Records
Control Schedule as set forth by the
National Archives and Records
Administration. For more information,
please see https://www.archives.gov/
records-mgmt/rcs.
Ill Person
We have modified the definition of Ill
person under 71.1 to include a person
who ‘‘(b)(2) Has a fever that has
persisted for more than 48 hours; or
(b)(3) Has acute gastroenteritis, which
means either diarrhea, defined as three
or more episodes of loose stools in a 24hour period or what is above normal for
the individual, or vomiting
accompanied by one or more of the
following: One or more episodes of
loose stools in a 24-hour period,
abdominal cramps, headache, muscle
aches, or fever (temperature of 100.4 °F
[38 °C] or greater).’’ This language was
quoted verbatim in the preamble of the
NPRM at 81 FR 54305 but was
inadvertently omitted from the
proposed regulatory text.
HHS/CDC received comments
regarding the updated definition of Ill
person which flight crews use to report
to the CDC occurrences of illnesses in
passengers or crew during travel.
Specifically, commenters expressed
concern that ‘‘non-medical personnel’’
such as flight attendants would report
such observations; others questioned
whether the definition is too broad and
may result in over-reporting of nonthreatening illnesses; others worried
that it could lead to unnecessary
apprehensions of individuals. One
commenter claimed to be ‘‘chemical
sensitive,’’ and worried that he or she
may be penalized for having a reaction
from sitting next to someone on a plane
wearing a ‘‘strong fragrance.’’ HHS/CDC
thanks the commenters for considering
the proposal and providing feedback.

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HHS/CDC clarifies that the purpose of
the ill person definition is to align with
current global and accepted detection
and reporting practices so that onboard
deaths and illnesses are reported by
airlines and, where necessary,
investigated by HHS/CDC. We note that
the ill person definition in this final rule
is consistent with the internationally
recognized and accepted illness
reporting guidelines published by the
International Civil Aviation
Organization (ICAO). This practice is
not new, but has been used successfully
for many years by aircraft and vessel
crews to assist public health officials in
preventing further transmission and
spread of communicable disease.
HHS/CDC also does not intend to
apprehend individuals based solely on
their meeting the definition of an ill
person. The purpose of an illness report
is to allow trained HHS/CDC public
health and medical officers to determine
whether an illness occurring onboard a
flight or voyage necessitates a public
health response. In contrast, an
apprehension of an individual is based
on a variety of criteria in addition to an
illness report including: Clinical
manifestations, contact or suspected
contact with infected individuals, host
susceptibility, travel to affected
countries or places, or other evidence of
exposure to or infection with a
quarantinable communicable disease.
Thus, HHS/CDC disagrees that the ill
person definition will lead to
unnecessary apprehensions of
individuals.
Several commenters noted that the
symptoms listed in HHS/CDC’s
definition of an ill person are common
symptoms of many non-threatening
conditions, and thus questioned their
inclusion in the definition. HHS/CDC
appreciates the opportunity to respond
to these concerns. The symptoms listed
in HHS/CDC’s ill person definition are
provided for airlines and vessels to
report to HHS/CDC so that HHS/CDC
can make a public health risk
assessment; the symptoms alone would
not result in issuance of a public health
order. In making such an assessment,
HHS/CDC medical and public health
officers consider the symptoms as well
as the medical history of the person and
any possible exposures that could
indicate that the person may be infected
with a quarantinable communicable
disease.
A few commenters stated that the
definition of ill person appears to
expand the scope of HHS/CDC’s
authority beyond the list of
quarantinable communicable diseases
specified through an Executive Order of
the President. HHS/CDC disagrees. The

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purpose of the ill person definition is to
help facilitate the identification,
particularly by flight crews, of
communicable diseases of public health
concern. Thus, HHS/CDC has defined ill
person in such a way that the term may
be understood by non-medically trained
crewmembers. While the reporting of an
ill person onboard a flight may trigger
a public health evaluation by a trained
quarantine officer in consultation with
an HHS/CDC medical officer, such
reporting does not expand the basis
upon which an ill person may be subject
to apprehension, detention, or
conditional release. As noted by the
commenter, such public health actions
are limited to those quarantinable
communicable diseases specified
through an Executive Order of the
President (e.g., cholera, diphtheria,
infectious tuberculosis, yellow fever,
viral hemorrhagic fevers, Severe Acute
Respiratory Syndromes, and pandemic
influenza).
A public health association suggested
that any changes to the list of signs and
symptoms within the definition of ill
person should be made available for
public comment. HHS/CDC assumes
this comment is in reference to section
(3) of the definition which provides for
reporting of ‘‘symptoms or other
indications of communicable disease, as
the HHS/CDC may announce through
posting of a notice in the Federal
Register.’’ HHS/CDC appreciates the
opportunity to clarify the purpose of
this section. Section (3) of the ill person
definition is intended to apply only to
new, emerging, and imminent threats to
public health. We expect it will only be
relied on in emergency situations where
a quick response is required to protect
the public. Other circumstances, where
the list of signs and symptoms may
change due to evolving science or
technology, will be made available for
public comment, through a similar
process as this rulemaking—Notices in
the Federal Register—and may also
request input from the public.
A number of commenters noted that
symptoms listed in HHS/CDC’s
definition of an ill person are common
symptoms of many conditions,
particularly ‘‘appears obviously unwell’’
which many commenters requested be
removed from the definition. HHS/CDC
appreciates the opportunity to clarify
that, with the exception of acute
gastroenteritis on vessels, HHS/CDC
only requires reporting of an ill traveler
on an aircraft or vessel if fever
‘‘accompanied by one or more of the
following’’ other symptoms listed are
present. Therefore, as an example,
headache alone would not be sufficient
to require reporting, but rather fever

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plus headache, fever plus cough, fever
plus persistent vomiting, fever plus
persistent diarrhea, etc. These
symptoms combined with fever are
frequently seen in communicable
diseases that could pose a public health
risk to others during travel. Because a
person with fever who also appears
obviously unwell could have a serious
communicable disease, HHS/CDC feels
it is appropriate to retain this symptom,
and further notes that its inclusion
better aligns with Note 1 to the
guidelines set forth by the International
Civil Aviation Organization in
paragraph 8.15 of Annex 9 to the
Convention on International Civil
Aviation.
One public health organization
commented that the definition of ill
person was broad and would be better
issued through agency guidance rather
than a rule. In response, HHS/CDC notes
that the existing regulation contains an
outdated and overly narrow definition
of ill person that does not reflect current
knowledge of communicable diseases,
and that the reporting of ill travelers has
been managed through a combination of
regulation and agency guidance. This
combination of ‘‘required’’ and
‘‘requested’’ reporting has proven
confusing to some airline and vessel
employees and this rule seeks to
mitigate such confusion by including all
relevant symptom clusters in the rule.
Further, HHS/CDC notes that the change
in the ill person definition better aligns
with guidelines set forth by the
International Civil Aviation
Organization and is supported in
comments received from the airline
industry.
One public health organization
commented on the different definitions
of ill person for aircraft and vessels and
recommended that the definitions be
combined and not depend on the mode
of transport. In response, HHS/CDC
wishes to point out three crucial
differences between aircraft and vessels
which HHS/CDC feels justify the
different definitions. One difference,
additionally noted by the commenting
organization, is the difference in time
that a traveler spends on an aircraft and
a vessel which makes the time frame (24
hours) specified in the definition of
acute gastroenteritis for vessels relevant
and minimizes the reporting of travelers
with a single episode of loose stool that
subsequently resolves, a common
occurrence. The second is the high risk
of spread of gastrointestinal infections
onboard vessels that is unlikely to occur
on aircraft; for this reason, reporting of
diarrheal illnesses on aircraft includes
the presence of fever which is more
likely to indicate a serious

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communicable disease, whereas the
definition on vessels includes diarrheal
illness without fever to allow for the
reporting of viral gastrointestinal
illnesses that typically do not cause
fever but have been known to cause
large outbreaks on cruise vessels. The
third difference is the presence onboard
cruise vessels of medical facilities
capable of making a diagnosis of
pneumonia which allows the inclusion
of pneumonia in the vessel definition.
In all other respects, the definitions are
the same. HHS/CDC adds that
combining the definitions would be
confusing to industry professionals
responsible for conducting this
reporting.
One public health organization
provided a recommendation to modify
the description of the ‘‘rash’’ component
in the definition of ill person to ensure
that the term fully encompassed the
range of potential skin rash symptoms.
The organization’s recommendation for
revisions was as follows: ‘‘The
individual has areas on the skin that are
red or purple, flat or bumps; with
multiple red bumps; red, flat spots; or
blister-like bumps filled with fluid or
pus that are intact, draining, or partly
crusted over; or dry and scaling patches.
The rash may be discrete or run
together, and may include one area of
the body, such as the face, or more than
one area.’’
HHS/CDC responds that it will not
change the regulatory text of the ill
person definition with this language
because we are concerned that this
might add too much complexity to the
regulatory definition. However,
consistent with the regulatory definition
of ‘‘ill person,’’ HHS/CDC will update
its reporting guidance for aircraft and
vessels to include this revised
description. Current guidance may be
found at: http://www.cdc.gov/
quarantine/air/reporting-deaths-illness/
guidance-reporting-onboard-deathsillnesses.html.
An air industry commenter suggested
another change to the ill person
definition. The proposed definition
included ‘‘headache with stiff neck,’’
and the commenter suggested that this
be modified to ‘‘severe headache of
recent onset with stiff neck.’’ While
HHS/CDC will not change the regulatory
definition of ill person to accommodate
this change, HHS/CDC believes this is a
useful modification to make in ill
person reporting guidance to aircraft
and vessels.
Incubation Period
HHS/CDC did not receive any
comments on the proposed definition of
Incubation period. However, upon a

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review of the definition, we have
decided that the definition should more
closely track the definition of
Precommunicable stage. For
quarantinable communicable diseases,
the Incubation period is defined as the
Precommunicable stage of the disease.
Thus, we have determined that the two
definitions should more closely align. A
substantive discussion of comments
received concerning the definition of
Precommunicable stage appears below.
Accordingly, we have modified the
definition of Incubation period to add
‘‘or, if signs and symptoms do not
appear, the latest date signs and
symptoms could reasonably be expected
to appear.’’ Other aspects of this
definition are finalized as proposed.
Indigent
HHS/CDC received comments relating
to the proposed definition of Indigent
which is used to determine whether a
detained individual qualifies for
appointment at government expense of
representatives to assist him/her during
a medical review. One comment from a
public health department suggested
raising the threshold for indigent status
to at least 200% of the applicable
poverty guideline. HHS/CDC agrees and
has made this change in the final
regulation.
One commenter opposed including a
definition for indigents and indicated
that HHS/CDC should assume all costs
whenever an individual is placed into
Federal isolation or quarantine. HHS/
CDC disagrees that assuming such costs
without regard to indigence is necessary
or appropriate.
Other substantive comments relating
to the appointment at government
expense of representatives to assist
detained indigent individuals during a
medical review are discussed below.

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Master or Operator
HHS/CDC did not receive any
comments on the definition of Master or
operator. Accordingly, this definition is
finalized as proposed.
Medical Examination
In response to comments received
regarding medical examinations under
sections 70.12 and 71.36, we have
modified the definition of Medical
Examination to indicate that the health
worker conducting the assessment must
be ‘‘licensed.’’ Comments regarding
sections 70.12 and 71.36 are addressed
below.
HHS/CDC received a comment
regarding the definition of Medical
Examination. The commenter stated
that the definition of medical
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health assessment because a mental
health condition may impact an
individual’s appreciation of his or her
public health risk to others. While HHS/
CDC acknowledges that a mental health
assessment may be useful as part of an
individual’s medical care and treatment
and that such an assessment may be
ordered as needed by a treating
clinician, HHS/CDC declines to make
such assessments a formal part of the
medical examination process.
Specifically, because a mental health
assessment is not generally needed to
diagnose or confirm the presence or
extent of infection with a quarantinable
communicable disease, HHS/CDC
disagrees that it is necessary or
appropriate to require such an
assessment as part of a Federal public
health order.
Medical Representative
HHS/CDC received several comments
relating to the proposed definitions of
Medical Representative and Medical
Reviewer as well as the potential use of
HHS/CDC employees as representatives
or medical reviewers. One commenter
suggested that it would be less
problematic for HHS/CDC to allow and
pay for outside participants to serve in
these capacities. First, HHS/CDC notes
that the definition of Medical
representative has been changed to
Representatives and revised as detailed
below. HHS/CDC disagrees with this
comment and notes that the definition
of both Representatives and Medical
reviewer would in fact allow for the
appointment of non-HHS/CDC
employees in these capacities as
suggested by the commenter. For this
reason, both Representatives and
Medical reviewer are broadly defined in
terms of the occupational qualifications
of these individuals. HHS/CDC also
does not consider it problematic to rely
on internal reviewers and notes that it
is not unusual, for instance, for
hospitals to rely on internal decisionmakers when determining whether to
commit a mental health patient on an
emergency basis.
HHS/CDC received a comment that
the ‘‘definition of medical exemption is
not apparent.’’ In response, HHS/CDC
notes that no clarification of what is
meant by ‘‘medical exemption’’ is
provided by the commenter and that
HHS/CDC did not propose adding such
a definition. While these regulations do
not authorize compulsory vaccination or
medical treatment, there is no
recognized ‘‘medical exemption’’ from
quarantine, isolation, or conditional
release and HHS/CDC declines to create
one.

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Non-Invasive
HHS/CDC received several comments
concerning the definition of Noninvasive, including support from a
public health association regarding the
definition. However, several individuals
disagreed with the proposed definition.
In response to public comment that the
definition of ‘‘non-invasive’’ allowed
too much physical contact between the
individual and public health officer,
HHS/CDC has replaced ‘‘physical’’ with
‘‘visual’’ and removed ‘‘auscultation;
external palpation; external
measurement of blood pressure’’ from
the definition. While HHS/CDC
continues to believe that these
procedures qualify as Non-invasive
under the definition, after considering
public comment and a review of
standard operating procedures, HHS/
CDC finds such procedures to be
unlikely to be conducted during a
public health risk assessment. Such
procedures may be conducted at a port
of entry by emergency medical service
personnel as part of a medical
assessment to determine the need for
emergency medical care. We also
modified the definition to clarify that
the individual conducting the public
health risk assessment will be a ‘‘public
health worker.’’ Public health workers
are individuals who have education and
training in the field of public health.
One commenter mentioned that the
new definition of Non-invasive states
that the HHS/CDC could order
laboratory testing under certain
conditions. The commenter further
asserted that forced laboratory testing,
without the option of quarantine
instead, is an invasive measure, and
questioned how this could be in line
with the concept of non-invasive. HHS/
CDC responds that the definition of noninvasive applies to procedures
conducted during a public health risk
assessment at a port of entry and that
this definition does not authorize
forcible or invasive procedures to
extract human biological samples for
laboratory testing. Should laboratory
testing be needed for a person
reasonably believed to be infected with
a quarantinable communicable disease,
such testing would be done as part of a
medical examination conducted at a
healthcare facility and performed with
the patient’s informed consent. HHS/
CDC has added language to the
regulatory text requiring that the
Director advise individuals of their right
to have medical testing and examination
conducted by an authorized and
licensed health worker and with prior
informed consent. While this regulation
does not authorize forcible testing,

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HHS/CDC may require laboratory test
results demonstrating that a
symptomatic individual is no longer
infectious prior to rescinding a Federal
isolation order.
Precommunicable Stage
HHS/CDC received comments relating
to the definition of Precommunicable
stage. One commenter suggested that
persons in the ‘‘precommunicable
stage’’ of a quarantinable communicable
disease pose no direct threat to the
public’s health. A public health
organization also stated that this
definition should not apply to nonsymptomatic people who have been
exposed to Ebola. HHS/CDC disagrees
with both comments. For instance, a
patient diagnosed with multidrugresistant or extensively drug-resistant
tuberculosis who is not currently
infectious, but who has not been
adequately treated and is thus at high
risk for relapse would be considered to
be in the ‘‘precommunicable stage’’ of
the disease and pose a direct threat to
the public’s health. Similarly, an
individual who is reasonably believed
to have been exposed to Ebola poses a
direct threat.
Several public health organizations
additionally expressed concerns
regarding the use of the
‘‘precommunicable stage’’ definition to
justify quarantine of healthcare workers
caring for patients with quarantinable
communicable diseases such as Ebola or
severe acute respiratory syndromes,
including healthcare workers providing
care in the United States or in other
countries. One such organization further
requested clarification of whether the
rule provides for the needs and
protection of healthcare workers who
voluntarily self-quarantine while
providing care for patients with the
quarantinable communicable diseases
noted above.
In response, HHS/CDC states that it
does not recommend quarantine or
occupational restrictions of healthcare
workers who follow recommended
infection control precautions while
providing care for patients with
quarantinable communicable diseases.
Healthcare workers who do not follow
infection control precautions or who
have had unprotected exposures to
patients with a quarantinable
communicable disease may be subject to
quarantine or occupational restrictions;
these individuals would be afforded the
same due process protections as other
exposed individuals.
Several commenters also questioned
CDC’s proposed definition for
Precommunicable stage stating that it
may result in an apprehension of an

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individual who displays no symptoms
of a communicable illness. In response,
HHS/CDC states that it has defined
Precommunicable stage consistent with
the public health practice of quarantine.
Quarantine refers to the public health
practice of separating and restricting the
movement of individuals who are
reasonably believed to have been
exposed to a communicable disease, but
are not yet ill. In contrast, isolation
refers to the public health practice of
separating and restricting the movement
of individuals who have been exposed
to a communicable disease and are
symptomatic from those who are not
sick.
The definition of Precommunicable
stage is finalized as proposed.
Public Health Emergency
HHS/CDC received several comments
relating to the definition of Public
health emergency. One commenter
stated that use of the term is duplicative
and unnecessary because the term is
used elsewhere in the Public Health
Service Act (42 U.S.C. 247d) and
appears in State-based legislation based
on the Model State Emergency Health
Powers Act. This commenter suggested
that to avoid confusion the term should
be renamed ‘‘Public Health Exigency.’’
HHS/CDC disagrees. Section 361(d) of
the Public Health Service Act (42 U.S.C.
264(d)(1)) authorizes the apprehension
and examination of individuals
traveling interstate who are in the
‘‘precommunicable stage’’ of a
quarantinable communicable disease,
but only if the disease ‘‘would be likely
to cause a public health emergency if
transmitted to other individuals.’’ Thus,
section 361(d) is unique and differs
from how the term public health
emergency is used in other statutes or
provisions of the Public Health Service
Act because it authorizes application of
specific public health measures
(apprehension and examination) to
specific individuals (those in the
precommunicable stage of a
quarantinable communicable disease),
but only if the disease would be likely
to cause a public health emergency.
Thus, HHS/CDC considers it essential to
define public health emergency because
the existence of such an emergency is a
necessary prerequisite to the
apprehension and examination of
individuals in the precommunicable
stage of a quarantinable communicable
disease.
This commenter also suggested that
the definition of public health
emergency contains an oversight
because it does not mention the
potential for an infectious condition
being highly likely to cause ‘‘short- or

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long-term disability.’’ HHS/CDC
disagrees because the definition
includes infectious diseases that are
highly likely to cause ‘‘serious illness’’
if not properly controlled. HHS/CDC
clarifies that ‘‘short- or long-term
disability’’ caused by an infectious agent
would be considered a ‘‘serious illness.’’
This commenter further suggested
that in addition to referencing a public
health emergency declaration by the
HHS Secretary, the definition should
also include similar declarations by the
President under the Stafford Act or
under the National Emergencies Act.
HHS/CDC disagrees. We note first that
the definition of public health
emergency is not limited to those
emergencies declared by the HHS
Secretary. Second, in the event of a
man-made or natural disaster that also
affects public health, the HHS Secretary
may issue a separate declaration under
the Public Health Service Act as was
done in response to the terrorist attacks
of September 11, 2001 and in response
to Hurricane Katrina. Thus, HHS/CDC
does not see a need to also reference
Presidential declarations as suggested
by the commenter.
This commenter also requested
clarification concerning whether the
World Health Organization’s (WHO)
declaration of a Public Health
Emergency of International Concern
(PHEIC) could continue to serve as the
basis for a ‘‘public health emergency’’ if
the President or HHS Secretary
disagreed with the declaration of a
PHEIC on legal, epidemiologic, or policy
grounds. In response, HHS/CDC notes
that the scenario proposed by the
commenter is unlikely, but that CDC
remains a component of HHS, subject to
the authority and supervision of the
HHS Secretary and President of the
United States.
HHS/CDC also received a comment
objecting to referencing the WHO’s
declaration of a Public Health
Emergency of International Concern
(PHEIC) in the definition of ‘‘public
health emergency’’ because this
ostensibly relinquishes U.S. sovereignty.
HHS/CDC disagrees. By including
references to a PHEIC, HHS/CDC is not
constraining its actions or makings its
actions subject to the dictates of the
WHO. Rather, the declaration or
notification of a PHEIC is only one way
for HHS/CDC to define when the
precommunicable stage of a
quarantinable communicable disease
may be likely to cause a public health
emergency if transmitted to other
individuals. While HHS/CDC will give
consideration to the WHO’s declaration
of a PHEIC or the circumstances under
which a PHEIC may be notified to the

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WHO, HHS/CDC will continue to make
its own independent decisions
regarding when a quarantinable
communicable disease may be likely to
cause a public health emergency if
transmitted to other individuals. Thus,
HHS/CDC disagrees that referencing the
WHO determination of a PHEIC results
in any relinquishment of U.S.
sovereignty.
The International Health Regulations
are an international legal instrument
that sets out the roles of WHO and State
parties in identifying, responding to,
and sharing information about public
health emergencies of international
concern. HHS/CDC believes that it
would be unlikely for the United States
to formally object to the WHO’s
declaration of a PHEIC, but that CDC
remains a component of HHS, subject to
the authority and supervision of the
HHS Secretary and President of the
United States.
Also regarding the definition of
‘‘public health emergency,’’ one public
health association expressed concern
that any disease considered to be a
public health emergency may qualify it
as quarantinable. Another commenter
noted that some PHEICs ‘‘most certainly
do not qualify as public health
emergencies’’ under the proposed
definition. HHS/CDC appreciates the
opportunity to clarify. Only those
communicable diseases listed by
Executive Order of the President may
qualify as quarantinable communicable
diseases. For example, Zika virus
infection, which although the current
epidemic was declared a PHEIC by
WHO, is not a quarantinable
communicable disease. The definition
of Public health emergency is finalized
as proposed.
Public Health Prevention Measures
HHS/CDC received one comment
relating to the definition of Public
health prevention measures. The
commenter stated that the second use of
‘‘and other non-invasive means’’ should
be deleted from the definition of public
health prevention measures as
redundant. HHS/CDC disagrees because
‘‘observation, questioning, review of
travel documents, and records review’’
as cited in the definition appears to
materially differ from ‘‘other noninvasive means’’ that may be used as a
part of public health prevention
measures such as temperature checks,
visual observation, or visual
examination of the ear, nose, or mouth.
Accordingly, HHS/CDC believes that the
updated definition provides greater
clarity as written. Further information,
including a discussion regarding
comments received on these proposed

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provisions, is discussed in the section
below titled Public Health Prevention
Measures to Detect Communicable
Disease. The definition is finalized as
proposed.
Qualifying Stage
HHS/CDC received several comments
relating to Qualifying stage. Several
commenters, including one public
health organization, expressed concern
that the definition was either too vague,
too broad, or too confusing. One
commenter suggested that the definition
for Qualifying stage is confusing
because it splits communicable diseases
into a ‘‘precommunicable stage’’ and a
‘‘communicable stage’’ and that a
communicable disease would not be on
the list of Federal quarantinable
communicable diseases if its spread did
not already have some potential to cause
a public health emergency. In response,
HHS/CDC notes that the term
‘‘qualifying stage’’ is defined under 42
U.S.C. 264(d)(2) to include both a
‘‘precommunicable stage’’ and a
‘‘communicable stage’’ and that this
definition explicitly references diseases
‘‘likely to cause a public health
emergency.’’ Thus, while HHS/CDC may
clarify and explain statutory terms
through regulation, it has no authority
to change the language of the statute.
One public health organization
recommended that HHS/CDC policy
implementing the Qualifying stage
definition acknowledge that a one-size
fits all protocol is not appropriate
because different diseases have different
transmission patterns and the need for
isolation and quarantine may differ.
HHS/CDC agrees that the need for
isolation and quarantine may differ
based on the disease and adds that it
conducts a public health risk
assessment before issuing Federal
public health orders. For example, HHS/
CDC does not typically issue Federal
public health orders for cholera, a
quarantinable communicable disease as
defined by Executive Order because the
sanitation infrastructure in the United
States makes cholera transmission
unlikely. HHS/CDC further notes that it
typically conducts the public health risk
assessment in coordination with the
State or local health department of
jurisdiction before issuing a Federal
public health order.
Public health organizations and other
commenters cautioned against
apprehending individuals or issuing
public health orders when the risk of
communicable disease spread during
the precommunicable period is low.
HHS/CDC agrees and further adds that
it will typically conduct a public health
risk assessment in coordination with

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State and local public health officials to
ensure that any restrictions imposed on
an individual are commensurate with
the degree of risk and using the least
restrictive means available.
The definition of Qualifying stage is
finalized as proposed.
Reasonably Believed To Be Infected, as
Applied to Individuals
HHS/CDC received several comments
regarding the definition of Reasonably
believed to be infected, as applied to an
individual. Several public health
organizations expressed concern there
could be undue burden placed on
healthcare facilities or health
departments by greatly expanding the
number of individuals requiring health
screening, medical examination and
testing, or placed under Federal
isolation of quarantine orders. HHS/
CDC disagrees. This rule represents a
codification of current practice and
decisions regarding the need for medical
examination of individuals suspected of
being infected with a quarantinable
communicable disease, including
during an outbreak or public health
emergency, will generally be based on
published disease-specific case
definitions for PUIs (persons under
investigation) that incorporate clinical
and epidemiologic factors. Furthermore,
decisions regarding the issuance of
Federal public health orders or medical
examination for a suspected
quarantinable communicable disease
would typically be made in
coordination with a State or local health
department of jurisdiction. Therefore,
HHS/CDC does not anticipate placing an
undue burden on healthcare facilities or
health departments as a result of these
definitions.
One commenter stated that the
Reasonably believed to be infected, as
applied to an individual definition
allows for apprehension, quarantine, or
isolation based solely on reasonable
inferences that the person was exposed
somehow or in some way to infectious
agents. HHS/CDC disagrees because as
stated in the definition reasonable
inferences may only be drawn from
‘‘specific articulable facts’’ that an
individual has been exposed to an
infectious agent such as through
‘‘contact with an infected person or an
infected person’s bodily fluids, a
contaminated environment, or through
an intermediate host or vector.’’ Thus,
HHS/CDC disagrees that this standard
does not comport with standard public
health practice.
HHS/CDC received a comment from a
public health agency expressing concern
that travel to other countries where
transmission of a quarantinable

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aligns the definition with the
Precommunicable stage definition.
• The definition of Indigent has been
modified to increase the threshold to
200% of the applicable poverty
guidelines.
• The definition of Medical
Examination has been modified to
indicate that the health worker
conducting the assessment must be
‘‘licensed.’’
• The definition of Medical
Representative has been changed to
Representatives and now includes in
addition to the appointment of a
medical professional, the appointment
of ‘‘an attorney who is knowledgeable of
public health practices.’’
• The definition of Non-invasive has
been modified to (1) replace ‘‘physical
examination’’ with ‘‘visual
examination,’’ (2) specify that the
Secretary
individual performing the assessment
must be a ‘‘public health worker (i.e., an
HHS/CDC has added a definition for
individual with education and training
Secretary meaning the Secretary of
in the field of public health)’’ and (3)
Health and Human Services (HHS) or
remove ‘‘auscultation, external
any other officer or employee of that
palpation, external measurement of
Department to whom the authority
blood pressure.’’
involved has been delegated. We note
• A definition for Secretary has been
that while the NPRM did not propose
this definition, the NPRM referenced the added and means ‘‘the Secretary of
Health and Human Services (HHS) or
Secretary in defining Public Health
Emergency. Thus, HHS/CDC considers it any other officer or employee of that
useful to also define the term Secretary. Department to whom the authority
involved has been delegated.’’
After consideration of comments
regarding Definitions, HHS/CDC has
d. Public Health Prevention Measures
made the following changes in the final
To Detect Communicable Disease
rule:
HHS/CDC received support from
• The definition of Agreements has
commenters on screening individuals
been withdrawn.
entering the U.S. from parts of the world
• The definition of Conditional
where highly infectious diseases are
Release under section 70.1 has been
common. One such commenter
modified to remove the internal crossrequested to know the criteria HHS/CDC
reference to the definition of
uses when deciding whether to detain
surveillance under section 71.1. The
definition of Conditional Release under an individual. Another commenter
stated that travel history ‘‘should be a
section 70.1 has been further modified
prerequisite for Federal orders to
to align with the definition of
quarantine’’ and ‘‘medical exam should
surveillance under section 71.1 and
be a prerequisite for Federal orders to
means ‘‘the temporary supervision by a
public health official (or designee) of an isolate.’’ HHS/CDC thanks these
individual or group, who may have been commenters and welcomes the
opportunity to explain this process.
exposed to a quarantinable
HHS/CDC’s decision to detain an
communicable disease to determine the
individual is based on several criteria,
risk of disease spread and includes
including: Clinical manifestations: Signs
public health supervision through inand symptoms consistent with those of
person visits, telephone, or through
a quarantinable communicable disease;
electronic or internet-based
known or suspected contact with cases,
monitoring.’’
i.e., patients either confirmed or
• The definition of Electronic or
suspected to be infected with a
internet-based monitoring has been
quarantinable communicable disease;
modified to indicate ‘‘communication
epidemiologic information/evidence
through’’ such means, and include
(travel history, exposure to animals);
‘‘audio’’ conference.
• The definition of Incubation period other documentary or physical evidence
in the individual’s possession, such as
has been modified to add ‘‘or, if signs
a physician’s note documenting
and symptoms do not appear, the latest
infection with or medication for
date signs and symptoms could
reasonably be expected to appear.’’ This treatment of a quarantinable disease;

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communicable disease has likely
occurred would be the sole basis upon
which HHS/CDC would form a
reasonable belief that an individual may
be infected with a quarantinable
communicable disease. In response,
HHS/CDC clarifies that travel to other
countries was simply used as an
illustrative example. The decision to
place an individual into isolation or
quarantine will ordinarily be based on
several factors, including travel, contact
with an infected person or an infected
person’s bodily fluids, host
susceptibility, and clinical
manifestations. HHS/CDC believes that
this definition is clear and that no
further changes are necessary.
The definition of Reasonably believed
to be infected as applied to an
individual is finalized as proposed.

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and/or public health authorities having
notified HHS/CDC that the individual is
known or suspected to be infected with
a quarantinable communicable disease
and likely non-adherent with public
health recommendations.
HHS/CDC has modified paragraph (b)
of the provisions relating to public
health prevention measures to detect
communicable disease (§§ 70.10 and
71.20) to include information about
‘‘known or possible exposure,’’ in
response to comments requesting
further clarity of CDC’s criteria.
One organization from the airline
industry was generally supportive of
70.10 and 71.20, public health
prevention measures to detect
communicable disease, and requested
that any measures, such as screening,
occur prior to individuals boarding an
aircraft, and preferably prior to arrival at
the gate. HHS/CDC thanks these
commenters for their support. In
response, while an operational plan for
each location has not yet been finalized,
HHS/CDC expects such measures to
occur prior to the boarding of an
aircraft, and to the extent possible, prior
to arrival at the gate. One airline
organization insisted that airline
operators should not be financially
responsible for any costs associated
with screening. HHS/CDC responds that
it does not expect airlines and airline
operators to assume direct costs
associated with public health screening,
such as providing additional personnel
to conduct the screening. However,
indirect costs such as missed flights of
passengers who are detained may occur.
Another airline organization
requested that HHS/CDC ensure waittimes in lines are not impacted by
screening, and encouraged HHS/CDC to
take into account the needs of all
stakeholders. HHS/CDC feels strongly
that in these rare circumstances, which
would only occur should a threat to
public health exist, preventing airline
employees and other passengers from
being exposed to a detained or delayed
individual provides a greater benefit
than the monetary loss of airfare. In
keeping with current practice, HHS/
CDC will work together with public
health partners, carriers, and all who
have equities, to ensure insofar as
possible that the least restrictive and
time-consuming measures are
implemented. Finally, commenters
requested that individuals who refuse to
undergo a public health risk assessment
prior to travel be denied boarding of an
aircraft. In response, HHS/CDC notes
that individuals may be denied boarding
for public health reasons pursuant to the
criteria published at 80 FR 16,400 (Mar.
27, 2015) titled Criteria for Requesting

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Federal Travel Restrictions for Public
Health Purposes, Including for Viral
Hemorrhagic Fevers.
HHS/CDC received a comment
expressing concern about conducting
public health prevention measures at
‘‘other locations’’ besides U.S. ports of
entry because the commenter found this
language vague. HHS/CDC clarifies that
this term is meant to include all
locations where individuals may enter
the United States from a foreign country
(i.e., border crossings) or gather for the
purposes of engaging in interstate travel
(e.g., airports, seaports, railway stations,
bus terminals), regardless of whether
such places are formally designated as
such.
One public health organization
requested clarification regarding what
information or event would justify
triggering the screening of travelers.
CDC’s response is that, while specific
triggers cannot be defined at this time,
screening of travelers may generally be
conducted during a public health
emergency if HHS/CDC determined that
monitoring of potentially exposed
travelers was needed to protect the
public’s health.
One public health organization and
many individual commenters asserted
that people exposed to measles should
not be ‘‘tracked’’ through the use of
Federal public health orders. First, we
reiterate that because measles is not a
quarantinable communicable disease,
HHS/CDC does not have the authority to
issue a public health order for this
illness. Second, it is not HHS/CDC’s
policy to monitor people following
measles exposures. Rather, HHS/CDC
notifies State or local health
departments regarding people in their
jurisdictions who may have been
exposed to measles. The State or local
health departments, in turn, choose to
notify people regarding their measles
exposure, assess their immunity to
measles and, if they are not immune,
offer vaccination with MMR vaccine to
prevent infection. State or local health
authorities may choose to monitor
people following exposures to measles
based on their own criteria.
One commenter asked whether
mandatory health screenings at airports
would be conducted privately, whether
processes would comply with HIPAA,
and how data would be protected at
airports. In response, HHS/CDC states
that, in all situations, HHS/CDC strives
to protect the privacy of individuals
subject to screening, collection of
information, or the issuance of Federal
public health orders under HHS/CDC’s
authority. While some aspects of the
entry risk assessment process conducted
during the 2014–2016 Ebola epidemic

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were performed in areas of the airport
that are not considered private, these
were limited to collection of contact
information, noncontact temperature
measurement, observation for visible
signs of illness, and superficial
screening questions that did not collect
sensitive information. Any more
detailed public health assessment
would be done in a private area.
HHS/CDC is bound by the Privacy Act
to protect personally identifiable data
collected and maintained in accordance
with that Act. Furthermore, HHS/CDC
will apply the protections of the SORN
to all travelers regardless of citizenship
or nationality. Personally identifiable
data collected by HHS/CDC at airports
are maintained in a secure database and
shared only for official purposes on a
need to know basis using secure
methods as described in CDC’s System
of Records Notice published at 72 FR
70867. HHS is also a hybrid entity
under HIPAA, but only those parts of
HHS that have been determined to be
health care components are subject to
the HIPAA Privacy Rule. CDC is
generally not a health care component
treated as a ‘‘covered entity’’ under the
HIPAA Privacy Rule. However, certain
specific offices of HHS, CDC, and the
National Institute for Occupational
Safety and Health (NIOSH) performing
activities related to the World Trade
Center Health Program are considered
health care components of HHS and
must comply with HIPAA and the
Privacy Rule.
One public health organization
recommended that the rulemaking
specify that individuals undergoing a
public health risk assessment only be
asked to provide contact tracing
information if the risk assessment leads
to a reasonable belief that the individual
may become infected. It is CDC’s policy
to conduct conveyance-related contact
investigations for confirmed cases of
communicable diseases. In instances
when confirmation cannot be obtained,
HHS/CDC may investigate contacts
based on reasonable belief of infection
following a public health risk
assessment which is typically
conducted in coordination with the
State or local health department of
jurisdiction. Such operational details
are generally defined in internal
protocols. State or local authorities may
conduct community-based contact
investigations within their jurisdictions
based on their own criteria.
After consideration of these
comments, HHS/CDC has modified
paragraph (b) the provisions relating to
Public Health Prevention Measures to
Detect Communicable Disease (§§ 70.10
and 71.20) to include information about

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‘‘known or possible exposure’’ in the list
of information that may be collected.
e. Apprehension and Detention of
Persons With Quarantinable
Communicable Diseases
HHS/CDC received several comments
relating to the ‘‘apprehension’’ of an
individual. One public health
association and a public health
department suggested that HHS/CDC
not use the term ‘‘apprehension’’
because this may create social stigma.
HHS/CDC uses this term in these
regulations to align with the statutory
terminology used in 42 U.S.C. 264(b)
which authorizes the ‘‘apprehension,
detention, or conditional release’’ of
individuals coming into a State or
possession from a foreign country or
possession for purposes of preventing
the introduction, transmission, and
spread of quarantinable diseases.
Similarly, 42 U.S.C. 264(d) authorizes
the ‘‘apprehension and examination’’ of
any individual in the qualifying stage of
a quarantinable communicable disease
who is moving or about to move
between States or constitutes a probable
source of infection to individuals
moving between States. While HHS/
CDC can clarify and explain this term,
only Congress has the authority to
change statutory language. In addition
to being a term specifically used in
statute under 42 U.S.C. 264, HHS/CDC
has determined that this term best
conveys that HHS/CDC may, based on
public health grounds, assume physical
custody of individuals. Furthermore,
using alternative terminology, may
reduce public understanding and
transparency regarding HHS/CDC’s legal
authorities.
One commenter stated that not every
social distancing technique needs to
involve taking physical custody of
individuals and that using more
voluntary-based options would be
advisable. HHS/CDC agrees that
attempting to obtain voluntary
compliance with public health measures
is more advisable than assuming legal
custody, but believes that maintaining
the authority to apprehend individuals
who may pose a public health risk is a
necessary tool to protect the public’s
health. HHS/CDC received a comment
regarding the ‘‘burden of proof’’ for an
apprehension. In response, HHS/CDC
notes that the applicable standard for an
apprehension of an interstate traveler is
‘‘reason to believe’’ that the individual
is in the qualifying stage of a
quarantinable communicable disease.
HHS/CDC notes that Reasonably
believed to be infected as applied to an
individual is defined under this final
rule.

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Several commenters expressed
concern that because the
‘‘apprehension’’ period is not explicitly
time-limited, that HHS/CDC may
‘‘apprehend’’ an individual indefinitely
without providing the individual with a
written public health order or a medical
review. One commenter noted that
HHS/CDC used the term ‘‘generally’’ in
the preamble of the NPRM and felt it
was too vague, stating ‘‘setting a firm
timeframe is vital.’’ A partnership of
public health legal scholars and
organizations stated that because HHS/
CDC did not explicitly limit how long
an individual could remain
apprehended that such apprehensions
could turn into the functional
equivalent of a quarantine thus
potentially raising Fourth and Fifth
Amendment concerns. In response to
these concerns, HHS/CDC has added
language requiring that it serve an
apprehended individual with a public
health order within 72 hours of that
individual’s apprehension.
HHS/CDC received several other
comments relating to the sections
authorizing the apprehension and
detention of persons with quarantinable
communicable diseases. A partnership
of public health legal scholars and
organizations suggested two public
health frameworks for apprehension and
detention, one for implementation
during non-exigent circumstances and a
second for exigent circumstances. As
described, the primary distinction
between the non-exigent and exigent
framework, is that in the former HHS/
CDC would be required to hold a due
process hearing prior to the imposition
of an isolation or quarantine, while in
the latter HHS/CDC may briefly detain
the individual prior to holding a
hearing. While HHS/CDC appreciates
the input provided by this partnership,
HHS/CDC declines to adopt this
suggestion. Importantly, unlike State
and local public health authorities who
have primary responsibility for the
imposition of public health measures
occurring within their jurisdictions,
HHS/CDC acts in time-sensitive
circumstances to prevent communicable
disease spread, such as at ports of entry,
upon the request of a State or local
public health authority of jurisdiction,
or when State or local control is
inadequate. Furthermore, unlike State
and local public health authorities who
generally have broad police-power
authority to protect the public’s health,
HHS/CDC’s statutory authority with
respect to isolation and quarantine is
limited to only those small, subset of
communicable diseases specified
through an Executive Order of the

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President as quarantinable. Accordingly,
HHS/CDC does not foresee sufficient
‘‘non-exigent’’ circumstances where it
would be necessary for it to issue a
Federal isolation or quarantine order
and thus declines to establish the
suggested alternative framework on this
basis.
The circumstances under which HHS/
CDC may apprehend and detain
individuals is limited by the terms of 42
U.S.C. 264. HHS/CDC may only isolate,
quarantine, or conditionally release an
individual if it reasonably believes that
the individual is infected with a
quarantinable communicable disease
and the individual is either arriving into
the U.S. from a foreign country, moving
between States, or constitutes a probable
source of infection to others who may
then move between States.
Accordingly, the circumstances under
which CDC is would issue a quarantine
or isolation order are ‘‘exigent’’ because
the individual constitutes a
communicable disease risk and is
actively engaged in travel or constitutes
a source of infection to others engaged
in travel. It is thus unnecessary and
impractical to provide a ‘‘predeprivation’’ hearing prior to
quarantining or isolating the individual
because he/she if released from custody
may be lost to public health follow-up
and may expose others. HHS/CDC
would not quarantine or isolate an
arriving traveler from a foreign country
where a single case of a communicable
disease such as Ebola exists unless it
reasonably believes that the traveler
arriving into the U.S. is infected with a
quarantinable communicable disease.
Commenters stated that individuals
must receive notice of their suspected
exposure and be permitted to speak
with legal counsel or have legal counsel
appointed to them. HHS/CDC agrees
that individuals should be adequately
notified of the basis for their detention
and directs this commenter to sections
70.14 and 71.37, which detail the
specific factual content that must be
included in a Federal order for
quarantine, isolation, or conditional
release. We have also modified these
sections to explicitly require that the
federal order include an explanation of
the right to request a medical review,
present witnesses and testimony at the
medical review, and to be represented at
the medical review by either an
advocate (e.g., family member,
physician, or attorney) at the
individual’s own expense, or, if
indigent, to have representatives
appointed at the government’s expense.
As previously stated, consistent with
principles of preventing communicable
disease spread, HHS/CDC will also take

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measures (such as ensuring phone
access) to allow apprehended
individuals to have contact with family
or legal counsel whom they hire at their
own expense. As explained further
below, HHS/CDC will also appoint
representatives, including a medical
representative and an attorney, if the
individual is indigent and requests a
medical review. Individuals who do not
qualify as indigent may also choose to
be represented at the medical review by
an advocate (e.g., an attorney, physician,
family member) and present a
reasonable number of medical experts,
of their own choosing and at their own
expense. HHS/CDC, however, rejects as
impractical the notion that indigent
individuals should have representatives
appointed to them at the moment of
apprehension because most illnesses of
public health concern can be ruled out
based on a short interview with a
quarantine officer involving an
assessment of symptoms and travel
history. Thus, the expected length of an
apprehension will be very short and not
justify the appointment of
representatives.
This commenter also requested clarity
on what legal recourse may be available
to apprehended individuals. While
HHS/CDC does not express an opinion
regarding what form of legal action an
aggrieved individual should pursue, we
note that these regulations do not
impact the constitutional or statutory
rights of individuals to seek judicial
redress for detention.
HHS/CDC received comments from
the public regarding HHS/CDC’s
authority to ‘‘arrest’’ individuals. One
commenter stated that individuals
should only be detained when a crime
has been committed. One association
objected to HHS/CDC’s ‘‘power to detain
an individual for 72 hours and longer
without any Federal court order.’’ Some
commenters also worried that any
person showing signs of a ‘‘common
cold’’ may be held. To be clear, HHS/
CDC is not a law enforcement agency, it
has no legal authority to ‘‘arrest’’
individuals, but rather has been granted
the authority by Congress to ‘‘apprehend
and detain’’ individuals for the
purposes of preventing the introduction,
transmission and spread of
quarantinable communicable disease as
specified in an Executive Order of the
President. 42 U.S.C. 264(b). This
provision further provides that
‘‘regulations may provide that if upon
examination any such individual is
found to be infected, he may be
detained for such time and in such
manner as may be reasonably
necessary.’’ 42 U.S.C. 264(d)(1). HHS/
CDC strongly believes that these

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authorities may be implemented in a
manner consistent with the U.S.
Constitution. Furthermore, during the
period of apprehension, HHS/CDC will
arrange for adequate food and water,
appropriate accommodation,
appropriate medical treatment, and
means of necessary communication.
HHS/CDC received comments from
the public inquiring about the criteria
that HHS/CDC uses to determine
whether an individual should be
detained and assessed. As provided for
in the regulation, HHS/CDC may
apprehend, examine, isolate, and
quarantine such individuals to protect
the public’s health. In determining
whether an individual poses a threat to
public health, HHS/CDC has developed
and uses the following criteria: Clinical
manifestations: Signs and symptoms
consistent with those of a quarantinable
disease; known or suspected contact
with a case, i.e., patients either
confirmed or suspected to be infected
with a quarantinable disease;
epidemiologic information/evidence
(travel history, exposure to animals);
other documentary or physical evidence
in the individual’s possession, such as
a physician’s note documenting
infection with or medication for
treatment of a quarantinable
communicable disease; and/or public
health authorities have notified HHS/
CDC that the individual is known or
suspected to be infected with a
quarantinable communicable disease
and non-adherent with public health
recommendations. This determination is
typically made in consultation and
coordination with State and local public
health authorities, as well as the treating
health care physician (when available).
One public health association agreed
that travel history (entering the U.S.
from a country where quarantinable
diseases occur) made sense for
screening, but not for a quarantine or
isolation order. HHS/CDC responds that
the criteria listed above, as well as those
within the NPRM, are examples of
factors that HHS/CDC takes into
consideration when determining the
totality of the circumstances—not one
criterion does, should, or will, decide if
the individual requires a public health
order.
One commenter questioned whether,
regarding the list of quarantinable
communicable diseases listed by
Executive Order of the President, a
‘‘common cold’’ would qualify as a
‘‘severe acute respiratory syndrome’’
and therefore subject the ill individual
to a public health order. In response, we
note that Executive Order 13295 (April
4, 2003), as amended by Executive
Order 13375 (April 1, 2005) and

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Executive Order 13674 (July 31, 2014),
explicitly excludes ‘‘influenza’’ from the
definition of severe acute respiratory
syndrome.
HHS/CDC received several comments
from a flight attendant union relating to
apprehension and detention of a flight
crew. These comments include that the
flight attendant’s employer should be
made aware of the apprehension, that
HHS/CDC should limit the personal
health information that is shared with
the employer, that the employer should
treat this information as confidential,
and that those apprehended should be
able to notify families and their union.
In response, HHS/CDC notes that it
works closely with the airline industry
regarding potential occupational
exposures to communicable diseases.
Furthermore, HHS/CDC notes that
personally identifiable health
information collected and maintained
under the Privacy Act will be disclosed
only with the consent of the subject
individual, in accordance with the
routine uses published in HHS/CDC’s
system of records notice (72 FR 70867),
or under an applicable exception to the
Privacy Act. While these regulations do
not mandate how employers should
treat the personal health information of
their employees, HHS/CDC agrees that
such information should be treated as
confidential. Lastly, consistent with
principles of preventing communicable
disease spread, HHS/CDC will allow
persons detained in accordance with
these regulations to communicate with
family, union representatives, legal
counsel whom they hire at their own
expense, and others of their choosing.
HHS/CDC will also appoint
representatives, including a medical
representative and an attorney, if the
individual is indigent and requests a
medical review.
One commenter asked about
provisions for people detained under
HHS/CDC’s authority who require
emergency medical care, and whether
the need to conduct a public health
assessment could impede such care
resulting in harm to the individual. In
response, HHS/CDC states that public
health officers at ports of entry work
closely with emergency medical service
(EMS) personnel and that emergency
medical care takes precedence over the
public health risk assessment. When an
individual suspected of being infected
with a quarantinable communicable
disease requires emergency care, the
individual would be transported
immediately by EMS to a medical
facility, using appropriate infection
control precautions. The public health
risk assessment would be completed
subsequently using information

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provided by the examining health care
provider in coordination with the health
department of jurisdiction.
After consideration of these
comments, HHS/CDC has finalized the
Apprehension and Detention of Persons
With Quarantinable Communicable
Diseases (§ 70.6) provision as proposed,
with the exception that Federal public
health orders must be served on the
individual within 72 hours of an
apprehension. As further detailed
below, the 72-hour period was
determined based on public comment
from health departments familiar with
the process, as well as CDC’s previous
experience of the time necessary to
conduct a medical examination, collect
and package laboratory specimens,
transport the specimens to an
appropriate laboratory (when
necessary), and conduct the testing.
f. Medical Examinations
HHS/CDC received several comments
relating to medical examinations. HHS/
CDC received a comment from a public
health agency stating that when an
individual agrees to submit to a medical
examination, it may be more
appropriate to medically examine the
patient during the ‘‘apprehension’’
period. In response, HHS/CDC notes
that these regulations do not prohibit
voluntary compliance with public
health recommendations in the absence
of a public health order.
Notwithstanding, HHS/CDC believes
that the ability to order a medical
examination as part of an order for
isolation, quarantine, or conditional
release is an important tool to protect
the public’s health. This agency also
stated that the definitions of ‘‘health
status’’ and ‘‘public health risk’’ should
be modified to ensure that the medical
examination contains the minimum
requirements needed to assess the
communicable disease of public health
concern. In response, HHS/CDC clarifies
that its sole purpose in ordering a
medical examination would be to
determine the presence, absence, or
extent of infection with a quarantinable
communicable disease. HHS/CDC notes,
however, that the medical examination
is conducted by clinical staff who have
primary responsibility for the patient’s
medical care and treatment and that a
medical examination would thus
ordinarily include the taking of a
medical history and physical
examination. HHS/CDC believes that
this definition is clear and that no
further modifications are needed.
HHS/CDC received a comment
expressing concern that an individual
would not be able to choose his or her
own clinical healthcare provider if

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ordered to undergo a medical
examination. One commenter raised
concerns about the possibility of
medical examinations being conducted
by ‘‘unqualified’’ or ‘‘non-medical
personnel.’’ In response, HHS/CDC
clarifies that, in keeping with current
practice, any medical evaluation
required by HHS/CDC would be
conducted at a healthcare facility by a
licensed healthcare practitioner.
Furthermore, HHS/CDC has determined
that it would be impractical to allow
individuals to choose their own medical
examiners. HHS/CDC notes that among
other considerations, it must ensure that
the healthcare facility where the
medical examination will be conducted
has appropriate containment facilities,
that necessary laboratory samples will
be properly collected, and that it is
HHS/CDC’s practice to coordinate
closely with State and local public
health authorities in the choosing of
clinical healthcare providers.
Accordingly, we have concluded that
the public interest is best served by
having HHS/CDC, in coordination with
the local health authority and EMS,
choose the healthcare facility where the
medical examination will be conducted
and not the detained individual.
One commenter expressed concern
that nonmedical personnel may be
allowed to make a determination of
illness resulting in actions being taken
based on potential misdiagnosis. HHS/
CDC appreciates the opportunity to
clarify this point. Decisions to issue
Federal public health orders are based
on the assessment of qualified and
licensed physicians. These decisions are
based on all available evidence,
including clinical presentation, medical
and exposure history, and the results of
medical evaluation and laboratory
testing. Treatment decisions are made
by the individual’s treating physician
with guidance from public health
subject-matter experts.
One commenter suggested that
medical examinations should be
conducted only with the informed
consent of the individual and should
not ‘‘forcibly’’ be required. HHS/CDC
clarifies that it may require a medical
examination under 42 U.S.C. 264(d)
because this section, among other
things, authorizes the ‘‘apprehension
and examination’’ of individuals
reasonably believed to be infected with
quarantinable communicable diseases in
a qualifying stage. CDC, however, agrees
that medical examinations may not be
conducted ‘‘forcibly.’’ Furthermore,
because medical examinations will
typically occur in a hospital setting and
be performed by clinical staff, it will be
incumbent upon clinical staff to obtain

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the patient’s informed consent
consistent with established standards of
medical practice.
Public health organizations provided
several comments regarding medical
examinations, including that they be
performed promptly so as not to curtail
liberty, include only minimal
components necessary to establish the
diagnosis of or rule out the
quarantinable communicable disease of
concern, and that specimens obtained
during such examinations not be used
for purposes other than diagnostic
testing without informed consent. In
response, HHS/CDC states that it agrees
with all of these points and that CDC,
in keeping with current practice, has a
commitment to upholding the highest
ethical standards for both medical care
and research.
One public health organization asked
for clarification of whether hospital staff
would be involved in obtaining consent
for medical examinations authorized
under this rule. In response, HHS/CDC
states that, while a public health order
authorizes that a medical examination
be conducted, should any invasive
procedures be determined by the
treating clinician to be necessary for
diagnostic or treatment purposes,
consent for such procedures should be
obtained by medical staff in accordance
with established standards.
One organization asked for
clarification of the location where
medical examinations would be
conducted, including whether inpatient
or ambulatory-care facilities would be
included. HHS/CDC responds that it
will coordinate with State or local
health departments of jurisdiction
concerning such operational details as
the exact locations where medical
examinations may be conducted.
Several public health organizations
commented on whether the issuance of
public health orders is needed prior to
medical examination if individuals
agree voluntarily to such examinations,
noting that a requirement for the
issuance of orders could impede or
delay the medical examination and that
the examination, itself, could determine
whether such orders are needed. In
response, HHS/CDC notes that it may
choose not to exercise its authority to
issue public health orders if an
individual complies voluntarily with
HHS/CDC’s requirements, including the
requirement of a medical examination.
However, HHS/CDC retains the right to
issue an order requiring a medical
examination should an individual not
comply voluntarily. Of note, one public
health organization supported the use of
Federal public health orders in
requiring medical examinations, stating

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that such orders had been used
effectively in the past to facilitate timely
examination.
One public health organization
requested that language be added to the
rule stating that medical examinations
will be performed with proper
adherence to worker safety and health
policies and protocols. HHS/CDC
responds that such occupational health
protections are beyond the scope of this
regulation and are covered by
regulations of the Occupational Safety
and Health Administration (OSHA).
HHS/CDC received several comments
from a flight attendant union relating to
medical examinations. This
organization stated that the regulations
should mandate that an employer pay a
flight attendant’s salary and per diem
and that no flight attendant should
incur discipline as a result of being
absent from work. This organization
further commented that any changes in
the employer-employee relationship
should be addressed through joint
guidance between government and
industry groups. This group also
commented that ‘‘promptly’’ should be
defined in terms of the length of time
that may be needed to arrange for a
medical exam and that no more than
five hours would be reasonable. This
group further stated that ‘‘reasonably
believed’’ should be defined to require
specific, articulable facts that a trained
medical professional can articulate.
HHS/CDC responds that these
regulations do not alter, define, or
mandate the employer-employee
relationship between flight attendants
and their employers. In regard to the
timeframe for arranging a medical
examination, HHS/CDC rejects a
specific 5-hour timeframe as too
prescriptive, but agrees that the medical
examination should be arranged as
quickly as possible based on the
circumstances of the event. HHS/CDC
further notes that the definition of
‘‘reasonably believed to be infected’’
already requires the existence of
‘‘specific articulable facts’’ articulated
by a public health officer. Such specific,
articulable facts would, for instance,
include ‘‘contact with an infected
person or an infected person’s bodily
fluids, a contaminated environment, or
through an intermediate host or vector.’’
HHS/CDC received a comment from a
partnership of public health legal
scholars and organizations expressing
concern that the regulations do not
appear to limit the invasiveness of a
medical examination, so long as the
examination itself is needed to diagnose
or determine the presence or extent of
infection with a quarantinable
communicable disease. HHS/CDC

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welcomes this opportunity to provide
further clarifications. HHS/CDC notes
that because medical examinations will
occur in a hospital setting and be
performed by the hospital’s clinical
staff, it will be incumbent upon clinical
staff to obtain the patient’s informed
consent consistent with established
standards of medical practice prior to
any examination occurring and that
such examinations may not be forcibly
conducted. HHS/CDC has also added a
requirement that the Director, as part of
the Federal order, the individual that
the medical examination shall be
conducted by an authorized and
licensed health worker with prior
informed consent. Furthermore, HHS/
CDC will implement this provision
consistent with U.S. constitutional
requirements and Articles 23 and 31 of
the International Health Regulations,
which requires that parties apply ‘‘the
least intrusive and invasive medical
examination that would achieve the
public health objective.’’
After consideration of these
comments, HHS/CDC has finalized the
provisions relating to Medical
Examination (§§ 70.12 and 71.36) as
proposed, with the exception that the
Director as part of the Federal order
must advise the individual that the
medical examination will be conducted
by an authorized and licensed health
worker with prior informed consent.
g. Requirements Relating to Issuance of
a Federal Order for Quarantine,
Isolation, or Conditional Release
HHS/CDC received several comments
relating to the issuance of Federal orders
for isolation or quarantine. A flight
attendant union commented that crew
lists should not be published as part of
a quarantine order posted in a
conspicuous location. This group
further stated that quarantine orders for
flight attendants should be treated
differently than those applicable to
passengers or other airline personnel
because flight attendants are health and
safety personnel trained in how to
perform CPR and operate defibrillators.
In response, HHS/CDC notes that if a
public health order is publicly posted,
the order will be written to refer to a
group of individuals, such as all
individuals onboard a particular
affected interstate or international flight.
Under such circumstances, HHS/CDC
expects that all members of the group
will receive individual copies of the
public health order. In some
circumstances, CDC anticipates that
issuance of a group federal order to an
individual may not be feasible—such as
when the location of the individual is
unknown. Thus, HHS/CDC does not

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expect to publish the names of
individual passengers or crew as part of
a publicly posted quarantine order.
Furthermore, while HHS/CDC agrees
that flight attendants provide an
important public health and safety role,
HHS/CDC disagrees that acknowledging
this role requires the issuance of
different public health orders than those
issued to other affected persons.
HHS/CDC received several comments
requesting the ‘‘least restrictive’’ means
with respect to quarantine and isolation.
HHS/CDC agrees and clarifies that in all
situations involving quarantine,
isolation, or other public health
measures, it seeks to use the least
restrictive means necessary to prevent
spread of disease. Regarding quarantine,
as an example, during the 2014–2016
Ebola epidemic, HHS/CDC
recommended monitoring of potentially
exposed individuals rather than
quarantine. Most of these people were
free to travel and move about the
community, as long as they maintained
daily contact with their health
department. For some individuals with
higher levels of exposure, HHS/CDC
recommended enhanced monitoring
(involving direct observation) and, in
some cases restrictions on travel and
being in crowded places, but did not
recommend quarantine. HHS/CDC has
the option of ‘‘conditional release’’ as a
less restrictive alternative to issuance of
an order of quarantine or isolation.
Under a conditional release order, the
person would not be confined as long as
the terms of the order were followed.
Should a quarantine or isolation order
be deemed necessary, home quarantine
or isolation would be considered as a
less restrictive option to confinement in
a guarded facility as long as this was
determined to be safe for other
household members, appropriate based
on the individual’s ability and
willingness to follow all necessary
precautions, and based on the
individual’s history of compliance with
public health recommendations.
One public health organization
requested that HHS/CDC specify the
types of locations of Federal quarantine
and asked clarification of whether this
would occur on lands or property under
Federal jurisdiction, and whether
Federal or State standards would apply
to an individual quarantined on lands or
property not under Federal control. In
response, HHS/CDC notes that
operational issues such as the exact
location of a quarantine and whether
Federal, State, and local orders would
be issued separately or concurrently
would depend on individual facts and
circumstances unique to each case.
HHS/CDC notes, however, that it is not

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unusual for the Federal government to
exercise jurisdiction concurrently with
State and local governments.
One public health organization noted
the longstanding difficulties faced by
Federal, State and local authorities in
identifying suitable facilities for
quarantining of large groups of people
(approximately 350, representing the
potential complement of travelers
onboard an international flight),
including the immediate availability of
such facilities in the event of an
emergency. HHS/CDC acknowledges
these difficulties and affirms that it is
actively working with Federal partners
to identify suitable locations to
accommodate large groups of people
while under a Federal public health
order.
One commenter stated, ‘‘If this is
enacted . . . everyone who works with
diseases . . . CDC, WHO, Labs, Drs.,
nurses etc. would have to be arrested as
potential carriers.’’ HHS/CDC disagrees
with this assertion. HHS/CDC is not a
law enforcement agency and does not
have authority to arrest individuals.
HHS/CDC’s authority to issue Federal
public health orders is limited to those
diseases defined by Executive Order as
quarantinable communicable diseases.
Furthermore, HHS/CDC does not
recommend restriction of movement for
healthcare workers, laboratory workers,
or others whose occupations involve
working with infectious pathogens as
long as the recommended infection
control precautions are followed.
Workers who do not take the necessary
precautions or have unprotected
exposures to a quarantinable
communicable disease may be subject to
restrictions if they meet the
requirements for issuance of Federal
public health orders.
Some commenters indicated that
vaccination or treatment should not be
‘‘conditions’’ under ‘‘conditional
release.’’ HHS/CDC confirms that this
final rule does not compel mandatory
vaccination or medical treatment of
individuals. HHS/CDC clarifies that
when medically appropriate,
vaccination or treatment, may be
‘‘conditions’’ of an individual’s release
from quarantine or isolation.
Individuals consent to these conditions.
A public health agency commented
that HHS/CDC should consider the
conditions of confinement to ensure that
certain minimum requirements, such as
access to telephones, and reasonable
accommodation of dietary restrictions,
are observed. Specifically, such
conditions should be considered at
different stages including as part of the
issuance of an order, during the
mandatory reassessment, and as a part

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of the medical review. In response,
HHS/CDC notes that in addition to
implementing these regulations
consistent with U.S. constitutional
requirements, CDC’s implementation
will also be consistent with Article 32
of the International Health Regulations
which, among other things, requires that
in implementing health measures under
the IHR the gender, sociocultural, ethnic
and religious concerns of the traveler be
taken into consideration. Furthermore,
Article 32 requires arranging for
adequate food and water, protection for
baggage and other possessions,
appropriate accommodation,
appropriate medical treatment, and
means of necessary communication for
those subject to public health orders.
Furthermore, as stated in the
regulations, as part of a mandatory
reassessment and medical review, HHS/
CDC will consider whether the least
restrictive means are being used to
protect the public health. HHS/CDC,
however, does not believe that it is
necessary for ‘‘conditions of
confinement’’ to be formally considered
as part of an administrative review
because many conditions of
confinement, such as availability of
entertainment or other amenities, may
be raised through informal means such
as making one’s concern known to the
facility where the individual is being
housed.
HHS/CDC received a comment from a
public health agency noting that it
should assume the responsibility of
providing translation and interpretation
services when issuing an order for
quarantine, isolation, or conditional
release, or when conducting a medical
review. HHS/CDC agrees and has
incorporated these changes into the
regulatory text.
HHS/CDC received a comment from a
partnership of public health legal
scholars and organizations requesting
clarification as to whether personal
service will occur when a quarantine
order is issued on a group basis and
posted in a conspicuous location. In
response, HHS/CDC notes that if a
public health order is publicly posted,
the order will be written to refer to a
group of individuals, such as all
individuals onboard a particular
affected interstate or international flight.
Under such circumstances, HHS/CDC
expects that all members of the group
will receive individual copies of the
public health order, thus addressing any
concerns about adequacy of notice.
Because HHS/CDC, however, cannot
foresee all of the circumstances that may
arise in an emergency situation, HHS/
CDC believes that it is appropriate for
these regulations to authorize service

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through posting or publication, but only
when individual service is
‘‘impracticable.’’
After consideration of these
comments, HHS/CDC has modified the
provisions regarding requirements
relating to issuance of a Federal order
for quarantine, isolation, or conditional
release (§§ 70.14 and 71.37). Paragraphs
(a)(5) and (4) of these provisions have
been modified, respectively, to require
that the federal order include an
explanation of the right to request a
medical review, present witnesses and
testimony at the medical review, and to
be represented at the medical review by
either an advocate (e.g., family member,
physician, or attorney) at the
individual’s own expense, or, if
indigent, to have representatives
appointed at the government’s expense.
Paragraph (b) of these provisions has
been modified to require that a Federal
public health order be served within 72
hours of an individual’s apprehension.
A new provision, paragraph (c), has
been added requiring that the Director
arrange for translation and
interpretation services of the Federal
order as needed.
h. Mandatory Reassessment of a Federal
Order for Quarantine, Isolation, or
Conditional Release
A number of commenters were
confused regarding the 72-hour period,
believing this period referred to the
period of apprehension pending the
issuance of a Federal public health
order and asked why 72 hours were
needed. The 72-hour period proposed
referred to the timeframe in which HHS/
CDC must conduct a mandatory
reassessment of the continued need for
isolating or quarantining an individual
following the service of a Federal public
health order. However, in response to
public comments HHS/CDC has also
added in sections 70.14(b) and 71.37(b)
a requirement that it serve the
individual with a Federal public health
order within 72 hours of that
individual’s apprehension.
Some commenters, including a public
health association, supported the
mandatory 72-hour reassessment
provision guaranteed by these
regulations. One of these commenters
also suggested the time be re-evaluated
periodically in the event that technology
provides a way of speeding up the
diagnosis process; another suggested the
time frame be expanded to five days to
account for weekends; one more
commenter noted that circumstances
may arise where an additional 72 hours
may be needed; and another commenter
stated that a second 72-hour
reassessment should be required. HHS/

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CDC is committed to performing a
reassessment within 72 hours of the
federal public health order being served
on the individual. If, at that time, HHS/
CDC determines that the order was
properly issued and that a public health
risk continues to exist, the order would
either be continued or HHS/CDC would
work with the State and local health
department to transfer custody. In the
event that HHS/CDC continues the
order, the individual may request a
medical review at that time.
A few commenters stated that the
reassessment of HHS/CDC’s orders
should be conducted in a shorter time
period than 72 hours such as within 12
hours, performed electronically and
conducted by a 3rd party. While HHS/
CDC appreciates the input provided by
these commenters, HHS/CDC finds
these suggestions impractical. Medical
examination to confirm or rule out
infection with a quarantinable
communicable disease may require up
to 72 hours to allow for laboratory
testing. While some communicable
diseases (typically viral infections) may
be diagnosed using molecular tests such
as polymerase chain reaction (PCR) that
take several hours to perform, others
require that the organism be cultured to
make a confirmed diagnosis or to
conduct antimicrobial sensitivity testing
in order to provide appropriate
treatment. This is typically needed for
bacterial infections, such as diphtheria
or plague, and may take 48–72 hours (or
longer) to complete. For some infectious
tuberculosis cases, laboratory
confirmation may take several weeks
although preliminary molecular testing
may assist in conducting an assessment
of risk sufficient to continue or rescind
the order. Specimen transportation time
may also need to be factored in as
testing for certain diseases is only
available at state public health
laboratories or CDC.
While HHS/CDC is required by this
provision to reassess the need for a
Federal public health order within 72
hours, HHS/CDC will immediately
release individuals from detention if at
any time it receives information
confirming the absence of infection with
a quarantinable communicable disease.
We note that while the medical
assessment is intended primarily as a
review of available medical records and
other relevant information, these
regulations do not prohibit HHS/CDC
from conducting the review
electronically, for instance by relying on
electronic medical records.
Furthermore, HHS/CDC disagrees that
relying on internal decision-makers for
the reassessment is inappropriate or
undesirable and thus does not consider

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it necessary to rely on a ‘‘3rd party.’’
However, the CDC official or employee
conducts the reassessment will not be
the same person who issued the
quarantine, isolation, or conditional
release order. Following the
reassessment, the detained individual
may also request a medical review as
described in these regulations.
HHS/CDC received a comment from a
public health agency requesting
clarification as to whether all
individuals within a group will receive
individual due process when a group
order is issued. This agency also
questioned the feasibility of providing a
mandatory reassessment and medical
review for large groups. In response,
HHS/CDC confirms that if a group order
is issued, all individuals within that
group will be accorded due process.
Furthermore, HHS/CDC has provided
flexibility in the regulations to allow for
a mandatory reassessment of the group
order and consolidation of medical
reviews where appropriate.
HHS/CDC received a comment from a
partnership of public health legal
scholars and organizations stating that
while the rule requires consideration of
least restrictive means upon
reassessment of an order and as part of
the medical review, HHS/CDC must also
consider least restrictive means prior to
the issuance of a quarantine or isolation
order. HHS/CDC agrees that all means
short of assuming legal custody of the
individual including attempting to
obtain voluntary compliance with
public health measures should be
explored. HHS/CDC notes, however,
that an isolation or quarantine order is
typically issued in time-sensitive
situations where because of the exigent
circumstances surrounding the risk of
communicable disease spread it is not
immediately possible to explore all
available less restrictive means,
including the appropriateness of a home
environment, instead of a hospital. For
this reason, HHS/CDC has chosen the
mandatory reassessment and medical
review as the appropriate time to
conduct a formal assessment of least
restrictive means. To the extent that the
commenters suggest that due process
requires more, we disagree. See Yin v.
California, 95 F.3d 864, 870 (9th Cir.
1996) (recognizing that in searches and
seizures justified by special needs, the
government does not have to use the
least restrictive means to further its
interests); Stockton v. City of Freeport,
Texas, 147 F.Supp.2d 642, 647 (S.D.
Tex. 2001) (recognizing that the Fourth
Amendment does not require that a
search or seizure be conducted through
the least restrictive means, but rather
that the alleged personal invasion be

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reasonable under all of the
circumstances).
After consideration of these
comments, HHS/CDC has finalized the
provisions relating to mandatory
reassessment of a Federal order for
quarantine, isolation, or conditional
release (§§ 70.15 and 71.38) as
proposed.
i. Medical Review of a Federal Order for
Quarantine, Isolation, or Conditional
Release
HHS/CDC received several comments
arguing that its proposed medical
review procedures are deficient.
Specifically, one commenter stated that
assessment procedures should be clearly
communicated to all affected persons;
that HHS/CDC should more clearly
delineate ‘‘less restrictive alternatives;’’
that affected individuals should have a
right to legal representation; and that
access to independent judicial review is
essential.
HHS/CDC agrees that it should clearly
communicate review procedures to
individuals subject to Federal isolation,
quarantine, or conditional release. We
note that sections 70.14 and 71.37 have
been modified to require that the federal
order authorizing isolation, quarantine,
or conditional release include an
explanation that the federal order will
be reassessed 72 hours after it is served
on the individual and of the right to
request a medical review, present
witnesses and testimony at the medical
review, and to be represented at the
medical review by either an advocate
(e.g., family member, physician, or
attorney) at the individual’s own
expense, or, if indigent, to have
representatives appointed at the
government’s expense. We further note
that the provisions relating to medical
reviews, sections 70.16 and 71.39 have
been revised to include new paragraphs
(q) which states that ‘‘The Director shall
arrange for translation or interpretation
services as needed for purposes of this
section.’’
Similarly, in regard to minor children
or adults with a cognitive disability,
HHS/CDC will work with a competent
guardian to ensure that procedures are
clearly communicated. In regard to less
restrictive alternatives, HHS/CDC
believes that it is not possible to
delineate with specificity all of the less
restrictive options that may be available
because such determinations will
inevitably be based on the individual
circumstances of each case, including
the severity of the particular diseasecausing agent, availability of treatment
options should the disease not be
adequately contained, the patient’s
particular level of infectivity or

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communicability, appropriateness of the
home environment, and the individual
patient’s understanding, ability, and
willingness to comply with less
restrictive alternatives. For this reason,
HHS/CDC has made consideration of
less restrictive alternatives a part of the
medical review proceeding where
evidence may be submitted into the
record, testimony obtained, and a
recommendation provided by the
medical reviewer. As a general matter,
however, HHS/CDC clarifies that less
restrictive alternatives would refer to
reasonable and available alternatives
that are adequate to protect the public’s
health other than confinement in a
guarded facility, such as home
quarantine, directly observed therapy,
or other forms of supervised release.
In response to concerns about legal
representation, HHS/CDC has amended
the definition of ‘‘Medical
representative’’ to ‘‘Representatives’’
and will now appoint ‘‘an attorney
knowledgeable of public health
practices’’ in addition to a ‘‘physician,
nurse practitioner, or similar medical
professional qualified in the diagnosis
and treatment of infectious diseases.’’
HHS/CDC hopes that by appointing both
an attorney and a qualified medical
professional for indigent individuals it
will alleviate concerns expressed by the
public regarding the medical review
process. We note that an attorney may
become ‘‘knowledgeable of public
health practices’’ in a number of ways,
for instance, through prior
representation of a public health agency
or advocacy organization, training
provided by a public health or advocacy
organization or other training that
would ordinarily occur through a
Continuing Legal Education (CLE)
event, law school coursework, or
through independent study. We further
note that for individuals qualifying as
indigent, HHS/CDC intends to provide
independent legal counsel from outside
of the agency. In doing so, HHS/CDC
may employ a variety of mechanisms,
such as through agreements or
memorandums of understanding with
law school legal clinics, State or local
bar associations, or public interest
groups representing indigent clients.
Individuals who do not qualify as
indigent may choose to be represented
at the medical review by an advocate
(e.g., an attorney, physician, family
member) and present a reasonable
number of medical experts, of their own
choosing and at their own expense.
HHS/CDC also agrees that access to
independent judicial review is essential
and assures the public that this final
rule does not affect the constitutional or
statutory rights of individual to seek

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judicial review through such traditional
mechanisms as a petition for a writ of
habeas corpus under 28 U.S.C. 2241. As
a Federal agency, however, HHS/CDC
would lack the legal authority through
regulation to grant Federal courts with
jurisdiction that they would not
otherwise possess because only
Congress may expand a Federal court’s
jurisdiction.
HHS/CDC received a comment from a
partnership of public health legal
scholars and organizations stating that
the CDC Director should not have
unfettered discretion to accept or reject
the medical reviewer’s decision, but
rather should only be allowed to reject
a decision based on lack of substantial
evidence. HHS/CDC believes that it
would be inappropriate to mandate
through regulation that the decision of
a medical reviewer (which may include
an HHS or CDC employee) should
displace the decision of the CDC
Director, particularly where the statute
and delegation of authority have
provided otherwise.
HHS/CDC received several comments
stating that a medical representative
should be appointed to anyone
regardless of their ability to pay. HHS/
CDC disagrees and notes that
appointment of a representative at the
government’s expense without regard to
the patient’s indigence is not required.
The status of ‘‘indigent’’ is self-reported
as HHS/CDC will not require access to
an individual’s financial records. Those
who self-identify as indigent may be
required to sign an affidavit or
declaration under penalty of perjury
stating they meet the threshold of at
least 200% of the applicable poverty
guidelines.
HHS/CDC received a comment from a
non-profit organization contending that
the medical review does not comport
with due process because there is no
limit on the number of reviews that may
be consolidated into a single
proceeding, no access to legal counsel,
no independence of the reviewer from
the initial decision-maker, no
confrontation or cross-examination of
witnesses, no compulsory process for
obtaining evidence or testimony, and no
judicial review. This group contends
that any detention that is non-exigent
should occur only based on the
‘‘informed explicit written consent’’ of
the patient or ‘‘utilize the existing legal
procedures for involuntary commitment
of persons.’’
HHS/CDC disagrees that the medical
review as described and set forth in the
regulations does not comport with due
process. While HHS/CDC acknowledges
that there is no numerical limit to the
number of medical reviews that may be

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consolidated, HHS/CDC believes that
the circumstances giving rise to the
need for consolidation will be
exceedingly rare and that medical
reviews will generally be conducted on
an individual basis.
HHS/CDC also disagrees that there is
no access to legal counsel because HHS/
CDC will, consistent with principles of
preventing communicable disease
spread, allow persons subject to public
health orders to communicate with
family and legal counsel whom they
hire at their own expense. Furthermore,
as described above, the regulations have
been amended to require the
appointment of both an attorney and a
medical professional if the detained
individual qualifies as an indigent and
requests a medical review. Individuals
who do not qualify as indigent may also
choose to be represented at the medical
review by an advocate (e.g., an attorney,
physician, family member) and present
a reasonable number of medical experts,
of their own choosing and at their own
expense.
HHS/CDC further believes that
reliance on internal reviewers does not
violate due process and notes that it is
not unusual, for instance, for hospitals
to rely on internal decision-makers
when determining whether to commit a
mental health patient on an emergency
basis. The regulations, moreover,
explicitly state that the medical
reviewer will not be the same individual
who initially authorized the quarantine
or isolation order. We note further that
the definition of both ‘‘representatives’’
and ‘‘medical reviewer’’ would in fact
allow for the appointment of non-HHS/
CDC employees in these capacities
because both terms are broadly defined
in terms of the professional
qualifications and not employment
status of these individuals. Thus, these
regulations do not prohibit the CDC
Director from appointing personnel
from outside of the agency to assist in
conducting a medical review. For
individuals qualifying as indigent, HHS/
CDC intends, generally, to provide
independent legal counsel from outside
of the agency.
HHS/CDC also clarifies that during
the course of a medical review, a
detained individual will be permitted to
present witnesses and question any
witnesses offered by HHS/CDC. Any
‘‘confrontation’’ of witnesses, however,
will be conducted in a manner
consistent with principles of preventing
communicable disease spread. HHS/
CDC, as a Federal agency, however lacks
the legal authority to allow a detained
individual to use compulsory processes,
such as a subpoena, to compel the
presence of witnesses. HHS/CDC will

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nevertheless make reasonable efforts to
produce any HHS/CDC employees that
would be critical to a detained
individual’s presentation of evidence
during a medical review.
HHS/CDC also disagrees that there is
no judicial review and notes that these
regulations do not impact an
individual’s constitutional or statutory
rights to contest their Federal detention
through such traditional mechanisms as
a petition for a writ of habeas corpus
under 28 U.S.C. 2241. To the extent,
however, that the commenter contends
that HHS/CDC should follow legal
procedures other than those set forth
through the Federal quarantine statute
at 42 U.S.C. 264, we disagree. HHS/CDC
notes that as a Federal agency it lacks
the ability to rewrite Federal statutes or
grant Federal courts with legal
jurisdiction that they do not already
possess. HHS/CDC also rejects as
impractical and as insufficient to protect
public health, the notion that isolation
or quarantine should only occur based
upon the consent of the subject
individual.
HHS/CDC received a comment from a
flight attendant union that as an
important ‘‘safety net’’ HHS/CDC should
pay for ‘‘second medical opinions.’’
HHS/CDC declines to extend payment
to medical examinations beyond those
required as part of a public health order,
but notes that as part of a medical
review individuals may submit
additional evidence into the record
concerning their health status and
potential public health risk to others.
One commenter noted language in the
NPRM stating that the ‘‘medical review
is not intended to address the concerns
of individuals who take issue with
amenities of their confinement . . .,’’
interpreting this to mean that ‘‘no
provision is made for those who must
use a CPAP (continuous positive airway
pressure) at night or who need
orthopedic appliances, or who have
food allergies, to name a few.’’ In
response, HHS/CDC states that, when
confinement of an individual under
Federal public health authorities is
needed, HHS/CDC will ensure that such
confinement will occur in a location
and with necessary amenities to ensure
the health and safety of the individual,
including provision for medical or
dietary requirements. Issues related to
health and safety will be addressed at
the time of the issuance of the order, or
as soon as HHS/CDC is made aware of
them, but are beyond the scope of the
medical review which is intended to reevaluate the continued need for the
Federal public health order based on a
review of the medical and other
evidence submitted into the record.

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HHS/CDC received a comment from a
partnership of public health legal
scholars and organizations stating that it
should provide for an oral hearing
whenever practical. HHS/CDC agrees
that an oral hearing is appropriate and
has modified the language to state: ‘‘The
medical review shall be conducted by
telephone, audio or video conference, or
through other means that the medical
reviewer determines in his/her
discretion are practicable for allowing
the individual under quarantine,
isolation, or conditional release to
participate in the medical review.’’
HHS/CDC received a comment from a
partnership of public health legal
scholars and organizations that the CDC
Director’s written order, which
constitutes final agency action, must
advise individuals of their rights to
appeal to Federal court. We note that
the commenters specifically cite the
Administrative Procedures Act (APA, 5
U.S.C. 704), which provides that ‘‘final
agency action for which there is no
other adequate remedy in a court are
subject to judicial review.’’ While HHS/
CDC agrees that independent judicial
review of agency decisions is available,
it takes no position as to whether such
reviews should occur under the APA (as
suggested by the commenters) or
through other traditional mechanisms as
a petition for a writ of habeas corpus
under 28 U.S.C. 2241. For this reason,
HHS/CDC believes that due process is
satisfied by designating the Director’s
written order as ‘‘final agency action’’
without further speculation as to the
exact form of further legal review.
However, to clarify HHS/CDC’s
intended we have added the following
language to the regulatory text:
‘‘Nothing in these regulations shall
affect the constitutional or statutory
rights of individuals to obtain judicial
review of their federal detention.’’
Accordingly, after consideration of
these comments, HHS/CDC has
modified paragraph (f) of the provisions
regarding medical review of a Federal
order for quarantine, isolation, or
conditional release (§§ 70.16 and 71.39)
to include the revised definition of
‘‘Representatives,’’ which now requires
HHS/CDC to appoint both a medical
professional and an attorney ‘‘to assist
the individual for purposes of the
medical review upon a request and
certification, under penalty of perjury,
by that individual that he or she is
indigent and cannot afford a
representative.’’

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j. Administrative Records Relating to a
Federal Order for Quarantine, Isolation,
or Conditional Release
HHS/CDC received a comment from a
flight attendant union concerning
whether an overlap existed between
CDC’s maintenance of administrative
records relating to the issuance of
Federal public health orders and an
employee’s access to exposure and
medical records under OSHA (29 CFR
1910.1020). We note that since HHS/
CDC is not a flight attendant’s employer,
HHS/CDC would not be covered by this
particular OSHA standard under these
circumstances. Furthermore, because
these regulations do not alter, define, or
mandate the employer-employee
relationship between flight attendants
and their employers, to the extent that
this question seeks input regarding an
employer’s obligations under OSHA,
HHS/CDC views the question as outside
the scope of the rulemaking.
HHS/CDC received a comment from a
partnership of public health legal
scholars and organizations stating that
the regulations should require quarterly
reporting to Congress to facilitate
transparency and oversight. While CDC
recognizes the additional transparency
that direct reporting of details related to
quarantine activities may provide to the
public, CDC notes that historically, the
issuance of Federal orders is rare (i.e.,
one to two orders issued per year).
Thus, publication of the specifics
surrounding individual quarantine cases
may raise significant privacy concerns
related to the individuals placed under
federal orders.
CDC does routinely describe its
practices in published Morbidity and
Mortality Weekly Reports (MMWR)
when new methods, technologies, or
other changes make it possible to revise
and improve programs (e.g. DNB, M&M
guidance, change in air contact
investigation algorithms), which all
serve to enhance transparency. Such
information is also found on CDC’s Web
site and publicly available standard
operating procedures.
After consideration of comments
received and as further explained
below, HHS/CDC has modified the
provisions regarding Administrative
Records relating to a Federal order for
quarantine, isolation, or conditional
release (§§ 70.17 and 71.29) to remove
paragraphs (5) regarding agreements
entered into between HHS/CDC and the
individual.
k. Other Due Process Concerns
HHS/CDC received many additional
comments from the public concerned
over whether this regulation violates

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rights guaranteed by the U.S.
Constitution, such as Due Process and
specifically during the medical review
process. HHS/CDC disagrees that the
regulations are insufficient to protect
the constitutional rights of individuals.
In regard to medical reviews, HHS/CDC
asserts that allowing individuals to
choose at the government’s expense
who will conduct the medical review is
not required by due process and that
there is no conflict of interest in
allowing the CDC Director to appoint
who will conduct the medical review on
the agency’s behalf. HHS/CDC asserts,
however, that individuals will be
allowed to submit relevant information,
including information provided by
outside doctors or other medical
specialists during the medical review.
HHS/CDC will further preserve relevant
agency documents for purposes of
ensuring a competent legal review in the
event that the individual seeks judicial
redress of their quarantine or isolation.
As explained elsewhere, law
enforcement support for quarantine or
isolation orders will generally be
provided by U.S. Customs and Border
Protection, U.S. Coast Guard, or other
Federal law enforcement programs, but
HHS/CDC may also accept voluntary
state and local assistance in enforcing
its Federal orders.
HHS/CDC received public comment
expressing concern with regard to
potential language barriers experienced
by foreign nationals during travel. HHS/
CDC responds that it has revised those
sections of the regulations dealing with
issuance of Federal orders to require
that HHS/CDC arrange for translation or
interpretation services of the Federal
order as needed. In circumstances
where it would be impractical to
provide a line-by-line translation of the
order, HHS/CDC may take other steps to
reasonably apprise individuals of the
contents of the order, for example, by
arranging for oral translation services.
One public health organization
questioned the feasibility of CDC’s
conducting the mandatory reassessment
or medical review of a group quarantine
order within the specified time frame. In
response, HHS/CDC states that a group
quarantine order would be issued on the
basis of a shared exposure for all
individuals in the group; therefore, the
mandatory reassessment or medical
review could be conducted based on the
shared exposure, unless certain
individuals in the group were
determined to be immune to the
quarantinable communicable disease in
question. Part of the reassessment
would include a determination of
whether the group order should be
revised as individual orders.

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HHS/CDC also received a comment
that the duration of a quarantine,
isolation, or conditional release period
is not adequately defined. HHS/CDC
disagrees because the regulations limit
these actions to only those who would
pose a public health threat, for instance,
by being in the ‘‘qualifying stage’’ or a
quarantinable communicable disease.
The ‘‘qualifying stage’’ of the disease is
defined as a communicable stage of the
disease or a precommunicable stage, but
only if the disease would be likely to
cause a public health emergency if
transmitted to other individuals. We
note that HHS/CDC’s ‘‘Health
Information for International Travel’’
(also known as the Yellow Book)
provides the public with general
guidance regarding the expected length
of communicability for many
quarantinable communicable diseases.
For more information, please see http://
wwwnc.cdc.gov/travel/yellowbook/
2016/table-of-contents.
HHS/CDC received a comment that
the qualifications of who may issue a
quarantine or isolation order are not
defined leading to concerns that such
orders will be issued by non-medically
trained personnel. In regard to the
qualifications of who may issue a
Federal public health order, HHS/CDC
notes that all orders are issued under
the authority of the CDC Director, but
that in practice such determinations are
made only by personnel trained in
public health and licensed to practice
medicine in the United States.
One organization requested that HHS/
CDC provide notification to the
appropriate embassy if a foreign
national is placed under a Federal order.
In regard to non-resident foreign
nationals, HHS/CDC clarifies that it will
coordinate closely with the U.S.
Department of State to ensure that all
rights and obligations under the Vienna
Convention on Consular Relations and
bilateral agreements will be observed.
Because of the complexity of this issue,
including reliance on the interpretation
of treaties and bilateral agreements,
HHS/CDC believes that it is best to
ensure compliance through operational
procedures, rather than to formalize
such obligations through regulatory text.
One commenter requested that HHS/
CDC clarify its handling of issues
relating to diplomatic immunity. HHS/
CDC recognizes that under the Vienna
Convention on Diplomatic Relations,
diplomats are not liable to any form of
‘‘detention.’’ It is HHS/CDC’s policy to
coordinate closely with the U.S.
Department of State regarding any
public health issues arising in regards to
diplomats and HHS/CDC will continue
to do so under these regulations.

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One public health organization
recommended that HHS/CDC include
written notification to individuals under
public health orders of the duration that
the order will be in effect. HHS/CDC
responds that it will provide
information on the incubation and
communicability period of the
quarantinable communicable disease, if
known, but that the duration of the
public health order may depend on a
variety of factors, such as demonstration
of non-infectiousness through repeated
laboratory testing. Thus, HHS/CDC is
unable to provide an exact numerical
limit (in terms of days or hours) that a
public health order will remain in
effect.
HHS/CDC received a comment from a
partnership of public health legal
scholars and organizations stating that
in exigent circumstances HHS/CDC may
isolate or quarantine an individual, but
should then be required to hold a
mandatory due process hearing within
48 hours before a neutral decisionmaker. At the outset, HHS/CDC agrees
with the commenters that the
appropriate framework for determining
the adequacy of due process procedures
are the factors articulated by the
Supreme Court in Matthews v. Eldridge,
424 U.S. 319 (1976). These factors
include: (1) The private interest affected
by the government’s actions; (2) the risk
of erroneous deprivation of such private
interest through the procedures used
and the probable value, if any, of
additional or substitute procedures; and
(3) the government’s interest, including
the function involved and the fiscal and
administrative burden of proposed
additional or substitute procedures.
Concerning the private interest at stake,
HHS/CDC disagrees that this interest
should be measured solely in terms of
the physical liberty of the individual,
but notes that the private interest also
includes an interest in receiving
medical treatment and in not harming
others, as would occur if the individual
was communicable. The Federal
government’s interest, moreover, is
particularly strong because it is not
simply guarding the welfare of a single
individual or even a small group of
individuals, but rather protecting the
public at large against the spread of a
quarantinable communicable disease.
Most importantly, HHS/CDC believes
that mandatory administrative hearings
are unlikely to significantly guard
against erroneous deprivations. Unlike
subjective determinations of behavior
which typically form the basis of a
mental health ‘‘civil commitment,’’
isolation and quarantine decisions are
based on objective criteria such as

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manifestations of physical illness or
laboratory test results. Thus, weighing
these factors, HHS/CDC disagrees that
due process requires it to adopt a system
of mandatory administrative hearings in
the absence of the individual requesting
a medical review.
Regarding the use of a ‘‘neutral’’
decision maker, HHS/CDC restates that
the definition of both ‘‘representatives’’
and ‘‘medical reviewer’’ would in fact
allow for the appointment of non-HHS/
CDC employees in these capacities. The
regulations, moreover, explicitly state
that the medical reviewer will not be the
same individual who initially
authorized the quarantine or isolation
order. Accordingly, HHS/CDC has
determined that the procedures it has
adopted for medical reviews comport
with due process.
l. Privacy
Several people commented on the
private nature of the doctor-patient
relationship. HHS/CDC appreciates the
opportunity to respond to this concern.
HHS/CDC is charged with protecting the
health of the public. At times, this
requires obtaining private information
about people’s health or exposure
history and taking certain actions to
protect others from becoming sick with
a communicable disease. HHS/CDC
works closely with State and local
health departments to ensure that ill
people detained or isolated under
Federal orders receive appropriate care
and treatment. HHS/CDC is also bound
by the Privacy Act to protect personally
identifiable information collected and
maintained under that Act. For a more
detailed explanation of how such
information is protected, please see
http://www.cdc.gov/sornnotice/09-200171.htm. For information on the
retention and maintenance of such
records, please see https://
www.archives.gov/records-mgmt/rcs.
HHS/CDC received a comment from a
professor of public health law and
ethics stating that HHS/CDC should
address how the HIPAA Privacy Rule,
Americans with Disabilities Act (ADA),
and Administrative Procedure Act
(APA) counterbalance the powers set
forth in the proposal and reflect
‘‘appropriate social distancing
practices.’’ The commenter did not
highlight which specific provisions of
these laws HHS/CDC should address or
the relationship that these laws have to
social distancing. Notwithstanding,
HHS/CDC may generally state that these
regulations will be carried out
consistent with Federal law.
We note that HHS is a hybrid entity
under HIPAA, but only those parts of
the Department that have been

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determined to be health care
components are subject to the HIPAA
Privacy Rule. CDC is generally not a
health care component treated as a
‘‘covered entity’’ under the HIPAA
Privacy Rule. However, certain specific
offices of HHS, CDC, and the National
Institute for Occupational Safety and
Health (NIOSH) performing activities
related to the World Trade Center
Health Program are considered health
care components of HHS and must
comply with HIPAA and the Privacy
Rule.
CDC most often acts as a public health
authority under the HIPAA Privacy
Rule. During the course of a public
health investigation it may seek the
support of a covered entity, such as a
hospital or private physician. The
HIPAA Privacy Rule permits the
disclosure of public health information
to public health authorities, such as the
CDC, and their authorized agents for
public health purposes including but
not limited to public health
surveillance, investigations, and
interventions. More information
concerning the HIPAA Privacy Rule
may be found here: http://www.cdc.gov/
mmwr/preview/mmwrhtml/
m2e411a1.htm.
Similarly, we note that this final rule
while formalizing administrative
policies and practices, does not affect
the rights of individuals under the ADA
or APA, which are statutes enacted by
Congress. One commenter opined that
collection of contact information as part
of public health prevention measures
and maintenance of administrative
records raise privacy concerns and that
HHS/CDC should consider ‘‘superenhanced privacy protections’’
consistent with the Model State Public
Health Privacy Act of 1999. HHS/CDC
disagrees. As a Federal agency, HHS/
CDC must abide by the laws established
by Congress for the protection of
records, specifically the Privacy Act of
1974, 5 U.S.C. 552. On December 13,
2007, HHS/CDC published a system of
records notice (72 FR 70867) under the
Privacy Act describing, among other
things, safeguards for preventing the
unauthorized use of information
collected from travelers. HHS/CDC will
make disclosures from this system only
with the consent of the subject
individual, in accordance with routine
uses published in its system notice, or
in accordance with an applicable
exception under the Privacy Act.
m. Payment for Care and Treatment
HHS/CDC received several comments
relating to payment for medical
expenses. One commenter stated that
HHS/CDC should assume payment for

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all related medical expenses, housing
costs, and other necessities for
individuals or groups subject to
deprivations of liberty and that it is
‘‘ethically unfair’’ for HHS/CDC to be
the ‘‘payer of last resort.’’ Another
commenter stated that ‘‘CDC must
guarantee financial help after third party
payments are exhausted.’’ While HHS/
CDC acknowledges that it has an ethical,
moral, and legal obligation to provide
care and treatment for individuals under
a Federal quarantine or isolation order,
HHS/CDC disagrees that it is ‘‘ethically
unfair’’ to excuse a medical insurer or
other entity with a contractual
obligation from paying for medical
expenses. Accordingly, HHS/CDC has
determined that it is appropriate for it
to maintain and affirm its status as a
‘‘payer of last resort.’’
Two public health organizations
asked whether nonmedical costs such as
training of staff, replenishing of
personal protective equipment,
managing and disposing of biological
waste and contaminated supplies, etc.,
are also subject to HHS/CDC payment
authorization. While the costs of care
and treatment of individual patients
under Federal public health orders are
authorized by this rule, these additional
costs to the extent that they are
unrelated to the individual patient’s
treatment and care would not be
covered by this rule.
HHS/CDC received a comment
suggesting that the regulations allow for
charging detainees the medical and
hospital costs of nonconsensual
treatment. HHS/CDC disagrees and first,
clarifies that these regulations do not
authorize compulsory medical
treatment. HHS/CDC further
acknowledges that constitutional
principles and medical ethics require
that those detained under isolation or
quarantine have access to adequate
nourishment, appropriate
accommodation, and medical treatment.
However, HHS/CDC has determined
that its obligation to pay for medical
care and treatment should be secondary
to the obligation of any third party, such
as a medical insurer that may have a
pre-existing contractual obligation with
the patient to pay for hospital expenses.
Accordingly, HHS/CDC declines to
make any changes to the provisions
authorizing payment for medical care
and treatment.
A flight attendant union commented
that HHS/CDC should pay for any
outside costs that the flight attendant
would normally incur relating to
medical treatment, e.g., copayments,
deductibles. HHS/CDC declines this
suggestion and notes that while it is not
HHS/CDC’s intent to unduly burden

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individuals with the costs of their own
isolation or quarantine, payment for
expenses will be made consistent with
constitutional and ethical obligations to
provide for the basic necessities, e.g.,
food, medical treatment, for those
subject to such public health orders.
Furthermore, these regulations do not
alter, define, or modify the contractual
relationship between insurance
companies and the insured.
After consideration of these
comments, HHS/CDC has finalized the
provisions relating to payment for care
and treatment (§§ 70.13 and 71.30) as
proposed.
n. Agreements
HHS/CDC received comments relating
to the intention and use of agreements.
Commenters worried that such
‘‘agreements’’ may be coerced, and
individuals would be compelled to
submit to involuntary testing or
‘‘research projects.’’ One commenter
stated that the definition of agreement is
circular and confusing because the word
‘‘agreement’’ appears in the definition.
This commenter also suggested that
what HHS/CDC proposes should more
aptly be labeled as an ‘‘Affidavit’’ or
‘‘Affirmation’’ because the definition as
proposed by HHS/CDC lacks bilateral
obligations on both parties.
Due to the number of public
comments received expressing
confusion over this public health
measure, HHS/CDC has removed the
provisions on Agreements (70.18 and
71.40), and modified other provisions of
the final rule (70.1, 71.1(b), and 70.5) to
remove references to ‘‘agreements.’’
o. Penalties
Many commenters expressed concern
over the penalties provisions contained
within the proposed regulation.
Specifically, one association objected to
‘‘CDC’s proposed increase in penalties.’’
Another stated that ‘‘CDC is not
qualified to decide upon the
punishment.’’ HHS/CDC takes this time
to better explain that the penalties listed
in today’s final rule, which have been
codified as proposed, are set forth by
Congress via statutory language and
codified into regulation to reflect
current practice. This regulation serves
to notify the public of the existing
statutory penalties for violation of
quarantine regulations, which HHS/CDC
has no authority to change.
One organization requested that
language be added to rules regarding the
issuance of penalties if an employer
provides an ‘‘unsafe work or
unhealthful working condition.’’ HHS/
CDC responds that such penalties are
beyond the scope of this rule and refers

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the commenter to regulations of the
Occupational Safety and Health
Administration.
HHS/CDC received a comment from a
flight attendant union regarding
criminal penalties stating that HHS/CDC
should provide further clarification as to
what constitutes a violation and clarify
that flight attendants who act in
accordance with their company’s
practices, policies, or procedures should
not be held criminally liable. In
response, HHS/CDC notes that while the
text of the regulation is being updated,
these regulations do not increase the
criminal penalties that may be imposed
for violations of quarantine regulations
or alter the manner in which liability
may be assessed. Rather, these
regulations serve to inform the public of
the criminal penalties that currently
exist in statute (42 U.S.C. 271 and 18
U.S.C. 3571). Furthermore, HHS/CDC
clarifies that criminal penalties, if any,
would be assessed by a court of law
based on an indictment or information
filed by an Assistant U.S. Attorney
based on individualized facts and
circumstances, and would not be
determined administratively by the
CDC.
HHS/CDC offers the following
explanation to inform the public
regarding this section. As prescribed in
section 368 (42 U.S.C. 271) and under
18 U.S.C. 3559 and 3571(c), criminal
sanctions exist for violating regulations
enacted under sections 361 and 362 (42
U.S.C. 264 and 265). 18 U.S.C. 3559
defines an offense (not otherwise
classified by letter grade) as a ‘‘Class A
misdemeanor’’ if the maximum term of
imprisonment is ‘‘one year or less but
more than six months.’’ 18 U.S.C. 3571
provides that individuals found guilty
of an offense may be sentenced to a fine.
Specifically, an individual may be fined
‘‘not more than the greatest of’’—(1) the
amount specified in the law setting forth
the offense; or (2) for a misdemeanor
resulting in death, not more than
$250,000; or (3) for a Class A
misdemeanor that does not result in
death, not more than $100,000.
Similarly, an organization, found guilty
of an offense may be fined ‘‘not more
than the greatest of’’—(1) the amount
specified in the law setting forth the
offense; or (2) for a misdemeanor
resulting in a death, not more than
$500,000; or (3) for a Class A
misdemeanor that does not result in
death, not more than $200,000. 42
U.S.C. 271 sets forth statutory penalties
of up to 1 year in jail and a fine of
$1,000. Therefore, it is classified as a
Class A misdemeanor under 18 U.S.C.
3559. Because the alternate fines set
forth under 18 U.S.C. 3571 are greater

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than the $1,000 set forth under 42
U.S.C. 271 (which sets a maximum
penalty of not more than $1,000 or one
year of jail, or both for violation of
quarantine laws), and because 42 U.S.C.
271 does not exempt its lower penalties
from 18 U.S.C. 3571(e), HHS/CDC has
chosen to codify the greater penalties of
18 U.S.C. 3571(b)(5) and (c)(5) and to
remove the lower penalties as stated in
42 CFR 71.2 from the regulation.
After consideration of these
comments, HHS/CDC has finalized the
provisions relating to Penalties (70.18
and 71.2) as proposed. Penalties has
been moved to section 70.18, since
proposed 70.18 Agreements has been
removed from this final rule.
p. Economic Impact
Within the analysis published with
the NPRM, HHS/CDC solicited public
comment regarding the cost and benefit
estimates for airlines and vessel
operators associated with improved
provision of traveler contact data. While
HHS/CDC received support for the data
collection from two public health
associations, HHS/CDC received a
comment from industry who misread
the proposals to mean that aircraft
operators would be required to develop
new capacity and processes to capture
and store a comprehensive set of
sensitive data, archive this data, and
then provide it to CDC.
HHS/CDC restates and clarifies that
today’s final rule does not impose any
new burdens upon the airline industry
but rather, codifies the current practice
of receiving a passenger manifest order
(if needed, as CDC currently collects
passenger information from CBP via
APIS and PNR) and providing HHS/CDC
with any data in an airline’s possession.
This regulatory impact analysis has
been revised to clarify that the rule does
not require an airline to solicit or store
additional data. Therefore, HHS/CDC
does not expect that formalizing its
current data collection practices will
increase costs. Neither airlines nor U.S.
Customs and Border Protection (CBP)
will need to develop new data systems
nor will travelers need to provide data
as part of the ‘‘check in process.’’
The same industry organization also
commented that they have been
complying effectively with the existing
requirements, but have, on occasion
found it difficult to locate, extract,
compile, format and transmit available
information within the timeframe
specified in orders from HHS/CDC.
They note that delays sometimes arise
because the manifest order may contain
incorrect flight or passenger
information. The discussion in the
regulatory impact analysis section has

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been revised to note that delays in
compliance with manifest order
requirements may result from HHS/CDC
having incorrect traveler information in
the manifest order.
The same industry organization also
reports that all of the data available to
them related to passengers are currently
transmitted as Advance Passenger
Information System (APIS), and
potentially under Passenger Name
Record (PNR), data to the Department of
Homeland Security (DHS) and that there
is no reason to burden airlines with an
order for passenger data. HHS/CDC
recognizes that industry does submit
certain passenger data to DHS and it is
not our intent to burden industry with
duplicative requirements, but rather to
effectively and efficiently protect public
health. In the experience of the HHS/
CDC, queries from APIS/PNR rarely
result in full sets of contact information
(i.e. the record includes all five
additional data fields as outlined in the
final rule). The data fields that are most
commonly missing from the records are
email addresses (missing 90 percent of
the time), secondary phone number
(missing 90 percent of the time), and
street addresses (missing or insufficient
for public health contact tracing up to
50 percent of the time). These data
elements are vital to a contact tracing
investigation. In looking at a random
sample of 20% of the compiled
international air travel manifests for
2015, those including a compiled data
set from NTC and the airlines, 100%
were missing at least one of the 5 data
fields. Email address and secondary
phone number were among those most
frequently missing. For context, there
were approximately 760,000 scheduled
flights that arrived into the United
States in 2015. In 2015, CDC issued
passenger manifest requests for 64
international flights arriving into the
United States. As noted in the RIA of
the final rule, from 2010 to 2015, CDC
conducted an average of 77 contact
investigations per year involving
arriving international flights.
Airlines are contacted for the majority
of contact investigations using a
manifest order document. At a
minimum, CDC needs to confirm the ill
traveler was on the flight and where the
individual sat in relation to other
travelers to determine risk of exposure.
In CDC’s experience the following has
been true:
• Only airlines can quickly and
efficiently produce a partial manifest
targeting affected rows;
• only airlines can confirm identity of
‘‘babes in arms’’ and their co-travelers
(Parent); this is important for measles
cases;

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• only airlines can quickly confirm
whether an individual actually flew (in
instances where individuals deplane
and do not re-board during a layover);
and
• only airlines can confirm a plane’s
configuration if there is a question with
the provided row numbers. Different
aircraft have different seating
arrangements depending on carrier and
layout. It is important to know if a
certain seat is separated by a bulkhead
or is a window seat.
In addition, HHS/CDC only requires a
partial manifest, e.g. 5 rows for travelers
with infectious tuberculosis, so that
NTC and HHS/CDC staff can limit the
investigation to only those passengers at
risk and supplement/cross reference
with APIS and PNR data. If a partial
manifest is not available from the
airlines, then each passenger record
must be researched individually to find
a seat number, and then the
configuration of an entire plane must be
populated to determine where the index
case sat in relation to other at-risk
passengers. For large flights from Asia,
this can pose a tremendous burden to
NTC and CDC staff while slowing the
ability of CDC to provide important
contact information to state and local
health departments. Manually
populating multiple 300+ person flights
is not feasible in a timely manner.
As part of its plan for retrospective
analysis under E.O. 13563, HHS/CDC
intends to synthesize, analyze, and
report within the next two years on
strategies to reduce duplication of the
collection of passenger/crew manifest
information in coordination with DHS/
CBP. The report will include any
recommendations (e.g., IT systems
improvements to facilitate enhanced
search capabilities of passenger data,
increased efficiency to relay passenger
data, improvements to the existing
CDC–CBP MOU) to ensure that the
collection of passenger or crew manifest
information do not unduly burden
airlines, vessels, and other affected
entities. HHS/CDC intends to seek
public comment on the report and any
recommendations regarding the costs
and benefits of activities implemented
in 42 CFR parts 71.4 and 71.5. Estimates
of both costs and benefits in the NPRM
regulatory impact analysis were not very
large because HHS/CDC is not
implementing a new data collection
requirement. The regulatory impact
analysis for the final rule has been
revised to reflect that HHS/CDC will
work with CBP to search for responsive
data to avoid duplicative data
requirements. Estimates of costs in the
revised regulatory impact analysis have
not been revised because the airline

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industry did not provide any new
information regarding costs to search for
responsive data when receiving
manifest orders. The benefit estimate
has been revised and is lower than the
estimate for the NPRM to indicate that
the airlines may not have any more
contact data than is already provided in
APIS or PNR data submitted to DHS.
HHS/CDC received a number of
comments from the general public that
compared the relatively small number of
measles cases in any given year to the
total numbers of vaccine-associated
adverse events and health department
spending to contain measles outbreaks.
Based on this comparison, commenters
believed that HHS/CDC and health
departments spend too much money on
communicable disease control and that
resources would be better allocated to
other activities. Some commenters
suggested that the costs of these adverse
events should be included in a Small
Business Regulatory Enforcement
Fairness Act analysis. In general, this
type of analysis is outside the scope of
this regulatory impact analysis because
this final rule does not require measles
vaccination. HHS/CDC’s recommended
vaccine schedule will not be affected by
this final rule. Although HHS/CDC
recommends that health departments
offer measles vaccine to non-immune
individuals exposed during travel,
measles is not a quarantinable
communicable disease and this final
rule does not require any individual to
receive a measles vaccine. Because
health departments offer measles
vaccines to exposed, non-immune
travelers, HHS/CDC estimates that the
final rule will only result in a small
number (6) of additional measles
vaccines. The costs of procuring and
administering these vaccines is
included in the analysis.
As noted in the regulatory impact
analysis, there are only 564 travelers
exposed to measles during international
travel in a given year. Most of these
travelers will already have immunity to
measles and the final rule is only
expected to have a small impact on the
ability of health departments to contact
travelers. The total costs of all measles
vaccine-associated adverse events is
outside the scope of the analysis for this
final rule as mentioned above.
One commenter suggested that the
cost estimates for the NPRM were too
low because the analysis did not
account for reduced willingness to
travel if vaccines against measles and
other communicable diseases are
required to travel. HHS/CDC disagrees
with this suggestion because
vaccination is not a requirement in this
final rule. HHS/CDC has on occasion

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requested that DHS/TSA restrict
interstate or international air travel for
people known to be infectious with
measles who were noncompliant with
public health recommendations not to
travel. However, HHS/CDC does not
recommend restricting the air travel of
persons who have not received the
measles vaccine.
One commenter questioned whether
the estimated value of statistical life
($9.4 million) should be multiplied by
the total number of measles vaccineassociated adverse events in the United
States. HHS/CDC appreciates this
thoughtful comment. This would result
in a larger estimate in the cost of
measles vaccine-associated adverse
events. However, this is not a correct
usage of the value of statistical life,
which should only be multiplied by an
estimated number of deaths. The
regulatory impact analysis has been
revised to better explain this distinction.
Another commenter suggested that
public health department measles
response costs were overestimated by
using a model-based approach rather
than estimating the cost of hiring of
additional staff to deal with measles
outbreaks. HHS/CDC addressed the
comment in the regulatory impact
analysis by clarifying that the analysis is
a published model-based analysis and
that the cost estimate is based on the
opportunity cost of public health
personnel and is not based on the cost
of hiring additional staff.
HHS/CDC received comments from
the airline industry indicating that the
definition of ill person under 71.1 does
align with Note 1 to Standard 8.15 of
ICAO’s Annex 9 to the Convention on
International Civil Aviation. HHS/CDC
also received comments from the airline
industry regarding the change to the
definition of ill person under 70.1 for
interstate flights contending that these
changes would increase costs.
Specifically, the airline industry
reported that not only does the
expansion of the definition of ill person
place a greater burden on airline staff,
the ambiguity of that definition
amplifies the burden or at least raises
questions as to the particular obligations
of the flight crew to determine if
someone is an ‘‘ill person.’’ Moreover,
the airline industry wanted to know
whether flight crews have an obligation
to conduct a physical examination of
the passenger to determine fever. The
airline industry also noted that under
the OSHA blood borne pathogens
standard, employers are prohibited from
exposing crewmembers to blood or
other potentially infectious materials.
The airline industry also questioned
whether the fever-related illness

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reporting in the proposal would require
that all carriers have the equipment
(thermometers) onboard to determine
fever. The proposal, as noted, has two
other ways to identify fever (warm to
touch or history of fever) which the
airline industry wanted to ensure would
remain viable options within the final
rule.
HHS/CDC notes that there is no
expectation that flight crews should
perform physical examinations as part
of illness reporting. HHS/CDC also notes
that the non-thermometer (warm to
touch or history of fever) remain in the
final rule. Regarding the potential for
increased costs associated with the
change in illness reporting for interstate
flights, HHS/CDC notes that the current
illness reporting requirements for
interstate travel appear in 42 CFR 70.4
and state that ‘‘The master of any vessel
or person in charge of any conveyance
engaged in interstate traffic, on which a
case or suspected case of a
communicable disease develops shall,
as soon as practicable, notify the local
health authority at the next port of call,
station, or stop, and shall take such
measures to prevent the spread of the
disease as the local health authority
directs.’’ Communicable disease is
defined in current 42 CFR 70.1 as
‘‘illnesses due to infectious agents or
their toxic products, which may be
transmitted from a reservoir to a
susceptible host either directly as from
an infected person or animal or
indirectly through an intermediate plant
or animal host, vector, or the inanimate
environment.’’
The changes in this final rule will not
result in substantially increased costs
because airlines would either: (1) Be
complying with the current regulatory
requirement and report all cases or
suspected cases of communicable
disease to local health departments; or
(2) report illnesses according to HHS/
CDC guidance available at http://
www.cdc.gov/quarantine/air/reportingdeaths-illness/guidance-reportingonboard-deaths-illnesses.html, which is
codified in this final rule. HHS/CDC
notes that changes in this final rule
align the symptoms requested for
international and interstate illness
reporting. In addition, according to
guidance, reports received by HHS/CDC
would be considered sufficient to satisfy
the requirement to report to local health
departments because HHS/CDC will
coordinate response activities with the
local health department after receiving
an illness report. In response to these
comments, HHS/CDC increased the
expected number of illness reports in
the upper bound analysis regulatory
impact analysis for the final rule. This

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upper bound analysis finds that a 100%
increase in info-only reports and 50%
increase in reports requiring response
would result in a marginal cost of
$20,573 for airlines and vessel
operators. This cost is negligible
compared to the annual revenue of the
international air and maritime travel
markets. HHS/CDC also received a
comment to include the cost of training
for illness reporting in the regulatory
impact analysis. HHS/CDC notes that
illness reporting is already required
under existing regulations and the
changes in this final rule more closely
align with ICAO guidance for illness
reporting for international flights and
represent a reduction in burden for
interstate flights, where reporting of all
cases or suspected cases of
communicable diseases is required.
HHS/CDC added an estimate of training
costs to the upper bound cost analysis
for airlines (an annualized $356,000 per
year).
HHS/CDC received a comment from a
local health department concerning the
rationale for reporting all illnesses and
deaths that occur on interstate flights.
This health department asked whether
evaluating illnesses and deaths that
occur on interstate flights may lead to
an increase in costs for State and local
health departments. HHS/CDC does not
anticipate an increase in costs for State
and local health departments because
evaluating illnesses and deaths
occurring on interstate flights is
consistent with existing HHS/CDC
guidance and represents a less
restrictive alternative compared to the
existing reporting requirement in 42
CFR 70.4. Furthermore, the costs to
State and local health departments may
decrease if HHS/CDC is able to filter out
reports that do not require a public
health response, which airlines would
have previously reported directly to the
health departments under 42 CFR 70.4.
If there is an increase in the number of
illness reports requiring a public health
response, HHS/CDC believes the costs to
health departments may decrease if the
health department is notified earlier.
A public health research center
questioned the value of nonmedical
personnel being able to differentiate
Ebola, Middle East respiratory
syndrome (MERS) or measles from other
medical issues. HHS/CDC appreciates
the concern and notes that the final rule
aligns the illness reporting requirement
with international guidelines and
represents a reduced burden for illness
reporting on interstate flights compared
to current regulatory language as
mentioned above. The intent of illness
reporting is not to diagnose disease
during flight, but rather to identify a

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limited number of instances in which it
would be advantageous to follow up
with ill travelers for an assessment upon
disembarkation. The current numbers of
illness reports received are summarized
in the regulatory impact analysis and
the number of reports is not expected to
increase significantly because the
regulatory text will better align with
publically available HHS/CDC guidance.
A number of comments from the
public questioned whether there would
be a huge cost resulting from the broad
definition of ill person. These
commenters expressed concern that
misdiagnosis by non-medically trained
personnel would lead to reduced travel
based on the public’s fear of being
wrongly detained by public health
officials. HHS/CDC notes that illness
reporting is already required for both
interstate and international travel. We
note that travelers are not placed under
public health orders simply as a result
of an illness report. Rather, orders are
issued only if a licensed medical officer
based on a public health risk assessment
has sufficient reason to believe that the
individual is infected with a
quarantinable communicable disease. In
addition, the new definition is
consistent with existing international
guidelines and HHS/CDC guidance.
Thus, HHS/CDC does not believe the
changes to illness reporting will result
in a large burden to the general public.
The cost analysis in the regulatory
impact analysis has been updated to
include the cost to travelers involved in
public health follow-up after an illness
report.
One commenter opposed the rule
because of a perceived negative
economic and/or social impact upon
individuals placed under a public
health order. Regarding the social
impact of the individual who may be
ostracized, HHS/CDC notes that public
health measures such as quarantine and
isolation are not new concepts or
practices, HHS/CDC has been
implementing these measures to protect
public health for many years. We
reemphasize that one compelling reason
for the publication of this final rule is
to make ‘‘quarantine’’ and ‘‘isolation’’
better understood by the public so that
these terms, its purposes, and meanings
become more familiar and thereby
decrease public anxiety over these
important protections. For the same
reason, HHS/CDC does not believe the
provisions in the final rule will increase
or decrease the cost of isolation or
quarantine. HHS/CDC does provide an
estimate of traveler cost in the sections
describing Ebola entry enhanced risk
assessment and management and illness

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reports in the regulatory impact
analysis.
One commenter suggested that the
costs incurred by airlines would be
passed along to the general U.S.
population purchasing tickets for air
travel. HHS/CDC concurs and mentions
this possibility in the regulatory impact
analysis. However, changes included in
this final rule are a codification of a
current practice and estimated total
costs are only $11,000 to $431,000 per
year. Thus, significant changes in ticket
prices are not expected.
One commenter suggested that
changes in infectious disease caseloads
would not result in cost savings to
public health agencies or individuals
because there is already a public health
workforce in place. HHS/CDC calculates
such costs based on the opportunity cost
of public health staff under the
presumption that such staff would be
involved in other productive activities if
not spending time addressing outbreaks.
HHS/CDC solicited comment from the
public regarding potential public
willingness to pay to be contacted in the
event of an exposure to a communicable
disease during travel. This was done to
help estimate the potential benefit to the
public of HHS/CDC’s efforts to work
with health departments to contact
travelers exposed to meningococcal
disease, viral hemorrhagic fevers, MERS
or other severe acute respiratory
syndromes, measles, and tuberculosis,
among other diseases. HHS/CDC
received a number of comments from
several individuals that they believe
public health measures to mitigate
measles transmission are unnecessary.
Some individuals also noted that Ebola
and MERS cases in the United States
have not led to widespread
transmission. These commenters either
indicated or inferred that they would be
unwilling to pay to be informed of
potential communicable disease
exposures during travel. The discussion
in the regulatory impact analysis has
been updated to incorporate this
feedback.
HHS/CDC solicited public comment
on willingness to pay to reduce Ebola
risk in the United States to near zero if
another international outbreak of Ebola
with widespread transmission occurs in
the future. HHS/CDC received
comments from an organization
representing flight attendants indicating
that they believe it is in the public
interest to reduce Ebola risk in the
United States to near zero in the event
of a future outbreak. They indicated that
there is no reason to believe that
achieving this objective would require
unsustainable levels of funding. HHS/
CDC incorporated this comment

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regarding public willingness to pay in
the regulatory impact analysis.
HHS/CDC also received comments
from several individuals regarding the
high cost of the measures taken to
reduce the risk of Ebola transmission in
the United States during the 2014–2016
Ebola epidemic in West Africa. Several
of these commenters indicated they had
zero willingness to pay for future public
health measures in the event of a large
Ebola outbreak.
Many commenters stressed the need
to reassess whether to implement such
activities in the event of a future Ebola
outbreak. An example of such
comments is provided by a research
center studying international response
efforts to emerging infectious disease
threats, who noted that despite 99%
complete active monitoring by health
departments, there was no evidence of
incident Ebola cases among individuals
traveling from Ebola-affected countries.
This does not include the two incident
cases that preceded active monitoring.
The commenters state that given this
evidence it is not advisable for HHS/
CDC to recommend active monitoring in
the event of future Ebola outbreaks.
In addition, a public health research
center cautioned against extrapolating
costs and benefits calculation methods
for measles and tuberculosis to Ebola,
MERS, and other rare diseases. The
research center further noted that
countermeasures for Ebola and MERS
do not exist (other than isolation and
quarantine). They suggest that this
would limit the effectiveness of point of
entry measures. These researchers also
point to the fact that transmission of
Ebola and MERS has not occurred
during air travel. They noted that point
of entry risk assessment programs may
increase anxiety (and costs) if cases are
detected in the community after the
implementation of point of entry
measures. Finally, the research center
noted that the costs for State and local
health departments to actively monitor
all arriving travelers for 21 days were
not included in the analysis.
In response to these comments, HHS/
CDC concurs that it would not be wise
to directly extrapolate approaches for
measles and tuberculosis to rare
diseases and has tried to provide as
much information as possible around
the decision to implement the Ebola risk
assessment program and
recommendations for active monitoring.
HHS/CDC did not simply extrapolate
the analysis for measles and
tuberculosis to Ebola.
HHS/CDC does not have data on State
and local spending to achieve the
objective of the 21-day active
monitoring program and concedes that

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the cost of active monitoring would
likely exceed the costs incurred at the
airports. However, HHS/CDC did
provide an estimate of total Federal
spending for both domestic and
international efforts to attempt to
quantify the cost of these efforts. Federal
money was used to support State/local
surveillance efforts. Federal money was
also used to support improvements in
laboratory capacity by States and
hospital infection control efforts, which
should have benefits beyond the 2014–
2016 Ebola epidemic. In addition,
Federal funding supported research into
potential Ebola vaccines and medicines.
The cost for the Ebola enhanced entry
risk assessment program was just a
portion of these costs and HHS/CDC
acknowledges that risk assessment
program at airports by itself would have
limited potential to reduce risk.
However, HHS/CDC also notes that the
costs of Ebola entry risk assessment at
points of entry included efforts to (1)
stratify travelers by risk level so that
health departments could focus more
intense monitoring efforts on travelers at
higher risk and (2) educate travelers on
Ebola risk factors and symptoms and
provide informational materials, a
thermometer, and a telephone to all
travelers to improve compliance with
active monitoring efforts. This led to a
higher cost, but more effective program
relative to an alternative in which
travelers would only be screened once
at the airport, such as occurred in other
countries implementing screening
programs during the 2003 Severe Acute
Respiratory Syndrome (SARS)
epidemic.
HHS/CDC believes that the risk of
Ebola infection in the U.S. population
was potentially reduced because of the
combination of measures to protect
against Ebola transmission in the United
States, including risk assessment at
ports of entry. HHS/CDC acknowledges
the risk was probably very low in the
absence of domestic activities.
HHS/CDC further notes that it
recommended active monitoring of
travelers as a less restrictive alternative
to more stringent measures such as
quarantines that were being demanded
by some members of the public.
Widespread implementation of
quarantine, particularly for healthcare
workers crucial to the response efforts
in West Africa and the United States,
would have greatly hampered outbreak
control measures by providing a strong
disincentive to healthcare workers
participating in the response.
To estimate the potential benefits of
the Ebola risk assessment program at
ports of entry, HHS/CDC provided a cost
comparison of the incident Ebola cases

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that occurred in Texas compared to New
York to estimate the difference in costs
between an Ebola case that was detected
quickly and treated in a pre-selected
hospital identified to be capable of
Ebola treatment in comparison to an
Ebola infection that was not initially
suspected to be Ebola leading to
community exposures and hospital
exposures in a hospital that was not a
pre-selected hospital capable of Ebola
treatment.
HHS/CDC also examined the recent
MERS outbreak in South Korea to
demonstrate that even relatively small
outbreaks of rare diseases such as MERS
and Ebola can have large economic costs
despite a relatively small number of
cases and deaths. HHS/CDC found that
the number of international travelers
(non-Korean citizens traveling to South
Korea) decreased by 40–50% during the
peak months of the 2015 MERS
outbreak. HHS/CDC further notes that
these declines in travel occurred in the
absence of widespread travel
restrictions. The costs incurred by South
Korea during the outbreak were used to
demonstrate the potential costs of a
larger Ebola outbreak in the United
States.
Given the evidence from the programs
implemented to mitigate risk during the
2014–16 Ebola epidemic, i.e., the small
number of international air travelers
from countries with widespread Ebola
transmission that later developed Ebola
and the very limited risk of transmission
by asymptomatic individuals with Ebola
infection, HHS/CDC may not elect to
implement an Ebola entry risk
assessment program in the event of a
future outbreak or to recommend 21-day
active monitoring of travelers from
countries with widespread
transmission.
HHS/CDC emphasizes that it will
continue to consider cost and work with
multiple U.S. government agencies, as
well as with airport authorities and
health departments in U.S. States and
territories, to apply the latest evidence
to future decision-making. In addition,
HHS/CDC will try to employ the least
restrictive measures to achieve public
health objectives. HHS/CDC notes that,
during the period that the Ebola entry
risk assessment and monitoring program
was in effect, only 0.08% (29/38,344) of
travelers assessed at U.S. airports were
recommended for medical evaluation at
hospitals and that no Federal quarantine
or isolation orders were issued during
the epidemic, although some States did
issue such orders under their own
authorities. These considerations have
been added to the regulatory impact
analysis in the final rule. Since this
analysis concerns a codification of

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existing authorities, this analysis has
been moved to a separate appendix after
incorporating public feedback.
A number of commenters suggested
that HHS/CDC did not include the cost
for people participating in the Ebola
enhanced risk assessment program.
However, HHS/CDC did provide such
an analysis of these costs. One public
commenter suggested that the
psychological cost of quarantine should
be considered in the economic impact
analysis. Although HHS/CDC generally
concurs with the idea of accounting for
all of the costs associated with time
spent in quarantine, HHS/CDC’s
authority to issue quarantine orders will
not change with the publication of this
final rule. Thus, this final rule does not
incur new psychological costs for
persons under quarantine orders.
HHS/CDC notes the opportunity costs
for persons undergoing risk assessment
at airports and/or evaluation at hospitals
during the 2014–16 Ebola entry risk
assessment and management program.
HHS/CDC estimates their opportunity
costs based on average wage rates, but
did not have additional data to estimate
a marginal psychological cost.
Opportunity costs were also estimated
for a more restrictive option compared
to the Ebola entry risk assessment and
management program, i.e. a suspension
of entry for 21 days after having been in
an Ebola-affected country.
One commenter suggested that this
rulemaking does not represent the ‘‘least
burden on society’’ because HHS/CDC
has failed to clearly identify a
‘‘compelling public need’’ for the rule.
HHS/CDC appreciates the comment and
responds that the regulatory impact
analysis cites a specific market failure
addressed by this final rule. The market
failure is that the costs associated with
the spread of communicable diseases
impacts the entire U.S. population, not
just the group of persons currently
infected with communicable diseases.
Since this final rule is primarily
implementing current practice, HHS/
CDC does not anticipate major new
benefits or costs.
One commenter stated that the cost/
benefit analyses was very vague,
meaning that there is no accountability
or way to measure whether or not the
final rule will achieve its intended
result of preventing the spread of
quarantinable communicable diseases
via travel, which the commenter stated
was already an extremely low risk.
HHS/CDC concurs that there is
uncertainty in the regulatory impact
analysis. However, HHS/CDC has tried
to indicate that one of the reasons for
this uncertainty is that this final rule is
primarily implementing current

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practice. Thus, where possible, HHS/
CDC tried to provide data on the current
burden of the provisions that are being
updated in this final rule. HHS/CDC
does not expect any major changes in
practice as a result of this final rule.
One commenter suggests that the cost/
benefit analyses was confusing because
quarantinable and non-quarantinable
diseases were not clearly identified.
HHS/CDC appreciates this feedback and
has updated the analyses to more clearly
differentiate quarantinable and nonquarantinable diseases.
One commenter suggested that HHS/
CDC took an unnecessarily extreme
position in analyzing an alternative of
removing all enforcement of current
regulations. HHS/CDC used this as an
alternative because this final rule is a
codification of current practice and does
not impose new regulatory burdens.
q. Paperwork Reduction Act
HHS/CDC published notices related to
modifications and a new information
collection in the Notice of Proposed
Rulemaking. Those information
collections are as follows:
(1) Foreign Quarantine Regulations
(42 CFR part 71) (OMB Control No.
0920–0134)—Nonmaterial/nonsubstantive change—National Center for
Emerging, and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
(2) Restrictions on Interstate Travel of
Persons (42 CFR part 70) (OMB Control
No. 0920–0488)—Nonmaterial/nonsubstantive change—National Center for
Emerging, and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
(3) Airline and Vessel and Traveler
Information Collection (42 CFR part
71)—New Information Collection
Request—National Center for Emerging,
and Zoonotic Infectious Diseases
(NCEZID), Centers for Disease Control
and Prevention (CDC).
One commenter stated that there are
no estimates of additional information
collection requirements resulting in a
clear violation of the Paperwork
Reduction Act. The commenter further
stated that requesting information when
HHS/CDC has no idea of the impact is
not a well thought out or planned
rulemaking. This commenter further
questioned the value of providing
comment when the agency purportedly
has no idea what additional burden it is
imposing on the public. HHS/CDC
disagrees with these assessments.
The focus of the final rule is to codify
current practices and to update
currently approved information
collections to better align with
operational procedures and other

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industry guidance related to illness
reporting on aircraft and vessels. Those
information collections are currently
approved under OMB control numbers
0920–0134 (Foreign Quarantine
Regulations), 0920–0488 (Restrictions
on Interstate Travel of Persons), and the
new information collection request
Airline and Vessel and Traveler
Information Collection (42 CFR part 71),
which is currently pending OMB
approval. The estimates of the burden
provided in the Paperwork Reduction
Act section of the NPRM were based on
previous experience with particular
information collections solicited or
required from the public or industry in
the past. In some cases, larger estimates
of the burden to account for an
increased number of reports to HHS/
CDC during disease outbreaks or public
health emergencies were included.
There are no information collections
requirements that are wholly new,
unreasonably burdensome, or outside
the scope of historical HHS/CDC
practices implemented to prevent the
introduction or spread of communicable
disease into or within the United States.
Another commenter suggested that
training in recognizing ill travelers is a
burden that was not adequately
considered. HHS/CDC disagrees because
it does not mandate specific training for
recognition of ill travelers. HHS/CDC is
seeking to better align the ill person
definition with the ICAO standard and
thus is not the only organization that
has this requirement. HHS/CDC
provides specific guidance for how to
recognize ill travelers and report to
HHS/CDC on its Web site. HHS/CDC
also believes this training is most likely
already part of the training process for
flight crews. An analysis of potential
training costs has been added to the
upper bound cost analysis in the
Regulatory Impact Analysis. The upper
bound annualized costs for additional
training are estimated at $356,000.
Finally, HHS/CDC is re-inserting ‘‘Has
a fever that has persisted for more than
48 hours’’ as a component in the
definition of Ill person in § 70.1 General
definitions and ‘‘Has acute
gastroenteritis, which means either
diarrhea, defined as three or more
episodes of loose stools in a 24-hour
period or what is above normal for the
individual, or vomiting accompanied by
one or more of the following: One or
more episodes of loose stools in a 24hour period, abdominal cramps,
headache, muscle aches, or fever
(temperature of 100.4 °F [38 °C] or
greater)’’ in § 71.1 General definitions.
This language was quoted verbatim in
the preamble of the NPRM at 81 FR

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54305 but was inadvertently omitted
from the proposed regulatory text.
B. Provisions Applicable Only to Part 70
Only (Domestic)
a. General
HHS/CDC received comments from
the public asserting that State and local
public health regulations already in
place are sufficient to protect
individuals without the need for Federal
involvement. HHS/CDC agrees that State
and local authorities play an integral
role in protecting public health, but
disagrees that there is no Federal role.
HHS/CDC’s DGMQ maintains
quarantine stations at major U.S. ports
of entry that fulfill a primary purpose in
preventing the introduction of
communicable diseases into the United
States, but also play an important role
in containing the interstate spread of
communicable disease. There are
several broad areas of cooperation
between quarantine field staff and State
and local health agencies, such as
contact tracing, which provide a
framework for responding to
communicable disease threats arising
from interstate travel and at the local
level. It is through these networks and
established partnerships, in keeping
with current practice, that the
provisions of the final rule will be
successfully implemented.
HHS/CDC received a comment to the
effect that quarantine specifically
should be left to the States. HHS/CDC
received another comment stating that
Federal authority should not take
precedence over State authority. In
contrast, a public health association
suggested that these regulations should
indicate that Federal public health
measures ‘‘supersede activities taken by
States.’’ We respond that while HHS/
CDC works closely with State and local
public health authorities, the Federal
government has a traditional role in
preventing introductions and spread of
communicable diseases at ports of entry
and interstate. HHS/CDC also disagrees
with the suggestion that it should not
intervene in the event of inadequate
local control or lacks authority to
protect the public’s health within the
authority granted to it by Congress.
Under 42 U.S.C. 264(e), Federal public
health regulations do not preempt State
or local public health regulations,
except in the event of a conflict with the
exercise of Federal authority. Other than
to restate this statutory provision, this
rulemaking does not alter the
relationship between the Federal
government and State/local
governments as set forth in 42 U.S.C.
264. Under, 42 CFR 70.2, HHS/CDC

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make take action to prevent the
interstate spread of communicable
diseases in the event that the CDC
Director determines that inadequate
local control exists. This longstanding
provision on preemption in the event of
a conflict with Federal authority is left
unchanged by this rulemaking.
One public health organization
requested clarification of the process to
transfer an individual from Federal to
State custody and further stipulated that
the State authority should require an
independent State assessment of risk
under State law. In response, HHS/CDC
notes that the issuance of Federal public
health orders is coordinated with State
and, when appropriate, local public
health authorities. Transfer of an
individual from Federal to State custody
would be similarly coordinated such
that the State would need to agree to
assume custody and the State’s order
would need to be in place prior to HHS/
CDC’s rescinding the Federal order.
When custody of an individual is
transferred to a State authority, the State
may choose, but would not be under a
Federal mandate, to conduct an
independent assessment of risk
pursuant to its own policies and
procedures. Furthermore, once the
transfer of custody has occurred, the
State’s laws and standards for due
process would apply.
Another public health authority asked
for clarification of how jurisdictional
issues regarding transfers of authority
affecting more than one State would be
handled for individuals under Federal
quarantine. HHS/CDC responds that if
more than one State is affected by the
transfer of authority, HHS/CDC will
work with all relevant States to
determine the most appropriate State or
local jurisdiction to accept custody of
the individual. If it is necessary to
transport the individual to another
State, for example to the individual’s
State of residence, HHS/CDC will work
with the affected States to facilitate such
a transfer under Federal orders.
One public health organization
requested clarification of the procedures
HHS/CDC would use to rescind a public
health order. HHS/CDC responds that it
would issue the detained individual a
written order rescinding the isolation,
quarantine, or conditional release. This
would be based on either one of two
criteria: The individual is determined to
no longer pose a public health threat or
custody of the individual has been
transferred to a State or local public
health authority.
HHS/CDC received a comment from a
public health department stating that
the regulations should include language
that HHS/CDC will coordinate with

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State and local public health authorities
and law enforcement regarding any
intended surveillance and enforcement
activities. HHS/CDC strongly believes
that coordination with State and local
public health authorities, as well as
relevant law enforcement entities, is
essential to the public health response
to individual cases as well as outbreaks
of communicable disease. On the few
occasions that HHS/CDC has issued
Federal isolation orders for travelers
with infectious tuberculosis, HHS/CDC
has worked closely with State and local
health departments to coordinate
transportation, medical evaluation, and
treatment of the ill traveler, including
law enforcement when needed. During
the 2014–2016 Ebola epidemic, HHS/
CDC issued guidance and alerted health
care and EMS workers to consider a
diagnosis of Ebola if patients had
compatible symptoms and had visited
an affected country within the previous
three weeks. HHS/CDC and State and
local health departments worked closely
to assess any potentially exposed
individuals with symptoms compatible
with Ebola to determine whether
medical evaluation was needed and, if
so, to ensure safe transportation to a
medical facility designated by the health
department. In light of HHS/CDC’s
history of close coordination with State
and local public health authorities,
including cooperating law enforcement
entities when needed, HHS/CDC has
determined that specific regulatory
language is unnecessary.
b. Requirements Relating to Travelers
Under a Federal Order of Isolation,
Quarantine, or Conditional Release
Some commenters questioned HHS/
CDC’s authority, as well as the need, to
restrict the movement of individuals
who are not ill but have been exposed.
HHS/CDC thanks these commenters for
their review and input. Some
quarantinable communicable diseases,
such as novel pandemic influenza
strains, may be contagious before the
infected person becomes symptomatic.
Therefore, in these situations, it may be
necessary to restrict the movement of
asymptomatic exposed people to make
sure they do not expose others
inadvertently while they are not aware
that they are contagious. It may also be
necessary to restrict movement of an
exposed person if public health
authorities are unable to ensure
appropriate monitoring of the person,
for example, if an individual is known
to have a history of noncompliance with
public health recommendations.
Exposed people whose movement is
restricted through quarantine or other
means may be offered vaccination, if a

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vaccine is available, but only with
informed consent.
One commenter noted that the
regulation allows HHS/CDC to issue
interstate travel permits to an infected
individual conditioned upon the
individual taking ‘‘precautionary
measures’’ as prescribed by HHS/CDC.
This commenter requested that HHS/
CDC clarify what precautionary
measures may be prescribed and stated
that such conditions should not be
based on factors unrelated to the
individual’s health condition, e.g.,
socio-economic, ethnic status. While
HHS/CDC agrees that the issuance of a
travel permit should not be based on
such factors as race, gender, ethnicity,
or socio-economic status, we note that
the issuance of a travel permit may be
conditioned on such factors as the
individual’s ability and willingness to
comply with the terms of the permit.
Furthermore, while the exact
precautionary measures prescribed may
vary based on the infectious agent, such
measures, for instance, may include:
Agreeing to minimize time in congregate
settings while traveling; avoiding eating
in restaurants or other enclosed public
places; traveling with no other people in
the vehicle or, if other people are
needed to safely operate the vehicle,
agreeing to wear a mask and ensure
good ventilation; and reporting to the
local health department upon arrival or
on route as needed.
This commenter also requested
clarification of the legal impact of a
person who is denied a permit or has
had a permit revoked. We note that per
the terms of the regulation persons
denied a travel permit or who have had
a travel permit revoked may submit a
written appeal. The right to a written
appeal, as well as the means by which
an appeal may be requested, will be
addressed in the written order denying
the request for a travel permit or
revoking an existing permit. The appeal
will be decided by an HHS/CDC official
who is senior to the employee who
denied or revoked the permit. HHS/CDC
declines to speculate as to what else this
commenter may be referring to by the
term ‘‘legal impact,’’ but notes that the
regulation does not impair the ability of
persons to seek judicial review of final
agency actions through the
Administrative Procedure Act.
This commenter also requested
clarification of how long an individual
may be restricted in his or her travel
under a Federal travel permit. We note
first that the restriction only applies to
those under a Federal public health
order or under a State or local order if
the State or local health department of
jurisdiction requests Federal assistance

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or there is inadequate local control. In
further response, HHS/CDC notes that
the restriction would remain in place so
long as the individual is infected or
capable of infecting others. This
commenter further requested
clarification of the impact of a
disagreement between HHS/CDC and
State or local public health authorities.
We note that by the terms of 42 U.S.C.
264(e), Federal public health regulations
do not preempt State or local public
health regulations except in the event of
a conflict with the exercise of Federal
authority. Moreover, per the terms of 42
CFR 70.2, HHS/CDC may take action to
prevent the interstate spread of
communicable diseases in the event that
the CDC Director determines that
inadequate local control exists.
HHS/CDC received a comment from a
flight attendant union requesting
clarification as to whether an employee
could be held criminally liable for
knowingly transporting someone in
violation of the terms of a travel permit
as specified under section 70.5. In
response, HHS/CDC clarifies that the
term ‘‘operator’’ is defined under 70.1
consistent with 14 CFR 1.1 and with
respect to an aircraft means, ‘‘any
person who uses, causes to use or
authorizes to use an aircraft, with or
without the right of legal control (as
owner, lessee, or otherwise).’’ We
further note that criminal liability, if
any, will be determined by a court of
law and not administratively by HHS/
CDC. Accordingly, we decline to
speculate as to whether employees who
knowingly violate the terms of a travel
permit may be held criminally liable.
One public health organization asked
for clarification of how local health
departments would be engaged in
conducting communicable disease
screening activities or enforcing Federal
public health travel restrictions for
individuals traveling interstate, given
that HHS/CDC staff are not present at
many points of interstate travel. HHS/
CDC acknowledges this limitation in
their presence at some ports of entry
and in regard to interstate travel and
intends to address this through future
guidance and discussion with
stakeholders.
In regard to interstate air travel, HHS/
CDC clarifies that the Federal public
health Do Not Board tool will deny
boarding of persons known to pose a
public health risk to other air travelers.
This tool is applicable to persons
boarding a commercial aircraft with an
origin or destination in the United
States, including interstate travel. See
80 FR 16400 (Mar. 27, 2015).
For other modes of travel, HHS/CDC
does not have a systematic mechanism

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of denying boarding and these situations
may need to be addressed on a case-bycase basis, either through direct
communication with a conveyance
operator or through application of other
movement restrictions such as the
issuance of State or Federal public
health orders. Such situations will
likely require the participation of State
or local public health authorities;
however, as noted by the commenting
organization, the Federal and State/local
costs and resources required during
such operations are not known. The
specific roles of State or local health
departments will be addressed through
future guidance or stakeholder
discussion.
HHS/CDC received a comment
contending that the extension of travel
permits to intrastate travel is in
violation of the Commerce Clause. HHS/
CDC disagrees. We note that HHS/CDC
will only require intrastate travel
permits when a State or local health
authority of jurisdiction requests federal
assistance or in the event that State and
local actions are inadequate to prevent
interstate communicable disease spread.
Under 42 U.S.C. 264, Congress acting
pursuant to its Commerce Clause
jurisdiction, has authorized HHS/CDC
to take measures to prevent the foreign
introduction and interstate spread of
communicable diseases. It is well
established that the Federal government
may act to protect interstate commerce,
even though the threat may come
entirely from intrastate activities. See
United States v. Lopez, 514 U.S. 549,
558–559 (1995).
One commenter requested that HHS/
CDC replace the word ‘‘traveler’’ with
‘‘passenger’’ with respect to mandatory
public health assessments, as a traveler
could be taken to mean ‘‘anybody in a
private vehicle lined up at a toll booth.’’
In response, HHS/CDC states that the
use of the word ‘‘traveler’’ with respect
to conveyances is intended to include
both passengers and crew. Furthermore,
HHS/CDC states that its authority
extends to all individuals engaging in
interstate travel including those
traveling by private vehicle, particularly
if they are in the ‘‘qualifying stage’’ of
a quarantinable communicable disease.
HHS/CDC received a comment from a
partnership of public health legal
scholars and organizations expressing
concern that requiring application for a
travel permit may be unduly
burdensome because individuals who
are served with a conditional release
order at an airport would then need to
apply for a separate travel permit to
travel to their home State of residence.
HHS/CDC disagrees because under such
circumstances the conditional release

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order itself would include authorization
for these individuals to continue travel
to their home State of residence
provided that they subsequently report
to public health authorities as needed.
For example, during the response to
Ebola, CDC worked with state public
health authorities to allow certain
individuals who met certain risk
thresholds to travel in private vehicles
to their place of residence while
maintaining a focus on protecting public
health. This was done on a case by case
basis, depending on distance of travel
and risk of exposure, and distance from
a health care facility with adequate
capacity to treat and contain Ebola. CDC
would make similar assessments in the
event that conditional release orders are
needed for other quarantinable
communicable diseases. We note that
the conditional release order itself
would provide permission to travel and
have added clarifying language to the
text.
HHS/CDC clarifies, however, that
after arriving in their home State,
should the individuals wish to engage
in further travel, a travel permit may be
needed at that time. In response to
comments from this partnership
organization, HHS/CDC also clarifies
that the travel permit, as provided for in
the regulations, will only be required
under circumstances where the
individual is already under a Federal,
State or local order of quarantine,
isolation, or conditional release.
Because the travel permit requirement is
only applicable to individuals who are
already under a Federal, State, or local
public health order, HHS/CDC believes
that this provision does not
impermissibly restrict an individual’s
right to travel.
In response to comments regarding
the time with which CDC may consider
a travel permit request, the CDC Director
shall respond to a request for a travel
permit within 5 business days Likewise,
one public health association suggested
that, in the event a travel permit is
denied, these regulations should state
the timeframe that HHS/CDC will issue
a response to the appeal; another
proposed the time period for CDC’s
response to be 72 hours. In response to
these comments, HHS/CDC has added a
requirement in the regulation that in the
event that a request for a travel permit
is denied, it must decide an appeal from
that denial within three (3) business
days. HHS/CDC believes that this
timeframe is appropriate because this
provision only applies to individuals
who already have had their travel
restricted through the issuance of a
public health order and deciding an

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appeal may involve coordination with
affected state or local jurisdictions.
After consideration of comments
received, HHS/CDC has modified
paragraphs (a), (b)(1), (b)(2), and (c) of
the provision concerning Requirements
Relating to Travelers Under a Federal
Order of Isolation, Quarantine, or
Conditional Release (§ 70.5) to remove
‘‘agreements,’’ referring to agreements
entered into by the CDC. We have also
modified paragraph (a)(5) to require that
HHS/CDC must issue a written response
to an appeal within three (3) business
days. Other provisions of this section
are finalized as proposed.
c. Report of Death or Illness Onboard
Aircraft Operated by an Airline
Several commenters expressed
concern that the new regulations
remove the requirement for a local
health authority to be notified when a
passengers falls ill or dies on board a
flight. The commenters insisted that this
could interfere with effective local
response to important communicable
disease threats. They propose that local
authorities should be notified in a
timely manner, such as within one hour
of initial reporting, and that HHS/CDC
should consult with local health
authorities on the necessary steps to
contain the spread of communicable
diseases. In contrast, one airline
supported the direct reporting to HHS/
CDC.
HHS/CDC carefully considered these
comments and responds that it will
continue its long standing partnership
with local authorities. The rationale
behind asking airlines to submit reports
of deaths or reportable illnesses directly
to HHS/CDC as opposed to local
authorities is to simplify and streamline
the reporting process for these airlines.
Under the final rule, airlines will not be
required to know the current points of
contact for multiple local jurisdictions,
but rather may report to HHS/CDC as a
single point of contact. HHS/CDC will
continue to share public health
information with State and local health
departments through approved
electronic disease reporting networks
such as the Epidemic Information
Exchange (Epi-X), HHS/CDC’s secure,
Web-based system. HHS/CDC may also
notify State or local authorities via
phone calls.
Some commenters questioned
whether HHS/CDC has adequate
resources to be the first responder at the
local level. HHS/CDC responds that it
regularly coordinates with Federal, State
and local agencies and other partners in
the airport environment. HHS/CDC
intends to continue working closely
with Federal, State, and local partners,

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including first responders such as EMS
and State and local health agencies,
when assistance is needed.
One commenter suggested that the
reporting of ill travelers ‘‘would be an
invasion of our liberty and privacy.’’
HHS/CDC disagrees. The report of
illness or death on board a carrier is a
longstanding regulatory provision and
practice. This final rule only changes to
whom the report is made (directly to
HHS/CDC), rather than to the local
health department of destination. We
further note that personally identifiable
information collected and maintained
under the Privacy Act will be handled
in accordance with that Act and CDC’s
system of records notice published at 72
FR 70867.
Another commenter worried that
‘‘having flight reservations require
health reports will significantly impede
air travel.’’ It is not HHS/CDC practice,
nor a requirement under this regulation,
for individuals to submit health reports
prior to or after making a flight or vessel
reservation. The only instance when
health documents may be required prior
to travel, is if a person is known to be
infectious with a communicable disease
that could spread during travel and has
been placed on the Federal Public
Health Do Not Board described in 80 FR
16400 (Mar. 27, 2015). Because this
practice is not new, HHS/CDC believes
it will not impede air travel.
A flight attendant association
suggested that HHS/CDC should adopt
training and awareness requirements for
airline employers to provide to flight
attendants concerning ‘‘what entails a
qualifying stage.’’ Industry also
expressed concern that flight crews may
be held responsible and penalized for
missed illness identification. HHS/CDC
understands that the statutory definition
of ‘‘qualifying stage’’ may be confusing
to lay persons and does not expect air
or vessel crewmembers to be trained in
the nuances of such language. Instead,
we have crafted a definition of ill person
to focus, in plain language, on the signs
and symptoms of communicable
diseases of public health concern and
quarantinable communicable diseases,
while taking into account the medical
resources available to aircrew. HHS/
CDC intends to enforce this provision
consistent with how reports of deaths
and illnesses are currently handled in
regard to foreign arrivals. We note that
flight crews have not been penalized in
the past for missed reports of illness.
HHS/CDC received comments from
industry that the report of death or
illness should not be limited only to the
pilot in command, given the many
duties already under his/her
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clarify first that this domestic provision
was proposed to mirror the current
foreign provision under 42 CFR
71.21(b)—which HHS/CDC did not
propose to change—and which states
‘‘the commander of an aircraft destined
for a U.S. airport shall report
immediately . . . any death or ill person
among passengers or crew.’’ While we
acknowledge the many duties of the
pilot in command, because this
individual is directly responsible and
has final authority over the operation of
the aircraft, in keeping with the practice
already established through regulation
under 42 CFR 71.21(b), we believe that
the responsibility for reporting ill
persons onboard should ultimately rest
with the pilot in command as stated in
the regulation. Thus, the text of the
regulation has not changed from the
proposal.
One industry group commented that
the role of flight attendants in
identifying sick travelers on board
should be addressed through guidance
developed in conjunction with HHS/
CDC and industry. HHS/CDC responds
that it routinely issues guidance for
flight crews, including standard
guidance for the recognition and
reporting of ill travelers and disease- or
situation-specific guidance during
outbreaks. Such guidance is published
on HHS/CDC’s Web site and
disseminated through established list
serves, industry associations, and any
other available means. HHS/CDC will
coordinate with industry partners to
determine whether additional guidance
may be needed and, if necessary, work
with these partners to develop such
guidance.
One industry organization
commented that the proposed rule
failed to recognize that airlines employ
intermediary professional medical
personnel. HHS/CDC responds that it
recognizes the role of intermediary
professional medical personnel in
assisting flight crews in managing an ill
traveler onboard and references such
personnel in industry guidance issued
at http://www.cdc.gov/quarantine/air/
index.html.
It is not HHS/CDC’s intent for the
public health assessment conducted by
HHS/CDC public health officers to
replace this role in medical
management. However, HHS/CDC
restates that the reporting of ill travelers
to HHS/CDC is the ultimate
responsibility of the pilot in command
as noted above.
One association requested that the
report of deaths on board a carrier be
modified and limited to those deaths
which resulted from a possible
communicable disease. HHS/CDC

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disagrees. In keeping with current
practice, HHS/CDC will continue to
require and receive the reports of all
deaths that occur on board a carrier,
regardless of the suspected cause, to
allow a public health official to conduct
an assessment.
One public health organization raised
concerns about replacing reporting to
local health authorities with reporting to
HHS/CDC. In response, HHS/CDC notes
that extensive input was sought in 2012
from the Association of State and
Territorial Health officers (ASTHO) and
National Association of County and City
Health Officials (NACCHO).
Representatives from those
organizations recommended that
requirements and protocols should be
the same for international and interstate
flights and procedures should be
outlined describing how this would
occur. These representatives
recommended that airlines should
report ill persons on domestic flights to
HHS/CDC and that HHS/CDC should
subsequently notify State or local health
departments. Subsequently, HHS/CDC
posted guidance to this effect on its Web
site and has continued response
planning and development of standard
operating procedures to implement
these recommendations. Thus, this
rulemaking codifies the current practice
and is consistent with recommendations
provided by ASTHO and NACCHO.
One commenter stated that it appears
HHS/CDC is ‘‘attempting to move
towards mandatory reporting by carriers
and border personnel, requiring
reporting of persons with signs of illness
as they cross borders, as opposed to
having to do large-scale individual
contact interviews and investigations
after an outbreak occurs.’’ In response,
HHS/CDC states that reporting by
carriers is already required under the
existing regulations and that this
regulation only codifies current practice
and guidance. In addition, DHS notifies
HHS/CDC of ill travelers detected by
border personnel. HHS/CDC and DHS
agreed to this notification process in a
memorandum of understanding and
therefore changes to this regulation are
unnecessary. HHS/CDC additionally
coordinates notification and
investigation of contacts during
exposure or outbreak situations when
necessary based on a public health risk
assessment. Such investigations are
standard public health practice and not
mutually exclusive of reporting by
carriers or notifications by border
personnel.
After consideration of these
comments, the title of the Radio Report
of Death or Illness (71.21) in the
provision has been finalized as

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proposed to remove the word ‘‘Radio,’’
and now reads Report of Death or
Illness.
C. Provisions Applicable to Part 71 Only
(Foreign)
One commenter questioned the
seriousness of communicable disease
spread on aircraft and vessels. Another
commenter noted an ‘‘extreme
unlikeliness of contracting any
communicable disease while traveling’’
and that, therefore, HHS/CDC failed to
prove a ‘‘compelling need’’ for the
proposed regulations. HHS/CDC
appreciates the opportunity to respond
to these comments. The spread of
communicable diseases on aircraft and
vessels is well documented. There are
numerous reports in the medical and
public health literature of spread of
measles, tuberculosis, SARScoronavirus, and influenza virus on
aircraft. Outbreaks of varicella
(chickenpox), influenza, and
gastrointestinal viruses such as
norovirus are common on cruise ships,
and spread of other diseases such as
measles, rubella (German measles),
tuberculosis, and other gastrointestinal
diseases has also been reported. Aircraft
and vessels have people together in
confined spaces for prolonged periods
of time. Therefore, conducting contact
investigations for certain communicable
diseases identified on aircraft or vessels
is standard public health practice, both
in the United States and internationally,
similar to public health practice in
community settings.
HHS/CDC received comments from
industry regarding ongoing efforts with
DHS/CBP to improve passenger data
collection, as announced in the NPRM.
Several commenters stated that HHS/
CDC should delay this final rule until
DHS/CBP has published a regulation to
ensure that a coordinated system is put
in place. HHS/CDC thanks these
commenters for their input but disagrees
that this final rule should be delayed.
This comprehensive regulation seeks to
protect public health, by implementing,
among other things, current passenger
and crew data collection practices.
One commenter objected to the
collection of health information prior to
using public transportation. Another
commenter opposed the idea of carriers
being ‘‘forced to collect and report 17
data elements on American travelers.’’ A
public health association also insisted
that data elements should only be
collected from people if there is a
reasonable belief that the person is
infected. This final rule does not require
carriers to collect or transmit any data
elements that are not currently collected
and transmitted to CBP via APIS and

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PNR as a result of normal operating
procedures. We also take this time to
emphasize two important points. First,
passengers are not required by HHS/
CDC to submit specific data elements
provided by passengers. Second, HHS/
CDC will only seek this information
from CBP or the airline in the event of
a confirmed or suspected communicable
disease on board a carrier which
requires contacting fellow passengers to
inform them of possible exposure.
While HHS/CDC received support for
the data collection from two public
health associations, a commenter
misread the proposals to mean that
aircraft operators would be required to
develop new capacity and processes to
capture and store a comprehensive set
of sensitive data, archive this data, and
then provide it to HHS/CDC. HHS/CDC
takes this opportunity to restate and
clarify that these final regulations do not
impose any new burdens upon the
airline industry but rather, codify the
current practice of receiving a passenger
manifest order (as needed) and
providing HHS/CDC with any data in an
airline’s possession. This rule places no
requirement on the airline to solicit or
store additional data than current
practices allow. Therefore, HHS/CDC
does not expect this formalization of
current practice to have an impact on
operations, including ‘‘check-in
process.’’ If an airline does not have in
its possession the five additional data
elements, it is not required to collect or
submit them to CDC.
One airline industry group
commented that the collection of
information from screened individuals
for the purpose of contact tracing should
apply only to passengers because
crewmember information would be
provided by the employer. HHS/CDC
responds that this may be the case
operationally; however, HHS/CDC
reserves the right to collect information
directly from crew members if
necessary.
HHS/CDC received a comment
expressing concern that individuals may
provide false contact information, e.g.
emails and telephone numbers, to
airlines, and thus that HHS/CDC would
lack the means of contacting
individuals. In response, HHS/CDC
notes that airlines are not required to
verify the accuracy of information
collected and HHS/CDC takes no
position on what consequences the
airline may impose if a traveler refuses
to provide information or provides
inaccurate information.
One public health organization
commented on the scope of HHS/CDC’s
protocols for when contact
investigations are conducted and how

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exposed contacts are defined following
exposures to measles or varicella on
aircraft or vessels. HHS/CDC appreciates
the comment but seeks to clarify that
these protocols were mentioned in the
NPRM solely for the purposes of
providing context for the economic
analysis and that the content of the
protocols themselves is beyond the
scope of this rulemaking.
One public health organization
commented on the fact that buses and
trains typically do not maintain or have
access to passenger manifests that
would allow for the collection of
information by HHS/CDC for the
purpose of contact tracing. HHS/CDC
agrees with this comment and notes that
these regulations do not require
operators of buses or trains to maintain
passenger manifests for purposes of
contact tracing. The organization also
commented on the utility of the
requirement that operators of buses or
trains not knowingly transport
individuals subject to a Federal public
health order. In response, HHS/CDC
notes that it is useful to prohibit
conveyance operators from knowingly
transporting someone under a Federal
public health order without a travel
permit or in violation of the terms of a
permit because this may limit
communicable disease spread. This
prohibition, however, would only apply
in circumstances where the operator
would know or have reason to know
that a travel permit is required, for
instance, if the conveyance operator has
been directly informed by the HHS/CDC
or another cooperating Federal, State, or
local agency.
A non-profit organization also
commented that requiring airlines to
disclose passenger information, upon
request, but without a warrant, for
purposes of notifying passengers of their
potential exposure to a communicable
disease violates the Fourth Amendment
to the U.S. Constitution. This
organization also contends that HHS/
CDC lacks the legal authority to require
that travelers provide certain contact
information, such as information
concerning their intended destination,
health status, and travel history as part
of a public health investigation.
Specifically, this group contends that
‘‘examination’’ as used in 42 U.S.C.
264(d)(1) should be understood as
referring only to an ‘‘inspection’’ not an
‘‘interrogation.’’ This group further
contends that because HHS/CDC lacks
the legal authority to collect information
under 42 U.S.C. 264 it also lacks the
authority to collect information under
the Privacy Act of 1974. Lastly, this
group contends that any compulsory
questioning of travelers about ‘‘acts of

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assembly or association’’ violates the
First Amendment to the U.S.
Constitution.
HHS/CDC disagrees with these
comments. HHS/CDC notes that the
requirement of a judicial warrant is not
applicable to requiring passenger and
crew information from air carriers.
Rather, this activity is permitted
without a warrant under the specialneeds doctrine articulated by the
Supreme Court in Skinner v. Railway
Labor Executives’ Ass’n, 489 U.S. 602
(1989) because of the ‘‘special need’’ in
preventing communicable disease
spread. Furthermore, requiring
passenger information from airlines and
questioning travelers is authorized
under 42 U.S.C. 264(a), which allows for
the promulgation of regulations
necessary for preventing the spread of
communicable diseases from foreign
countries into the United States and
interstate. In carrying out and enforcing
these regulations, 42 U.S.C. 264(a),
authorizes ‘‘inspection’’ and ‘‘other
measures’’ as may be necessary which
allows for inspection of airline records
and questioning of travelers regarding
their health status and travel history.
While 42 U.S.C. 264(d)(1) is not directly
implicated in questioning of travelers
because such questioning may occur
without a specific reason to believe that
the individual traveler may be infected
with a quarantinable communicable
disease, we note that the commenter’s
suggestion that an ‘‘examination’’
excludes ‘‘interrogation’’ is not
supported by common understanding or
language usage. We note that Merriam
Webster defines ‘‘examination’’ among
other things as ‘‘a formal interrogation.’’
Thus, this commenter’s suggestion that
because HHS/CDC purportedly lacks the
legal authority to collect traveler
information under 42 U.S.C. 264 it also
lacks authority to collect information
under the Privacy Act is without merit.
HHS/CDC also rejects the suggestion
that questioning of travelers violates
their rights to free association under the
First Amendment. The U.S. Supreme
Court has recognized a ‘‘freedom of
association’’ in only two distinct areas:
(1) Choices to enter into and maintain
certain personal human relationships
(as an element of personal liberty); and
(2) a right to associate for the purpose
of engaging in other activities protected
by the First Amendment, i.e., speech,
assembly, petition for redress of
grievances, exercise of religious
freedom. City of Dallas v. Stanglin, 490
U.S. 19, 23–24 (1989). The purpose of
this proposed requirement is to protect
the vital health interests of passengers
and crew so that individuals who have
been exposed to a communicable

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disease during travel may be contacted,
informed, and provided with
appropriate public health follow-up.
HHS/CDC measures to prevent the
introduction, transmission, or spread of
communicable diseases do not implicate
any of these constitutionally-protected
areas.
HHS/CDC further notes that its
purpose in collecting passenger
information is to notify passengers who
have been potentially exposed to
communicable diseases of public health
concern. For some of these diseases,
there are preventive medications or
vaccines that the individual may be
made aware of and wish to obtain to
keep from becoming sick. Therefore,
HHS/CDC considers the collection of
passenger locating information to be of
benefit to these passengers and in
keeping with standard public health
practice to prevent further
communicable disease transmission.
After considering these comments,
HHS/CDC has finalized these provisions
(71.4 and 71.5) as proposed, with the
exception that the title has been
modified to remove references to
‘‘collection’’ and ‘‘storage’’ of
information to more accurately reflect
the requirements under this section.
References to the CDC have also been
replaced with Director throughout these
sections.
a. Suspension of Entry of Animals,
Articles, or Things From Designated
Foreign Countries and Places Into the
United States
Regarding provision 71.63 Suspension
of entry of animals, articles, or things
from designated foreign countries and
places into the United States, one public
health association proposed that the
restriction of animals should include an
exception for ports of entry that could
provide for physical inspection. In
response, HHS/CDC clarifies that if the
CDC Director determines an imported
animal (or product) poses a significant
public health threat, this provision
requires the Director to designate the
period of time and conditions under
which entry into the United States shall
be suspended, which may include
limiting entries to certain ports where
physical inspections are available. In
keeping with current practice, HHS/
CDC will implement public health
protection measures that strike the
appropriate balance between protecting
the public’s health and continued
importation and trade.
HHS/CDC received a comment that
the term ‘‘thing’’ as used in 71.63
authorizing the suspension of ‘‘animals,
articles, or things,’’ based on the
existence of communicable disease in a

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foreign country is unduly vague. In
response, we explain that HHS/CDC
may take public health measures in
regard to animals, articles, or things, to
prevent the introduction, transmission,
and spread of communicable diseases
into the United States and interstate.
‘‘Article’’ generally refers to an article of
commerce, such as a specific product
that someone wishes to import into the
United States or move between States
that poses a public health risk. In
contrast, a ‘‘thing’’ simply refers to a
material object that poses a public
health risk regardless of whether there
is a specific intent to import or move
between States. For instance, on July 10,
2001, CDC issued an order under the
authority of section 71.32(b) requiring
that imports of ‘‘lucky bamboo’’ (a
decorative plant) shipped in standing
water be prohibited from entering the
United States because the water (i.e., the
method of packing the lucky bamboo)
constituted a potential vector for
mosquito-borne illnesses. See 66 FR
35984 (July 10, 2001). In contrast,
shipments of ‘‘lucky bamboo’’ that were
packed dry (not in standing water) were
permitted entry into the United States.
In this case, ‘‘lucky bamboo’’ (the
decorative plant) would constitute the
‘‘article’’ and the standing water would
constitute the ‘‘thing.’’
HHS/CDC received a question
regarding the fate of animals or articles
denied entry under this regulation,
stating that ‘‘articles might presumably
be forfeited and pets will be executed,’’
and questioning whether this provision
aligns with due process, particularly
with respect to the right to appeal. In
response, HHS/CDC states that the
provision authorizing temporary
suspension of entry of certain animals,
articles and things based on the
existence of a communicable disease in
a foreign country and to protect the
public’s health is intended to prevent
the arrival of these items at a U.S. port
of entry. Therefore, HHS/CDC will seek
to ensure travelers are informed of the
restriction and will also work with
carriers to prevent these animals or
items from being loaded onto aircraft or
vessels traveling to the United States. If
such animals or items do arrive at a U.S.
port of entry, HHS/CDC will take
measures as needed to protect the
public’s health. Such measures will be
determined on a case-by-case basis and
may include, at the owner’s expense,
confinement, re-exportation, or
destruction. Re-exportation may be
considered if there is no public health
risk during travel. HHS/CDC would also
consider euthanasia of animals if there

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are no other reasonable alternatives to
protect the public’s health.
In response to the concern expressed
about an ‘‘appeal,’’ HHS/CDC notes that
the Director’s suspension order would
ordinarily constitute ‘‘final agency
action’’ under the Administrative
Procedure Act, 5 U.S.C. 704. However,
HHS/CDC will consider the
appropriateness of offering an
administrative appeal as it develops the
relevant suspension order.
After considering these comments,
HHS/CDC has finalized the Suspension
of Entry of Animals, Articles, or Things
From Designated Foreign Countries and
Places Into the United States (71.63)
provision as proposed.
VI. Alternatives Considered
Under Executive Order 13563
agencies are asked to consider all
feasible alternatives to current practice
and the rulemaking as drafted. One less
restrictive alternative would be for
HHS/CDC to stop enforcing its
regulations and make compliance with
current regulations voluntary. Under
this scenario, HHS/CDC would not
obtain contact data from airlines or
provide such data to health departments
in order to conduct contact
investigations. HHS/CDC would not
require illness and death reports on
aircraft or vessels, but would still
follow-up with airlines and vessel
operators upon request. This alternative
would put travelers at greater risk of
becoming infected with communicable
diseases, reduce the ability of public
health departments to offer postexposure prophylaxis or other measures
to prevent communicable disease spread
from travelers known to have been
exposed, and generally increase the risk
of communicable disease transmission
in the United States.
Another alternative, is to extend the
scope of the regulations by closing U.S.
borders and ports of entry to incoming
traffic from countries experiencing
widespread transmission of
quarantinable communicable diseases to
protect public health is also analyzed
based on the 2014–16 Ebola outbreak in
West Africa as well as recent
importations of Middle East respiratory
syndrome. HHS/CDC believes this
approach is neither practicable nor is it
desirable.
In a separate appendix, alternatives
are considered to increase or decrease
HHS/CDC’s required payments for care
and treatment for individuals under
Federal orders as specified in 42 CFR
70.13 and 42 CFR 71.30. Also in a
separate appendix, alternatives are also
considered in which HHS/CDC does not
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embargos (less restrictive) or does not
allow importation of animals under
temporary embargos for science,
education, and exhibition when
accompanied by a special permit.
We believe the regulations described
above and set forth below in text offer
the best solutions for protecting U.S.
public health while allowing for
continued travel. HHS/CDC believes
that this rulemaking complies with
Executive Order 13563; all of these
changes provide good alternatives to the
current baseline.
VII. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
HHS/CDC has examined the impacts
of the final rule under Executive Order
12866, Regulatory Planning and Review
(58 FR 51735, October 4, 1993) 2 and
Executive Order 13563, Improving
Regulation and Regulatory Review, (76
FR 3821, January 21, 2011).3 Both
Executive Orders direct agencies to
evaluate any rule prior to promulgation
to determine the regulatory impact in
terms of costs and benefits to United
States populations and businesses.
Further, together, the two Executive
Orders set the following requirements:
Quantify costs and benefits where the
new regulation creates a change in
current practice; define qualitative costs
and benefits; choose approaches that
maximize net benefits including
potential economic, environmental,
public health and safety, and other
advantages; support regulations that
protect public health and safety; and
minimize the adverse impact of
regulation. HHS/CDC has analyzed the
final rule as required by these Executive
Orders and has determined that it is
consistent with the principles set forth
in the Executive Orders and the
Regulatory Flexibility Act,4 as amended
by the Small Business Regulatory
Enforcement Fairness Act (SBREFA) 5
and that, relative to the status quo, the
final rule will not be economically
significant because the sum of
2 Executive Order 12866 of September 30, 1993:
Regulatory Planning and Review. Federal Register.
Monday, October 4, 1993; 58(190). http://
www.archives.gov/federal-register/executive-orders/
pdf/12866.pdf. Accessed January 2016.
3 Executive Order 13563 of January 18, 2011:
Improving Regulation and Regulatory Review.
Federal Register. Friday, January 21, 2011; 76(14).
http://www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/
2011-1385.pdf. Accessed January 2016.
4 U.S. Small Business Administration. Regulatory
Flexibility Act. http://www.sba.gov/advocacy/823.
Accessed January 2016.
5 Summary of the Unfunded Mandates Reform
Act. 2 U.S.C. 1501 et seq. (1995). http://
www2.epa.gov/laws-regulations/summaryunfunded-mandates-reform-act. Accessed January
2016.

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annualized costs and benefits are
estimated to be much less than $100
million in any given year.
However, there is uncertainty about
the appropriate analytic baseline, and
relative to some possible baselines, the
effects of the rule are non-negligible. For
example, if in the absence this rule,
some aspects of future HHS/CDC
screening or risk assessment activities
are found to be legally impermissible,
then the status quo baseline would not
represent a reasonable approximation of
the state of the world without the rule.
Relative to a non-status quo baseline,
the rule would lead to activities (e.g.,
the 2014–16 Ebola risk assessment and
management program) that have both
substantial costs and substantial
benefits. Analyses relative to this nonstatus quo baseline are presented in a
separate appendix.
This Regulatory Impact Analysis
(RIA) section presents the anticipated
costs and benefits that are quantified
where possible are relative to the status
quo baseline. Where quantification is
not possible, a qualitative discussion is
provided of the costs and/or benefits
that HHS/CDC anticipates from issuing
these regulations.
Need for Rule
The 2014–2016 Ebola response
highlights the inadequacies and
limitations of the current regulatory
provisions on the traveler data
collection process in which CDC must
request traveler manifests from airlines
and manually search for contact data in
order to know who enters the United
States, where they go, and how to
contact them.
Airlines have been slow to respond to
HHS/CDC requests for traveler
manifests:
Æ 30% arrive more than three days
after a request,
Æ 15% arrive more than six days late.
In addition, available locating
information is usually incomplete:
HHS/CDC receives only the name and
seat number for 61% of travelers, and
one or more additional pieces of
information for 39% of travelers. This
final rule clarifies HHS/CDC’s existing
authority to request any available
contact data from airlines and vessel
operators, which may improve the
timeliness and completeness of future
requests from airlines or vessel
operators for data not already submitted
to the Department of Homeland
Security.
Some traveler contact data is available
in the APIS/PNR dataset already
submitted by airlines to CBP. In the
experience of the HHS/CDC, queries
from APIS/PNR rarely result in full sets

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Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations
of contact information (i.e. the record
includes all five additional data fields as
outlined in the final rule). The data
fields that are most commonly missing
from the records are email addresses
(missing 90 percent of the time),
secondary phone number (missing 90
percent of the time), and street
addresses (missing or insufficient for
public health contact tracing up to 50
percent of the time). These data
elements are vital to a contact tracing
investigation. In looking at a random
sample of 20% of the compiled
international air travel manifests for
2015, those including a compiled data
set from NTC and the airlines, 100%
were missing at least one of the 5 data
fields. Email address and secondary
phone number were among those most
frequently missing. For context, there
were approximately 760,000 scheduled
flights that arrived into the United
States in 2015. In 2015, HHS/CDC
issued passenger manifest requests for
64 international flights arriving into the
United States. As noted in the RIA of
the final rule, from 2010 to 2015, HHS/
CDC conducted an average of 77 contact
investigations per year involving
arriving international flights.
Airlines are contacted for the majority
of contact investigations using a
manifest order document. At a
minimum, HHS/CDC needs to confirm
the ill traveler was on the flight and
where the individual sat in relation to
other travelers to determine risk of
exposure. Further, in HHS/CDC’s
experience, only airlines can:
• Quickly and efficiently produce a
partial manifest targeting affected rows
• confirm identity of ‘‘babes in arms’’
and their co-travelers (Parent); this is
important for measles cases;
• quickly confirm whether an
individual actually flew (in instances
where individuals deplane and do not
re-board during a layover); and
• confirm a plane’s configuration if
there is a question with the provided
row numbers. Different aircraft have
different seating arrangements
depending on carrier and layout. It is
important to know if a certain seat is
separated by a bulkhead or is a window
seat.
In addition, HHS/CDC only requires a
partial manifest, e.g. 5 rows for travelers
with infectious tuberculosis, so that
NTC and HHS/CDC staff can limit the
investigation to only those passengers at
risk and supplement/cross reference
with APIS and PNR data. If a partial
manifest is not available from the
airlines, then each passenger record
must be researched individually to find
a seat number, and then the
configuration of an entire plane must be

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populated to determine where the index
case sat in relation to other at-risk
passengers. For large flights from Asia,
this can pose a tremendous burden to
NTC and CDC staff while slowing the
ability of CDC to provide important
contact information to state and local
health departments. Manually
populating multiple 300+ person flights
is not feasible in a timely manner.
Finally, CDC wishes to reiterate its
desire for the above-described
operations to be published in regulation
to provide the public, as well as
industry, with understanding of the
efforts made by CDC to protect public
health.
The other change to the economic
baseline that may result from this final
rule was the need to change the
definition of an ‘‘ill person’’ to better
match HHS/CDC guidance and the
guidelines contained in Note 1 to
paragraph 8.15 of Annex 9 to the
Convention on International Civil
Aviation. Where possible, the marginal
costs and benefits of these changes
relative to the status quo baseline are
monetized.
In addition, HHS/CDC believes that
there is a need to better communicate to
the public the actions that it has taken
in accordance with its regulatory
authority under 42 CFR 70.6
Apprehension and detention of persons
with specific diseases, 42 CFR 71.32
Persons, carriers, and things, and
§ 71.33—Persons: Isolation and
surveillance. HHS/CDC believes it is
necessary for the public to better
understand actions that may be taken to
prevent the importation of
communicable diseases and to explain
the due process available to individuals
under Federal orders for isolation,
quarantine, or conditional release. HHS/
CDC also believes it is important to
explain when HHS/CDC may authorize
payment for the care and treatment of
individuals subject to medical
examination, quarantine, isolation and
conditional release.
Finally, HHS/CDC believes it is
important to explain its regulatory
authority to suspend entry of animals,
articles or things from designated
foreign countries and places into the
United States when importation
increases the risk of the introduction
and/or transmission of a communicable
disease within the United States.
The specific market failure addressed
by these regulations is that the costs
associated with the spread of
communicable diseases impacts the
entire U.S. population, not just the
group of persons currently infected with
communicable diseases or with business
interests in providing interstate or

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6931

international travel to persons or
animals infected with communicable
diseases.
The economic impact analysis of this
final rule is subdivided into four
sections:
1. An analysis of 42 CFR 70.1, 42 CFR
71.1/71.4/71.5, for which the primary
costs may be incurred by aircraft and
vessel operators and the primary benefit
is improved public health
responsiveness to assess and provide
post-exposure prophylaxis to travelers
exposed to communicable diseases of
public health concern.
2. An analysis of a number of
provisions that aim to improve
transparency of how HHS/CDC uses
regulatory authorities to protect public
health. These changes are not intended
to provide HHS/CDC with new
regulatory authorities, but rather to
clarify the agency’s standard operating
procedures and policies, and due
process rights for individuals. HHS/CDC
believes that improving the quality of its
regulations by providing clearer
explanations of its policies and
procedures is an important public
benefit. However, HHS/CDC is not able
to attach a dollar value to this added
benefit in a significant way. In a
separate appendix, HHS/CDC analyzes
the costs and benefits associated with
the 2014–2016 Ebola enhanced risk
assessment and management program
are used to illustrate the costs and
benefits of implementation of some of
these authorities, and are especially
relevant when analyzing the effects of
the rule relative to a non-status quo
baseline.
3. In a separate appendix, HHS/CDC
provides an analysis of the revisions to
42 CFR 70.13/71.30: Payment for care
and treatment, which 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. The
primary benefit of codification is
increased transparency around HHS/
CDC policies to assist in paying for
treatment or transportation for
individuals under Federal orders. The
analysis for these provisions is an
examination in potential transfer
payments between HHS/CDC and
healthcare facilities that provide
treatment to individuals under Federal
orders or to other payers.
4. In a separate appendix, HHS/CDC
provides an analysis of 42 CFR 71.63:
Suspension of entry of animals, articles,
or things from designated foreign
countries and places into the United
States. In this final rule, HHS/CDC is

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explaining its existing regulatory
authority. HHS/CDC cannot predict how
often such authority may be used in the
future or for what purpose. HHS/CDC
previously exercised this authority on
June 11, 2003, when under 42 CFR
71.32(b), HHS/CDC implemented an
immediate embargo on the importation

of all rodents from Africa (order
Rodentia).6 A simple economic impact
analysis of this embargo is performed to
demonstrate the costs and benefits of
one example, but HHS/CDC does not
anticipate an increase in frequency of
such actions based on the provisions
included in this final rule. The primary

purpose of the analysis is to
demonstrate potential costs and benefits
using a realistic example.
Table 1 provides a summary of
whether quantitative or qualitative
analyses were performed for each of the
provisions in the final rule.

TABLE 1—SUMMARY OF PROVISIONS INCLUDED IN THIS FINAL RULE
Qualitative
impacts only

Codification
of existing
authority

General Definitions ..........................................................................................................................

No a ................

§ 70.5 Requirements relating to travelers under a federal order of isolation, quarantine, or conditional release
§ 70.6 Apprehension and detention of persons with specific diseases; § 71.32 Persons, carriers, and things
(no change to title).
§ 70.10/§ 71.20 Public health prevention measures to detect communicable disease ........................................
§ 70.11 Report of death or illness onboard aircraft operated by an airline .........................................................
§ 70.12/§ 71.36 Medical examinations ..................................................................................................................
§ 70.13/§ 71.30 Payment for Care and Treatment ...............................................................................................
§ 70.14/§ 71.37 Requirements relating to the issuance of a Federal order for quarantine, isolation, or conditional release.
§ 70.15/§ 71.38 Mandatory reassessment of a federal order for quarantine, isolation, or conditional release ...
§ 70.16/§ 71.39 Medical review of a federal order for quarantine, isolation, or conditional release ....................
§ 70.17/§ 71.29 Administrative records relating to federal quarantine, isolation, or conditional release .............
§ 70.18/§ 71.2 Penalties ........................................................................................................................................
§ 71.4 Requirements relating to collection, storage and transmission of airline passenger, crew and flight information for public health purposes.
§ 71.5 Requirements relating to collection, storage and transmission of vessel passenger, crew, and voyage
information for public health purposes.
§ 71.33 Persons: Isolation and surveillance .........................................................................................................
§ 71.63 Suspension of entry of animals, articles, or things from designated foreign countries and places into
the United States.

Yes .................
Yes .................

Yes (except
definition of
‘‘ill person’’).
Yes.
Yes.

Yes b ..............
Yes .................
Yes .................
Yes c ...............
Yes .................

Yes.
Yes.
Yes.
Yes.
Yes.

Yes .................
Yes .................
Yes .................
Yes .................
No a ................

Yes.
Yes.
Yes.
Yes.
Yes.

No a ................

Yes.

Yes .................
Yes d ..............

Yes.
Yes.

Provision
§ 70.1/§ 71.1

a Analyzed

in RIA.
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 immediate embargo on the importation of all rodents from Africa.
b The

Executive Summary of the Costs and
Benefits of 42 CFR 70.1, 42 CFR 71.1/
71.4/71.5

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Estimated Costs
The quantified costs and benefits of
the final rule are estimated for the
following stakeholders: Air and
maritime conveyance operators, State
and local public health departments
(PHDs), individuals exposed to
communicable diseases during travel
and United States Government (USG).
The most likely estimates of primary
costs are low ($32,622, range $10,959 to
$430,839) because the final rule
primarily codifies existing practice or
improves alignment between regulatory
text and the symptoms reporting
guidelines provided by the International
Civil Aviation Organization (ICAO). The

cost estimates are based on an increase
in:
• The number of illness reports
delivered by airlines and vessel
operators to CDC, relay of air illness
reports to CDC by the Federal Aviation
Administration (FAA) when such
reports are received by FAA air traffic
service units, illness reports processed
by HHS/CDC and time for travelers;
• increased costs for airlines and
vessel operators to comply with HHS/
CDC requests for traveler contact data;
• increased costs for State and local
public health departments to follow up
with a larger number of travelers
exposed to communicable diseases
during travel;
• The upper bound cost estimate also
includes a substantial increase in
training costs for the changes to illness
reporting.

Estimated Benefits
The best estimate of quantified
benefits of the final rule is also
relatively small $110,045 (range $26,337
to $297,393). This estimate is based on
expected improvements in illness
reporting and in the timeliness,
completeness, and accuracy of contact
data. These improvements should result
in increased efficiencies for HHS/CDC
and State and local public health
departments in conducting contact
investigations among travelers exposed
to communicable diseases on aircraft
and vessels and reduced illness costs
associated with the reduced risk of
measles and tuberculosis morbidity and
mortality in exposed travelers.
Other potential but non-quantified
benefits of the final rule would be
associated with future outbreaks of

6 Federal Register 62353 Vol. 68, No. 213
Tuesday, November 4, 2003. P. 62353–69.

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infectious disease cases for which
improved compliance by airlines and
vessel operators to provide available
traveler contact data would reduce
onward spread of disease in the
destination communities of exposed
travelers. In addition, the change to the
definition of ‘‘ill person’’ may also
increase reporting of communicable
diseases of public health concern
onboard conveyances. Reduction in
onward spread would also lead to the
ability of the public health
establishment to reduce effects of
disease outbreaks, e.g., delay the spread
of disease until a vaccine is available or
limit the numbers of outbreaks and
cases or reduce public anxiety
associated with the risk of transmission.
There may also be a reduction in the
economic costs of many business sectors
such as avoidance of costs to the travel
and tourism industry 7 8 when a disease
is contained in its early stages.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of
[$146,000,000 in 2015 USD] or more.’’
Not only will this final rule not cost
State, local and tribal governments any
expenditure, it is possible that these
stakeholders who might be engaged in
contact tracing may see a reduction in
costs if the final rule is implemented
and there is an improvement in airline
compliance with HHS/CDC requests to
provide traveler data.
The Final Rule
Traveler contact information will only
be requested by HHS/CDC after a case
of serious communicable disease (index
case) is reported in a person who
traveled on a commercial airline or
vessel while contagious. Examples of
serious communicable diseases include
measles, novel influenzas, and viral
hemorrhagic fevers such as Ebola among
others. This type of situation
necessitates identifying and locating
passengers seated near the index case in
order to conduct a contact investigation
(CI). This final rule would lead to better
health outcomes if public health
departments are more quickly and
7 Rassy

D, Smith RD. The economic impact of
H1N1 on Mexico’s tourist and pork sectors. Health
Econ. 2013;22(7):824–34. doi: 10.1002/hec.2862.
PubMed PMID: 23744805.
8 Keogh-Brown MR, Smith RD. The economic
impact of SARS: How does the reality match the
predictions? Health Policy. 2008;88(1):110–20.

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effectively able to contact persons
potentially exposed to the index case on
an aircraft or vessel. These increased
efficiencies should lead to smaller
infectious disease outbreaks and fewer
public health resources needed to
control an outbreak.
There are multiple communicable
diseases including quarantinable (e.g.,
tuberculosis, MERS, and Ebola) and
non-quarantinable (e.g., measles,
varicella, pertussis, rabies,
meningococcal, and rubella) diseases
that may necessitate a contact
investigation to prevent spread of
disease in the community. HHS/CDC
notes that for non-quarantinable
diseases, HHS/CDC efforts would
primarily be limited to assisting health
departments to notify individuals of
their potential exposures. HHS/CDC was
unable to quantify the benefits of
preventing the spread of all diseases as
a group because of differences in the
characteristics of each disease. The
differences with respect to potential
spread and impact make it difficult to
assess the benefits that may accrue from
reduced spread of all diseases. The
quantified analysis focuses on the two
diseases that generate the greatest
number of contacts to follow up:
Measles and tuberculosis.
The ongoing persistence of measles in
the United States provides a good
example of the need for this final rule.
In 2000, measles was declared no longer
endemic in the United States due to
high vaccination rates. Cases and
outbreaks of measles continue to occur,
however, as a result of importation from
other countries and lack of adherence to
the recommendation for measles
vaccination (http://www.cdc.gov/
vaccines/hcp/acip-recs/vacc-specific/
mmr.html). The United States is
currently discovering the greatest
number of measles cases that have been
identified since the declaration of
measles elimination; 97% of recent
cases were associated with importations
from other countries. Of 45 direct
importations, 40 occurred in U.S.
citizens after traveling abroad.9
Among air travelers exposed to
measles during flights, post-exposure
prophylaxis (PEP) with measlescontaining vaccine (within 72 hours) or
immune globulin (within 6 days) can
prevent onset of disease,10 halting
outbreaks before they begin. However,
9 Gastan
˜ aduy, P.A., S.B. Redd, A.P. Fiebelkorn,
J.S. Rota, P.A. Rota, W.J. Bellini, J.F. Seward and
G.S. Wallace (2014). ‘‘Measles—United States,
January 1–May 23, 2014.’’ MMWR 63(22): 496–499.
10 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.

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6933

without accurate and timely contact
data, it is frequently difficult to
intervene within these timelines. A
recent analysis showed that 9 cases
likely occurred as a result of exposure
during 108 flights with 74 case-travelers
over 3 years. Although there was no
onward transmission from these 9
cases,11 future cases may lead to larger
outbreaks.
Measles outbreaks can have
substantial associated costs. One modelbased analysis showed that 16 outbreaks
with 107 confirmed measles cases cost
an estimated $2.7 million to $5.3
million U.S. dollars for public health
departments to contain.12 The estimate
is based on outbreak-specific travel
expenses and the opportunity cost of
diverting public health staff to outbreak
response activities and is not based on
the cost of hiring additional staff. This
corresponds to an average cost per
outbreak of about $250,000 in 2015
USD. In comparison, a total of 125 cases
occurring in 8 States and three countries
were associated with a single measles
outbreak that originated in late
December 2014 in amusement theme
parks in Orange County, California.13
Thus, the number of cases in this one
outbreak exceeded the total number of
outbreak-associated cases identified in
16 outbreaks during 2011. The source of
the initial exposure has not been
identified so it is not possible to
determine where this index case was
exposed. However, this example
demonstrates the speed with which
communicable diseases can be
transmitted and the importance of
quickly identifying persons that may
have been exposed during air or
maritime travel. It is possible that the
costs of this one outbreak, which spread
across 8 States, exceeded the total costs
of all 16 outbreaks that occurred in 2011
and were estimated to cost public health
departments a total of $2.7 million to
$5.4 million dollars.14
In the absence of interventions by
public health departments, travelers
11 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.
12 Ortega-Sanchez, I.R., M. Vijayaraghavan, A.E.
Barskey and G.S. Wallace (2012). ‘‘The economic
burden of sixteen measles outbreaks on United
States public health departments in 2011.’’ Vaccine
32(11).
13 Jennifer Zipprich, Kathleen Winter, Jill Hacker,
Dongxiang Xia, James Watt, Kathleen Harriman.
(2015) Measles Outbreak—California, December
2014–February 2015. MMWR/February 20, 2015/
Vol. 64/No. 6: 153–154.
14 Ortega-Sanchez, I.R., M. Vijayaraghavan, A.E.
Barskey and G.S. Wallace (2012). ‘‘The economic
burden of sixteen measles outbreaks on United
States public health departments in 2011.’’ Vaccine
32(11).

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infected with measles during
international travel would be as likely
as any other individuals to initiate a
measles outbreak. In the absence of
HHS/CDC efforts to retrieve and
transmit contact data, public health
departments would not be able to
contact travelers to offer post-exposure
prophylaxis and to recommend selfmonitoring for potential measles
symptoms.
Summary of Quantifiable and
Qualitative Results of the Regulatory
Impact Analysis
The Summary Table provides
estimated total monetary results for
stakeholders’ costs and benefits of
implementing the final rule. The
Summary Table (Table 2) includes
estimates associated with changes to the
definition of ‘ill person’ in 42 CFR 70.1/
71.1 and the codification of
international traveler data collection
processes of aircraft and vessel contact
investigations under 42 CFR 71.4/71.5.
The best estimates of annual costs are
$32,622 compared to the best estimate
of annual benefits at $110,045. The
upper bound annual quantified costs are

$430,839 and the upper bound
quantified benefits are $297,393. Lower
bound quantified costs are $10,959 and
benefits are $26,337.
The measles and tuberculosis
examples should not be considered a
complete estimate of non-quantified
benefits associated with this final rule,
because the impact of this final rule to
mitigate many different types of
infectious disease outbreaks cannot be
quantified. It just provides examples
based on the two diseases for which
contact investigations are most
frequently undertaken. Besides
communicable diseases commonly
reported in the United States (e.g.,
measles, tuberculosis), this final rule
may also improve HHS/CDC’s ability to
respond to diseases that are infrequently
diagnosed in the United States (e.g.,
Ebola, novel influenza, Middle East
Respiratory Syndrome). For example, it
is possible that HHS/CDC may need to
prepare to address both Ebola and
another disease such as novel influenza
or Middle East Respiratory Syndrome
(MERS) occurring in two separate
countries or regions during a given year.

For example, in 2014, two international
travelers on commercial flights from the
Middle East arrived in the United States
while infected with MERS and two
international travelers on commercial
flights from West Africa arrived while
infected with Ebola. Regardless of the
infectious disease scenarios faced by
HHS/CDC in a given year, this final rule
should improve HHS/CDC’s ability to
mitigate infectious diseases in the
future. To the extent that the final rule
would lead to improved responsiveness
of airlines and vessel operators to HHS/
CDC traveler data requests via manifest
orders, HHS/CDC may become better
able to respond to infectious diseases
threats and (1) reduce case-loads during
infectious disease outbreaks, (2) reduce
public anxiety during disease 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 contact
investigations in response to a new
infectious disease or one with serious
public health and medical consequences
like Ebola.

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

Category

Lower bound
estimate

Upper bound
estimate

Source citation
(RIA,
preamble, etc.)

BENEFITS
Annual monetized routine benefits from reduced effort by CDC and health
department to search for exposed contacts (0% discount rate).
Annual monetized routine benefits from reduced illness (0% discount rate)
Total annual monetized routine benefits (0% discount rate) ..........................
Qualitative (unquantified benefits) ...................................................................

$12,218

$0

$12,218

RIA.

$97,828
$110,045

$26,337
$26,337

$272,958
$285,175

RIA.
RIA.

To the extent that airlines or vessel operators
have data available and improve responsiveness 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 respond to infectious diseases threats and (1) reduce case-loads during infectious disease outbreaks, (2) reduce public anxiety during disease 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 consequences like Ebola.

RIA.

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COSTS
Annual monetized costs for changes to illness reporting (airlines and vessel
operators, 0% discount rate) *.
Annual monetized costs for changes to codification of manifest order process (airlines and vessel operators), 0% discount rate) *.
Annual monetized costs for additional activities by health department contacting individuals exposed to communicable diseases during international travel (0% discount rate).
Total annual monetized routine costs (0% discount rate) ..............................

VerDate Sep<11>2014

23:46 Jan 18, 2017

Jkt 241001

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$0

$0

$376,554

RIA.

$12,654

$0

$25,308

RIA.

$19,968

$10,959

$28,977

RIA.

$32,622

$10,959

$430,839

RIA.

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Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations
TABLE 2—SUMMARY OF MONETIZED AND QUALITATIVE BENEFITS AND COSTS OF THE FINAL RULE—Continued
[2015 USD]
Most likely
estimate

Category

Lower bound
estimate

Upper bound
estimate

Source citation
(RIA,
preamble, etc.)

Annual quantified, but unmonetized, costs .....................................................

None

RIA.

Qualitative (unquantified) costs .......................................................................

None

RIA.

The second analysis in this final rule
is of a number of provisions that aim to
improve transparency of how HHS/CDC
uses its regulatory authorities to protect
public health. These changes are not
intended to provide HHS/CDC with new
regulatory authorities, but rather to
clarify the agency’s standard operating
procedures and policies with regard to
pre-existing regulations in 42 CFR parts
70 and 71 including due process rights
for individuals under Federal orders.
HHS/CDC believes that improving the
quality of its regulations by providing
clearer explanations of its policies and

procedures is an important public
benefit. However, HHS/CDC is not able
to attach a dollar value to this added
benefit in a significant way.
Economic Baseline
Regulated Entities: Airlines and Vessel
Operators
The group of entities that may be
affected by this final rule would include
international and interstate aircraft
operators, vessel operators, travelers,
State or local health departments and
the Federal government agencies that
interact with these groups. Since this

final rule primarily updates regulatory
requirements to better match current
practice, the economic impacts are
marginal changes to current practice
that result from codification of current
practices.
The North American Industry
Classification System (NAICS) is used
by Federal statistical agencies in
classifying business establishments for
the purpose of collecting, analyzing, and
publishing statistical data related to the
U.S. business economy. A summary of
the total numbers of each entity is
summarized in Table 3.

TABLE 3—SUMMARY OF THE NUMBER OF FIRMS ENGAGED IN INTERSTATE AND INTERNATIONAL AIR AND MARITIME TRAVEL
NAICS codes
481111
481112
481219
483111
483112
483113
483114
483211
483212

...............
...............
...............
...............
...............
...............
...............
...............
...............

Number of
firms in
industry

NAICS description
Scheduled Passenger Air Transportation ............................................................................................................
Scheduled Freight Air Transportation ..................................................................................................................
Other Nonscheduled Air Transportation ..............................................................................................................
Deep Sea Freight Transportation ........................................................................................................................
Deep Sea Passenger Transportation ..................................................................................................................
Coastal and Great Lakes Freight Transportation ................................................................................................
Coastal and Great Lakes Passenger Transportation ..........................................................................................
Inland Water Freight Transportation ....................................................................................................................
Inland Water Passenger Transportation ..............................................................................................................

264
212
516
191
54
337
110
318
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
Aviation Administration, in 2012, U.S.
civil aviation-related economic activity
generated $1.5 trillion and supported
11.8 million jobs with $459.4 billion in
earnings.17 In 2015, the domestic U.S.
market for air travel included 696
million passengers and the international
market included another 198 million
travelers.18

mstockstill on DSK3G9T082PROD with RULES3

15 http://www.census.gov/econ/susb/.
16 https://www.census.gov/cgi-bin/sssd/naics/
naicsrch.
17 U.S. Department of Transportation, Federal
Aviation Administration (January 2015) The
Economic Impact of Civil Aviation on the U.S.
Economy: Economic Impact of Civil Aviation by
State. http://www.faa.gov/air_traffic/publications/
media/2015-economic-impact-report.pdf (Accessed
5/2/2016).
18 Bureau of Transportation Statistics T–100
Market data. http://www.transtats.bts.gov/Data_
Elements.aspx?Data=1 (Accessed 5/2/2016).

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23:46 Jan 18, 2017

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In 2011, there were approximately 11
million North American cruise ship
passengers spending 71.8 million
passenger nights on board vessels. The
cruise ship market was highly
concentrated with four firms accounting
for 98% of the total market.19 In total,
approximately 18 million travelers enter
the United States each year via cruise or
cargo ships.20
The domestic/international air carrier
market is an ever-shifting corporate
19 U.S. Department of Transportation Maritime
Administration (March 2012) North American
Cruise Statistical Snapshot, 2011 http://
www.marad.dot.gov/wp-content/uploads/pdf/
North_American_Cruise_Statistics_Quarterly_
Snapshot.pdf (Accessed 5/2/2016).
20 According to the U.S. Department of Homeland
Security, 54,236 passengers and crew arrive via
vessel each day, which correspond to
approximately 18 million per year. https://
www.transportation.gov/policy/aviation-policy/usinternational-air-passenger-and-freight-statisticsreport Accessed on 5/2/2106.

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landscape. Both U.S. and foreign
airlines engage in ‘‘code-sharing’’
arrangements, whereby the marketing
carrier places its call sign (or code) on
the operating carrier’s flight. For
purposes of this rule, reporting duty
would require the operating carrier to
report on all passengers and
crewmembers, whether traveling on the
operator’s code or another carrier’s.
The complexity of the domestic/
foreign airline-corporations’ legal and
financial arrangements makes it very
difficult to ascertain exactly how each
and every domestic and foreign airline
would be affected by the
implementation costs associated with
this final rule; presumably, some of the
costs might be passed along to the
carrier putting its code on the operating
carrier, pursuant to the particular terms
of each applicable contract.

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Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

Under this final rule, the operator of
any airline operating a flight arriving
into the United States must make
certain contact information described
below available within 24 hours of a
request by HHS/CDC, to the extent that
such data are available to the operator.
This requirement also applies to the
operator of any vessel carrying 13 or
more passengers (excluding crew) and,
which is not a ferry as defined in under
46 U.S.C. 2101 and U.S. Coast Guard
(USCG) regulations (46 CFR 2.10–25).
This requirement is a codification of
current practice, and applies to any of
the data elements that the airline or
vessel operator may have available and
authorizes the airline or vessel operator
to transmit the contact information in
any format and through any system
available and acceptable to both the
airline and HHS/CDC. Again, because
this is a codification of current
practices, HHS/CDC assumes airlines
and vessel operators will continue to
submit data through current
mechanisms, although HHS/CDC will
accept others that are mutually
acceptable.
To simplify the analysis and to
develop conservative cost estimates,
HHS/CDC assumed that all costs to
airlines and vessel operators would be
passed along to U.S.-based airlines,
vessel operators, or U.S. consumers.
Diseases Affected by the Rule
HHS/CDC has gathered statistics, or
reported information on, a number of
notifiable and quarantinable diseases
(Table 4) that form the basis for
estimates of quantitative and qualitative
benefits. The final rule provides CDC
with the authority to take certain actions
with regard to both quarantinable and
non-quarantinable diseases. For nonquarantinable diseases, efforts would be
primarily limited to early identification
and notification of exposed individuals
and transmission of contact data to local
and State health departments. For

quarantinable diseases, efforts could
include issuance of Federal orders for
quarantine, isolation, or conditional
release of exposed/infected individuals.

TABLE 4—DISEASES ANALYZED
Non-quarantinable
Measles
Pertussis
Rabies
Meningococcal disease
Varicella
Rubella

Quarantinable
Tuberculosis.
Viral Hemorrhagic Fevers.
Middle East Respiratory Syndrome
Coronavirus
(MERS).

In addition, these diseases for which
HHS/CDC currently issues manifest
orders and conducts contact
investigations can also be subdivided to
identify those encountered with some
frequency (routine diseases):
Tuberculosis, measles, meningococcal
disease, pertussis and rubella. Among
these diseases, only tuberculosis is a
quarantinable disease. The second class
is a group of new or emerging diseases,
or diseases with serious public health
and medical consequences, that are not
currently prevalent, but are foreseeable
as a future threat, e.g., severe acute
respiratory syndromes (including SARS
and MERS), Ebola. This second group
only includes quarantinable diseases,
which may be updated in the future by
Executive Order, but which are not
being updated as a part of the final rule.
Although HHS/CDC may help identify
travelers ill with or exposed to measles,
meningococcal disease, pertussis,
rubella, rabies, and varicella, HHS/CDC
does not have the authority to place any
travelers with such illnesses or
exposures under Federal orders. For
quarantinable diseases, illness reporting
could lead to issuance of Federal orders
if travelers are reasonably believed to be
infected with a quarantinable
communicable disease in a qualifying
stage. Such restrictions would not occur
based simply on an illness report by

airline or vessel operator staff and
would require a medical assessment by
a public health professional.
Contact Investigations and Diseases—
Interstate and International
The number of travelers exposed to an
index case that are subject to a contact
investigation (CI) varies by disease and
may include only the two passengers
sitting adjacent to the index case
(meningococcal disease or pertussis) or
as much as the entire aircraft (e.g.,
initial investigations of cases of MERS
or Ebola) (Table 5). The entire aircraft or
vessel may be subject to CI if the disease
is new and transmission patterns are not
well understood (e.g., MERS) or if the
disease is felt to have serious medical or
public health consequences (e.g., Ebola).
Some CIs are only initiated for longduration travel (e.g., tuberculosis for
flights of 8 hours or longer). For other
diseases (e.g., measles, MERS), CIs are
undertaken regardless of duration.
The table also includes criteria to be
considered a contact for persons
exposed on vessels. In contrast to air
contact investigations, most maritime
contact investigations are undertaken
before travelers disembark from vessels.
Another difference between air and
maritime contact investigations is that
varicella contact investigations are
frequently undertaken among maritime
travelers on vessels, but are not pursued
for air travelers. In addition, HHS/CDC
has not yet had to conduct a contact
investigation for Middle East
Respiratory Syndrome or viral
hemorrhagic fever for travelers exposed
on vessels. The criteria listed in Table
5 are current as of October 2016, but
may be updated in the future based on
reviews of the effectiveness of contact
investigations. For example, HHS/CDC
stopped providing contact data to health
departments for mumps investigations
after reviewing evidence of the
effectiveness of mumps contact
investigations.

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

mstockstill on DSK3G9T082PROD with RULES3

Ebola (Quarantinable).

VerDate Sep<11>2014

CI initiated if

Persons contacted, aircraft

Persons contacted, vessels

All cases ................................

All passengers and crew as
of April 2016. In the future,
the recommendation may
change to include fewer
passengers and crew.

Cruise vessel—any passenger or crew who made
have come into contact with
the index case’s body fluids
while the index case was
symptomatic.
Cargo vessel—all on board
the vessel while the index
case was symptomatic.

23:46 Jan 18, 2017

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19JAR3

Recommended activities
Monitoring for 21 days after
last potential exposure.

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

mstockstill on DSK3G9T082PROD with RULES3

Disease

CI initiated if

Persons contacted, aircraft

Persons contacted, vessels

Recommended activities

Passengers seated within 2
rows either direction of the
index case, all babies-inarms, crew in same cabin.
All passengers and crew on
flights with <50 seats.
Passengers or crew sitting directly to the left and right of
the index case or with potential for direct contact
with oral or respiratory secretions.

Direct face-to-face contact or
shared confined space >1
hour with symptomatic
case-patient.

Offer MMR vaccination if nonimmune and <72 hrs. since
exposure; immune globulin
if indicated and within 6
days of exposure.

Cruise vessels—Cabin mates
of or potential for direct
contact with oral or respiratory secretions of casepatient during the 7 days
prior to symptom onset until
24 hours after implementation of effective antimicrobial therapy.
Cargo vessels—All on board
the vessel during the 7
days prior to symptom
onset of case-patient until
24 hours after implementation of effective antimicrobial therapy.
All crew and passengers .......

Post-exposure
chemoprophylaxis.

Measles (Nonquarantinable).

All cases if notification received within 21 days of
flight.

Meningo-coccal disease
(Non-quarantinable).

Case meets the definition of
meningococcal disease
within 14 days of travel.
For air travel: Flight >8 hrs.
(or shorter flights if direct
exposure reported).

New or reemerging influenza viruses (Quarantinable).
Pertussis
(Non-quarantinable).

All cases during early stages
of international spread.

All passengers and crew .......

All cases if notification is received within 21 days of
travel.

Passengers sitting next to
index case.

Rubella (Nonquarantinable).

All cases if notification is received within 60 days of
travel.

Severe Acute
Respiratory
Syndromes
(Quarantinable).

All cases ................................

Passengers seated within 2
rows + crew in same cabin.
All passengers and crew on
flights with <50 seats.
SARS-Coronavirus: All passengers and crew.
MERS: All passengers and
crew contacted during 2014
CIs. Future CIs will include
passengers seated within 2
rows of index case.

TB (Quarantinable).

Notification received within 3
months of travel, clinical criteria met For air travel:
Flight >8 hrs.

Passengers seated within 2
rows.

Varicella (Nonquarantinable).

All cases on vessels ..............

NA ..........................................

The Quarantine Activity Reporting
System (QARS), which contains, among
other data, information collected under
OMB Control Numbers 0920–0134,
0920–0488, 0920–0821, and 0920–0900,
is a web-based and secure electronic
system that supports collection of data
for ill persons on inbound or interstate

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23:46 Jan 18, 2017

Jkt 241001

Direct face-to-face contact or
shared confined space >1
hour with symptomatic
case-patient.
Direct face-to-face contact or
shared confined space >1
hour with symptomatic
case-patient.
Cruise vessel—any passenger or crew who had direct face-to-face contact or
shared confined space >1
hour with symptomatic
case-patient.
Cargo vessel—all on board
the vessel while the index
case was symptomatic.
Cargo vessel: All crew members within 3 months of diagnosis who worked with
case-patient.
Cruise vessel: Passenger
travel companions or crew
working in close proximity/
sharing living quarters.
Any person who has had ≥5
minutes of direct face-toface contact with a varicella
case during the infectious
period.

flights and vessels and at land border
crossings; infectious disease threats, and
follow-up actions. Currently, HHS/CDC
Quarantine Stations at U.S. ports of
entry are using the system to record
their daily activities. All CIs undertaken
by HHS/CDC are documented in QARS.

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Monitoring for 10 days after
last potential exposure;
possible serologic testing.
Post-exposure
chemoprophylaxis.
Serologic testing and guidance for pregnant women.
Monitoring for 10–14 days
after last potential exposure; potential serologic
testing.

Aircraft: Testing for latent TB
infection; chest radiograph
if the LTBI test is positive.
Vessels: Clinical assessment
for symptoms and chest
radiograph.
Varicella vaccination if
unvaccinated/non-immune
and <3 days since exposure (possibly up to 5
days). High-risk contacts
evaluated Varicella Zoster
immune globulin if <10
days after exposure.

CIs for international flights from
January 2010 through December 2015
are summarized in Table 6. More than
half (73.2%) were initiated as a result of
tuberculosis cases. Measles is the next
most common disease (20.8%). The
remaining 6% are subdivided across
rubella, pertussis, meningococcal

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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
Total
investigations

Disease

Total contacts

Average
investigations
per year

Average
contacts
per year

Percent of
total contacts

Influenza, avian ................................................................
MERS Coronavirus b ........................................................
Measles ............................................................................
Meningococcal disease ....................................................
Other ................................................................................
Pertussis ..........................................................................
Rabies ..............................................................................
Rubella .............................................................................
TB (clinically active) .........................................................
Viral hemorrhagic fever ....................................................

0
2
94
8
3
11
3
17
318
7

0
270
3,381
9
97
18
4
532
11,928
53

0.0
0.3
15.7
1.3
0.5
1.8
0.5
2.8
53.0
1.2

0.0
45.0
563.5
1.5
16.2
3.0
0.7
88.7
1,988.0
8.8

0.0
1.7
20.8
0.1
0.6
0.1
0.0
3.3
73.2
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 protocol, flights from January 2010 to May 2011 have been excluded from the above-reported counts. In addition, CIs for mumps have been discontinued. 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
contact data to support contact
investigations for travelers exposed to
infectious diseases on interstate flights.
The numbers of investigations and
contacts during 2010–15 are

summarized in Table 7. In contrast to
international flights, very few contact
investigations for tuberculosis were
undertaken on interstate flights, because
most interstate flights do not meet the
8-hour time requirement for

tuberculosis contact investigations
(Table 5). The majority of contacts were
investigated after exposure to measles
cases (76%) followed by MERS (8.4%)
and viral hemorrhagic fevers including
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]
Total
investigations

Disease

Total contacts

Average
number of
investigations
per year

Average
number of
contacts
per year

Measles ............................................................................
Meningococcal disease ....................................................
MERS Coronavirus a ........................................................
Other ................................................................................
Pertussis ..........................................................................
Rabies ..............................................................................
Rubella .............................................................................
TB (clinically active) .........................................................
Viral hemorrhagic fever ....................................................

72
1
2
0
43
3
8
2
4

3033
1
334
0
83
3
172
40
319

12.0
0.2
0.3
0.0
7.2
0.5
1.3
0.3
0.7

505.5
0.2
55.7
0.0
13.8
0.5
28.7
6.7
53.2

Total ..........................................................................

135

3,985

22.5

664.2

Percent of
total contacts
76.1
0.0
8.4
0.0
2.1
0.1
4.3
1.0
8.0

mstockstill on DSK3G9T082PROD with RULES3

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
contact investigations are summarized
in Table 8. For maritime investigations,
the majority of contacts were
investigated for varicella (∼79%)
followed by tuberculosis (∼13%) and

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23:46 Jan 18, 2017

Jkt 241001

measles (∼6%). Most of the varicella and
measles contact investigations were
initiated while travelers were still on
vessels. Besides the investigations listed
in Table 8, gastrointestinal illness cases
on cruise vessels carrying 13 or more

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passengers are reported to HHS/CDC’s
Vessel Sanitation Program and cases of
Legionnaires’ disease are reported
directly to HHS/CDC’s Respiratory
Diseases Branch.

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Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations
TABLE 8—MARITIME PASSENGER DATA COLLECTION, AVERAGE NUMBER OF ANNUAL CONTACTS BY DISEASE
[January 2010–December 2015]
Total
investigations

Passengers per voyage

Average
number of
investigations
per year

Average
number of
contacts
per year

Percent of
total contacts

Measles ............................................................................
Meningococcal disease ....................................................
MERS Coronavirus ** .......................................................
Other ................................................................................
Pertussis ..........................................................................
Rabies ..............................................................................
Rubella .............................................................................
TB (clinically active) .........................................................
Viral hemorrhagic fever ....................................................
Varicella (chickenpox) a ....................................................

5
3
0
1
3
0
2
50
0
206

288
22
0
9
14
0
26
585
0
3,627

0.83
0.5
0
0.17
0.5
0
0.33
8.3
0
34.3

48
3.67
0
1.5
2.33
0
4.33
97.5
0
604.5

6.3
0.5
0.0
0.2
0.3
0.0
0.6
12.8
0.0
79.3

Total ..........................................................................

270

4,571

45

761.8

100.0

a One

mstockstill on DSK3G9T082PROD with RULES3

Total contacts

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

Traveler Manifest Orders for Airlines
Contact tracing is most effective at
reducing cases of communicable disease
at the early stages of a potential
outbreak as soon after initial exposure
as possible. Therefore, if an efficient
contact system is not in place when the
first ill travelers arrive, the benefits of
contact tracing are greatly diminished.
Contact data requests only occur after
a case of serious communicable disease
(index case) is reported in a person who
traveled on a commercial airline or
vessel while contagious. This type of
situation necessitates identifying and
locating travelers seated near the index
case in order to conduct a CI.
At present, HHS/CDC uses a multistep process to obtain traveler contact
information from airlines. HHS/CDC
issues a written order to the airline that
requires the airline to provide HHS/CDC
with contact information about the
index case and traveler contacts. The
order cites current regulatory language
in 42 CFR 71.32(b), as authorized by 42
U.S.C. 264. HHS/CDC requires that the
airline provide it with the traveler’s first
and last name, seat number, two phone
numbers and email address. HHS/CDC
instructs airlines and vessel operators to
provide data when available or to report
when data are unavailable. The time it
takes for HHS/CDC to obtain the
available traveler contact data can range
from a few hours to a few days. From
2010 through May 2015, about 70% of
manifests from airlines arrived within 3
days of the request, 15% arrived
between 3 and 6 days after a request,
15% arrived after more than six days,
and nine requests took more than a
month or were never received by HHS/
CDC.
At present, HHS/CDC requests that
airlines and vessels provide available
traveler contact data within 24 hours for

VerDate Sep<11>2014

23:46 Jan 18, 2017

Jkt 241001

‘‘urgent’’ manifest requests. In current
practice, requests for contact data are
only considered ‘‘non-urgent’’ for
contact investigations in which travelers
had rubella (for which there is no
available prophylaxis) or tuberculosis or
for situations in which HHS/CDC is not
notified of travelers diagnosed with
some communicable diseases until after
a certain amount of time during which
prophylaxis would be effective (e.g., for
measles: 6 days). If the analysis is
limited to diseases where requests for
traveler contact data are marked
‘‘urgent’’ by HHS/CDC (measles,
meningococcal disease, MERS, viral
hemorrhagic fevers, and rabies),
performance improved such that 51%
arrived within 24 hours of a request,
33% arrived between 1–3 days after a
request, 13% between 3–6 days and
only 3% arrived after 6 days. HHS/CDC
notes that there may be instances where
CDC may not have included the correct
information in a manifest order (e.g.,
flight number or port of entry). The
provision of incorrect flight information
may have caused delay submission in
some of the instances cited above.
While HHS/CDC requires that all
information be provided upon first
order for information, HHS/CDC has
consistently seen that the information
provided by a majority of airlines
appears limited to frequent flyer
information, or other limited contact
information. Overall, the completeness
of data provided by airlines varied such
that airlines generally fell into two
categories. Some airlines always
provided only the passenger name and
seat number. Other airlines would
provide some additional contact
information for passengers. However,
even among these airlines, contact data
for some of the passengers only
included names and seat numbers.

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Considering all requests from 2014, at
least one additional piece of contact
information was provided for only about
39% of passengers. If the sample were
restricted to only flights for which any
contact information was provided (1,270
out of 2,411 total passengers), the
fraction of passengers with at least one
piece of contact information beyond
name and seat number increased from
39% to 73.9%. This contact information
would include U.S. address for 41.7% of
passengers and one phone number for
45% of passengers. As a result of HHS/
CDC’s use of available information and
technology and its partnerships with
other Federal agencies, contact tracing
of exposed travelers can now be
accomplished more rapidly than would
be possible if only the contact data
provided by airlines were used.
However, if airlines or vessel operators
have additional data relative to what is
currently provided to DHS, the
efficiency of contact investigations
could improve.
Change to Definition of an ‘‘Ill Person’’
HHS/CDC is updating the definition
of ‘‘ill person’’ in 42 CFR 70.1 and 71.1
to better facilitate identification of
communicable diseases of public health
concern aboard flights and voyages.
However, HHS/CDC currently requests
that aircraft and vessels report several of
the symptoms included in the revised
definition of ill person. Besides aircraft
and vessel operators, quarantine stations
also receive illness reports from U.S.
Customs and Border Protection, U.S.
Coast Guard, State and local health
departments, and health facilities. These
reports are not included in this analysis,
which focuses on reporting during
travel.
HHS/CDC has crafted the definition of
‘‘ill person’’ in such a way that it should

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be understood by non-medically trained
crewmembers and used to discern
illnesses of public health interest that
HHS/CDC would like to be made aware
of according to 42 CFR 70.4 from those
that it does not (e.g., common cold),
while more closely aligning the
definition with the symptoms reporting
guidelines published by ICAO in Note 1
to paragraph 8.15 of Annex 9 to the
Convention on International Civil
Aviation. To further assist flight
crewmembers (and vessel crewmembers
under part 71) in identifying individuals
with a reportable illness, HHS/CDC
provides the following in-depth
explanations and examples of the
communicable diseases that such signs
and symptoms might indicate. Note that
these explanations also apply to the
definition of ‘‘ill person’’ under part 71
and are discussed in the preamble of
this final rule.
The current illness reporting
requirements for interstate travel are
summarized in 42 CFR 70.4 and state
that ‘‘The master of any vessel or person
in charge of any conveyance engaged in
interstate traffic, on which a case or
suspected case of a communicable
disease develops shall, as soon as
practicable, notify the local health
authority at the next port of call, station,
or stop, and shall take such measures to
prevent the spread of the disease as the
local health authority directs.’’
Communicable disease is defined in 42
CFR 70.1 as ‘‘illnesses due to infectious
agents or their toxic products, which
may be transmitted from a reservoir to
a susceptible host either directly as from
an infected person or animal or

indirectly through the agency of an
intermediate plant or animal host,
vector, or the inanimate environment.’’
Thus, the changes in this final rule
would amount to fewer illness reports
than may be anticipated under the
current regulation. However, in practice,
according to CDC guidance available at
http://www.cdc.gov/quarantine/air/
reporting-deaths-illness/guidancereporting-onboard-deathsillnesses.html, the symptoms requested
for international and interstate illness
reporting are the same subset. In
addition, according to guidance, reports
received by HHS/CDC would be
considered sufficient to satisfy the
requirement to report to local health
departments since HHS/CDC would
coordinate any response activities with
the local health department after receipt
of the illness report.
This final rule would align the
definition from CDC guidance with
regulatory text by requiring reports of ill
travelers with fever and persistent
cough, persistent vomiting, difficulty
breathing, headache with stiff neck,
decreased consciousness, travelers
appearing obviously unwell, or
unexplained bleeding. In practice, the
codification of such guidance may
increase costs to some or all airlines and
vessel operators who submit illness
reports based only upon symptoms
currently identified in 42 CFR 71.1 and
not based on HHS/CDC guidance. For
illness reports from aircraft, DOT/FAA
may also incur additional costs if the
number of illness reports made by
aircraft pilots in command to air traffic
control and reported to HHS/CDC via
the Domestic Events Network increases.

For aircraft, the updated definition
better aligns with symptoms reporting
guidelines published by ICAO in Note 1
to paragraph 8.15 of Annex 9 to the
Convention on International Civil
Aviation. Therefore, HHS/CDC does not
anticipate much additional burden on
airlines and vessel operators to report ill
travelers during travel.
Although HHS/CDC estimates the net
change will be no cost to airline or
vessel operators, it may be possible to
examine the potential increase using
simple assumptions. Table 9 shows the
number of reports by pilots in command
during flights and recorded in HHS/
CDC’s Quarantine Activity Reporting
System (QARS). These include reports
of illness that fit the illness definition
specified in current 42 CFR 71.1, reports
based on HHS/CDC’s guidance for
airlines and vessel operators, reports
made based on the guidelines in Note 1
to paragraph 8.15 of Annex 9 to the
Convention on International Civil
Aviation, or illness reports unrelated to
current regulation or guidance. Such
reports can also be subdivided into
reports requiring HHS/CDC response
(‘‘response reports’’) and reports that
HHS/CDC receives, but which do not
require an HHS/CDC response (‘‘infoonly reports’’). Info-only reports may
include symptoms included in HHS/
CDC guidance, but for which the
underlying condition can easily be
diagnosed not to be a communicable
disease of public health concern (e.g.,
influenza-like illness on an aircraft).
Info-only reports can also be based on
illnesses not requested by HHS/CDC
guidance (e.g., motion sickness).

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

Based on
symptoms
included
in final rule

Reports not
based on
symptoms
included in
either current
regulation or
final rule

Year

Category

2015 ..............................

Info-only ..............................................................
Response ............................................................
Info-only ..............................................................
Response ............................................................
Info-only ..............................................................
Response ............................................................
Info-only ..............................................................
Response ............................................................
Info-only ..............................................................
Response ............................................................

30
33
33
19
31
21
34
12
27
25

55
22
61
36
46
25
58
18
39
29

43
15
42
12
29
4
38
2
25
13

128
70
136
67
106
50
130
32
91
67

Average, Info-only ..........................................................................................
Average Response ........................................................................................
Average, total .................................................................................................

31
22
53

51.8
26
77.8

35.4
9.2
44.6

118.2
57.2
175.4

2014 ..............................
2013 ..............................
2012 ..............................
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Based on
symptoms
included
in current
regulation

2011 ..............................

Total

In addition to illness reports, HHS/CDC receives an average of 10 death reports during air travel each year. Since death reporting requirements are not changing, these are not analyzed.

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Table 9 shows that HHS/CDC already
receives a number of reports based on
symptoms included in HHS/CDC
guidance that will be codified with this
final rule. On average, among the total
175 illness reports per year, about 78
annual reports are based on symptoms
included in the final rule, but not in
current regulations compared to 53
reports based on symptoms already
listed in current regulations. The
remaining 45 reports would include
those based on fever alone or based on

symptoms not included either in current
regulatory text or in this final rule.
The number of illness reports from
master of vessels during voyages is
summarized in Table 10. Compared to
the breakdown in reports for aircraft, the
vast majority of illness reports during
voyages are for response as opposed to
info-only. There may be greater
specificity in reports from cruise vessels
because of the presence of medical
officers onboard vessels. On average,
there were about 208 reports requiring

follow-up and 10.6 info-only reports
each year. In contrast to reports from
aircraft, most of the reporting for vessels
pertains to symptoms included in the
current regulation (175 per year) as
opposed to those specified in this final
rule (32 per year). Very few reports from
vessels (3.4 per year) were based on
fever only or based on symptoms not
included in either current regulation or
specified in this final rule.

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]
Based on
symptoms
included
in current
regulation

Based on
symptoms
included
in final rule

Reports not
based on
symptoms
included in
either current
regulation or
final rule

Year

Type of report

2015 .......

Info-only .....................................................................................
Response ...................................................................................
Info-only .....................................................................................
Response ...................................................................................
Info-only .....................................................................................
Response ...................................................................................
Info-only .....................................................................................
Response ...................................................................................
Info-only .....................................................................................
Response ...................................................................................

5
179
6
168
1
145
5
167
1
196

4
21
3
21
1
48
7
19
3
32

4
1
3
12
3
11
3
1
4
19

13
201
12
201
5
204
15
187
8
247

Average, Info-only ..........................................................................................
Average Response ........................................................................................
Average, total .................................................................................................

3.6
171
174.6

3.6
28.2
31.8

3.4
8.8
12.2

10.6
208
218.6

2014 .......
2013 .......
2012 .......
2011 .......

Total

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In addition to the illness reports reported in the table, HHS/CDC receives about 115 reports of death during maritime travel each year. In addition, HHS/CDC requests, but not require reporting of influenza-like-illness from cruise vessels (also not included in above table).

Baseline Contact Investigation Process
for Routinely Imported Diseases
This section reports the primary steps
of CIs for routine diseases:
• A traveler (the index case) is
identified as ill either during the flight
or voyage with a reportable illness or
after with a notifiable disease. The
aircraft pilot in command or master of
vessel may report the illness directly to
HHS/CDC. Illnesses on aircraft may also
be reported indirectly to HHS/CDC via
air traffic control. The FAA then passes
the report to CDC through the Domestic
Event Network. If the report occurs after
travel, a healthcare facility would then
report the illness either to HHS/CDC or
public health departments (PHDs).
• If CI criteria are met, HHS/CDC
contacts the airlines for
Æ a manifest to determine where the
index case was seated in relation to
other passengers or crew members,
D HHS/CDC then requests information
available from DHS’ databases to verify
or obtain passenger contact information
not included in the manifest.

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D If data are not available in DHS
databases, HHS/CDC will require (as
part of the manifest order) for the
airlines to provide any available traveler
contact information. The number of
travelers for which contact data will be
requested is based on the diseasespecific criteria listed in Table 5.
Once HHS/CDC has the traveler
contact information and flight-seating
chart, the CI begins. Current CI
procedures are cumbersome, in part
because of the difficulties associated
with obtaining traveler contact
information. HHS/CDC staff may contact
airlines more than once to obtain
traveler contact data including email
address, one or two phone numbers, and
address in the United States for U.S.
citizens and permanent residents.
When passenger contact information
is delayed or partial, State/local public
health departments are delayed in
starting CIs and, depending on the
disease, this delay could make it
impossible to prevent illness and/or the
transmission of disease. Further, PHDs

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could have improved success contacting
passengers with more accurate or
timelier data.
The model for estimating the benefits
of CIs is: Current number of CIs ×
(reduction in HHS/CDC and health
department staff time/resources per
contact) × value of staff time.
The rest of this section reports both
the quantifiable benefits arising from
streamlining the CI process and a
discussion of health benefits. The
differential impacts of the various
diseases make it hard to summarize the
final rule’s effects given uncertainty
around future probabilities of case(s) of
multiple such notifiable disease(s). The
timeliness of contact investigations
could also be improved if improvements
in illness reporting led to earlier
diagnoses of communicable diseases.
Estimating the Number of Infected
Travelers
Most air travelers with illness are not
identified in flight, but rather seek
medical care and are identified as an

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index case after their travel is
completed. Compared to air travelers,
maritime travelers spend more time on
vessels during voyages and medical
officers may be employed on cruise
vessels.
When communicable diseases are
diagnosed after travel, the medical
practitioner should notify HHS/CDC or
a PHD if the diagnosed disease is on
either the list of quarantinable
communicable diseases or the list of
notifiable diseases. If HHS/CDC can
draw upon improved contact
information based on the codification of
requests for traveler contact data to
aircraft and vessel operators as set forth
in this final rule, the risk of onward
disease transmission can be reduced. By
contacting ill travelers more quickly,
HHS/CDC may slow the spread and the
severity of the outbreak. The benefits
therefore depend on:
• How many infected travelers are
expected to enter the United States;
• How many quarantinable or
notifiable diseases are detected either
on-board the aircraft/vessel or reported
to HHS/CDC by PHDs;
• How many exposed travelers will
become ill as a result of exposure during
travel;
• How the infection will be
transmitted within the U.S. population;
• How effective public health agency
contact tracing will be with and without
the final rule.
In addition to improved efficiencies
associated with more timely or more
complete provision of traveler contact
data by airlines and vessel operators,
there may also be an increase in the
number of reports of ill travelers during
travel that require HHS/CDC follow-up.
Under the most likely scenario, there
will not be a change in these reports,
since the new definition better
corresponds to reporting guidelines
published by ICAO in Note 1 to
paragraph 8.15 of Annex 9 to the
Convention on International Civil
Aviation and current HHS/CDC
guidance. However, there may be an
increase in illness reports depending on
whether airlines and vessel operators
increase reporting for required rather
than recommended symptoms.
Contact Investigations Supported by
CDC and Undertaken by Partners at
State and Local Health Departments
The change to the definition of an ‘‘ill
person’’ for the purposes of illness
reporting and the codification of HHS/
CDC requests from airlines and vessel
operators for traveler contact data may
improve HHS/CDC’s ability to respond
effectively and mitigate infectious
disease outbreaks. There are a number

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of intermediate steps between either an
illness report or receiving more
complete or timelier traveler data and
stopping an infectious disease outbreak.
For example, the travelers exposed to
the infectious disease would have to be
contacted by health departments and
comply with recommended public
health measures, which could include
some form of public health or medical
follow up to mitigate their risk of
becoming ill, or self-monitoring/
quarantine to mitigate the risk of
transmitting that disease to other
individuals.
The amount of time HHS/CDC staff
spend per air or maritime contact varies
with the size of the CI because some
tasks are CI-specific, such as filling out
reports or obtaining manifests, and some
are contact-specific such as determining
a specific traveler’s contact information.
The CI-specific labor time costs less per
contact when an investigation includes
more contacts, e.g., a manifest that takes
60 minutes of HHS/CDC staff time to
obtain for 2 contacts is the equivalent of
30 minutes-staff-time-per-contact while
the same manifest listing 30 contacts is
the equivalent of 2 minutes-staff-timeper-contact. On the other hand, the
traveler-specific time tends to increaseper-contact with less information and
decrease-per-contact with more
information.21 Further, the QARS
system used to document and follow up
on CIs requires full-time personnel to
maintain the system, pull regular
reports, and monitor follow-up of
travelers contacted during CIs. Finally,
HHS/CDC has two full-time persons
regularly assigned as liaisons to DHS
whose duties include gathering contact
information from DHS systems.
Therefore, for HHS/CDC staff time to
initiate and follow up on different sized
CIs, to track down traveler contact
information from multiple sources, to
work with PHDs, document and report
on CIs, update and train in systems, and
manage the staff involved in CIs, a cost
of $180 per contact is estimated. This is
the equivalent of 2 hours of a HHS/CDC
staff person’s being paid the salary of a
GS–13, step 4 plus 100% for benefits
and employee overhead costs (Table 11).
For PHD resources, HHS/CDC also
estimated a cost-per-contact of $180,
which is consistent with HHS/CDC
costs and a recent publication adjusted
to 2015 dollars.22 PHD processes vary
greatly from State to State and at the
21 Margaret

S. Coleman, unpublished data.
M.S., Marienau, K.J., Marano, N.,
Marks, S.M., Cetron, M.S. (2014). ‘‘Economics of
United States tuberculosis airline contact
investigation policies: a return on investment
analysis.’’ TMAID 12(1):63–71.
22 Coleman,

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local level within a State. A couple of
examples:
• One State assigns 2 registered
nurses (RNs) who perform 5 CIs or fewer
per year for the entire State another
State assigns 3 RNs, a Public Health
Service Medical Officer, a physician,
and a data analyst and conducts about
25 CIs a year.23
• When one State receives
information about passenger contacts
from HHS/CDC, the State
epidemiologist creates several
documents to fax to the relevant county
health departments, a team of an
epidemiologist and RNs at the county
then either call or visit the contacts if
there is an address. But the State
epidemiologist will make every effort to
locate travelers even if their final
destination is unclear.24
Finally, different diseases may elicit
different levels of response at the PHD
level, with a more rapid response for
highly infectious diseases like measles
that can be prevented with timely postexposure prophylaxis and a more
measured response for less infectious
diseases like TB. By using the same cost
for HHS/CDC and for PHDs, HHS/CDC
believes the potential reductions in cost
from reduced effort for PHDs to locate
infectious disease contacts are
conservatively estimated.

TABLE 11—COST-PER-CONTACT
CDC

PHD

$180 ......................................

$180

Infectious Disease Transmission During
International Travel
For some diseases, there is empirical
data from which onboard transmission
can be estimated. According to a
published analysis of the outcomes of
measles contact investigations (74 casetravelers on 108 flights resulting in
3,399 contacts) in the United States
between December 2008 and December
2011, HHS/CDC could not assign 9% of
measles contacts (322) to a health
department due to insufficient contact
data. Another 12% of these contacts
(397) were believed to be outside the
United States.25 After HHS/CDC
provides contact data to State health
departments, HHS/CDC requests, but
does not require health departments to
23 Personal communication from states to Dr.
Margaret S. Coleman 2010.
24 Discussion between Dr. Brian Maskery, Dr.
Margaret S. Coleman and State and County Health
Department contacts 11/21/2014.
25 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.

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provide data on the outcomes of their
attempts to follow-up with travelers.
Among the 2,673 contacts assigned to
U.S. public health departments in 2008–
11, HHS/CDC only received outcome
data for 1,177 out of the 2,673 assigned
contacts. This outcome data included
reports from State health departments
that 225 out of the 1,177 assigned
contacts could not be located (19%).
Among the 952 contacts for which HHS/
CDC received measles outcome data
from health departments, there were 9
lab-confirmed measles cases (1%). Since
there may be reporting bias from health
departments (i.e. health departments
would be more likely to report outcome
data for contacts that developed measles
than for other exposed travelers that did
not develop measles, HHS/CDC
considers a range of measles incidence
rates among exposed travelers from 9
cases/2,673 contacts assigned to health
departments (0.34%) to 9 cases/952
exposed contacts with outcome data
reported to HHS/CDC (0.95%). This
probability could overstate or understate
the true transmission rate depending on
the length of the flight and seating
configuration. On the other hand, it may
understate the probability if cases were
not reported or occurred overseas.
The majority of travelers exposed to
measles on aircraft (∼74%) had preexisting immunity based on past
measles immunization, past measles
illness, or being born prior to 1957 and
thus likely to have measles immunity
even if they do not recall experiencing
the disease.26 Among the 952 exposed
travelers, 8 cases occurred in the 247
contacts (3.2%) without known preexisting immunity compared to 1 case
in the 705 contacts with past history of
vaccination or measles illness (0.1%).
The median age of measles cases in
exposed air traveler contacts was 1.6
years.
Intervention by public health
departments mitigates the risk of
measles transmission in two ways. First,
exposed travelers without measles
immunity may be offered voluntary
post-exposure prophylaxis with
measles-containing vaccine (within 72
hours) or immune globulin (within 6
days),27 which can prevent onset of
disease, halting outbreaks before they
begin. Under the status quo, relatively
few exposed travelers receive postexposure prophylaxis (just 11 out of 248
26 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.
27 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.

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travelers with no history of measles
immunization or infection). Second,
exposed travelers would be counseled
by health departments to self-isolate and
seek treatment if they started to
experience symptoms consistent with
measles onset. For example infants
exposed during travel and too young to
be vaccinated could arrange for special
precautions if they visit a pediatrician
after becoming ill with measles-like
symptoms to minimize the transmission
to other unvaccinated infants. Both
activities will limit the possibility of
measles transmission to family members
or others in the community. The attack
rate for measles is estimated to be 90%,
but the high background immunization
rate and high efficacy of measles
vaccine attenuates the burden of
measles outbreaks in the United States.
In summary, the potential size of a
measles outbreak occurring depends on:
• The number of persons contacted
by the infectious measles patient
• Background immunity among
persons contacted
Æ Survey estimates have shown
considerable heterogeneity in
background vaccination rates such that
80% of unvaccinated children live in
counties comprising 40% of the total
population.28
For tuberculosis, it is difficult to
estimate the transmission rate on an
aircraft or vessel. A modeling study
suggests that the risk of infection is
about 1/1000 on an 8.7 hour flight and
that persons seated closer to the index
case are at greater risk of infection.29
Only 5–10% of persons infected with
the bacteria Mycobacterium tuberculosis
will go on to develop active, infectious
disease and the risk of progression is
greatest within the first two years after
infection.30
An analysis of the epidemiology and
outcomes of HHS/CDC-led flight-related
tuberculosis contact investigations
conducted in the United States from
January 2007 to June 2008 examined
131 case-travelers and 4,550 passengercontacts.31 Among 3,375 (74%)
28 Smith P, Marcuse E, Seward J, Zhao Z, WA O.
Children and Adolescents Unvaccinated Against
Measles: Geographic Clustering, Parents’ Beliefs,
and Missed Opportunities. Public Health Rep.
2015;5:485–504.
29 Ko G, Thompson KM, Nardell EA. Estimation
of tuberculosis risk on a commercial airliner. Risk
Anal 2004;24:379e88.
30 Marienau KJ, Cramer EH, Coleman MS, Marano
N, Cetron MS. Flight related tuberculosis contact
investigations in the United States: comparative risk
and economic analysis of alternate protocols. Travel
Med Infect Dis. 2014;12(1):54–62.
31 Marienau KJ, Burgess GW, Cramer E, et al.
Tuberculosis investigations associated with air
travel: US Centers for Disease Control and
Prevention, January 2007–June 2008. Travel Med
Infect Dis 2010;8:104e12.

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passenger-contacts whose information
was provided to health departments,
HHS/CDC received results for 861
(26%). HHS/CDC found that 103/861
(12%) had a previous history of a
positive TB screening test result or
treatment for latent tuberculosis or
active disease and were not re-tested. Of
the remaining 758 passenger contacts,
182 (24%) tested positive. The majority
of travelers with data about TB risk
factors (other than exposure to cases
during air travel) had at least one risk
factor (130/142 or 92%). Risk factors
included having been born or lived in
a country with high TB prevalence
(prevalence >100 per 100,000
population). Although passengercontacts with risk factors were more
likely to have pre-existing latent
tuberculosis infection, the authors could
not exclude the possibility that infection
was acquired during the flights when
the travelers were exposed.
Furthermore, because outcomes data
were reported for only 26% of passenger
contacts forwarded to U.S. health
departments (19% of all passenger
contacts) the precise determination of
in-flight transmission risk of M.
tuberculosis was not feasible.32
The results from this investigation
were used in a cost-effectiveness study
to estimate the return on investment for
tuberculosis CIs. The authors examined
a range of latent tuberculosis prevalence
rates among exposed travelers that
varied between 19% and 24% for two
different HHS/CDC CI protocols for
flight-related TB investigations. The
return on investment was calculated
based on the likelihood that travelers
with latent tuberculosis infection would
initiate and complete a treatment
regimen to clear the infection, the
average cost of tuberculosis treatment, a
tuberculosis case fatality rate of 5% and
a conservative value of statistical life
estimate of $4.2 million (in 2009 USD)
to account for the value of mortality risk
reduction from avoided tuberculosis
disease. The return on investment
depended on the probability assumed
for persons with latent TB infection to
develop active disease (5–10%) and
variation in the costs to health
departments to locate exposed travelers
($28 to $164). Using the expected latent
tuberculosis prevalence rate of 19% in
travelers identified for contact
investigations on flights and a health
department cost per contact of $164, the
return on investment was estimated to
32 Marienau KJ, Burgess GW, Cramer E, et al.
Tuberculosis investigations associated with air
travel: US Centers for Disease Control and
Prevention, January 2007–June 2008. Travel Med
Infect Dis 2010;8:104e12.

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vary between $1.01 and $3.20. The
return on investment formula was
calculated based on (Expected
benefits¥Expected costs)/Expected
costs. Thus, for each $1 in Federal and
State resources spent on contact
investigations and offering treatment to
persons infected with latent
tuberculosis infections would result in
benefits in excess of costs equal to $1.01
to $3.20 33 34 on average. At the upper
bound latent tuberculosis prevalence
estimate (24%), the return on
investment was estimated to vary
between $1.35 and $3.92.
There is also empirical data for SARS
infections occurring on an aircraft. A
study reported that 37 infections
resulted from 40 flights with infectious
passengers on board. Of the 40 flights,
four have documented aircraft sizes.
They average 127 passengers per
plane.35 Therefore the on board
transmission rate could be estimated to
be 0.73% among all travelers. In
comparison, there is no evidence of
transmission of MERS Coronavirus or

viral hemorrhagic fevers during travel
on aircraft or vessels. However, there
have not been enough observations to
determine that there is no risk.
For the remainder of the diseases,
empirical data does not exist. Like
measles, immunizations are
recommended to prevent pertussis,
rubella, and meningococcal disease.
Since meningococcal conjugate vaccine
was more recently added to the United
States vaccination schedule, it is likely
that background immunity is much
lower relative to measles, rubella or
pertussis.
In the absence of data for some
diseases, the infection rate of measles is
used to estimate the infection rates by
using the ratio of basic reproduction
numbers (R0). The basic reproduction
number is a measure of disease
infectiousness. Specifically, it is an
estimate of new infections in a
completely susceptible population. For
example, rubella has an R0 of 9 to 10
while measles has an R0 of 15 to 17.36
The infection rate of measles is

multiplied (0.0034 to 0.0095) by the
ratio of the average basic reproductive
numbers (9.5/16) to arrive at a
transmission rate (0.002 to 0.006) for
rubella on airplanes. This rate is
approximately 60% of the rate for
measles. The estimated transmission
rates for some diseases are reported in
Table 12. The exceptions are for
meningococcal disease and tuberculosis.
For meningococcal disease, the risk of
transmission in household contacts
0.002 to 0.004 37 is used in the absence
of other data and taking account that CIs
are only performed for travelers sitting
adjacent to the index case or in the
event of other known exposures. For
tuberculosis, the probability that
exposed travelers have latent
tuberculosis 38 (19%–24%) is used,
although infection may have occurred
prior to air travel. For the purposes of
evaluating the economic impact of
tuberculosis investigations, it does not
matter if travelers were infected during
travel or before.

TABLE 12—ESTIMATED TRANSMISSION RATE ON PLANE FOR EXPOSED TRAVELERS
Disease

Diphtheria (quarantinable) ........................................................................................................
Measles (non-quarantinable) ....................................................................................................
Meningococcal Disease (non-quarantinable) ...........................................................................
Pertussis (non-quarantinable) ...................................................................................................
Rubella (non-quarantinable) .....................................................................................................
TB (quarantinable) ....................................................................................................................

11 to 14 ............
15 to 17 ............
NA .....................
4 to 5 ................
9 to 10 ..............
NA ....................

Lower bound

Upper bound

0.0026
0.0034
<2/1000
0.001
0.002
0.19

0.0074
0.0095
<4/1000
0.003
0.006
0.24

The number of potential contacts for
each disease can be multiplied by the
estimated transmission rate by disease
in Table 12 to generate a rough estimate
of the annual number of cases among
traveler contacts. These numbers of
contacts for each disease are
summarized in Tables 6 and 7 for
interstate and international CIs

respectively. Contact investigations on
vessels are excluded for this analysis.
Based on this analysis, tuberculosis (19
to 48) and measles cases (3.6 to 10.1) are
the most likely diseases that will be
diagnosed among contacts exposed
during travel (Table 13). Tuberculosis
contact investigations only occur for
international flights with the very rare
exception of a domestic flight with a
duration greater than 8 hours. The
numbers of contacts and outcomes are

much more uncertain for other diseases.
The number of tuberculosis cases are
adjusted from the number of contacts
with tuberculosis by assuming that only
5% (lower bound) to 10% (upper
bound) of infected contacts will go on
to develop clinical disease.39
For viral hemorrhagic fevers and
MERS, there is no evidence of
transmission, but there have not been
very many observations.

33 Coleman M, Marienau K, Marano N, Marks S,
Cetron M, Dis TMI. Economics of United States
Tuberculosis Airline Contact Investigation Policies.
Travel Medicine and Infectious Disease.
2014;12:63–71.
34 Marienau KJ, Burgess GW, Cramer E, et al.
Tuberculosis investigations associated with air
travel: US Centers for Disease Control and
Prevention, January 2007–June 2008. Travel Med
Infect Dis 2010;8:104e12.

35 Mangili A, Gendreau MA. Transmission of
infectious diseases during commercial air travel.
Lancet. 2005;365:989–96.
36 Anderson RM. The concept of herd immunity
and the design of community-based immunization
programmes. Vaccine. 1992;10(13):928–35.
37 Chapter 14. Meningococcal Disease, The Pink
Book, CDC http://www.cdc.gov/vaccines/pubs/
pinkbook/mening.html Accessed 5/2/2016.

38 Marienau KJ, Burgess GW, Cramer E, et al.
Tuberculosis investigations associated with air
travel: US Centers for Disease Control and
Prevention, January 2007–June 2008. Travel Med
Infect Dis 2010;8:104e12.
39 Coleman M, Marienau K, Marano N, Marks S,
Cetron M, Dis TMI. Economics of United States
Tuberculosis Airline Contact Investigation Policies.
Travel Medicine and Infectious Disease.
2014;12:63–71.

Estimated Number of Cases in Traveler
Contacts

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Estimated transmission rate on
aircraft to exposed passengers

R0

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6945

TABLE 13—ANNUAL ESTIMATED NUMBER OF CASES AMONG INTERNATIONAL PASSENGER CONTACTS BY DISEASE
Number of
contacts

Passengers per flight

MERS Coronavirus (quarantinable) .........................................

101

Measles (non-quarantinable) ...................................................
Meningococcal Disease (non-quarantinable) ..........................
Pertussis (non-quarantinable) ..................................................
Rubella (non-quarantinable) ....................................................
TB a (quarantinable) .................................................................

1,069
1.7
16.8
117
1,995

Viral Hemorrhagic Fever (quarantinable) ................................

62.0

Total ..................................................................................

3,362

Expected
incidence
among
contacts
(lower bound)

Expected
incidence
among
contacts
(upper bound)

Expected
number of
new cases
(lower bound)

Expected
number of
new cases
(upper bound)

Insufficient data
0.0034
0.00200
0.001
0.002
b 0.19

0.0095
0.00400
0.003
0.006
b 0.24

3.6
0.0033
0.02
0.2
c 18.9

10.1
0.0067
0.04
0.7
c 47.90

22.8

58.7

Insufficient data
........................

........................

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 clinical disease.

These estimates of cases may be a
lower bound, because potential cases
resulting from flights in which contact
investigations were not performed are
not included. Especially for tuberculosis
cases, many international travelers may
return to their home countries before
seeking treatment and such cases may
not lead to contact investigations if
HHS/CDC is not informed.
Marginal Costs of Final Rule
Data Collection
Since the final rule does not change
the timeframe or amount of data
requested from airlines or vessel
operators, the most likely economic
impact is a small change in the amount
of effort for airlines to provide more
complete and timely information. To the
extent that airlines would respond more
quickly or with additional data, it
would require some airline information
technology staff to expedite requests or
to search in more depth for available
data. HHS/CDC estimates this may
require one hour of staff time per
request. HHS/CDC has no way to predict
how much more complete, timely, or
accurate contact from airlines would
become as a result of this final rule. On

average, HHS/CDC acted upon 77
requests per year to airlines for
international traveler contact data
between 2010 and 2015 (Table 6). In
addition, HHS/CDC made 22.5 requests
per year for interstate traveler data
(Table 7) over the same period. There
were 45 contact investigations per year
among travelers on vessels (Table 8);
however, most of these were undertaken
before travelers disembarked vessels in
which case contact data could be
collected directly from exposed
travelers as part of the investigation.
The number of maritime contact
investigations requiring manifest
requests after disembarkation is
estimated to be less than 10 per year.
Overall, including international air
and maritime activities, the estimated
number of contact data requests after
disembarkation was estimated at 100 to
account for the fact that HHS/CDC
sometimes requests traveler contact data
for infectious disease events prior to
confirmed diagnoses. On occasion, it
turns out that travelers are not infected
with diseases that require a public
health response. This rounding up
should also account for a year in which
there is a significant increase in the

number of contact investigations among
exposed air or maritime travelers. HHS/
CDC notes the manifest order process
for interstate flights is not codified in
the final rule. The data is provided here
for completeness.
The average wages for computer and
information systems managers
(occupation code 11–3021) reported in
the Bureau of Labor Statistics, May 2015
Occupational Employment Statistics 40
were $63.27 per hour. On average,
under the baseline, HHS/CDC assumes
that it would require 6 hours of work by
airlines to search databases and provide
data. For the final rule, HHS/CDC
assumes that a management-level
computer specialist will spend
additional time to provide the best
possible contact data for potentially
exposed travelers. The base salary is
multiplied by an overhead multiplier of
100% to account for non-wage benefits
and other overhead costs for supporting
each employee (Table 14). The lower
bound estimate ($0) is no change from
current practice, while the upper bound
estimate assumes 2 hours of time
instead of one ($25,308). These costs are
applied to an estimated 100 manifest
requests per year.

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TABLE 14—ESTIMATE OF COSTS FOR AIRLINES AND VESSEL OPERATORS TO IMPROVE COMPLIANCE WITH HHS/CDC
REQUESTS FOR TRAVELER CONTACT DATA, 2015 USD
Average
number of
manifest
requests
per year

Baseline ...........................................................................
Best estimate ...................................................................

Increased
effort to
provide more
complete or
timelier
passenger
contact data
(hrs.)

100
100

Average hourly
wage rate
of IT staff
(2015 USD)

6
1

$63.27
63.27

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

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Overhead
multiplier
(%)

100
100

Total cost

$75,924
12,654

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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
provide more
complete or
timelier
passenger
contact data
(hrs.)

Average
number of
manifest
requests
per year

Lower bound ....................................................................
Upper bound ....................................................................

Illness Reporting Costs
When reports are received, public
health officers at Quarantine Stations
perform case assessments, may request
follow-up information, and may consult
with HHS/CDC medical officers to
determine if additional action such as a
contact investigation, onboard response,
or notification to State and local health
departments is warranted. Under one
assumed upper bound scenario, the
change in the definition of ‘‘ill person’’
included in the final rule could result in
a 100% increase in the number of infoonly reports from airlines and a 25%
increase from vessels. On average, there
are 129 info-only reports for aircraft and
vessels each year and these increases
would correspond to an annual increase
of 119 info-only reports on aircraft and
3 info-only reports on vessels (Table 15).
If the average time for each report is
estimated to be 2 minutes for aircraft
pilots in command or masters of vessels
to make the report, 10 minutes for a
traveler to discuss the illness with

100
100

Average hourly
wage rate
of IT staff
(2015 USD)

0
2

public health officer, and 60 minutes for
HHS/CDC to document the info-only
report, the estimated cost of the
additional reports can be estimated
based on the opportunity cost of time
for each type of personnel. In addition
to the time required for aircraft pilots in
command and masters of vessels to
make reports, the personnel in the
Department of Transportation’s Federal
Aviation Administration (DOT/FAA)
may incur additional costs to relay
reports of suspected cases of
communicable disease received by air
traffic control to CDC through the
Domestic Events Network. The amount
of DOT/FAA staff time is estimated at
26 minutes for a government employee
at GS-level 15, step 6 based in
Washington, DC. In reality, there would
be three DOT/FAA employees involved
including 1 GS–15/16 level employee at
air traffic control (10 minutes), 1 GS–15
level employee at the Domestic Events
Network (10 minutes), and 1 GS–14
level employee at DOT/FAA’s

63.27
63.27

Overhead
multiplier
(%)

100
100

Total cost

0
25,308

Washington Operations Center Complex
(6 minutes).41
For aircraft pilots in command or
masters of vessels (occupation codes
53–2011 and 53–5021) and travelers
(average across all occupations code 00–
0000), their opportunity cost is
estimated from Bureau of Labor
Statistics, May 2015 Occupational
Employment Statistics 42 based on the
average salary of aircraft pilots or
copilots ($57.35 per hour), traveler
($23.23 per hour) or vessel captain,
mate, or pilot ($39.95 per hour). For
HHS/CDC employees, the average wage
rate is based on the Federal
government’s general salary scale for a
GS–12, step 5 employee based in
Atlanta, GA). Base salaries are
multiplied by an overhead multiplier of
100% to account for non-wage benefits
and other overhead costs for supporting
each employee. Travelers do not have
overhead costs. The annual quantified
costs of 122 additional info-only reports
would be $17,471.

TABLE 15—CHANGES IN NUMBERS OF INFO-ONLY REPORTS AND ASSOCIATED COSTS FOR THE FINAL RULE UPPER
BOUND, 2015 USD
Change in
number
of info-only
reports

Employee type

mstockstill on DSK3G9T082PROD with RULES3

Aircraft:
Aircraft Pilots or Copilots ..............................................
CDC employee .............................................................
DOT/FAA employees ....................................................
Traveler .........................................................................

Amount
of time
required
per report
(min)

Estimated
wage rate
(2015 USD
per hr.)

Overhead
multiplier
(%)

Estimated
cost

119
119
119
119

2
60
26
10

$57.35
39.83
70.57
23.23

100
100
100
0

$455
9,480
7,278
461

Air total ..................................................................
Vessels:
Air or maritime conveyance officer ...............................
Captains, Mates, and Pilots of Water Vessels .............
CDC employee .............................................................
Traveler .........................................................................

........................

........................

........................

........................

17,213

........................
3
3
3

........................
2
60
10

........................
39.95
439.83
23.23

........................
100
100
0

........................
8
239
12

Maritime total .........................................................

........................

........................

........................

........................

259

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
Maskery and DOT/FAA.

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Besides the possible change in costs
of info-only reports, the other potential
change would be an increase in the
number of reports that require HHS/
CDC follow-up. Under the most likely
scenario, there will not be a change in
these reports since the new definition
better corresponds to HHS/CDC
guidance and to reporting guidelines
published by ICAO in Note 1 to
paragraph 8.15 of Annex 9 to the
Convention on International Civil
Aviation. However, there may be an
increase in the number of reports
requiring a response. Under this
scenario, there may be an increase in
costs for air or masters of vessels to
report illnesses. The upper bound
increase in reports requiring response is
assumed to be 50% of the average
annual illness reports from airlines and
a 10% increase from vessels (refer to
Tables 10 and 11 for baseline number of

reports): 29 reports per year on aircraft
and 21 reports per year on vessels. HHS/
CDC assumes that the time required to
submit illness reports and for DOT/FAA
staff to relay reports requiring responses
is the same as for info-only reports (2
minutes for pilots in command and
masters of vessels and 26 minutes for
DOT/FAA to relay reports, Table 16).
Further, HHS/CDC assumes that
travelers could spend up to 60 minutes
talking to HHS/CDC and/or State and
local public health officers for reports
requiring response. The upper bound
estimate of total costs associated with
the increase in the number of illness
reports requiring response is estimated
to be $3,102.
There would likely be no change or a
decrease in HHS/CDC costs because
earlier reporting would lead to a more
efficient HHS/CDC response relative to
an alternative in which the illness was

6947

not reported during travel, but instead
was later reported by a public health
department to HHS/CDC. In addition,
the public health response to the illness
would likely be more efficient because
exposed travelers could be contacted
earlier. In rare situations, such travelers
may potentially be informed of their
potential exposure at the gate after
disembarking the aircraft or vessel. Such
actions should not result in significant
delays by holding travelers on board.
HHS/CDC did not include any
training costs because the change in the
‘‘ill person’’ definition in this final rule
is consistent with the internationally
recognized and accepted illness
reporting guidelines published by ICAO
for international travelers and
represents a reduced burden compared
to the previous illness reporting
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
of time
required
per report
(min)

Change
in number
of reports

Employee type

Aircraft:
Aircraft Pilots or Copilots ..............................................
CDC employee .............................................................
DOT/FAA employee ......................................................
Traveler .........................................................................

Estimated
wage rate
(2015 USD
per hr.)

Overhead
multiplier
(%)

Estimated
cost
(2015 USD)

29
29
29
29

2
0
26
60

$57.35
39.83
70.57
23.23

100
100
100
0

$111
0
1,774
674

Total .......................................................................
Vessels:
Captains, Mates, and Pilots of Water Vessels .............
CDC employee .............................................................
Traveler .........................................................................

........................

........................

........................

........................

2,558

21
21
21

2
0
60

39.95
39.83
23.23

100
100
0

56
0
488

Total .......................................................................

........................

........................

........................

........................

544

Total ..............................................................................

........................

........................

........................

........................

3,102

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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
associated with updating training to
reflect the new regulatory text. As noted
above, HHS/CDC reiterates that the
change to regulatory text is a
codification of HHS/CDC guidance and
better aligns with international guidance
(Note 1 to paragraph 8.15 of Annex 9 to
the Convention on International Civil
Aviation). Further for interstate travel,
these changes result in relaxed illness
reporting compared to status quo
regulatory text. Thus any airlines using
either ICAO or HHS/CDC guidance to
support training efforts for illness
reporting should not need to change
training materials. At most, it may be
necessary to clarify that some symptoms
that were previously requested are now
required. However, for some airlines or

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vessel operators, it may be necessary to
revise training materials.
The cost of training was estimated
based on the number of pilots and flight
attendants and their average wage rates
as reported in the Bureau of Labor
Statistics, May 2015 Occupational
Employment Statistics.43 HHS/CDC
assumes that the opportunity cost of
employee time spent in training would
be the primary cost as opposed to the
cost of developing training materials. As
an upper bound, HHS/CDC assumed the
cost of training could be estimated
based on assuming that all employees
would require 10 minutes of training to
summarize the changes. As noted above,
since this change aligns regulatory text
43 http://www.bls.gov/oes/current/oes_nat.htm.

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with existing HHS/CDC and ICAO
guidance documents, this change may
not result in a new training requirement
for all airlines since some presumably
already use HHS/CDC guidance in
training. This 10 minute estimate does
not necessarily mean all 230,000 pilots
and flight attendants each require 10
minutes of training. For example, 50%
of each could require 20 minutes of
training, while the other 50% may
already conduct training in accordance
with either CDC or ICAO guidance. The
total cost of the one-time change in
training is about $3.1 million. If this
cost is annualized over 10 years, the
average annual cost depends on the
discount rate assumed and varies from
$313,000 per year (7% discount rate) to
$416,000 (0% discount rate). These

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Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

results are summarized in Table 17.
These costs (3% discount rate) are
added to the upper bound cost estimate

for illness reporting. The lower bound
and best estimates are $0 since the

changes to the definition better align
with existing CDC and ICAO guidance.

TABLE 17—ESTIMATED COSTS FOR ONE-TIME TRAINING ABOUT CHANGES IN ILLNESS REPORTING FOR AIRLINES, 2015
USD
Amount of
time required
for training
per employee
(minutes)

Number of
employees

Employee type

Estimated
wage rate
(2015 USD
per hr.)

Estimated
cost or
benefit
(2015 USD)

Overhead
multiplier
(%)

Aircraft Pilots or Copilots .....................................................
Flight attendants ..................................................................

121,110
108,510

10
10

57.35
22.46

100
100

2,315,220
812,465

Total ..............................................................................

........................

........................

........................

........................

3,127,685

7% discount rate ...

$312,768

Annualized cost over 10-year time horizon

3% discount rate ...

The monetized annual costs resulting
from the change in the definition of ‘‘ill

$355,981

0% discount rate ...

person’’ are summarized in Table 18.
The benefits in regard to reductions in

$416,179

communicable disease transmission are
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
estimate

Lower
bound

Upper
bound

Costs
Final Rule:
Aircraft ..................................................................................................................................
Vessels .................................................................................................................................

$0
0

$0
0

$375,751
802

Total ...............................................................................................................................

0

0

376,554

The total costs of the final rule are
summarized in Table 19 and include the

costs of the change to the definition of
an ‘‘ill person’’ and the codification of

the requirement for airlines to provide
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
estimate

Lower
bound

Upper
bound

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

$12,654
0

$0
0

$25,308
376,554

Total costs .....................................................................................................................

12,654

0

401,862

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Benefits From Streamlining the CI
Process for Routinely Imported Diseases
This section reports the benefits that
HHS/CDC anticipates from
implementation of the final rule in
avoiding the costs incurred annually for
CIs of infectious diseases. The model for
estimating the benefits of CIs is: Current
number of CIs × (reduction in HHS/CDC
and health department staff time/
resources per contact) × value of staff
time.
HHS/CDC obtained the total number
of contacts traced (2,715 per year, Table

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6) for all diseases reported on
international flights. International flight
data were extracted for this analysis
because the codification of the
requirements to provide timelier and
more complete contact data is limited to
international arrivals. In comparison,
HHS/CDC requests contact information
for approximately 664 contacts per year
on interstate flights (Table 7). HHS/CDC
also supports contact investigations
affecting an average of 762 contacts per
year for illnesses on board vessels
(Table 8); however, many of these
investigations occur before travelers

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disembark vessels. By limiting the
analysis to contacts on international
flights, HHS/CDC conservatively
estimates the potential benefits
associated with this final rule. HHS/
CDC multiplied the average annual
number of contacts on international
flights by the cost-per-contact for HHS/
CDC and PHDs (Table 11) to estimate
the costs of CIs under the current
baseline.
To estimate the benefits (Tables 20
and 21), HHS/CDC assumed a percent
reduction in staff time for CIs at HHS/
CDC (0–3%) and PHD levels (0–2%)

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based on internal conversations with
personnel directly involved in the CI
process. The reduction in staff time that
would result from implementation of
this final rule would arise from the
ability of HHS/CDC to have a better
starting point with which to provide
traveler contact data to State and local
health departments as a result of the
receipt of more complete and timely
traveler contact data from airlines. The
impact of codification is expected to be
limited and would depend on instances
in which airlines have more data than
what is currently provided to DHS.
Better data would improve HHS/CDC’s
ability to transmit information to
destination States more quickly and for
States to contact exposed travelers
earlier. This would allow States to start
their investigations more quickly,
contact more travelers faster to conduct
public health assessments and
potentially offer preventive medications

or vaccines in a more timely fashion or
to recommend self-monitoring to
mitigate onward transmission. In
addition, it would be less likely that
HHS/CDC would send incorrect contact
data to States. With all of the preceding
factors in mind, HHS/CDC estimated
that the final rule would reduce labor
time by between 0% to 3% at HHS/CDC,
and 0% to 2% at PHDs. The higher
percentage of avoided costs at HHS/CDC
reflect reduced efforts by HHS/CDC to
search for accurate contact data for
travelers due to untimely or inaccurate
data. The lower percentage of avoided
costs at PHDs reflects a more diffuse
(e.g., multiple local PHDs in a State)
infrastructure and the more laborintensive tasks of following up on
individuals. These estimates are small
because the change is a clarification and
codification of a current practice
authorized under broad statutory and
regulatory authority rather than a new

6949

regulatory requirement. In addition, the
change to the definition of ‘‘ill person’’
may lead to the earlier diagnoses of
some travelers with communicable
disease, which may lead to earlier and
more efficient public health responses.
HHS/CDC annual costs to engage in
international air, interstate air, and
maritime CIs are about $745,000 or
roughly the equivalent of 3.8 HHS/CDC
full-time employees (FTEs) at the wage
level of GS–13, step 4 plus benefits and
overhead (Table 21). The final rule
should have the greatest effect on the
international air CIs. The annual
reduction in contact tracing costs from
implementing the final rule (Table 22)
for HHS/CDC ranged from $0 to $14,661
based on a 0–3% reduction in effort on
international CIs. For PHDs, the
reduction in costs ranged from $0 at the
lower bound to $9,774 at the upper
bound (Table 22).

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

HHS/CDC

PHD costs

Total costs

HHS/CDC and PHD Baseline Costs (Current Practice)
International air contacts .................................................................................
Interstate air contacts ......................................................................................
Maritime contacts .............................................................................................

2,715
664
762

$488,700
119,520
137,160

$488,700
119,520
137,160

$977,400
239,040
274,320

Total baseline costs ..................................................................................
Viral hemorrhagic fever, MERS, and SARS contacts .....................................

4,141
163

745,380
29,340

745,380
29,340

1,490,760
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
contacts
International contacts .......................................................................

HHS/CDC

2,715

PHD

$488,700

$488,700

HHS/CDC and PHD Costs With the Final Rule
Estimated Costs for HHS/CDC After
Efficiency Improvement with Final
Rule
0%, Lower
bound
International contacts costs assuming reduction in time (2,715) ....

3%, Upper
bound

$488,700

Estimated Costs for PHDs After Efficiency Improvement with Final
Rule
0%, Lower
bound

$474,039

2%, Upper
bound

$488,700

$478,926

Benefits From Implementing the Final Rule

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HHS/CDC 0% and 3% Reduction in
effort
Benefits (Reduced costs) ................................................................

The best estimate of benefits are the
midpoint of the lower bound and upper
bound estimates for both HHS/CDC and

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PHDs ($12,218). The lower bound ($0)
and upper bound estimates ($24,435) for

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PHD (0% and 2% Reduction in
effort)

$14,661

$0

$9,774

both entities are also reported in Table
22.

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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
benefits
Best estimate ...............................................................................................................................
Lower bound ................................................................................................................................
Upper bound ................................................................................................................................

The total annual monetized benefits
by stakeholder from the potential

PHD benefits

$7,331
0
14,661

$4,887
0
9,774

Total
$12,218
0
24,435

reduced effort for contact investigations
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
benefits, USD

PHD benefits,
USD

$7,331
0
14,661

$4,887
0
9,774

Best estimate ...................................................................................................
Lower bound ....................................................................................................
Upper bound ....................................................................................................

Marginal Impact of Final Rule—Measles
Health Outcome Benefits
On average, HHS/CDC identified 564
travelers exposed to measles cases on
international flights during 2010–2015
(Table 6). The final rule may affect the
cost for health departments to
implement public health measures in
two ways: (1) Health departments may
contact exposed travelers more quickly
and (2) health departments may be able
to contact a higher percentage of
exposed travelers. For the first set of
travelers that are contacted earlier with
the final rule than under the status quo,
the cost to both the contacted travelers
and to health departments should be
less than under the status quo. For
measles contacts, earlier follow-up with
public health departments should lead
to more travelers being offered
voluntary measles vaccines within 72
hours. This would potentially reduce
the cost of following up with exposed
travelers at which time health
departments could offer to administer
immune globulin or health departments
may monitor travelers that have been
located after the 72-hour window in

which measles vaccination would
reduce their risk of developing
symptomatic measles. At present, very
few travelers receive post-exposure
prophylaxis, 11/248 or 4.4%.44 In
addition, health departments have
implemented quarantine (usually
voluntary) for unvaccinated, high risk
measles exposures.45 HHS/CDC notes
that measles is not a quarantinable
communicable disease under Federal
regulations, but may be quarantinable
under a State’s authorities. HHS/CDC
also notes that measles vaccine is
recommended for all persons lacking
immunity. Thus, the costs of
vaccination for exposed travelers as part
of the contact investigation may have
been incurred at a later date if travelers’
health care providers recommended
measles vaccination at a more routine
health care visit in the future.46
However, to be conservative, HHS/CDC
includes the full additional cost to
administer such vaccines to persons
contacted.
Among the contacts, HHS/CDC
estimates that approximately 25% (141
contacts per year) cannot be located by

Airlines, USD
$0
0
0

Total
$12,218
0
24,435

public health departments (Table 24),
either because HHS/CDC cannot assign
the contacts to health departments or
because the information provided by
HHS/CDC is not sufficient to enable
health departments to locate contacts
after assignment from HHS/CDC.
Among these contacts, HHS/CDC
assumes that 10% of all contacts (56) are
not located because HHS/CDC cannot
assign contacts to State health
departments due to insufficient data.
For these contacts, health departments
would not incur any contact tracing
costs because such contacts would not
be assigned. HHS/CDC assumes a 15%
improvement from baseline as a result
of this final rule (Table 24). This would
result in 8.5 additional contacts per year
assigned to health departments for
contact tracing. As shown in Table 11,
HHS/CDC estimates that health
departments incur an estimated cost of
$180 per contact. The marginal cost
incurred from this final rule for
additional measles contacts assigned to
health departments would be $180 × 8.5
= $1,530 per year (Table 25).

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

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Description

n

Average contacts per year for measles, (a) ........................................................................................
Estimated number of contacts for which HHS/CDC cannot assign to a health department, (b) =
10% × (a).
44 Nelson K, Marienau K, Schembri C, Redd S.
Measles transmission during air travel, United
States. Travel Medicine and Infectious Disease
(2013) 11, 81e89. 2013;11:81–9.

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45 P Kutty, J Rota, W Bellini, SB Redd, A Barskey,
G Wallace. (2014) Manual for the Surveillance of
Vaccine-Preventable Diseases: Chapter 7 Measles.
http://www.cdc.gov/vaccines/pubs/surv-manual/
chpt07-measles.html Accessed 5/8/2016.

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564
56

Reference
Table 6.
Nelson et al. 2013.47

46 CDC (2015) Epidemiology and Prevention of
Vaccine-Preventable Diseases: Measles. http://
www.cdc.gov/vaccines/pubs/pinkbook/meas.html
Accessed 5/8/2016.

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6951

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

n

Estimated improvement in HHS/CDC’s ability to assign contacts to health department (c) = 15% ×
(b).
Numbers of people who are not currently contacted due to lack of contact information, (d) = (a) ×
25%.
Expected numbers of people who could be contacted with final rule, (e) = (d) × 15% .....................
Among those contacted, 70% would have evidence of measles immunity (f) = (e) × 70% ...............
Among those contacted, 30% may be susceptible to measles (g) = (e) × 30% ................................

Reference
8.5

141
21
15
6

Assumption.
Nelson et al. 2013.
Assumption.
Nelson et al. 2013 (Table 2).
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) ..............................................................................................................
Additional cost per contact to health department to search for and examine contacts (USD per contact) (h) .................................
Additional cost to health department to search for contacts, total (USD), (i) = (c) × (h) ....................................................................
MMR vaccine price per dose (USD) (j) ...............................................................................................................................................
Vaccine administration (k) ...................................................................................................................................................................
Estimated cost prophylactic measles vaccine per person (USD), (l) = (j) + (k) .................................................................................
Number of individuals who may receive measles vaccine, (g) ...........................................................................................................
Cost of measles vaccination, total (USD) (m) = (g) × (l) ....................................................................................................................
Total additional annual cost to follow up with more contacts (USD), (i) + (m) ...................................................................................

In addition, HHS/CDC assumes that
the final rule could improve health
departments’ abilities to contact 15% of
those who could not be currently
contacted because of insufficient contact
information (21 contacts per year). HHS/
CDC does not have any data to measure
the magnitude of improvement and
applies a range of 10% to 20% to
calculate lower and upper bounds. If
airlines and vessel operators do not
have any additional data besides what is
already transmitted to DHS, there will

8.5
$180
$1,530
$39
$31
$70
6
$420
$1,950

would be adults and would be
vaccinated with the measles-mumpsrubella (MMR) vaccine. The vaccine
price for adults is estimated from the
Vaccines for Children vaccine price
archives (July 2014 and July 2015) 48
based on the public sector price for the
vaccine. Vaccine administration costs
are estimated from Healthcare
Solutions’ 2015 Physicians’ Fee &
Coding Guide (CPT 90471).49 Total costs
resulting from the final rule are
summarized in Table 26.

be very little improvement. Among the
21 additional exposed travelers that
would be contacted, 70% of them (15
per year) are expected to have measles
immunity because they were born
before 1957, had history of measles, or
received one or more doses of measles
vaccine. The remaining 6 travelers per
year without proven measles immunity
would incur additional costs if they are
vaccinated (vaccine costs + vaccine
administration, Table 25).
To be conservative, HHS/CDC
assumes that all 6 exposed travelers

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TABLE 26—MARGINAL IMPACT OF FINAL RULE TO IMPROVE CONTACT INVESTIGATIONS
Marginal cost for measles investigations

Additional
names provided to
health
departments

Addition contacts
reached by
health departments

Number of
travelers provided
post-exposure
prophylaxis

Number of
travelers identified
earlier

Average probability
that contact
is infected

$1,950 ...................................

8.5

21

6

Unknown ...............................

0.0035–0.0095

In the absence of interventions by
public health departments, travelers
infected with measles during
international travel would be as likely
as any other individuals to spark a
measles outbreak. In the absence of
HHS/CDC efforts to retrieve and
transmit contact data, public health
departments would not be able contact
travelers to offer post-exposure
prophylaxis and/or to recommend self-

monitoring for potential measles
symptoms.
For measles in 2011, 16 outbreaks
occurred leading to 107 cases. An
outbreak was defined based on 3 or
more cases in a cluster.50 The remaining
113 cases reported in 2011 resulted in
one or two cases per cluster. Thus, the
probability that any individual measles
index case leads to an outbreak was
between 16/(16+113) = 12.4% and 16/

(16+57) = 20.1%. The lower bound
represents an assumption that all of the
113 cases unassociated with outbreaks
of 3 or more cases occurred in clusters
with just one case each. The upper
bound represents a scenario with 56
clusters of two cases each with one
cluster with one case. Thus, the
probability that any individual measles
case could spark an outbreak of 3 or
more cases is 12.4% to 20.1%. The

48 http://www.cdc.gov/vaccines/programs/vfc/
awardees/vaccine-management/price-list/
archive.html Accessed 5/2/2016.

49 InGauge Healthcare Solutions. 2015 Physicians’
Fee & Coding Guide. Atlanta GA2013.
50 Ortega-Sanchez IR, Vijayaraghavan M, Barskey
AE, Wallace GS. The economic burden of sixteen

measles outbreaks on United States public health
departments in 2011. Vaccine. 2012;32(11).

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average cost to public health
departments per measles outbreak is
$250,000 and the upper bound cost is $1
million.51
HHS/CDC assumes that the
probability that a measles case resulting
from exposure during travel and that is
not contacted by a public health
department is as likely as any other
measles case to initiate a measles
outbreak of 3 or more cases, which
occurs at an approximate probability of
12.4% to 21.9%. The average cost to
health departments is $250,000 for each
of these outbreaks and the average
outbreak size is about 7 cases (107
cases/16 outbreaks).

The estimated illness costs for
measles are $300 ($86–$515) for
outpatient cases and $24,500 ($3,900–
$45,052) for inpatient cases.52 The
probability of hospitalization is
estimated to be 44.3%.53 A range of
hospitalization rates is estimated based
on 50% to 150% of this base case
estimate (22%–66%). The measles case
fatality rate has been estimated to be
0.2%.54 HHS/CDC assumes that the
value of statistical life is $9.4 million
(range $4.3 million to $14.2 million).
This value is an estimate of the average
willingness to pay to reduce one’s
mortality risk by a small increment not
an estimate of the value of any specific

person’s life. For example if 1,000
people were willing to pay $1,000 each
to reduce their risk of death by 1/1,000,
the value of statistical life would be
equal to $1,000/0.001 change in risk of
death = $1 million. Alternatively 1,000
people each experiencing a mortality
risk reduction of 0.001 would
correspond to 1,000 people × 0.001
mortality risk reduction = 1 statistical
life; 1,000 people each willing to pay
$1,000 = 1,000 × $1,000 = $1 million to
avert that one statistical death. Using
these estimates, the average illness costs
associated with a measles case (Table
27) is about $30,000 ($9,500 to $58,000).

TABLE 27—ESTIMATED ILLNESS AND MORTALITY COSTS PER MEASLES CASE
Best estimate
Outpatient cost, a ......................................................................................................
Inpatient cost, b .........................................................................................................
Hospitalization rate, c ................................................................................................
Case fatality rate, d ...................................................................................................
VSL, e ........................................................................................................................
Total cost per case (b × c + a × (1¥c) + d × e) .......................................................

The estimated number of measles
cases that will occur in contacts
exposed during travel (3.6 to 10.1) can
be multiplied by the probability of an
outbreak with 3 or more cases (12.4% to
21.7%) to estimate the expected number

Lower bound

$300
$24,500
44.30%
0.2%
$9,400,000
$29,821

of outbreaks in the absence of public
health intervention to conduct contact
investigations in exposed travelers. For
each outbreak, HHS/CDC assumes that
an average of 6 additional cases occur
with associated morbidity and mortality

$86
$3,943
22.0%
0.2%
$4,300,000
$9,535

Upper bound
$515
$45,052
66.0%
0.2%
$14,200,000
$58,309

costs. The estimated costs of measles
outbreaks in the absence of contact
investigations for exposed travelers is
presented in Table 28.

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

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Estimated number of measles cases among contacts, a .........................................
Probability of measles outbreak, b ............................................................................
Number of additional cases per outbreak, c .............................................................
Estimated number of outbreaks, d = a × b ...............................................................
Estimated number of outbreak cases, e = a × b × c ................................................
Estimated health department costs per outbreak, f ..................................................
Estimated health department costs, g = f × d ...........................................................
Average cost per case, h ..........................................................................................
Estimated illness costs, I = h × e ..............................................................................
Estimated total costs, g + i ........................................................................................

Lower bound

6.85
17
6
1.18
7.06
250,000
293,989
29,821
210,406
504,395

3.6
12.4
6
0.45
2.68
250,000
111,607
9,535
25,539
137,146

Upper bound
10.1
21.9
6
2.22
13.29
250,000
553,758
58,309
774,944
1,328,703

HHS/CDC has not received any
reports of large measles outbreaks
associated with measles cases in
patients exposed during travel and
contacted by State or local public health
departments. As a result, HHS/CDC
believes that when measles cases occur
in contacts reached by health
departments, the probability of an

outbreak is significantly mitigated by
pre-warning of exposure before disease
outset. Given that HHS/CDC estimates
that health departments are able to
reach approximately 75% of contacts
under the status quo, HHS/CDC assumes
that the risk of an outbreak has been
reduced by at least 60% under the status
quo. Further, HHS/CDC assumes that

the provisions in the final rule further
improve health departments’ ability to
prevent measles outbreaks in cases that
occur among travelers exposed during
flights. A modest improvement of 15%
is assumed (range 10%–20%) resulting
in estimated benefits of about $45,000
($8,000 to $159,000) in Table 29.

51 Ortega-Sanchez IR, Vijayaraghavan M, Barskey
AE, Wallace GS. The economic burden of sixteen
measles outbreaks on United States public health
departments in 2011. Vaccine. 2012;32(11).
52 Zhou F, Shefer A, Wenger J, Messonnier M,
Wang LY, Lopez A, et al. Economic Evaluation of
the Routine Childhood Immunization Program in

the United States, 2009. Pediatrics. 2014;133:577–
85.
53 Mason WH, Ross LA, Lanson J, Wright HT.
Epidemic measles in the postvaccine era: evaluation
of epidemiology, clinical presentation, and
complications during an urban outbreak. Pediatr
Infect Dis J. 1993;12:42–8.

54 Centers for Disease Control and Prevention.
Epidemiology and Prevention of VaccinePreventable Diseases, 13th Edition—Measles April
2015 http://www.cdc.gov/vaccines/pubs/pinkbook/
downloads/meas.pdf. Accessed 6/13/2016.

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

total costs without intervention, j = g + i ..................................................
effectiveness of outbreak prevention baseline, k .....................................
cost of measles outbreaks under baseline, j × (1¥k) .............................
effectiveness of outbreak prevention with final rule, l ..............................
cost of measles outbreaks with final rule, m = j × (1¥l) .........................
benefit associated with final rule, n = j¥m ..............................................

Marginal Impact on Tuberculosis
Investigations
Although measles is not a
quarantinable disease and tuberculosis
is a quarantinable disease, HHS/CDC’s
and health departments’ approaches to
contact investigations are relatively
similar. However, HHS/CDC may issue
isolation orders for individuals with
active tuberculosis in some situations,
but would not have authority to issue
isolation (or quarantine orders) for
individuals with measles. The expected
benefits associated with reduced
tuberculosis morbidity and mortality of
contact investigations for exposed
travelers are based on a previous
analysis, which estimated a return on
investment of $1.01 to $3.20 for the
baseline situation in which an estimated
19% of exposed contacts are found to

Lower bound

$504,395
60%
$201,758
69%
$156,363
$45,396

Upper bound

$137,146
60%
$54,858
66%
$46,630
$8,229

$1,328,703
60%
$531,481
72%
$372,037
$159,444

treatment and the remaining 26% start,
but do not complete treatment. The
authors estimated that the risk of
progression to active tuberculosis is
reduced by 80% for those that complete
treatment. The authors assumed that
there is no effect for individuals that
start, but do not complete treatment.
HHS/CDC assumes that under the status
quo that health departments are able to
contact 75% of exposed travelers (based
on the reported outcomes from measles
contact investigations).57
The costs to provide treatment for
latent tuberculosis infections under the
status quo are summarized in Table 30.
In total, the costs are almost $900,000
including about $720,000 to locate
contacts and about $180,000 to provide
treatment to individuals with latent
tuberculosis infection.

have latent tuberculosis infection.55 The
contact rate for exposed tuberculosis
contacts is probably higher than for
measles because the vast majority of
tuberculosis contacts are exposed
during international travel as exposed to
measles contacts, which are
approximately evenly divided between
interstate and international travel.
The estimated costs to provide testing
and treatment to contacts that test
positive for latent tuberculosis infection
are estimated to be $1,044 for infected
contacts that complete a full course of
treatment and $591 for infected contacts
that discontinue treatment after 30
days.56 Following the assumptions in
the article, an estimated 28% of persons
who test positive for latent tuberculosis
infection do not start treatment. An
estimated 46% start and complete

TABLE 30—BASELINE ESTIMATED COSTS TO CONDUCT TUBERCULOSIS CONTACT INVESTIGATIONS AND TO PROVIDE
TREATMENT

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Number of
contacts

Estimated cost
per contact

Estimated cost

Notes

Estimated cost of contact investigations ........

1,995

$360

$718,092

Estimated number of contacts reached by
health departments (75%).
Estimated number of contacts reached by
health departments and have latent TB infection (19% of 75%).
Number of contacts that never start treatment
(28%).
Number of contacts that complete treatment
(46%).
Number of contacts that start, but not compete treatment, (26%).

1,496

NA

........................

284

NA

........................

79.6

0

0

28% of 284 contacts with LTBI.

130.8

1,044

136,506

46% of 284 contacts with LTBI.

73.9

591

43,677

26% of 284 contacts with LTBI.

Total cost .................................................

........................

........................

898,275

The benefits associated with
tuberculosis contact investigations are
estimated from a published article,
which reported a range of $1.01 to
$3.20. This analysis did not include the
potential benefits from reduced onward

transmission of tuberculosis among
averted cases, potentially resulting in a
conservative estimate of the return on
investment. The formula used to derive
estimated benefits from the return on
investment (ROI) is Estimated Benefits =

55 Coleman M, Marienau K, Marano N, Marks S,
Cetron M, Dis TMI. Economics of United States
Tuberculosis Airline Contact Investigation Policies.
Travel Medicine and Infectious Disease.
2014;12:63–71.

56 Coleman M, Marienau K, Marano N, Marks S,
Cetron M, Dis TMI. Economics of United States
Tuberculosis Airline Contact Investigation Policies.
Travel Medicine and Infectious Disease.
2014;12:63–71.

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Number of contacts from Table 13 and cost
per contact from Table 11.
Estimated at 75% similar to measles from
Table 24.
Estimated 19% of contacts have LTBI (Table
13).

Estimated Costs × ROI + Estimated
Costs. The estimated benefits are $2.6
million and are shown in Table 31
(range: $1.8 million to $3.8 million).

57 Nelson K, Marienau K, Schembri C, Redd S.
Measles transmission during air travel, United
States, December 1, 2008–December 31, 2011.
Travel Med Infect Dis. 2013;11(2):81–9.

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TABLE 31—BASELINE ESTIMATED COSTS AND BENEFITS FOR TUBERCULOSIS CONTACT INVESTIGATIONS, 2015 USD
Best estimate
Estimate costs for contact investigations and
treatment.
Return on investment from tuberculosis contact investigations.
Estimated benefits ..........................................

The provisions in the final rule
should result in a small increase
(assumed baseline of 10%, range: 5–
15%) in the number of contacts reached
by health departments and offered
treatment for latent tuberculosis
infection. This estimated improvement
is less than that assumed for measles
because tuberculosis usually involves a

Lower bound

Upper bound

$898,260

$898,260

$898,260

1.91

1.01

3.20

2,613,936

1,805,502

3,772,691

much longer period of latent infection
prior to active disease; thus,
tuberculosis contact investigations are
less time sensitive relative to measles
contact investigations. The estimated
costs associated with this marginal
improvement to reach more contacts can
be estimated by multiplying the costs of
providing latent tuberculosis ($180,000)

Notes
Table 30.
Coleman et al.
= Cost × ROI + Costs.

by this range of improvement (5%–15%)
as shown in Table 32. This results in
marginal increased costs associated with
the final rule of $18,000 (range: $9,000
to $27,000). The estimated benefits
(Table 32) associated with the final rule
are $52,000 (range: $18,000 to
$114,000).

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

Lower bound

Upper bound

Baseline contact investigation costs ...............
Baseline latent tuberculosis treatment costs ..

$718,080
$180,180

$718,080
$180,180

$718,080
$180,180

Estimated improvement in health departments’ abilities to contact exposed travelers.
Estimated increased cost for latent tuberculosis treatment under final rule.
Estimated costs under final rule .....................

10%

5%

15%

$18,018

$9,009

$27,027

$916,278

$907,269

$925,287

$1.91
$2,666,368

$1.01
$1,823,610

$3.20
$3,886,204

$18,018

$9,009

$27,027.

$52,432

$18,108

$113,513

Estimated ROI .................................................
Estimated benefits for final rule ......................
.
Estimated costs associated with final rule ......
Estimated benefits associated with final rule

Total Costs and Benefits for Measles and
Tuberculosis Contact Investigations
The total costs for measles and
tuberculosis contact investigation

activities are estimated by summing the
costs and benefits of measles contact
investigations (Table 29) and
tuberculosis contact investigations

Notes
Table 30 costs for latent tuberculosis treatment and testing.
Assumed.
Estimated cost for improvement in contact
rate as result of final rule.
Estimated baseline cost + increased cost as
result of final rule.
Table 30.
= Cost × ROI + Costs.
Calculated from the difference in costs for
the final rule—Baseline costs.
Calculated from the difference in benefits for
the final rule—Baseline benefits.

(Table 32). The results are summarized
in Table 33.

TABLE 33—CHANGES IN MEASLES AND TUBERCULOSIS CONTACT INVESTIGATIONS COSTS AND BENEFITS RELATIVE TO
BASELINE, 2015 USD
Best estimate
Final rule benefits ......................................................................................................
Final rule costs ..........................................................................................................

Lower bound

$97,828
19,968

Upper bound

$26,337
10,959

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Note: This table includes the sum of results in Tables 29 and 32.

Total Annual 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) Leading
to Improved Contact Investigations and
Health Outcomes for Measles and
Tuberculosis
The total quantified benefits (Table
34) resulting from the improvement of

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the quality and timeliness of traveler
contact data or the improvement of
illness reporting is summarized by
summing the improved efficiency for
HHS/CDC to provide contact data to
health departments and improved
efficiency for health departments to
contact exposed travelers (Table 23) and
the reductions associated with measles

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and tuberculosis morbidity and
mortality (Table 33).

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28,977

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TABLE 34—TOTAL ANNUAL COSTS AND BENEFITS ASSOCIATED WITH IMPROVED EFFICIENCY PUBLIC HEALTH RESPONSE
ACTIVITIES, 2015 USD
Best estimate
Final rule benefits ......................................................................................................
Final rule costs ..........................................................................................................

The benefits and costs associated with
improved effectiveness of contact
investigations (Table 34) can be
combined with the increased costs to

Lower bound

$110,045
19,968

airlines, vessel operators, DOT/FAA,
and HHS/CDC to submit and respond to
illness reports or to provide more timely
and complete traveler contact data for

$26,337
10,959

Upper bound
$297,393
28,977

manifest requests (Table 19) to estimate
the total annual costs and benefits of the
final rule (Table 35).

TABLE 35—TOTAL ANNUAL COSTS AND BENEFITS OF THE FINAL RULE, 2015 USD
Best estimate
Final rule benefits ......................................................................................................
Final rule costs ..........................................................................................................

Other Diseases (Besides Measles and
Tuberculosis)

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HHS/CDC does not have sufficient
data to quantify the health impact of
contact investigations for pertussis,
rubella, varicella (vessels only), viral
hemorrhagic fevers (including Ebola),
MERS, or SARS. HHS/CDC attempts to
continuously update its contact
investigation protocols based on
available evidence. In the past few
years, HHS/CDC has stopped requesting
data to conduct mumps contact
investigations 58 and has modified its
protocol to reduce the number of
tuberculosis contacts investigated.59
Experience from interstate flight
contact investigations suggest that
travelers may want to know when they
have been exposed to communicable
diseases during flights. The first Ebola
contact investigation conducted in the
United States occurred in October, 2014,
and found that 60 travelers out of 164
had no contact information on the
manifest that was provided by the
airline. A second request was made to
the airline after it was announced to the
media that the airline had contacted
over 800 travelers, including travelers
who had flown on the same plane
subsequent to the flight with the Ebola.
At that time the airline was able to
provide HHS/CDC more complete
information for all travelers.
It is likely that the need for CDC to
put out media requests for travelers to
58 Nelson KR, Marienau KJ, Barskey AE, Schembri
C. No evidence of mumps transmission during air
travel, United States, November 1, 2006–October
31, 2010. Travel Medicine and Infectious Disease.
2012;10:165–71.
59 Marienau KJ, Cramer EH, Coleman MS, Marano
N, Cetron MS. Flight related tuberculosis contact
investigations in the United States: comparative risk
and economic analysis of alternate protocols. Travel
Med Infect Dis. 2014;12(1):54–62.

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$110,045
32,622

contact the Agency created a level of
fear in the general population that may
not have been necessary if better contact
data were available. In addition, this
fear may have led to non-health costs
(such as fear of airplane travel) that
would have been mitigated if the
Agency were able to contact all
passengers without the media request.
However, when HHS/CDC solicited
public comment about perceived
willingness to pay to be contacted in the
event of an exposure to a communicable
disease during, HHS/CDC only received
a few public comments, all of which
indicated that they had zero willingness
to pay in the event of an exposure to a
communicable disease.
In summary, improved alignment
between regulatory text and HHS/CDC’s
publicly available guidance should
reduce compliance costs for airlines and
vessel operators while improving HHS/
CDC’s ability to respond to public
health threats associated with
international and interstate travel. To
the extent that airlines and vessel
operators improve responsiveness to
HHS/CDC traveler data requests, HHS/
CDC may become better able to respond
to infectious diseases threats and (1)
reduce case-loads during infectious
disease outbreaks, (2) reduce public
anxiety during disease 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
consequences like Ebola. HHS/CDC will
make all reasonable efforts to work with
DHS/CBP via CDC’s liaison located at
the National Targeting Center, as
provided through internal
Memorandum of Understanding, to

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Lower bound
$26,337
10,959

Upper bound
$297,393
430,839

search and obtain data collected from
their APIS and PNR data sets prior to
contacting airlines or vessel operators
with duplicate data requests.
Analysis of Alternatives
Traveler Contact Data Alternatives
For the less restrictive alternative,
HHS/CDC assumes that the process of
requesting contact data from airlines
and vessel operators would be
discontinued. Thus, the cost to provide
such data can be modeled as a benefit
to airlines and vessel operators equal to
their costs under the baseline. For the
more restrictive alternative, HHS/CDC
assumes that suspension of entry may
be implemented for travelers from
countries experiencing widespread
transmission of quarantinable
communicable diseases. HHS/CDC
notes that suspension of entry would
not be considered for non-quarantinable
diseases (refer to Table 4). Specifically,
HHS/CDC assumes that persons
traveling from affected countries are not
permitted entry to the United States
unless such persons spend an amount of
time equivalent to the incubation period
for the target disease at a location where
they are not at risk of exposure and are
also screened for symptoms of the
disease prior to travel to the United
States. During the 2014–2016 Ebola
epidemic, travelers from Liberia, Sierra
Leone or Guinea would not be able to
enter until 21 days in another country
or within the affected country but
separated from others in a manner that
excludes the possibility of interaction
with potentially infected individuals.
On average, HHS/CDC has conducted
about 2.5 contact investigations for viral
hemorrhagic fevers and MERS
coronavirus over the past six years.
HHS/CDC assumes that if suspensions

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of entry may be in place, some fraction
of these contact investigations may not
be conducted.
Thus, the cost to airlines and vessel
operators to provide traveler contact
data would decrease for the less

for 2.5 investigations ($12,338 vs.
$12,654) and calculating the cost
reduction of doing 2.5 fewer contact
investigations each year ($1,898) (Table
36).

restrictive alternative resulting in
estimated benefits of $75,924. For the
more restrictive scenario, the costs are
relatively similar as for the final rule
except for the reduction in cost
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
Baseline
Baseline number of contact investigations ......................................................

Less
restrictive
alternative a

Final rule

More
restrictive
alternative b

100

100

0

97.5

NA
NA
NA

$12,654
0
25,308

$0
0
0

$12,338
0
24,802

NA
NA
NA

$0
0
0

$75,924
75,924
75,924

$1,898
1,898
1,898

Costs
Best estimate ...................................................................................................
Lower bound ....................................................................................................
Upper bound ....................................................................................................
Benefits
Best estimate ...................................................................................................
Lower bound ....................................................................................................
Upper bound ....................................................................................................

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
HHS/CDC examines two alternatives:
A less restrictive alternative in which
HHS/CDC relaxes its regulatory
authorities to make illness reporting
compliance voluntary rather than
compulsory. Under the more restrictive
alternative HHS/CDC may enforce the
current requirement that airlines report
all persons with communicable diseases
to local health departments in addition
to reporting to HHS/CDC.
The current status quo for illness
reporting is summarized in Tables 9 and
10. Reports can be subdivided by
illnesses that fit (1) the ill person
definition specified in current 42 CFR
71.1, (2) reports based on HHS/CDC’s
guidance for airlines and vessel
operators, or (3) illness reports
unrelated to current regulation or
guidance. As shown in Table 9, only
about 53 out of 175.4 (30%) illness
reports during air travel appear to be
based on symptoms included in the
current definition of an ill person in
existing 71.1. The remaining 70% of

reports are based on symptoms
currently requested by HHS/CDC, but
not required. In addition, only 67% of
illness reports during air travel require
HHS/CDC response and follow-up. In
comparison, illness reports from vessels
are much more likely to be based on the
definition of ill person as defined in
current 71.1 (174.6/218.6 or 80%). In
addition, a much greater proportion of
reports require an HHS/CDC follow-up
(>95%). This may result from
differences in the types of illnesses
observed on vessels relative to aircraft
or because of the presence of medical
officers on cruise vessels, who may be
better able to identify communicable
diseases of public health concern during
travel relative to aircraft personnel.
If illness reporting were entirely
voluntary, HHS/CDC assumes the
number of reports (both info-only and
reports requiring response) would
decrease by 50% from both airlines and
vessel operators (refer to Tables 9 and
10) from the current status quo. HHS/
CDC does not have any data to estimate

the magnitude of decrease in reporting.
HHS/CDC believes that both HHS/CDC
and DOT/FAA would continue to
maintain their current infrastructure to
effectively respond to public health
emergencies either on aircraft or vessels.
Thus, relative to the status quo, the
primary impact of voluntary reporting
would be reduced incremental time
costs for pilots in command and masters
of vessels, travelers, DOT/FAA, and
HHS/CDC, especially for info-only
illness reports. This 50% reduction in
illness reporting would generate
benefits from cost reductions for airlines
and vessel operators, HHS/CDC,
travelers, and DOT/FAA of
approximately $14,700 (Tables 37 and
38).
The adverse impact for the less
restrictive alternative relative to the
baseline would be reduced capacity for
HHS/CDC to respond quickly to
communicable disease threats occurring
during travel. This is analyzed in a
subsequent section on the health impact
of regulated activities.

TABLE 37—LESS RESTRICTIVE ALTERNATIVE FOR ILLNESS REPORTING
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[Effect on info-only reports, 2015 USD]
Change in
number of
info-only
reports

Employee type

Aircraft:
Aircraft Pilots or Copilots ..........................................

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Amount
of time
required
per report
(min)

60

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Estimated
wage rate
(per hr.)

2

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$57.35

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Overhead
multiplier
(%)

100

Estimated
benefit
(cost reduction)

$229

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TABLE 37—LESS RESTRICTIVE ALTERNATIVE FOR ILLNESS REPORTING—Continued
[Effect on info-only reports, 2015 USD]
Amount
of time
required
per report
(min)

Change in
number of
info-only
reports

Employee type

Estimated
wage rate
(per hr.)

Overhead
multiplier
(%)

Estimated
benefit
(cost reduction)

CDC employee .........................................................
DOT/FAA employees ................................................
Traveler .....................................................................

60
60
60

60
26
10

39.83
70.57
23.23

100
100
0

4,780
3,670
232

Air total ..............................................................
Vessels:
Captains, Mates, and Pilots of Water Vessels .........
CDC employee .........................................................
Traveler .....................................................................

........................

........................

........................

........................

8,911

6
6
6

2
60
10

39.95
39.83
23.23

100
100
0

16
478
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
of time
required
per report
(min)

Change in
number of
info-only
reports

Employee type

Aircraft:
Aircraft pilots or copilots ...........................................
CDC employee .........................................................
DOT/FAA employee ..................................................
Traveler .....................................................................

Estimated
wage rate
(per hr.)

Overhead
multiplier
(%)

Estimated
benefit
(cost reduction)

29
29
29
29

2
0
26
60

$57.35
39.83
70.57
23.23

100
100
100
0

$111
1,774
674

Total ...................................................................
Vessels:
Captains, mates, and pilots (masters) of vessels ....
CDC employee .........................................................
Traveler .....................................................................

........................

........................

........................

........................

2,558

104
104
104

2
0
60

39.95
39.83
23.23

100
100
0

277
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).

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Under the more restrictive alternative,
HHS/CDC would require duplicate
illness reporting both to HHS/CDC and
to local health departments with
jurisdiction upon arrival for interstate
flights and voyages. This alternative is
based upon the existing regulatory text
under 42 CFR 70.4. HHS/CDC assumes
that 50% of illness reports occur during
interstate (relative to international) air
travel and that 15% of maritime illness

reports occur during interstate travel.
The time required for pilots in
command and masters of vessels is
assumed to be about 4 minutes. This
duration is greater than the amount of
time estimate for reporting to HHS/CDC
because pilots in command and masters
of vessels may have to search for contact
information for local health departments
and because local health departments
may have less experience dealing with

illness reports than HHS/CDC. The costs
to airlines and vessel operators is
estimated to be $848 per year (Table 39).
Since HHS/CDC would coordinate
responses to illness reports with local
health departments under the status
quo, there are no additional costs or
benefits to requiring duplicative reports
to local health departments. These costs
would be added to the costs of the
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

Employee type

Aircraft pilots or copilots ......................................................

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(min)

Change in
number of
info-only
reports

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per hr.)
4

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(%)
100

Estimated
cost
($2015 USD)
$673

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TABLE 39—MORE RESTRICTIVE ALTERNATIVE (ILLNESS REPORTING IN DUPLICATE TO HHS/CDC AND TO LOCAL HEALTH
DEPARTMENTS), 2015 USD—Continued
Amount
of time
required
per report
(min)

Change in
number of
info-only
reports

Employee type

Estimated
wage rate
(2015 USD
per hr.)

Overhead
multiplier
(%)

Estimated
cost
($2015 USD)

Captains, mates, and pilots (masters) of vessels ...............

33

4

39.83

100

175

Total ..............................................................................

........................

........................

........................

........................

848

The total costs and benefits associated
with the more and less restrictive illness

reporting scenarios as compared to the
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 ..................................................................................................................................
Vessels .................................................................................................................................
Total ...............................................................................................................................
Less Restrictive Alternative: a
Aircraft ..................................................................................................................................
Vessels .................................................................................................................................

$0
0

$0
0

$375,751
802

0

0

376,554

0
0

0
0

0
0

Total ...............................................................................................................................
More Restrictive Alternative:
Aircraft ..................................................................................................................................
Vessels .................................................................................................................................

0

0

0

673
175

673
175

376,424
978

Total ...............................................................................................................................

848

848

377,402

0
0

0
0

0
0

0

0

0

11,469
3,210

11,469
3,210

11,469
3,210

Total ...............................................................................................................................
More Restrictive Alternative:
Aircraft ..................................................................................................................................
Vessels .................................................................................................................................

14,679

14,679

14,679

0
0

0
0

0
0

Total ...............................................................................................................................

0

0

0

Benefits
Final Rule:
Aircraft ..................................................................................................................................
Vessels .................................................................................................................................
Total ...............................................................................................................................
Less Restrictive Alternative: a
Aircraft ..................................................................................................................................
Vessels .................................................................................................................................

a For

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

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The total costs of the alternatives
compared to the final rule are
summarized in Table 41 and include the

costs of the change to the definition of
an ‘‘ill person’’ and the codification of
the requirement for airlines to provide

passenger contact data for the final rule,
the less restrictive alternative, and the
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)
Best estimate

Lower bound

Upper bound

Costs
Final Rule:
71.4 and 71.5 Passenger data collection .............................................................................

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

12,654

0

401,862

0
0

0
0

0
0

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

0

0

0

12,338
848

0
848

24,802
377,402

Total costs .....................................................................................................................

13,186

848

402,204

0
0

0
0

0
0

0

0

0

75,924
14,679

75,924
14,679

75,924
14,679

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

90,603

90,603

90,603

1,898
0

1,898
0

1,898
0

Total benefits .................................................................................................................

1,898

1,898

1,898

Benefits
Final Rule:
71.4 and 71.5 Passenger data collection .............................................................................
70.1 and 71.1 Change in definition of an ‘‘ill person’’ ..........................................................
Total benefits .................................................................................................................
Less Restrictive Alternative:
71.4 and 71.5 Passenger data collection .............................................................................
70.1 and 71.1 Change in definition of an ‘‘ill person’’ ..........................................................

Staff Time for Contact Investigations
For the less restrictive alternative, the
change relative to baseline is equal to
the current cost of performing Cis for
travelers exposed on international
flights ($745,000 each for HHS/CDC and
local health departments or a total of
about $1.5 million, Table 20). Under the

more restrictive alternative (i.e.
implementing travel restrictions
immediately upon evidence of
widespread transmission of viral
hemorrhagic fevers, SARS or MERS, the
costs of these contact investigations are
assumed to be avoided (potential cost
reductions of about $29,000 each to

HHS/CDC and health departments or
$58,000 in total). The benefits of the
avoided contacted investigations are
then added to the cost savings for the
remaining contacts assuming a 0–3%
improvement in HHS/CDC efficiency
and a 0–2% improvement in PHD
efficiency as for the final rule (Table 42).

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

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Final Rule:
Best estimate ........................................................................................................................
Lower bound .........................................................................................................................
Upper bound .........................................................................................................................
Less Restrictive Alternative:
Best estimate ........................................................................................................................
Lower bound .........................................................................................................................
Upper bound .........................................................................................................................
More Restrictive Alternative:
Best estimate ........................................................................................................................
Lower bound .........................................................................................................................
Upper bound .........................................................................................................................

Measles Contact Investigation Health
Outcomes—Alternatives
For this analysis, under the less
restrictive alternative, HHS/CDC
assumes that no contact investigations
are performed for measles. As a result,

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the probability of onward transmission
from 3.6 to 10.1 measles patients
exposed each year during travel greatly
increases and is modeled based on the
estimated costs of measles in the
absence of intervention $504,000 (range:

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PHD
benefits

Total

$7,331
0
14,661

$4,887
0
9,774

$12,218
0
24,435

745,380
745,380
745,380

745,380
745,380
745,380

1,490,760
1,490,760
1,490,760

36,671
29,340
44,001

34,227
29,340
39,114

70,898
58,680
83,115

$137,000 to $1.3 million) (Table 28).
Measles outcomes for the more
restrictive alternative are the same as
estimated for the final rule since there
is no difference in measles efforts
between the final rule and the more

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restrictive alternative because measles is
not a quarantinable disease. The
comparative benefits relative to the

status quo baseline are shown in Table
43. For the less restrictive alternative,
costs are estimated based on an increase

in measles outbreak costs relative to the
baseline.

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 .....................................................................................................................................
Less Restrictive Alternative .........................................................................................................
More Restrictive Alternative .........................................................................................................

$45,396
0
45,396

$8,229
0
8,229

$159,444
0
159,444

1,950
201,758
1,950

1,950
54,858
1,950

1,950
531,481
1,950

Costs
Final Rule .....................................................................................................................................
Less Restrictive Alternative a .......................................................................................................
More Restrictive Alternative .........................................................................................................

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
Health Outcomes—Alternatives
Under the less restrictive alternative,
tuberculosis contact investigation are no
longer conducted for persons exposed
during travel. Relative to the baseline,
there are neither costs to conduct such
investigations (resulting in benefits of

about $180,000 to forego providing
treatment for latent tuberculosis
treatment) or benefits associated with
reduced tuberculosis morbidity and
mortality. Relative to the baseline, the
estimated cost of increased tuberculosis
morbidity and mortality is estimated to
be $2.6 million (range: $1.8 million to
$3.8 million). Under the more restrictive

alternative in which suspension of entry
is enforced in response to quarantinable
communicable disease outbreaks, there
is no change relative to the final rule
results because it is unlikely that a
tuberculosis outbreak would cause
suspension of entry. Results are
summarized in Table 44.

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 ........................................................
Less Restrictive Alternative ............................

$52,432
180,180

18,108
180,180

113,513
180,180

More Restrictive Alternative ............................

52,432

18,108

113,513

Table 32.
Assumed to be the cost to provide LTBI
treatment under the baseline (Table 32).
The more restrictive alternative has the
same effect on TB contact investigations
as the final rule.

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Costs
Final Rule ........................................................
Less Restrictive Alternative ............................

18,018
$2,613,936

9,009
$1,805,502

27,027
$3,772,691

More Restrictive Alternative ............................

18,018

9,009

27,027

The total costs and benefits of changes
in health outcomes associated with the
more and less restrictive alternatives
compared to the provisions included in
the Final Rule are summarized in Table
45. The less restrictive alternative in

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which contact investigations are no
longer pursued shows a large increase in
costs relative to the baseline and in
comparison to the provisions in the
final rule. In addition, there are some
benefits, but not enough to offset the

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Table 32.
Estimated based on the benefits of avoided
TB morbidity and mortality resulting from
contact investigations under the baseline.
The more restrictive alternative has the
same effect on TB contact investigations
as final rule.

costs. The more restrictive alternative
does not change health outcomes for
tuberculosis and measles in comparison
to the final rule.

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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 .....................................................................................................................................
Less Restrictive Alternative .........................................................................................................
More Restrictive Alternative .........................................................................................................

$97,828
180,180
97,828

$26,337
180,180
26,337

$272,958
180,180.
272,958

19,968
2,815,694
19,968

10,959
1,860,360
10,959

28,977
4,304,172
28,977

Costs
Final Rule .....................................................................................................................................
Less Restrictive Alternative .........................................................................................................
More Restrictive Alternative .........................................................................................................
Note: This table includes the sum of results in Tables 43 and 44.

The total quantified costs and benefits
(Table 46) resulting from the additional
data provision and timeliness of traveler
contact data or the improvement of
illness reporting for alternatives to the

provisions included in the final rule is
summarized by summing the improved
efficiency for HHS/CDC to provide
contact data to health departments and
improved efficiency for health

departments to contact exposed
travelers (Table 42) and the reductions
associated with measles and
tuberculosis morbidity and mortality
(Table 45).

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

Lower
bound

Upper
bound

Benefits
FR ................................................................................................................................................
Less Restrictive Alternative .........................................................................................................
More Restrictive Alternative .........................................................................................................

$110,045
1,670,940
168,725

$26,337
1,670,940
85,017

$297,393
1,670,940
356,073

19,968
2,815,694
19,968

10,959
1,860,360
10,959

28,977
4,304,172
28,977

Costs
FR ................................................................................................................................................
Less Restrictive Alternative .........................................................................................................
More Restrictive Alternative .........................................................................................................

The total annual costs and benefits for
the alternatives compared to the final
rule are summarized in Table 47.
Although the benefits for the more
restrictive alternative in which
suspensions of entry would be
implemented for countries experiencing
outbreaks of quarantinable
communicable diseases are greater than
the quantified annual benefits of the

final rule, the costs are underestimated.
HHS/CDC does not have sufficient data
to quantify the long term costs of
implementing suspensions of entry for
countries experiencing outbreaks of
quarantinable diseases; however, such
costs would probably exceed the
$100,000 in estimated benefits
associated with suspensions of entry
that may result in fewer contact

investigations for quarantinable diseases
such as Ebola and MERS. Refer to the
appendix for some details of potential
costs associated with hypothetical
suspensions of entry for the countries
with widespread Ebola transmission
during the 2014–2016 global Ebola
epidemic.

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

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Benefits
Final Rule .....................................................................................................................................
Less Restrictive Alternative .........................................................................................................
More Restrictive Alternative .........................................................................................................

$110,045
1,780,524
170,623

$26,337
1,780,524
86,915

$297,393
1,780,524
357,971

32,622
2,815,694
33,154

10,959
1,860,360
11,807

430,839
4,304,172
431,181

Costs
Final Rule .....................................................................................................................................
Less Restrictive Alternative .........................................................................................................
More Restrictive Alternative .........................................................................................................

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Codification of Current Practice
(Multiple Provisions in Final Rule)
HHS/CDC does not expect that most
of the provisions included in the final
rule will result in measurable changes
relative to the economic baseline. The
primary purpose of the provisions
summarized in list below is to explain
how HHS/CDC interprets its current
statutory and regulatory authority under
the Public Health Service Act (42 U.S.C.
264, 265) and regulations at 42 CFR
parts 70 and 71. HHS/CDC is grouping
the complementary provisions in part
70 and part 71 in the list below, when
they align, to facilitate public review of
the current provisions as well as those
included in the final rule. These
changes are intended to clarify the
agency’s standard operating procedures
and policies, and due process rights for
individuals. HHS/CDC believes that
such clarity is an important qualitative
benefit of the provisions in this final
rule, but is not able to monetize this
impact in a significant way.
• New Provisions: § 70.5
Requirements relating to travelers under
a Federal order of isolation, quarantine,
or conditional release.
Æ Baseline and Current Regulatory
Provision: § 70.5 Certain communicable
disease; special requirements.
D Without the final rule, HHS/CDC
may issue Federal orders to restrict
travel for persons infected or exposed to
quarantinable communicable diseases.
However, this process is less transparent
and efficient than allowing travel (i.e.
issue travel permits to allow interstate
travel to persons under Federal orders
for diseases not currently identified
under existing 42 CFR 70.5.) Under
current practice, HHS/CDC issues
approximately one Federal order per
year, most frequently for tuberculosis,
which is a disease not included in the
current 70.5.
Æ Change relative to baseline as result
of final rule
D With the final rule, HHS/CDC is
aligning the list of diseases for which
individuals under Federal orders may
be allowed to travel with the
quarantinable communicable diseases
specified in Executive Order. A
potential future qualitative benefit
would be to reduce uncertainty by the
individual subject to the order, carrier
operators, and cooperating health and
law enforcement entities about whether
HHS/CDC could issue a travel permit to
an individual under a Federal order and
quantifiable benefit would be the
avoided cost of potential legal
challenge.
Æ Qualitative benefit/cost of final rule
D Improved transparency for HHS/
CDC’s ability to allow individuals under

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Federal orders to issue travel permits to
allow individuals to travel (interstate).
HHS/CDC may allow persons under
Federal orders to travel interstate for
whom there is greater uncertainty
regarding HHS/CDC restricting their
travel.
Æ Monetized benefit/cost of final rule
D Increased clarity around due
process may result in fewer resources
and time expended by individuals
under orders and HHS/CDC in
disagreements over HHS/CDC’s
authority to issue Federal public health
orders that limit an individual’s
movement. This includes the potential
costs of litigation and associated
activities.
• New provisions: § 70.6
Apprehension and detention of persons
with specific diseases; § 71.32 Persons,
carriers, and things (no change to title)
Æ Baseline and Current Regulatory
Provision:
D Under current 42 CFR 70.6 and
§ 71.32, HHS/CDC has regulatory
authority to apprehend and detain
individuals with quarantinable
communicable diseases.
Æ Change relative to baseline as result
of final rule
D As a result of these new provisions,
the major change would be improved
transparency of HHS/CDC’s regulatory
authority with regard to the issuance of
Federal quarantine, isolation, or
conditional release orders of individuals
traveling interstate.
Æ Qualitative benefit/cost of final rule
D ;Improved transparency and
compliance with Federal orders.
Æ Monetized benefit/cost of final rule
D Increased clarity around due
process may result in fewer resources
and time expended by individuals
under orders, cooperating entities, and
CDC in disagreements over HHS/CDC’s
authority to issue Federal public health
orders that limit an individual’s
movement. This includes the potential
costs of litigation and associated
activities.
• New Provisions: § 70.10 Public
health prevention measures to detect
communicable disease; § 71.20 Public
health prevention measures to detect
communicable disease.
Æ Baseline and Current Regulatory
Provisions: No explicit regulatory
provision.
D In the absence of the final rule and
under existing statutory authority
provided in the Public Health Service
Act and regulatory authority provided
by 42 CFR 70.2 and 71.32(b), HHS/CDC
could still implement public health
measures at locations where individuals
may gather for interstate travel or at U.S.
ports of entry. However, without more

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transparent regulatory authority to
require such measures, travelers may be
less likely to comply, either by refusing
to answer risk assessment questions or
providing false information. This lack of
compliance may require that HHS/CDC,
if it reasonably believes that the
individual is infected with or has been
exposed to a quarantinable
communicable disease, to quarantine,
isolate, or place the individual under
surveillance under 42 CFR 70.6 or 71.32
and 71.33. HHS/CDC has not
implemented public health measures at
locations where individuals may
congregate for the purposes of interstate
travel in at least 50 years and cannot
predict if or how often it may
implement measures in the future.
Æ Change relative to baseline as result
of final rule
D Improved transparency and
potentially improved compliance in the
event that HHS/CDC implements such
measures in the future.
Æ Qualitative benefit/cost of final rule
D Improved transparency and public
understanding of HHS/CDC’s rationale
and authority to conduct such measures
and require individuals to comply.
Æ Monetized benefit/cost of final rule
D Increased clarity around due
process procedures may result in fewer
resources and time expended by
individuals under orders and HHS/CDC
in disagreements over HHS/CDC’s
authority to issue Federal public health
orders that limit an individual’s
movement. This includes the potential
costs of litigation and associated
activities.
• New Provisions: § 70.12 Medical
examinations; § 71.36 Medical
Examinations
Æ Baseline and Current Regulatory
Provisions: 71.33 Persons: Isolation and
Surveillance.
D This is carried out under statutory
authority and under the regulatory
authorities in 42 CFR 70.6 and 71.32(a),
71.33, which would allow for medical
examinations of individuals under
Federal orders.
Æ Change to baseline as result of final
rule
D With the final rule, the major
change would be an alignment between
the statutory language in the Public
Health Service Act and improved
transparency of HHS/CDC’s regulatory
authority.
Æ Qualitative benefit/cost of final rule
D Improved transparency and public
understanding of HHS/CDC’s rationale
and authority to conduct such measures
and require individuals to comply.
Æ Monetized benefit/cost of final rule
D Increased clarity around due
process procedures may result in fewer

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Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations
resources and time expended by
individuals under orders, cooperating
entities, and HHS/CDC in disagreements
over HHS/CDC’s authority to issue
Federal public health orders that limit
an individual’s movement. This
includes the potential costs of litigation
and associated activities.
• New Provisions: § 70.13 Payment
for Care and Treatment; § 71.30 Payment
for Care and Treatment
Æ Baseline and Current Regulatory
Provisions: No current explicit
regulatory provision.
D This addition is 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. The
provisions included in the final rule are
similar to a Memorandum of Agreement
between a number of hospitals and
HHS/CDC. Under the terms of the
Memorandum of Agreement, the
hospital can be reimbursed for incurred
medical expenses subject to HHS/CDC’s
discretion, availability of
appropriations, and limited to what a
hospital would bill Medicare. The
Memorandum of Agreement also
indicates that HHS/CDC should be the
payer of last resort.
D HHS/CDC issued 12 isolation orders
between Jan 1, 2005 and May 10, 2016,
which would correspond to an average
of about 1 order per year over the past
11.3 years. HHS/CDC has information
on payments made for 3 of the 12 cases.
In most cases, HHS/CDC makes
payment directly to healthcare facilities,
sometimes in lieu of payments that
would be made by State or local health
departments. Among the three instances
for which HHS/CDC has some data on
payments for treatment, care, and
transportation of individuals under
Federal orders:
D HHS/CDC’s expected annual
payments for care and treatment are
estimated to be between $0 and
$1,000,000 in any given year under the
current baseline. This upper bound cost
would correspond to a year in which
HHS/CDC would have to incur the costs
of two patients at $500,000 per patient.
This roughly corresponds to the average
cost to treat an extremely drug-resistant
tuberculosis case (XDR–TB).
Alternatively, this could represent a
situation in which HHS/CDC may have
to pay a significant fraction of the total
costs for one very complicated illness
associated with a quarantinable
communicable disease not endemic to
the United States (e.g., Ebola).
D HHS/CDC has not incurred any
costs for the care and treatment of any

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individuals besides for those under
Federal isolation orders.
Æ Change to baseline as result of final
rule
D Improved transparency around
HHS/CDC’s authority for, and
requirements and processes related to
payment for care and treatment.
Æ Qualitative benefit/cost of final rule
D Improved transparency and public
knowledge of HHS/CDC’s procedures
and regulatory requirements.
Æ Monetized benefit/cost of final rule
D None. This is a clarification of HHS/
CDC’s current practice. (For more
details, please refer to separate RIA
Appendix)
• New Provisions: § 70.14
Requirements relating to the issuance of
a Federal order for quarantine, isolation,
or conditional release; § 71.37
Requirements relating to the issuance of
a Federal order for quarantine, isolation,
or conditional release
Æ Baseline and Current Regulatory
Provisions: No current explicit
regulatory provision
D Without the final rule, HHS/CDC
can under current statutory provided by
the Public Health Service Act and
regulatory authority under 42 CFR 70.6
and 71.32(a), 71.33 continue to issue
Federal quarantine, isolation, or
condition release orders. However, the
issuance of federal orders is
implemented through internal policies
and standard operating procedures that
are not as transparent to the public as
detailed regulations outlining
requirements.
Æ Change to baseline as result of final
rule
D Improved transparency around
HHS/CDC’s authority for, and
requirements and processes related to,
the issuance of Federal quarantine,
isolation, and conditional release
orders.
Æ Qualitative benefit/cost of final rule
D Improved transparency and public
knowledge of HHS/CDC’s procedures
and regulatory requirements.
Æ Monetized benefit/cost of final rule
D None. This is a clarification of HHS/
CDC’s current practice.
• New Provisions: § 70.15 Mandatory
reassessment of a Federal order for
quarantine, isolation, or conditional
release; § 71.38 Mandatory reassessment
of a Federal order for quarantine,
isolation, or conditional release
Æ Baseline and Current Regulatory
Provisions: No current explicit
regulatory provision.
D Without the final rule, HHS/CDC
can under current statutory authority
provided by the Public Health Service
Act and regulatory authority under 42
CFR 70.6 and 71.32(a), 71.33 continue to

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6963

issue Federal quarantine, isolation, or
conditional release orders. However, the
process for reassessing a Federal order
is implemented through internal policy
and standard operating procedures that
are not as transparent to the public as
detailed regulations outlining
requirements.
Æ Change to baseline as result of final
rule:
D With the final rule, individuals
under Federal order may be more aware
of the mandatory reassessment of a
Federal quarantine, isolation, or
conditional release order.
Æ Qualitative benefit/cost of final rule
D Improved transparency and
understanding of due process
protections under a Federal public
health order.
Æ Monetized benefit/cost of final rule
D Increased clarity around due
process protections may result in fewer
resources and time expended by
individuals under orders and HHS/CDC
in disagreements over HHS/CDC’s
authority to issue Federal public health
orders that limit an individual’s
movement. This includes the potential
costs of litigation and associated
activities.
• New Provisions: § 70.16 Medical
review of a Federal order for quarantine,
isolation, or conditional release; § 71.39
Medical review of a Federal order for
quarantine, isolation, or conditional
release
Æ Baseline and Current Regulatory
Provisions: No current explicit
regulatory provision.
D Without the final rule, HHS/CDC
can under current statutory authority
provided by the Public Health Service
Act and regulatory authority under 42
CFR 70.6 and 71.32, 71.33 continue to
issue Federal quarantine, isolation, or
conditional release orders. However, the
process for a medical review of a
Federal order is outlined in internal
policy and standard operating
procedures that are not as transparent to
the public as detailed regulations
outlining requirements.
Æ Change to baseline as result of final
rule:
D With the final rule, individuals
under Federal order may become aware
of their right to a medical review, and
exercise that right, under this due
process provision.
Æ Qualitative benefit/cost of final rule
D Improved transparency and
understanding of due process afforded
to individuals under a Federal order
Æ Monetized benefit/cost of final rule
D Increased clarity around due process
protections may result in fewer
resources and time expended by
individuals under orders and HHS/CDC

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in disagreements over HHS/CDC’s
authority to issue Federal public health
orders that limit an individual’s
movement. This includes the potential
costs of litigation and associated
activities.
D One potential change that could
have an economic effect is the
requirements to appoint medical and
legal representatives for individuals that
qualify as ‘‘indigent’’. The status of
‘‘indigent’’ is self-reported as HHS/CDC
will not require access to an
individual’s financial records. Those
who self-identify as indigent may be
required to sign an affidavit or
declaration under penalty of perjury
stating they meet the threshold of at
least 200% of the applicable poverty
guidelines. HHS/CDC notes that in
practice it has never denied a request for
a representative. HHS/CDC estimates
the cost of providing one medical
representative and one legal
representative based on the average
hourly wage for physicians and
surgeons ($97.33, occupation code 29–
1060) and lawyers ($65.51, occupation
code 23–1011) as reported from the
Bureau of Labor Statistics’ May 2015
National Occupational Employment and
Wage Estimates. Assuming that it takes
about 40 hours of physician time and 40
hours of lawyer time per review and an
overhead cost multiplier of 100%, the
expected cost is about $13,000 per
review. HHS/CDC notes that public
health orders are issued on average once
per year. The need for HHS/CDC to pay
for medical and legal representatives
will depend on the income level for
persons placed under federal orders, but
should not exceed this $13,000 estimate
in most years and will be $0 in many
years. Without the new regulatory
provision, as part of current practice,
HHS/CDC would still attempt to appoint
legal and medical representatives if
requested for the medical review by
individuals unable to afford the cost of
such representation. Thus, relative to
current practice, there should be
minimal costs associated with this
provision.
• New Provisions: § 70.17
Administrative records relating to
Federal quarantine, isolation, or
conditional release; § 71.29
Administrative records relating to
Federal quarantine, isolation, or
conditional release
Æ Baseline and Current Regulatory
Provisions: No current explicit
regulatory provision.
D Without the final rule, HHS/CDC
can issue under current statutory
provided by the Public Health Service
Act and regulatory authority under 42
CFR 70.6 and 71.32(a), 71.33 continue to

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issue Federal quarantine, isolation, or
conditional release orders. However, the
process for documenting the
administrative record is implemented
internal policy and standard operating
procedures that are not as transparent to
the public as a detailed regulation
outlining this requirement.
Æ Change to baseline as result of final
rule
D The requirement, with which HHS/
CDC is already complying, will clarify
for the public that certain documents
must be retained for the administrative
record.
Æ Qualitative benefit/cost of final rule
D Improved transparency
Æ Monetized benefit/cost of final rule
D Not applicable. This is a
codification of an administrative
activity within HHS/CDC.
• New Provisions: § 70.18 Penalties/
§ 71.2 Penalties
Æ Baseline and Current Regulatory
Provision: § 71.2 Penalties. Part 70
currently has no penalties provision.
D Without the final rule, individuals
may not be aware that 18 U.S.C. 3559
and 3571 increased the maximum
penalties for violations of regulations
under 42 CFR part 70 and part 71. And
it may not be clear to individuals that
violating quarantine regulation under 42
CFR part 70 may result in criminal
penalties.
Æ Change to baseline as result of final
rule
D With the NRPM, there will be less
confusion about the maximum criminal
penalties for a violation of regulations
under 42 CFR 70 and 71.
Æ Qualitative benefit/cost of final rule
D Improved transparency and
alignment with current law under 18
U.S.C. 3559 and 3571.
Æ Monetized benefit/cost of final rule
• No individual or organization has
been assessed criminal penalties for
violating these regulations, so
monetizing this benefit or cost is not
feasible. This is simply an effort to align
the domestic and foreign quarantine
penalties provisions, and updates
outdated regulatory language so that it
reflects current statutory language
concerning criminal penalties.
• New Provisions: § 71.63 Suspension
of entry of animals, articles, or things
from designated foreign countries and
places into the United States
Æ Baseline and Current Regulatory
Provision: § 71.32(b) has previously
been used to justify the temporary
embargo of imported African rodents
prior to the codification of this as a
requirement in existing 42 CFR 71.56.
D Without the final rule, individuals
may not be aware that HHS/CDC’s
authority to temporarily suspend entry

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Sfmt 4700

of animals, articles or things from
designated foreign countries and places
into the United States based on existing
42 CFR 71.32(b).
Æ Change to baseline as result of final
rule
D With the NRPM, there will be less
confusion about HHS/CDC’s ability to
temporarily restrict importations
associated with communicable disease
risks.
Æ Qualitative benefit/cost of final rule
D Improved transparency.
Æ Monetized benefit/cost of final rule
D Refer to the appendix for an
analysis of the temporary embargo of
African rodents implemented in 2003.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act,
as amended by the Small Business
Regulatory Enforcement Fairness Act
(SBREFA), agencies are required to
analyze regulatory options to minimize
significant economic impact of a rule on
small businesses, small governmental
units, and small not-for-profit
organizations. We have analyzed the
costs and benefits of the final rule, as
required by Executive Order 12866, and
a preliminary regulatory flexibility
analysis that examines the potential
economic effects of this rule on small
entities, as required by the Regulatory
Flexibility Act. Based on the cost benefit
analysis, we expect the rule to have
little or no economic impact on small
entities.
C. The Paperwork Reduction Act
HHS/CDC has determined that this
final rule contains proposed information
collections that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3520). A description of these proposed
provisions is given below with an
estimate of the annual reporting and
recordkeeping burden. Included in the
estimate is the time for reviewing
instructions, searching existing data
sources, gathering and maintaining the
data needed, and completing and
reviewing each collection of
information. Comments are invited on
the following subjects.
• Whether the proposed collection of
information is necessary for the proper
performance of the functions of HHS/
CDC, including whether the information
will have practical utility.
• The accuracy of HHS/CDC’s
estimate of the burden of the collection
of information.
• Ways to enhance the quality, utility,
and clarity of the information to be
collected.

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Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations
• Ways to minimize the burden of the
collection of information on
respondents, including by using
information technology.
While HHS/CDC currently has
approval to collect certain information
concerning illnesses and travelers under
OMB Control Numbers 0920–0134
(Foreign Quarantine Regulations,
expiration date 05/31/2019) and 0920–
0488 (Restrictions on Interstate Travel of
Persons, expiration date 05/31/2019),
CDC is requesting updates to certain
information collections within these
control numbers.
In another information collection
request associated with this final rule,
CDC is also requesting approval to
require that airlines and vessels provide
certain data elements to CDC, as
described in proposed 71.4 and 71.5, for
the purposes of contact tracing. This
information is used to locate
individuals, both passengers and
crewmembers, who may have been
exposed to a communicable disease
during travel and to provide them with
appropriate public health follow-up.
Written comments should be received
within 30 days of the publication of this
final rule. Please send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.

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Proposed Projects
(1) Foreign Quarantine Regulations
(42 CFR part 71) (OMB Control No.
0920–0134)—Nonmaterial/nonsubstantive change—National Center for
Emerging, and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
(2) Restrictions on Interstate Travel of
Persons (42 CFR part 70) (OMB Control
No. 0920–0488)—Nonmaterial/nonsubstantive change—National Center for
Emerging, and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC)
(3) Airline and Vessel and Traveler
Information Collection (42 CFR and
71)—New Information Collection
Request—National Center for Emerging,
and Zoonotic Infectious Diseases
(NCEZID), Centers for Disease Control
and Prevention (CDC).
Description
Section 361 of the Public Health
Service (PHS) Act (42 U.S.C. 264)
authorizes the Secretary of Health and
Human Services to make and enforce
regulations necessary to prevent the
introduction, transmission, or spread of
communicable diseases from foreign
countries into the United States and
interstate. Legislation and existing
regulations governing foreign and

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Jkt 241001

interstate quarantine activities (42 CFR
parts 70 and 71) authorize quarantine
officers and other personnel to inspect
and undertake necessary control
measures in order to protect the public
health. Currently, with the exception of
the CDC’s Vessel Sanitation Program,
inspections are performed only on those
vessels and aircraft that report illness
before arriving or when illness is
discovered upon arrival. Other
inspection agencies assist quarantine
officers in public health risk assessment
and management of persons, pets, and
other importations of public health
importance. These practices and
procedures ensure protection against the
introduction and spread of
communicable diseases into the United
States with a minimum of
recordkeeping and reporting as well as
a minimum of interference with trade
and travel. The information collection
burden is associated with these
recordkeeping and reporting
requirements.
At present, HHS/CDC has approval
from OMB to collect certain information
and impose recordkeeping requirements
related to foreign quarantine
responsibilities under OMB Control
Number 0920–0134 (expiration 05/31/
2019). The specific provisions within 42
CFR part 71 that include information
collection under are as follows:
42 CFR 71.21(a), (b), and (c) Report of
death and illness.
42 CFR 71.33(c) Report of persons
held in isolation or surveillance.
42 CFR 71.35 Report of death or
illness on carrier during stay in port.
42 CFR 71.51 Dogs and cats.
42 CFR 71.52 Turtles, terrapins,
tortoises.
42. CFR 71.56 African Rodents
HHS/CDC has also used its authority
under 42 CFR 71.32 to require importers
to submit statements or documentation
of non-infectiousness for those items
that may constitute a public health risk
if not rendered non-infectious.
Finally, HHS/CDC has approval from
OMB to collect from importers/filers
certain documents and data elements to
identify and clear HHS/CDC regulated
imports via the Automated Commercial
Environment and the International
Trade Data System using the Document
Imaging System and Partner
Government Agency Message Sets.
These CDC Partner Government Agency
Message Sets are currently limited to:
CDC PGA Message Set for Importing
Cats and Dogs, CDC PGA Message Set
for Importing African Rodents, CDC
PGA Message Set for Importing African
Rodent and All Family Viverridae
Products.

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6965

In this final rule, CDC is requesting
approval from OMB for 4 nonsubstantive changes to OMB Control
Number 0920–0134 Foreign Quarantine
Regulations (42 CFR part 71):
(1) Updating the definition of ‘‘ill
person,’’ which relates to the illness
reporting requirements under 42 CFR
71.21(a), (b), and (c) for airlines and
vessels arriving into the United States.
CDC is updating the definition of ‘‘ill
person’’ by implementing current
practice with the anticipated effect of
better facilitating identification of
communicable diseases of concern and
quarantinable communicable diseases
aboard flights and maritime voyages to
the United States, diseases such as
measles, viral hemorrhagic fevers, active
tuberculosis, and influenza caused by
novel or re-emergent influenza viruses
that are causing or have the potential to
cause a pandemic. CDC is also including
a provision to allow the Director to add
new symptoms to the definition of ill
person to respond to unknown
communicable diseases that may emerge
as future concerns.
The final rule updates the current
definition of ill person to better focus on
the signs and symptoms of
communicable diseases of public health
concern and quarantinable
communicable diseases. The changes
define an ill person in the context of the
medical resources available to the
operator of an airline or vessel.
CDC already requests from pilots in
command of aircraft and commanders of
vessels several of the symptoms
included in the revised definition of ill
person through publicly available
guidance to airlines and vessels.
Moreover, for airlines, the updated
definition also better aligns with
symptoms reporting guidelines
published by ICAO in Note 1 to
paragraph 8.15 of Annex 9 to the
Convention on International Civil
Aviation, and the definition of ‘‘acute
gastroenteritis’’ is used by the WHO and
is currently included in reporting
guidance from CDC’s Vessel Sanitation
Program. Therefore, CDC does not
anticipate additional burden on airlines
or vessel operators to respond to these
information collections.
(2) CDC is requesting a change in the
title of the information collection
pertaining to reports of death and illness
from vessels to CDC. The former title is
Radio Report of death or illness—illness
reports from ships. CDC sought a change
to remove ‘‘Radio’’ from the title. This
change reflects the fact that reports to
CDC primarily via means other than
radio, such as the Maritime Illness and
Death Reporting System, managed by
CDC’s Vessel Sanitation Program. CDC

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Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

did not receive any public comments to
this change, and it is therefore finalized
as proposed.
(3) CDC is seeking a change in the title
of a specific information collection
pertaining to reports of gastro-intestinal
illness to CDC. CDC is updating the
definition of ill person and is replacing
the term ‘‘gastro-intestinal’’ with ‘‘acute
gastroenteritis’’; therefore, the title
change is requested to align with the
definition.
(4) CDC is seeking a change in title of
respondents from ‘‘Maritime
Conveyance Operator’’ to ‘‘Maritime
Vessel Operator’’ and from ‘‘Airline

Commander or Operator’’ to ‘‘Pilot in
Command.’’
Table 1 below presents estimates of
annual burden (in hours) associated
with each reporting and recordkeeping
requirement under this OMB control
number, accounting for the rule
changes.
Description of Respondents.
Respondents to this data collection
include pilots in command of aircraft,
maritime vessel operators, importers/
filers, and travelers/general public. The
nature of the response to HHS/CDC
dictates which forms are completed and
by whom. The total requested burden
hours are 82,779.

There is no burden to respondents
other than the time taken to complete
the reports to CDC, maintain
recordkeeping of illness aboard vessels
and records of sickness or death in
imported cats and dogs, as outlined in
the table below. If a cat or dog is ill
upon arrival, or dies prior to arrival, an
exam is required, the initial exam fee
may be between $100 and $200. Rabies
testing on a dog that dies may be
between $50 and $100. The expected
number of ill or dead dogs arriving into
the United States for which CDC may
require an examination is estimated at
less than 30 per year.

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 0920–0134

Type of respondent

Regulatory provision or form name

Maritime Vessel Operators .........

42 CFR 71.21(a) Report of illness or death from
ships—Maritime Vessel Illness or Death Investigation Form/Cumulative Influenza/Influenza-Like Illness
(ILI) Form/Radio report or transcribed email.
42 CFR 71.21 (b) Death/Illness reports from aircraft ....
42 CFR 71.21(c) (MIDRS) Acute Gastro-Enteritis reports (24 and 4 hours before arrival).
42 CFR 71.21 (c) Recordkeeping-Medical logs .............
42 CFR 71.33 Report by persons in isolation or surveillance.
42 CFR 71.35 Report of death/illness during stay in
port.
42 CFR 71.51(c)(1), (d)—Valid Rabies Vaccination
Certificates.
CDC Form 75.37 Notice To Owners And Importers Of
Dogs: Requirement for Dog Confinement.
42 CFR 71.51(c)(i), (ii), and (iii) exemption criteria for
the importation of a dog without a rabies vaccination
certificate.
42 CFR 71.51(c)(2), (d) Application for a Permit to Import A Dog Inadequately Immunized Against Rabies.
42 CFR 71.51(b) (3) Dogs/cats: Record of sickness or
deaths.
42 CFR 71.51_CDC Requested Data on Regulated Imports: Domestic Dogs and Cats (PGA Message Set).
42 CFR 71.52(d) Turtle Importation Permits .................
42 CFR 71.55, 42 CFR 71.32 Dead Bodies—Death
certificates.
42 CFR 71.56 (a)(2) African Rodents—Request for exemption.
42 CFR 71.56(a)(iii) Appeal ...........................................
42 CFR 71.56 CDC Requested Data on Regulation Imports: Live African Rodents (PGA Message Set).
42 CFR 71.32 Statements or documentation of non-infectiousness.
42 CFR 71.56, 42 CFR 71.32 CDC Requested Data
on Regulated Imports: Products of African Rodents;
Products of all Family Viverridae (PGA Message
Set).

Pilot in Command .......................
Maritime Vessel Operators .........
Maritime Vessel Operators .........
Isolated or Quarantined individuals.
Maritime Vessel Operators .........
Importer .......................................
Importer .......................................
Importer .......................................
Importer .......................................
Importer .......................................
Importer/Filer ...............................
Importer .......................................
Importers .....................................
Importer .......................................
Importer .......................................
Importer/Filer ...............................
Importer/Filer ...............................
Importer/Filer ...............................

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No. of
respondents

Total .....................................

.........................................................................................

The estimates are based on experience
to date with current recordkeeping and
reporting requirements of 42 CFR part
71, with additional burden included to

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Average
burden
per
response
(in hours)

Total
burden
hours

2,000

1

2/60

67

1,700
17,000

1
1

2/60
3/60

57
850

17,000
11

1
1

3/60
3/60

850
1

5

1

30/60

3

245,310

1

15/60

61,328

1,400

1

10/60

233

43,290

1

15/60

10,823

1,400

1

15/60

350

20

1

15/60

5

30,000

1

15/60

7,500

5
5

1
1

30/60
1

3
5

20

1

1

20

2
60

1
1

1
15/60

2
15

2,000

1

5/60

167

2,000

1

15/60

500

....................

....................

................

82,779

account for the potential for increased
reports of illness during an outbreak and
for reports of disease that may have

PO 00000

No. of
responses
per
respondent

been missed by airlines or vessels and
are reported to CDC after travel.
Under this final rule, CDC is also
requesting a nonmaterial/non-

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Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations
substantive change to Restrictions on
Interstate Travel of Persons (42 CFR part
70) (OMB Control No. 0920–0488). The
regulations at 42 CFR part 70 are
intended to prevent the interstate spread
of disease, and include a requirement
that the master of vessel or person in
charge of conveyance to report the
occurrence on board of communicable
disease. Under this regulation and
control number, CDC has approval to
collect the following information:
• 42 CFR 70.4 Report by the master of
a vessel or person in charge of
conveyance of the incidence of a
communicable disease occurring while
in interstate travel.
Through this final rule, CDC is adding
the provision 70.11 Report of death or
illness onboard aircraft operated by
airline, which specifies that the pilot in
command of an aircraft operating on
behalf of an airline who conducts a
commercial passenger flight in interstate
traffic under a regular schedule shall
report as soon as practicable to HHS/
CDC the occurrence onboard of any
deaths or ill persons among passengers
or crew and take such measures as HHS/
CDC may direct to prevent the potential
spread of the communicable disease.
HHS/CDC notes that it is changing the
existing regulatory requirement at 42
CFR 70.4, which states that the master
of a vessel or person in charge of any
conveyance engaged in interstate traffic

on which a case or suspected case of
communicable disease develops shall,
as soon as practicable, notify the local
health authority.
Under the final rule, pilots in
command of an aircraft, operating on
behalf of an airline, that submit the ill
person or death report to HHS/CDC
under new 70.11 will not be required to
also submit a report to the local health
authority under current 70.4. HHS/CDC
will continue to share public health
information with State and local health
departments through electronic disease
reporting networks. It is unlikely that
HHS/CDC would request follow-up
reports of illnesses that are reported to
the local health authorities, unless there
was an urgent public health need.
Therefore, CDC does not anticipate any
additional burden to the respondents;
however, the accounting for burden in
Table 2 will add 70.11 Report of death
or illness onboard aircraft operated by
airline.
As a result of this final rule, CDC does
not anticipate a change in total burden.
CDC is instead allocating 95% of the
reports of illness or death within the
proposed 70.11 Report of death or
illness onboard aircraft operated by
airline. The remains 5% will remain
within 70.4 Report by the master of a
vessel or person in charge of
conveyance of the incidence of a
communicable disease occurring while

6967

in interstate travel, in the event that
some reports are still made to State
health authorities.
In addition to the requirement to
report directly to HHS/CDC, HHS/CDC
is updating the definition of ‘‘ill person’’
for the purposes of illness reports to
HHS/CDC in 42 CFR part 70. HHS/CDC
has, as a matter of agency guidance,
communicated with airlines that the
same current set of required and
requested signs and symptoms of
disease, as well as any death, apply to
domestic as well as international flights.
This guidance is similar to that of the
guidelines issued by ICAO under Note
1 to paragraph 8.15 of Annex 9 to the
Convention on International Civil
Aviation. Therefore, the new proposed
definition of ill person should not affect
standard practice, and no change in
burden is anticipated.
Table 2 below presents estimates of
annual burden (in hours) associated
with each reporting and recordkeeping
requirement under this OMB control
number, accounting for the rule
changes.
Description of Respondents
Respondents to this data collection
include masters of vessels or persons in
charge of conveyance and pilots in
command of aircraft.

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 0920–0488
No. of
responses
per
respondent

Average
burden
per
response
(in hours)

Total
burden
(in hours)

Type of respondent

Form name

Pilot in command ........................

42 CFR 70.11 Report of death or illness onboard aircraft operated by airline.
42 CFR 70.4 Report by the master of a vessel or person in charge of conveyance of the incidence of a
communicable disease occurring while in interstate
travel.

190

1

7/60

22

10

1

7/60

1

.........................................................................................

200

....................

................

23

Master of vessel or person in
charge of conveyance.

Total .....................................

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No. of
respondents

The total requested burden hours are
23. There is no burden to respondents
other than the time taken to complete
the reports. The estimates are based on
experience to date with current
recordkeeping and reporting
requirements of 42 CFR part 70, and
take into account the potential for
additional burden from increased
reports of illness during an outbreak and
for reports of disease that may have
been missed by respondents during
travel and are reported to CDC by other
means.

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Finally, under this final rule HHS/
CDC is requesting approval for a new
information collection, Airline and
Vessel and Traveler Information
Collection (42 CFR part 71). This
information collection request
accompanies the codification of issuing
orders to airlines and vessel operators
for the provision to CDC of airline and
vessel and traveler information (aka
manifests) in the event that a
quarantinable communicable disease or
a communicable disease of public
health concern, or a death caused by a
quarantinable communicable disease or

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Sfmt 4700

communicable disease of public health
concern, occurs during travel to the
United States and public health followup is warranted. These proposed
provisions are found in 42 CFR 71.4 for
airlines and 71.5 for vessels.
The ordering of manifests from
airlines and vessel operators arriving
into the United States is an ongoing
activity executed under CDC’s broad
regulatory authority found at 42 CFR
71.32 Persons, carriers, and things. To
increase transparency with regard to
CDC’s authorities and manifest order
process, CDC is proposing specific

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Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations

regulatory provisions that outline the
particular data elements CDC requires to
perform contact tracing investigations.
As stated in the final rule, CDC is not
mandating the collection of additional
data. Only that if the airlines or
maritime operators have the data
elements listed in 71.4 and 71.5 in their

possession, they must be provided to
CDC within 24 hours.
Table 3 below presents estimates of
annual burden (in hours) associated
with each reporting and recordkeeping
requirement under this OMB control
number, accounting for the final rule
changes.

Description of Respondents
Respondents to this data collection
include the Airline Medical Officer or
Equivalent and a Computer and
Information Systems Manager.

TABLE 3—ESTIMATE OF ANNUAL BURDEN AIRLINE AND VESSEL MANIFEST ORDERS
No. of
responses
per
respondent

Average
burden
per
response
(in hours)

Total
burden
(in hours)

Type of respondent

Form name

Airline Medical Officer or Equivalent/Computer and Information
Systems Manager.
Airline Medical Officer or Equivalent/Computer and Information
Systems Manager.

International TB Manifest Template ...............................

67

1

360/60

402

International Non-TB Manifest Template. ......................

29

1

360/60

174

Total .....................................

.........................................................................................

96

....................

................

576

The total requested burden hours
included in this final rule is 576. There
is no burden to respondents other than
the time taken to complete the manifest
information and send to CDC. The
estimates are based on experience to
date with current manifest order
process.
D. National Environmental Policy Act
(NEPA)
HHS/CDC has determined that the
amendments to 42 CFR parts 70 and 71
will not have a significant impact on the
human environment.
E. Executive Order 12988: Civil Justice
Reform
HHS/CDC has reviewed this rule
under Executive Order 12988 on Civil
Justice Reform and determines that this
final rule meets the standard in the
Executive Order.

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No. of
respondents

F. Executive Order 13132: Federalism
Under Executive Order 13132, a
Federalism analysis is required if a
rulemaking has Federalism
implications, would limit or preempt
State or local law, or impose substantial
direct compliance costs on State or local
governments. Under such
circumstances, a Federal agency must
consult with State and local officials.
Federalism implications is defined as
having substantial direct effects on State
or local governments, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Under 42 U.S.C.
264(e), Federal public health regulations
do not preempt State or local public

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Jkt 241001

health regulations, except in the event
of a conflict with the exercise of Federal
authority. Other than to restate this
statutory provision, this rulemaking
does not alter the relationship between
the Federal government and State/local
governments as set forth in 42 U.S.C.
264. The longstanding provision on
preemption in the event of a conflict
with Federal authority (42 CFR 70.2) is
left unchanged by this rulemaking.
Additionally, there are no provisions in
these regulations that impose direct
compliance costs on State and local
governments. Therefore, HHS/CDC
believes that the rule does not warrant
additional consultation under Executive
Order 13132.
G. The Plain Language Act of 2010
Under 63 FR 31883 (June 10, 1998),
Executive Departments and Agencies
are required to use plain language in all
proposed and final rules. HHS/CDC
received several comments suggesting
that the proposed regulation was not
written in plain language and was
therefore difficult to understand. Prior
to publication, this final rule was
reviewed by specialists in health
communication and education to ensure
the content and intention, as well as
substance, were clear and accurate.
List of Subjects in 70.1, 70.5, 70.6,
70.10–70.18, 71.1, 71.2, 71.4, 71.5,
71.12, 71.20, 71.29, 71.30, 71.36–71.39,
71.63
Apprehension, Communicable
diseases, Conditional release, CDC, Ill
person, Isolation, Non-invasive, Public
health emergency, Public health
prevention measures, Qualifying stage,

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Sfmt 4700

Quarantine, Quarantinable
Communicable Disease.
For the reasons discussed in the
preamble, we amend 42 CFR parts 70
and 71 as follows:
PART 70—INTERSTATE QUARANTINE
1. The authority citation for part 70
continues to read as follows:

■

Authority: Secs. 215 and 311 of the Public
Health Service (PHS) Act, as amended (42
U.S.C. 216, 243) section 361–369, PHS Act,
as amended (42 U.S.C. 264–272); 31 U.S.C.
9701.

2. Amend § 70.1 by—
a. Adding in alphabetical order
definitions for ‘‘Airline’’,
‘‘Apprehension’’, and ‘‘Communicable
stage’’;
■ b. Revising the definition of
‘‘Conditional release’’;
■ c. Adding in alphabetical order a
definitions for ‘‘Contaminated
environment;’’
■ d. Revising the definition of
‘‘Conveyance’’;
■ e. Adding in alphabetical order
definitions for ‘‘Electronic or Internetbased monitoring’’ and ‘‘Ill person’’;
■ f. Revising the definition of
‘‘Incubation period’’;
■ g. Adding in alphabetical order a
definition for ‘‘Indigent’’;
■ h. Revising the definition of
‘‘Interstate traffic’’;
■ i. Revising the definition of ‘‘Master or
operator’’;
■ j. Adding in alphabetical order
definitions for ‘‘Medical examination’’,
‘‘Medical reviewer’’, ‘‘Non-invasive’’,
‘‘Precommunicable stage’’, ‘‘Public
health emergency’’, ‘‘Public health
■
■

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prevention measures’’, ‘‘Qualifying
stage’’, ‘‘Reasonably believed to be
infected, as applied to an individual’’,
and ‘‘Representatives’’.
The additions and revisions read as
follows:

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§ 70.1

General definitions.

Airline means any air carrier or
foreign air carrier providing air
transportation as that term is defined in
49 U.S.C. 40102(a)(2), (a)(5), and (a)(21).
Apprehension means the temporary
taking into custody of an individual or
group for purposes of determining
whether Federal quarantine, isolation,
or conditional release is warranted.
*
*
*
*
*
Communicable stage means the stage
during which an infectious agent may
be transmitted either directly or
indirectly from an infected individual to
another individual.
Conditional release means the
temporary supervision by a public
health official (or designee) of an
individual or group, who may have been
exposed to a quarantinable
communicable disease to determine the
risk of disease spread and includes
public health supervision through inperson visits, telephone, or through
electronic or Internet-based monitoring.
Contaminated environment means the
presence of an infectious agent on a
surface, including on inanimate articles,
or in a substance, including food, water,
or in the air.
Conveyance means an aircraft, train,
road vehicle, vessel (as defined in this
section) or other means of transport,
including military.
*
*
*
*
*
Electronic or Internet-based
monitoring means mechanisms or
technologies allowing for the temporary
public health supervision of an
individual under conditional release
and may include communication
through electronic mail, SMS texts,
video or audio conference, webcam
technologies, integrated voice-response
systems, entry of information into a
Web-based forum, wearable tracking
technologies, and other mechanisms or
technologies as determined by the
Director or supervising health authority.
Ill person means an individual who:
(1) Has a fever (a measured
temperature of 100.4 °F [38 °C] or
greater, or feels warm to the touch, or
gives a history of feeling feverish)
accompanied by one or more of the
following: Skin rash, difficulty
breathing, persistent cough, decreased
consciousness or confusion of recent
onset, new unexplained bruising or
bleeding (without previous injury),

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persistent diarrhea, persistent vomiting
(other than air sickness), headache with
stiff neck, appears obviously unwell; or
(2) Has a fever that has persisted for
more than 48 hours; or
(3) Has symptoms or other indications
of communicable disease, as the CDC
may announce through posting of a
notice in the Federal Register.
Incubation period means the time
from the moment of exposure to an
infectious agent that causes a
communicable disease until signs and
symptoms of the communicable disease
appear in the individual or, if signs and
symptoms do not appear, the latest date
signs and symptoms could reasonably
be expected to appear. For a
quarantinable communicable disease,
incubation period means the
precommunicable stage.
Indigent means an individual whose
annual family income is below 200% of
the applicable poverty guidelines
updated periodically in the Federal
Register by the U.S. Department of
Health and Human Services under the
authority of 42 U.S.C. 9902(2) or, if no
income is earned, liquid assets totaling
less than 15% of the applicable poverty
guidelines.
Interstate traffic (1) Means:
(i) The movement of any conveyance
or the transportation of persons or
property, including any portion of such
movement or transportation that is
entirely within a State or possession—
(ii) From a point of origin in any State
or possession to a point of destination
in any other State or possession; or
(iii) Between a point of origin and a
point of destination in the same State or
possession but through any other State,
possession, or contiguous foreign
country.
(2) Interstate traffic does not include
the following:
(i) The movement of any conveyance
which is solely for the purpose of
unloading persons or property
transported from a foreign country, or
loading persons or property for
transportation to a foreign country.
(ii) The movement of any conveyance
which is solely for the purpose of
effecting its repair, reconstruction,
rehabilitation, or storage.
*
*
*
*
*
Master or operator with respect to a
vessel, means the sea crew member with
responsibility for vessel operation and
navigation, or a similar individual with
responsibility for a conveyance.
Consistent with the definition of
‘‘operate’’ in 14 CFR 1.1, ‘‘operator’’
means, with respect to aircraft, any
person who uses, causes to use, or
authorizes to use an aircraft, for the

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purpose (except as provided in 14 CFR
91.13) of air navigation including the
piloting of an aircraft, with or without
the right of legal control (as owner,
lessee, or otherwise).
Medical examination means the
assessment of an individual by an
authorized and licensed health worker
to determine the individual’s health
status and potential public health risk to
others and may include the taking of a
medical history, a physical examination,
and collection of human biological
samples for laboratory testing as may be
needed to diagnose or confirm the
presence or extent of infection with a
quarantinable communicable disease.
Medical reviewer means a physician,
nurse practitioner, or similar medical
professional qualified in the diagnosis
and treatment of infectious diseases
who is appointed by the Secretary or
Director to conduct medical reviews
under this part and may include an HHS
or CDC employee, provided that the
employee differs from the CDC official
who issued the Federal order for
quarantine, isolation, or conditional
release.
Non-invasive means procedures
conducted by an authorized public
health worker (i.e., an individual with
education and training in the field of
public health) or another individual
with suitable public health training and
includes the visual examination of the
ear, nose, and mouth; temperature
assessments using an ear, oral,
cutaneous, or noncontact thermometer,
or thermal imaging; and other
procedures not involving the puncture
or incision of the skin or insertion of an
instrument or foreign material into the
body or a body cavity excluding the ear,
nose, and mouth.
*
*
*
*
*
Precommunicable stage means the
stage beginning upon an individual’s
earliest opportunity for exposure to an
infectious agent and ending upon the
individual entering or reentering the
communicable stage of the disease or, if
the individual does not enter the
communicable stage, the latest date at
which the individual could reasonably
be expected to have the potential to
enter or reenter the communicable stage.
Public health emergency as used in
this part means:
(1) Any communicable disease event
as determined by the Director with
either documented or significant
potential for regional, national, or
international communicable disease
spread or that is highly likely to cause
death or serious illness if not properly
controlled; or
(2) Any communicable disease event
described in a declaration by the

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Secretary pursuant to 319(a) of the
Public Health Service Act (42 U.S.C.
247d (a)); or
(3) Any communicable disease event
the occurrence of which is notified to
the World Health Organization, in
accordance with Articles 6 and 7 of the
International Health Regulations, as one
that may constitute a Public Health
Emergency of International Concern; or
(4) Any communicable disease event
the occurrence of which is determined
by the Director-General of the World
Health Organization, in accordance with
Article 12 of the International Health
Regulations, to constitute a Public
Health Emergency of International
Concern; or
(5) Any communicable disease event
for which the Director-General of the
World Health Organization, in
accordance with Articles 15 or 16 of the
International Health Regulations, has
issued temporary or standing
recommendations for purposes of
preventing or promptly detecting the
occurrence or reoccurrence of the
communicable disease.
Public health prevention measures
means the assessment of an individual
through non-invasive procedures and
other means, such as observation,
questioning, review of travel
documents, records review, and other
non-invasive means, to determine the
individual’s health status and potential
public health risk to others.
Qualifying stage is statutorily defined
(42 U.S.C. 264(d)(2)) to mean:
(1) The communicable stage of a
quarantinable communicable disease; or
(2) The precommunicable stage of the
quarantinable communicable disease,
but only if the quarantinable
communicable disease would be likely
to cause a public health emergency if
transmitted to other individuals.
*
*
*
*
*
Reasonably believed to be infected, as
applied to an individual, means specific
articulable facts upon which a public
health officer could reasonably draw the
inference that an individual has been
exposed, either directly or indirectly, to
the infectious agent that causes a
quarantinable communicable disease, as
through contact with an infected person
or an infected person’s bodily fluids, a
contaminated environment, or through
an intermediate host or vector, and that
as a consequence of the exposure, the
individual is or may be harboring in the
body the infectious agent of that
quarantinable communicable disease.
Representatives means a physician,
nurse practitioner, or similar medical
professional qualified in the diagnosis
and treatment of infectious diseases,

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and an attorney who is knowledgeable
of public health practices, who are
appointed by the Secretary or Director
and may include HHS or CDC
employees, to assist an indigent
individual under Federal quarantine,
isolation, or conditional release with a
medical review under this part.
*
*
*
*
*
Secretary means the Secretary of
Health and Human Services (HHS) or
any other officer or employee of that
Department to whom the authority
involved has been delegated.
*
*
*
*
*
■ 3. Revise § 70.5 to read as follows:
§ 70.5 Requirements relating to travelers
under a Federal order of isolation,
quarantine, or conditional release.

(a) The following provisions are
applicable to any individual under a
Federal order of isolation, quarantine, or
conditional release with regard to a
quarantinable communicable disease or
to any individual meeting the
requirements of paragraph (d), (e), or (f)
of this section:
(1) Except as specified under the
terms of a Federal conditional release
order, no such individual shall travel in
interstate traffic or from one State or
U.S. territory to another without a
written travel permit issued by the
Director.
(2) Requests for a travel permit must
state the reasons why the travel is being
requested, mode of transportation, the
places or individuals to be visited, the
precautions, if any, to be taken to
prevent the potential transmission or
spread of the communicable disease,
and other information as determined
necessary by the Director to assess the
individual’s health condition and
potential for communicable disease
spread to others.
(3) The Director will consider all
requests for a permit and, taking into
consideration the risk of introduction,
transmission, or spread of the
communicable disease, may condition
the permit upon compliance with such
precautionary measures as the Director
shall prescribe. The Director shall
respond to a request for a permit within
5 business days.
(4) An individual to whom a permit
has been issued shall retain it in his/her
possession throughout the course of his/
her authorized travel and comply with
all conditions prescribed therein,
including presentation of the permit to
the operators of conveyances, as
required by its terms.
(5) An individual who has had his/her
request for a permit denied, or who has
had a travel permit suspended or

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revoked, may submit a written appeal to
the Director (excluding the CDC official
who denied, suspended, or revoked the
permit). The appeal must be in writing,
state the factual basis for the appeal, and
be submitted to the Director (excluding
the CDC official who denied,
suspended, or revoked the permit)
within 10 calendar days of the denial,
suspension, or revocation of the permit.
The Director (excluding the CDC official
who denied, suspended, or revoked the
permit) will issue a written response to
the appeal within 3 business days,
which shall constitute final agency
action.
(b) The operator of any conveyance
operating in interstate traffic shall not:
(1) Accept for transportation any
individual whom the operator knows, or
reasonably should know, to be under a
Federal order of isolation, quarantine, or
conditional release, unless such an
individual presents a permit issued by
the Director or a copy of the Federal
conditional release order authorizing
such travel;
(2) Transport any individual whom
the operator knows, or reasonably
should know, to be under a Federal
order of isolation, quarantine, or
conditional release in violation of any of
the terms or conditions prescribed in
the travel permit or conditional release
order issued by the Director.
(c) Whenever a conveyance operating
in interstate traffic transports an
individual under a Federal order or
travel permit, the Director may require
that the operator of the conveyance
submit the conveyance to inspection,
sanitary measures, and other measures,
as the Director deems necessary to
prevent the possible spread of
communicable disease.
(d) The Director may additionally
apply the provisions in paragraphs (a)
through (c) of this section to individuals
traveling entirely intrastate and to
conveyances that transport such
individuals upon the request of a State
or local health authority of jurisdiction.
The Director shall consider the State or
local health authority’s request for
assistance and taking into consideration
the risk of introduction, transmission, or
spread of the communicable disease,
grant or deny, in his/her discretion, the
request for assistance.
(e) The Director may additionally
apply the provisions in paragraphs (a)
through of this section (c) to individuals
traveling interstate or entirely intrastate
and to conveyances that transport such
individuals whenever the Director
makes a determination under 42 CFR
70.2 that based on the existence of
inadequate local control such measures
are needed to prevent the spread of any

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of the communicable diseases from such
State or U.S. territory to any other State
or U.S. territory.
(f) The Director may additionally
apply the provisions in paragraphs (a)
through (c) of this section to individuals
under a State or local order, or written
agreement, for quarantine, isolation, or
conditional release and to conveyances
that may transport such individuals,
upon the request of a State or local
health authority of jurisdiction or
whenever the Director makes a
determination of inadequate local
control under 42 CFR 70.2. The Director
shall consider the State or local health
authority’s request for assistance and
taking into consideration the risk of
introduction, transmission, or spread of
the communicable disease, grant or
deny, in his/her discretion, the request
for assistance.
(g) The Director may exempt
individuals and non-public
conveyances, such as ambulances, air
ambulance flights, or private vehicles,
from the requirements of this section.
■ 4. Revise § 70.6 to read as follows:

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§ 70.6 Apprehension and detention of
persons with quarantinable communicable
diseases.

(a) The Director may authorize the
apprehension, medical examination,
quarantine, isolation, or conditional
release of any individual for the purpose
of preventing the introduction,
transmission, and spread of
quarantinable communicable diseases,
as specified by Executive Order, based
upon a finding that:
(1) The individual is reasonably
believed to be infected with a
quarantinable communicable disease in
a qualifying stage and is moving or
about to move from a State into another
State; or
(2) The individual is reasonably
believed to be infected with a
quarantinable communicable disease in
a qualifying stage and constitutes a
probable source of infection to other
individuals who may be moving from a
State into another State.
(b) The Director will arrange for
adequate food and water, appropriate
accommodation, appropriate medical
treatment, and means of necessary
communication for individuals who are
apprehended or held in quarantine or
isolation under this part.
■ 5. Add §§ 70.10 through 70.18 to read
as follows:
Sec.

*

*

*

*

*

70.10 Public health prevention measures to
detect communicable disease.
70.11 Report of death or illness onboard
aircraft operated by an airline.

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70.12 Medical examinations.
70.13 Payment for care and treatment.
70.14 Requirements relating to the issuance
of a Federal order for quarantine,
isolation, or conditional release.
70.15 Mandatory reassessment of a Federal
order for quarantine, isolation, or
conditional release.
70.16 Medical review of a Federal order for
quarantine, isolation, or conditional
release.
70.17 Administrative records relating to
Federal quarantine, isolation, or
conditional release.
70.18 Penalties.
§ 70.10 Public health prevention measures
to detect communicable disease.

(a) The Director may conduct public
health prevention measures at U.S.
airports, seaports, railway stations, bus
terminals, and other locations where
individuals may gather to engage in
interstate travel, through non-invasive
procedures determined appropriate by
the Director to detect the presence of
communicable diseases.
(b) As part of the public health
prevention measures, the Director may
require individuals to provide contact
information such as U.S. and foreign
addresses, telephone numbers, email
addresses, and other contact
information, as well as information
concerning their intended destination,
health status, known or possible
exposure history, and travel history.
§ 70.11 Report of death or illness onboard
aircraft operated by an airline.

(a) The pilot in command of an
aircraft operated by an airline who is
conducting a commercial passenger
flight in interstate traffic under a regular
schedule shall report as soon as
practicable to the Director the
occurrence onboard of any deaths or the
presence of ill persons among
passengers or crew and take such
measures as the Director may direct to
prevent the potential spread of the
communicable disease, provided that
such measures do not affect the
airworthiness of the aircraft or the safety
of flight operations.
(b) The pilot in command of an
aircraft operated by an airline who
reports in accordance with paragraph (a)
of this section shall be deemed to satisfy
the reporting obligation under 42 CFR
70.4.
§ 70.12

Medical examinations.

(a) The Director may require an
individual to undergo a medical
examination as part of a Federal order
for quarantine, isolation, or conditional
release for a quarantinable
communicable disease.
(b) The Director shall promptly
arrange for the medical examination to

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be conducted when one is required
under this section and shall as part of
the Federal order advise the individual
that the medical examination shall be
conducted by an authorized and
licensed health worker, and with prior
informed consent.
(c) As part of the medical
examination, the Director may require
an individual to provide information
and undergo such testing as may be
reasonably necessary to diagnose or
confirm the presence or extent of
infection with a quarantinable
communicable disease.
(d) Individuals reasonably believed to
be infected based on the results of a
medical examination may be isolated, or
if such results are inconclusive or
unavailable, individuals may be
quarantined or conditionally released in
accordance with this part.
§ 70.13

Payment for care and treatment.

(a) The Director may authorize
payment for the care and treatment of
individuals subject to medical
examination, quarantine, isolation, and
conditional release, subject to
paragraphs (b) through (h) of this
section.
(b) Payment for care and treatment
shall be in the CDC’s sole discretion and
subject to the availability of
appropriations.
(c) Payment shall be secondary to the
obligation of the United States or any
third-party (i.e., any State or local
governmental entity, private insurance
carrier, or employer), under any other
law or contractual agreement, to pay for
such care and treatment, and shall be
paid by the Director only after all thirdparty payers have made payment in
satisfaction of their obligations.
(d) Payment may include costs for
providing ambulance or other medical
transportation when such services are
deemed necessary by the Director for
the individual’s care and treatment.
(e) Payment shall be limited to those
amounts the hospital, medical facility,
or medical transportation service would
customarily bill the Medicare system
using the International Classification of
Diseases, Clinical Modification (ICD–
CM), and relevant regulations
promulgated by the Centers for
Medicare and Medicaid Services in
existence at the time of billing.
(f) For quarantinable communicable
diseases, payment shall be limited to
costs for services and items reasonable
and necessary for the care and treatment
of the individual or group for the time
period beginning when the Director
refers the individual or group to the
hospital or medical facility and ends
when, as determined by the Director,

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the period of apprehension, quarantine,
isolation, or conditional release expires.
(g) For diseases other than those
described in paragraph (f) of this
section, such payment shall be limited
to costs for services and items
reasonable and necessary for care and
treatment of the individual for the time
period that begins when the Director
refers the individual to the hospital or
medical facility and ends when the
individual’s condition is diagnosed, as
determined by the Director, as an illness
other than a quarantinable
communicable disease.
(h) For ambulance or other medical
transportation, payment shall be limited
to the costs for such services and other
items reasonable and necessary for the
individual’s safe medical transport.

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§ 70.14 Requirements relating to the
issuance of a Federal order for quarantine,
isolation, or conditional release.

(a) A Federal order authorizing
quarantine, isolation, or conditional
release shall be in writing, signed by the
Director, and contain the following
information:
(1) The identity of the individual or
group subject to the order;
(2) The location of the quarantine or
isolation or, in the case of conditional
release, the entity to who and means by
which the individual shall report for
public health supervision;
(3) An explanation of the factual basis
underlying the Director’s reasonable
belief that the individual is in the
qualifying stage of a quarantinable
communicable disease;
(4) An explanation of the factual basis
underlying the Director’s reasonable
belief that the individual is moving or
about to move from one State into
another or constitutes a probable source
of infection to others who may be
moving from one State into another;
(5) An explanation that the Federal
order will be reassessed no later than 72
hours after it has been served and an
explanation of the medical review of the
Federal order pursuant to this part,
including the right to request a medical
review, present witnesses and testimony
at the medical review, and to be
represented at the medical review by
either an advocate (e.g., an attorney,
family member, or physician) at the
individual’s own expense, or, if
indigent, to have representatives
appointed at the government’s expense;
(6) An explanation of the criminal
penalties for violating a Federal order of
quarantine, isolation, or conditional
release; and
(7) An explanation that if a medical
examination is required as part of the
Federal order that the examination will

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be conducted by an authorized and
licensed health worker, and with prior
informed consent.
(b) A Federal order authorizing
quarantine, isolation, or conditional
release shall be served on the individual
no later than 72 hours after the
individual has been apprehended,
except that the Federal order may be
published or posted in a conspicuous
location if the Federal order is
applicable to a group of individuals and
individual service would be
impracticable.
(c) The Director shall arrange for
translation or interpretation services of
the Federal order as needed.
(d) Nothing in this section shall affect
the constitutional or statutory rights of
individuals to obtain judicial review of
their Federal detention.
§ 70.15 Mandatory reassessment of a
Federal order for quarantine, isolation, or
conditional release.

(a) The Director (excluding the CDC
official who issued the quarantine,
isolation, or conditional release order)
shall reassess the need to continue the
quarantine, isolation, or conditional
release of an individual no later than 72
hours after the service of the Federal
order.
(b) As part of the reassessment, the
Director (excluding the CDC official
who issued the quarantine, isolation, or
conditional release order) shall review
all records considered in issuing the
Federal order, including travel records,
records evidencing exposure or
infection with a quarantinable
communicable disease, as well as any
relevant new information.
(c) As part of the reassessment, and
where applicable, the Director
(excluding the CDC official who issued
the quarantine, isolation, or conditional
release order) shall consider and make
a determination regarding whether less
restrictive alternatives would
adequately serve to protect the public
health.
(d) At the conclusion of the
reassessment, the Director (excluding
the CDC official who issued the
quarantine, isolation, or conditional
release order) shall promptly issue and
serve a written Federal order directing
that the quarantine, isolation, or
conditional release be continued,
modified, or rescinded.
(e) In the event that the Director
orders that the quarantine, isolation, or
conditional release be continued or
modified, the written Federal order
shall explain the process for requesting
a medical review under this part.
(f) The Director’s written Federal
order shall be promptly served on the

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individual, except that the Federal order
may be served by publication or by
posting in a conspicuous location if the
Federal order is applicable to a group of
individuals and individual service
would be impracticable.
(g) The Director shall arrange for
translation or interpretation services of
the Federal order as needed.
§ 70.16 Medical review of a Federal order
for quarantine, isolation, or conditional
release.

(a) The Director shall, as soon as
practicable, arrange for a medical review
upon a request by an individual under
Federal quarantine, isolation, or
conditional release.
(b) A request for a medical review
may only occur after the Director’s
mandatory reassessment under section
70.15 and following the service of a
Federal order continuing or modifying
the quarantine, isolation, or conditional
release.
(c) The medical review shall be for the
purpose of ascertaining whether the
Director has a reasonable belief that the
individual is infected with a
quarantinable communicable disease in
a qualifying stage.
(d) The Director shall notify the
individual in writing of the time and
place of the medical review.
(e) The Director (excluding the CDC
official who issued the quarantine,
isolation, or conditional release order)
shall designate a medical reviewer to
review the medical or other evidence
presented at the review, make medical
or other findings of fact, and issue a
recommendation concerning whether
the Federal order for quarantine,
isolation, or conditional release should
be rescinded, continued, or modified.
(f) The individual under Federal
quarantine, isolation, or conditional
release may authorize an advocate (e.g.,
an attorney, family member, or
physician) at his or her own expense to
submit medical or other evidence and,
in the medical reviewer’s discretion, be
allowed to present a reasonable number
of medical experts. The Director
(excluding the CDC official who issued
the quarantine, isolation, or conditional
release order) shall appoint
representatives at government expense
to assist the individual for purposes of
the medical review upon a request and
certification, under penalty of perjury,
by that individual that he or she is
indigent.
(g) Prior to the convening of the
review, the individual or his/her
authorized advocate or representatives
shall be provided a reasonable
opportunity to examine the available
medical and other records involved in

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Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations
the medical review that pertain to that
individual.
(h) The Director shall take such
measures that he/she determines to be
reasonably necessary to allow an
individual under Federal quarantine or
isolation to communicate with any
authorized advocate or representatives
in such a manner as to prevent the
possible spread of the quarantinable
communicable disease.
(i) The medical reviewer may order a
medical examination of an individual
when, in the medical reviewer’s
professional judgment, such an
examination would assist in assessing
the individual’s medical condition.
(j) As part of the review, and where
applicable, the medical reviewer shall
consider and accept into the record
evidence concerning whether less
restrictive alternatives would
adequately serve to protect public
health.
(k) The medical review shall be
conducted by telephone, audio or video
conference, or through other means that
the medical reviewer determines in his/
her discretion are practicable for
allowing the individual under
quarantine, isolation, or conditional
release to participate in the medical
review.
(l) At the conclusion of the review,
the medical reviewer shall, based upon
his or her review of the facts and other
evidence made available during the
medical review, issue a written report to
the Director (excluding the CDC official
who issued the quarantine, isolation, or
conditional release order) concerning
whether, in the medical reviewer’s
professional judgment, the Federal
quarantine, isolation, or conditional
release should be rescinded, continued,
or modified. The written report shall
include a determination regarding
whether less restrictive alternatives
would adequately serve to protect
public health. The written report shall
be served on the individual and the
individual’s authorized advocate or
representatives.
(m) The Director (excluding the CDC
official who issued the quarantine,
isolation, or conditional release order)
shall, as soon as practicable, review the
written report and any objections that
may be submitted by the individual or
the individual’s authorized advocate or
representatives that contest the findings
and recommendation contained in the
medical reviewer’s written report. Upon
conclusion of the review, the Director
(excluding the CDC official who issued
the quarantine, isolation, or conditional
release order) shall promptly issue a
written Federal order directing that the
quarantine, isolation, or conditional

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release be continued, modified, or
rescinded. In the event that the Director
(excluding the CDC official who issued
the quarantine, isolation, or conditional
release order) continues or modifies the
Federal quarantine, isolation, or
conditional release, the Director’s
written order shall include a statement
that the individual may request that the
Director rescind the Federal quarantine,
isolation, or conditional release, but
based only on a showing of significant,
new or changed facts or medical
evidence that raise a genuine issue as to
whether the individual should continue
to be subject to Federal quarantine,
isolation, or conditional release. The
written Federal order shall be promptly
served on the individual and the
individual’s authorized advocate or
representatives, except that the Federal
order may be served by publication or
by posting in a conspicuous location if
applicable to a group of individuals and
individual service would be
impracticable.
(n) The Director’s written order shall
not constitute final agency action until
it has been served on the individual and
the individual’s authorized advocate or
representatives, or alternatively, if
applicable to a group of individuals and
individual service would be
impracticable, it is published or posted.
(o) The Director (excluding the CDC
official who issued the quarantine,
isolation, or conditional release order)
may order the consolidation of one or
more medical reviews if the number of
individuals or other factors makes the
holding of individual medical reviews
impracticable.
(p) The Director may issue additional
instructions as may be necessary or
desirable governing the conduct of
medical reviews.
(q) The Director shall arrange for
translation or interpretation services as
needed for purposes of this section.
§ 70.17 Administrative records relating to
Federal quarantine, isolation, or conditional
release.

(a) The administrative record of an
individual under Federal quarantine,
isolation, or conditional release shall,
where applicable, consist of the
following:
(1) The Federal order authorizing
quarantine, isolation, or conditional
release, including any subsequent
Federal orders continuing or modifying
the quarantine, isolation or conditional
release;
(2) Records of any available medical,
laboratory, or other epidemiologic
information that are in the agency’s
possession and that were considered in
issuing the Federal quarantine,

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isolation, or conditional release order,
or any subsequent Federal orders;
(3) Records submitted by the
individual under quarantine, isolation,
or conditional release, or by an
authorized advocate or representatives,
as part of a request for rescission of the
Federal quarantine, isolation, or
conditional release or as part of a
medical review;
(4) The written findings and report of
the medical reviewer, including any
transcripts of the medical review and
any written objections submitted by the
individual under Federal quarantine,
isolation, or conditional release, or by
any authorized advocate or
representatives;
(b) An individual subject to a Federal
public health order shall upon request
be served with a copy of his or her own
administrative record in its entirety.
§ 70.18

Penalties.

(a) Persons in violation of this part are
subject to a fine of no more than
$100,000 if the violation does not result
in a death or one year in jail, or both,
or a fine of no more than $250,000 if the
violation results in a death or one year
in jail, or both, or as otherwise provided
by law.
(b) Violations by organizations are
subject to a fine of no more than
$200,000 per event if the violation does
not result in a death or $500,000 per
event if the violation results in a death
or as otherwise provided by law.
PART 71—FOREIGN QUARANTINE
6. The authority citation for part 71
continues to read as follows:

■

Authority: Secs. 215 and 311 of the Public
Health Service (PHS) Act, as amended (42
U.S.C. 216, 243) section 361–369, PHS Act,
as amended (42 U.S.C. 264–272).

7. Amend § 71.1, paragraph (b), by—
a. Adding in alphabetical order
definitions for ‘‘Airline’’ and
‘‘Apprehension’’;
■ b. Revising the definition of
‘‘Commander’’;
■ c. Adding in alphabetical order
definitions for ‘‘Conditional release’’,
‘‘Contaminated environment’’, and
‘‘Electronic or Internet-based
monitoring’’;
■ d. Revising the definition of ‘‘Ill
person’’;
■ e. Adding in alphabetical order a
definition for ‘‘Indigent’’;
■ f. Revising the definition of
‘‘International voyage’’;
■ g. Adding in alphabetical order
definitions for ‘‘Master or operator’’,
‘‘Medical examination’’, ‘‘Medical
reviewer’’, ‘‘Non-invasive’’, ‘‘Public
health prevention measures’’,
‘‘Representatives’’, and ‘‘Secretary’’.
■
■

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The additions and revisions read as
follows:
§ 71.1

General definitions.

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*

*
*
*
*
(b) * * *
Airline means any air carrier or
foreign air carrier providing air
transportation, as that term is defined in
49 U.S.C. 40102(a)(2), (a)(5), and (a)(21).
Apprehension means the temporary
taking into custody of an individual or
group for purposes of determining
whether quarantine, isolation, or
conditional release is warranted.
*
*
*
*
*
Commander means the pilot in
command of an aircraft as defined in 14
CFR 1.1.
*
*
*
*
*
Conditional release means
surveillance as defined under this part
and includes public health supervision
through in-person visits by a health
official or designee, telephone, or
through any electronic or internet-based
means as determined by the Director.
Contaminated environment means the
presence of an infectious agent on a
surface, including on inanimate articles,
or in a substance, including food, water,
or in the air.
*
*
*
*
*
Electronic or internet-based
monitoring means mechanisms or
technologies allowing for the temporary
public health supervision of an
individual under conditional release
and may include communication
through electronic mail, SMS texts,
video or audio conference, webcam
technologies, integrated voice-response
systems, entry of information into a
web-based forum, wearable tracking
technologies, and other mechanisms or
technologies as determined by the
Director.
Ill person means an individual:
(i) Who if onboard an aircraft:
(A) Has a fever (a measured
temperature of 100.4 °F [38 °C] or
greater, or feels warm to the touch, or
gives a history of feeling feverish)
accompanied by one or more of the
following: Skin rash, difficulty
breathing, persistent cough, decreased
consciousness or confusion of recent
onset, new unexplained bruising or
bleeding (without previous injury),
persistent diarrhea, persistent vomiting
(other than air sickness), headache with
stiff neck, appears obviously unwell; or
(B) Has a fever that has persisted for
more than 48 hours; or
(C) Has symptoms or other indications
of communicable disease, as the
Director may announce through posting
of a notice in the Federal Register.

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(ii) Who if onboard a vessel:
(A) Has a fever (a measured
temperature of 100.4 °F [38 °C] or
greater; or feels warm to the touch; or
gives a history of feeling feverish)
accompanied by one or more of the
following: Skin rash, difficulty
breathing or suspected or confirmed
pneumonia, persistent cough or cough
with bloody sputum, decreased
consciousness or confusion of recent
onset, new unexplained bruising or
bleeding (without previous injury),
persistent vomiting (other than sea
sickness), headache with stiff neck; or
(B) Has a fever that has persisted for
more than 48 hours; or
(C) Has acute gastroenteritis, which
means either diarrhea, defined as three
or more episodes of loose stools in a 24hour period or what is above normal for
the individual, or vomiting
accompanied by one or more of the
following: One or more episodes of
loose stools in a 24-hour period,
abdominal cramps, headache, muscle
aches, or fever (temperature of 100.4 °F
[38 °C] or greater); or
(D) Has symptoms or other
indications of communicable disease, as
the Director may announce through
posting of a notice in the Federal
Register.
Indigent means an individual whose
annual family income is below 200% of
the applicable poverty guidelines
updated periodically in the Federal
Register by the U.S. Department of
Health and Human Services under the
authority of 42 U.S.C. 9902(2) or, if no
income is earned, liquid assets totaling
less than 15% of the applicable poverty
guidelines.
*
*
*
*
*
International voyage means:
(i) In the case of a carrier, a voyage
between ports or airports of more than
one country, or a voyage between ports
or airports of the same country if the
ship or aircraft stopped in any other
country on its voyage; or
(ii) In the case of a person, a voyage
involving entry into a country other
than the country in which that person
begins his/her voyage.
*
*
*
*
*
Master or operator with respect to a
vessel, means the sea crew member with
responsibility for vessel operation and
navigation, or a similar individual with
responsibility for a carrier. Consistent
with the definition of ‘‘operate’’ in 14
CFR 1.1, ‘‘operator’’ means, with respect
to aircraft, any person who uses, causes
to use or authorizes to use aircraft, for
the purpose (except as provided in 14
CFR 91.13) of air navigation including
the piloting of aircraft, with or without

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the right of legal control (as owner,
lessee, or otherwise).
Medical examination means the
assessment of an individual by an
authorized and licensed health worker
to determine the individual’s health
status and potential public health risk to
others and may include the taking of a
medical history, a physical examination,
and collection of human biological
samples for laboratory testing as may be
needed to diagnose or confirm the
presence or extent of infection with a
quarantinable communicable disease.
Medical reviewer means a physician,
nurse practitioner, or similar medical
professional qualified in the diagnosis
and treatment of infectious diseases
who is appointed by the Secretary or
Director to conduct medical reviews
under this part and may include an HHS
or CDC employee, provided that the
employee differs from the CDC official
who issued the Federal order for
quarantine, isolation, or conditional
release.
*
*
*
*
*
Non-invasive means procedures
conducted by an authorized public
health worker (i.e., an individual with
education and training in the field of
public health) or another individual
with suitable public health training and
includes the visual examination of the
ear, nose, and mouth; temperature
assessments using an ear, oral,
cutaneous, or noncontact thermometer,
or thermal imaging; and other
procedures not involving the puncture
or incision of the skin or insertion of an
instrument or foreign material into the
body or a body cavity excluding the ear,
nose, and mouth.
*
*
*
*
*
Public health prevention measures
means the assessment of an individual
through non-invasive procedures and
other means, such as observation,
questioning, review of travel
documents, records review, and other
non-invasive means, to determine the
individual’s health status and potential
public health risk to others.
Representatives means a physician,
nurse practitioner, or similar medical
professional qualified in the diagnosis
and treatment of infectious diseases,
and an attorney who is knowledgeable
of public health practices, who are
appointed by the Secretary or Director
and may include HHS or CDC
employees, to assist an indigent
individual under Federal quarantine,
isolation, or conditional release with a
medical review under this part.
*
*
*
*
*
Secretary means the Secretary of
Health and Human Services (HHS) or

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any other officer or employee of that
Department to whom the authority
involved has been delegated.
*
*
*
*
*
■ 8. Revise § 71.2 to read as follows:
§ 71.2

Penalties.

(a) Persons in violation of this part are
subject to a fine of no more than
$100,000 if the violation does not result
in a death or one year in jail, or both,
or a fine of no more than $250,000 if the
violation results in a death or one year
in jail, or both, or as otherwise provided
by law. (b) Violations by organizations
are subject to a fine of no more than
$200,000 per event if the violation does
not result in a death or $500,000 per
event if the violation results in a death
or as otherwise provided by law.
■ 9. Add 71.4 to subpart A to read as
follows:

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§ 71.4 Requirements relating transmission
of airline passenger, crew and flight
information for public health purposes.

(a) Any airline with a flight arriving
into the United States, including any
intermediate stops between the flight’s
origin and final destination, shall make
the data elements in paragraph (b) of
this section available to the Director for
passengers or crew who, as determined
by the Director, may be at risk of
exposure to a communicable disease, to
the extent that such data are already
available and maintained by the airline,
within 24 hours of an order by the
Director and in a format available and
acceptable to both the airline and the
Director.
(b) The data elements referred to in
paragraph (a) of this section include:
(1) Full name (last, first, and, if
available, middle or others);
(2) Date of birth;
(3) Sex;
(4) Country of residence;
(5) If a passport is required: Passport
number, passport country of issuance,
and passport expiration date;
(6) If a travel document other than a
passport is required: Travel document
type, travel document number, travel
document country of issuance and
travel document expiration date;
(7) Address while in the United States
(number and street, city, State, and zip
code), except that U.S. citizens and
lawful permanent residents will provide
address of permanent residence in the
U.S. (number and street, city, State, and
zip code);
(8) Primary contact phone number to
include country code;
(9) Secondary contact phone number
to include country code;
(10) Email address;
(11) Airline name;

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(12) Flight number;
(13) City of departure;
(14) Departure date and time;
(15) City of arrival;
(16) Arrival date and time; and
(17) Seat number.
(c) No later than February 18, 2019,
the Secretary or Director will publish
and seek comment on a report
evaluating the burden of this section on
affected entities and duplication of
activities in relation to mandatory
passenger data submissions to DHS/
CBP. The report will specifically
recommend actions that streamline and
facilitate use and transmission of any
duplicate information collected.
■ 10. Add § 71.5 to subpart A to read as
follows:

(14) Embarkation port and date;
(15) Disembarkation port and date;
(16) All port stops; and
(17) Cabin number.
(c) No later than February 21, 2019,
the Secretary or Director will publish
and seek comment on a report
evaluating the burden of this section on
affected entities and duplication of
activities in relation to mandatory
passenger data submissions to DHS/
CBP. The report will specifically
recommend actions that streamline and
facilitate use and transmission of any
duplicate information collected.
■ 11. Add § 71.20 to subpart C to read
as follows:

§ 71.5 Requirements relating transmission
of vessel passenger, crew, and voyage
information for public health purposes.

(a) The Director may conduct public
health prevention measures, at U.S.
ports of entry or other locations, through
non-invasive procedures as defined in
section 71.1 to detect the potential
presence of communicable diseases.
(b) As part of the public health
prevention measures, the Director may
require individuals to provide contact
information such as U.S. and foreign
addresses, telephone numbers, email
addresses, and other contact
information, as well as information
concerning their intended destination,
health status, known or possible
exposure history, and travel history.
■ 12. Add §§ 71.29 and 71.30 to subpart
D to read as follows:

(a) The operator of any vessel carrying
13 or more passengers (excluding crew)
and, which is not a ferry as defined
under 46 U.S.C. 2101 and U.S. Coast
Guard (USCG) regulations (46 CFR 2.10–
25), shall make the data elements in
paragraph (b) of this section available to
the Director for passengers or crew who,
as determined by the Director, may be
at risk of exposure to a communicable
disease, to the extent that such data are
already in the operator’s possession,
within 24 hours of an order by the
Director and in a format available and
acceptable to both the operator and the
Director.
(b) The data elements referred to in
paragraph (a) of this section include:
(1) Full name (last, first, and, if
available middle or others);
(2) Date of birth;
(3) Sex;
(4) Country of residence;
(5) If a passport is required: Passport
number, passport country of issuance,
and passport expiration date;
(6) If a travel document other than a
passport is required: Travel document
type, travel document number, travel
document country of issuance and
travel document expiration date;
(7) Address while in the United States
(number and street, city, State, and zip
code), except that U.S. citizens and
lawful permanent residents will provide
address of permanent residence in the
United States (number and street, city,
State, and zip code; as applicable);
(8) Primary contact phone number to
include country code;
(9) Secondary contact phone number
to include country code;
(10) Email address;
(11) Vessel operator;
(12) Vessel name;
(13) Voyage number;

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§ 71.20 Public health prevention measures
to detect communicable disease.

§ 71.29 Administrative records relating to
quarantine, isolation, or conditional release.

(a) The administrative record of an
individual under quarantine, isolation,
or conditional release shall, where
applicable, consist of the following:
(1) The Federal order authorizing
quarantine, isolation, or conditional
release, including any subsequent
Federal orders continuing or modifying
the quarantine, isolation or conditional
release;
(2) Records of any available medical,
laboratory, or other epidemiologic
information that are in the agency’s
possession and that were considered in
issuing the Federal quarantine,
isolation, or conditional release order,
or any subsequent Federal orders;
(3) Records submitted by the
individual under quarantine, isolation,
or conditional release, or by an
authorized advocate or representatives,
as part of a request for rescission of the
quarantine, isolation, or conditional
release or as part of a medical review;
(4) The written findings and report of
the medical reviewer, including any
transcripts of the medical review and
any written objections submitted by the

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individual under Federal quarantine,
isolation, or conditional release, or by
an authorized advocate or
representatives;
(b) An individual subject to a Federal
public health order shall, upon request,
be served with a copy of his or her own
administrative record in its entirety.

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§ 71.30

Payment for care and treatment.

(a) The Director may authorize
payment for the care and treatment of
individuals subject to medical
examination, quarantine, isolation, and
conditional release, subject to
paragraphs (b) through (h) of this
section.
(b) Payment for care and treatment
shall be in the Director’s sole discretion
and subject to the availability of
appropriations.
(c) Payment shall be secondary to the
obligation of the United States or any
third-party (including any State or local
governmental entity, private insurance
carrier, or employer), under any other
law or contractual agreement, to pay for
such care and treatment, and shall be
paid by the Director only after all thirdparty payers have made payment in
satisfaction of their obligations.
(d) Payment may include costs for
providing ambulance or other medical
transportation when such services are
deemed necessary by the Director for
the individual’s care and treatment.
(e) Payment shall be limited to those
amounts the hospital, medical facility,
or medical transportation service would
customarily bill the Medicare system
using the International Classification of
Diseases, Clinical Modification (ICD–
CM), and relevant regulations
promulgated by the Centers for
Medicare and Medicaid Services in
existence at the time of billing.
(f) For quarantinable communicable
diseases, payment shall be limited to
costs for services and items reasonable
and necessary for the care and treatment
of the individual for the time period
beginning when the Director refers the
individual to the hospital or medical
facility and ends when, as determined
by the Director, the period of
apprehension, quarantine, isolation, or
conditional release expires.
(g) For diseases other than those
described in paragraph (f) of this
section, such payment shall be limited
to costs for services and items
reasonable and necessary for care and
treatment of the individual for the time
period that begins when the Director
refers the individual to the hospital or
medical facility and ends when the
individual’s condition is diagnosed, as
determined by the Director, as an illness

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other than a quarantinable
communicable disease.
(h) For ambulance or other medical
transportation, payment shall be limited
to the costs for such services and other
items reasonable and necessary for the
safe medical transport of the individual.
■ 13. Amend § 71.33 by revising
paragraphs (a) and (c) to read as follows:
§ 71.33 Persons: Isolation and
surveillance.

(a) The Director will arrange for
adequate food and water, appropriate
accommodation, appropriate medical
treatment, and means of necessary
communication for persons who are
apprehended or held in isolation or
quarantine under this subpart.
*
*
*
*
*
(c) Every person who is placed under
surveillance by authority of this subpart
shall, during the period of surveillance:
(1) Give information relative to his/
her health and his/her intended
destination and submit to surveillance,
including electronic and internet-based
monitoring as required by the Director
or by the State or local health
department having jurisdiction over the
areas to be visited, and report for such
medical examinations as may be
required.
(2) Inform the Director prior to
departing the United States or prior to
traveling to any address other than that
stated as the intended destination.
*
*
*
*
*
■ 14. Add §§ 71.36 through 71.39 to
subpart D to read as follows:
Sec.

*

*

*

*

*

71.36 Medical examinations.
71.37 Requirements relating to the issuance
of a Federal order for quarantine,
isolation, or conditional release.
71.38 Mandatory reassessment of a Federal
order for quarantine, isolation, or
conditional release (surveillance).
71.39 Medical review of a Federal order for
quarantine, isolation, or conditional
release.
§ 71.36

Medical examinations.

(a) The Director may require that an
individual arriving into the United
States undergo a medical examination
as part of a Federal order for quarantine,
isolation, or conditional release.
(b) The Director shall promptly
arrange for the medical examination to
be conducted when one is required
under this section and shall as part of
the Federal order advise the individual
that the medical examination shall be
conducted by an authorized and
licensed health worker, and with prior
informed consent.
(c) As part of the medical
examination, the Director may require

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that an individual provide information
and undergo such testing, as may be
reasonably necessary, to diagnose or
confirm the presence, absence, or extent
of infection with a quarantinable
communicable disease.
(d) Individuals reasonably believed to
be infected, based on the results of a
medical examination, may be isolated,
or if such results are inconclusive or
unavailable, individuals may be
quarantined or conditionally released in
accordance with this part.
§ 71.37 Requirements relating to the
issuance of a Federal order for quarantine,
isolation, or conditional release.

(a) A Federal order authorizing
quarantine, isolation, or conditional
release shall be in writing, signed by the
Director, and contain the following
information:
(1) The identity of the individual or
group subject to the order;
(2) The location of the quarantine or
isolation or, in the case of conditional
release, the entity to who and means by
which the individual shall report for
public health supervision;
(3) An explanation of the factual basis
underlying the Director’s reasonable
belief that the individual is exposed to
or infected with a quarantinable
communicable disease;
(4) An explanation that the Federal
order will be reassessed no later than 72
hours after it has been served and an
explanation of the medical review of the
Federal order pursuant to this part,
including the right to request a medical
review, present witnesses and testimony
at the medical review, and to be
represented at the medical review by
either an advocate (e.g., an attorney,
family member, or physician) at the
individual’s own expense, or, if
indigent, to have representatives
appointed at the government’s expense;
(5) An explanation of the criminal
penalties for violating a Federal order of
quarantine, isolation, or conditional
release; and
(6) An explanation that if a medical
examination is required as part of the
Federal order that the examination will
be conducted by an authorized and
licensed health worker, and with prior
informed consent.
(b) A Federal order authorizing
quarantine, isolation, or conditional
release shall be served on the individual
no later than 72 hours after the
individual has been apprehended,
except that the Federal order may be
published or posted in a conspicuous
location if applicable to a group of
individuals and individual service
would be impracticable.

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Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Rules and Regulations
(c) The Director shall arrange for
translation or interpretation services of
the Federal order as needed.
(d) Nothing in these regulations shall
affect the constitutional or statutory
rights of individuals to obtain judicial
review of their federal detention.

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§ 71.38 Mandatory reassessment of a
Federal order for quarantine, isolation, or
conditional release (surveillance).

(a) The Director (excluding the CDC
official who issued the quarantine,
isolation, or conditional release order)
shall reassess the need to continue the
quarantine, isolation, or conditional
release of an individual no later than 72
hours after the service of the Federal
order.
(b) As part of the reassessment, the
Director (excluding the CDC official
who issued the quarantine, isolation, or
conditional release order) shall review
all records considered in issuing the
Federal order, including travel records,
records evidencing exposure or
infection with a quarantinable
communicable disease, as well as any
relevant new information.
(c) As part of the reassessment, and
where applicable, the Director
(excluding the CDC official who issued
the quarantine, isolation, or conditional
release order) shall consider and make
a determination regarding whether less
restrictive alternatives would
adequately serve to protect the public
health.
(d) At the conclusion of the
reassessment, the Director (excluding
the CDC official who issued the
quarantine, isolation, or conditional
release order) shall promptly issue a
written Federal order directing that the
quarantine, isolation, or conditional
release be continued, modified, or
rescinded.
(e) In the event that the Director
orders that the quarantine, isolation, or
conditional release be continued or
modified, the written Federal order
shall explain the process for requesting
a medical review under this part.
(f) The Director’s written Federal
order shall be promptly served on the
individual, except that the Federal order
may be served by publication or by
posting in a conspicuous location if
applicable to a group of individuals and
individual service would be
impracticable.
(g) The Director shall arrange for
translation or interpretation services of
the Federal order as needed.
§ 71.39 Medical review of a Federal order
for quarantine, isolation, or conditional
release.

(a) The Director shall, as soon as
practicable, arrange for a medical review

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upon a request by an individual under
Federal quarantine, isolation, or
conditional release.
(b) A request for a medical review
may only occur after the Director’s
mandatory reassessment under 71.38
and following the issuance and service
of a Federal order continuing or
modifying the quarantine, isolation, or
conditional release.
(c) The medical review shall be for the
purpose of ascertaining whether the
Director has a reasonable belief that the
individual is infected with a
quarantinable communicable disease.
(d) The Director shall notify the
individual in writing of the time and
place of the medical review.
(e) The Director (excluding the CDC
official who issued the quarantine,
isolation, or conditional release order)
shall designate a medical reviewer to
review the medical or other evidence
presented at the review, make medical
or other findings of fact, and issue a
recommendation concerning whether
the Federal order for quarantine,
isolation, or conditional release should
be rescinded, continued, or modified.
(f) The individual subject to Federal
quarantine, isolation, or conditional
release may authorize an advocate (e.g.,
an attorney, family member, or
physician) at his or her own expense to
submit medical or other evidence and,
in the medical reviewer’s discretion, be
allowed to present a reasonable number
of medical experts. The Director shall
appoint representatives at government
expense to assist the individual for
purposes of the medical review upon a
request and certification, under penalty
of perjury, by that individual that he/
she is indigent.
(g) Prior to the convening of the
review, the individual or his/her
authorized advocate or representatives
shall be provided a reasonable
opportunity to examine the available
medical and other records involved in
the medical review pertaining to that
individual.
(h) The Director shall take such
measures that he/she determines to be
reasonably necessary to allow an
individual under Federal quarantine or
isolation to communicate with any
authorized advocate or representatives
in such a manner as to prevent the
possible spread of the quarantinable
communicable disease.
(i) The medical reviewer may order a
medical examination of an individual
when, in the medical reviewer’s
professional judgment, such an
examination would assist in assessing
the individual’s medical condition.
(j) As part of the review, and where
applicable, the medical reviewer shall

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consider and accept into the record
evidence concerning whether less
restrictive alternatives would
adequately serve to protect public
health.
(k) The medical review shall be
conducted by telephone, audio or video
conference, or through other means that
the medical reviewer determines in his/
her discretion are practicable for
allowing the individual under
quarantine, isolation, or conditional
release to participate in the medical
review.
(l) At the conclusion of the review,
the medical reviewer shall, based upon
his or her review of the facts and other
evidence made available during the
medical review, issue a written report to
the Director (excluding the CDC official
who issued the quarantine, isolation, or
conditional release order) concerning
whether, in the medical reviewer’s
professional judgment, the Federal
quarantine, isolation, or conditional
release should continue. The written
report shall include a determination
regarding whether less restrictive
alternatives would adequately serve to
protect public health. The written report
shall be served on the individual and
the individual’s authorized advocate or
representatives.
(m) The Director (excluding the CDC
official who issued the quarantine,
isolation, or conditional release order)
shall, as soon as practicable, review the
written report and any objections that
may be submitted by the individual or
the individual’s advocate or
representatives that contest the findings
and recommendation contained in the
medical reviewer’s written report. Upon
conclusion of the review, the Director
(excluding the CDC official who issued
the quarantine, isolation, or conditional
release order) shall promptly issue a
written Federal order directing that the
quarantine, isolation, or conditional
release be continued, modified, or
rescinded. In the event that the Director
(excluding the CDC official who issued
the quarantine, isolation, or conditional
release order) continues or modifies the
Federal quarantine, isolation, or
conditional release, the Director’s
written order shall include a statement
that the individual may request that the
Director rescind the Federal quarantine,
isolation, or conditional release, but
based only on a showing of significant,
new or changed facts or medical
evidence that raise a genuine issue as to
whether the individual should continue
to be subject to Federal quarantine,
isolation, or conditional release. The
written Federal order shall be promptly
served on the individual and the
individual’s authorized advocate or

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representatives, except that the Federal
order may be served by publication or
by posting in a conspicuous location if
applicable to a group of individual’s and
individual service would be
impracticable.
(n) The Director’s written order shall
not constitute final agency action until
it has been served on the individual or
the individual’s authorized advocate or
representatives, or alternatively, if
applicable to a group of individuals and
individual service would be
impracticable, it is published or posted.
(o) The Director (excluding the CDC
official who issued the quarantine,
isolation, or conditional release order)
may order the consolidation of one or
more medical reviews if the number of
individuals or other factors makes the
holding of individual medical reviews
impracticable.
(p) The Director may issue additional
instructions as may be necessary or

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desirable governing the conduct of
medical reviews.
(q) The Director shall arrange for
translation or interpretation services as
needed for purposes of this section.
■ 15. Add § 71.63 to subpart F to read
as follows:
§ 71.63 Suspension of entry of animals,
articles, or things from designated foreign
countries and places into the United States.

(a) The Director may suspend the
entry into the United States of animals,
articles, or things from designated
foreign countries (including political
subdivisions and regions thereof) or
places whenever the Director
determines that such an action is
necessary to protect the public health
and upon a finding that:
(1) There exists in a foreign country
(including one or more political
subdivisions and regions thereof) or
place a communicable disease the
introduction, transmission, or spread of

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which would threaten the public health
of the United States; and
(2) The entry of imports from that
country or place increases the risk that
the communicable disease may be
introduced, transmitted, or spread into
the United States.
(b) The Director shall designate the
foreign countries or places and the
period of time or conditions under
which the introduction of imports into
the United States shall be suspended.
The Secretary or Director will
coordinate in advance with other
Federal agencies that have overlapping
authority in the regulation of entry of
animals, articles, or other things, as may
be necessary to implement and enforce
this provision.
Dated: January 9, 2017.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2017–00615 Filed 1–12–17; 4:15 pm]
BILLING CODE 4163–18–P

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