[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Rules and Regulations]
[Pages 6890-6978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00615]



[[Page 6889]]

Vol. 82

Thursday,

No. 12

January 19, 2017

Part IV





Department of Health and Human Services





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42 CFR Parts 70 and 71





Control of Communicable Diseases; Final Rule

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

[[Page 6890]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Parts 70 and 71

[CDC Docket No. CDC-2016-0068]
RIN 0920-AA63


Control of Communicable Diseases

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Final rule.

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SUMMARY: 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.

DATES: 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 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.

Table of Contents

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 (Sec. Sec.  70.1 and 71.1(b))
    C. Apprehension and Detention of Persons With Quarantinable 
Communicable Diseases (70.6)
    D. Medical Examinations (Sec. Sec.  70.12 and 71.36)
    E. Requirements Relating to the Issuance of a Federal Order for 
Quarantine, Isolation, or Conditional Release (Sec. Sec.  70.14 and 
71.37)
    F. Mandatory Reassessment of a Federal Order for Quarantine, 
Isolation, or Conditional Release (Sec. Sec.  70.15 and 71.38)
    G. Medical Review of a Federal Order for Quarantine, Isolation, 
or Conditional Release (Sec. Sec.  70.16 and 71.39)
    H. Administrative Records Relating to a Federal Order for 
Quarantine, Isolation, or Conditional Release (Sec. Sec.  70.17 and 
71.29)
    I. Payment for Care and Treatment (70.13 and 71.30)
    J. Agreements (Sec. Sec.  70.18 and 71.40)
    K. Penalties (Sec. Sec.  70.18 and 71.2)
    L. Public Health Prevention Measures To Detect Communicable 
Disease (Sec. Sec.  70.10 and 71.20)
    M. Requirements Relating to Travelers Under a Federal Order of 
Isolation, Quarantine, or Conditional Release (Sec.  70.5)
    N. Report of Death or Illness Onboard Aircraft Operated by an 
Airline (Sec.  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 (Sec. Sec.  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 (Sec. Sec.  71.4 and 
71.5)
    Q. Report of Death or Illness (Sec.  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
    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

[[Page 6891]]

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 non-invasive 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 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 post-exposure 
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 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 large-scale 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 ``non-invasive'' aligns with 
common perceptions of what constitutes non-invasive 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 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).
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    \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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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 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-
by-section 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[emsp14][deg]F [38[deg]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.

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 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 (Sec. Sec.  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 (Sec. Sec.  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 (Sec. Sec.  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 
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 (Sec. Sec.  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 (Sec. Sec.  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 (Sec. Sec.  70.18 and 71.40)

    These provisions have been removed.

K. Penalties (Sec. Sec.  70.18 and 71.2)

    The content of these provisions has been finalized as proposed. 
Proposed Sec.  70.19 Penalties has been moved to Sec.  70.18, since 
proposed Sec.  70.18 Agreements has been removed from this final rule.

L. Public Health Prevention Measures To Detect Communicable Disease 
(Sec. Sec.  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

[[Page 6894]]

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 
(Sec.  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 (Sec.  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 (Sec.  71.63)

    This provision has been finalized as proposed with the exception 
that references to CDC have been replaced with Director throughout this 
section.

Q. Report of Death or Illness (Sec.  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 compel vaccination or involuntary 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).

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

[[Page 6895]]

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 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 21-day 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 21-day 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.
     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 
non-evidence-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.

[[Page 6896]]

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, 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 
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

[[Page 6897]]

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/notice-proposed-rulemaking-control-communicable-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 relevant 
Federal and State agencies to 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 communicate with family or legal 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

[[Page 6898]]

apprehending and quarantining travelers entering the US or traveling 
between States, who have not been vaccinated with MMR (measles-mumps-
rubella 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 
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 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.

[[Page 6899]]

    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 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 anti-
psychotic drugs to prison inmates); Sell v. United States, 539 U.S. 166 
(2003)(upholding certain strict due process protections before any 
involuntary administration of anti-psychotic 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 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 border-search 
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 
special-needs doctrine articulated by the

[[Page 6900]]

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 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 cross-examine 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 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 Federal law enforcement programs, but

[[Page 6901]]

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.
c. Definitions

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.
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-to-human 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 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.
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 in-person 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 cross-
reference 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.
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, SMS texts, video or audio conference, webcam 
technologies, integrated voice-response 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

[[Page 6902]]

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 use.
    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 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-hour period, abdominal cramps, headache, muscle 
aches, or fever (temperature of 100.4[emsp14][deg]F [38 [deg]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 non-
threatening 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.
    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

[[Page 6903]]

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 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 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-deaths-illnesses.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

[[Page 6904]]

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.
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 
examination should include a mental 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 decision-
makers 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.
Non-Invasive
    HHS/CDC received several comments concerning the definition of Non-
invasive, 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 non-invasive 
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,

[[Page 6905]]

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 non-symptomatic 
people who have been exposed to Ebola. HHS/CDC disagrees with both 
comments. For instance, a patient diagnosed with multidrug-resistant 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 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 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

[[Page 6906]]

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 non-invasive 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 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 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

[[Page 6907]]

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.
Secretary
    HHS/CDC has added a definition for Secretary meaning 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.
    After consideration of comments regarding Definitions, HHS/CDC has 
made the following changes in the final rule:
     The definition of Agreements has been withdrawn.
     The definition of Conditional Release under section 70.1 
has been modified to remove the internal cross-reference to the 
definition of surveillance under section 71.1. The definition of 
Conditional Release under section 70.1 has been further modified to 
align with 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 in-person visits, telephone, 
or through electronic or internet-based monitoring.''
     The definition of Electronic or internet-based monitoring 
has been modified to indicate ``communication through'' such means, and 
include ``audio'' conference.
     The definition of Incubation period has been modified to 
add ``or, if signs and symptoms do not appear, the latest date signs 
and symptoms could reasonably be expected to appear.'' This 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 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 and 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.''
d. Public Health Prevention Measures To Detect Communicable Disease
    HHS/CDC received support from commenters on screening individuals 
entering the U.S. from parts of the world where highly infectious 
diseases are common. One such commenter requested to know the criteria 
HHS/CDC uses when deciding whether to detain an individual. Another 
commenter stated that travel history ``should be a prerequisite for 
Federal orders to quarantine'' and ``medical exam should be a 
prerequisite for Federal orders to isolate.'' HHS/CDC thanks these 
commenters and welcomes the opportunity to explain this process.
    HHS/CDC's decision to detain an individual is based on several 
criteria, including: Clinical manifestations: Signs and symptoms 
consistent with those of a quarantinable communicable disease; known or 
suspected contact with cases, i.e., patients either confirmed or 
suspected to be infected with a quarantinable communicable 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 disease; 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 
(Sec. Sec.  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 wait-
times 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

[[Page 6908]]

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 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 (Sec. Sec.  70.10 and 71.20) to 
include information about ``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.

[[Page 6909]]

    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 
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 ``pre-
deprivation'' 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 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

[[Page 6910]]

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 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 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 (Sec.  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

[[Page 6911]]

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 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 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

[[Page 6912]]

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 (Sec. Sec.  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 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 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

[[Page 6913]]

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 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 (Sec. Sec.  
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/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

[[Page 6914]]

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 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 (Sec. Sec.  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 disease-causing agent, availability of treatment options 
should the disease not be adequately contained, the patient's 
particular level of infectivity or 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

[[Page 6915]]

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 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 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 re-evaluate the continued need for 
the Federal public health order based on a review of the medical and 
other evidence submitted into the record.

[[Page 6916]]

    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 
(Sec. Sec.  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.''
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 (Sec. Sec.  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 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.

[[Page 6917]]

    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.
    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 decision-maker. 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 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/09-20-0171.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

[[Page 6918]]

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 ``super-enhanced 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 
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 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 (Sec. Sec.  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

[[Page 6919]]

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 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 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;

[[Page 6920]]

     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 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 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 
vaccine-associated 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

[[Page 6921]]

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/reporting-deaths-illness/guidance-reporting-onboard-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 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 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

[[Page 6922]]

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 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 
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

[[Page 6923]]

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 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 
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 non-
quarantinable 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/non-substantive 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/non-substantive 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

[[Page 6924]]

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 Sec.  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 24-hour period, abdominal cramps, 
headache, muscle aches, or fever (temperature of 100.4 [deg]F [38 
[deg]C] or greater)'' in Sec.  71.1 General definitions. This language 
was quoted verbatim in the preamble of the NPRM at 81 FR 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 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

[[Page 6925]]

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 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 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

[[Page 6926]]

of denying boarding and these situations may need to be addressed on a 
case-by-case 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 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 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 (Sec.  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,

[[Page 6927]]

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 responsibility. HHS/CDC disagrees. We 
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 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

[[Page 6928]]

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, SARS-coronavirus, 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 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 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

[[Page 6929]]

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 special-needs 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 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 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

[[Page 6930]]

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 
post-exposure 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 implement temporary animal import 
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 annualized costs and benefits are estimated to be much less than 
$100 million in any given year.
---------------------------------------------------------------------------

    \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/summary-unfunded-mandates-reform-act. Accessed January 2016.
---------------------------------------------------------------------------

    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 non-status 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:
    [cir] 30% arrive more than three days after a request,
    [cir] 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

[[Page 6931]]

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 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 Sec.  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 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

[[Page 6932]]

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.
---------------------------------------------------------------------------

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

    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    Codification of
           Provision                    only          existing authority
------------------------------------------------------------------------
Sec.   70.1/Sec.   71.1         No \a\.............  Yes (except
 General Definitions.                                 definition of
                                                      ``ill person'').
Sec.   70.5 Requirements        Yes................  Yes.
 relating to travelers under a
 federal order of isolation,
 quarantine, or conditional
 release.
Sec.   70.6 Apprehension and    Yes................  Yes.
 detention of persons with
 specific diseases; Sec.
 71.32 Persons, carriers, and
 things (no change to title).
Sec.   70.10/Sec.   71.20       Yes \b\............  Yes.
 Public health prevention
 measures to detect
 communicable disease.
Sec.   70.11 Report of death    Yes................  Yes.
 or illness onboard aircraft
 operated by an airline.
Sec.   70.12/Sec.   71.36       Yes................  Yes.
 Medical examinations.
Sec.   70.13/Sec.   71.30       Yes \c\............  Yes.
 Payment for Care and
 Treatment.
Sec.   70.14/Sec.   71.37       Yes................  Yes.
 Requirements relating to the
 issuance of a Federal order
 for quarantine, isolation, or
 conditional release.
Sec.   70.15/Sec.   71.38       Yes................  Yes.
 Mandatory reassessment of a
 federal order for quarantine,
 isolation, or conditional
 release.
Sec.   70.16/Sec.   71.39       Yes................  Yes.
 Medical review of a federal
 order for quarantine,
 isolation, or conditional
 release.
Sec.   70.17/Sec.   71.29       Yes................  Yes.
 Administrative records
 relating to federal
 quarantine, isolation, or
 conditional release.
Sec.   70.18/Sec.   71.2        Yes................  Yes.
 Penalties.
Sec.   71.4 Requirements        No \a\.............  Yes.
 relating to collection,
 storage and transmission of
 airline passenger, crew and
 flight information for public
 health purposes.
Sec.   71.5 Requirements        No \a\.............  Yes.
 relating to collection,
 storage and transmission of
 vessel passenger, crew, and
 voyage information for public
 health purposes.
Sec.   71.33 Persons:           Yes................  Yes.
 Isolation and surveillance.
Sec.   71.63 Suspension of      Yes \d\............  Yes.
 entry of animals, articles,
 or things from designated
 foreign countries and places
 into the United States.
------------------------------------------------------------------------
\a\ Analyzed in RIA.
\b\ The costs and benefits associated with the 2014-2016 Ebola enhanced
  risk assessment and management program are used to illustrate the
  costs and benefits in a separate appendix.
\c\ In a separate appendix, an analysis of previous HHS/CDC payments for
  care and treatment is provided. However, the provisions in the Final
  Rule are not expected to lead to a change in HHS/CDC policy under
  which HHS/CDC may act as the payer of last resort for individuals
  subject to medical examination, quarantine, isolation, and conditional
  release under Federal orders.
\d\ In a separate appendix, HHS/CDC provides an analysis of this
  provision based on past experience when HHS/CDC implemented an
  immediate embargo on the importation of all rodents from Africa.

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

[[Page 6933]]

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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 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\
---------------------------------------------------------------------------

    \9\ Gasta[ntilde]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.
---------------------------------------------------------------------------

    Among air travelers exposed to measles during flights, post-
exposure prophylaxis (PEP) with measles-containing vaccine (within 72 
hours) or immune globulin (within 6 days) can prevent onset of 
disease,\10\ halting outbreaks before they begin. However, 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.
---------------------------------------------------------------------------

    \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.
    \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.
---------------------------------------------------------------------------

    Measles outbreaks can have substantial associated costs. One model-
based 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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    In the absence of interventions by public health departments, 
travelers

[[Page 6934]]

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 self-monitoring 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     Lower bound     Upper bound      Source citation (RIA,
              Category                   estimate        estimate        estimate           preamble, etc.)
----------------------------------------------------------------------------------------------------------------
                                                    BENEFITS
----------------------------------------------------------------------------------------------------------------
Annual monetized routine benefits            $12,218              $0         $12,218  RIA.
 from reduced effort by CDC and
 health department to search for
 exposed contacts (0% discount rate).
Annual monetized routine benefits            $97,828         $26,337        $272,958  RIA.
 from reduced illness (0% discount
 rate).
Total annual monetized routine              $110,045         $26,337        $285,175  RIA.
 benefits (0% discount rate).
                                     ------------------------------------------------
Qualitative (unquantified benefits).       To the extent that airlines or vessel      RIA.
                                         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.
----------------------------------------------------------------------------------------------------------------
                                                      COSTS
----------------------------------------------------------------------------------------------------------------
Annual monetized costs for changes                $0              $0        $376,554  RIA.
 to illness reporting (airlines and
 vessel operators, 0% discount rate)
 *.
Annual monetized costs for changes           $12,654              $0         $25,308  RIA.
 to codification of manifest order
 process (airlines and vessel
 operators), 0% discount rate) *.
Annual monetized costs for                   $19,968         $10,959         $28,977  RIA.
 additional activities by health
 department contacting individuals
 exposed to communicable diseases
 during international travel (0%
 discount rate).
Total annual monetized routine costs         $32,622         $10,959        $430,839  RIA.
 (0% discount rate).
                                     ------------------------------------------------

[[Page 6935]]

 
Annual quantified, but unmonetized,                        None                       RIA.
 costs.
                                     ------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
                                                                                                     Number of
             NAICS codes                                   NAICS description                         firms in
                                                                                                     industry
----------------------------------------------------------------------------------------------------------------
481111...............................  Scheduled Passenger Air Transportation...................             264
481112...............................  Scheduled Freight Air Transportation.....................             212
481219...............................  Other Nonscheduled Air Transportation....................             516
483111...............................  Deep Sea Freight Transportation..........................             191
483112...............................  Deep Sea Passenger Transportation........................              54
483113...............................  Coastal and Great Lakes Freight Transportation...........             337
483114...............................  Coastal and Great Lakes Passenger Transportation.........             110
483211...............................  Inland Water Freight Transportation......................             318
483212...............................  Inland Water Passenger Transportation....................             193
----------------------------------------------------------------------------------------------------------------
Statistics of U.S. Businesses, 2013 U.S. all industries.\15\
2012 North American Industry Classification System (NAICS).\16\

    According to a report by the Federal 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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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/us-international-air-passenger-and-freight-statistics-report Accessed on 5/2/2106.
---------------------------------------------------------------------------

    The domestic/international air carrier market is an ever-shifting 
corporate 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.

[[Page 6936]]

    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 non-
quarantinable 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                      Quarantinable
------------------------------------------------------------------------
Measles                               Tuberculosis.
Pertussis                             Viral Hemorrhagic Fevers.
Rabies                                Middle East Respiratory Syndrome
Meningococcal disease                  Coronavirus (MERS).
Varicella
Rubella
------------------------------------------------------------------------

    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 long-duration 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
----------------------------------------------------------------------------------------------------------------
                                                      Persons contacted,  Persons contacted,      Recommended
             Disease                CI initiated if        aircraft             vessels           activities
----------------------------------------------------------------------------------------------------------------
Ebola (Quarantinable)...........  All cases.........  All passengers and  Cruise vessel--any  Monitoring for 21
                                                       crew as of April    passenger or crew   days after last
                                                       2016. In the        who made have       potential
                                                       future, the         come into contact   exposure.
                                                       recommendation      with the index
                                                       may change to       case's body
                                                       include fewer       fluids while the
                                                       passengers and      index case was
                                                       crew.               symptomatic.
                                                                          Cargo vessel--all
                                                                           on board the
                                                                           vessel while the
                                                                           index case was
                                                                           symptomatic.

[[Page 6937]]

 
Measles (Non-quarantinable).....  All cases if        Passengers seated   Direct face-to-     Offer MMR
                                   notification        within 2 rows       face contact or     vaccination if
                                   received within     either direction    shared confined     non-immune and
                                   21 days of flight.  of the index        space >1 hour       <72 hrs. since
                                                       case, all babies-   with symptomatic    exposure; immune
                                                       in-arms, crew in    case-patient.       globulin if
                                                       same cabin. All                         indicated and
                                                       passengers and                          within 6 days of
                                                       crew on flights                         exposure.
                                                       with <50 seats.
Meningo-coccal disease (Non-      Case meets the      Passengers or crew  Cruise vessels--    Post-exposure
 quarantinable).                   definition of       sitting directly    Cabin mates of or   chemoprophylaxis.
                                   meningococcal       to the left and     potential for
                                   disease within 14   right of the        direct contact
                                   days of travel.     index case or       with oral or
                                  For air travel:      with potential      respiratory
                                   Flight >8 hrs.      for direct          secretions of
                                   (or shorter         contact with oral   case-patient
                                   flights if direct   or respiratory      during the 7 days
                                   exposure            secretions.         prior to symptom
                                   reported).                              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.
New or reemerging influenza       All cases during    All passengers and  All crew and        Monitoring for 10
 viruses (Quarantinable).          early stages of     crew.               passengers.         days after last
                                   international                                               potential
                                   spread.                                                     exposure;
                                                                                               possible
                                                                                               serologic
                                                                                               testing.
Pertussis (Non-quarantinable)...  All cases if        Passengers sitting  Direct face-to-     Post-exposure
                                   notification is     next to index       face contact or     chemoprophylaxis.
                                   received within     case.               shared confined
                                   21 days of travel.                      space >1 hour
                                                                           with symptomatic
                                                                           case-patient.
Rubella (Non-quarantinable).....  All cases if        Passengers seated   Direct face-to-     Serologic testing
                                   notification is     within 2 rows +     face contact or     and guidance for
                                   received within     crew in same        shared confined     pregnant women.
                                   60 days of travel.  cabin. All          space >1 hour
                                                       passengers and      with symptomatic
                                                       crew on flights     case-patient.
                                                       with <50 seats.
Severe Acute Respiratory          All cases.........  SARS-Coronavirus:   Cruise vessel--any  Monitoring for 10-
 Syndromes (Quarantinable).                            All passengers      passenger or crew   14 days after
                                                       and crew.           who had direct      last potential
                                                      MERS: All            face-to-face        exposure;
                                                       passengers and      contact or shared   potential
                                                       crew contacted      confined space >1   serologic
                                                       during 2014 CIs.    hour with           testing.
                                                       Future CIs will     symptomatic case-
                                                       include             patient.
                                                       passengers seated  Cargo vessel--all
                                                       within 2 rows of    on board the
                                                       index case.         vessel while the
                                                                           index case was
                                                                           symptomatic.
TB (Quarantinable)..............  Notification        Passengers seated   Cargo vessel: All   Aircraft: Testing
                                   received within 3   within 2 rows.      crew members        for latent TB
                                   months of travel,                       within 3 months     infection; chest
                                   clinical criteria                       of diagnosis who    radiograph if the
                                   met For air                             worked with case-   LTBI test is
                                   travel: Flight >8                       patient.            positive.
                                   hrs.                                   Cruise vessel:      Vessels: Clinical
                                                                           Passenger travel    assessment for
                                                                           companions or       symptoms and
                                                                           crew working in     chest radiograph.
                                                                           close proximity/
                                                                           sharing living
                                                                           quarters.
Varicella (Non-quarantinable)...  All cases on        NA................  Any person who has  Varicella
                                   vessels.                                had >=5 minutes     vaccination if
                                                                           of direct face-to-  unvaccinated/non-
                                                                           face contact with   immune and <3
                                                                           a varicella case    days since
                                                                           during the          exposure
                                                                           infectious period.  (possibly up to 5
                                                                                               days). High-risk
                                                                                               contacts
                                                                                               evaluated
                                                                                               Varicella Zoster
                                                                                               immune globulin
                                                                                               if <10 days after
                                                                                               exposure.
----------------------------------------------------------------------------------------------------------------

    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 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.
    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

[[Page 6938]]

disease and other diseases. This table also includes CIs undertaken for 
MERS.

   Table 6--International Air Contact Investigations, Average Number of Annual Investigations and Contacts by
                                       Disease, Jan 2010 Through Dec 2015
                                                  [QARS data] a
----------------------------------------------------------------------------------------------------------------
                                                                     Average          Average
            Disease                  Total       Total contacts   investigations   contacts per     Percent of
                                 investigations                      per year          year       total contacts
----------------------------------------------------------------------------------------------------------------
Influenza, avian..............                0               0              0.0             0.0             0.0
MERS Coronavirus \b\..........                2             270              0.3            45.0             1.7
Measles.......................               94           3,381             15.7           563.5            20.8
Meningococcal disease.........                8               9              1.3             1.5             0.1
Other.........................                3              97              0.5            16.2             0.6
Pertussis.....................               11              18              1.8             3.0             0.1
Rabies........................                3               4              0.5             0.7             0.0
Rubella.......................               17             532              2.8            88.7             3.3
TB (clinically active)........              318          11,928             53.0         1,988.0            73.2
Viral hemorrhagic fever.......                7              53              1.2             8.8             0.3
                               ---------------------------------------------------------------------------------
    Total.....................              463          16,292             77.2           2,715  ..............
----------------------------------------------------------------------------------------------------------------
\a\ In May 2011, CIs were discontinued for international outbound flights. To give a better picture of what CIs
  will look like under this new 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]
----------------------------------------------------------------------------------------------------------------
                                                                  Average number
                                     Total                              of        Average number    Percent of
            Disease              investigations  Total contacts   investigations    of contacts   total contacts
                                                                     per year        per year
----------------------------------------------------------------------------------------------------------------
Measles.......................               72            3033             12.0           505.5            76.1
Meningococcal disease.........                1               1              0.2             0.2             0.0
MERS Coronavirus \a\..........                2             334              0.3            55.7             8.4
Other.........................                0               0              0.0             0.0             0.0
Pertussis.....................               43              83              7.2            13.8             2.1
Rabies........................                3               3              0.5             0.5             0.1
Rubella.......................                8             172              1.3            28.7             4.3
TB (clinically active)........                2              40              0.3             6.7             1.0
Viral hemorrhagic fever.......                4             319              0.7            53.2             8.0
                               ---------------------------------------------------------------------------------
    Total.....................              135           3,985             22.5           664.2
----------------------------------------------------------------------------------------------------------------
Notes:
\a\ For these CIs, contact information for the entire flight was required.
In rare instances, a disease is ruled out after a CI has happened.

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

[[Page 6939]]



            Table 8--Maritime Passenger Data Collection, Average Number of Annual Contacts by Disease
                                          [January 2010-December 2015]
----------------------------------------------------------------------------------------------------------------
                                                                  Average number
                                     Total                              of        Average number    Percent of
     Passengers per voyage       investigations  Total contacts   investigations    of contacts   total contacts
                                                                     per year        per year
----------------------------------------------------------------------------------------------------------------
Measles.......................                5             288             0.83              48             6.3
Meningococcal disease.........                3              22              0.5            3.67             0.5
MERS Coronavirus **...........                0               0                0               0             0.0
Other.........................                1               9             0.17             1.5             0.2
Pertussis.....................                3              14              0.5            2.33             0.3
Rabies........................                0               0                0               0             0.0
Rubella.......................                2              26             0.33            4.33             0.6
TB (clinically active)........               50             585              8.3            97.5            12.8
Viral hemorrhagic fever.......                0               0                0               0             0.0
Varicella (chickenpox) \a\....              206           3,627             34.3           604.5            79.3
                               ---------------------------------------------------------------------------------
    Total.....................              270           4,571               45           761.8           100.0
----------------------------------------------------------------------------------------------------------------
\a\ One CI for varicella involved entire crew of the vessel (1224).

Traveler Manifest Orders for Airlines
    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 multi-step 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 ``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. 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

[[Page 6940]]

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/guidance-reporting-onboard-deaths-illnesses.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 (``info-only 
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]
----------------------------------------------------------------------------------------------------------------
                                                                                   Reports not
                                                    Based on                         based on
                                                    symptoms        Based on         symptoms
             Year                  Category        included in      symptoms       included in         Total
                                                     current       included in    either current
                                                   regulation      final rule     regulation or
                                                                                    final rule
----------------------------------------------------------------------------------------------------------------
2015.........................  Info-only.......              30              55               43             128
                               Response........              33              22               15              70
2014.........................  Info-only.......              33              61               42             136
                               Response........              19              36               12              67
2013.........................  Info-only.......              31              46               29             106
                               Response........              21              25                4              50
2012.........................  Info-only.......              34              58               38             130
                               Response........              12              18                2              32
2011.........................  Info-only.......              27              39               25              91
                               Response........              25              29               13              67
------------------------------------------------
Average, Info-only.............................              31            51.8             35.4           118.2
Average Response...............................              22              26              9.2            57.2
Average, total.................................              53            77.8             44.6           175.4
----------------------------------------------------------------------------------------------------------------
 In addition to illness reports, HHS/CDC receives an average of 10 death reports during air travel each year.
  Since death reporting requirements are not changing, these are not analyzed.


[[Page 6941]]

    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]
----------------------------------------------------------------------------------------------------------------
                                                                                   Reports not
                                                    Based on                         based on
                                                    symptoms        Based on         symptoms
         Year               Type of report        included  in      symptoms       included in         Total
                                                     current      included  in    either current
                                                   regulation      final rule     regulation or
                                                                                    final rule
----------------------------------------------------------------------------------------------------------------
2015.................  Info-only...............               5               4                4              13
                       Response................             179              21                1             201
2014.................  Info-only...............               6               3                3              12
                       Response................             168              21               12             201
2013.................  Info-only...............               1               1                3               5
                       Response................             145              48               11             204
2012.................  Info-only...............               5               7                3              15
                       Response................             167              19                1             187
2011.................  Info-only...............               1               3                4               8
                       Response................             196              32               19             247
------------------------------------------------
Average, Info-only.............................             3.6             3.6              3.4            10.6
Average Response...............................             171            28.2              8.8             208
Average, total.................................           174.6            31.8             12.2           218.6
----------------------------------------------------------------------------------------------------------------
 In addition to the illness reports reported in the table, HHS/CDC receives about 115 reports of death during
  maritime travel each year. In 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
    [cir] a manifest to determine where the index case was seated in 
relation to other passengers or crew members,
    [ssquf] HHS/CDC then requests information available from DHS' 
databases to verify or obtain passenger contact information not 
included in the manifest.
    [ssquf] 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 disease-specific 
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 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 x (reduction in HHS/CDC and health department staff time/resources 
per contact) x 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

[[Page 6942]]

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 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-time-per-contact. On the 
other hand, the traveler-specific time tends to increase-per-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).
---------------------------------------------------------------------------

    \21\ Margaret S. Coleman, unpublished data.
---------------------------------------------------------------------------

    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 local level within a State. A couple of examples:
---------------------------------------------------------------------------

    \22\ Coleman, 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.
---------------------------------------------------------------------------

     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\
---------------------------------------------------------------------------

    \23\ Personal communication from states to Dr. Margaret S. 
Coleman 2010.
---------------------------------------------------------------------------

     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\
---------------------------------------------------------------------------

    \24\ Discussion between Dr. Brian Maskery, Dr. Margaret S. 
Coleman and State and County Health Department contacts 11/21/2014.
---------------------------------------------------------------------------

    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 post-exposure 
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 case-travelers 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

[[Page 6943]]

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    The majority of travelers exposed to measles on aircraft (~74%) had 
pre-existing 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 pre-existing 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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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 post-exposure prophylaxis (just 11 out of 248 
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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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
    [cir] 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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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 passenger-contacts.\31\ Among 3,375 (74%) 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 
passenger-contacts 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\
---------------------------------------------------------------------------

    \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.
    \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.
---------------------------------------------------------------------------

    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

[[Page 6944]]

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \35\ Mangili A, Gendreau MA. Transmission of infectious diseases 
during commercial air travel. Lancet. 2005;365:989-96.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.

                      Table 12--Estimated Transmission Rate on Plane for Exposed Travelers
----------------------------------------------------------------------------------------------------------------
                                                                                 Estimated transmission rate on
                                                                                 aircraft to exposed passengers
                  Disease                                   R0                 ---------------------------------
                                                                                  Lower bound      Upper bound
----------------------------------------------------------------------------------------------------------------
Diphtheria (quarantinable)................  11 to 14..........................          0.0026           0.0074
Measles (non-quarantinable)...............  15 to 17..........................          0.0034           0.0095
Meningococcal Disease (non-quarantinable).  NA................................         <2/1000          <4/1000
Pertussis (non-quarantinable).............  4 to 5............................           0.001            0.003
Rubella (non-quarantinable)...............  9 to 10...........................           0.002            0.006
TB (quarantinable)........................  NA................................            0.19             0.24
----------------------------------------------------------------------------------------------------------------

Estimated Number of Cases in Traveler Contacts
    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    For viral hemorrhagic fevers and MERS, there is no evidence of 
transmission, but there have not been very many observations.

[[Page 6945]]



          Table 13--Annual Estimated Number of Cases Among International Passenger Contacts by Disease
----------------------------------------------------------------------------------------------------------------
                                                     Expected        Expected
                                                     incidence       incidence       Expected        Expected
       Passengers per flight          Number of        among           among      number of  new  number of  new
                                       contacts      contacts        contacts      cases  (lower   cases  (upper
                                                   (lower bound)   (upper bound)      bound)          bound)
----------------------------------------------------------------------------------------------------------------
MERS Coronavirus (quarantinable)...          101                         Insufficient data
                                                 ---------------------------------------------------------------
Measles (non-quarantinable)........        1,069          0.0034          0.0095             3.6            10.1
Meningococcal Disease (non-                  1.7         0.00200         0.00400          0.0033          0.0067
 quarantinable)....................
Pertussis (non-quarantinable)......         16.8           0.001           0.003            0.02            0.04
Rubella (non-quarantinable)........          117           0.002           0.006             0.2             0.7
TB \a\ (quarantinable).............        1,995        \b\ 0.19        \b\ 0.24        \c\ 18.9       \c\ 47.90
                                                 ---------------------------------------------------------------
Viral Hemorrhagic Fever                     62.0                         Insufficient data
 (quarantinable)...................
                                    ----------------------------------------------------------------------------
    Total..........................        3,362  ..............  ..............            22.8            58.7
----------------------------------------------------------------------------------------------------------------
\a\ For tuberculosis, travelers contacts are typically found to test positive for infection, but do not have
  active disease.
\b\ These probabilities indicate the likelihood that a contact will test positive for infection.
\c\ The expected numbers of cases adjust for the finding that only 5-10% of individuals that test positive for
  infection will go on to develop 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.
---------------------------------------------------------------------------

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

  Table 14--Estimate of Costs for Airlines and Vessel Operators To Improve Compliance With HHS/CDC Requests for
                                         Traveler Contact Data, 2015 USD
----------------------------------------------------------------------------------------------------------------
                                                   Increased
                                                   effort to
                                    Average       provide more    Average hourly
                                   number of      complete or     wage rate  of      Overhead
                                   manifest         timelier     IT staff  (2015  multiplier (%)    Total cost
                                 requests  per     passenger           USD)
                                     year         contact data
                                                     (hrs.)
----------------------------------------------------------------------------------------------------------------
Baseline......................             100                6           $63.27             100         $75,924
Best estimate.................             100                1            63.27             100          12,654

[[Page 6946]]

 
Lower bound...................             100                0            63.27             100               0
Upper bound...................             100                2            63.27             100          25,308
----------------------------------------------------------------------------------------------------------------

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 info-only 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 
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 Washington Operations 
Center Complex (6 minutes).\41\
---------------------------------------------------------------------------

    \41\ Personal communication between Dr. Brian Maskery and DOT/
FAA.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \42\ http://www.bls.gov/oes/current/oes_nat.htm.

 Table 15--Changes in Numbers of Info-Only Reports and Associated Costs for the Final Rule Upper Bound, 2015 USD
----------------------------------------------------------------------------------------------------------------
                                                    Amount  of       Estimated
                                     Change in     time required     wage rate       Overhead        Estimated
          Employee type           number of info-   per report     (2015 USD per  multiplier (%)       cost
                                   only  reports       (min)           hr.)
----------------------------------------------------------------------------------------------------------------
Aircraft:
    Aircraft Pilots or Copilots.             119               2          $57.35             100            $455
    CDC employee................             119              60           39.83             100           9,480
    DOT/FAA employees...........             119              26           70.57             100           7,278
    Traveler....................             119              10           23.23               0             461
                                 -------------------------------------------------------------------------------
        Air total...............  ..............  ..............  ..............  ..............          17,213
Vessels:
    Air or maritime conveyance    ..............  ..............  ..............  ..............  ..............
     officer....................
    Captains, Mates, and Pilots                3               2           39.95             100               8
     of Water Vessels...........
    CDC employee................               3              60          439.83             100             239
    Traveler....................               3              10           23.23               0              12
                                 -------------------------------------------------------------------------------
        Maritime total..........  ..............  ..............  ..............  ..............             259
                                 -------------------------------------------------------------------------------
    Total costs, aircraft and     ..............  ..............  ..............  ..............          17,471
     vessels....................
----------------------------------------------------------------------------------------------------------------
Notes: Assumes 100% increase in info-only reports from airlines and 25% from vessel operators.


[[Page 6947]]

    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 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       Estimated
                                    Change  in    time  required     wage rate       Overhead        Estimated
          Employee type              number of      per report     (2015 USD per  multiplier (%)    cost  (2015
                                      reports          (min)           hr.)                            USD)
----------------------------------------------------------------------------------------------------------------
Aircraft:
    Aircraft Pilots or Copilots.              29               2          $57.35             100            $111
    CDC employee................              29               0           39.83             100               0
    DOT/FAA employee............              29              26           70.57             100           1,774
    Traveler....................              29              60           23.23               0             674
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............           2,558
Vessels:
    Captains, Mates, and Pilots               21               2           39.95             100              56
     of Water Vessels...........
    CDC employee................              21               0           39.83             100               0
    Traveler....................              21              60           23.23               0             488
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............             544
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           3,102
----------------------------------------------------------------------------------------------------------------
Notes: Assume 50% increase in air illness and a 10% increase in maritime illness reports requiring response
  (international and interstate).

    There may also be a one-time cost 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 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 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

[[Page 6948]]

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.
---------------------------------------------------------------------------

    \43\ http://www.bls.gov/oes/current/oes_nat.htm.

    Table 17--Estimated Costs for One-Time Training About Changes in Illness Reporting for Airlines, 2015 USD
----------------------------------------------------------------------------------------------------------------
                                                     Amount of
                                                   time required     Estimated                       Estimated
          Employee type              Number of     for training      wage rate       Overhead         cost or
                                     employees     per employee    (2015 USD per  multiplier (%)  benefit  (2015
                                                     (minutes)         hr.)                            USD)
----------------------------------------------------------------------------------------------------------------
Aircraft Pilots or Copilots.....         121,110              10           57.35             100       2,315,220
Flight attendants...............         108,510              10           22.46             100         812,465
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       3,127,685
----------------------------------------------------------------------------------------------------------------


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

    The monetized annual costs resulting from the change in the 
definition of ``ill person'' are summarized in Table 18. The benefits 
in regard to reductions in 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....................................................              $0              $0        $375,751
    Vessels.....................................................               0               0             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.....................         $12,654              $0         $25,308
    70.1 and 71.1 Change in definition of an ``ill person''.....               0               0         376,554
                                                                 -----------------------------------------------
        Total costs.............................................          12,654               0         401,862
----------------------------------------------------------------------------------------------------------------

Benefits From Streamlining the CI 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 x (reduction in HHS/CDC and 
health department staff time/resources per contact) x value of staff 
time.
    HHS/CDC obtained the total number of contacts traced (2,715 per 
year, Table 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 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%)

[[Page 6949]]

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 labor-intensive 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 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......................           2,715        $488,700        $488,700        $977,400
Interstate air contacts.........................             664         119,520         119,520         239,040
Maritime contacts...............................             762         137,160         137,160         274,320
----------------------------------------------------------------------------------------------------------------
    Total baseline costs........................           4,141         745,380         745,380       1,490,760
Viral hemorrhagic fever, MERS, and SARS contacts             163          29,340          29,340          58,680
----------------------------------------------------------------------------------------------------------------


  Table 21--Annual For HHS/CDC and PHDs: Baseline Costs, Final Rule Costs, Benefits With the Final Rule (Number
                        Contacts Annualized From January 2010 to December 2015), 2015 USD
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
                                HHS/CDC and PHD Baseline Costs (Current Practice)
----------------------------------------------------------------------------------------------------------------
                                            Annual number        HHS/CDC                      PHD
                                              contacts
                                         -----------------------------------------------------------------------
International contacts..................             2,715          $488,700                   $488,700
----------------------------------------------------------------------------------------------------------------
                                    HHS/CDC and PHD Costs With the Final Rule
----------------------------------------------------------------------------------------------------------------
                                           Estimated Costs for HHS/CDC After
                                           Efficiency Improvement with Final
                                                         Rule
                                            Estimated Costs for PHDs After
                                           Efficiency Improvement with Final
                                                         Rule
                                         -----------------------------------------------------------------------
                                           0%, Lower bound   3%, Upper bound   0%, Lower bound   2%, Upper bound
                                         -----------------------------------------------------------------------
International contacts costs assuming             $488,700          $474,039          $488,700          $478,926
 reduction in time (2,715)..............
----------------------------------------------------------------------------------------------------------------
                                    Benefits From Implementing the Final Rule
----------------------------------------------------------------------------------------------------------------
                                            HHS/CDC 0% and 3% Reduction in
                                                        effort
                                              PHD (0% and 2% Reduction in
                                                        effort)
                                         -----------------------------------------------------------------------
Benefits (Reduced costs)................                $0           $14,661                $0            $9,774
----------------------------------------------------------------------------------------------------------------

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

[[Page 6950]]



  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      PHD benefits        Total
----------------------------------------------------------------------------------------------------------------
Best estimate...................................................          $7,331          $4,887         $12,218
Lower bound.....................................................               0               0               0
Upper bound.....................................................          14,661           9,774          24,435
----------------------------------------------------------------------------------------------------------------

    The total annual monetized benefits by stakeholder from the 
potential 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      PHD benefits,
                                                   benefits, USD        USD        Airlines, USD       Total
----------------------------------------------------------------------------------------------------------------
Best estimate...................................          $7,331          $4,887              $0         $12,218
Lower bound.....................................               0               0               0               0
Upper bound.....................................          14,661           9,774               0          24,435
----------------------------------------------------------------------------------------------------------------

Marginal Impact of Final Rule--Measles 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.
---------------------------------------------------------------------------

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

    Among the contacts, HHS/CDC estimates that approximately 25% (141 
contacts per year) cannot be located by 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 x 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
----------------------------------------------------------------------------------------------------------------
                 Description                      n                             Reference
----------------------------------------------------------------------------------------------------------------
Average contacts per year for measles, (a)..     564    Table 6.
Estimated number of contacts for which HHS/       56    Nelson et al. 2013.\47\
 CDC cannot assign to a health department,
 (b) = 10% x (a).

[[Page 6951]]

 
Estimated improvement in HHS/CDC's ability         8.5  Assumption.
 to assign contacts to health department (c)
 = 15% x (b).
Numbers of people who are not currently          141    Nelson et al. 2013.
 contacted due to lack of contact
 information, (d) = (a) x 25%.
Expected numbers of people who could be           21    Assumption.
 contacted with final rule, (e) = (d) x 15%.
Among those contacted, 70% would have             15    Nelson et al. 2013 (Table 2).
 evidence of measles immunity (f) = (e) x
 70%.
Among those contacted, 30% may be                  6    Nelson et al. 2013 (Table 2).
 susceptible to measles (g) = (e) x 30%.
----------------------------------------------------------------------------------------------------------------
\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,                8.5
 (c)....................................................
Additional cost per contact to health department to                 $180
 search for and examine contacts (USD per contact) (h)..
Additional cost to health department to search for                $1,530
 contacts, total (USD), (i) = (c) x (h).................
MMR vaccine price per dose (USD) (j)....................             $39
Vaccine administration (k)..............................             $31
Estimated cost prophylactic measles vaccine per person               $70
 (USD), (l) = (j) + (k).................................
Number of individuals who may receive measles vaccine,                 6
 (g)....................................................
Cost of measles vaccination, total (USD) (m) = (g) x (l)            $420
Total additional annual cost to follow up with more               $1,950
 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 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 
would be adults and would be vaccinated with the measles-mumps-rubella 
(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.
---------------------------------------------------------------------------

    \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.

                                        Table 26--Marginal Impact of Final Rule To Improve Contact Investigations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                                          Average
                                             Additional  names   Addition contacts  travelers provided      Number of  travelers       probability  that
 Marginal cost for measles investigations   provided to health  reached by  health     post-exposure         identified  earlier          contact  is
                                                departments         departments         prophylaxis                                        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

[[Page 6952]]

average cost to public health departments per measles outbreak is 
$250,000 and the upper bound cost is $1 million.\51\
---------------------------------------------------------------------------

    \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).
    \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).
---------------------------------------------------------------------------

    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 x 
0.001 mortality risk reduction = 1 statistical life; 1,000 people each 
willing to pay $1,000 = 1,000 x $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).
---------------------------------------------------------------------------

    \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 Vaccine-Preventable Diseases, 13th Edition--
Measles April 2015 http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/meas.pdf. Accessed 6/13/2016.

                        Table 27--Estimated Illness and Mortality Costs per Measles Case
----------------------------------------------------------------------------------------------------------------
                                                           Best estimate       Lower bound        Upper bound
----------------------------------------------------------------------------------------------------------------
Outpatient cost, a.....................................               $300                $86               $515
Inpatient cost, b......................................            $24,500             $3,943            $45,052
Hospitalization rate, c................................             44.30%              22.0%              66.0%
Case fatality rate, d..................................               0.2%               0.2%               0.2%
VSL, e.................................................         $9,400,000         $4,300,000        $14,200,000
Total cost per case (b x c + a x (1-c) + d x e)........            $29,821             $9,535            $58,309
----------------------------------------------------------------------------------------------------------------

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

    HHS/CDC has not received any 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.

[[Page 6953]]



 Table 29--Estimated Benefits Associated With Improvement of Measles Contact Investigations as a Result of This
                                                   Final Rule
----------------------------------------------------------------------------------------------------------------
                                                           Best estimate       Lower bound        Upper bound
----------------------------------------------------------------------------------------------------------------
Estimated total costs without intervention, j = g + i..           $504,395           $137,146         $1,328,703
Estimated effectiveness of outbreak prevention                         60%                60%                60%
 baseline, k...........................................
Estimated cost of measles outbreaks under baseline, j x           $201,758            $54,858           $531,481
 (1-k).................................................
Estimated effectiveness of outbreak prevention with                    69%                66%                72%
 final rule, l.........................................
Estimated cost of measles outbreaks with final rule, m            $156,363            $46,630           $372,037
 = j x (1-l)...........................................
Estimated benefit associated with final rule, n = j-m..            $45,396             $8,229           $159,444
----------------------------------------------------------------------------------------------------------------

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 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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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 
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\
---------------------------------------------------------------------------

    \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.
    \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.
---------------------------------------------------------------------------

    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.

   Table 30--Baseline Estimated Costs To Conduct Tuberculosis Contact Investigations and To Provide Treatment
----------------------------------------------------------------------------------------------------------------
                                           Number of    Estimated cost
                                           contacts       per contact   Estimated cost            Notes
----------------------------------------------------------------------------------------------------------------
Estimated cost of contact                        1,995            $360        $718,092  Number of contacts from
 investigations.                                                                         Table 13 and cost per
                                                                                         contact from Table 11.
Estimated number of contacts reached             1,496              NA  ..............  Estimated at 75% similar
 by health departments (75%).                                                            to measles from Table
                                                                                         24.
Estimated number of contacts reached               284              NA  ..............  Estimated 19% of
 by health departments and have latent                                                   contacts have LTBI
 TB infection (19% of 75%).                                                              (Table 13).
Number of contacts that never start               79.6               0               0  28% of 284 contacts with
 treatment (28%).                                                                        LTBI.
Number of contacts that complete                 130.8           1,044         136,506  46% of 284 contacts with
 treatment (46%).                                                                        LTBI.
Number of contacts that start, but not            73.9             591          43,677  26% of 284 contacts with
 compete treatment, (26%).                                                               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 = Estimated Costs x 
ROI + Estimated Costs. The estimated benefits are $2.6 million and are 
shown in Table 31 (range: $1.8 million to $3.8 million).

[[Page 6954]]



        Table 31--Baseline Estimated Costs and Benefits for Tuberculosis Contact Investigations, 2015 USD
----------------------------------------------------------------------------------------------------------------
                                         Best estimate    Lower bound     Upper bound             Notes
----------------------------------------------------------------------------------------------------------------
Estimate costs for contact                    $898,260        $898,260        $898,260  Table 30.
 investigations and treatment.
Return on investment from tuberculosis            1.91            1.01            3.20  Coleman et al.
 contact investigations.
Estimated benefits....................       2,613,936       1,805,502       3,772,691  = Cost x ROI + Costs.
----------------------------------------------------------------------------------------------------------------

    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 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) 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             Notes
----------------------------------------------------------------------------------------------------------------
Baseline contact investigation costs..        $718,080        $718,080        $718,080  ........................
Baseline latent tuberculosis treatment        $180,180        $180,180        $180,180  Table 30 costs for
 costs.                                                                                  latent tuberculosis
                                                                                         treatment and testing.
Estimated improvement in health                    10%              5%             15%  Assumed.
 departments' abilities to contact
 exposed travelers.
Estimated increased cost for latent            $18,018          $9,009         $27,027  Estimated cost for
 tuberculosis treatment under final                                                      improvement in contact
 rule.                                                                                   rate as result of final
                                                                                         rule.
Estimated costs under final rule......        $916,278        $907,269        $925,287  Estimated baseline cost
                                                                                         + increased cost as
                                                                                         result of final rule.
Estimated ROI.........................           $1.91           $1.01           $3.20  Table 30.
Estimated benefits for final rule.....      $2,666,368      $1,823,610      $3,886,204  = Cost x ROI + Costs.
 
Estimated costs associated with final          $18,018          $9,009        $27,027.  Calculated from the
 rule.                                                                                   difference in costs for
                                                                                         the final rule--
                                                                                         Baseline costs.
Estimated benefits associated with             $52,432         $18,108        $113,513  Calculated from the
 final rule.                                                                             difference in benefits
                                                                                         for the final rule--
                                                                                         Baseline benefits.
----------------------------------------------------------------------------------------------------------------

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 (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       Lower bound        Upper bound
----------------------------------------------------------------------------------------------------------------
Final rule benefits....................................            $97,828            $26,337           $272,958
Final rule costs.......................................             19,968             10,959             28,977
----------------------------------------------------------------------------------------------------------------
Note: This table includes the sum of results in Tables 29 and 32.

Total Annual Benefits Resulting From 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 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 
and tuberculosis morbidity and mortality (Table 33).

[[Page 6955]]



Table 34--Total Annual Costs and Benefits Associated With Improved Efficiency Public Health Response Activities,
                                                    2015 USD
----------------------------------------------------------------------------------------------------------------
                                                           Best estimate       Lower bound        Upper bound
----------------------------------------------------------------------------------------------------------------
Final rule benefits....................................           $110,045            $26,337           $297,393
Final rule costs.......................................             19,968             10,959             28,977
----------------------------------------------------------------------------------------------------------------

    The benefits and costs associated with improved effectiveness of 
contact investigations (Table 34) can be combined with the increased 
costs to 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 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       Lower bound        Upper bound
----------------------------------------------------------------------------------------------------------------
Final rule benefits....................................           $110,045            $26,337           $297,393
Final rule costs.......................................             32,622             10,959            430,839
----------------------------------------------------------------------------------------------------------------

Other Diseases (Besides Measles and Tuberculosis)
    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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 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 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

[[Page 6956]]

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 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 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).

 Table 36--Estimate of the Costs and Benefits to Airlines and Vessel Operators To Provide Traveler Contact Data,
                                                    2015 USD
----------------------------------------------------------------------------------------------------------------
                                                                                       Less            More
                                                                                    restrictive     restrictive
                                                     Baseline       Final rule      alternative     alternative
                                                                                        \a\             \b\
----------------------------------------------------------------------------------------------------------------
Baseline number of contact investigations.......             100             100               0            97.5
----------------------------------------------------------------------------------------------------------------
                                                      Costs
----------------------------------------------------------------------------------------------------------------
Best estimate...................................              NA         $12,654              $0         $12,338
Lower bound.....................................              NA               0               0               0
Upper bound.....................................              NA          25,308               0          24,802
----------------------------------------------------------------------------------------------------------------
                                                    Benefits
----------------------------------------------------------------------------------------------------------------
Best estimate...................................              NA              $0         $75,924          $1,898
Lower bound.....................................              NA               0          75,924           1,898
Upper bound.....................................              NA               0          75,924           1,898
----------------------------------------------------------------------------------------------------------------
\a\ The less restrictive alternative is less expensive than the status quo, because HHS/CDC does not request
  data from airlines and attempt to provide data to health departments to follow up with exposed travelers.
\b\ The more restrictive alternative also could potentially reduce costs to airlines and vessel operators
  because HHS/CDC would restrict travel to countries undergoing widespread transmission of quarantinable
  communicable diseases such as viral hemorrhagic fevers, MERS or SARS.

Illness Reporting Alternatives
    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
                                     [Effect on info-only reports, 2015 USD]
----------------------------------------------------------------------------------------------------------------
                                   Change in    Amount of time     Estimated                        Estimated
         Employee type          number of info-  required per      wage rate       Overhead      benefit  (cost
                                 only reports    report (min)      (per hr.)    multiplier (%)     reduction)
----------------------------------------------------------------------------------------------------------------
Aircraft:
    Aircraft Pilots or                      60               2          $57.35             100              $229
     Copilots.................

[[Page 6957]]

 
    CDC employee..............              60              60           39.83             100             4,780
    DOT/FAA employees.........              60              26           70.57             100             3,670
    Traveler..................              60              10           23.23               0               232
                               ---------------------------------------------------------------------------------
        Air total.............  ..............  ..............  ..............  ..............             8,911
Vessels:
    Captains, Mates, and                     6               2           39.95             100                16
     Pilots of Water Vessels..
    CDC employee..............               6              60           39.83             100               478
    Traveler..................               6              10           23.23               0                23
                               ---------------------------------------------------------------------------------
        Maritime total........  ..............  ..............  ..............  ..............               517
                               ---------------------------------------------------------------------------------
            Total (Air +        ..............  ..............  ..............  ..............             9,428
             Maritime)........
----------------------------------------------------------------------------------------------------------------
 Assume 50% reduction in reports.


                          Table 38--Less Restrictive Alternative for Illness Reporting
                                [Effect on reports requiring response, 2015 USD]
----------------------------------------------------------------------------------------------------------------
                                   Change in      Amount  of
                                   number of    time  required     Estimated       Overhead         Estimated
         Employee type             info-only       per report      wage rate    multiplier (%)   benefit  (cost
                                    reports          (min)         (per hr.)                       reduction)
----------------------------------------------------------------------------------------------------------------
Aircraft:
    Aircraft pilots or                      29               2          $57.35             100              $111
     copilots.................
    CDC employee..............              29               0           39.83             100
    DOT/FAA employee..........              29              26           70.57             100             1,774
    Traveler..................              29              60           23.23               0               674
                               ---------------------------------------------------------------------------------
        Total.................  ..............  ..............  ..............  ..............             2,558
Vessels:
    Captains, mates, and                   104               2           39.95             100               277
     pilots (masters) of
     vessels..................
    CDC employee..............             104               0           39.83             100
    Traveler..................             104              60           23.23               0             2,416
                               ---------------------------------------------------------------------------------
        Total.................  ..............  ..............  ..............  ..............             2,693
                               ---------------------------------------------------------------------------------
            Total (Air +        ..............  ..............  ..............  ..............             5,251
             Maritime)........
----------------------------------------------------------------------------------------------------------------
Notes: Assume 50% reduction in air illness reports and 15% of maritime illness reports (response, international
  and interstate).

    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
----------------------------------------------------------------------------------------------------------------
                                     Change in      Amount  of       Estimated
                                     number of    time  required     wage rate       Overhead        Estimated
          Employee type              info-only       per report    (2015 USD per  multiplier (%)   cost  ($2015
                                      reports          (min)           hr.)                            USD)
----------------------------------------------------------------------------------------------------------------
Aircraft pilots or copilots.....              88               4          $57.35             100            $673

[[Page 6958]]

 
Captains, mates, and pilots                   33               4           39.83             100             175
 (masters) of vessels...........
                                 -------------------------------------------------------------------------------
    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....................................................              $0              $0        $375,751
    Vessels.....................................................               0               0             802
                                                                 -----------------------------------------------
        Total...................................................               0               0         376,554
Less Restrictive Alternative: \a\
    Aircraft....................................................               0               0               0
    Vessels.....................................................               0               0               0
                                                                 -----------------------------------------------
        Total...................................................               0               0               0
More Restrictive Alternative:
    Aircraft....................................................             673             673         376,424
    Vessels.....................................................             175             175             978
                                                                 -----------------------------------------------
        Total...................................................             848             848         377,402
----------------------------------------------------------------------------------------------------------------
                                                    Benefits
----------------------------------------------------------------------------------------------------------------
Final Rule:
    Aircraft....................................................               0               0               0
    Vessels.....................................................               0               0               0
                                                                 -----------------------------------------------
        Total...................................................               0               0               0
Less Restrictive Alternative: \a\
    Aircraft....................................................          11,469          11,469          11,469
    Vessels.....................................................           3,210           3,210           3,210
                                                                 -----------------------------------------------
        Total...................................................          14,679          14,679          14,679
More Restrictive Alternative:
    Aircraft....................................................               0               0               0
    Vessels.....................................................               0               0               0
                                                                 -----------------------------------------------
        Total...................................................               0               0               0
----------------------------------------------------------------------------------------------------------------
\a\ For the less restrictive scenario, the current reporting requirement is relaxed leading to a reduction in
  costs.

    The total costs of the alternatives 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.....................         $12,654              $0         $25,308

[[Page 6959]]

 
    70.1 and 71.1 Change in definition of an ``ill person''.....               0               0         376,554
                                                                 -----------------------------------------------
        Total costs.............................................          12,654               0         401,862
Less Restrictive Alternative:
    71.4 and 71.5 Passenger data collection.....................               0               0               0
    70.1 and 71.1 Change in definition of an ``ill person''.....               0               0               0
                                                                 -----------------------------------------------
        Total costs.............................................               0               0               0
More Restrictive Alternative:
    71.4 and 71.5 Passenger data collection.....................          12,338               0          24,802
    70.1 and 71.1 Change in definition of an ``ill person''.....             848             848         377,402
                                                                 -----------------------------------------------
        Total costs.............................................          13,186             848         402,204
----------------------------------------------------------------------------------------------------------------
                                                    Benefits
----------------------------------------------------------------------------------------------------------------
Final Rule:
    71.4 and 71.5 Passenger data collection.....................               0               0               0
    70.1 and 71.1 Change in definition of an ``ill person''.....               0               0               0
                                                                 -----------------------------------------------
        Total benefits..........................................               0               0               0
Less Restrictive Alternative:
    71.4 and 71.5 Passenger data collection.....................          75,924          75,924          75,924
    70.1 and 71.1 Change in definition of an ``ill person''.....          14,679          14,679          14,679
                                                                 -----------------------------------------------
        Total benefits..........................................          90,603          90,603          90,603
More Restrictive Alternative:
    71.4 and 71.5 Passenger data collection.....................           1,898           1,898           1,898
    70.1 and 71.1 Change in definition of an ``ill person''.....               0               0               0
                                                                 -----------------------------------------------
        Total benefits..........................................           1,898           1,898           1,898
----------------------------------------------------------------------------------------------------------------

Staff Time for Contact Investigations
    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      PHD  benefits       Total
----------------------------------------------------------------------------------------------------------------
Final Rule:
    Best estimate...............................................          $7,331          $4,887         $12,218
    Lower bound.................................................               0               0               0
    Upper bound.................................................          14,661           9,774          24,435
Less Restrictive Alternative:
    Best estimate...............................................         745,380         745,380       1,490,760
    Lower bound.................................................         745,380         745,380       1,490,760
    Upper bound.................................................         745,380         745,380       1,490,760
More Restrictive Alternative:
    Best estimate...............................................          36,671          34,227          70,898
    Lower bound.................................................          29,340          29,340          58,680
    Upper bound.................................................          44,001          39,114          83,115
----------------------------------------------------------------------------------------------------------------

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, 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: $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

[[Page 6960]]

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......................................................         $45,396          $8,229        $159,444
Less Restrictive Alternative....................................               0               0               0
More Restrictive Alternative....................................          45,396           8,229         159,444
----------------------------------------------------------------------------------------------------------------
                                                      Costs
----------------------------------------------------------------------------------------------------------------
Final Rule......................................................           1,950           1,950           1,950
Less Restrictive Alternative \a\................................         201,758          54,858         531,481
More Restrictive Alternative....................................           1,950           1,950           1,950
----------------------------------------------------------------------------------------------------------------
\a\ For the less restrictive alternative, contact investigations are not performed so the cost can be estimated
  based on the estimated public health benefit of contact investigations performed under the baseline (Table
  29).

Tuberculosis Contact Investigations 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............................         $52,432          18,108         113,513  Table 32.
Less Restrictive Alternative..........         180,180         180,180         180,180  Assumed to be the cost
                                                                                         to provide LTBI
                                                                                         treatment under the
                                                                                         baseline (Table 32).
More Restrictive Alternative..........          52,432          18,108         113,513  The more restrictive
                                                                                         alternative has the
                                                                                         same effect on TB
                                                                                         contact investigations
                                                                                         as the final rule.
----------------------------------------------------------------------------------------------------------------
                                                      Costs
----------------------------------------------------------------------------------------------------------------
Final Rule............................          18,018           9,009          27,027  Table 32.
Less Restrictive Alternative..........      $2,613,936      $1,805,502      $3,772,691  Estimated based on the
                                                                                         benefits of avoided TB
                                                                                         morbidity and mortality
                                                                                         resulting from contact
                                                                                         investigations under
                                                                                         the baseline.
More Restrictive Alternative..........          18,018           9,009          27,027  The more restrictive
                                                                                         alternative has the
                                                                                         same effect on TB
                                                                                         contact investigations
                                                                                         as final rule.
----------------------------------------------------------------------------------------------------------------

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

[[Page 6961]]



  Table 45--Changes in Measles and Tuberculosis Contact Investigations Costs and Benefits Relative to Baseline,
                                                    2015 USD
----------------------------------------------------------------------------------------------------------------
                                                                   Best estimate    Lower bound     Upper bound
----------------------------------------------------------------------------------------------------------------
                                                    Benefits
----------------------------------------------------------------------------------------------------------------
Final Rule......................................................         $97,828         $26,337        $272,958
Less Restrictive Alternative....................................         180,180         180,180        180,180.
More Restrictive Alternative....................................          97,828          26,337         272,958
----------------------------------------------------------------------------------------------------------------
                                                      Costs
----------------------------------------------------------------------------------------------------------------
Final Rule......................................................          19,968          10,959          28,977
Less Restrictive Alternative....................................       2,815,694       1,860,360       4,304,172
More Restrictive Alternative....................................          19,968          10,959          28,977
----------------------------------------------------------------------------------------------------------------
Note: This table includes the sum of results in Tables 43 and 44.

    The total quantified costs and benefits (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..............................................................        $110,045         $26,337        $297,393
Less Restrictive Alternative....................................       1,670,940       1,670,940       1,670,940
More Restrictive Alternative....................................         168,725          85,017         356,073
----------------------------------------------------------------------------------------------------------------
                                                      Costs
----------------------------------------------------------------------------------------------------------------
FR..............................................................          19,968          10,959          28,977
Less Restrictive Alternative....................................       2,815,694       1,860,360       4,304,172
More Restrictive Alternative....................................          19,968          10,959          28,977
----------------------------------------------------------------------------------------------------------------

    The total annual costs and benefits for 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
----------------------------------------------------------------------------------------------------------------
                                                    Benefits
----------------------------------------------------------------------------------------------------------------
Final Rule......................................................        $110,045         $26,337        $297,393
Less Restrictive Alternative....................................       1,780,524       1,780,524       1,780,524
More Restrictive Alternative....................................         170,623          86,915         357,971
----------------------------------------------------------------------------------------------------------------
                                                      Costs
----------------------------------------------------------------------------------------------------------------
Final Rule......................................................          32,622          10,959         430,839
Less Restrictive Alternative....................................       2,815,694       1,860,360       4,304,172
More Restrictive Alternative....................................          33,154          11,807         431,181
----------------------------------------------------------------------------------------------------------------


[[Page 6962]]

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: Sec.  70.5 Requirements relating to 
travelers under a Federal order of isolation, quarantine, or 
conditional release.
    [cir] Baseline and Current Regulatory Provision: Sec.  70.5 Certain 
communicable disease; special requirements.
    [ssquf] 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.
    [cir] Change relative to baseline as result of final rule
    [ssquf] 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.
    [cir] Qualitative benefit/cost of final rule
    [ssquf] Improved transparency for HHS/CDC's ability to allow 
individuals under 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.
    [cir] Monetized benefit/cost of final rule
    [ssquf] 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: Sec.  70.6 Apprehension and detention of 
persons with specific diseases; Sec.  71.32 Persons, carriers, and 
things (no change to title)
    [cir] Baseline and Current Regulatory Provision:
    [ssquf] Under current 42 CFR 70.6 and Sec.  71.32, HHS/CDC has 
regulatory authority to apprehend and detain individuals with 
quarantinable communicable diseases.
    [cir] Change relative to baseline as result of final rule
    [ssquf] 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.
    [cir] Qualitative benefit/cost of final rule
    [ssquf] ;Improved transparency and compliance with Federal orders.
    [cir] Monetized benefit/cost of final rule
    [ssquf] 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: Sec.  70.10 Public health prevention 
measures to detect communicable disease; Sec.  71.20 Public health 
prevention measures to detect communicable disease.
    [cir] Baseline and Current Regulatory Provisions: No explicit 
regulatory provision.
    [ssquf] 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 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.
    [cir] Change relative to baseline as result of final rule
    [ssquf] Improved transparency and potentially improved compliance 
in the event that HHS/CDC implements such measures in the future.
    [cir] Qualitative benefit/cost of final rule
    [ssquf] Improved transparency and public understanding of HHS/CDC's 
rationale and authority to conduct such measures and require 
individuals to comply.
    [cir] Monetized benefit/cost of final rule
    [ssquf] 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: Sec.  70.12 Medical examinations; Sec.  
71.36 Medical Examinations
    [cir] Baseline and Current Regulatory Provisions: 71.33 Persons: 
Isolation and Surveillance.
    [ssquf] 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.
    [cir] Change to baseline as result of final rule
    [ssquf] 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.
    [cir] Qualitative benefit/cost of final rule
    [ssquf] Improved transparency and public understanding of HHS/CDC's 
rationale and authority to conduct such measures and require 
individuals to comply.
    [cir] Monetized benefit/cost of final rule
    [ssquf] Increased clarity around due process procedures may result 
in fewer

[[Page 6963]]

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: Sec.  70.13 Payment for Care and 
Treatment; Sec.  71.30 Payment for Care and Treatment
    [cir] Baseline and Current Regulatory Provisions: No current 
explicit regulatory provision.
    [ssquf] 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.
    [ssquf] 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:
    [ssquf] 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).
    [ssquf] HHS/CDC has not incurred any costs for the care and 
treatment of any individuals besides for those under Federal isolation 
orders.
    [cir] Change to baseline as result of final rule
    [ssquf] Improved transparency around HHS/CDC's authority for, and 
requirements and processes related to payment for care and treatment.
    [cir] Qualitative benefit/cost of final rule
    [ssquf] Improved transparency and public knowledge of HHS/CDC's 
procedures and regulatory requirements.
    [cir] Monetized benefit/cost of final rule
    [ssquf] None. This is a clarification of HHS/CDC's current 
practice. (For more details, please refer to separate RIA Appendix)
     New Provisions: Sec.  70.14 Requirements relating to the 
issuance of a Federal order for quarantine, isolation, or conditional 
release; Sec.  71.37 Requirements relating to the issuance of a Federal 
order for quarantine, isolation, or conditional release
    [cir] Baseline and Current Regulatory Provisions: No current 
explicit regulatory provision
    [ssquf] 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.
    [cir] Change to baseline as result of final rule
    [ssquf] Improved transparency around HHS/CDC's authority for, and 
requirements and processes related to, the issuance of Federal 
quarantine, isolation, and conditional release orders.
    [cir] Qualitative benefit/cost of final rule
    [ssquf] Improved transparency and public knowledge of HHS/CDC's 
procedures and regulatory requirements.
    [cir] Monetized benefit/cost of final rule
    [ssquf] None. This is a clarification of HHS/CDC's current 
practice.
     New Provisions: Sec.  70.15 Mandatory reassessment of a 
Federal order for quarantine, isolation, or conditional release; Sec.  
71.38 Mandatory reassessment of a Federal order for quarantine, 
isolation, or conditional release
    [cir] Baseline and Current Regulatory Provisions: No current 
explicit regulatory provision.
    [ssquf] 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 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.
    [cir] Change to baseline as result of final rule:
    [ssquf] 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.
    [cir] Qualitative benefit/cost of final rule
    [ssquf] Improved transparency and understanding of due process 
protections under a Federal public health order.
    [cir] Monetized benefit/cost of final rule
    [ssquf] 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: Sec.  70.16 Medical review of a Federal 
order for quarantine, isolation, or conditional release; Sec.  71.39 
Medical review of a Federal order for quarantine, isolation, or 
conditional release
    [cir] Baseline and Current Regulatory Provisions: No current 
explicit regulatory provision.
    [ssquf] 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.
    [cir] Change to baseline as result of final rule:
    [ssquf] 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.
    [cir] Qualitative benefit/cost of final rule
    [ssquf] Improved transparency and understanding of due process 
afforded to individuals under a Federal order
    [cir] Monetized benefit/cost of final rule
    [ssquf] Increased clarity around due process protections may result 
in fewer resources and time expended by individuals under orders and 
HHS/CDC

[[Page 6964]]

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.
    [ssquf] 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: Sec.  70.17 Administrative records 
relating to Federal quarantine, isolation, or conditional release; 
Sec.  71.29 Administrative records relating to Federal quarantine, 
isolation, or conditional release
    [cir] Baseline and Current Regulatory Provisions: No current 
explicit regulatory provision.
    [ssquf] 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 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.
    [cir] Change to baseline as result of final rule
    [ssquf] The requirement, with which HHS/CDC is already complying, 
will clarify for the public that certain documents must be retained for 
the administrative record.
    [cir] Qualitative benefit/cost of final rule
    [ssquf] Improved transparency
    [cir] Monetized benefit/cost of final rule
    [ssquf] Not applicable. This is a codification of an administrative 
activity within HHS/CDC.
     New Provisions: Sec.  70.18 Penalties/Sec.  71.2 Penalties
    [cir] Baseline and Current Regulatory Provision: Sec.  71.2 
Penalties. Part 70 currently has no penalties provision.
    [ssquf] 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.
    [cir] Change to baseline as result of final rule
    [ssquf] With the NRPM, there will be less confusion about the 
maximum criminal penalties for a violation of regulations under 42 CFR 
70 and 71.
    [cir] Qualitative benefit/cost of final rule
    [ssquf] Improved transparency and alignment with current law under 
18 U.S.C. 3559 and 3571.
    [cir] 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: Sec.  71.63 Suspension of entry of 
animals, articles, or things from designated foreign countries and 
places into the United States
    [cir] Baseline and Current Regulatory Provision: Sec.  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.
    [ssquf] Without the final rule, individuals may not be aware that 
HHS/CDC's authority to temporarily suspend entry of animals, articles 
or things from designated foreign countries and places into the United 
States based on existing 42 CFR 71.32(b).
    [cir] Change to baseline as result of final rule
    [ssquf] With the NRPM, there will be less confusion about HHS/CDC's 
ability to temporarily restrict importations associated with 
communicable disease risks.
    [cir] Qualitative benefit/cost of final rule
    [ssquf] Improved transparency.
    [cir] Monetized benefit/cost of final rule
    [ssquf] 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.

[[Page 6965]]

     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.
Proposed Projects
    (1) Foreign Quarantine Regulations (42 CFR part 71) (OMB Control 
No. 0920-0134)--Nonmaterial/non-substantive 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/non-substantive 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 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.
    In this final rule, CDC is requesting approval from OMB for 4 non-
substantive 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

[[Page 6966]]

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
----------------------------------------------------------------------------------------------------------------
                                                                                             Average
                                                                                  No. of      burden
                                         Regulatory provision or     No. of     responses      per       Total
          Type of respondent                    form name         respondents      per       response    burden
                                                                                respondent     (in       hours
                                                                                              hours)
----------------------------------------------------------------------------------------------------------------
Maritime Vessel Operators.............  42 CFR 71.21(a) Report          2,000            1       2/60         67
                                         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.
Pilot in Command......................  42 CFR 71.21 (b) Death/         1,700            1       2/60         57
                                         Illness reports from
                                         aircraft.
Maritime Vessel Operators.............  42 CFR 71.21(c) (MIDRS)        17,000            1       3/60        850
                                         Acute Gastro-Enteritis
                                         reports (24 and 4 hours
                                         before arrival).
Maritime Vessel Operators.............  42 CFR 71.21 (c)               17,000            1       3/60        850
                                         Recordkeeping-Medical
                                         logs.
Isolated or Quarantined individuals...  42 CFR 71.33 Report by             11            1       3/60          1
                                         persons in isolation or
                                         surveillance.
Maritime Vessel Operators.............  42 CFR 71.35 Report of              5            1      30/60          3
                                         death/illness during
                                         stay in port.
Importer..............................  42 CFR 71.51(c)(1), (d)--     245,310            1      15/60     61,328
                                         Valid Rabies
                                         Vaccination
                                         Certificates.
Importer..............................  CDC Form 75.37 Notice To        1,400            1      10/60        233
                                         Owners And Importers Of
                                         Dogs: Requirement for
                                         Dog Confinement.
Importer..............................  42 CFR 71.51(c)(i),            43,290            1      15/60     10,823
                                         (ii), and (iii)
                                         exemption criteria for
                                         the importation of a
                                         dog without a rabies
                                         vaccination certificate.
Importer..............................  42 CFR 71.51(c)(2), (d)         1,400            1      15/60        350
                                         Application for a
                                         Permit to Import A Dog
                                         Inadequately Immunized
                                         Against Rabies.
Importer..............................  42 CFR 71.51(b) (3) Dogs/          20            1      15/60          5
                                         cats: Record of
                                         sickness or deaths.
Importer/Filer........................  42 CFR 71.51_CDC               30,000            1      15/60      7,500
                                         Requested Data on
                                         Regulated Imports:
                                         Domestic Dogs and Cats
                                         (PGA Message Set).
Importer..............................  42 CFR 71.52(d) Turtle              5            1      30/60          3
                                         Importation Permits.
Importers.............................  42 CFR 71.55, 42 CFR                5            1          1          5
                                         71.32 Dead Bodies--
                                         Death certificates.
Importer..............................  42 CFR 71.56 (a)(2)                20            1          1         20
                                         African Rodents--
                                         Request for exemption.
Importer..............................  42 CFR 71.56(a)(iii)                2            1          1          2
                                         Appeal.
Importer/Filer........................  42 CFR 71.56 CDC                   60            1      15/60         15
                                         Requested Data on
                                         Regulation Imports:
                                         Live African Rodents
                                         (PGA Message Set).
Importer/Filer........................  42 CFR 71.32 Statements         2,000            1       5/60        167
                                         or documentation of non-
                                         infectiousness.
Importer/Filer........................  42 CFR 71.56, 42 CFR            2,000            1      15/60        500
                                         71.32 CDC Requested
                                         Data on Regulated
                                         Imports: Products of
                                         African Rodents;
                                         Products of all Family
                                         Viverridae (PGA Message
                                         Set).
                                                                 -----------------------------------------------
    Total.............................  ........................  ...........  ...........  .........     82,779
----------------------------------------------------------------------------------------------------------------

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

[[Page 6967]]

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 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
----------------------------------------------------------------------------------------------------------------
                                                                                             Average
                                                                                  No. of      burden     Total
                                                                     No. of     responses      per       burden
          Type of respondent                    Form name         respondents      per       response     (in
                                                                                respondent     (in       hours)
                                                                                              hours)
----------------------------------------------------------------------------------------------------------------
Pilot in command......................  42 CFR 70.11 Report of            190            1       7/60         22
                                         death or illness
                                         onboard aircraft
                                         operated by airline.
Master of vessel or person in charge    42 CFR 70.4 Report by              10            1       7/60          1
 of conveyance.                          the master of a vessel
                                         or person in charge of
                                         conveyance of the
                                         incidence of a
                                         communicable disease
                                         occurring while in
                                         interstate travel.
                                       -------------------------------------------------------------------------
    Total.............................  ........................          200  ...........  .........         23
----------------------------------------------------------------------------------------------------------------

    The total requested burden hours are 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.
    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 
communicable disease of public health concern, occurs during travel to 
the United States and public health follow-up 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

[[Page 6968]]

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
----------------------------------------------------------------------------------------------------------------
                                                                                             Average
                                                                                  No. of      burden     Total
                                                                     No. of     responses      per       burden
          Type of respondent                    Form name         respondents      per       response     (in
                                                                                respondent     (in       hours)
                                                                                              hours)
----------------------------------------------------------------------------------------------------------------
Airline Medical Officer or Equivalent/  International TB                   67            1     360/60        402
 Computer and Information Systems        Manifest Template.
 Manager.
Airline Medical Officer or Equivalent/  International Non-TB               29            1     360/60        174
 Computer and Information Systems        Manifest Template..
 Manager.
                                                                 -----------------------------------------------
    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.

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 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, 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

0
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.


0
2. Amend Sec.  70.1 by--
0
a. Adding in alphabetical order definitions for ``Airline'', 
``Apprehension'', and ``Communicable stage'';
0
b. Revising the definition of ``Conditional release'';
0
c. Adding in alphabetical order a definitions for ``Contaminated 
environment;''
0
d. Revising the definition of ``Conveyance'';
0
e. Adding in alphabetical order definitions for ``Electronic or 
Internet-based monitoring'' and ``Ill person'';
0
f. Revising the definition of ``Incubation period'';
0
g. Adding in alphabetical order a definition for ``Indigent'';
0
h. Revising the definition of ``Interstate traffic'';
0
i. Revising the definition of ``Master or operator'';
0
j. Adding in alphabetical order definitions for ``Medical 
examination'', ``Medical reviewer'', ``Non-invasive'', 
``Precommunicable stage'', ``Public health emergency'', ``Public health

[[Page 6969]]

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


Sec.  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 
in-person 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 [deg]F [38 [deg]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
    (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 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

[[Page 6970]]

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, 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.
* * * * *

0
3. Revise Sec.  70.5 to read as follows:


Sec.  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 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

[[Page 6971]]

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.

0
4. Revise Sec.  70.6 to read as follows:


Sec.  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.

0
5. Add Sec. Sec.  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.
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.


Sec.  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.


Sec.  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.


Sec.  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 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.


Sec.  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 third-party 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,

[[Page 6972]]

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.


Sec.  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 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.


Sec.  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 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.


Sec.  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

[[Page 6973]]

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 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.


Sec.  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, 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.


Sec.  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

0
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).


0
7. Amend Sec.  71.1, paragraph (b), by--
0
a. Adding in alphabetical order definitions for ``Airline'' and 
``Apprehension'';
0
b. Revising the definition of ``Commander'';
0
c. Adding in alphabetical order definitions for ``Conditional 
release'', ``Contaminated environment'', and ``Electronic or Internet-
based monitoring'';
0
d. Revising the definition of ``Ill person'';
0
e. Adding in alphabetical order a definition for ``Indigent'';
0
f. Revising the definition of ``International voyage'';
0
g. Adding in alphabetical order definitions for ``Master or operator'', 
``Medical examination'', ``Medical reviewer'', ``Non-invasive'', 
``Public health prevention measures'', ``Representatives'', and 
``Secretary''.

[[Page 6974]]

    The additions and revisions read as follows:


Sec.  71.1   General definitions.

* * * * *
    (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 [deg]F [38 [deg]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.
    (ii) Who if onboard a vessel:
    (A) Has a fever (a measured temperature of 100.4 [deg]F [38 [deg]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 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-
hour period, abdominal cramps, headache, muscle aches, or fever 
(temperature of 100.4 [deg]F [38 [deg]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 
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

[[Page 6975]]

any other officer or employee of that Department to whom the authority 
involved has been delegated.
* * * * *

0
8. Revise Sec.  71.2 to read as follows:


Sec.  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.

0
9. Add 71.4 to subpart A to read as follows:


Sec.  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;
    (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.

0
10. Add Sec.  71.5 to subpart A to read as follows:


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

    (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;
    (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.

0
11. Add Sec.  71.20 to subpart C to read as follows:


Sec.  71.20   Public health prevention measures to detect communicable 
disease.

    (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.

0
12. Add Sec. Sec.  71.29 and 71.30 to subpart D to read as follows:


Sec.  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

[[Page 6976]]

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.


Sec.  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 third-party 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 
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.

0
13. Amend Sec.  71.33 by revising paragraphs (a) and (c) to read as 
follows:


Sec.  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.
* * * * *

0
14. Add Sec. Sec.  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.


Sec.  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 
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.


Sec.  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.

[[Page 6977]]

    (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.


Sec.  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.


Sec.  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 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 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

[[Page 6978]]

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 desirable governing the conduct of medical reviews.
    (q) The Director shall arrange for translation or interpretation 
services as needed for purposes of this section.

0
15. Add Sec.  71.63 to subpart F to read as follows:


Sec.  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 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