[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)]
[Proposed Rules]
[Pages 54230-54316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18103]



[[Page 54229]]

Vol. 81

Monday,

No. 157

August 15, 2016

Part II





 Department of Health and Human Services





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42 CFR Parts 70 and 71





Control of Communicable Diseases; Proposed Rule

  Federal Register / Vol. 81 , No. 157 / Monday, August 15, 2016 / 
Proposed Rules  

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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: Notice of Proposed Rulemaking (NPRM).

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SUMMARY: Through this Notice of Proposed Rulemaking (NPRM), the Centers 
for Disease Control and Prevention (CDC) in the Department of Health 
and Human Services (HHS) is amending its domestic (interstate) and 
foreign quarantine regulations to best protect the public health of the 
United States. These amendments are being proposed to aid public health 
responses to outbreaks of communicable diseases such as the largest 
recorded outbreak of Ebola virus disease (Ebola) in history, the recent 
outbreak of Middle East Respiratory Syndrome (MERS) in South Korea, and 
repeated outbreaks and responses to measles in the United States, as 
well as the ongoing threat of other new or re-emerging communicable 
diseases. The provisions contained herein provide additional clarity to 
various safeguards to prevent the importation and spread of 
communicable diseases affecting human health into the United States and 
interstate.

DATES: Written or electronic comments on the NPRM must be received by 
October 14, 2016.
    Paperwork Reduction Act Public Comments: Submit written or 
electronic comments by October 14, 2016. Please see the Paperwork 
Reduction Act section for instructions on how to submit comments.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0068 or RIN 0920-AA63 by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Division of Global Migration and Quarantine, Centers 
for Disease Control and Prevention, 1600 Clifton Road NE., MS E-03, 
Atlanta, GA 30329, ATTN: Quarantine NPRM.
    Instructions: All submissions received must include the agency name 
and docket number or Regulatory Information Number (RIN) for this 
rulemaking. All relevant comments received will be posted without 
change to http://www.regulations.gov, including any personal 
information provided. For access to the docket to read background 
documents or comments received, go to http://www.regulations.gov.
    Comments will also be available for public inspection from Monday 
through Friday, except for legal holidays, from 9 a.m. to 5 p.m., 
Eastern Time, at 1600 Clifton Road NE., Atlanta, Georgia 30329. Please 
call ahead to 404-498-1600 and ask for a representative from the 
Division of Global Migration and Quarantine (DGMQ) to schedule your 
visit.

FOR FURTHER INFORMATION CONTACT: For information regarding this NPRM: 
Ashley A. Marrone, J.D., Division of Global Migration and Quarantine, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
E03, Atlanta, GA 30329. For information regarding CDC operations 
related to this NPRM: ATTN: Nicole J. Cohen, M.D., Division of Global 
Migration and Quarantine, Centers for Disease Control and Prevention, 
1600 Clifton Road NE., MS-E03, Atlanta, GA 30329. Either may also be 
reached by telephone 404-498-1600 or email [email protected].

SUPPLEMENTARY INFORMATION: The NPRM is organized as follows:

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. Historical Background for This Rulemaking
IV. Rationale for Notice of Proposed Rulemaking
V. Ongoing Efforts With DHS/CBP To Improve Passenger Data Collection
VI. Summary of Notice of Proposed Rulemaking
    A. Updates to Part 70
    1. Section 70.1 General Definitions
    2. Section 70.5 Requirements Relating to Travelers Under a 
Federal Order of Isolation, Quarantine, or Conditional Release
    3. Section 70.6 Apprehension and Detention of Persons With 
Quarantinable Communicable Diseases
    4. Section 70.10 Public Health Prevention Measures To Detect 
Communicable Disease
    5. Section 70.11 Report of Death or Illness Onboard Aircraft 
Operated by Airline
    6. Section 70.12 Medical Examinations
    7. Section 70.13 Payment for Care and Treatment
    8. Section 70.14 Requirements Relating to Issuance of a Federal 
Order for Quarantine, Isolation, or Conditional Release
    9. Section 70.15 Mandatory Reassessment of a Federal Order for 
Quarantine, Isolation, or Conditional Release
    10. Section 70.16 Medical Review of a Federal Order for 
Quarantine, Isolation, or Conditional Release
    11. Section 70.17 Administrative Records Relating to a Federal 
Order for Quarantine, Isolation, or Conditional Release
    12. Section 70.18 Agreements
    13. Section 70.19 Penalties
    B. Updates to Part 71
    1. Section 71.1 Definitions
    2. Section 71.2 Penalties
    3. Section 71.4 Requirements Relating to Collection, Storage, 
and Transmission of Airline Passenger, Crew, and Flight Information 
for Public Health Purposes
    4. Section 71.5 Requirements Relating To Collection, Storage and 
Transmission of Vessel Passenger, Crew and Voyage Information for 
Public Health Purposes
    5. Section 71.20 Public Health Prevention Measures To Detect 
Communicable Disease
    6. Section 71.29 Administrative Records Relating to a Federal 
Order for Quarantine, Isolation, or Conditional Release
    7. Section 71.30 Payment for Care and Treatment
    8. Section 71.36 Medical Examinations
    9. Section 71.37 Requirements Relating to Issuance of a Federal 
Order for Quarantine, Isolation, or Conditional Release
    10. Section 71.38 Mandatory Reassessment of a Federal Order for 
Quarantine, Isolation, or Conditional Release
    11. Section 71.39 Medical Review of a Federal Order for 
Quarantine, Isolation, or Conditional Release
    12. Section 71.40 Agreements
    13. Section 71.63 Suspension of Entry of Animals, Articles, or 
Things From Designated Foreign Countries and Places Into the United 
States
VII. Alternatives Considered
VIII. Required Regulatory Analyses
    A. Executive Orders 12866 and 13563
    B. The Regulatory Flexibility Act
    C. Paperwork Reduction Act of 1995
    D. National Environmental Policy Act (NEPA)
    E. E.O. 12988: Civil Justice Reform
    F. E.O. 13132: Federalism
    G. 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 which protect U.S. public health from communicable 
diseases, including quarantinable communicable diseases as specified in 
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 proposed 
rulemaking was reinforced during HHS/CDC's response to the largest 
outbreak of Ebola virus disease (Ebola) on record,

[[Page 54231]]

followed by the recent outbreak of Middle East Respiratory Syndrome 
(MERS) in South Korea, both quarantinable communicable diseases, and 
repeated outbreaks and responses to measles, a non-quarantinable 
communicable disease of public health concern, in the United States. 
The provisions contained within this proposal will enhance HHS/CDC's 
ability to prevent the further importation 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 NPRM include new 
proposed public health definitions; new proposed regulatory language 
codifying HHS/CDC's activities concerning implementation of non-
invasive public health prevention measures (i.e., traveler health 
screening) at U.S. ports and other U.S. locations (i.e., railway 
stations, bus terminals); and proposed provisions for affording persons 
served with a Federal public health order (e.g., isolation, quarantine) 
with due process, 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.
    In addition, the domestic portion of this NPRM also proposes 
reporting requirements for commercial passenger flights of death or 
illness to CDC; a provision allowing for implementation of travel 
restrictions and issuance of travel permits by CDC for individuals 
under Federal quarantine, isolation, or conditional release orders, or 
in response to a state or local request for assistance; and 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,'' which 
determines whether such an individual may be apprehended or examined 
for potential infection with a quarantinable communicable disease. The 
foreign portion of this NPRM also proposes new regulatory authority 
permitting the CDC Director to prohibit the importation of animals or 
products that pose a threat to public health. HHS/CDC is also proposing 
to change the text of the current regulation to reflect modern 
terminology, technology, and plain language currently used by private 
industry, public health partners, and the public. The NPRM further 
authorizes expanded forms of public health monitoring, beyond an in-
person visit by a public health officer, for individuals who are 
reasonably believed to be exposed to or infected with a quarantinable 
communicable disease and subject to a conditional release order. This 
would include monitoring through electronic and internet-based means, 
such as email and webcam application tools. Finally, while neither 
modifying nor authorizing additional criminal penalties for violations 
of quarantine rules and regulations, this NPRM 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 NPRM. The economic impact analysis of 
this NPRM is subdivided into four sections.
    The first analysis is of proposed 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 provide 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 
($35,785, range $10,959 to $65,644) because the NPRM primarily codifies 
existing practice or improves alignment between existing regulatory 
text as well as the International Civil Aviation Organization (ICAO)'s 
guidelines for symptoms to report. The cost estimates in this NPRM are 
based on an anticipated small increase in the number of illness reports 
delivered by airlines and processed by HHS/CDC and 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. 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 NPRM are 
$117,376 (range $26,337 to $312,054) 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 proposed in this NPRM, 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 larger scale public health and medical consequences like Ebola.
    The second analysis in this NPRM 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 
existing regulations in 42 CFR parts 70 and 71 including due process 
rights for individuals. HHS/CDC believes that such clarity is an 
important qualitative benefit of the provisions proposed in this NPRM, 
but it is not able to monetize this increase in clarity in a robust 
way. Although the provisions updated in this NPRM do not provide HHS/
CDC with new regulatory authority, the 2014-16 Ebola Entry Risk 
Assessment program is used the demonstrate the economic impact of the 
implementation of activities associated with these authorities.
    The third analysis is of the proposed 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 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. Because this analysis deals only with transfer payments 
between HHS/CDC, any marginal costs to HHS/CDC associated with a change 
in payments would correspond exactly to a benefit to healthcare 
facilities. In the absence of the NPRM, the only possible change to the 
current baseline is an

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unanticipated precedent-changing event, which would require an increase 
in payments from HHS/CDC to healthcare treatment facilities. The 
resulting extreme upper bound estimate of the provisions in the NPRM 
would be a benefit of $500,000 to HHS/CDC and a corresponding cost to 
healthcare facilities of $500,000.
    The fourth analysis is of the impact of the proposed 42 CFR 71.63: 
Suspension of entry of animals, articles, or things from designated 
foreign countries and places into the United States. In this NPRM, HHS/
CDC is elucidating its authority to temporarily suspend entry of 
animals, articles or things from designated foreign countries and 
places into the United States. HHS/CDC cannot predict how often such 
authority may be used in the future or for what animal, article or 
thing. 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).'' This 
embargo was necessary to halt transmission of a monkeypox outbreak in 
the United States, which caused 71 cases (16 hospitalized). Most cases 
resulted from contact with prairie dogs after monkeypox had been 
transmitted from African rodents to prairie dogs as part of the U.S. 
pet trade.
    A simple economic impact analysis of this embargo is performed to 
demonstrate the costs and benefits of such actions, but HHS/CDC does 
not anticipate an increase in frequency of such actions based on the 
provisions included in this NPRM. The primary purpose of the analysis 
is to demonstrate potential costs and benefits using a realistic 
example. Based on this simple analysis, the annual cost associated with 
the embargo of African rodents is estimated to be around $19,000. An 
average of 959 rodents per year were imported in the three years 
preceding the embargo (2000-2002). In comparison a very conservative 
estimate of some of the cost of the monkeypox outbreak is $3.3 million 
inclusive of illness costs to persons contracting monkeypox in the 
United States, a portion of HHS/CDC and local and state health 
department monkeypox outbreak response costs, and a one-time cost to 
the U.S. domestic prairie dog market. Comparing the benefits associated 
with the avoidance of a re-introduction of the monkeypox virus to the 
United States with the annual costs to the African rodent import 
market, the benefits of the embargo are likely to greatly exceed the 
cost. The permanent restriction of African rodent imports to the United 
States was later codified in current 42 CFR 71.56.

II. Public Participation

    Interested persons or organizations are invited to participate in 
this rulemaking by submitting written views, recommendations, and data 
on all aspects of the proposed rule. Comments received should reference 
a specific portion of the rule, and inclusion of any attachments and 
other supporting materials, are part of the public record and subject 
to public disclosure. Do not include any information in your comment or 
supporting materials that you consider confidential or inappropriate 
for public disclosure. HHS/CDC will carefully consider and address all 
comments submitted and may revise the content of the rule as 
appropriate at the final rulemaking stage. HHS/CDC will publish a final 
rule after the comment period that reflects any content changes made as 
a result of comments received. As emphasized in the text below, HHS/CDC 
would appreciate public comment on data collection and any privacy 
concerns associated with this process, public health prevention 
measures, contact tracing, medical review process, and the availability 
of assistance for individuals who are indigent.

III. Background

A. Legal Authority

    The primary legal authority supporting this rulemaking is sections 
361 and 362 of the Public Health Service Act (42 U.S.C. 264, 265). 
Section 361, among other things, authorizes the Secretary \1\ of HHS to 
make and enforce such regulations as in the Secretary's judgment are 
necessary to prevent the introduction, transmission, or spread of 
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. Such regulations currently define 
communicable disease as an illness due to a specific infectious agent 
or its toxic products which arises through transmission of that agent 
or its products from an infected person or animal or a reservoir to a 
susceptible host, either directly or indirectly through an intermediate 
animal host, vector, or the inanimate environment. See 42 CFR 70.1, 
71.1. Such regulations also define possession as a U.S. territory 
meaning any territory of the United States, including American Samoa, 
Guam, the Northern Mariana Islands, the Commonwealth of Puerto Rico, 
and the U.S. Virgin Islands. See 42 CFR 70.1, 71.1. On August 16, 2000, 
the Secretary transferred the authority for interstate control of 
communicable disease, including the authority to apprehend, examine, 
detain, and conditionally release individuals moving from one state 
into another from the U.S. Food and Drug Administration (FDA) to CDC. 
This authority is implemented in 42 CFR part 70. FDA retained its 
concurrent regulatory authority under section 361 of the Public Health 
Service Act for purposes of regulating animals and other products that 
may transmit or spread communicable diseases interstate. Thus, both CDC 
and FDA may take actions under section 361 of the Public Health Service 
Act to prevent interstate spread of communicable diseases in regard to 
animals or products, though in practice such actions would be 
coordinated internally between these agencies. The Secretary took this 
action to consolidate regulations designed to control the spread of 
communicable diseases, thereby increasing the efficiency and 
effectiveness of both agencies. This rule is not intended to have any 
effect upon FDA's authority under section 361 of the Public Health 
Service Act. Authority for carrying out CDC's functions under sections 
361-369 (42 U.S.C. 264-272) has been delegated to HHS/CDC's Division of 
Global Migration and Quarantine (DGMQ). Regulations that implement 
Federal quarantine authority are currently promulgated in 42 CFR parts 
70 and 71. Part 71 contains regulations to prevent the introduction, 
transmission, and spread of communicable diseases into the states and 
territories of the United States, while part 70 contains regulations to 
prevent the introduction, transmission, or spread of communicable 
diseases from one state or U.S. territory into another.
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    \1\ 42 U.S.C. 264 and 265 by their terms grant authority to the 
U.S. Surgeon General. The Reorganization Plan No. 3 of 1966 
abolished the Office of the Surgeon General and transferred the 
Surgeon General's functions to the Secretary of Health, Education, 
and Welfare (now Secretary of HHS). 31 FR 8855, 80 Stat. 1610 (Jun. 
25, 1966). The Secretary of Health, Education, and Welfare was re-
designated the Secretary of Health and Human Services by section 
509(b) of Public Law 96-88, 93 Stat. 695 (codified at 20 U.S.C. 
3508(b)). Although the Office of the Surgeon General was re-
established in 1987, the Secretary of HHS has retained her 
authorities under 42 U.S.C. 264, 265.
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    Section 361 (42 U.S.C. 264) is divided into five subsections, (a)-
(e). Section 361(a) (42 U.S.C. 264(a) states that the Secretary may 
make and enforce regulations as necessary to prevent the introduction, 
transmission, and spread of ``communicable diseases'' from foreign 
countries into the United States or from one state or possession (U.S.

[[Page 54233]]

territory) into any other state or possession (U.S. territory). By its 
terms, subsection (a) does not seek to limit the types of communicable 
diseases for which regulations may be enacted, but rather applies to 
all communicable diseases that may impact human health. Section 361(a) 
(42 U.S.C. 264(a)) further authorizes the Secretary to promulgate and 
enforce a variety of public health regulations to prevent the spread of 
these communicable diseases including: Inspection, fumigation, 
disinfection, sanitation, pest extermination, destruction of animals or 
articles found to be sources of dangerous infection to human beings, 
and other measures. In contrast, section 361(b) (42 U.S.C. 264(b)) 
authorizes the ``apprehension, detention, or conditional release'' of 
individuals for the purpose of preventing the introduction, 
transmission, and spread of a limited subset of communicable diseases, 
specifically those communicable diseases specified in an Executive 
Order of the President, upon recommendation of the Secretary in 
consultation with the Surgeon General. HHS/CDC refers to this limited 
subset of communicable diseases as ``quarantinable communicable 
diseases'' because these are the communicable disease for which by 
statute quarantine, isolation, or conditional release are authorized. 
Section 361(c) (42 U.S.C. 264(c)) states that, except as provided in 
subsection (d), regulations regarding apprehension, detention, 
examination, or conditional release shall only be applicable to 
individuals coming into a state or U.S. territory from a foreign 
country or U.S. territory. 42 U.S.C. 264(c). Thus, subsection (c) 
provides the basis for the quarantine, isolation, or conditional 
release of individuals arriving into the United States from foreign 
countries for the purposes of preventing the introduction, 
transmission, and spread of quarantinable communicable diseases (as 
specified by Executive Order) while subsection (d) provides the 
statutory basis for interstate quarantine, isolation, and conditional 
release measures.
    Section 361(d)(2) (42 U.S.C. 264(d)(2)) imposes two main 
requirements on the interstate quarantine, isolation, or conditional 
release of individuals: (1) The qualifying-stage requirement; and (2) 
the requirement for an effect on interstate movement. Both of these 
requirements must be satisfied. Subsection (d) states that regulations 
may provide for the apprehension and examination of any individual 
``reasonably believed to be infected with a communicable disease in a 
qualifying stage.'' 42 U.S.C. 264(d)(1). As defined by this subsection, 
a ``qualifying stage'' means that the communicable disease is in ``a 
precommunicable stage, if the disease would be likely to cause a public 
health emergency if transmitted to other individuals'' or ``a 
communicable stage.'' 42 U.S.C. 264(d)(2). The subsection further 
states that if upon examination any such individual is found to be 
infected, he or she may be detained for such time and in such manner as 
may be reasonably necessary. 42 U.S.C. 264(d)(1). In addition to the 
qualifying-stage requirement, this subsection further requires a 
reasonable belief that the individual: (A) Be moving or about to move 
from a state to another state; or (B) be a probable source of infection 
to individuals who, while infected with such disease in a qualifying 
stage, will be moving from a state to another state. 42 U.S.C. 
264(d)(1).
    As provided for under section 361(b) (42 U.S.C. 264(b)), the 
Secretary's authority to allow for 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.'' These quarantinable 
communicable diseases currently include 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,\2\ and influenza caused by 
novel or re-emergent influenza viruses that are causing or have the 
potential to cause a pandemic. Executive Order 13295 (April 4, 2003), 
as amended by Executive Order 13375 (April 1, 2005) and Executive Order 
13674 (July 31, 2014).
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    \2\ The Executive Order defines severe acute respiratory 
syndromes as follows: ``Severe acute respiratory syndromes, which 
are diseases that are associated with fever and signs and symptoms 
of pneumonia or other respiratory illness, are capable of being 
transmitted from person to person, and that either are causing, or 
have the potential to cause, a pandemic, or, upon infection, are 
highly likely to cause mortality or serious morbidity if not 
properly controlled. This subsection does not apply to influenza.''
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    Lastly, section 361(e) (42 U.S.C. 264(e) states that nothing in 
this section nor in section 363 (42 U.S.C. 266) (a different section 
authorizing quarantine in time of war) nor in regulations promulgated 
under these sections, shall be construed as superseding any provision 
under state law (including in regulations and provisions established by 
political subdivisions of states), except to the extent that such 
provisions conflict with the exercise of Federal authority. 
Accordingly, by its plain language, section 361 (42 U.S.C. 264) does 
not preempt state or local public health laws or regulations, except in 
the event of a conflict with the exercise of Federal public health 
authority.
    In addition to section 361 (42 U.S.C. 264), HHS/CDC believes that 
the following Public Health Service Act sections are also 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 362 (42 U.S.C. 
265), section 365 (42 U.S.C. 268), and sections 367-69 (42 U.S.C. 270-
72). Section 311 authorizes the Secretary to accept state and local 
assistance in the enforcement of quarantine rules and regulations and 
to assist states and their political subdivisions in the control of 
communicable diseases. Section 321 provides for the selection, 
establishment, control, management, and operation of institutions, 
hospitals, and stations as may be necessary to carry out public health 
functions. Section 322 authorizes payment for the care and treatment, 
in a public or private facility, of individuals detained in accordance 
with quarantine laws. Section 362 authorizes (in accordance with 
regulations approved by the President \3\) suspending the entry of 
imports into the United States based on the presence of a communicable 
disease in a foreign country or place. Section 365 provides that it 
shall be the duty of customs officers (e.g., U.S. Customs and Border 
Protection officers) and of U.S. Coast Guard officers to aid in the 
enforcement of quarantine rules and regulations. Section 367 authorizes 
the application of certain sections of the Public Health Service Act 
and promulgated regulations (including penalties and forfeitures for 
violations of such sections and regulations) to air navigation and 
aircraft to such extent and upon such conditions as deemed necessary 
for safeguarding public health.
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    \3\ 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)) have 
been assigned to the HHS Secretary. See Exec. Order 13295 (Apr. 4, 
2003), as amended by Exec. Order 13375 (Apr. 1, 2005) and Exec. 
Order 13674 (July 31, 2014).
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    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

[[Page 54234]]

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 plans 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.
    Lastly, section 369 (42 U.S.C. 272) provides that quarantine 
officers are authorized to take declarations and administer oaths in 
matters pertaining to the administration of quarantine laws and 
regulations of the United States.

B. Historical Background for This Rulemaking

    On November 30, 2005, HHS/CDC published a notice of proposed 
rulemaking (70 FR 71892) proposing to update its existing foreign and 
interstate quarantine regulations to prevent the introduction, 
transmission, or spread of communicable diseases from foreign countries 
into the U.S. and from one State or U.S. territory into another. HHS/
CDC received extensive comments on this proposed rulemaking. The 2005 
proposed rule would have required airlines and vessels to request 
certain information from passengers and crew and to maintain data in an 
electronic database for 60 days following the culmination of the flight 
or voyage. The proposed rule would have also modified Federal 
regulations governing the apprehension, detention, examination, and 
conditional release of individuals reasonably believed to be infected 
with a quarantinable communicable disease. CDC received significant 
comment on the 2005 NPRM from industry that felt that the development 
of the passenger information data storage system was overly burdensome.
    HHS/CDC also received comments contending that its procedures for 
quarantine and isolation lacked clarity and, in some instances, were 
not sufficiently protective of the individual. For instance, the 2005 
proposal used the term ``provisional quarantine'' to denote the time 
period during which an individual could be held pending the issuance of 
a written order for quarantine, isolation, or conditional release or 
confirmation that the individual was not infected with a quarantinable 
communicable disease. The 2005 proposal also stated that ``provisional 
quarantine'' could last up to 3 business days. CDC received public 
comments that the term ``provisional quarantine'' was inconsistent with 
public health practice and that relying on ``business days'' which by 
definition excludes weekends and holidays was inappropriate. In 
response, the current proposal does not use the term ``provisional 
quarantine,'' but rather uses the term ``apprehension'' which is a 
statutory term used in section 361 of the Public Health Service Act (42 
U.S.C. 264(c) and (d)(1)), and is defined in this proposal as ``the 
temporary taking into custody of an individual or group for purposes of 
determining whether Federal quarantine, isolation, or conditional 
release is warranted.'' Furthermore, as explained in the preamble text 
explaining the use of the term ``apprehension,'' based on past 
experience, HHS/CDC believes that the service of a written order for 
quarantine, isolation, or conditional release can generally be 
accomplished within 24-48 hours of an apprehension. Moreover, while the 
2005 proposal stated that individuals subject to an order for 
quarantine, isolation, or conditional release could ``authorize a 
representative'' for purposes of a medical review hearing, the proposal 
did not have any provision authorizing Federal appointment of such a 
representative for individuals who are indigent. Accordingly, in 
response to public comments criticizing the lack of such an 
appointment, the current proposal contains specific language 
authorizing the appointment of a ``medical representative'' for anyone 
who qualifies as ``indigent.'' Proposed definitions for ``medical 
representative'' and ``indigent'' are contained in this current 
proposal and HHS/CDC invites public comment on these proposed 
definitions as well as the proposed ``apprehension'' activities.
    HHS/CDC ultimately did not publish a final rule based on this 2005 
proposal and since that time its views have been informed by the public 
health response to more recent communicable disease outbreaks, 
including Ebola, MERS, and continuing sporadic outbreaks of measles. 
Through the publication of today's NPRM, CDC is formally withdrawing 
the 2005 NPRM and submitting a new proposal for public comment. 
Notably, today's proposal does have some similarities with the 2005 
proposal, for instance by proposing specific provisions governing the 
content of written Federal orders for quarantine, isolation, and 
conditional release, proposed procedures for administrative hearings to 
review these written Federal orders, and a specific provision governing 
the content and compiling of an administrative record. However, today's 
proposal is more limited in scope than the 2005 proposal and does not 
contain any provisions affecting Tribal lands, authorizing quarantine 
``in time of war,'' or altering HHS/CDC practices in regard to ``bills 
of health'' or yellow fever vaccination centers.
    On December 26, 2012, HHS/CDC simultaneously published two direct 
final rules (DFR) and notices of proposed rulemaking (NPRM) to update 
the Scope and Definitions in both parts 70 (77 FR 75880 and 77 FR 
75936) and 71 (77 FR 75885 and 77 FR 75939) to reflect modern 
terminology and plain language used globally by industry and public 
health partners. HHS/CDC did not receive significant adverse comment to 
either proposals and on February 25, 2013, published notices in the 
Federal Register confirming the effective dates of the DFRs (February 
25, 2013) (78 FR 12621 and 78 FR 12622) and withdrawing the NPRMs from 
rulemaking (78 FR 12702).

IV. Rationale for Notice of Proposed Rulemaking

    A timely and efficient public health response during an outbreak is 
critical to preventing the introduction, transmission or spread of 
communicable disease. Globally, there are several current and recurring 
communicable disease outbreaks imminently threatening human health and 
safety. Ebola, also known as Ebola hemorrhagic fever or Ebola virus 
disease, is a rare and deadly disease caused by infection with one of 
the Ebola virus strains. The 2014-2016 Ebola epidemic was unprecedented 
in its scope and complexity, and it triggered the largest public health 
response in CDC's history. Outbreaks begin when Ebola is transmitted 
from an infected animal to a human, and then from human to human. 
Animal species carrying viruses

[[Page 54235]]

that are capable of infecting humans are known as reservoir hosts.\4\ 
For Ebola, fruit bats are believed to be the reservoir.5 6 
However, it is unclear whether the first infected human in the outbreak 
was infected with Ebola directly from a bat, or whether a second, 
intermediate animal host, such as a nonhuman primate (e.g., monkeys, 
gorillas, and chimpanzees) or duiker (a type of forest antelope), was 
involved.7 8 The virus can be transmitted from animal to 
human via contact with bodily fluids of infected animals. In West 
Africa, it's not uncommon for people to come into contact with animals 
while hunting or preparing food. As of the date of publication of this 
NPRM, although progress has been made and vaccine trials are underway 
in West Africa, there is no approved vaccine for Ebola, nor is there 
specific approved antiviral treatment.
---------------------------------------------------------------------------

    \4\ ``Glossary of Epidemiology Terms.'' Centers for Disease 
Control and Prevention Resource Library, 2014. Web, accessed 15 July 
2014.
    \5\ ``Ebola Hemorrhagic Fever: Ebolavirus Ecology.'' CDC.gov, 
2014. Web, accessed 8 July 2014.
    \6\ Vogel, Gretchen. ``Are Bats Spreading Ebola Across Sub-
Saharan Africa?'' Science, 2014. Vol. 344: p.140
    \7\ Bagcchi, Sanjeet. ``Ebola haemorrhagic fever in west 
Africa.'' The Lancet, 2014. Vol. 14: p.375
    \8\ Baize, Sylvain, et al. ``Emergence of Zaire Ebola Virus 
Disease in Guinea--Preliminary Report.'' The New England Journal of 
Medicine, 2014 (NEJM.ORG).
---------------------------------------------------------------------------

    As of March 3, 2016, a total of 28,603 cases of Ebola and 11,301 
deaths have been reported worldwide.9 10 The majority of 
cases occurred in Guinea, Liberia and Sierra Leone, with smaller 
outbreaks in Nigeria and Mali, and cases exported to four other 
countries including the United States. Liberia was first declared free 
of Ebola virus transmission (as defined by zero cases for at least 42 
days) by the World Health Organization (WHO) on May 9, 2015; Sierra 
Leone on November 7, 2015; and Guinea on December 29, 2015. On January 
14, 2016, WHO officially declared all three countries that were 
hardest-hit (Guinea, Liberia, and Sierra Leone) to be free of Ebola 
virus transmission for the first time since the start of the epidemic 
more than two years ago. However, each of the three countries has 
experienced one or more clusters of Ebola cases after having initially 
been declared free of Ebola transmission, and WHO warns that new cases 
could still appear because the virus can be transmitted through sexual 
activity with some male Ebola survivors for as long as one year after 
infection, and that efforts are still needed to prevent and respond to 
any new outbreaks.\11\
---------------------------------------------------------------------------

    \9\ http://www.afro.who.int/en/media-centre/pressreleases/item/8252-end-of-ebola-transmission-in-guinea.html.
    \10\ Case numbers obtained from the World Health Organization 
(http://apps.who.int/ebola/ebola-situation-reports).
    \11\ http://www.afro.who.int/en/media-centre/pressreleases/item/8252-end-of-ebola-transmission-in-guinea.html.
---------------------------------------------------------------------------

    Before the 2014-2016 Ebola epidemic in West Africa, reports of 
Ebola exportation to other countries were rare, a fact generally 
attributed in part to the remote, rural locations of previous 
outbreaks. The establishment of Ebola transmission in 2014 in the 
capital cities of Guinea, Liberia and Sierra Leone, with large 
populations and international airports and other connections to 
international transportation networks, raised concerns about the 
potential for spread through international travel to other parts of the 
world. These concerns were validated by the recognition of at least 
eight exported cases, three of which resulted in additional spread and 
infection of 29 people.\12\
---------------------------------------------------------------------------

    \12\ Cases were exported to United States (2), United Kingdom, 
Nigeria, Mali (2), Senegal, Italy; further spread occurred in 
Nigeria, the United States and Mali.
---------------------------------------------------------------------------

    In October, 2014, after a case of Ebola was imported and identified 
in the United States from West Africa, resulting in two domestic cases 
and extensive contact investigations of travelers onboard aircraft and 
the larger community, questions were raised concerning whether HHS/CDC 
should strengthen the domestic response to Ebola by prohibiting travel 
to the United States from the three countries with widespread 
transmission. HHS/CDC projected that such a travel ban would cause 
greater harm than good to the public health response by hampering 
travel of responders and delivery of supplies into the region, and 
could paradoxically increase the risk of spread via potentially 
infected individuals engaging in travel through covert and circuitous 
travel routes. Instead, HHS/CDC recommended that public health 
authorities assume the responsibility for monitoring of all travelers 
arriving from countries with Ebola outbreaks. Because complete and 
timely contact information was not available for these travelers, in-
person questioning at the arrival airport was required to gather such 
information.
    Therefore, in response to the imported Ebola case, as well as 
consideration of potential response activities, beginning October 11, 
2014, HHS/CDC and the U.S. Department of Homeland Security (DHS) began 
a new enhanced entry risk assessment and management program at the five 
U.S. international airports that routinely received approximately 90 
percent of travelers from Guinea, Liberia, and Sierra Leone: New York's 
John F. Kennedy, Washington-Dulles, Newark Liberty, Chicago-O'Hare, and 
Atlanta Hartsfield Jackson.\13\ This operation of unprecedented 
magnitude required coordination of multiple U.S. Government agencies, 
as well as airport authorities and health departments in all U.S. 
states and territories. Travelers from Mali were later added on 
November 17, 2014, in response to an outbreak in that country; Mali's 
outbreak was short-lived, and enhanced entry risk assessment and 
management for travelers from Mali was discontinued on January 6, 2015. 
Following the declaration that the outbreak had ended in Liberia and 
the establishment of control measures in that country, on September 21, 
2015, the United States discontinued enhanced entry risk assessment and 
management for travelers from Liberia. On November 7, 2015, WHO 
declared Sierra Leone free of Ebola virus transmission and enhanced 
entry risk assessment and management for travelers from Sierra Leone 
was discontinued on December 22, 2015. In addition, Guinea was declared 
free of Ebola virus transmission on December 29, 2015, and enhanced 
entry risk assessment and management for travelers from Guinea was 
discontinued on February, 19, 2016, thus bringing an end to the 
enhanced entry risk assessment and management program in the US. 
Between October 11, 2014 and February 19, 2016, enhanced entry risk 
assessment was conducted for approximately 38,000 travelers.
---------------------------------------------------------------------------

    \13\ See 79 FR 63313 (October 23, 2014).
---------------------------------------------------------------------------

    A second relevant example of the importance of CDC improving the 
efficiency of it public health response is illustrated by CDC's 
response to two imported cases of MERS into the United States in 2014. 
While no additional transmissions occurred as a result of these 
importations, the subsequent investigation required the tracking and 
monitoring of more than 700 household, healthcare, community, and 
travel-related contacts, including almost 650 travelers onboard 
commercial aircraft. If the cost estimates in the RIA for the average 
cost per contact to CDC ($180) and to public health departments ($180) 
\14\ are applied to these investigations (704 contacts), the total cost 
to evaluate MERS contacts would be approximately $250,000. However, 
this may underestimate the actual cost if state and local health 
departments deployed more resources per contact to locate MERS contacts 
more rapidly than would be the case for contact investigations for 
diseases more

[[Page 54236]]

commonly reported in the United States (e.g., tuberculosis). First 
identified and reported to cause severe acute respiratory infection in 
September 2012, MERS has caused infections worldwide, with at least 25 
countries reporting cases to date. All reported cases have been 
directly or indirectly linked through travel or residence to nine 
countries: The Kingdom of Saudi Arabia (KSA), the United Arab Emirates 
(UAE), Qatar, Jordan, Oman, Kuwait, Yemen, Lebanon, and Iran. The 
majority of cases (~85%) have been reported from KSA, where there is 
strong evidence for ongoing, sporadic introductions from animals (e.g., 
camels) to humans, followed by both healthcare-related and community 
human-to-human transmission. In May 2015, a case in a person who had 
travelled through several countries in the Arabian Peninsula and 
returned to the Republic of Korea started the largest outbreak of MERS 
outside of the Arabian Peninsula. The Korea outbreak resulted in 186 
cases and 36 deaths.
---------------------------------------------------------------------------

    \14\ Refer to the RIA for more details.
---------------------------------------------------------------------------

    A third and historically more common example is measles. Measles is 
a highly contagious, acute viral illness that can lead to serious 
complications such as pneumonia, encephalitis, and even death. Although 
not a quarantinable communicable disease, every case of measles in the 
United States is considered a public health emergency because of its 
extremely high transmissibility. As a result of high vaccination 
coverage, measles was declared eliminated (defined as interruption of 
year-round endemic transmission) from the United States in 2000; 
however, importations from other countries where measles remains 
endemic continue to occur, which can lead to clusters of measles cases 
in the United States in pockets of unvaccinated persons. Of note, an 
unprecedented outbreak that originated in late December 2014 in Orange 
County, California resulted in 125 cases; measles cases associated with 
this outbreak were reported in eight U.S. states, Mexico, and Canada. 
Between 2010 and 2014, HHS/CDC investigated 91 measles exposures on 
international or interstate flights, which required time-consuming and 
labor-intensive location and evaluation of more than 4700 individuals, 
resulting in the identification of 12 cases of onward transmission.\15\
---------------------------------------------------------------------------

    \15\ CDC. Measles Outbreak--California, December 2014-February 
2015. Morb Mortal Wkly Rep. 2015; 64(06): 153-154. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6406a5.htm.
---------------------------------------------------------------------------

    Global public health authorities have clearly indicated, and 
evidence has shown, that Ebola, MERS, and measles could spread between 
countries, and a re-emergence after the current outbreaks are 
controlled is always a risk. Additionally, although public health 
responses to measles have become routine over the past decade, the 
recent unprecedented outbreak in a large U.S. tourist destination with 
high potential for onward travel by exposed individuals identified 
greater danger for measles becoming reestablished in the United States 
in communities with lower rates of immunization. These three examples 
demonstrate the need for a more timely, efficient, and complete public 
health response, so that CDC can better protect individuals and prevent 
the further importation and spread of communicable disease.
    This NPRM clarifies and provides greater transparency regarding the 
tools HHS/CDC uses to identify and respond quickly and effectively to 
prevent introduction and spread of these and other communicable 
diseases in the United States. Currently, these processes are governed 
by standard and internal operating procedures and policies, based upon 
broad statutory authorities. For instance, it is anticipated that 
explicit regulatory authority, as proposed in this notice of proposed 
rulemaking, may lead to quicker and more accurate illness reporting, 
which would enhance HHS/CDC's ability to evaluate an ill traveler and 
assess the public health risk. The current definition of ``ill person'' 
does not include the range of signs and symptoms for many of the 
quarantinable communicable diseases, including Ebola and MERS, nor does 
it allow for detection of new or emerging communicable diseases. 
Currently the broader range of signs and symptoms is already requested 
on a voluntary basis; however, the current regulations do not require 
mandatory reporting of ill persons as defined by this broader 
definition, thus requiring HHS/CDC to rely on the voluntary compliance 
of conveyance operators. Given the grave consequences for mortality and 
morbidity of introducing and spreading these diseases, a strengthening 
of this reporting requirement via mandatory reporting according to the 
revised definition of an ill person, as described in this NPRM, is 
essential. This is validated by several recent instances of individuals 
traveling interstate while symptomatic with MERS, Ebola, Lassa fever, 
and measles. Conducting contact investigations on interstate flights is 
labor-intensive and often inaccurate and untimely given the current 
quality of passenger data. This NPRM through proposed section 42 CFR 
70.11 would improve HHS/CDC's ability to receive reports of symptomatic 
interstate travelers allowing for more efficient evaluation and 
enabling HHS/CDC to expedite its domestic response activities, (e.g. 
distributing Passenger Locator Forms) to more quickly and efficiently 
locate and assess exposed travelers, and mitigate the spread of 
disease. The proposed updated definition of ``ill person'' also 
includes a provision for the CDC Director to revise the symptom 
definition as needed in response to a newly identified communicable 
disease; this will greatly enhance HHS/CDC's ability to respond rapidly 
to emerging public health threats. By expanding the current regulatory 
definition to include the requested symptoms, CDC is improving the 
sensitivity of the system that requires reporting of ill travelers on 
conveyances, allowing CDC to then make a determination of whether the 
illness may represent a communicable disease of public health concern.
    Since 2007, HHS/CDC has employed basic tools, such as public health 
travel restrictions list (``Do Not Board list'') to prevent travel by 
commercial airline of individuals infectious with communicable diseases 
that pose a public health threat to the traveling public.\16\ During 
the 2014-2016 Ebola epidemic, HHS/CDC revised the criteria for use of 
Federal travel restrictions to address the need to prevent travel by 
persons potentially exposed to Ebola or other communicable diseases but 
not yet considered contagious. The updated criteria provided HHS/CDC 
with greater flexibility to control the movement of persons who pose a 
public health threat during travel and to apply Federal travel 
restrictions in support of outbreak control. In certain circumstances, 
HHS/CDC has allowed people contagious with or exposed to serious 
communicable diseases to travel interstate if this can be done in a 
manner that does not expose the public (e.g., by private vehicle). 
However, the needs of the individual to engage in travel must be 
carefully weighed against the public health risk due to the potential 
lack of public health oversight, especially during travel over long 
distances or crossing multiple states. For this reason, during the 
2014-2016 Ebola epidemic, HHS/CDC recommended against long-distance 
travel by private vehicle for people with certain types of exposures to 
Ebola.

[[Page 54237]]

State and local public health authorities, relying on their own legal 
processes, enforced these recommendations by imposing their own 
movement restrictions on individuals potentially exposed to Ebola. 
While HHS/CDC could similarly impose movement restrictions for 
individuals reasonably believed to be infected with a quarantinable 
communicable disease through the issuance of a Federal order for 
isolation, quarantine, or conditional release, codifying in regulation 
a separate, formal process to issue interstate travel permits for 
individuals subject to controlled movement allows for greater 
transparency and public understanding of what actions HHS/CDC may take 
to condition an individual's travel on the observance of public health 
measures to assure the safety of other travelers and communities.
---------------------------------------------------------------------------

    \16\ See Criteria for Requesting Federal Travel Restrictions for 
Public Health Purposes, Including for Viral Hemorrhagic Fevers, 80 
FR 16,400 (Mar. 27, 2015).
---------------------------------------------------------------------------

    In the last century, 60% of newly identified infectious diseases in 
humans globally were zoonotic (transmitted from animals to humans). As 
mentioned above, evidence indicates that both MERS and Ebola are 
associated with animal reservoirs (camels and bats, respectively). It 
is possible any future outbreaks may be linked to animal sources for 
which an emergency ban on certain animals or cargo (e.g., animal 
products) would be necessary to protect the public. In the past, HHS/
CDC has issued import embargoes either through publication of an 
interim final rule (e.g., 68 FR 62353 (Nov. 4, 2003) (imposing 
restrictions on African rodents)) or through issuance of an emergency 
order under the authority of 42 CFR 71.32(b) (allowing for the 
application of public health measures to arriving carriers and animals, 
articles, or things found onboard such arriving carriers) (See http://www.cdc.gov/sars/media/civet-ban.html).
    Codifying in regulation a provision explicitly relating to HHS/
CDC's ability to impose an import embargo provides greater transparency 
and will greatly enhance HHS/CDC's ability to protect the public from 
ongoing hazardous importations. We note that while proposed Sec.  71.63 
serves to clarify CDC's authority to temporarily ban certain imports, 
this is not a new authority and will not alter current CDC practices. 
HHS/CDC will continue to coordinate in advance with other Federal 
agencies that have overlapping authority, as may be necessary to 
implement and enforce this provision.
    Finally, this NPRM contains due process provisions (requirements 
relating to administrative records, quarantine, isolation, conditional 
release, medical examination, and agreements; authorization for payment 
for medical care and treatment; and an explanation of applicable 
criminal penalties) which are intended to inform the U.S. public of 
what steps HHS/CDC might take to protect public health during an 
outbreak while safeguarding the rights of the individual. Although 
these processes have been implemented through internal standard 
operating procedures, these procedures have not been codified, 
explicitly set forth in regulation, and made publicly available until 
today. These provisions are needed to provide transparency and assure 
the traveling public and any individual potentially placed under a 
Federal public health order that HHS/CDC will protect their individual 
liberties.
    The provisions in this NPRM describe the regulatory activities that 
HHS/CDC may undertake to reduce and mitigate the risk of outbreaks of 
Ebola, MERS, measles, and other communicable diseases in the United 
States. Greater transparency and public understanding of its processes, 
authorities, and procedures, will allow HHS/CDC to respond more 
effectively to these public health emergencies.

V. Ongoing Efforts With U.S Department of Homeland Security (DHS)/U.S. 
Customs and Border Protection (DHS/CBP) To Improve Passenger Data 
Collection

    CDC is currently working with DHS/CBP to update existing DHS/CBP 
regulations that will require the electronic collection and submission 
of additional passenger and crew contact information to the Advance 
Passenger Information System (APIS) which would streamline the 
collection of additional data to minimize the burden on airline 
operators and travelers. We also plan to work with DHS/U.S. Coast Guard 
(USCG) to develop a comparable electronic data collection mechanism for 
vessels and their passengers and crew. Therefore this NPRM also informs 
airline and vessel industry, as well as travelers that HHS/CDC is 
working with DHS on expanding the data elements currently required and 
collected via APIS (e.g., seat or cabin number, primary and secondary 
phone numbers, address information, and email address) that would be 
reported to CBP regarding passengers and crew on applicable 
international flights and vessel voyages. These data and additional 
contact information collected by DHS would then be shared with HHS/CDC 
as necessary for use in public health contact tracing. We have included 
the chart below to reflect the data elements of public health interest 
that are collected under current CDC manifest order practice, which 
HHS/CDC seeks to codify through this regulation.
---------------------------------------------------------------------------

    \17\ See 19 CFR 122.49a for a list of the elements CBP requires 
for inbound commercial air travel.

----------------------------------------------------------------------------------------------------------------
                                                                                  DHS/CBP-APIS    CDC-- manifest
          Currently required data elements of public health interest                  \17\            order
----------------------------------------------------------------------------------------------------------------
Full name (last, first, and, if available, middle or others)..................               X                X
Date of Birth.................................................................               X                X
Sex...........................................................................               X                X
Country of Residence..........................................................               X                X
If a passport is required; passport number, passport country of issuance, and                X                X
 passport expiration date.....................................................
Travel document information...................................................               X                X
Name of Airline...............................................................               X                X
Flight number.................................................................               X                X
City of departure.............................................................               X                X
Departure date................................................................               X                X
City of arrival...............................................................               X                X
Arrival date..................................................................               X                X

[[Page 54238]]

 
Address while in the United States (number and street, city, state, and zip             (\18\)                X
 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; as applicable).................................................
Primary contact phone number to include country code..........................  ...............               X
Secondary contact phone number to include country code........................  ...............               X
Email Address.................................................................  ...............               X
Seat or Cabin Number..........................................................  ...............               X
----------------------------------------------------------------------------------------------------------------

V. Summary of Notice of Proposed Rulemaking
---------------------------------------------------------------------------

    \18\ Under APIS, address while in the United States (number and 
street, city, state, and zip code), except that this information is 
not required for U.S. citizens, lawful permanent residents, or 
persons who are in transit to a location outside the United States.
---------------------------------------------------------------------------

A. Updates to Part 70

1. Sec.  70.1 General Definitions
    Section 70.1 contains the definitions used in this NPRM. The NPRM 
proposes new or updated definitions to be consistent with modern 
quarantine concepts and current medical and public health principles 
and practice.
Apprehension
    Under section 361(d)(1) of the PHS Act (42 U.S.C. 264(d)(1)), HHS/
CDC may promulgate regulations that provide for the apprehension and 
examination of any individual reasonably believed to be infected with a 
quarantinable communicable disease in a qualifying stage. In addition, 
HHS/CDC must reasonably believe that the individual is moving or about 
to move between states or constitutes a probable source of infection to 
others who may be moving between states. Thus, HHS/CDC believes that it 
is important to define for the public what is meant by the term 
``apprehension.'' Apprehension means the temporary taking into custody 
of an individual or group for purposes of determining whether 
quarantine, isolation, or conditional release is warranted.
    Although each instance is unique, an apprehension will typically 
occur at the request of a state or local health department or in other 
time-sensitive situations, such as at a U.S. port of entry, where it is 
necessary for HHS/CDC to take immediate action to protect public 
health. The factors that may give rise to an apprehension are discussed 
in detail in the preamble section discussing the definition of 
``reasonably believed to be infected, as applied to an individual.'' 
When an apprehension occurs, the individual is not free to leave or 
discontinue his/her discussion with an HHS/CDC public health or 
quarantine officer. In some cases, an apprehension may last from twenty 
minutes to one to two hours if, for instance, based on a public health 
assessment, HHS/CDC is able to quickly rule out the presence of a 
quarantinable communicable disease. In certain circumstances, the 
individual may remain apprehended pending confirmation that he or she 
is not infected or not reasonably believed to be infected with a 
quarantinable communicable disease. If it is necessary to issue the 
individual a Federal order for quarantine, isolation, or conditional 
release, the individual will remain apprehended pending the service of 
the written order. The factors that may give rise to an order for 
quarantine, isolation, or conditional release are discussed in detail 
in the preamble section discussing the definition of ``reasonably 
believed to be infected, as applied to an individual.'' Based on past 
experience, HHS/CDC believes that a written Federal order may be served 
to an individual within 24-48 hours of an apprehension. These 
timeframes are merely offered as guidance and HHS/CDC believes that the 
facts and circumstances of each case will dictate the expected length 
of an apprehension. Generally, however, HHS/CDC does not expect that 
the typical public health apprehension will last longer than 72 hours. 
It is not HHS/CDC's intent through this definition to allow for 
extended apprehensions absent the issuance of a Federal order for 
quarantine, isolation, or conditional release. HHS/CDC requests public 
comment concerning the expected apprehension period (no longer than 72 
hours), and whether there are any public concerns with the absence of a 
specific maximum apprehension period in the regulation.
Communicable Period
    HHS/CDC is proposing to revise the definition of communicable 
period in part 70. As listed in the table above, under the new 
definition, communicable period would mean the period during which an 
infectious agent may be transmitted either directly or indirectly from 
an infected individual to another individual. Under section 361 (b) and 
(d) of the Public Health Service Act, to authorize the quarantine, 
isolation, or conditional release of any individual traveling 
interstate, HHS/CDC must reasonably believe that an individual is 
infected with a quarantinable communicable disease in a qualifying 
stage. 42 U.S.C. 264(b) and (d)(1). As defined by the statute, a 
``qualifying stage'' means that the communicable disease is in ``a 
precommunicable stage, if the disease would be likely to cause a public 
health emergency if transmitted to other individuals'' or ``a 
communicable stage.'' Thus, HHS/CDC believes that it is necessary to 
provide a clear definition for what it means for an individual to be in 
the communicable stage of a communicable disease. HHS/CDC's proposed 
revised definition is consistent with how this term is commonly 
understood in the public health community.
    There are numerous resources to describe the communicability of 
specific diseases. 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. The most current version is 
available on CDC's Web site. For more information, please see http://wwwnc.cdc.gov/travel/yellowbook/2016/table-of-contents.
Agreement
    HHS/CDC is proposing a definition for ``agreement'' which refers to 
an agreement entered into between the CDC and an individual expressing 
agreement between the parties that the individual will observe public 
health measures authorized under this part, as the CDC considers 
reasonably necessary to protect the public's health, including 
quarantine, isolation, conditional release, medical examination, 
hospitalization, vaccination, and treatment. An explanation of the 
reasons for why HHS/CDC is including a

[[Page 54239]]

regulatory provision explicitly allowing for agreements is discussed in 
detail in the preamble section explaining proposed Sec.  70.8. HHS/CDC 
believes that the proposed definition is consistent with public health 
practice and common usage.
Contaminated Environment
    HHS/CDC is proposing to define a contaminated environment as 
meaning the presence of an infectious agent on a surface, including on 
inanimate articles, or in a substance, including food, water, or in the 
air. Exposure to a contaminated environment is one method through which 
an individual may become infected with a communicable disease. Thus, 
HHS/CDC believes that it is important to define this term for 
transparency and to enhance the public's understanding of HHS/CDC's 
practices. HHS/CDC believes that the term is being defined consistently 
with public health practice and common usage.
Conditional Release
    HHS/CDC is proposing to define conditional release to mean 
``surveillance'' as that term is proposed in 42 CFR 71.1 and update the 
definition to include public health supervision through in-person 
visits by a public health official (or designee), telephone, or through 
electronic or internet-based monitoring as that term is defined. 
Surveillance under Sec.  71.1 is currently defined as 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. HHS/CDC is proposing 
to expand the definition of conditional release to clarify that it may 
include electronic or internet-based monitoring in addition to in-
person visits by a public health official or telephone reporting by the 
individual under a conditional release order. A proposed definition for 
electronic or internet-based monitoring has been included as part of 
this proposal and is discussed below. In general, such monitoring may 
include electronic or internet-based systems, such as video chat and 
voice calls from computers, tablets and mobile devices. This language 
is intended to be broad and would apply to any new or existing 
technologies that would allow for the public health supervision and 
monitoring of an individual under a conditional release order.
Electronic or Internet-Based Monitoring
    HHS/CDC has proposed a definition for ``electronic or internet-
based monitoring'' that defines this term as referring to mechanisms or 
technologies allowing for the temporary public health supervision of an 
individual under conditional release, including electronic mail, SMS 
texts, video conference or 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. HHS/CDC 
specifically solicits comment regarding whether this proposed 
definition is sufficiently broad to apply to any new or existing 
technologies that would allow for the public health supervision and 
monitoring of an individual under a conditional release order. HHS/CDC 
also solicits comment regarding whether the proposed definition raises 
any privacy implications for an individual who is reasonably believed 
to be infected with a quarantinable communicable disease and who is 
subject to a conditional release order.
Ill Person
    HHS/CDC is including a proposed definition of ``ill person'' under 
part 70 to facilitate identification of communicable diseases of public 
health concern. Changes in the ill person definition, including the 
revised temperature threshold and inclusion of persistent diarrhea and 
vomiting, are particularly aimed at improving HHS/CDC's ability to 
detect Ebola. The NPRM definition of ``ill person'' focuses on the 
signs and symptoms of communicable diseases of public health concern to 
ensure such diseases are recognized and reported.
    However, HHS/CDC is also including a provision in this NPRM to 
allow it to include additional signs and symptoms of illness in case 
our understanding of the recognizable symptoms of communicable diseases 
of public health concern, such as Ebola, may change or to respond to 
communicable diseases that may emerge as future concerns. Notice of 
such additional signs and symptoms will be published in the Federal 
Register.
    HHS/CDC has crafted the proposed definition of ``ill person'' in 
such a way that it should 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.
    1. Fever: This term means that the person has a measured 
temperature of 100.4[emsp14][deg]F (38[deg]C) or greater, feels warm to 
the touch, or gives a history of feeling feverish. While a measured 
temperature is the preferable and more accurate method to determine 
whether a person has a fever, it is not always possible to obtain. The 
measured temperature also may not reflect the presence of a recent 
fever, for example, if the individual has taken a fever-reducing 
medication. For these reasons, the revised ``ill person'' definition 
includes other methods that may be used by crewmembers as proxies for a 
measured temperature. If it is not feasible or advisable to touch the 
individual or if the individual does not disclose a history of feeling 
feverish, then, while not definitive, the observer should consider his/
her appearance, such as having a flushed face, glassy eyes, or chills 
as possible indications of the presence of a fever. A self-reported 
history of feeling feverish is included in the event that the ill 
person has taken medication that would lower the measured temperature 
or if the fever fluctuates as part of the natural course of the 
disease.
    2. Skin rash: This term means that the individual has areas on the 
skin with multiple red bumps; red, flat spots; or blister-like bumps 
filled with fluid or pus that are intact or partly crusted over. The 
rash may be discrete or may run together, and may include one area of 
the body, such as the face, or more than one area. The presence of skin 
rash, along with fever, may indicate that the traveler has measles, 
rubella (German measles), varicella (chickenpox), meningococcal 
disease, or smallpox.
    3. Difficulty breathing: This term means that the individual is 
gasping for air, is unable to ``catch'' his/her breath, is breathing 
too fast and shallow to get enough air, or cannot control his/her own 
secretions. These symptoms may be apparent or self-reported if not 
obvious. Difficulty breathing, along with fever, may indicate a 
traveler has tuberculosis, diphtheria, influenza with pandemic 
potential, or a severe acute respiratory syndrome.
    4. Persistent cough: This term means that the cough is frequent and 
severe

[[Page 54240]]

enough that it catches the attention of the crewmember, or the 
individual or another passenger voices concern about it. Persistent 
cough, along with fever, may indicate the traveler has pertussis/
whooping cough (vomiting may occur at the end of a coughing fit), 
tuberculosis, severe acute respiratory syndrome, or influenza with 
pandemic potential.
    5. Decreased consciousness or confusion of recent onset: This term 
means that the individual is not fully aware of his/her surroundings or 
may be unusually difficult to awaken. The individual may appear to be 
confused or disoriented. Decreased consciousness, along with fever, may 
indicate the traveler has meningococcal disease, another serious 
neurological infection, or serious infection in another body system.
    6. Bruising or bleeding (without previous injury): This term means 
that the person has noticeable and unusual bruising or bleeding from 
gums, ears, nose or areas on skin for which there is no obvious 
explanation. Unexplained bruising or bleeding, along with fever, may 
indicate the person has a hemorrhagic fever, such as Ebola, or plague.
    7. Persistent diarrhea: This term means that the diarrhea is 
frequent and severe enough that the air crewmember notices, for 
example, that the person has been to the restroom numerous times, or 
the individual or another passenger voices concern about it. Persistent 
diarrhea may indicate the person has a foodborne or waterborne 
infection such as norovirus or cholera, or another serious communicable 
disease, such as Ebola. Many infections that cause persistent diarrhea 
can be spread easily from person to person, either directly or 
indirectly through food or water, and cause large outbreaks.
    8. Persistent vomiting: This term means that the individual has 
vomited two or more times (not due to air or sea sickness) and either 
expresses concern to the air/vessel crew or comes to the attention of 
others onboard (air/vessel crew or passengers). Persistent vomiting may 
indicate the person has a foodborne or waterborne infection such as 
norovirus, or another serious communicable disease, such as Ebola.
    9. Headache with stiff neck: This term means that the individual is 
self-reporting a headache accompanied by difficulty moving his/her 
neck. These symptoms may indicate that the individual has bacterial 
meningitis, such as meningococcal meningitis. Meningococcal meningitis 
has a high death rate and a significant proportion of survivors have 
residual impairments, such as deafness or injury to the brain. 
Individuals in close contact with ill persons with meningococcal 
disease are at elevated risk for contracting the disease.
    10. Obviously unwell: HHS/CDC has included this description into 
the proposed definition of ``ill person'' as it is used in ICAO 
guidelines to aid crewmembers in the identification of symptoms of 
communicable disease. See Note 1 to paragraph 8.15 of Annex 9 to the 
Convention on International Civil Aviation.
Indigent
    CDC conducts a mandatory reassessment 72 hours after the service of 
all Federal orders for quarantine, isolation, or conditional release. A 
medical review is part of the administrative appeals process whereby an 
individual under a Federal order may request a separate medical review 
of his/her case after the mandatory reassessment is complete. HHS/CDC 
is defining the term ``indigent'' for purposes of appointing a medical 
representative for indigent individuals placed under a Federal order of 
quarantine, isolation, or conditional release who request a medical 
review and appointment of a medical representative.
    An indigent individual is defined as one whose annual family income 
is below 150% 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 liquid assets 
totaling less than 15% of the applicable poverty guidelines if no 
income is earned. The poverty guidelines are updated periodically by 
HHS and are used for determining eligibility for a number of Federal, 
state, local, and private programs. The poverty guidelines for 2016 are 
published at 81 FR 4036 (Jan. 25, 2016). The medical review process is 
explained in more detail below. CDC specifically requests public 
comment on whether the use of this standard definition 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.
Medical Examination
    Under section 361(d)(1) of the PHS Act (42 U.S.C. 264(d)(1)), HHS/
CDC may promulgate and enforce regulations concerning the apprehension 
and examination of any individual reasonably believed to be infected 
with a quarantinable communicable disease in a qualifying stage who is, 
or is reasonably expected to be, moving or about to be moving between 
states or constitutes a probable source of infection to others who may 
be moving between states. Thus, HHS/CDC believes that it is important 
to define for the public what is meant by a medical examination. Under 
this NPRM, we define Medical examination to mean the assessment of an 
individual by an authorized 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 
the collection of human biological samples for laboratory testing. 
Medical examination may be authorized as part of a Federal order for 
quarantine, isolation, or conditional release. The process for ordering 
a medical examination is explained in more detail in the portion of the 
preamble discussing that substantive provision at Sec.  70.12.
Medical Representative
    HHS/CDC is providing an opportunity for any individual under a 
Federal order of quarantine, isolation, or conditional release to 
request a medical review. As part of this process, the individual under 
the Federal order may choose anyone to represent him/her at the medical 
review at his/her own expense or to represent himself/herself. However, 
in the case of an individual who is indigent and cannot afford his/her 
own representative, HHS/CDC will appoint at government expense a 
medical representative to assist the indigent individual with the 
presentation of evidence during the medical review. Appointments by 
HHS/CDC will be made only if the individual qualifies as an indigent, 
requests a medical review, and specifically requests the appointment of 
a medical representative. Again, individuals who do not qualify as 
indigent may choose to be represented by anyone at their own expense or 
to represent themselves at the medical review. Because HHS/CDC views 
the medical review process as a medical fact-finding, it has defined 
the ``medical representative'' in terms of the relevant medical 
qualifications. Medical representative means a physician, nurse 
practitioner, or similar medical professional qualified in the 
diagnosis and treatment of infectious diseases who is appointed by the 
HHS Secretary or CDC Director to assist an indigent individual under 
Federal quarantine, isolation, or conditional release with a medical 
review. The medical representative's role will be to assist the 
indigent individual with the examination of witnesses and the 
presentation of factual and scientific

[[Page 54241]]

evidence during the medical review. The medical representative and the 
medical reviewer will not be the same individual. Individuals who do 
not qualify as indigent may choose to be represented by anyone at their 
own expense or to represent themselves at the medical review.
    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 HHS Secretary or CDC 
Director to conduct a medical review. The medical reviewer may be an 
HHS or HHS/CDC employee, but only if the employee differs from the HHS/
CDC official who issued the Federal order for quarantine, isolation, or 
conditional release. The medical reviewer's role will be to review the 
medical or other evidence presented, make medical or scientific 
findings of fact, and issue a recommendation to the CDC Director 
concerning whether the quarantine, isolation, or conditional release 
should be continued, rescinded, or modified. The medical reviewer and 
the medical representative will be different individuals.
Non-Invasive
    The definition of non-invasive has been added to this NPRM to 
provide the public with reasonable assurances and expectations 
regarding what measures may be employed as part of a public health risk 
assessment or following reporting of an ill traveler. We define non-
invasive as ``procedures conducted by an authorized health worker or 
other individual with suitable training and includes the visual 
examination of the ear, nose, and mouth; temperature assessments using 
an ear, oral, or cutaneous or noncontact thermometer or thermal 
imaging; auscultation; external palpation; external measurement of 
blood pressure; 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, except the ear, nose, or mouth.'' HHS/
CDC specifically requests comment concerning this definition including 
whether the definition aligns with common perceptions of what 
constitutes non-invasive procedures that may be conducted outside of a 
traditional clinical setting.
Precommunicable Stage
    Under section 361(d) of the Public Health Service Act, to authorize 
the quarantine, isolation, or conditional release of an individual 
traveling interstate, CDC must reasonably believe that the individual 
is infected with a communicable disease in a qualifying stage. 42 
U.S.C. 264(d)(1). As defined by the statute, a ``qualifying stage'' 
means that the communicable disease is in ``a precommunicable stage, if 
the disease would be likely to cause a public health emergency if 
transmitted to other individuals'' or ``a communicable stage.'' Thus, 
HHS/CDC believes that it is necessary to define the precommunicable 
stage of a communicable disease to adequately inform the public of when 
quarantine, isolation, or conditional release may be authorized. HHS/
CDC defines precommunicable stage to mean 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. For instance, a patient diagnosed with multidrug-
resistant or extensively drug-resistant tuberculosis who is not 
currently infectious but has not been adequately treated for the 
disease and is thus considered to be at high risk of relapse to an 
infectious state would be in the ``precommunicable stage'' of the 
disease. For clarity, and to be consistent with statutory language, we 
have also updated the definition of ``incubation period'' to mean 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 for a quarantinable communicable 
disease the precommunicable stage of the disease.
    While it is important that HHS/CDC maintain flexibility to evaluate 
each case individually regarding the length of quarantine, CDC's Health 
Information for International Travel (also known as the Yellow Book) 
provides the public with general guidance regarding the expected 
incubation period for many quarantinable communicable diseases. The 
most current version is available on CDC's Web site. For more 
information, please see http://wwwnc.cdc.gov/travel/yellowbook/2016/table-of-contents.
Public Health Emergency
    Under section 361(d) of the Public Health Service Act, in order to 
authorize the quarantine, isolation, or conditional release of any 
individual traveling interstate, CDC must reasonably believe that an 
individual is infected with a communicable disease in a qualifying 
stage. 42 U.S.C. 264(d)(1). As defined by this subsection, a 
``qualifying stage'' means that the communicable disease is in ``a 
precommunicable stage, if the disease would be likely to cause a public 
health emergency if transmitted to other individuals'' or ``a 
communicable stage.'' 42 U.S.C. 264(d)(2). While the phrase ``public 
health emergency'' also appears under section 319 of the Public Health 
Service Act (42 U.S.C. 247d(a)), the use of the same phrase in both 
sections 319 and 361(d)(2) are not necessarily synonymous. Accordingly, 
HHS/CDC felt it was important to define ``public health emergency'' as 
used under section 361(d)(2) to provide the public with a clear 
understanding of HHS/CDC's authority for interstate quarantine, 
isolation or conditional release. Public health emergency as used in 
this part means any communicable disease event as determined by the CDC 
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 any communicable disease event described in a 
declaration by the Secretary pursuant to Sec.  319(a) of the Public 
Health Service Act (42 U.S.C. 247d(a)); or 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 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 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. HHS/CDC specifically requests 
public comment on this definition 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).
Public Health Prevention Measures
    Under this NPRM, Public health prevention measures means the 
assessment of an individual through non-invasive procedures and other 
means, such as observation,

[[Page 54242]]

questioning, review of travel documents, review of other available 
records to determine the individual's health status and potential 
public health risk to others (i.e., passenger screening). HHS/CDC 
believes that this definition is consistent with how public health risk 
assessments are generally conducted at U.S. ports and other locations, 
including by HHS/CDC personnel. HHS/CDC is publishing this definition 
to describe its authority to conduct public health prevention measures 
and is not effecting a change in operations.
Qualifying Stage
    Under this NPRM, ``qualifying stage'' means the communicable stage 
of a quarantinable communicable disease, or 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. This NPRM also 
separately defines ``communicable stage'' and ``precommunicable 
stage.'' HHS/CDC believes that these definitions are consistent with 
public health practice and the requirements of 42 U.S.C. 264(d)(2).
Reasonably Believed To Be Infected, as Applied to Individuals
    HHS/CDC is including this definition in this NPRM for transparency 
and so that the public understands the factors taken into consideration 
when HHS/CDC makes a determination to issue a Federal order for 
quarantine, isolation, or conditional release. By adding this 
definition, HHS/CDC is not changing its operations, but rather is 
codifying and providing an explanation to the public. Under this NPRM, 
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. HHS/CDC believes that this standard is consistent with the 
legal requirements of the statute, public health practice, and long-
standing historical practice concerning the quarantine and isolation of 
individuals.
    The determination as to whether an individual is ``reasonably 
believed to be infected,'' as defined in this NPRM, with a 
quarantinable communicable disease in a qualifying stage is made on a 
case-by-case basis. Notwithstanding, the following illustrative 
examples are provided to help explain to the public when facts or 
circumstances may exist giving rise to a reasonable belief that an 
individual is infected with a quarantinable communicable disease in its 
qualifying stage. These include: Clinical manifestations in the 
individual consistent with those of a quarantinable communicable 
disease; suspected contact with cases or suspect cases of individuals 
infected with a quarantinable communicable disease in its communicable 
stage; host susceptibility to a quarantinable communicable disease 
combined with opportunity for exposure; travel to countries and places 
where transmission of a quarantinable communicable disease has likely 
occurred; reports of the individual exhibiting illness or symptoms 
consistent with those of a quarantinable communicable disease; or other 
evidence of possible infection, including exposure to the infectious 
agent that causes a quarantinable communicable disease. These factors 
are meant to be illustrative and provide only general guidance. HHS/CDC 
specifically solicits public comment regarding this definition, in 
particular, whether the definition aligns with established public 
health practice regarding the handling of individuals exposed to or 
infected with communicable diseases.
2. Sec.  70.5 Requirements Relating to Travelers Under a Federal Order 
of Isolation, Quarantine, or Conditional Release
    This provision of the NPRM proposes to replace the previous Sec.  
70.5 Certain Communicable Diseases; special requirements that imposes 
an interstate travel permit requirement for persons in the communicable 
stage of cholera, plague, smallpox, typhus, or yellow fever. The 
existing provision also prohibits conveyance operators from 
``knowingly'' accepting for transportation any individual in the 
communicable stage of any of the specified diseases or in violation of 
the terms of the travel permit.
    Under this NPRM, any individual under a Federal order, or 
agreement, of isolation, quarantine, or conditional release for a 
quarantinable communicable disease, as specified by Executive Order, 
may be prohibited from traveling in interstate traffic, unless the 
individual has received a written travel permit issued by HHS/CDC. The 
term ``interstate traffic'' is currently defined in HHS/CDC regulations 
at 42 CFR 70.1 and includes movement from a point of origin in any 
state or possession to a point of destination in any other state or 
possession. This provision also applies to an ``agreement'' for 
isolation, quarantine, or conditional release. An individual must 
retain the travel permit in his/her possession and comply with the 
conditions for travel set forth in the permit.
    If an individual is denied an application for a travel permit, the 
denial will be issued in writing. The letter of denial will include the 
reasons for the denial as well as detailed instructions on whom to 
contact for questions, including name, address, and telephone number, 
as well as how to submit an appeal. Individuals who wish to contest 
HHS/CDC's determination will have 10 calendar days after receiving the 
letter of denial to submit an appeal. The appeal must be submitted in 
writing to the CDC, stating the reasons for the appeal and showing that 
there is a genuine and material issue of fact in dispute. Individuals 
should include also the reference number listed in the notification 
letter they received. The appeal should be addressed to: Director, 
Division of Global Migration and Quarantine, ATTN: Travel Restriction 
and Intervention Activity, Centers for Disease Control and Prevention, 
1600 Clifton Road NE., MS E-03, Atlanta, GA 30329. Appeals may also be 
faxed to HHS/CDC at (404) 718-2158 or emailed to 
[email protected].
    HHS/CDC will issue a written response to an appeal, which shall 
constitute final agency action. The appeal will be reviewed and decided 
upon by an HHS/CDC senior official who will be senior to the employee 
who issued the initial letter of denial. This appeal process is also 
applicable to revocations and suspensions of a travel permit.
    Conveyance operators are also prohibited from ''knowingly'' 
transporting an individual under a Federal order, or agreement, of 
isolation, quarantine, or conditional release without a travel permit 
or someone who is in violation of the terms of a permit. This 
prohibition only applies in circumstances where the operator would be 
reasonably considered to know or have knowledge that the individual is 
under a public health order and requires a travel permit. For instance, 
if the operator has been informed directly by the CDC, or if DHS,

[[Page 54243]]

upon the request of CDC, has placed the individual's name on a Federal 
public health travel restrictions list (``Do Not Board'' (DNB) list)--
which would only apply to aircraft operators.
    The provisions of this section may also be applied to individuals 
under a state or local order, or an agreement, (if operators are 
directly notified by authorities that an individual is under a state or 
local order) for quarantine, isolation, or conditional release, or to 
those individuals traveling entirely within a state and to intrastate 
conveyance operators at the request of a state or local health 
department or in the event of inadequate local control as determined by 
the CDC Director under 42 CFR 70.2. In the event that this provision is 
applied intrastate, CDC will work with the relevant state or local 
health department of jurisdiction to inform intrastate conveyance 
operators (e.g., bus operators) on a case-by-case basis of the names of 
individuals subject to this restriction. The application of these 
provisions to intrastate travel is authorized under section 361(a) of 
the Public Health Service Act (42 U.S.C. 264(a)) to the extent that 
such measures are necessary to prevent the interstate spread of 
communicable diseases. Specifically, because the statute authorizes the 
promulgation of regulations that are necessary to ``prevent'' 
interstate spread of disease, HHS/CDC may regulate certain activities 
that occur entirely within a State if those activities present a risk 
of interstate disease spread, as would occur, for instance, in the 
event of inadequate local control. This approach is consistent with how 
courts have interpreted the scope of the Federal government's authority 
under the Commerce Clause to the U.S. Constitution. See United States 
v. Lopez, 514 U.S. 549, 558-559 (1995) (noting that the Commerce Clause 
authorizes the regulation of the instrumentalities of interstate 
commerce, or persons or things in interstate commerce, even though the 
threat to interstate commerce may come only from intrastate 
activities). This provision is also consistent with HHS/CDC's Interim 
U.S. Guidance for the Monitoring and Movement of Persons with Potential 
Ebola Virus Exposure, published during the 2014-2016 Ebola epidemic (a 
description of the guidance is available at http://www.cdc.gov/vhf/ebola/hcp/monitoring-and-movement-of-persons-with-exposure.html). HHS/
CDC specifically requests public comment on this proposed provision.
    HHS/CDC recognizes that the right to engage in travel within the 
United States is a privilege of national citizenship protected by the 
Privileges and Immunities Clause of the U.S. Constitution, as well as 
an aspect of liberty protected by the Due Process Clauses of the Fifth 
and Fourteenth Amendments. See Jones v. Helms, 452 U.S. 412, 418 
(1981). However, this right is not unqualified and travel restrictions 
based on the threat posed by communicable diseases are valid. See Zemel 
v. Rusk, 381 U.S. 1, 15-16 (1965) (``The right to travel within the 
United States is of course also constitutionally protected . . . [b]ut 
that freedom does not mean that areas ravaged by flood, fire or 
pestilence cannot be quarantined when it can be demonstrated that 
unlimited travel to the area would directly and materially interfere 
with the safety and welfare of the area or the Nation as a whole.''). 
Furthermore, HHS/CDC will afford individuals subject to these travel 
restrictions with adequate due process through the previously mentioned 
written appeals process.
    This new regulatory provision also serves as an important 
complement to the public health ``Do Not Board'' (DNB) list. In June 
2007, HHS/CDC and the Department of Homeland Security (DHS) developed a 
public health DNB list, enabling domestic and international public 
health officials to request that individuals with communicable diseases 
who meet specific criteria, including posing a public health threat to 
the traveling public, be restricted from boarding commercial aircraft 
arriving into, departing from, or traveling within the United States. 
See Criteria for Requesting Federal Travel Restrictions for Public 
Health Purposes, Including for Viral Hemorrhagic Fevers. Available at: 
https://www.Federalregister.gov/articles/2015/03/27/2015-07118/criteria-for-requesting-Federal-travel-restrictions-for-public-health-purposes-including-for-viral.
    The public health DNB list, which is administered by DHS with HHS/
CDC's assistance, is primarily intended to supplement state and local 
public health measures to prevent individuals who are infectious or at 
risk of becoming infectious from boarding commercial aircraft. However, 
because use of the DNB list is limited to commercial aircrafts, the 
public health protections offered by the DNB list do not extend to 
vessels, or other forms of interstate transportation, such as trains 
and buses. Thus, this new provision allows for an enhanced HHS/CDC 
public health response to quarantinable communicable diseases by 
establishing a permitting process that restricts interstate travel to 
modes of conveyance that do not put the public at risk of exposure, and 
ensures that appropriate public health measures are in place. CDC 
specifically requests public comment on this provision. In particular, 
HHS/CDC requests comment on whether stakeholders have concerns 
regarding the requirement imposed on conveyance operators to not 
``knowingly'' transport individuals under a Federal order and the 
feasibility of this requirement. HHS/CDC also requests public comment 
on the application of this provision to individuals under state/local 
order as well as individuals traveling entirely within a state.
3. Sec.  70.6 Apprehension and Detention of Persons With Quarantinable 
Communicable Diseases
    Through this NPRM, HHS/CDC has proposed to change the text of this 
provision.
    We have modified ``infected with a quarantinable communicable 
disease'' to clarify, consistent with the statute's requirements, that 
the individual must be in the ``qualifying stage'' of a quarantinable 
communicable disease, which we also define. We did this to better align 
our regulations with the Public Health Service Act which authorizes the 
``apprehension and examination of any individual reasonably believed to 
be infected with a [quarantinable communicable] disease in its 
qualifying stage and (A) moving or about to move from a state to 
another state; or (B) to be a probable source of infection to 
individuals who, while infected with such disease in a qualifying 
stage, will be moving from a state to another state.'' See 42 U.S.C. 
264(d)(1)(2). The statute's requirement for interstate movement is 
reflected in the requirement in Sec.  70.6 that HHS/CDC's custody of 
the individual be ``for the purposes of preventing the interstate 
introduction, transmission, or spread of quarantinable communicable 
diseases.''
4. Sec.  70.10 Public Health Prevention Measures To Detect Communicable 
Disease
    This provision is authorized by the Public Health Service Act. 
Section 361(a) of the PHS Act (42 U.S.C. 264(a)) authorizes the HHS 
Secretary to promulgate regulations to prevent the interstate 
introduction, transmission, and spread of communicable diseases. As 
previously mentioned, section 361(a) (42 U.S.C. 264(a)) applies broadly 
to communicable diseases generally and is not limited to those subset 
of communicable diseases referred to as ``quarantinable communicable 
diseases'' for which quarantine, isolation, or

[[Page 54244]]

conditional release are authorized. Section 361(a) includes the 
authority to allow for a variety of public health measures in regard to 
communicable diseases including: Inspection, fumigation, disinfection, 
sanitation, pest extermination, destruction of animals or articles 
found to be sources of dangerous infection to human beings, and other 
measures to protect public health. Specifically, this list of public 
health actions does not involve taking persons into custody or require 
reasonable suspicion as a predicate to implementation. In contrast an 
``apprehension, detention, or conditional release'' as used in section 
361(b) involves custodial situations and requires, with regard to 
persons moving between states or U.S. territories, a reasonable belief 
that the individual is in the qualifying stage of a quarantinable 
communicable disease.
    In addition to being consistent with the requirements of section 
361 of the Public Health Service Act, this provision is also consistent 
with constitutional principles and requirements. For instance, in the 
analogous situation of an airport security screening, it is well 
established that the Transportation Security Administration may conduct 
routine warrantless searches of all carry-on luggage without 
individualized suspicion because of the compelling government interest 
involved. See United States v. Doe, 61. F.3d 107, 110 (1st Cir. 1995) 
(``Routine security searches at airport checkpoints pass constitutional 
muster because the compelling public interest in curbing air piracy 
generally outweighs their limited intrusiveness.''); see also Russkai 
v. Pistole, 775 F.3d 61, 68 (1st Cir. 2014) (noting that transit 
security screenings are treated as ``administrative'' or ``special 
needs'' searches, which may be conducted, at least initially, without 
individualized suspicion, a warrant, or probable cause). HHS/CDC 
believes that the rationale for airport security screenings may be 
extended to other forms of transportation, e.g., trains and buses, 
because of the similar ``administrative'' or special governmental need 
in preventing interstate communicable disease spread. Public health 
risk assessments are limited to non-invasive means, as defined in this 
NPRM, which includes temperature assessments using an ear, oral, 
cutaneous, or noncontact thermometer, auscultation, external palpation, 
external measurement of blood pressure, as well as questioning of 
individuals and review of travel documents. HHS/CDC does not intend 
through this provision to engage in medical testing of individuals (as 
would typically occur in a hospital or other clinical setting) at ports 
of entry or other places where individuals may engage in travel or to 
collect human biological samples for subsequent laboratory testing.
    HHS/CDC's intent under this provision is to provide for mandatory 
public health risk assessment and management at ports or other 
locations where individuals may gather to engage in interstate traffic. 
However, as in other circumstances where individuals are screened, such 
as airport security screenings, an individual's willingness to be 
screened may be inferred from his or her queueing with other travelers 
who may be engaging in interstate travel. See United States v. 
Herzbrun, 723 F.2d 773, 775 (11th Cir. 1984) (holding that a passenger 
consents to an airport security search by presenting himself/herself 
for boarding and that such consent may not be revoked by simply walking 
away). Thus, in order to protect interstate travel from communicable 
disease threats, HHS/CDC intends for this section to apply broadly to 
all circumstances where individuals may queue with other travelers 
because certain communicable diseases may be spread from person to 
person under such circumstances. This includes circumstances where only 
a certain percentage of travelers may be intending to subsequently 
engage in interstate travel or, for instance, the individual traveler 
is intending to engage in foreign travel outside the country as opposed 
to domestic interstate travel because by queuing in line with others at 
the airport he or she may expose other travelers intending to engage in 
interstate travel. HHS/CDC specifically requests public comment on this 
proposed provision and whether the public has any concerns regarding 
the mandatory health screening of passengers using non-invasive means 
as defined in this proposed rule.
    During a public health risk assessment, if facts or circumstances 
are discovered that give rise to a reasonable belief that the 
individual is infected, as defined under this NPRM, with a 
quarantinable communicable disease in its qualifying stage, CDC may 
authorize the quarantine, isolation, or conditional release of the 
individual. Similarly, an individual's refusal to be screened may 
result in quarantine, isolation, or conditional release, but only if 
sufficient facts and circumstances otherwise exist giving rise to a 
reasonable belief that the individual is infected with a quarantinable 
communicable disease in its qualifying stage.
    Under section 311 of the PHS Act (42 U.S.C. 243), HHS/CDC may 
accept state and local assistance in the enforcement of Federal 
quarantine rules and regulations, though these entities are not 
obligated to provide such assistance. In appropriate cases, Federal law 
enforcement agencies may also be able to assist in the enforcement of 
Federal public health orders. Under section 365 of the PHS Act (42 
U.S.C. 268) it shall be the duty of ``customs officers'' and ``Coast 
Guard officers'' to aid in the enforcement of Federal quarantine rules 
and regulations. ``Customs officers'' includes U.S. Customs and Border 
Protection (CBP) officers, U.S. Border Patrol agents, U.S. Immigration 
and Customs Enforcement (ICE) officers, and U.S. Coast Guard 
Commissioned, Warrant, and Petty Officers pursuant to 14 U.S.C. 143 and 
19 U.S.C. 1401(i).
    This section also requires individuals undergoing a public health 
risk assessment to provide basic contact tracing information which 
would be used to locate and notify individuals of a potential exposure 
to a communicable disease. This information would include U.S. and 
foreign addresses, telephone numbers, email addresses, used to locate 
and notify an individual. This section would also require that 
individuals undergoing a public health risk assessment provide 
additional information that would be used to assess an individual's 
health status and make a determination as to whether the individual may 
pose a public health risk to others. This would include information 
concerning the individual's intended destination, health status, and 
history of travel to places where exposure to communicable disease may 
have occurred. HHS/CDC specifically requests public comment on this 
proposed provision to collect additional personal information from 
screened individuals for the purposes of contact tracing.
    On December 13, 2007, HHS/CDC published a notice of a new system of 
records (SORN) under the Privacy Act of 1974 that is relevant to the 
activities that would be carried out under a future rule related to 
collecting, retaining, and disseminating passenger and crew data for 
public health purposes (72 FR 70867). HHS/CDC accepted public comment 
on its proposed routine uses of this information at that time. As 
required under the Privacy Act, in its notice, HHS/CDC described the 
proposed system of records; the proposed routine uses, disclosures of 
system data, the benefits and need for this data, agency policies and 
procedures, restrictions on the use of this information, and, most 
important,

[[Page 54245]]

HHS/CDC's safeguards to prevent unauthorized use. Data collected from 
travelers, ill persons, and individuals under Federal public health 
orders will be maintained in accordance with the Privacy Act and the 
system of records notice regardless of whether the individual is a U.S. 
citizen or foreign national. More information regarding the storage, 
maintenance, and routine uses of this information may be found at 72 FR 
70867 (Dec. 13, 2007). HHS/CDC will make disclosures from the system of 
records only with the consent of the subject individual or in 
accordance with the Privacy Act or its Privacy Act system of records 
notice. As a matter of practice, HHS/CDC applies these same 
requirements and protections afforded by its Privacy Act system of 
records notice to non-U.S. persons whose personal information is 
collected and maintained in this system of records.
5. Sec.  70.11 Report of Death or Illness Onboard Aircraft Operated by 
Airline
    This NPRM 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 the 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, provided that such measures do not affect the aircraft's 
airworthiness or safety of flight operations. While this provision 
specific to interstate travel is new to the regulation, the reporting 
of deaths or illnesses among passengers and crew has been a long-
established practice for flights arriving into the United States. 
Between 2010 and 2015, per year on average, HHS/CDC received about 175 
illness and 10 death reports on aircraft and about 220 illness reports 
and 115 death reports from vessels. In light of recent events, such as 
the outbreaks of Ebola, measles and MERS, and the possibility that 
symptomatic, infectious individuals may board interstate flights, HHS/
CDC believes it important to introduce this section to ensure that 
domestic flights report directly to HHS/CDC.
    This proposed section of the rule applies to aircraft and does not 
apply to other forms of transportation, such as buses and trains, 
because air travel generally carries an especially high risk of rapid 
transmission and dispersal of communicable disease as air travelers are 
able to easily connect to other flights and move around the country in 
just a few hours. Furthermore, if a traveler developed symptoms of a 
serious communicable disease onboard a bus or train, it might be easier 
for the bus or train operator to segregate or remove the ill person 
than onboard an aircraft. CDC also believes that it is easier for a 
local public health authority to respond to reports of an ill person 
onboard a bus or train traveling through its jurisdiction, even if 
ultimately on an interstate journey, than it would be for the same 
authority to respond to reports of an ill person on an aircraft. 
Furthermore, if the requirement were extended to interstate buses and 
trains, HHS/CDC believes that implementing this provision would be 
overly burdensome.
    HHS/CDC further notes that it is making no changes to its 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 this NPRM, the pilot in command of an aircraft 
operating on behalf of an airline who submits the ill person report to 
HHS/CDC will not be required to also submit a report to the local 
health authority. HHS/CDC will continue to share public health 
information with state and local health departments through electronic 
disease reporting networks such as the Epidemic Information Exchange 
(Epi-X), HHS/CDC's secure, web-based system. CDC may also notify local 
authorities via a Health Alert Notice (HAN), and when necessary, via 
phone calls, email, or other direct communication.
    If finalized as proposed, in implementing this provision, an 
airline should establish a notification system sufficient to ensure 
that any death or ill person, as defined, that is made known to the 
pilot in command is reported to CDC either through the quarantine 
station of jurisdiction for the destination airport or the CDC 
Emergency Operations Center (EOC), where possible, at least one hour 
before arrival. The EOC serves an important triage function within HHS/
CDC and operates 24-hours a day. CDC's EOC also is capable of quickly 
contacting the relevant state and local health authority and quarantine 
station of jurisdiction as well as assembling the necessary subject-
matter experts for purposes of conducting a public heath investigation.
    This proposed provision is intended to provide airlines with 
flexibility regarding the exact routing of reports of deaths or ill 
persons, as defined. Thus, this NPRM explicitly authorizes airlines to 
develop and adopt a notification system that relays information from 
the pilot in command to CDC's EOC through a designated official of the 
airline. This may be accomplished by the pilot-in-command making a 
report of a death or ill person to the U.S. Department of 
Transportation (DOT)'s Federal Aviation Administration (FAA) air 
traffic control (ATC) facility. In such cases, the DOT/FAA will notify 
the CDC's EOC via DOT/FAA's Domestic Events Network (DEN), of the 
report. However, ATC channels will not be used by CDC or airlines for 
any subsequent coordination regarding the public health response that 
follows the initial report, unless no other reasonable alternative 
exists. ATC channels are open radio frequencies whose primary purpose 
is ensuring the safe and efficient movement of aircraft in the National 
Airspace System, and any personal health information broadcast over 
them may be overhead by any person with the appropriate equipment.
    HHS/CDC believes that an airline is in the best position to develop 
a notification system, because airlines presumably already have such 
systems in place for reporting of deaths or illnesses under CDC's 
existing regulations in 42 CFR parts 70 and 71 and to the relevant 
authorities for international flights. HHS/CDC, in coordination with 
DOT/FAA, may issue additional guidance to airlines regarding 
recommended procedures for the domestic reporting to the CDC's EOC of 
any death or ill person made known to the pilot in command. HHS/CDC 
will consider the adoption and implementation by an airline of a 
notification system as a measure of an airline's compliance with this 
provision.
6. Sec.  70.12 Medical Examinations
    Under section 361(d)(1) of the PHS Act (42 U.S.C. 264(d)(1)), HHS/
CDC may promulgate and enforce regulations concerning the apprehension 
and examination of any individual reasonably believed to be infected 
with a quarantinable communicable disease in a qualifying stage e. In 
addition, HHS/CDC must reasonably believe that the individual is moving 
or about to move between states or constitutes a probable source of 
infection to others who may be moving between states. Statutory support 
for medical examinations may be found directly under 42 U.S.C. 
264(d)(1) which authorizes regulations allowing the ``apprehension and 
examination'' of any individual reasonably believed to be infected with 
a quarantinable communicable disease in a qualifying stage. Thus, HHS/
CDC believes it is important to make this process more

[[Page 54246]]

transparent and explicit. Accordingly, HHS/CDC is clarifying that the 
requirement for a medical examination by an authorized health worker 
may be included as part of a Federal order for quarantine, isolation, 
or conditional release. We specifically request public comment on this 
proposed provision and whether there are any concerns regarding the 
proposed practice to issue Federal orders before a medical examination 
has taken place.
    HHS/CDC will promptly arrange for a medical examination to be 
conducted in circumstances where such an examination is necessary to 
confirm the presence or absence of infection with a quarantinable 
communicable disease. A medical examination will typically occur in a 
hospital setting and be performed by clinical staff that will have 
primary responsibility for the patient's medical care and treatment. 
HHS/CDC will consult with hospital staff regarding the public health 
management of the case. A medical examination may include the taking of 
a medical history, a physical examination, and taking of laboratory 
samples.
    The determination as to whether a medical examination may be 
necessary in any given circumstances is by its nature highly fact 
dependent. Notwithstanding, the following illustrative examples are 
provided to help explain to the public when facts or circumstances may 
exist giving rise to a need for a medical examination. These include 
the following circumstances: Clinical manifestations in the individual 
consistent with those of a quarantinable communicable disease; 
suspected contact with cases or suspect cases of individuals infected 
with a quarantinable communicable disease in its communicable stage; 
host susceptibility to a quarantinable communicable disease combined 
with opportunity for exposure; travel to countries and places where 
transmission of a quarantinable communicable disease has likely 
occurred; reports of the individual exhibiting illness or symptoms 
consistent with those of a quarantinable communicable disease; or other 
evidence of possible infection, including exposure to the infectious 
agent that causes a quarantinable communicable disease. These factors 
are meant to be illustrative and provide only general guidance.
7. Sec.  70.13 Payment for Care and Treatment
    Under this proposed section, HHS/CDC may pay for the care and 
treatment of individuals subject to apprehension, medical examination, 
quarantine, isolation, and conditional release after the exhaustion of 
all third party payments. This section implements Sec.  322 of the 
Public Health Service Act (42 U.S.C. 249) which authorizes HHS/CDC to 
provide for the care and treatment of individuals detained in 
accordance with quarantine laws. Payment for care and treatment under 
this section is in the CDC's sole discretion, subject to the 
availability of appropriations, and after all third-party payments have 
been exhausted. This section also authorizes payment for ambulance or 
other medical transportation services whenever the HHS/CDC considers 
such services to be a necessary part of an individual's care and 
treatment. HHS/CDC, in consultation with state and local health 
departments, may make advance arrangements with medical providers 
through a memorandum of agreement or other mechanisms regarding payment 
for the care and treatment of individuals subject to public health 
actions.
    Under this proposed section, HHS/CDC may assume responsibility for 
payment for the care and treatment of individuals subject to Federal 
apprehension, medical examination, quarantine, isolation, and 
conditional release. For individuals requiring hospitalization for 
other reasons, however, payment will not be made for costs incurred 
after it is determined that the individual does not have a 
quarantinable communicable disease because medical services beyond that 
point are no longer for the benefit of the public's health. We 
reemphasize that any payment by HHS/CDC under this section will be made 
only after all third party payments have been exhausted. Through this 
proposal, HHS/CDC will arrange for appropriate care and treatment of 
individuals consistent with U.S. constitutional principles. The 
issuance of a formal written Federal order is also not a prerequisite 
for the payment of care and treatment under this section.
    HHS/CDC also clarifies that it may pay for ambulance services if 
necessary for an individual's care and treatment. Relocating an 
individual by use of ambulance services to a dedicated isolation 
facility can be reasonably considered to fall under ``care and 
treatment.'' It is HHS/CDC's intent that neither medical providers, nor 
travelers, be financially penalized for their cooperation with public 
health authorities. If finalized as proposed, in implementing this 
section, HHS/CDC intends to coordinate with state and local health 
departments and medical providers. HHS/CDC specifically requests public 
comment on this proposed provision and whether there are any concerns 
regarding the proposal 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.
8. Sec.  70.14 Requirements Relating to Issuance of a Federal Order for 
Quarantine, Isolation, or Conditional Release
    Through this rulemaking, HHS/CDC is describing the process for 
issuance of Federal orders for isolation, quarantine, and conditional 
release and required content of such public health orders. Individuals 
under quarantine, isolation, or conditional release, will be served 
with written orders describing the facts and circumstances supporting 
the imposition of such public health measures. This section also 
proposes to permit the issuance of public health orders to a group of 
individuals. Thus, in particular circumstances, the Federal order may 
be written to refer generally to a group of individuals, e.g. all 
individuals onboard a particular interstate flight. HHS/CDC expects 
that when a Federal quarantine order is written in such a manner that 
all individuals within that group will still receive separate copies of 
the group order. HHS/CDC also expects that the circumstances giving 
rise to a group Federal quarantine order will be exceedingly rare and 
that most Federal quarantine orders will be written so that they 
contain the names of those individuals subject to the Federal order and 
be issued on an individual basis. HHS/CDC specifically requests public 
comment on this proposed provision to issue Federal orders to entire 
groups rather than individuals.
    This proposed provision requires that orders for quarantine, 
isolation, or conditional release be in writing, signed by the HHS/CDC 
authorizing official, and contain specific information such as the 
identity of the individual or group subject to the order; the factual 
basis for the quarantine, isolation or conditional release; and the 
rights and obligations of individuals subject to the order. This 
proposed provision also requires personal service of the order, or when 
such service is impracticable, that the notice be posted or published 
in a conspicuous location. Thus, for instance, if all individuals are 
to be confined in a common location, the Federal order of quarantine 
may be posted in a conspicuous place viewable by all of the inhabitants 
of that location. HHS/CDC believes that these standards

[[Page 54247]]

for notice are consistent with due process.
    HHS/CDC's current practice is to inform individuals of its public 
health requirements in a language they can understand, to the extent 
practicable. HHS/CDC will make reasonable efforts to issue orders for 
quarantine, isolation, or conditional release in languages 
understandable to those who are subject to these orders. In 
circumstances where it is impractical to immediately 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 or summary 
translations. HHS/CDC specifically requests public comment on this 
proposed provision and whether this provision sufficiently informs the 
public all 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.
9. Sec.  70.15 Mandatory Reassessment of a Federal Order for Qarantine, 
Isolation, or Conditional Release
    This proposed provision requires HHS/CDC to reassess the need to 
continue the quarantine, isolation, or conditional release of an 
individual or group no later than 72 hours after the Federal order was 
first served. A reassessment will only occur once after the first 72 
hours and will not continue to reoccur every 72 hours. As part of the 
mandatory reassessment, HHS/CDC will review all records considered in 
issuing the quarantine, isolation, or conditional release order, as 
well as any relevant new information. If HHS/CDC decides to continue 
the quarantine, isolation, or conditional release or modifies it, it 
will notify the individual of his/her right to request a medical 
review. A medical review may be requested by anyone under a Federal 
public health order, after the mandatory reassessment is complete. As 
part of the mandatory reassessment and where applicable, HHS/CDC will 
also consider whether less restrictive alternatives would adequately 
serve to protect the public health. Thus, for instance, if an 
individual is confined in a guarded facility, HHS/CDC will consider 
whether less restrictive alternatives, such as home quarantine, would 
adequately serve to protect the public health. HHS/CDC's review of less 
restrictive alternatives may include not just an analysis of the nature 
of the quarantinable communicable disease, but also an assessment of an 
individual's willingness, ability, and likelihood of complying with 
less restrictive alternatives.
    The mandatory reassessment is designed to minimize the chance that 
a quarantine, isolation, or conditional release has been misapplied and 
will consist primarily of a review of the written record, as well as 
any relevant new information. HHS/CDC has determined that 72 hours is a 
point at which to reassess these actions because HHS/CDC considers it 
the minimum amount of time needed to collect medical samples, transport 
those samples to laboratories, and obtain preliminary results of 
diagnostic testing on most quarantinable communicable disease agents. 
Seventy-two hours also represents an appropriate time period in which 
to review past actions that were taken to protect public health and to 
reassess the need for continued actions. HHS/CDC specifically requests 
public comment on this provision--in particular, 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.
    At the conclusion of the reassessment, HHS/CDC will issue a written 
Federal order directing that the quarantine, isolation, or conditional 
release be continued, modified, or rescinded. HHS/CDC may continue 
these actions in circumstances where it determines that such a Federal 
order was correctly applied and in circumstances where the existence of 
a quarantinable communicable disease has either been determined to be 
present or has not yet been ruled out.
10. Sec.  70.16 Medical Review of a Federal Order for Quarantine, 
Isolation, or Conditional Release
    This proposed provision provides an individual under Federal 
quarantine, isolation, or conditional release with an opportunity to 
request a medical review. HHS/CDC believes that the term ``medical 
review'' best conveys that the review is intended primarily as a 
medical fact-finding and is not intended to determine legal rights or 
duties. Upon the request of an individual under a Federal quarantine, 
isolation, or conditional release order, and after HHS/CDC's mandatory 
reassessment of the order, HHS/CDC will, as soon as practicable, 
arrange for a medical review.
    HHS/CDC will endeavor to convene the medical review within three to 
four business days of a request, but may allow for extensions, for 
instance, to permit the quarantined or isolated individual to confer 
with his/her chosen representative (or in the case of indigent 
individuals the appointed medical representative), review medical 
records, and arrange for witnesses, or when other facts and 
circumstances warrant. HHS/CDC believes that a more flexible standard 
concerning the timeframe for when a medical review must be conducted is 
reasonable and ensures a higher caliber of review by allowing more time 
to assemble and review the administrative record, conduct further 
examinations, and assemble necessary parties.
    The medical review is for the purpose of ascertaining whether the 
HHS/CDC has a reasonable belief that the individual is infected with a 
quarantinable communicable disease, including having been exposed to 
the infectious agent that causes a quarantinable communicable disease, 
and is in the qualifying stage of the quarantinable communicable 
disease. The medical review is not intended to address concerns of 
individuals who take issue with the amenities of their confinement, but 
do not otherwise dispute HHS/CDC's reasonable belief. Individuals who, 
for instance, object to the quality of food, housing, or entertainment 
available to them while subject to Federal quarantine or isolation may 
express such concerns through any available means, such as informally 
raising their concerns with the treatment facility in which they are 
being confined, without the need for HHS/CDC to conduct a medical fact-
finding, which is the purpose of a medical review. However, as part of 
the medical review, the medical reviewer will consider and accept into 
the record evidence as to whether less restrictive alternatives would 
adequately serve to protect public health. Thus, for instance, if the 
individual is confined in a guarded facility, the medical reviewer will 
consider whether home quarantine would adequately serve to protect 
public health. HHS/CDC specifically requests public comment on this 
proposed provision--in particular, 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.
    The medical review is primarily a medical fact-finding and is also 
not intended to address issues of law or policy. The types of medical 
issues HHS/CDC expects would be raised at the medical review are those 
that pertain to the infectious agent at issue, the individual's 
susceptibility, and the environment in which the individual may (or may 
not) have been exposed to the infectious agent. Individuals may

[[Page 54248]]

also raise basic factual questions tending to refute the Director's 
reasonable belief that the individual is infected with a quarantinable 
communicable disease, e.g., mistaken identity; not a passenger onboard 
an affected conveyance; not in contact with an infected individual. 
Individuals seeking to challenge the legal basis for their quarantine 
may do so through whatever legal mechanism may be available. HHS/CDC 
does not express an opinion regarding what form the legal action should 
take or what legal remedies may be available to individuals seeking to 
challenge their public health restrictions.
    HHS/CDC will notify individuals under a Federal quarantine, 
isolation, or conditional release order in writing of the time and 
place of the medical review. HHS/CDC has defined a ``medical reviewer'' 
as a physician, nurse practitioner, or similar medical professional 
qualified in the diagnosis and treatment of infectious diseases who is 
appointed by the HHS Secretary or CDC Director to conduct a medical 
review. The medical reviewer may be an HHS or HHS/CDC employee, but 
only if the employee differs from the HHS/CDC official who issued the 
Federal order for quarantine, isolation, or conditional release. HHS/
CDC believes that allowing for the use of HHS or HHS/CDC employees to 
serve as medical reviewers is consistent with standards of due process. 
For instance, HHS/CDC notes that it is not unusual for hospitals to 
rely on internal decision-makers during emergency civil commitments. 
The medical reviewer's role will be to review the medical or other 
evidence presented, make medical or scientific findings of fact, and 
issue a recommendation to the CDC Director concerning whether the 
quarantine, isolation, or conditional release should be continued, 
rescinded, or modified. The medical reviewer's role is distinct from 
the role of an appointed medical representative and will not be the 
same individual.
    An individual under Federal quarantine, isolation, or conditional 
release may choose to be represented by anyone at their own expense 
during a medical review or to represent themselves. However, if an 
individual is indigent and cannot afford a representative, HHS/CDC will 
appoint a medical representative upon request at the government's 
expense. HHS/CDC specifically requests public comment on this 
provision--in particular, whether the public believes that there may be 
non-indigent individuals, as defined in this NPRM, who may have 
difficulty affording a representative. The individual requesting such 
representation would be expected to sign a statement under penalty of 
perjury that he/she is indigent as established in the regulation. HHS/
CDC would accept the signed statement as prima facie evidence that the 
standard for indigence has been satisfied and proceed with appointing a 
medical representative. HHS/CDC does not expect to independently verify 
income or assets at the time of the appointment. If the individual 
knowingly makes a false statement, then the individual could be 
prosecuted. The statement would include the following language, ``In 
accordance with 28 U.S.C. 1746, I declare under penalty of perjury that 
the foregoing statement is true and correct.''
    Because the purpose of the medical review is primarily one of 
medical fact-finding, it is anticipated that an appointed medical 
representative will be a physician or similar qualified medical 
professional, and not an attorney, although a patient may also choose 
to have an attorney present. The medical representative may be an 
individual from within HHS or HHS/CDC, but will be someone that is 
unconnected to the agency's original decision to impose the public 
health restriction. HHS/CDC will use its best efforts to ensure that 
the medical reviewer and medical representative possess familiarity 
with the particular communicable disease at issue and with general 
principles of communicable disease transmission. The facts and 
circumstances of each case will dictate the type and level of expertise 
that may be needed in a representative. HHS/CDC believes that these 
procedures are consistent with the requirements for due process.
    At the conclusion of the review, the medical reviewer will issue a 
written report to the CDC Director as to whether, in the medical 
reviewer's professional judgment, the quarantine, isolation, or 
conditional release should be continued, modified, or rescinded. The 
written report will also be served on the individual under public 
health restrictions and his/her representative. The Director will 
review the written report, as well as any objections that may be 
submitted by the individual under public health restrictions or his/her 
representative contesting the medical reviewer's findings and 
recommendation. Upon the conclusion of the review, the Director will 
promptly issue an order to continue, modify, or rescind the order.
    In the event that the Director, after reviewing the medical 
reviewer's report, continues or modifies the quarantine, isolation, or 
conditional release, the Director's written order will include a 
statement that the individual may request that the CDC rescind the 
public health restriction, but based only on significant, new or 
changed facts or medical evidence showing that a genuine issue exists 
as to whether the individual should remain under quarantine, isolation, 
or conditional release. The Director's order will not constitute final 
agency action until it is served on the individual or, alternatively, 
if individual service would be impracticable, it is posted or 
published. ``Final agency action'' means that while HHS/CDC will 
continue to review the need for the public health restriction to ensure 
that individuals are not detained longer than necessary, HHS/CDC has 
issued what it believes to be its final agency decision with respect to 
the quarantine, isolation, or conditional release.
    To help facilitate the review, this section also allows HHS/CDC to 
issue additional or updated instructions through standard operating 
procedures governing the conduct of medical reviews. Such instructions, 
for instance, may govern the format and length of written submissions 
to the medical reviewer, specific number and order of witnesses, and 
length of oral presentations.
11. Sec.  70.17 Administrative Records Relating to Quarantine, 
Isolation, or Conditional Release
    This proposed provision describes the administrative record as it 
pertains to an individual under a Federal quarantine, isolation, or 
conditional release order. The administrative record is the ``paper 
trail'' that documents the agency's decision-making process and 
explains the basis for the agency's decisions. The administrative 
record contains the available documents that were considered by CDC in 
making its public health decision to quarantine, isolate, or 
conditionally release an individual. The administrative record will 
typically be compiled as documents are generated or received during the 
course of the agency's decision-making, but may be compiled after the 
agency's action, for example, in response to litigation.
    HHS/CDC offers the following guidance concerning the administrative 
record. The following types of records would generally not be 
considered part of the administrative record: (1) Documents that are 
not relevant to the agency's decision-making process, e.g., fax cover 
sheets, emails that do not contain relevant information or information 
documenting the decision-making process; (2) primary documents that did 
not exist or were unavailable at

[[Page 54249]]

the time that the agency made its decision; (3) personal notes, 
journals, appointment calendars, and other similar documents, 
maintained solely for personal use and not under the agency's control, 
possession, or maintenance; and (4) internal ``working'' drafts of 
documents.
    Once the administrative record has been reviewed and compiled, it 
will be certified as the agency's official record. The individual 
certifying the administrative record will be an agency official who can 
attest that the record is complete, accurate, and was considered by the 
agency in making its decision. A copy of this record will be served on 
the individual subject to the Federal order upon the individual's 
request.
12. Sec.  70.18 Agreements
    This proposed provision allows HHS/CDC to enter into an agreement 
with an individual, upon such terms as HHS/CDC considers to be 
reasonably necessary, indicating that the individual agrees to any of 
the public health measures authorized under this part, including 
quarantine, isolation, conditional release, medical examination, 
hospitalization, vaccination, and treatment; provided that the 
individual's agreement shall not be considered as a prerequisite to the 
exercise of the CDC's authority under this part. In circumstances where 
an individual is unable to confirm agreement, for instance a minor or 
an individual with a cognitive disability or other incapacity, CDC may 
enter into an agreement with a parent or other appropriate guardian 
authorized to act on the individual's behalf.
    HHS/CDC believes that the availability of agreements is an 
important tool to obtain an individual's compliance with public health 
measures and as a means of building trust with the individual. An 
agreement, for instance, may be used in circumstances where an 
individual agrees to comply with the instructions of public health 
staff, such as to not engage in travel, limit social contacts, or 
remain in home quarantine. An agreement will typically include a 
statement indicating the individual chooses to enter into the agreement 
on a voluntary basis, without duress or coercion, and with full 
knowledge of the facts and circumstances of his/her individual case. 
Individuals who decline to enter into such agreements will not face 
criminal or other penalties for not entering into such agreements. 
However, individuals who violate the terms of the agreement or the 
terms of the Federal order for quarantine, isolation, or conditional 
release (even if no agreement is in place between the individual and 
the government), he or she may be subject to criminal penalties as 
explained in the preamble to section 70.19. These criminal penalties 
will also be explained in the text of the agreement itself. HHS/CDC 
specifically solicits public comment on the utility and appropriateness 
of using agreements as described in this preamble, particularly 
regarding whether such agreements are confusing to individuals as they 
shall not be considered a prerequisite to the exercise of the CDC's 
authority under this part.
13. Sec.  70.19 Penalties
    This proposed section describes the criminal penalties for 
violations of quarantine regulations. 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 Sec.  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, and because the lower penalties 
established in 42 U.S.C. 271 do not exempt by specific reference the 
offense from the applicability of the fines under 18 U.S.C. 3571 (18 
U.S.C. 3571(e)), the greater penalties of 18 U.S.C. 3571(b)(5) and 
(c)(5) apply and will thus be incorporated into 42 CFR part 70.
    The intent of this proposed section is to inform individuals and 
entities of the available criminal penalties that currently exist in 
statute for violations of quarantine regulations. This section 
clarifies that of the statutory penalties imposed for violation of 
quarantine regulations (i.e., 42 U.S.C. 271 and 18 U.S.C. 3571), this 
rule will codify the higher penalty as established in 18 U.S.C. 3571. 
Furthermore, the penalties described in this section are criminal in 
nature referring to criminal violations of Federal quarantine 
regulations. Thus, these penalties would be pursued through the courts 
and would not be imposed administratively. HHS/CDC specifically 
requests public comment on this proposed provision--in particular, 
whether the penalties as proposed in this rule are clearly defined and 
the circumstances under which such penalties may be imposed.

B. Updates to Part 71

1. Sec.  71.1 Definitions
    Through this NPRM, HHS/CDC is proposing to include new and updated 
definitions to part 71 to provide clarity and help the public 
understand the intent behind the updated and new provisions.

Agreement

    HHS/CDC proposes to define ``agreement'' in the same manner as 
how that term is defined under Sec.  70.1.

Airline

    HHS/CDC proposes to define ``airline'' in a similar manner as 
how that term is defined under Sec.  70.1.

Apprehension

    This provision defines apprehension in the same manner as under 
part 70.

Conditional Release

    This proposed provision defines conditional release in the same 
manner as ``surveillance'' under Sec.  71.1 and includes public 
health supervision through in-person visits by a public health 
official (or designee) telephone, or through any electronic or 
internet-based means as determined by HHS/CDC. HHS/CDC is proposing 
to use the term conditional release and cross-referencing the 
definition of surveillance so that the language of this rule is 
consistent with the agency's current terminology and practices. As 
explained in the preamble to this definition under Sec.  70.1, HHS/
CDC is also proposing to expand this definition to permit additional 
forms of public health monitoring to include electronic monitoring 
and video chat.

Conditional Release

    HHS/CDC proposes to define ``conditional release'' in same 
manner as how the term is defined under Sec.  70.1.

Contaminated Environment

    HHS/CDC proposes to define ``contaminated environment'' in the 
same manner as how that term is defined under Sec.  70.1.

[[Page 54250]]

Electronic or Internet-Based Monitoring

    HHS/CDC proposes to define ``electronic or internet-based 
monitoring'' in the same manner as how that term is defined under 
Sec.  70.1.

Ill Person

    We are proposing to update the definition of ``ill person'' 
under part 71 for a few reasons. First, we are correcting the 
temperature correlation from 100 degrees Fahrenheit to 100.4 
Fahrenheit in the current definition so that the conversion 
accurately equals 38 degrees Celsius. Second, we are more closely 
aligning the HHS/CDC definition with the ICAO guidelines regarding 
illness reporting, which will also have the effect of capturing 
other symptoms of communicable disease of public health concern. The 
NPRM applies the same plain-language approach as described for the 
definition of ``ill person'' in part 70 and the above in-depth 
explanations and examples of the communicable diseases that such 
signs and symptoms might indicate also apply to this definition 
under part 71.
    Lastly, the new proposed definition of ``ill person'' under part 
71 includes two separate contexts and locations for the purposes of 
reporting the ill person: One onboard an aircraft and one onboard a 
vessel. Both subsections include a provision allowing HHS/CDC to 
include additional signs and symptoms of illness in case our 
understanding of the recognizable symptoms of communicable diseases 
of concern, such as Ebola, change or to respond to communicable 
diseases with unique signs and symptoms that may emerge as future 
concerns. Notice of such additional signs and symptoms will be 
published in the Federal Register.
    This NPRM does not propose to create any substantive changes 
from current regulations in gastrointestinal illness (i.e., 
diarrheal) reporting for vessels, nor does it change any current 
operations of HHS/CDC's Vessel Sanitation Program (VSP). HHS/CDC 
believes that any distinction in reporting requirements between 
vessels and aircrafts is justified by the fact that vessels, in 
particular cruise vessels, typically contain medical facilities 
onboard and are places where ill persons can be more easily 
segregated from other passengers and crew. Further, because 
individuals are typically onboard vessels for a longer duration than 
an aircraft, it is possible to track the occurrence in a 24-hour 
period of a greater than normal (for the person) amount of loose 
stools, per the existing reporting requirements under 42 CFR 
71.21(b).

Indigent

    This provision defines indigent in the same manner as under 
Sec.  70.1. CDC specifically requests public comment on whether the 
use of this standard definition (150% of the applicable HHS poverty 
guidelines in the Federal Register) 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.

Medical Examination

    This provision defines medical examination in the same manner as 
under Sec.  70.1.

Medical Representative

    This provision defines medical representative in the same manner 
as under Sec.  70.1.

Non-Invasive

    While not a new concept for HHS/CDC operations, the proposed 
definition of non-invasive is being added to this regulation to 
provide the public with reasonable assurance and expectations of 
what measures may be employed as part of a public health risk 
assessment or following a report of illness. We define non-invasive 
as ``procedures conducted by an authorized health worker or another 
individual with suitable training and includes the physical 
examination of the ear, nose, and mouth; temperature assessments 
using an ear, oral, cutaneous or noncontact thermometer; thermal 
imaging; auscultation; external palpation; external measurement of 
blood pressure; 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.'' Non-invasive has the same 
meaning in part 71 as under part 70. HHS/CDC specifically requests 
comment concerning this definition including whether the definition 
aligns with common perceptions of what constitutes non-invasive 
procedures that may be conducted outside of a traditional clinical 
setting (e.g., airports, train stations).

Public Health Prevention Measures

    Under section 361 of the PHS Act (42 U.S.C. 264(a)), the HHS 
Secretary has legal authority to approve measures to prevent the 
introduction, transmission, and spread of communicable disease into 
the United States. Furthermore, the U.S. government is generally 
understood to exercise plenary authority at the border. This section 
authorizes public health screening, risk assessment and management 
at ports of entry, including U.S. international airports, seaports, 
and land border crossings, upon terms similar to those described 
under part 70.
    HHS/CDC believes that the provisions of this section may be 
applied broadly to all travelers at a U.S. port, including airports 
and seaports, who intend to travel internationally, regardless of 
whether the particular traveler is arriving into or departing from 
the United States. For example, it is widely known that most U.S. 
travelers departing the United States for purposes of engaging in 
international travel are doing so on round-trip itineraries and thus 
intend to return to the United States. Thus, it is possible for some 
of those travelers who may be in the incubation period of a 
communicable disease to return to the United States while infectious 
and infect others once in the United States. Collectively, over 350 
million international travelers arrive into the U.S. every year. 
HHS/CDC's Division of Global Migration and Quarantine (DGMQ) helps 
to protect our nation's health by working to prevent the 
introduction and spread of communicable diseases into the U.S. While 
HHS/CDC has quarantine stations located at or near certain 
international airports and land border crossings, U.S. Customs and 
Border Protection (CBP) inspects international travelers arriving at 
U.S. ports of entry and has over 25,000 officers at all U.S. ports 
of entry where international travelers arrive. CBP's unique position 
makes them an important partner in identifying and responding to 
suspected cases of communicable disease. CBP officers serve as HHS/
CDC's ``eyes and ears'' by visually observing travelers for certain 
signs of illness and notifying the HHS/CDC Quarantine Station of 
jurisdiction when ill travelers are detected. CDC staff are 
consulted to determine whether ill travelers may have a communicable 
disease of public health concern and whether any additional public 
health action is needed.
    Although new to this proposed regulation, public health risk 
assessment and management is not a new concept. This NPRM informs 
the public of HHS/CDC's authority to conduct public health risk 
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. For example, due to the 2014-2016 Ebola epidemic, 
HHS/CDC and DHS began enhanced entry risk assessment and management 
(i.e. ``public health prevention measures'') at five U.S. airports 
(New York's John F. Kennedy International, Washington-Dulles 
International, Newark Liberty International, Chicago-O'Hare 
International, and Atlanta Hartsfield Jackson International) to take 
additional steps to help prevent further spread of Ebola and to 
ensure that anyone found to have symptoms of Ebola at one of these 
airports was immediately isolated and received appropriate medical 
examination and care. Public health entry prevention measures enable 
evaluation of travelers from countries with widespread transmission 
of communicable disease, as well as the opportunity to provide 
travelers with educational materials and potential follow up. HHS/
CDC requests public comment on these proposed public health 
prevention measures.
2. Sec.  71.2 Penalties
    This proposed provision updates the explanation of criminal 
penalties under 42 CFR 71.2, which currently states in existing 
regulation that ``any person violating any provision of these 
regulations shall be subject to a fine of not more than $1,000 or to 
imprisonment for not more than 1 year, or both as provided in section 
368 of the Public Health Service Act (42 U.S.C. 271).'' As explained in 
the preamble language to the penalties provision under part 70, the 
intent of this section is to inform individuals and entities of the 
available alternate criminal penalties that currently exist for 
violations of quarantine regulations.

[[Page 54251]]

This section thus codifies the alternate criminal penalties as 
established in 18 U.S.C. 3571.
3. 71.4 Requirements Relating to Collection, Storage, and Transmission 
of Airline Passenger, Crew, and Flight Information for Public Health 
Purposes
    At present, HHS/CDC uses a multi-step process to obtain passenger 
contact information. HHS/CDC issues a written order under the current 
authority of 42 CFR 71.32(b) to the airline that requires the airline 
to provide HHS/CDC with contact information about the index case and 
passenger contacts. The order requires that the airline provide it with 
each traveler's first and last name, seat number, two phone numbers and 
email address. Such orders can be marked ``urgent'' depending on the 
seriousness of the communicable disease. However, airlines may not be 
in possession of the contact information sought by HHS/CDC and may not 
be able to transmit contact data to HHS/CDC in a timely fashion. HHS/
CDC instructs airlines to provide data when available or to inform CDC 
when data are unavailable.
    Under this NPRM, upon confirmation by HHS/CDC of a case or 
suspected case of a communicable disease on board an aircraft, 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 and already maintained by the operator. This proposed 
requirement is a codification of current practice, wherein CDC directly 
issues a manifest order to the airline, which applies to certain data 
elements as described in this NPRM that the airline may already have 
available and authorizes the airline 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 
proposed codification of current practices, we assume airlines will 
continue to submit data through current mechanisms, although we will 
accept others that are mutually acceptable. Further, in keeping with 
current practices, under this proposal, airlines are not required to 
verify the accuracy of the information collected, and airlines are not 
required to collect additional information from passengers than already 
collected and maintained by the carrier. Because airline manifest data 
are often insufficient to contact potentially exposed travelers 
reliably, CDC will supplement these data with information from CBP, 
including APIS and Passenger Name Record (PNR), consistent with current 
practice.
    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. The 
measure also serves public health purposes generally by helping prevent 
the introduction, transmission, and spread of communicable disease into 
the United States. Although trends in infectious disease cannot be 
foreseen precisely, in recent years HHS/CDC only infrequently has had 
occasion to order airlines to provide the specified contact information 
for travelers on a given flight. Under the NPRM, orders would continue 
to be made on a case-by-case basis only, based exclusively on medically 
indicated criteria. Consistent with prior practice, such orders 
typically would be limited to information for certain passengers or 
crew who were seated within a certain distance of an individual 
infected or reasonably believed to be infected with a communicable 
disease, and are generally based on medical examination or reports from 
state or local health authorities. Such passengers and crew are thus at 
higher risk of exposure to such a disease and stand to benefit most 
from timely information, assessment and post exposure prophylaxis (if 
appropriate).
    Additionally, we note also that HHS/CDC is committed to protecting 
the privacy of the information collected. On December 13, 2007, HHS/CDC 
published a notice of a new system of records (SORN) under the Privacy 
Act of 1974 that would be applicable to its conduct of activities under 
this NPRM (72 FR 70867). HHS/CDC accepted public comment on its 
proposed routine uses of this information at that time. As required 
under the Privacy Act, HHS/CDC in its notice described the proposed 
system of records, the proposed routine uses, disclosures of system 
data, the benefits and need for the routine uses of these data, our 
agency's policies and procedures, restrictions on the routine uses of 
this information, and most importantly, our safeguards to prevent 
unauthorized use. Data collected from passengers; crew; ill persons; 
and individuals under Federal public health orders will be used 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. Such data will be maintained in a manner that is 
consistent with Article 45(2) of the International Health Regulations 
and will be released to authorized users only, including, where 
necessary, State and local government health related agencies directly 
involved in the contact tracing related to the original purpose of the 
collection. In addition, HHS/CDC will make disclosures from the system 
only with the consent of the subject individual, in accordance with its 
routine uses, or in accordance with an applicable exception under the 
Privacy Act or system of records notice. HHS/CDC emphasizes that the 
information will be maintained and used in accordance with the Privacy 
Act and the above-described system of records. Furthermore, HHS/CDC 
will apply the protections of the SORN to all travelers regardless of 
citizenship or nationality. HHS/CDC specifically requests public 
comment on this proposed provision, and has included the chart below to 
reflect the data elements that are collected under current practice, 
which CDC seeks to codify through regulation. CDC also requests comment 
on the applicability of the December 13, 2007 system of records (SORN) 
to the activities proposed in this provision (72 FR 70867), and whether 
the SORN sufficiently addresses the public's concerns related to 
maintenance and protection of the data elements proposed. HHS/CDC 
requests public comment from operators of airlines regarding the 
request for a manifest within 24 hours and whether the provision grants 
sufficient time for operators to respond to manifests orders. HHS/CDC 
also requests comment regarding the likelihood that the passenger and 
crew data elements requested are already collected and maintained by 
airline operators for transmission to CDC.
4. Sec.  71.5 Requirements Relating to Collection, Storage and 
Transmission of Vessel Passenger, Crew and Voyage Information for 
Public Health Purposes
    Under this NPRM, upon confirmation or reasonable suspicion by HHS/
CDC of a case or suspected case of a communicable disease on board a 
vessel, the operator of any vessel arriving into the United States must 
make certain contact information described below available within 24 
hours of an order by the HHS/CDC, to the extent that such data are 
available and already maintained by the operator. This proposal is a 
codification of current practice and applies to any of the data 
elements that the vessel operator may already have available and 
authorizes the vessel operator to

[[Page 54252]]

transmit the contact information in any format and through any system 
available and acceptable to both the vessel and HHS/CDC. Again, because 
this is a codification of current practices, we assume vessel operators 
will continue to submit data through their current mechanisms, although 
we will accept others that are mutually agreeable.
    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. The 
measure also serves public health purposes generally by helping prevent 
the introduction, transmission, and spread of communicable disease into 
the United States. Although trends in infectious disease cannot be 
foreseen precisely, in recent years HHS/CDC only infrequently has had 
occasion to order vessels to provide the specified contact information. 
Under the NPRM, orders would continue to be made on a case-by-case 
basis only, based exclusively on medically indicated criteria. 
Consistent with prior practice, such orders typically would be limited 
to information for certain passengers or crew who were seated within a 
certain distance of an individual infected or reasonably believed to be 
infected with a communicable disease, and are generally based on 
medical examination or reports from state or local health authorities. 
Such passengers and crew are thus at higher risk of exposure to such a 
disease and stand to benefit most from timely information, assessment, 
and post-exposure prophylaxis (if appropriate).
    The NPRM proposes the same data submission approach for vessels 
with minor changes to reflect the differences between air and sea 
travel (cabin number as opposed to seat number). The NPRM also 
explicitly excludes ferries, as defined under 46 U.S.C. 2101 and U.S. 
Coast Guard (USCG) regulations (46 CFR 2.10-25). The NPRM also excludes 
collecting passenger information from vessels that are carrying fewer 
than 13 passengers (excluding crew). HHS/CDC selected 13 passengers, 
excluding crew, as the dividing point since vessels with 13 or more 
passengers are primarily passenger vessels (as opposed to cargo vessels 
with ancillary passenger service) and has successfully used this 
criterion for many decades. HHS/CDC decided to exclude vessels with 
fewer than 13 passengers because of their lower expected probability of 
introducing and transmitting communicable disease in the U.S. HHS/CDC 
decided to focus public health resources on vessels with the greatest 
number of passengers and the greatest chance of introduction, 
transmission and spread of infectious disease into the United States. 
However, we note that we would collect contact information from these 
vessels if needed for an investigation. The rationale is analogous to 
HHS/CDC's decision to require the collection of information of airline 
passengers only rather than passengers on all aircraft, where again, 
CDC would collect contact information if needed to protect public 
health.
    Under the U.S. Coast Guard's definition referenced in this NPRM, 
HHS/CDC is also excluding ferries that travel distances of less than 
300 miles. Passengers and crew will spend much less time on these 
voyages as compared to a typical passenger cruise. Therefore, the 
opportunities for transmitting diseases are lower.
    Also in keeping with current practices, under this proposal, vessel 
operators are not required to verify the accuracy of the information 
collected and HHS/CDC takes no position on what consequences the vessel 
operator can impose if a traveler refuses to provide the information, 
such as refusing to board the traveler.
    Finally, we note also that HHS/CDC is committed to protecting the 
privacy of the information collected. On December 13, 2007, HHS/CDC 
published a notice of a new SORN under the Privacy Act of 1974 that 
would be applicable to its conduct of activities under this NPRM (72 FR 
70867). HHS/CDC accepted public comment on its proposed routine uses of 
this information at that time. As required under the Privacy Act, HHS/
CDC in its notice described the proposed system of records, the 
proposed routine uses, disclosures of system data, the benefits and 
need for the routine uses of these data, our agency's policies and 
procedures, restrictions on the routine uses of this information, and 
most importantly, our safeguards to prevent unauthorized use. Data 
collected from passengers, crew, ill persons, and individuals under 
Federal public health orders will be used 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. Such 
data will be maintained in a manner that is consistent with Article 
45(2) of the International Health Regulations and will be released to 
authorized users only, including, where necessary, state and local 
government health related agencies directly involved in the contact 
tracing related to the original purpose of the collection. In addition, 
HHS/CDC will make disclosures from the system only with the consent of 
the subject individual, in accordance with its routine uses, or in 
accordance with an applicable exception under the Privacy Act or system 
of records notice. HHS/CDC emphasizes that the information will be 
maintained and used in accordance with the Privacy Act and the above 
described system of records. Furthermore, HHS/CDC is committed to 
treating all passenger information under the SORN in the same manner 
regardless of citizenship or nationality. HHS/CDC requests public 
comment concerning the mandatory submission of crew and passenger 
manifests to HHS/CDC containing personally identifiable contact 
information for the purposes of conducting contact tracing. HHS/CDC 
specifically requests public comment on this proposed provision. In 
particular, HHS/CDC requests comment from the general public regarding 
whether they have any privacy concerns regarding the collection of the 
specified data elements proposed in this rule, the protection and 
maintenance of their personally identifiable information by HHS/CDC, 
and the disclosure of such identifiable information by the airlines and 
vessels to CDC during contact tracing. HHS/CDC also requests public 
comment from vessel operators concerning the feasibility of compliance 
with this provision, whether such operators anticipate having access to 
the proposed data elements in this rule, and if they have any concerns 
regarding the submission of passenger and crew information to HHS/CDC 
as described in this NPRM.
5. Sec.  71.20 Public Health Prevention Measures To Detect Communicable 
Disease
    Through this NPRM, HHS/CDC has included a proposed provision which 
explicitly authorizes the Director to conduct public health risk 
assessments of individuals or groups, at U.S. ports of entry or other 
locations, through non-invasive procedures as defined in 71.1 to detect 
the potential presence of communicable diseases. This proposal is 
authorized under section 361(a) of the PHS act (42 U.S.C. 264(a)) and 
will be implemented in a manner similar to what was described in part 
70. This section also proposes to require individuals undergoing a 
public health risk assessment to submit information for purposes of 
contact tracing and assessing whether the individual may pose a 
communicable disease risk. HHS/CDC requests public comment concerning 
the proposed public health

[[Page 54253]]

prevention measures using techniques as described in this section and 
the proposed scope of application of such measures at any US port of 
entry (such as at airports, train stations, etc.). HHS/CDC also 
requests public comment on the proposal to collect passenger contact 
tracing information during the implementation of such passenger risk 
assessment and management activities.
6. Sec.  71.29 Administrative Records Relating to Quarantine, 
Isolation, or Conditional Release
    This proposed provision explains the compiling of an administrative 
record regarding the issuance of Federal orders for quarantine, 
isolation, or conditional release. HHS/CDC will compile the 
administrative records in the same manner as described in the preamble 
language under part 70. The individual placed under a Federal public 
health order will be served upon request with a copy of his or her own 
administrative record.
5. Sec.  71.30 Payment for Care and Treatment
    This proposed provision explains the process of authorizing payment 
for the medical care and treatment (including room and board costs) of 
individuals under Federal orders for quarantine, isolation, and 
conditional release. HHS/CDC will implement this provision in the same 
manner as described in the preamble language under part 70. HHS/CDC 
requests public comment concerning the determination that any CDC 
authorization of payment for the care and treatment of individuals will 
be secondary to the obligation of any third-party.
6. Sec.  71.33 Persons: Isolation and Surveillance
    HHS/CDC is proposing to revise this provision to clarify that it 
may include other forms of public health supervision besides in-person 
visits or telephone reporting by the individual under a conditional 
release order. Such additional forms of monitoring includes 
``electronic or internet-based monitoring,'' such as video chat and 
voice calls from computers, tablets and mobile devices. The proposed 
definition of ``electronic or internet-based monitoring'' is intended 
to be broad and would apply to any new or existing technologies that 
would allow for the public health supervision and monitoring of an 
individual under a conditional release order. For clarity, HHS/CDC is 
also replacing the reference to the ``local health officer'' with the 
``state or local health officer.'' HHS/CDC requests public comment 
concerning the extension of public health observation and surveillance 
to include the use of electronic and internet-based technologies as 
defined in 71.1 for persons under a Federal conditional release order, 
including any privacy concerns that might arise.
7. Sec.  71.36 Medical Examinations
    This proposed provision explains the process of requiring a medical 
examination of arriving individuals under Federal quarantine, 
isolation, and conditional release. If finalized as proposed, HHS/CDC 
will implement this provision in the same manner as described in the 
preamble language under part 70. HHS/CDC requests public comment 
concerning the proposed activities related to medical examinations as 
described in this section--specifically whether medical examinations 
may be conducted after a Federal order for quarantine/isolation/
conditional release is issued, or if medical examinations should be a 
prerequisite and basis of such Federal orders.
8. Sec.  71.37 Requirements Relating to Issuance of a Federal Order for 
Quarantine, Isolation, or Conditional Release
    This proposed provision explains the process of issuing Federal 
orders for quarantine, isolation, and conditional release for 
individuals arriving into the United States from a foreign country or 
foreign territory. If finalized as proposed, HHS/CDC will implement 
this provision in the same manner as described in the preamble language 
under part 70. HHS/CDC requests public comment concerning whether the 
information as provided in this section sufficiently informs the public 
of when HHS/CDC will issue a Federal order for quarantine, isolation, 
or conditional release, what conditions must be met for an individual 
to receive a Federal order, and the procedural details with which each 
Federal order will be implemented (e.g., duration, scope, and 
enforcement).
9. Sec.  71.38 Mandatory Reassessment of a Federal Order for 
Quarantine, Isolation, or Conditional Release
    This proposed provision explains the mandatory reassessment of 
Federal orders for quarantine, isolation, and conditional release for 
individuals arriving into the United States. If finalized as proposed, 
HHS/CDC will implement this provision in the same manner as described 
in the preamble language under part 70. HHS/CDC requests public comment 
concerning whether the 72-hour limit within which a mandatory 
reassessment must take place represents an appropriate threshold. HHS/
CDC also requests public comment on the proposed activities that 
mandatory reassessment would entail as specified in this section.
10. Sec.  71.39 Medical Review of a Federal Order for Quarantine, 
Isolation, or Conditional Release
    This proposed provision explains the process for a medical review 
available to arriving individuals under Federal orders of quarantine, 
isolation, and conditional release. If finalized as proposed, HHS/CDC 
will implement this provision in the same manner as described in the 
preamble language under part 70. HHS/CDC requests public comment 
concerning whether the medical review process as described in this 
section would adequately provide the necessary means for individuals to 
appeal within HHS/CDC a Federal order for quarantine, isolation, or 
conditional release. HHS/CDC also requests comment on the Federal 
appointment of a medical representative to ``indigent'' individuals as 
defined in Sec.  71.1 and whether such a threshold would sufficiently 
permit individuals who cannot afford a medical representative to 
receive a Federally appointed medical representative.
11. Sec.  71.40 Agreements
    This proposed provision authorizes the use of agreements as 
explained in the preamble text explaining the use of these agreements 
under Sec.  70.18. HHS/CDC specifically solicits public comment on the 
utility and appropriateness of using agreements as described in this 
preamble given that the individual's consent shall not be considered as 
a prerequisite to the exercise of the CDC's authority under this part.
12. Sec.  71.63 Suspension of Entry of Animals, Articles, or Things 
From Designated Foreign Countries and Places Into the United States
    This section of the NPRM proposes to implement statutory authority 
contained in section 362 of the Public Health Service Act (42 U.S.C. 
265). This proposed provision would allow the HHS/CDC to suspend the 
entry of animals, articles, or things into the United States from 
designated foreign countries (including political subdivisions and 
regions thereof) or places whenever the Director determines that such 
an action is necessary to protect public health. If finalized as 
proposed, the CDC Director will designate the specific animals, 
articles, or things, as well as the foreign countries or places covered 
by the

[[Page 54254]]

temporary prohibition on entry. The CDC Director will also designate 
the period of time or conditions under which the entry of imports 
covered by the Director's determination into the United States will be 
suspended. A temporary suspension on the entry of imports covered by 
the Director's determination into the United States is an important 
public health tool to slow the introduction of communicable disease 
into the United States from affected foreign countries or places.
    For example, there is strong evidence to indicate that bats may be 
the primary host of Ebola, and HHS/CDC may wish to temporarily restrict 
the import of bats based on this evidence.\19\ While bats are 
considered wildlife reservoirs of numerous zoonotic diseases 
(infections that can be transmitted from animals to humans), bats have 
been known to host deadly viral hemorrhagic fever diseases, such as 
Ebola.\20\ The risk of Ebola virus infection in bats, in particular, is 
not limited to any one region of the world as a recent study found 
serologic evidence of Ebola virus infection in bats in China.\21\ A 
2012 study of animals (nonhuman primates, including gorillas, 
chimpanzees, and guenons; duiker; bats) collected during an Ebola virus 
disease outbreak in Africa (Democratic Republic of Congo, Gabon, 
Republic of Congo) determined that nearly 33% of animals found dead had 
laboratory evidence of Ebola virus infection.\22\ Although the 
mechanisms of transmission of Ebola virus from animal reservoirs to 
humans are not completely understood, at least one Ebola virus disease 
outbreak in Africa has been attributed to direct human contact with 
fruit bats.\23\ African fruit bats in particular have been associated 
with Ebola virus infection.\24\
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    \19\ http://www.cdc.gov/vhf/ebola/about.html.
    \2\ Smith I and Wange LF. Bats and their virome: An important 
source of emerging viruses capable of infecting humans Curr Opin 
Virol. 2013 (Feb;3(2):84-91.
    \3\ Yang J, Zhang Y, Li J, et al. Serological evidence of 
ebolavirus infection in bats, China. Virol J. 2012 Oct. 13;9:236.
    \4\ OLson SH, Reed P, Cameron KN, et al. Dead or alive: animal 
sampling during Ebola hemorrhagic fever outbreaks in humans. Emerg 
Health Threat J. 2012;5.
    \23\ Leroy EM, Epelboin A, Mondonge V, et al. Human Ebola 
outbreak resulting from direct exposure to fruit bats in Luebo, 
Democratic Republic of Congo, 2007. Vector Borne Zoonotic Dis. 2009 
Dec;9(6):723-8.
    \24\ Leroy EM, Kumulungui B, Pourrut X, et al. Fruit bats as 
reservoirs of Ebola virus. Nature. 2005 Dec 1;438(7068):575-6.
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    We note again that the ability to suspend the entry of imported 
animals, articles, or things is not a new practice. In the past, HHS/
CDC has taken actions on an emergency basis to prevent the 
introduction, transmission, and spread of communicable diseases into 
the United States arising from affected animals, articles, or products 
onboard arriving conveyances. These actions have included an embargo of 
birds and bird products from specified Southeast Asian and other 
countries based on concerns arising from H5N1 influenza virus (69 FR 
7165 (February 13, 2004)) and an embargo of civets based on concerns 
arising from Severe Acute Respiratory Syndrome (69 FR 3364 (January 23, 
2004)). HHS/CDC based these actions on authority contained in existing 
regulations in 42 CFR 71.32(b). However, unlike Sec.  71.32(b), the new 
provision in this NRPM will not require that HHS/CDC demonstrate a 
reason to believe that a prohibited animal, article, or thing, was or 
will be ``onboard'' an arriving conveyance. HHS/CDC will exercise this 
new provision for the purposes of temporarily suspending the 
introduction of animals, articles, or things from designated foreign 
countries or places into the United States.
    This proposed section applies broadly to any animal, article, or 
thing that may be brought into the United States and is not limited to 
items intended for commercial importation or sale. The CDC Director 
will designate the specific animals (by species or other taxonomic 
designation), articles or things as well as the foreign countries or 
places from which and the period of time or conditions under which HHS/
CDC will suspend the entry of animals, articles, or things into the 
United States. For instance, the CDC Director could reinstitute the 
entry of imports into the United States that the CDC Director has 
previously prohibited when, in the CDC Director's determination 
adequate measures to protect public health have been implemented in the 
affected foreign country or place. Under this proposal, the CDC 
Director may also condition the entry of imports into the United States 
on measures to be taken by the importer in foreign countries such as 
rendering a product noninfectious or, in the case of a live animal, 
obtaining a health certificate signed by a licensed veterinarian. HHS/
CDC may also implement this authority through the issuance of specific 
import permits. The conditions for the permit and the application 
process will be published on HHS/CDC's Web site at the time that this 
authority is invoked. HHS/CDC will determine the conditions of the 
permit on a case-by-case basis. We note that this proposed provision 
applies broadly to ``animals, articles, or things,'' and the preamble 
language discussing restricting imports of bats due to the risk of 
Ebola is simply being used as an example to highlight how this 
authority could be exercised. For more information on CDC's animal 
import processes and procedures, please see http://www.cdc.gov/importation.
    Prior to issuing a restriction on any animal, article or thing, 
HHS/CDC will continue to coordinate with other Federal partners with 
who have regulatory equities, such as USDA/APHIS, DOI/FWS, and FDA, 
balancing important public health issues with private property rights 
and effects on the global economy and foreign relations, as well as 
other important public interests such as the need for service animals 
by people with disabilities. HHS/CDC realizes there may be costs 
imposed on travel providers, such as vessel companies, but HHS/CDC also 
believes this provision is sufficiently important to global health to 
justify the costs. This proposed provision is meant to allow HHS/CDC to 
respond to events of public health concern, such as the recent outbreak 
of Ebola in West Africa. We note again that HHS/CDC does not anticipate 
a current need to exercise this authority and expects to invoke this 
provision rarely and based on sound epidemiological information of 
animal-to-human transmission either in the United States (through 
importation) or in a country where an outbreak is occurring, laboratory 
testing of humans or animals, or other evidence that suggests risk of 
importation of a communicable disease vector to the United States.
    In implementing this section, if finalized as proposed, HHS/CDC 
will work with U.S. Department of Homeland Security, U.S. Customs and 
Border Protection (CBP) regarding any action to seize, export, or 
detain inbound cargo, or destruction by HHS/CDC, which CBP will then 
transmit to the importer and carrier of the cargo through the approved 
electronic data system used to file advance information or entry 
information for the importation of that cargo. HHS/CDC will also 
continue to consult with other Federal agencies that have overlapping 
authority, such as the Animal and Plant Health Inspection Service 
(APHIS) of the U.S. Department of Agriculture (USDA), the U.S. Food and 
Drug Administration (FDA), the U.S. Fish and Wildlife Service of the 
U.S. Department of Interior, and the Department of Transportation, to 
implement actions that may be taken with respect to prohibited cargo. 
HHS/CDC will also work with companies to resolve issues particular to 
their situation. HHS/CDC is mindful that these actions may have 
economic or other consequences and will only take such actions as may 
be

[[Page 54255]]

necessary to protect the public health. HHS/CDC specifically requests 
public comment on this proposed provision, particularly regarding any 
concerns regarding coordination of activities with other agencies 
regulating the same space, as well as any industry concerns regarding 
whether this provision provides sufficient information detailing under 
what circumstances a Federal embargo on importation of animals, 
articles, or things would be implemented.

VII. Alternatives Considered

    Under Executive Order 13563 agencies are asked to consider all 
feasible alternatives to current practice and the rulemaking as 
drafted. HHS/CDC notes that the main impact of the proposals within 
this rule is to strengthen our regulations by codifying statutory 
language to describe HHS/CDC's authority to prevent the introduction, 
transmission, and spread of communicable diseases. The intent of these 
proposed updates is to best protect U.S. public health and to inform 
the regulated community of these updates. 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 solicit contact data from airlines or 
provide such data to health departments in order to conduct contact 
investigations. HHS/CDC would not request illness and death reports on 
aircraft or vessels, but would still follow-up with airlines and vessel 
operators upon request. HHS/CDC would not prohibit interstate or 
international travel for persons known to be infected with 
quarantinable communicable diseases, or conduct entry risk assessment 
as was done to mitigate the potential spread of Ebola in the United 
States. This alternative would put travelers at greater risk of 
becoming infected with communicable diseases, reduce the ability of 
public health departments to provide post-exposure prophylaxis or other 
measure 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, to 
over-regulate 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. HHS/CDC is 
neither practicable, nor is it desirable.
    Alternatives are proposed to increase or decrease HHS/CDC's 
required payments for care and treatment for individuals under Federal 
orders as proposed in 42 CFR 70.13 and 42 CFR 71.30. Alternatives are 
also proposed 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 proposed 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 the spirit of the Executive Order 13563; all 
of these changes provide good alternatives to the current

VII. Required Regulatory Analyses

A. Executive Orders 12866 and 13563

    HHS/CDC has examined the impacts of the proposed rule under 
Executive Order 12866, Regulatory Planning and Review (58 FR 51735, 
October 4, 1993) \25\ and Executive Order 13563, Improving Regulation 
and Regulatory Review, (76 FR 3821, January 21, 2011).\26\ 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; support regulations that protect 
public health and safety; and minimize the adverse impact of 
regulation. HHS/CDC has analyzed the NPRM 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,\27\ as amended by the Small Business Regulatory 
Enforcement Fairness Act (SBREFA) \28\ and that, relative to the status 
quo, the NPRM will create minimal impact. However, there is notable 
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 of the codification provided by this 
rule, some aspects of future CDC entry screening and risk assessment 
activities are found to be legally impermissible, then the status quo 
would not represent a reasonable approximation of the state of the 
world without the rule. Relative to this example 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.
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    \25\ The President. Presidential documents. 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.
    \26\ The President. Presidential documents. 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.
    \27\ U.S. Small Business Administration. Regulatory Flexibility 
Act. http://www.sba.gov/advocacy/823. Accessed January 2016.
    \28\ 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.
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    This regulatory impact section presents the anticipated costs and 
benefits that are quantified where possible. (Most of these quantified 
effects are relative to the status quo baseline, so unless otherwise 
noted, references in subsequent portions of this RIA to the 
``baseline'' indicate the status quo.) Where quantification is not 
possible (as is largely the case with the non-status quo baseline), 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 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 are often slow to respond to 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: 
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 
NPRM seeks to clarify HHS/CDC's existing authority to request any 
available contact data from airlines and vessel operators to improve 
the timeliness and completeness of future requests.
    The other change to the economic baseline that may result from this 
NPRM was the need to change the definition of

[[Page 54256]]

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.
    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 elucidate the due process of individuals 
under Federal orders for isolation, quarantine, or conditional release. 
HHS/CDC also believes it is important to elucidate when 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 elucidate 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 NPRM is subdivided into four 
sections:
    1. An analysis of proposed 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 such clarity is an important 
qualitative benefit of the provisions proposed this NPRM, but is not 
able to monetize this increase in clarity in a robust way. 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. An analysis of the proposed 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. An analysis of the proposed 42 CFR 71.63: Suspension of entry of 
animals, articles, or things from designated foreign countries and 
places into the United States. In this NPRM, HHS/CDC is elucidating 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).'' \29\ 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 NPRM. The primary purpose of the analysis 
is to demonstrate potential costs and benefits using a realistic 
example.
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    \29\ Federal Register 62353 Vol. 68, No. 213 Tuesday, November 
4, 2003. P. 62353-69.
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    Each of the four analyses has a unique set of costs and benefits so 
four separate analyses are performed as summarized below.
Cost Overview Proposed 42 CFR 70.1, 42 CFR 71.1/71.4/71.5, Using a 
Status Quo Baseline
    The quantified costs and benefits of the Notice of Proposed 
Rulemaking are estimated for the following stakeholders: Air and 
maritime conveyance operators, state and local public health 
departments (Ph.D.s), individuals exposed to communicable diseases 
during travel and United States Government (USG). The most likely 
estimates of primary costs are low ($35,785, range $10,959 to $65,644) 
because the NPRM primarily codifies existing practice or improves 
alignment between regulatory text and the symptoms reporting guidelines 
provided by ICAO. The cost estimates are based on an increase in
     the number of illness reports delivered by airlines and 
vessel operators, relay of air illness reports by the Federal Aviation 
Authority through air traffic control, processed by HHS/CDC;
     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.
Benefits, Using a Status Quo Baseline
    The best estimate of quantified benefits of the NPRM is also 
relatively small $117,376 (range $26,337 to $312,054) and mostly 
results from increased efficiencies for HHS/CDC and state and local 
public health departments to conduct contact investigations among 
travelers on aircraft and vessels exposed to communicable diseases and 
reduced costs associated with measles and tuberculosis morbidity and 
mortality in exposed travelers.
    Other potential but non-quantified benefits of the NPRM would be 
associated with future outbreaks of 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

[[Page 54257]]

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 30 31 when a 
disease is contained in its early stages.
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    \30\ 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.
    \31\ Keogh-Brown MR, Smith RD. The economic impact of SARS: How 
does the reality match the predictions? Health Policy. 
2008;88(1):110-20.
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    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 NPRM not cost State, local and tribal governments any 
expenditure, it is probable that these stakeholders who might be 
engaged in contact tracing may see a reduction in costs if the proposed 
NPRM is implemented and there is an improvement in airline compliance 
with HHS/CDC requests to provide traveler data.
The Notice of Proposed Rulemaking
    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 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 NPRM 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 (e.g., measles, 
tuberculosis, and Ebola) that may necessitate a contact investigation 
to prevent spread of disease in the community. 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 NPRM. 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.\32\
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    \32\ 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.
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    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,\33\ 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,\34\ future cases may lead to larger outbreaks.
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    \33\ 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.
    \34\ Nelson, K., Marienau, K.J., Schembri, C. and Redd, S. 
(2013). ``Measles transmission during air travel, United States.'' 
Travel Medicine and Infectious Disease (2013) 11, 81e89 11: 81-89.
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    Measles outbreaks can have substantial associated costs. One study 
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.\35\ 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.\36\ 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.\37\
---------------------------------------------------------------------------

    \35\ 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).
    \36\ 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.
    \37\ 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 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 contact travelers to 
provide post-exposure prophylaxis and to self-monitor 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 NPRM. HHS/CDC 
finds (Summary Table) that the lower bound estimates of quantified 
costs and benefits are zero because this NPRM is primarily codifying 
existing guidance and practice. The Summary Table 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

[[Page 54258]]

$35,785 compared to the best estimate of annual benefits at $117,376. 
The upper bound annual quantified costs are $65,644 and the upper bound 
quantified benefits are $312,054. 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 NPRM, 
because the impact of this NPRM 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 NPRM 
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 NPRM will improve HHS/CDC's ability to mitigate infectious 
diseases in the future. To the extent that the NPRM would lead to 
improved responsiveness of airlines and vessel operators 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 contact investigations in response to a new 
infectious disease or one with serious public health and medical 
consequences like Ebola .

  Summary Table of Monetized and Qualitative Benefits and Costs of NPRM (2015 USD), Using a Status Quo Baseline
                                                       **)
----------------------------------------------------------------------------------------------------------------
                                       Most likely     Lower bound     Upper bound      Source citation (RIA,
              Category                  estimate        estimate        estimate           preamble, etc.)
----------------------------------------------------------------------------------------------------------------
                                                    Benefits
----------------------------------------------------------------------------------------------------------------
Annual monetized benefits (0%              $117,376         $26,337        $312,054  RIA.
 discount rate).
                                    ------------------------------------------------
Qualitative (unquantified benefits)   To the extent that improved responsiveness of  RIA.
                                        airlines and vessel operators to HHS/CDC
                                         traveler data requests results from the
                                      implementation of the provisions proposed in
                                      this NPRM, 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 (0% discount         $35,785         $10,959         $65,644  RIA.
 rate).
                                    ------------------------------------------------
Annual quantified, but unmonetized,                       None                       RIA.
 costs.
                                    ------------------------------------------------
Qualitative (unquantified) costs...                       None                       RIA.
----------------------------------------------------------------------------------------------------------------
** Costs and benefits relative to a non-status quo baseline would be of much greater magnitude than the
  estimates shown in this table.

Regulated Entities: Airlines and Vessel Operators
    The group of entities that may be affected by this NPRM 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 NPRM 
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.

[[Page 54259]]



     Table 3--Summary of the Number Firms Engaged in Interstate and
                  International Air and Maritime Travel
------------------------------------------------------------------------
                                                             Number of
        NAICS codes               NAICS description          firms in
                                                             industry
------------------------------------------------------------------------
481111.....................  Scheduled Passenger Air                 264
                              Transportation.
481112.....................  Scheduled Freight Air                   212
                              Transportation.
481219.....................  Other Nonscheduled Air                  516
                              Transportation.
483111.....................  Deep Sea Freight                        191
                              Transportation.
483112.....................  Deep Sea Passenger                       54
                              Transportation.
483113.....................  Coastal and Great Lakes                 337
                              Freight Transportation.
483114.....................  Coastal and Great Lakes                 110
                              Passenger Transportation.
483211.....................  Inland Water Freight                    318
                              Transportation.
483212.....................  Inland Water Passenger                  193
                              Transportation.
------------------------------------------------------------------------

    Statistics of U.S. Businesses, 2013 U.S. all industries.\38\
---------------------------------------------------------------------------

    \38\ http://www.census.gov/econ/susb/.
---------------------------------------------------------------------------

    2012 North American Industry Classification System (NAICS).\39\
---------------------------------------------------------------------------

    \39\ https://www.census.gov/cgi-bin/sssd/naics/naicsrch.
---------------------------------------------------------------------------

    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.\40\ In 2015, the domestic U.S. market for air travel included 
696 million passengers and the international market included another 
198 million travelers.\41\
---------------------------------------------------------------------------

    \40\ 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).
    \41\ 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.\42\ In total, approximately 18 
million travelers enter the United States each year via cruise or cargo 
ships.\43\
---------------------------------------------------------------------------

    \42\ 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).
    \43\ 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 NPRM; 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.
    Under this NPRM, 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 proposed 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 proposed 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.
    In keeping with current practices, under this proposal, airlines 
and vessel operators are not required to verify the accuracy of the 
information collected and HHS/CDC takes no position on what 
consequences the airlines or vessel operators can impose if a traveler 
refuses to provide the contact information, such as refusing to board 
the traveler. 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.

                       Table 4--Diseases Analyzed
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Measles...................................  Pertussis
Tuberculosis..............................  Rubella.
Rabies....................................  Viral Hemorrhagic Fevers.
Meningococcal disease.....................  Middle East Respiratory
                                             Syndrome Coronovirus
                                             (MERS).
Varicella.................................  ............................
------------------------------------------------------------------------

    These diseases fall into two classes. The first class is the group 
of diseases that HHS/CDC currently encounters with some frequency 
(routine diseases): Tuberculosis, measles, meningococcal disease, 
pertussis and rubella. 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), pandemic influenza, Ebola.
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

[[Page 54260]]

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.

                        Table 5--Contact Investigation Criteria by Disease, PHD Follow Up
----------------------------------------------------------------------------------------------------------------
                                                  Persons contacted,    Persons contacted,       Recommended
         Disease              CI Initiated if          aircraft               vessels             activities
----------------------------------------------------------------------------------------------------------------
Ebola....................  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 come    potential
                                                  future, the           into contact with     exposure.
                                                  recommendation may    the index case's
                                                  change to include     body fluids while
                                                  fewer passengers      the index case was
                                                  and crew.             symptomatic.
                                                                       Cargo vessel--all on
                                                                        board the vessel
                                                                        while the index
                                                                        case was
                                                                        symptomatic.
Measles..................  All cases if          Passengers seated     Direct face-to-face   MMR vaccination if
                            notification          within 2 rows         contact or shared     unvaccinated and
                            received within 21    either direction of   confined space >1     <72 hrs since
                            days of flight.       the index case, all   hour with             exposure; immune
                                                  babies-in-arms,       symptomatic case-     globulin if
                                                  crew in same cabin.   patient.              indicated and
                                                 All passengers and                           within 6 days of
                                                  crew on flights                             exposure.
                                                  with <50 seats.
Meningococcal disease....  Case meets the        Passengers or crew    Cruise vessels--      Post-exposure
                            definition of         sitting directly to   Cabin mates of or     chemoprophylaxis.
                            meningococcal         the left and right    potential for
                            disease within 14     of the index case     direct contact with
                            days of travel.       or with potential     oral or respiratory
                           For air travel:        for direct contact    secretions of case-
                            flight >8 hrs (or     with oral or          patient during the
                            shorter flights if    respiratory           7 days prior to
                            direct exposure       secretions.           symptom onset until
                            reported).                                  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          All cases during      All passengers and    All crew and          Monitoring for 10
 influenza viruses.         early stages of       crew.                 passengers.           days after last
                            international                                                     potential
                            spread.                                                           exposure; possible
                                                                                              serologic testing.
Pertussis................  All cases if          Passengers sitting    Direct face-to-face   Post-exposure
                            notification is       next to index case.   contact or shared     chemoprophylaxis.
                            received within 21                          confined space >1
                            days of travel.                             hour with
                                                                        symptomatic case-
                                                                        patient.
Rubella..................  All cases if          Passengers seated     Direct face-to-face   Serologic testing
                            notification is       within 2 rows +       contact or shared     and guidance for
                            received within 60    crew in same cabin.   confined space >1     pregnant women.
                            days of travel.      All passengers and     hour with
                                                  crew on flights       symptomatic case-
                                                  with <50 seats.       patient.
Severe Acute Respiratory   All cases...........  SARS-Coronavirus:     Cruise vessel--any    Monitoring for 10-
 Syndromes.                                       All passengers and    passenger or crew     14 days after last
                                                  crew.                 who had direct face-  potential
                                                 MERS: All passengers   to-face contact or    exposure;
                                                  and crew contacted    shared confined       potential
                                                  during 2014 CIs.      space >1 hour with    serologic testing.
                                                  Future CIs will       symptomatic case-
                                                  include passengers    patient.
                                                  seated within 2      Cargo vessel--all on
                                                  rows of index case.   board the vessel
                                                                        while the index
                                                                        case was
                                                                        symptomatic.
TB.......................  Notification          Passengers seated     Cargo vessel: All     Aircraft: Testing
                            received within 3     within 2 rows.        crew members within   for latent TB
                            months of travel,                           3 months of           infection; chest
                            clinical criteria                           diagnosis who         radiograph if the
                            met.                                        worked with case-     LTBI test is
                           For air travel:                              patient Cruise        positive Vessels:
                            Flight >8 hrs.                              vessel: Passenger     Clinical
                                                                        travel companions     assessment for
                                                                        or crew working in    symptoms and chest
                                                                        close proximity/      radiograph.
                                                                        sharing living
                                                                        quarters.

[[Page 54261]]

 
Varicella................  All cases on vessels  NA..................  Any person who has    Varicella
                                                                        had >=5 minutes of    vaccination if
                                                                        direct face-to-face   unvaccinated/non-
                                                                        contact with a        immune and <3 days
                                                                        varicella case        since exposure
                                                                        during the            (possibly up to 5
                                                                        infectious period.    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, 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 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          1988.0            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      Average
                                     Total                              of           number of      Percent of
            Disease              investigations  Total contacts   investigations   contacts  per  total contacts
                                                                     per year          year
----------------------------------------------------------------------------------------------------------------
Measles.......................               72           3,033             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

[[Page 54262]]

 
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  ..............
----------------------------------------------------------------------------------------------------------------
Note:
\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 CDC's 
Respiratory Diseases Branch.

            Table 8--Maritime Passenger Data Collection, Average Number of Annual Contacts by Disease
                                          [January 2010-December 2015]
----------------------------------------------------------------------------------------------------------------
                                                                 Average  number      Average
                                     Total                              of           number of      Percent of
     Passengers per voyage       investigations  Total contacts   investigations   contacts  per  total contacts
                                                                     per year          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 Contact Data Requests From Airlines
    For routine contact investigations performed during business hours 
without HHS/CDC surge staff, HHS/CDC experience suggests that following 
a flight, it takes airlines up to seven days to respond to a single 
request for traveler manifest and contact data information currently 
collected.
    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 requests 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 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 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

[[Page 54263]]

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.
    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.
    Since the proposed NPRM 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 become more compliant, 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 NPRM. 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, interstate air, and maritime 
activities, the estimated number of contact data requests after 
disembarkation was rounded up to 125 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.
    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 \44\ 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 
NPRM, 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 9). The lower bound 
estimate is no change from current practice, while the upper bound 
estimate assumes 2 hours of time instead of one. HHS/CDC specifically 
solicits public comment on cost estimates associated with improved 
provision of travel contact data by affected airlines and vessel 
operators.
---------------------------------------------------------------------------

    \44\ http://www.bls.gov/oes/current/oes_nat.htm.

  Table 9--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
                                     number of      complete or     hourly wage      Overhead
                                     manifest       more timely     rate of  IT     multiplier      Total cost
                                   requests  per     passenger      staff (2015      (percent)
                                       year        contact data        USD)
                                                       (hrs)
----------------------------------------------------------------------------------------------------------------
Baseline........................             125               6          $63.27             100         $94,905
Best estimate...................             125               1           63.27             100          15,818
Lower bound.....................             125               0           63.27             100               0
Upper bound.....................             125               2           63.27             100          31,635
----------------------------------------------------------------------------------------------------------------

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. Specifically, HHS/CDC assumes that persons 
traveling from affected countries are not permitted entry to the United 
States

[[Page 54264]]

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 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 $94,905. For the more restrictive 
scenario, the costs are relatively similar as for the NPRM except for 
subtracting the cost of providing contact data for 2.5 investigations 
($15,501 vs. $15,818) and calculating the benefit of doing 2.5 fewer 
contact investigations each year ($1,898) (Table 10).

   Table 10--Estimate of the Cost to Airlines and Vessel Operators to Provide Traveler Contact Data, 2015 USD
----------------------------------------------------------------------------------------------------------------
                                                                                      Less
                                                                                   restrictive         More
                                                    Baseline          NPRM         alternative     restrictive
                                                                                       \a\       alternative \b\
----------------------------------------------------------------------------------------------------------------
Baseline number of contact investigations......             125             125               0            122.5
Costs..........................................  ..............  ..............  ..............  ...............
Best estimate..................................              NA         $15,818              $0          $15,501
Lower bound....................................              NA               0               0                0
Upper bound....................................              NA          31,635               0           31,002
Benefits.......................................  ..............  ..............  ..............  ...............
Best estimate..................................              NA               0          94,905            1,898
Lower bound....................................              NA               0          94,905            1,898
Upper bound....................................              NA               0          94,905            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

Change to Definition of an ``Ill Person''
    HHS/CDC is proposing to update the definition of ``ill person'' in 
42 CFR Sec.  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 aircrafts 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 proposed definition of ``ill person'' in 
such a way that it should 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.
    1. Fever: This term means that the person has a measured 
temperature of 100.4 [deg]F (38 [deg]C) or greater, feels warm to the 
touch, or gives a history of feeling feverish. While a measured 
temperature is the preferable and more accurate method to determine 
whether a person has a fever, it is not always possible to obtain. The 
measured temperature also may not reflect the presence of a recent 
fever, for example, if the individual has taken a fever-reducing 
medication. For these reasons, the revised ``ill person'' definition 
includes other methods that may be used by crewmembers as proxies for a 
measured temperature. If it is not feasible or advisable to touch the 
individual or if the individual does not disclose a history of feeling 
feverish, then, while not definitive, the observer should consider his/
her appearance, such as having a flushed face, glassy eyes, or chills 
as possible indications of the presence of a fever. A self-reported 
history of feeling feverish is included in the event that the ill 
person has taken medication that would lower the measured temperature 
or if the fever fluctuates as part of the natural course of the 
disease.
    2. Skin rash: This term means that the individual has areas on the 
skin with multiple red bumps; red, flat spots; or blister-like bumps 
filled with fluid or pus that are intact or partly crusted over. The 
rash may be discrete or may run together, and may include one area of 
the body, such as the face, or more than one area. The presence of skin 
rash, along with fever, may indicate that the traveler has measles, 
rubella (German measles), varicella (chickenpox), meningococcal 
disease, or smallpox.
    3. Difficulty breathing: This term means that the individual is 
gasping for air, is unable to ``catch'' his/her breath, is breathing 
too fast and shallow to get enough air, or cannot control his/her own 
secretions. These symptoms may be apparent or self-reported if not 
obvious. Difficulty breathing, along with fever, may indicate a 
traveler has tuberculosis, diphtheria, influenza with pandemic 
potential, or a severe acute respiratory syndrome.
    4. Persistent cough: This term means that the cough is frequent and 
severe enough that it catches the attention of the crewmember, or the 
individual or another passenger voices concern about it. Persistent 
cough, along with fever,

[[Page 54265]]

may indicate the traveler has pertussis/whooping cough (vomiting may 
occur at the end of a coughing fit), tuberculosis, severe acute 
respiratory syndrome, or influenza with pandemic potential.
    5. Decreased consciousness or confusion of recent onset: This term 
means that the individual is not fully aware of his/her surroundings or 
may be unusually difficult to awaken. The individual may appear to be 
confused or disoriented. Decreased consciousness, along with fever, may 
indicate the traveler has meningococcal disease, another serious 
neurological infection, or serious infection in another body system.
    6. Bruising or bleeding (without previous injury): This term means 
that the person has noticeable and unusual bruising or bleeding from 
gums, ears, nose or areas on skin for which there is no obvious 
explanation. Unexplained bruising or bleeding, along with fever, may 
indicate the person has a hemorrhagic fever, such as Ebola, or plague.
    7. Persistent diarrhea: This term means that the diarrhea is 
frequent and severe enough that the air crewmember notices, for 
example, that the person has been to the restroom numerous times, or 
the individual or another passenger voices concern about it. Persistent 
diarrhea may indicate the person has a food or waterborne infection 
such as norovirus or cholera, or another serious communicable disease, 
such as Ebola. Many infections that cause persistent diarrhea can be 
spread easily from person to person, either directly or indirectly 
through food or water, and cause large outbreaks.
    8. Persistent vomiting: This term means that the individual has 
vomited two or more times (not due to air or sea sickness) and either 
expresses concern to the air/vessel crew or comes to the attention of 
others onboard (air/vessel crew or passengers). Persistent vomiting may 
indicate the person has a food- or waterborne infection such as 
norovirus, or another serious communicable disease, such as Ebola.
    9. Headache with stiff neck: This term means that the individual is 
self-reporting a headache accompanied by difficulty moving his/her 
neck. These symptoms may indicate that the individual has bacterial 
meningitis, such as meningococcal meningitis. Meningococcal meningitis 
has a high death rate and a significant proportion of survivors have 
residual impairments, such as deafness or injury to the brain. 
Individuals in close contact with ill persons with meningococcal 
disease are at elevated risk for contracting the disease.
    The current illness reporting requirements for interstate travel 
are summarized in 42 CFR Sec.  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 Sec.  
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 proposed in this NPRM 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 NPRM 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 70.1 and not based on CDC guidance. For illness 
reports from aircraft, 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 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 11 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). HHS/CDC specifically solicits public comment on cost 
estimates associated with changes to illness reporting for air and 
maritime travel and based on the change to the definition of an `ill 
person'.

[[Page 54266]]



            Table 11--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         NPRM        regulation or
                                                                                       NPRM
----------------------------------------------------------------------------------------------------------------
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.

    Table 11 shows that HHS/CDC already receives a number of reports 
based on symptoms included in HHS/CDC guidance that will be codified 
with this NPRM. On average, among the total 175 illness reports per 
year, about 78 annual reports are based on symptoms included in the 
NPRM, 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 proposed in this 
NPRM.
    The number of illness reports from master of vessels during voyages 
is summarized in Table 12. 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 
proposed for this NPRM (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 proposed in this NPRM.

 Table 12--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                 Year/category    included in       symptoms       included in
                                                                     current       included in    either current
                                                                   regulation          NPRM        regulation or
                                                                                                       NPRM
----------------------------------------------------------------------------------------------------------------
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

[[Page 54267]]

 
    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 does not require reporting of influenza-like-
  illness from cruise vessels (also not included in above table).

    When reports are received, public health officers at Quarantine 
Stations perform case assessments, may request follow-up information, 
and may consult with 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 scenario, the change in the definition of ``ill person'' 
included in the NPRM could result in a 25% increase in the number of 
info-only reports. On average, there are 129 info-only reports for 
aircraft and vessels each year and a 25% increase would correspond to 
an annual increase of 30 info-only reports on aircraft and 3 info-only 
reports on vessels (Table 13). 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 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 FAA may incur 
additional costs to relay reports to air traffic control through the 
Domestic Events Network. The amount of 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 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 FAA's Washington Operations 
Center Complex (6 minutes).\45\
---------------------------------------------------------------------------

    \45\ 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), their opportunity cost is estimated from 
Bureau of Labor Statistics, May 2015 Occupational Employment Statistics 
\46\ based on the average salary of aircraft pilots or copilots ($57.35 
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. The annual quantified costs of 35 additional 
info-only reports would be $4,586.
---------------------------------------------------------------------------

    \46\ http://www.bls.gov/oes/current/oes_nat.htm.

          Table 13--Changes in Numbers of Info-Only Reports and Associated Costs for the NPRM, 2015 USD
----------------------------------------------------------------------------------------------------------------
                                   Annual change  Amount of time
                                   in number of    required per   Estimated wage     Over-head       Estimated
          Employee type              info-only        report      rate per hour,    multi-plier      cost, USD
                                      reports        (minutes)          USD          (percent)
----------------------------------------------------------------------------------------------------------------
Aircraft:
    Air or maritime conveyance                30               2          $57.35             100            $115
     officer....................
    CDC employee................              30              60           39.83             100           2,390
    FAA employees...............              30              26           70.57             100           1,835
        Total Cost, aircraft....  ..............  ..............  ..............  ..............           4,339
Vessels:
    Air or maritime conveyance                 3               2           39.95             100               8
     officer....................
    CDC employee................               3              60           39.83             100             239
        Total costs, vessels....  ..............  ..............  ..............  ..............             247
                                 -------------------------------------------------------------------------------
            Total costs,          ..............  ..............  ..............  ..............           4,586
             aircraft and
             vessels............
----------------------------------------------------------------------------------------------------------------

    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

[[Page 54268]]

scenario, there may be an increase in costs for air or masters of 
vessels to report illnesses. The increase in reports requiring response 
is assumed to be 10% of the average annual reports summarized in Tables 
10 and 11: 6 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 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 FAA to relay reports, Table 14).
    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 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 before disembarking an aircraft or vessel or at the 
gate after disembarking the aircraft or vessel. Such actions should not 
result in significant delays by holding travelers on board. In such a 
situation, monetary benefits could greatly exceed monetary costs ($446) 
associated with the time required to make and relay the report.

  Table 14--Changes in Annual Numbers of Reports Requiring Response and Associated Costs for the NPRM, 2015 USD
----------------------------------------------------------------------------------------------------------------
                                     Change in    Amount of time
                                  annual  number   required per   Estimated wage     Overhead
          Employee type            of  info-only      report       rate per hour    multiplier    Estimated cost
                                      reports        (minutes)                       (percent)
----------------------------------------------------------------------------------------------------------------
Aircraft:
    Air or maritime conveyance                 6               2          $57.35             100             $23
     officer....................
    CDC employee................               6               0           39.83             100               0
    FAA employees...............               6              26           70.57             100             367
                                 -------------------------------------------------------------------------------
        Total Cost..............  ..............  ..............  ..............  ..............             390
Vessels:
    Air or maritime conveyance                21               2           39.95             100              56
     officer....................
    CDC employee................              21               0           39.83             100               0
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............              56
----------------------------------------------------------------------------------------------------------------

Illness Reporting Alternatives
    Illness reporting, contact investigations, quarantine, isolation, 
and public health measures at ports of entry (e.g., 2014-16 Ebola) are 
all necessary to improve HHS/CDC's ability to effectively respond to 
infectious disease threats. Since this NPRM primarily codifies existing 
practices, HHS/CDC examines two alternatives: A less restrictive 
alternative in which HHS/CDC relaxes it regulatory authorities to make 
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 11 and 12. 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 10, 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 (Tables 11 and 
12). HHS/CDC does not have any data to estimate the magnitude of 
decrease in reporting and requests public comment from airlines and 
vessel operators to better quantify this reduction. HHS/CDC believes 
that both HHS/CDC and 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 benefits of voluntary reporting would be reduced incremental 
time costs for pilots in command and masters of vessels, DOT/FAA, and 
HHS/CDC, especially for info-only illness reports. This 50% reduction 
in illness reporting would generate cost savings for airlines and 
vessel operators, HHS/CDC, and DOT/FAA of approximately $11,300 (Tables 
15 and 16).
    The primary cost 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.

[[Page 54269]]



                          Table 15--Less Restrictive Alternative for Illness Reporting
                                          [Effect on info-only reports]
----------------------------------------------------------------------------------------------------------------
                                     Change in    Amount of time                     Overhead
          Employee type           number of info-  required per   Estimated wage    multiplier    Estimated cost
                                   only  reports      report           rate          (percent)      or benefit
----------------------------------------------------------------------------------------------------------------
Aircraft:
    Aircraft Pilots or Copilots.              60               2          $57.35             100            $229
    CDC employee................              60              60           39.83             100           4,780
    FAA employees...............              60              26           70.57             100           3,670
        Air total...............  ..............  ..............  ..............  ..............           8,679
Vessels:
    Air or maritime conveyance    ..............  ..............  ..............  ..............  ..............
     officer....................
    Captains, Mates, and Pilots                6               2           39.95             100              16
     of Water Vessels...........
    CDC employee................               6              60           39.83             100             478
                                 -------------------------------------------------------------------------------
        Maritime total..........  ..............  ..............  ..............  ..............             494
                                 -------------------------------------------------------------------------------
            Total (Air +          ..............  ..............  ..............  ..............           9,173
             Maritime)..........
----------------------------------------------------------------------------------------------------------------


                          Table 16--Less Restrictive Alternative for Illness Reporting
                                     [Effect on reports requiring response]
----------------------------------------------------------------------------------------------------------------
                                     Change in
                                     number of    Amount of time                     Overhead
          Employee type               reports      required per   Estimated wage    multiplier    Estimated cost
                                     requiring        report           rate          (percent)      or benefit
                                     response
----------------------------------------------------------------------------------------------------------------
Air:
    Aircraft pilots or copilots.              29               2          $57.35             100            $111
    CDC employee................              29               0           39.83             100               0
    FAA employee................              29              26           70.57             100           1,774
        Total...................  ..............  ..............  ..............  ..............           1,885
Maritime illness reports:
    Captains, mates, and pilots              104               2           39.95             100             277
     (masters) of vessels.......
    CDC Employee................             104               0           39.83             100  ..............
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............             277
                                 -------------------------------------------------------------------------------
            Tot (Air + Maritime)  ..............  ..............  ..............  ..............           2,162
----------------------------------------------------------------------------------------------------------------

    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 
17). 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 NPRM.

      Table 17--More Restrictive Alternative (Illness Reporting in Duplicate to HHS/CDC and to Local Health
                                             Departments), 2015 USD
----------------------------------------------------------------------------------------------------------------
                                     Change in    Amount of time
          Employee type           number of info-  required per   Estimated wage     Overhead     Estimated cost
                                   only  reports      report           rate         multiplier      or benefit
----------------------------------------------------------------------------------------------------------------
Aircraft pilots or copilots.....              88               4          $57.35            100%            $673
Captains, mates, and pilots                   33               4           39.83            100%             175
 (masters) of vessels...........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             848
----------------------------------------------------------------------------------------------------------------


[[Page 54270]]

    The monetized annual costs resulting from the change in the 
definition of ``ill person'' are summarized in Table 18.

 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
----------------------------------------------------------------------------------------------------------------
                                                                   Best estimate    Lower bound     Upper bound
----------------------------------------------------------------------------------------------------------------
                                                      Costs
----------------------------------------------------------------------------------------------------------------
NPRM:
    Aircraft....................................................  ..............  ..............         $ 4,729
    Vessels.....................................................  ..............  ..............             303
                                                                 -----------------------------------------------
        Total...................................................  ..............  ..............           5,032
Less Restrictive Alternative: \a\
    Aircraft....................................................  ..............  ..............  ..............
    Vessels.....................................................  ..............  ..............  ..............
                                                                 -----------------------------------------------
        Total...................................................  ..............  ..............  ..............
More Restrictive Alternative:
    Aircraft....................................................           $ 673           $ 673           5,402
    Vessels.....................................................             175             175             478
                                                                 -----------------------------------------------
        Total...................................................             848             848           5,880
----------------------------------------------------------------------------------------------------------------
                                                    Benefits
----------------------------------------------------------------------------------------------------------------
NPRM:
    Aircraft....................................................  ..............  ..............  ..............
    Vessels.....................................................  ..............  ..............  ..............
                                                                 -----------------------------------------------
        Total...................................................  ..............  ..............  ..............
Less Restrictive Alternative: \a\
    Aircraft....................................................          10,563          10,563          10,563
    Vessels.....................................................             771             771             771
                                                                 -----------------------------------------------
        Total...................................................          11,334          11,334          11,334
More Restrictive Alternative:
    Aircraft....................................................  ..............  ..............  ..............
    Vessels.....................................................  ..............  ..............  ..............
                                                                 -----------------------------------------------
        Total...................................................  ..............  ..............  ..............
----------------------------------------------------------------------------------------------------------------
\a\ For the less restrictive scenario, the current reporting requirement is relaxed leading to a reduction in
  costs.

    The total costs of the proposed NPRM 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 NPRM, the less restrictive alternative, 
and the more restrictive alternative.

 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
----------------------------------------------------------------------------------------------------------------
NPRM:
    71.4 and 71.5 Passenger data collection.....................         $15,818              $0         $31,635
    70.1 and 71.1 Change in definition of an ``ill person``.....               0               0           5,032
                                                                 -----------------------------------------------
        Total costs.............................................          15,818               0         36, 667
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.....................          15,501               0          31,002
    70.1 and 71.1 Change in definition of an ``ill person``.....             848             848           5,880
                                                                 -----------------------------------------------
        Total costs.............................................          16,349             848          36,883
----------------------------------------------------------------------------------------------------------------

[[Page 54271]]

 
                                                    Benefits
----------------------------------------------------------------------------------------------------------------
NPRM:
    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.....................          94,905          94,905          94,905
    70.1 and 71.1 Change in definition of an ``ill person``.....          11,334          11,334          11,334
                                                                 -----------------------------------------------
        Total benefits..........................................         106,239         106,239         106,239
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``.....
                                                                 -----------------------------------------------
        Total benefits..........................................           1,898           1,898           1,898
----------------------------------------------------------------------------------------------------------------

    Benefits from streamlining the CI process for routinely imported 
diseases
    This section reports the benefits that HHS/CDC anticipates from 
implementation of the NPRM in avoiding the costs incurred annually for 
CIs of infectious diseases. The primary steps of CIs for routine 
diseases are:
     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 and then 
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 (Ph.D.s).
     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 also asks the airlines for traveler contact 
information
    [ssquf] HHS/CDC then requests information available in multiple 
DHS' databases to verify or obtain passenger contact information not 
included in the manifest.
    Once HHS/CDC has the traveler contact information and flight-
seating chart, the CI begins. Current CI procedures are cumbersome, 
primarily 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. Because of missing or incorrect 
contact data from airlines, HHS/CDC also works with DHS to access 
contact information for travelers exposed to communicable diseases on 
international flights.
    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 have 
less success contacting passengers with partial information than they 
would if airlines' and vessel operators' compliance with requests was 
improved as a result of this NPRM.
    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 that can be substantial but cannot be directly quantified on 
an annual basis. The differential impacts of the various diseases make 
it hard to summarize NPRM effects given uncertainty around future 
probabilities of case(s) of multiple such notifiable disease(s). 
Instead, HHS/CDC presents a simple example based on the average PHD 
costs associated with a measles outbreak in case such an outbreak could 
be avoided as a result of either improved illness reporting onboard 
conveyances or as a result of improved compliance with HHS/CDC requests 
for traveler contact data.
    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 index case after 
their travel is completed. Since travelers spend more time on vessels 
during maritime trips, more illnesses are detected during voyages and 
contact investigations may be implemented on board vessels. When 
illnesses are detected 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 the improved contact information 
based on the codification of requests for traveler contact data to 
aircraft and vessel operators as set forth in this NPRM to locate 
travelers exposed to an index case before he/she becomes ill, 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 NPRM.
    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.

[[Page 54272]]

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, as reported in Table 13, there may be an increase of 
23 reports requiring a response during flights and voyages. Under this 
scenario, there would likely be no change or a decrease in HHS/CDC 
costs because earlier reporting would lead to a more efficient public 
health response relative to an alternative in which the illness was 
later identified after presentation to a health care provider and 
reported by a Ph.D. In addition, the public health response to the 
illness would likely be more efficient because exposed travelers could 
be contacted earlier, potentially before disembarking the aircraft or 
vessel.
    Primary benefits: Improved efficiency of contact investigations 
undertaken by CDC and partners at state and local health departments 
and reduced risk of infectious disease outbreaks
    The primary monetized annual benefit for both 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 is an improvement in 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 comply with public health measures to 
mitigate either their risk of becoming ill with a specific infectious 
disease or transmitting that disease to other individuals.
    The amount of time HHS/CDC staff spent 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 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.\47\ 
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 20).
---------------------------------------------------------------------------

    \47\ 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.\48\ PHD processes vary greatly from state to 
state and at the local level within a state. A couple of examples:
---------------------------------------------------------------------------

    \48\ 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 \49\
---------------------------------------------------------------------------

    \49\ 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.\50\
---------------------------------------------------------------------------

    \50\ 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 cost savings from reduced effort for PHDs to 
locate infectious disease contacts are conservatively estimated.

                       Table 20--Cost-per-Contact
------------------------------------------------------------------------
                          CDC                                  PHD
------------------------------------------------------------------------
$180...................................................            $180
------------------------------------------------------------------------

    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 expected to have the greatest impact on HHS/CDC and PHD 
activities and potential benefits. 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 
NPRM. HHS/CDC multiplied the average annual number of contacts on 
international flights by the cost-per-contact for HHS/CDC and PHDs 
(Table 20) to estimate the costs of CIs under the current baseline.
    To estimate the benefits (Table 21), HHS/CDC assumed a percent 
reduction in staff time for CIs at HHS/CDC (0-5%) and PHD levels (0-3%) 
based on internal conversations with personnel directly involved in the 
CI process. The reduction in staff time that would result from 
implementation of this NPRM 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. This 
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. 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 NPRM would reduce 
labor time

[[Page 54273]]

by between 0% to 5% at CDC, and 0% to 3% 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 provided by airlines. 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 should be conservative if there is a 
substantial improvement by airlines in responding to requests for 
traveler contact data or if the change to the definition of ``ill 
person'' leads to more reports of ill travelers during travel.
    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 NPRM should have the 
greatest effect on the international air CIs. The annual reduction in 
contact tracing costs from implementing the NPRM (Table 22) for HHS/CDC 
ranged from $0 to $24,435 based on a 0-5% reduction in effort on 
international CIs. For PHDs, the reduction in costs ranged from $0 at 
the lower bound to $14,661 at the upper bound (Table 22).

              Table 21--Annually for CDC and PHD: Baseline Costs, NPRM Costs, Savings With the NPRM
----------------------------------------------------------------------------------------------------------------
                                                     Annual #
                                                     contacts           CDC          PHD costs      Total costs
----------------------------------------------------------------------------------------------------------------
                                  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 22--Annual For CDC and PHDs: Baseline Costs, NPRM Costs, Benefits with the NPRM (# contacts annualized
                                  from January 2010 to December 2015), 2015 USD
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
                                  CDC and PHD Baseline Costs (Current Practice)
----------------------------------------------------------------------------------------------------------------
                                              Annual #             CDC                        PHD
                                              contacts
                                         -----------------------------------------------------------------------
International contacts..................             2,715          $488,700               $488,700
----------------------------------------------------------------------------------------------------------------
                                         CDC and PHD Costs with the NPRM
----------------------------------------------------------------------------------------------------------------
                                           Estimated costs for HHS/CDC after
                                           efficiency improvement with NPRM
                                            Estimated costs for PHDs after
                                           efficiency improvement with NPRM
                                         -----------------------------------------------------------------------
                                           0%, Lower bound   5%, Upper bound   0%, Lower bound   3%, Upper bound
                                         -----------------------------------------------------------------------
International contacts costs assuming             $488,700          $464,265          $488,700          $474,039
 reduction in time (2,715)..............
----------------------------------------------------------------------------------------------------------------
                                       Benefits from Implementing the NPRM
----------------------------------------------------------------------------------------------------------------
                                           CDC 0% and 5% reduction in effort
                                           PHD 0% and 3% reduction in effort
                                         -----------------------------------------------------------------------
Benefits (Reduced costs)................                $0           $24,435                $0           $14,661
----------------------------------------------------------------------------------------------------------------

    The best estimate of benefits are the midpoint of the lower bound 
and upper bound estimates for both HHS/CDC and PHDs ($19,548). The 
lower bound ($0) and upper bound estimates ($39,096) for both entities 
are also reported 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 (NPRM), 2015 USD
----------------------------------------------------------------------------------------------------------------
                                                                      HHS/CDC
                                                                     benefits      PHD benefits        Total
----------------------------------------------------------------------------------------------------------------
Best estimate...................................................         $12,218          $7,331         $19,548
Lower bound.....................................................               0               0               0
Upper bound.....................................................          24,435          14,661          39,096
----------------------------------------------------------------------------------------------------------------

    The total annual monetized benefits by stakeholder from the 
potential reduced effort for contact investigations are summarized in 
Table 24.

[[Page 54274]]



  Table 24--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...................................         $12,218          $7,331              $0         $19,548
Lower bound.....................................               0               0               0               0
Upper bound.....................................          24,435          14,661               0          39,096
----------------------------------------------------------------------------------------------------------------

    For the less restrictive alternative, the change relative to 
baseline is equal to the current cost of performing CIs ($745,000 each 
for HHS/CDC and local health departments or a total of about $1.5 
million). 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 
savings to HHS/CDC of about $29,000 each or $59,000 in total). The 
benefits of the avoided contacted investigations are then added to the 
cost savings for the remaining contacts assuming a 0-5% improvement in 
HHS/CDC efficiency and a 0-3% improvement in Ph.D. efficiency as for 
the NPRM (Table 25).

          Table 25--Estimated Benefits Associated with Reduced Costs to Conduct Contact Investigations
----------------------------------------------------------------------------------------------------------------
                                                                      HHS/CDC
                                                                     benefits      PHD benefits        Total
----------------------------------------------------------------------------------------------------------------
NPRM
    Best estimate...............................................         $12,218          $7,331         $19,548
    Lower bound.................................................               0               0               0
    Upper bound.................................................          24,435          14,661          39,096
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...............................................          41,558          36,671          78,228
    Lower bound.................................................          29,340          29,340          58,680
    Upper bound.................................................          53,775          44,001          97,776
----------------------------------------------------------------------------------------------------------------

Potential Reduction in Costs of Infectious Disease Outbreaks
    For some diseases, there is empirical data from which on board 
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.\51\ After HHS/CDC provides contact data to state health 
departments, HHS/CDC requests, but does not require health departments 
to 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.
---------------------------------------------------------------------------

    \51\ 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.\52\ 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 was 1.6 years.
---------------------------------------------------------------------------

    \52\ 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 post-exposure prophylaxis with measles-
containing vaccine (within 72 hours) or immune globulin (within 6 
days),\53\ 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

[[Page 54275]]

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

    \53\ 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 80% of unvaccinated children live in 
counties comprising 40% of the total population.\54\
---------------------------------------------------------------------------

    \54\ 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.\55\ 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.\56\
---------------------------------------------------------------------------

    \55\ Ko G, Thompson KM, Nardell EA. Estimation of tuberculosis 
risk on a commercial airliner. Risk Anal 2004;24:379e88.
    \56\ 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 CDC-led flight-
related tuberculosis contact investigations conducted in the United 
States from January 2007 to June 2008 involved 131 case-travelers and 
4,550 passenger-contacts.\57\ 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 US health 
departments (19% of all passenger contacts) the precise determination 
of in-flight transmission risk of M. tuberculosis was not feasible.\58\
---------------------------------------------------------------------------

    \57\ 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.
    \58\ 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% to 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 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 spent on contact investigations 
(including Federal and state resources) 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 59 60 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.
---------------------------------------------------------------------------

    \59\ 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.
    \60\ 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.\61\ 
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.
---------------------------------------------------------------------------

    \61\ 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.\62\ 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

[[Page 54276]]

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 26. The 
exceptions are for meningococcal disease and tuberculosis. For 
meningococcal disease, the risk of transmission in household contacts 
0.002 to 0.004 \63\ 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 \64\ (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.
---------------------------------------------------------------------------

    \62\ Anderson RM. The concept of herd immunity and the design of 
community-based immunization programmes. Vaccine. 1992;10(13):928-
35.
    \63\ Chapter 14. Meningococcal Disease, The Pink Book, CDC 
http://www.cdc.gov/vaccines/pubs/pinkbook/mening.html Accessed 5/2/
2016.
    \64\ 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.
    \65\

                      Table 26--Estimated Transmission Rate on Plane for Exposed Travelers
----------------------------------------------------------------------------------------------------------------
                                                                                  Estimated transmission rate on
                                                                                  aircraft to exposed passengers
                    Disease                                    R0                -------------------------------
                                                                                    Lower bound     Upper bound
----------------------------------------------------------------------------------------------------------------
Diphtheria....................................  11 to 14........................          0.0026          0.0074
Measles.......................................  15 to 17........................          0.0034          0.0095
Meningococcal Disease.........................  NA..............................         <2/1000         <4/1000
Pertussis.....................................  4 to 5..........................           0.001           0.003
Rubella.......................................  9 to 10.........................           0.002           0.006
TB............................................  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 26 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 27). 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.\65\
    For viral hemorrhagic fevers and MERS, there is no evidence of 
transmission, but there have not been very many observations. The costs 
of a MERS outbreak in South Korea and U.S. Ebola cases are presented in 
another section of the RIA that analyzes the economic impact of the 
Ebola Enhanced entry risk assessment and management program.

          Table 27--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................             101                         Insufficient data
                                                 ---------------------------------------------------------------
Measles.........................            1069          0.0034          0.0095             3.6            10.1
Meningococcal Disease...........             1.7         0.00200         0.00400          0.0033          0.0067
Pertussis.......................            16.8           0.001           0.003            0.02            0.04
Rubella.........................             117           0.002           0.006             0.2             0.7
TB\a\...........................           1,995        \b\ 0.19        \b\ 0.24        \c\ 18.9       \c\ 47.90
                                                 ---------------------------------------------------------------
Viral Hemorrhagic Fever.........            62.0                         Insufficient data
                                                 ---------------------------------------------------------------
    Total.......................           3,362  ..............  ..............            22.8            58.7
----------------------------------------------------------------------------------------------------------------
\a\ For tuberculosis, travelers contacts are typically found to test positive for infection, but do not have
  active disease.
\b\ These probabilities indicate the likelihood that a contact will test positive for infection.
\c\ The expected numbers of case 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.

Impact of NPRM--Measles

    On average, HHS/CDC identified 564 travelers exposed to measles 
cases on international flights during 2010-2015

[[Page 54277]]

(Table 6). The NPRM 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 NPRM 
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 receiving measles vaccines within 72 
hours. This would potentially reduce the cost of following up with 
exposed travelers or to administer immune globulin or to 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%.\66\ In addition, health departments have 
implemented quarantine (usually voluntary) for unvaccinated, high risk 
measles exposures.\67\ HHS/CDC 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.\68\ However, to be conservative, HHS/CDC includes 
the full additional cost to administer such vaccines to persons 
contacted.
---------------------------------------------------------------------------

    \66\ 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.
    \67\ 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.
    \68\ CDC (2015) Epidemiology and Prevention of Vaccine-
Preventable Diseases: Measles. http://www.cdc.gov/vaccines/pubs/pinkbook/meas.html. Accessed 5/8/2016.
    \69\ 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.
---------------------------------------------------------------------------

    Among the contacts, HHS/CDC estimates that approximately 25% (141 
contacts per year) cannot be located by public health departments 
(Table 28), 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 NPRM (Table 28). This 
would result in 8.5 additional contacts per year assigned to health 
departments for contact tracing. As shown in Table 20, HHS/CDC 
estimates that health departments incur an estimated cost of $180 per 
contact. The marginal cost incurred from this NPRM for additional 
measles contacts assigned to health departments would be $180 x 8.5 = 
$1,530 per year (Table 29).

   Table 28--Estimated Marginal Improvement in the Numbers of Measles Contacts Who Could be Treated With NPRM
----------------------------------------------------------------------------------------------------------------
                 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 \69\.
 CDC cannot assign to a health department,
 (b) = 10% x (a).
Estimated improvement in HHS/CDC's ability to      8.5  Assumption.
 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 NPRM, (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 susceptible        6  Nelson et al. 2013 (Table 2).
 to measles (g) = (e) x 30%.
----------------------------------------------------------------------------------------------------------------


  Table 29--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 cost (k).........................             $31
Estimated cost prophylactic measles vaccine per person               $70
 (USD), (l) = (j) + (k).................................
Number of individuals requiring measles vaccine, (g)....               6
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 NPRM 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). 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 to be vaccinated (Table 29).

[[Page 54278]]

    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) 
\70\ based on the public sector price for the vaccine. Vaccine 
administration costs are estimated from Healthcare Solutions' 2015 
Physicians' Fee & Coding Guide (CPT 90471).\71\ Total costs to 
vaccinate 6 people are estimated to be $420 at $70 per person 
vaccinated. Total costs resulting from the NPRM are summarized in Table 
30.
---------------------------------------------------------------------------

    \70\ http://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/archive.html Accessed 5/2/2016.
    \71\ InGauge Healthcare Solutions. 2015 Physicians' Fee & Coding 
Guide. Atlanta GA2013.

                                           Table 30--Marginal Impact of NPRM To Improve Contact Investigations
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Number of
                                          Additional names    Addition contacts       travelers                                             Average
  Net cost for measles investigations    provided to health   reached by health    provided post-          Number of  travelers        probability that
                                             departments         departments          exposure             identified  earlier            contact  is
                                                                                     prophylaxis                                           infected
--------------------------------------------------------------------------------------------------------------------------------------------------------
$1,950.................................                8.5                  21                   6   Unknown........................     0.0035--0.0095
--------------------------------------------------------------------------------------------------------------------------------------------------------

Baseline Measles Burden

    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 fact, 
travelers exposed during international travel may be more likely to 
visit a high traffic tourist destination leading to more exposures than 
the average measles case in the United States. In the absence of HHS/
CDC efforts to retrieve and transmit contact data, public health 
departments would not be able contact travelers to provide post-
exposure prophylaxis and to self-monitor 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.\72\ 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 average cost to 
public health departments per measles outbreak is $250,000 and the 
upper bound cost is $1 million.\73\
---------------------------------------------------------------------------

    \72\ 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).
    \73\ 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 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.\74\ 
The probability of hospitalization is estimated to be 44.3%.\75\ 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%.\76\ 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. Using these estimate the average illness 
costs associated with a measles case (Table 31) is about $30,000 
($9,500 to $58,000).
---------------------------------------------------------------------------

    \74\ 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.
    \75\ 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.
    \76\ 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 31--Estimated Illness and Mortality Costs for Measles Cases
----------------------------------------------------------------------------------------------------------------
                                                                   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...........................................           0.20%            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

[[Page 54279]]

costs. The estimated costs of measles outbreaks in the absence of 
contact investigations for exposed travelers is presented in Table 32.

      Table 32--Estimate 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 NPRM 
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 33.

 Table 33--Estimated Benefits Associated With Improvement of Measles Contact Investigations as a Result of This
                                                      NPRM
----------------------------------------------------------------------------------------------------------------
                                                                   Best estimate    Lower bound     Upper bound
----------------------------------------------------------------------------------------------------------------
Estimated total costs without intervention, j = g + i...........        $504,395        $137,146      $1,328,703
Estimated effectiveness of outbreak prevention baseline, k......             60%             60%             60%
Estimated cost of measles outbreaks under baseline, j x (1 - k).        $201,758         $54,858        $531,481
Estimated effectiveness of outbreak prevention with NPRM, l.....             69%             66%             72%
Estimated cost of measles outbreaks with NPRM, m = j x (1 - l)..        $156,363         $46,630        $372,037
Estimated benefit associated with NPRM, n = j - m...............         $45,396          $8,229        $159,444
----------------------------------------------------------------------------------------------------------------

Alternatives--Measles Contact Investigations
    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 33). 
Measles outcomes for the more restrictive alternative are the same as 
estimated for the NPRM since there is no difference in measles efforts 
between the NPRM and the more restrictive alternative. The comparative 
benefits relative to the status quo baseline are shown in Table 34. For 
the less restrictive alternative, costs are estimated based on an 
increase in measles outbreak costs relative to the baseline.

     Table 34--Estimated Benefits Associated With Averted Costs From Measles Outbreaks Relative to Baseline
----------------------------------------------------------------------------------------------------------------
                                                                   Best estimate    Lower bound     Upper bound
----------------------------------------------------------------------------------------------------------------
                                                    Benefits
----------------------------------------------------------------------------------------------------------------
NPRM............................................................         $45,396          $8,229        $159,444
Less Restrictive Alternative....................................               0               0               0
More Restrictive Alternative....................................          45,396           8,229         159,444
----------------------------------------------------------------------------------------------------------------
                                                      Costs
----------------------------------------------------------------------------------------------------------------
NPRM............................................................           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.


[[Page 54280]]

Effects on Tuberculosis Investigations
    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.\77\ 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.
---------------------------------------------------------------------------

    \77\ 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 for 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.\78\ 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).\79\
---------------------------------------------------------------------------

    \78\ 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.
    \79\ 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 35. 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 35--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 27 and cost per
                                                                                         contact from Table 20.
Estimated number of contacts reached             1,496              NA  ..............  Estimated at 75% similar
 by health departments (75%).                                                            to measles from Table
                                                                                         28.
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 27).
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.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    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 estimate 
costs and return on investment (ROI) is Estimated Costs x ROI + 
Estimated Costs. The estimated benefits are $2.6 million and are shown 
in Table 36 (range: $1.8 million to $3.8 million).

        Table 36--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 35.
 investigations and treatment.
Return on investment from                1.91            1.01            3.20  Coleman et al.
 tuberculosis contact
 investigations.
Estimated benefits...........       2,613,936       1,805,502       3,772,691  = Cost x ROI + Costs.
----------------------------------------------------------------------------------------------------------------

    The provisions in the NPRM should result in a small increase 
(assumed 5-15%) in the number of contacts reached by health departments 
and offered treatment for latent tuberculosis infection. 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 37. This results in marginal increased cost associated with 
NPRM of $18,000 (range: $9,000 to $27,000). The estimated benefits 
(Table 37) associated the NPRM are $52,000 (range: $18,000 to 
$114,000).

[[Page 54281]]



 Table 37--Estimated Costs and Benefits for Tuberculosis Contact Investigations Associated With This NPRM, 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 35 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 NPRM.                                                      improvement in contact
                                                                                         rate as result of NPRM.
Estimated costs under NPRM............         916,278         907,269         925,287  Estimated baseline cost
                                                                                         + increased cost as
                                                                                         result of NPRM.
Estimated ROI.........................            1.91            1.01            3.20  Table 35.
Estimated benefits for NPRM...........       2,666,368       1,823,610       3,886,204  = Cost x ROI + Costs.
Estimated costs associated with NPRM..          18,018           9,009          27,027  Calculated from the
                                                                                         difference in costs for
                                                                                         the NPRM--Baseline
                                                                                         costs.
Estimated benefits associated with              52,432          18,108         113,513  Calculated from the
 NPRM.                                                                                   difference in benefits
                                                                                         for the NPRM - Baseline
                                                                                         benefits.
----------------------------------------------------------------------------------------------------------------

Alternatives--Tuberculosis Contact Investigations

    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 NPRM 
results because it is unlikely that a tuberculosis outbreak would cause 
suspension of entry. Results are summarized in Table 38.

   Table 38--Changes in Tuberculosis Contact Investigations Costs and Benefits Relative to Baseline, 2015 USD
----------------------------------------------------------------------------------------------------------------
                                         Best estimate    Lower bound     Upper bound             Notes
----------------------------------------------------------------------------------------------------------------
                                                    Benefits
----------------------------------------------------------------------------------------------------------------
NPRM..................................         $52,432         $18,108        $113,513  Table 37.
Less Restrictive Alternative..........         180,180         180,180         180,180  Assumed to be the cost
                                                                                         to provide LTBI
                                                                                         treatment under the
                                                                                         baseline (Table 37).
More Restrictive Alternative..........          52,432          18,108         113,513  The more restrictive
                                                                                         alternative has the
                                                                                         same effect on TB
                                                                                         contact investigations
                                                                                         as NPRM.
----------------------------------------------------------------------------------------------------------------
                                                      Costs
----------------------------------------------------------------------------------------------------------------
NPRM..................................          18,018           9,009          27,027  Table 37.
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 NPRM.
----------------------------------------------------------------------------------------------------------------

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 34) and tuberculosis contact 
investigations (Table 38). The results are summarized in Table 39.

  Table 39--Changes in Measles and Tuberculosis Contact Investigations Costs and Benefits Relative to Baseline,
                                                    2015 USD
----------------------------------------------------------------------------------------------------------------
                                                                   Best estimate    Lower bound     Upper bound
----------------------------------------------------------------------------------------------------------------
                                                    Benefits
----------------------------------------------------------------------------------------------------------------
NPRM............................................................         $97,828         $26,337        $272,958
Less Restrictive Alternative....................................         180,180         180,180         180,180

[[Page 54282]]

 
More Restrictive Alternative....................................          97,828          26,337         272,958
----------------------------------------------------------------------------------------------------------------
                                                      Costs
----------------------------------------------------------------------------------------------------------------
NPRM............................................................          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 34 and 38.

    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 40) 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 39).

Table 40--Total Annual Costs and Benefits Associated With Improved Efficiency Public Health Response Activities,
                                                    2015 USD
----------------------------------------------------------------------------------------------------------------
                                                                   Best estimate    Lower bound     Upper bound
----------------------------------------------------------------------------------------------------------------
                                                    Benefits
----------------------------------------------------------------------------------------------------------------
NPRM............................................................        $117,376         $26,337        $312,054
Less Restrictive Alternative....................................       1,670,940       1,670,940       1,670,940
More Restrictive Alternative....................................         176,056          85,017         370,734
----------------------------------------------------------------------------------------------------------------
                                                      Costs
----------------------------------------------------------------------------------------------------------------
NPRM............................................................         $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 benefits and costs associated with improved effectiveness of 
contact investigations (Table 40) 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 NPRM and for the less 
restrictive and more restrictive alternatives (Table 41).

 Table 41--Total Annual Costs and Benefits of the NPRM, Less Restrictive and More Restrictive Alternatives, 2015
                                                       USD
----------------------------------------------------------------------------------------------------------------
                                                                   Best estimate    Lower bound     Upper bound
----------------------------------------------------------------------------------------------------------------
                                                    Benefits
----------------------------------------------------------------------------------------------------------------
NPRM............................................................        $117,376         $26,337        $312,054
Less Restrictive Alternative....................................       1,777,179       1,777,179       1,777,179
More Restrictive Alternative....................................         177,954          86,915         372,632
----------------------------------------------------------------------------------------------------------------
                                                      Costs
----------------------------------------------------------------------------------------------------------------
NPRM............................................................          35,785          10,959          65,644
Less Restrictive Alternative....................................       2,815,694       1,860,360       4,304,172
More Restrictive Alternative....................................          36,317          11,807          65,860
----------------------------------------------------------------------------------------------------------------

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 does attempt 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 
\80\ and has modified its

[[Page 54283]]

protocol to reduce the number of tuberculosis contact 
investigations.\81\
---------------------------------------------------------------------------

    \80\ 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.
    \81\ 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 want to know when they have been exposed to communicable 
diseases during flights. The first Ebola contact investigation 
conducted in the United States in October, 2014, found that 60 
travelers out of 164 had no contact information on the manifest that 
was provided by the airline. After an all-night effort by CBP's 
National Targeting Center, there were still 24 travelers with no 
contact information. 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. On 
a second flight, no contact information was provided to HHS/CDC for 
111/132 travelers. HHS/CDC again had to request significant assistance 
from the National Targeting Center to obtain additional contact 
information. Despite 24 staff-hours spent searching, 28 travelers did 
not have sufficient information to be able to locate them. HHS/CDC 
released the flight information in order to inform the public in the 
hope that the remaining travelers would contact CDC.
    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. 
HHS/CDC would like to solicit public comment about potential public 
willingness to pay to be contacted in the event of exposure to a 
communicable disease during travel to help estimate the potential 
benefit to the public of HHS/CDC efforts to work with health 
departments to contact travelers exposed to meningitis, viral 
hemorrhagic fevers (including MERS or SARS) among other diseases.
    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 .

Codification of Current Practice (Multiple Provisions in NPRM)

    HHS/CDC does not expect that most of the provisions included in the 
NPRM will result in measurable changes relative to the economic 
baseline. The primary purpose of the provisions summarized in list 
below is to elucidate how HHS/CDC interprets its current statutory and 
regulatory authority under the Public Health Service Act and 42 CFR 70 
and 71 regulations. HHS/CDC is grouping the mirror provisions in 70 and 
71 in the list below, when they align, to facilitate public review of 
the current and proposed provisions. 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 such clarity is 
an important qualitative benefit of the provisions proposed this NPRM, 
but is not able to monetize this impact in a robust way.
     Proposed 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 NPRM, 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 NPRM
    [ssquf] With the NPRM, HHS/CDC is proposing to align 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 NPRM
    [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 NPRM
    [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.
     Proposed 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 Sec.  70.6 Apprehension and detention of persons with 
specific diseases and Sec.  71.32 Persons, carriers, and things HHS/CDC 
currently has regulatory authority to apprehend and detain individuals 
with quarantinable communicable diseases.
    [cir] Change relative to baseline as result of NPRM
    [ssquf] As a result of these proposed 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 NPRM
    [ssquf] Improved transparency and compliance with Federal orders.
    [cir] Monetized benefit/cost of NPRM
    [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

[[Page 54284]]

orders that limit an individual's movement. This includes the potential 
costs of litigation and associated activities.
     Proposed 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 NPRM and under existing statutory 
authority provided in the Public Health Service Act, 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 concrete regulatory authority to require such measures, 
travelers may not 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 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 NPRM
    [ssquf] Improved transparency and potentially improved compliance 
in the event that HHS/CDC implements such measures in the future.
    [cir] Qualitative benefit/cost of NPRM
    [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 NPRM
    [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.
     Proposed 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 71.33 Persons: Isolation and 
surveillance, which have been interpreted to allow for medical 
examinations of individuals under Federal orders.
    [cir] Change to baseline as result of NPRM
    [ssquf] With the NPRM, 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 NPRM
    [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 NPRM
    [ssquf] Increased clarity around due process may result in fewer 
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.
     Proposed 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 NPRM, HHS/CDC can under current statutory 
provided by the Public Health Service Act and regulatory authority 
continue to issue Federal quarantine, isolation, or condition release 
orders. However, the process executed under statutory authority and 
internal policy and standard operating procedures derived from 
regulations at 42 CFR 71.32 Persons, carriers, and things and 71.33 
Persons: Isolation and Surveillance, which is not as transparent to the 
public as an explicit regulation outlining requirements.
    [cir] Change to baseline as result of NPRM
    [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 NPRM
    [ssquf] Improved transparency and public knowledge of HHS/CDC's 
procedures and regulatory requirements.
    [cir] Monetized benefit/cost of NPRM
    [ssquf] None. This is a clarification of HHS/CDC's current 
practice.
     Proposed 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 NPRM, HHS/CDC can under current statutory 
authority provided by the Public Health Service Act and regulatory 
authority under 42 CFR 71.32 Persons, carriers, and things and 71.33 
Persons: Isolation and Surveillance continue to issue Federal 
quarantine, isolation, or condition release orders. However, the 
process for a reassessment of a Federal order is executed under 
internal policy and standard operating procedures, which is not as 
transparent to the public as regulation.
    [cir] Change to baseline as result of NPRM:
    [ssquf] With the NPRM, individuals under Federal order may be more 
aware of mandatory reassessment of a Federal quarantine, isolation, or 
conditional release order.
    [cir] Qualitative benefit/cost of NPRM
    [ssquf] Improved transparency and understanding of due process 
protections under a Federal public health order.
    [cir] Monetized benefit/cost of NPRM
    [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.
     Proposed 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 NPRM, HHS/CDC can under current statutory 
authority provided by the Public Health Service Act and regulatory 
authority under 42 CFR 71.32 Persons, carriers, and things and 71.33 
Persons: Isolation and Surveillance continue to issue Federal 
quarantine, isolation, or condition release orders. However, the 
process for a medical review of a Federal order is executed under 
internal policy and standard operating procedures, which is not as 
transparent to the public as regulation.

[[Page 54285]]

    [cir] Change to baseline as result of NPRM:
    [ssquf] With the NPRM, 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 NPRM
    [ssquf] Improved transparency and understanding of due process 
afforded to individuals under a Federal order
    [cir] Monetized benefit/cost of NPRM
    [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.
     Proposed 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 NPRM, HHS/CDC can issue under current statutory 
provided by the Public Health Service Act and regulatory authority 
under 42 CFR 71.32 Persons, carriers, and things and 71.33 Persons: 
Isolation and Surveillance continue to issue Federal quarantine, 
isolation, or condition release orders. However, the process and 
requirement for documentation for the administrative record is executed 
under statutory authority, internal policy and standard operating 
procedures, which is not as transparent to the public as regulation.
    [cir] Change to baseline as result of NPRM
    [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 NPRM
    [ssquf] Improved transparency
    [cir] Monetized benefit/cost of NPRM
    [ssquf] Not applicable. This is a codification of an administrative 
activity within HHS/CDC.
     Proposed Provisions: Sec.  70.18 Agreements; Sec.  71.40 
Agreements
    [cir] Baseline and Current Regulatory Provisions: No current 
explicit regulatory provision.
    [ssquf] Without the NPRM, individuals may not be aware of the 
agreement process. HHS/CDC can under current statutory and regulatory 
authority continue to issue Federal quarantine, isolation, or condition 
release orders. However, the process and requirement for documentation 
for the consent process is executed under statutory authority, internal 
policy and standard operating procedures, which is not as transparent 
to the public as regulation.
    [cir] Change to baseline as result of NPRM
    [ssquf] With the NPRM, individuals are more likely to be aware of 
the agreement process.
    [cir] Qualitative benefit/cost of NPRM
    [ssquf] Improved transparency
    [cir] Monetized benefit/cost of NPRM
    [ssquf] Increased clarity around due process may result in fewer 
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.
     Proposed Provisions: Sec.  70.19 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 NRPM, individuals may not be aware of the 
increase in the maximum allowable penalties for a violation of 
regulations under 42 CFR 70 and 71. And it may not be clear to 
individuals that a violation of quarantine regulation found in 42 CFR 
part 70 may result in penalties.
    [cir] Change to baseline as result of NPRM
    [ssquf] With the NRPM, there will be less confusion about the 
maximum allowable penalties for a violation of regulations under 42 CFR 
70 and 71.
    [cir] Qualitative benefit/cost of NPRM
    [ssquf] Improved transparency and alignment with current law under 
18 U.S.C. 3559 and 3571.
    [cir] Monetized benefit/cost of NPRM
    [ssquf] No individual has been issued a penalty under this 
regulation, 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.
The 2014-2016 Ebola Outbreak
    The costs and benefits from the 2014-2016 Ebola enhanced entry risk 
assessment and management program are used to demonstrate the costs and 
benefits of implementation of its regulatory authorities, and are 
especially relevant when analyzing the effects of the rule relative to 
a non-status quo baseline. Although most of the costs incurred by HHS/
CDC, DHS/CBP, and travelers can be quantified, the benefits are more 
difficult to quantify. This program is chosen because of its 
significant economic impacts. For this outbreak analysis, a less 
restrictive alternative would be for HHS/CDC not to execute its 
existing regulatory authorities to implement the Ebola enhanced entry 
risk assessment and management program. The more restrictive 
alternative would be a suspension of entry for persons from countries 
with widespread transmission for a period of 21 days (equivalent the 
maximum expected incubation period for Ebola disease).
    The quantified cost of the Ebola enhanced entry risk assessment and 
management program ($109 million) outweighs what HHS/CDC estimates as 
directly associated-benefits ($7.7 million), but there are multiple 
benefits that HHS/CDC could not estimate. Around the time the program 
was implemented, public opinion surveys ranked Ebola as the third 
highest health care concern among a list of issues facing the country, 
only health care costs and access to care ranked higher. The same poll 
found that about 45% were either somewhat worried or very worried that 
they or someone in their family could become sick with Ebola. The Ebola 
enhanced entry risk assessment and management program in combination 
with a number of other Federally-funded initiatives helped reduce the 
potential risk for Ebola exposure in the United States from travelers 
from the affected countries to almost zero.\82\ The average cost per 
American citizen for these programs was approximately $17. Thus, if 
willingness to pay for such a risk reduction was greater than $17 per 
person on average, the programs would pass a cost-benefit test. Finally 
HHS/CDC examined the economic impact of the recent MERS outbreak in 
South Korea and asks the question, what would be the cost to the United 
States if an outbreak of similar magnitude occurred. HHS/CDC estimates 
the cost of such an outbreak could be as much as $58 billion indicating 
the potential costs associated with unexpected outbreaks of 
quarantinable communicable diseases.
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    \82\ SteelFisher GK, Blendon RJ, Lasala-Blanco N. Ebola in the 
United States--Public Reactions and Implications. N Eng J Med. 
2015;373:789-91.
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    In late 2014, two imported cases of Ebola were identified in the 
United States, one of which resulted in two domestic cases and 
extensive contact investigations in the community and for

[[Page 54286]]

travelers on two domestic flights.83 84 85 86
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    \83\ Chevalier MS, Chung W, Smith J, et al. Ebola virus disease 
cluster in the United States--Dallas County, Texas, 2014. MMWR Morb 
Mortal Wkly Rep 2014;63:1087-8.
    \84\ McCarty CL, Basler C, Karwowski M, et al. Response to 
importation of a case of Ebola virus disease--Ohio, October 2014. 
MMWR Morb Mortal Wkly Rep 2014;63:1089-91.
    \85\ Regan JJ, Jungerman R, Montiel SH, et al. Public health 
response to commercial airline travel of a person with Ebola virus 
infection--United States, 2014. MMWR Morb Mortal Wkly Rep 
2015;64:63-6.
    \86\ Yacisin K, Balter S, Fine A, et al. Ebola virus disease in 
a humanitarian aid worker--New York City, October 2014. MMWR Morb 
Mortal Wkly Rep 2015;64:321-3.
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    Around the same time, some political leaders and members of the 
public demanded increasing the domestic response, including banning air 
travel between the United States and the three countries with 
widespread transmission.\87\ Many public health professionals cautioned 
that such a ban would cause greater harm than good to the public health 
response by hampering travel of responders and delivery of supplies 
into the region and paradoxically could increase the risk for spread 
via covert and circuitous travel routes.88 89 The paradox 
results because travel restrictions cannot stop people from moving 
across borders and spreading disease to new countries, especially 
because such travel is often more difficult to track than if travel is 
not restricted entirely.\90\
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    \87\ McAuliff M. Lawmakers ignore experts, push for Ebola travel 
ban. The Huffington Post. October 16, 2014. http://www.huffingtonpost.com/2014/10/16/congress-ebola_n_5997214.html9. 
Nuzzo JB, Cicero AJ, Waldhorn R, Inglesby TV. Travel bans will 
increase the damage wrought by Ebola. Biosecur Bioterror 
2014;12:306-9. http://dx.doi.org/10.1089/bsp.2014.1030
    \88\ Nuzzo JB, Cicero AJ, Waldhorn R, Inglesby TV. Travel bans 
will increase the damage wrought by Ebola. Biosecur Bioterror 
2014;12:306-9. http://dx.doi.org/10.1089/bsp.2014.1030
    \89\ Poletto C, Gomes MF, Pastore y Piontti A, et al. Assessing 
the impact of travel restrictions on international spread of the 
2014 West African Ebola epidemic. Euro Surveill 2014;19:pii 20936. 
http://dx.doi.org/10.2807/1560-7917.ES2014.19.42.20936
    \90\ Frieden T. CDC Chief: Why I don't support a travel ban to 
combat Ebola outbreak (2014). http://www.foxnews.com/opinion/2014/10/09/cdc-chief-why-dont-support-travel-ban-to-combat-ebola-outbreak.html Accessed 6/9/2015.
---------------------------------------------------------------------------

    To reduce the risk of importation of Ebola to the United States, 
HHS/CDC supported the implementation of exit screening at international 
airports in countries with widespread Ebola transmission. After Ebola 
spread from Liberia to Nigeria by air travel, concerned airlines 
canceled flights to Guinea, Liberia, and Sierra Leone, and multiple 
countries closed their borders to travelers from these countries; \91\ 
the shortage of commercial flights caused delays to the provision of 
humanitarian aid, resulting in shortages of medical supplies, personal 
protective equipment, and food.\92\ The few airlines that continued to 
fly to the countries with Ebola outbreaks insisted that departing 
travelers be screened before boarding.\93\ HHS/CDC Border Health teams 
in Guinea, Liberia, Nigeria, and Sierra Leone, and later Mali and 
Senegal, helped airport and health authorities implement airport exit 
screening measures that included administering an exposure-and-symptom 
questionnaire and at least one temperature check with a handheld 
noncontact thermometer to all departing passengers. Health screeners 
were trained to conduct secondary assessments of travelers who reported 
possible exposures or who had symptoms compatible with Ebola. 
Symptomatic or exposed travelers were denied boarding and referred for 
further medical and public health assessment. As national databases of 
known contacts became more robust, they were matched against passenger 
manifests for departing flights. These measures helped countries with 
Ebola outbreaks meet WHO recommendations and ensured that some 
commercial air carriers continued to fly to these countries, serving as 
vital conduits for supplies and response personnel.
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    \91\ Anderson M. Ebola: airlines cancel more flights to affected 
countries. The Guardian. August 22, 2014. http://www.theguardian.com/society/2014/aug/22/ebola-airlines-cancel-flights-guinea-liberia-sierra-leone. Accessed 6/9/2016.
    \92\ Balen B. Ebola supplies sit as airlines cancel flights to 
countries with infection. The Guardian. September 8, 2014. http://guardianlv.com/2014/09/ebola-supplies-sit-as-airlines-cancel-flights-to-countries-with-infection/. Accessed 6/9/3026.
    \93\ Anderson M. Ebola: airlines cancel more flights to affected 
countries. The Guardian. August 22, 2014. http://www.theguardian.com/society/2014/aug/22/ebola-airlines-cancel-flights-guinea-liberia-sierra-leone. Accessed 6/9/2016.
---------------------------------------------------------------------------

    During August 2014-January 2016, approximately 300,000 travelers 
were screened in Guinea, Liberia, and Sierra Leone. Only four cases of 
Ebola were exported through air travel to other countries (United 
States [two cases], United Kingdom [one case], Italy [one case]) after 
exit screening was implemented; none of the infected travelers were 
overtly symptomatic at the time of travel.94 95 96 97 No 
Ebola cases were reported to have been detected during exit screening.
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    \94\ Chevalier MS, Chung W, Smith J, et al. Ebola virus disease 
cluster in the United States--Dallas County, Texas, 2014. MMWR Morb 
Mortal Wkly Rep 2014;63:1087-8.
    \95\ Yacisin K, Balter S, Fine A, et al. Ebola virus disease in 
a humanitarian aid worker--New York City, October 2014. MMWR Morb 
Mortal Wkly Rep 2015;64:321-3.
    \96\ Gulland A. Second Ebola patient is treated in UK. BMJ 
2014;349:g7861. http://dx.doi.org/10.1136/bmj.g7861 PubMed.
    \97\ World Health Organization. Ebola virus disease--Italy. 
Disease Outbreak News, May 13, 2015. http://www.who.int/csr/don/13-may-2015-ebola/en/.
---------------------------------------------------------------------------

    To build on the exit screening already in place, HHS/CDC 
collaborated with the U.S. Department of Homeland Security to initiate 
an enhanced entry risk assessment and management program for travelers 
from countries with Ebola outbreaks. This unprecedented operation 
required coordination across multiple U.S. government agencies, as well 
as with airport authorities and health departments in all U.S. states 
and territories.\98\
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    \98\ Brown CM, Aranas AE, Benenson GA, et al. Airport exit and 
entry screening for Ebola--August-November 10, 2014. MMWR Morb 
Mortal Wkly Rep 2014;63:1163-7.
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    HHS/CDC issued revised interim guidance in October 2014 \99\ after 
the first imported case of Ebola in the United States was identified 
(and initially diagnosed as presumed sinusitis) in Dallas, Texas;\100\ 
an infected U.S. health care worker (HCW) flew on two domestic 
commercial flights, causing panic among U.S. travelers and disrupting 
the travel industry;101 102 103 and an infected humanitarian 
aid worker was reported to have been in public areas, including the New 
York City subway, during the early stages of his 
illness.104 105 CDC's guidance was revised in response to 
assertions that self-monitoring was insufficient; growing concerns 
about infected HCWs in Spain, the United

[[Page 54287]]

States, and the West African countries with Ebola outbreaks; 
106 107 108 109 and renewed calls for travel bans.\110\ 
Demands to restrict movement of HCWs caring for patients with Ebola 
were countered by predictions that stringent restrictions would 
discourage HCWs from supporting the response in West Africa or taking 
care of patients with Ebola at designated facilities in the United 
States.111 112 The revised guidance recommended that state 
or local public health authorities assume responsibility for monitoring 
all potentially exposed persons for the duration of the 21-day 
incubation period (active monitoring); established a higher standard of 
monitoring (direct active monitoring that included daily direct 
observation by public health officials) for persons with greater 
potential risk for exposure, including HCWs; and provided guidance for 
possible application of movement restrictions within communities. 
Although CDC's guidance represented a minimum standard, states could, 
and in many cases did, apply more restrictive measures (e.g., 
temporarily quarantining HCWs returning from West Africa).\113\ Many of 
these measures were enacted before CDC issued the updated guidance.
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    \99\ CDC. Notes on the interim U.S. guidance for monitoring and 
movement of persons with potential Ebola virus exposure. February 
19, 2016. http://www.cdc.gov/vhf/ebola/exposure/monitoring-and-movement-of-persons-with-exposure.html.
    \100\ Chevalier MS, Chung W, Smith J, et al. Ebola virus disease 
cluster in the United States--Dallas County, Texas, 2014. MMWR Morb 
Mortal Wkly Rep 2014;63:1087-8.
    \101\ Regan JJ, Jungerman R, Montiel SH, et al. Public health 
response to commercial airline travel of a person with Ebola virus 
infection--United States, 2014. MMWR Morb Mortal Wkly Rep 
2015;64:63-6.
    \102\ Bever L. Chain reaction: concern about Ebola nurse's 
flight prompts school closings in two states. The Washington Post. 
October 16, 2014. https://www.washingtonpost.com/news/morning-mix/wp/2014/10/16/after-concern-about-ebola-patients-flight-schools-close-in-two-cities/.
    \103\ Mejia P. Planes, automobiles and cruise ships: vehicles 
for Ebola panic. Newsweek. October 17, 2014. http://www.newsweek.com/planes-automobiles-and-cruise-ships-vehicles-ebola-panic-278206
    \104\ Yacisin K, Balter S, Fine A, et al. Ebola virus disease in 
a humanitarian aid worker--New York City, October 2014. MMWR Morb 
Mortal Wkly Rep 2015;64:321-3.
    \105\ Spencer C. Having and fighting Ebola--public health 
lessons from a clinician turned patient. N Engl J Med 2015;372:1089-
91. http://dx.doi.org/10.1056/NEJMp1501355.
    \106\ Chevalier MS, Chung W, Smith J, et al. Ebola virus disease 
cluster in the United States--Dallas County, Texas, 2014. MMWR Morb 
Mortal Wkly Rep 2014;63:1087-8.
    \107\ Yacisin K, Balter S, Fine A, et al. Ebola virus disease in 
a humanitarian aid worker--New York City, October 2014. MMWR Morb 
Mortal Wkly Rep 2015;64:321-3.
    \108\ Forrester JD, Hunter JC, Pillai SK, et al. Cluster of 
Ebola cases among Liberian and U.S. health care workers in an Ebola 
treatment unit and adjacent hospital--Liberia, 2014. MMWR Morb 
Mortal Wkly Rep 2014;63:925-9. PubMed.
    \109\ Matanock A, Arwady MA, Ayscue P, et al. Ebola virus 
disease cases among health care workers not working in Ebola 
treatment units--Liberia, June-August, 2014. MMWR Morb Mortal Wkly 
Rep 2014;63:1077-81.
    \110\ McAuliff M. Lawmakers ignore experts, push for Ebola 
travel ban. The Huffington Post. October 16, 2014. http://www.huffingtonpost.com/2014/10/16/congress-ebola_n_5997214.html.
    \111\ Infectious Diseases Society of America. IDSA statement on 
involuntary quarantine of healthcare workers returning from Ebola-
affected countries. http://www.idsociety.org/2014_ebola_quarantine/.
    \112\ Devaney T. Fauci calls Ebola quarantines ``draconian.'' 
The Hill. October 26, 2014. http://thehill.com/policy/healthcare/221890-top-nih-officials-calls-quarantines-draconian.
    \113\ American Civil Liberties Union; Yale Global Health Justice 
Partnership. Fear, politics, and Ebola: how quarantines hurt the 
fight against Ebola and violate the Constitution. December 2015. 
https://www.aclu.org/sites/default/files/field_document/aclu-ebolareport.pdf.
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Objectives of the Enhanced Entry Risk Assessment Process
    Enhanced entry risk assessment had three main objectives:
     To identify travelers who may have been exposed to Ebola, 
or be sick when they arrive in the United States,
     To ensure that these travelers were directed to 
appropriate care and monitoring, if needed, which would also help 
protect the health of all Americans, and
     To educate travelers and provide tools to help them 
monitor themselves for symptoms, and report to the local or state 
health department at their domestic destination(s) for active 
monitoring and health care if they developed symptoms.
    Beginning October 2014, all travelers from Guinea, Sierra Leone and 
Liberia were required to undergo risk assessment for Ebola. Enhanced 
entry risk assessment was discontinued for countries after widespread 
transmission of Ebola had been halted. The last travelers from Guinea 
were screened in February 2016. Enhanced entry risk assessment at U.S. 
airports included processes (referred to operationally as ``primary 
screening'') to identify travelers from countries with Ebola outbreaks, 
either through scheduled flight itineraries or during customs and 
immigration inspections. CBP officers and other U.S. Department of 
Homeland Security staff collected contact and locating information, 
administered an exposure-and-symptom questionnaire, checked travelers' 
temperatures with noncontact thermometers, and observed travelers for 
signs of illness. Data were entered electronically through an online 
interface and transmitted securely to a CDC database and then to 
states. These processes were collectively referred to as ``secondary 
screening.'' Travelers who were symptomatic or who reported possible 
exposures were referred to CDC for an in-depth public health risk 
assessment (referred to as ``tertiary screening''). Symptomatic 
travelers who met predefined criteria were referred for medical 
evaluation to designated assessment hospitals, in consultation with the 
health department with jurisdiction for the airport. Travelers with 
certain types of higher risk exposures were not permitted to travel 
further by commercial transport even if they were not symptomatic.
    HHS/CDC developed a new intervention called the CARE (Check and 
Report Ebola) Program to supplement the Ebola entry screening process. 
Airport-located CARE `Ambassadors' that connected with travelers were 
trained health educators, counselors, or social workers. Each traveler 
arriving from West Africa was counseled by a CARE Ambassador and 
received a CARE Kit that included educational materials, a digital 
thermometer, and a pre-paid cell phone to help with daily reporting to 
state or local health departments.
Analysis of the Costs of Ebola Enhanced Entry Risk Assessment and 
Management Program
    Every public health emergency is different, but HHS/CDC is 
confident that had the agency been able to answer `who, where and how,' 
the government expenditures on Ebola entry risk assessment program 
would have been lower. In the absence of such data, HHS/CDC had to 
implement an expensive program in part just to help identify the small 
number of people within the United States that had been in countries 
with widespread Ebola transmission within the previous 21 days.
    While some HHS/CDC and CBP personnel would still undoubtedly have 
been assigned to airports, some costs associated with travel time, 
training, and airport Ebola response work may have been avoided with 
the availability of better traveler contact data. More specifically, 
some examples cutting back on the domestic response might include:
     Reduction in travel of HHS/CDC employees assigned to 
airports. Each reassigned employee receives airfare, hotel, and per 
diem for incidentals such as meals.
     Reduction in overtime. Initially, staff at airports 
universally worked seven days a week, 12 to 16 hours a day, for 30 days 
at a time. At HHS/CDC headquarters, the Emergency Operations Center had 
persons answering calls 24-7, and many others working seven days to 
make travel arrangements, provide supplies, and answer press or 
congressional inquiries. Middle- and upper-level managers in more than 
one CDC center and division, as well as the HHS/CDC Director and staff, 
were on call 24-7.
     Reduction in supplies. The people reporting to airports 
needed personal protective gear, cellphones, laptops, and phones. At 
different points in time during the response, some airports needed to 
supply special contractors to remove used protective gear.
    During the past fifteen years there have been several international 
disease events where this type of risk assessment was either considered 
by HHS/CDC or suggested by other branches of Federal government, e.g., 
SARS, MERS, and multiple novel influenzas. However, this was the first 
instance in which such a program was implemented.

[[Page 54288]]

Ebola Entry Risk Assessment Cost Estimates
    First this section estimates the time-costs or opportunity costs to 
travelers from West Africa to comply with protocols at the ports of 
entry. Then HHS/CDC provides estimates of the budgetary costs to HHS/
CDC and CBP for standing up the Ebola entry risk assessment program.
Screened-Traveler Opportunity and Out-of-Pocket Costs
    The actual number of travelers who underwent the risk assessment 
program at airports between October 11, 2014 and February 18, 2016 is 
summarized in Table 42. These numbers were tabulated using electronic 
records kept by HHS/CDC of the number of West African travelers 
screened at U.S. airports.
    Using the numbers of travelers screened, HHS/CDC estimates the 
opportunity costs for travelers. To represent the time involved in 
waiting for, and complying with, risk assessment for travelers, HHS/CDC 
assumes 30 minutes per traveler for secondary screening and an 
additional 30 minutes for travelers that had to undergo tertiary 
screening. Primary screening time was not included because all 
international travelers already interact with CBP in order to enter the 
United States.
    Hospital evaluations would require an additional 24 hours. The cost 
to provide transportation to hospitals from airports and to conduct 
further evaluation was covered by travelers and/or their insurance 
providers or employers. Over the 16 month period of this program, a 
total of 29 travelers out of 38,344 screened (0.08%) were recommended 
to travel from the airport to a hospital for further testing. All 
travelers complied voluntarily and there was no need to issue a Federal 
order. HHS/CDC does not have any data to estimate the cost of 
transportation to and evaluation at hospitals. The cost to treat Ebola 
patients was reported to be about $30,000 per day at the Nebraska 
Medical Center and about $50,000 per day at the National Institutes of 
Health.\114\ If the daily cost of evaluation is estimated to be similar 
to the cost of treating Ebola patients (i.e. $30,000--$50,000 per day) 
and it is assumed that evaluation requires 24-48 hours, a lower bound 
cost estimate for evaluation would be $30,000/day x 1 day = $30,000 and 
an upper bound cost estimate can be calculated from $50,000/day x 2 
days = $100,000. The midpoint cost estimate is $65,000. For 29 patients 
at the midpoint cost estimate, the total cost is 29 patients x $65,000 
per patient = $1,885,000.
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    \114\ Sun L.H. Cost to treat Ebola in the U.S.: $1.16 million 
for 2 patients. Washington Post November 18, 2014 https://www.washingtonpost.com/news/post-nation/wp/2014/11/18/cost-to-treat-ebola-in-the-u-s-1-16-million-for-2-patients/?utm_term=.283370dc6c47. Accessed6/10/2016.
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    During a one-year period from August 2013 through July 2014, 
approximately 90% of passengers from Liberia, Guinea, and Sierra Leone 
entered the United States at the five airports that CBP funneled all 
West African travelers for Ebola risk assessment. Therefore, HHS/CDC 
assumes that 10% of travelers designated for risk assessment had to 
change travel plans to comply with the funneling restrictions. This re-
routing likely resulted in increased time spent in transit and some 
unplanned out-of-pocket expenditures for items such as rescheduled 
flights, layover delays or meals. In the absence of data to quantify 
these costs, HHS/CDC assumed that re-routing required an additional 6 
hours of travel time and a $100 increase in costs for each traveler 
redirected from their original destination. This would apply to 10% of 
38,344 (3,834) travelers over an 18-month period.
    Traveler opportunity costs are valued at $23.23 per hour \115\/60 
minutes to arrive at an estimate of $0.39 per minute using the 2015 
U.S. average hourly wage reported by the Bureau of Labor Statistics. 
The total opportunity costs for travelers funneled to airports and 
participating in risk assessment is estimated to be $744,834 and the 
total out-of-pocket cost is estimated at $2.3 million (including the 
cost of evaluation at hospitals after referrals from airports. Thus, 
the total traveler cost is $3,146,596 (Table 42).
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    \115\ Bureau of Labor Statistics May 2015 National Occupational 
Employment and Wage Estimates United States. http://www.bls.gov/oes/current/oes_nat.htm. Accessed 6/12/2016.

                     Table 42--Traveler Opportunity and Out-of-Pocket Cost Estimates for Ebola Risk Assessment (16 Months), 2015 USD
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Time per      Time cost per       Total
                                                             Number of       traveler      traveler-hour    opportunity    Out-of-pocket       Total
                                                           travelers \a\       (min)            \b\            cost          cost \c\
--------------------------------------------------------------------------------------------------------------------------------------------------------
2nd \d\.................................................          38,344              30          $23.23        $445,366              $0        $445,366
3rd \d\.................................................           2,736              30           23.23          32,867               0          32,867
Hosp....................................................              29           1,440           23.23          25,471       1,885.000       1,910,471
Funnel..................................................           3,834             360           23.23         374,453         383,440         757,893
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total...............................................          38,344              NA              NA         744,834       2,268,440       3,146,596
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ All travelers identified from countries with widespread Ebola transmission.
\b\ Time cost is estimated by multiplying no. of minutes/60 by $23.23 (average hourly wages according to the 2015 Occupation and Employment Survey.
\c\ Assumed $100 per travelers for 10% of travelers that are redirected.
\d\ Secondary and Tertiary Screening

Federal Government Spending for Ebola Entry Risk Assessment
    Current and projected spending for initiation and compliance with 
Ebola entry risk assessment is about $96M for HHS/CDC. All HHS/CDC 
funds have been either spent or are obligated in Fiscal Year (FY) 2016. 
CBP spending as of May 18, 2015 was $4.9 M. If this level of spending 
is extrapolated to 16 months of steady state spending, CBP costs would 
be $9.8 million. HHS/CDC does not have estimates of the costs to the 
other Federal or state agencies or airlines for time spent working in 
conjunction with HHS/CDC staff to develop the domestic response to 
Ebola.
    Although Federal government spending occurred over 16 months, the 
monies were allocated and obligated within a single calendar year. 
Thus, the spending amounts are not discounted, but rather are treated 
as a one-time spending event. The total cost ($109 million) to the U.S. 
Federal government

[[Page 54289]]

and to travelers is summarized in Table 43.

     Table 43--U.S. Govt. and Traveler Cost Estimates for Ebola Risk
                    Assessment (18 Months), 2015 USD
------------------------------------------------------------------------
                  Budget/cost category                      Event cost
------------------------------------------------------------------------
CDC Budget..............................................     $96,026,532
CBP Budget..............................................       9,830,583
Passenger Opportunity and Out-of-Pocket Cost............       3,146,596
    Total 16 Months.....................................     109,003,711
------------------------------------------------------------------------

Analysis of the Benefits of Ebola Enhanced Entry Risk Assessment and 
Management
    The benefits of the Ebola enhanced entry risk assessment and 
management program are much more difficult to quantify than the costs. 
This program was part of more than $5.4 billion spent on emergency 
Federal programs in the United States and abroad to contain the Ebola 
epidemic in West Africa to minimize the risk to the U.S. public.
    The potential benefits from the enhanced entry risk assessment and 
management program include:
     Reduced time to health care evaluation/isolation for cases
     Treatment at appropriate facilities leads to better 
outcomes, reduced transmission risk
     Quarantine of persons at high risk to prevent transmission
     Reduction in effort by state/local health departments to 
conduct active monitoring due to increased engagement/communication 
tools (CARE program)
    For the Ebola enhanced entry risk assessment and management program 
to be effective, there were a number of other activities conducted in 
parallel. Health departments had to effectively implement active 
monitoring and quarantine restrictions to respond to travelers who may 
become ill during the 21-day period in which travelers from Ebola-
affected countries could become ill. Available evidence suggests that 
all states conducted active monitoring at least as stringently as the 
guidelines circulated by HHS/CDC. In fact, analysis of publicly 
available state guidelines determined that 17 states and the District 
of Columbia had policies that were more restrictive than HHS/CDC 
guidance, 35 states and territories had policies equivalent to HHS/CDC 
guidance, and no states or territories had guidance that was less 
restrictive than HHS/CDC guidance.\116\ Travelers must comply with 
monitoring/quarantine and give accurate information during entry risk 
assessment. Treatment facilities must be able to appropriately evaluate 
and treat patients. Part of the Federal Ebola funding was used to 
identify and prepare hospitals to treat Ebola patients. Laboratory 
testing must be accessible, accurate, and timely to properly diagnose 
patients with communicable diseases not commonly seen in the United 
States.
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    \116\ Sunshine G, Pepin D, Cetron M, Penn M. State and 
Territorial Ebola Screening, Monitoring, and Movement Policy 
Statements -- United States, August 31, 2015. Morbidity and 
Mortality Weekly Report (MMWR). 2015;64(40):1145-6.
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    The groups at greatest risk to contract Ebola, MERS, and SARS in 
non-endemic countries have been health care workers and patients in 
hospital settings.\117\ This points to the importance of infection 
control processes at hospitals. However, the outcome from the first 
Ebola patient diagnosed with Ebola after arrival in the United States 
can be compared to the outcome of the second patient to demonstrate the 
utility of properly linking persons with potentially devastating 
communicable disease to treatment at a facility that has prepared to 
treat such patients. All of the other Ebola cases treated in the United 
States were diagnosed while the patients were in West Africa and are 
not included in this analysis.
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    \117\ Weber DJ, William A. Rutala, William A. Fischer, Hajime 
Kanamori, Sickbert-Bennett EE. Emerging infectious diseases: Focus 
on infection control issues for novel coronaviruses (Severe Acute 
Respiratory Syndrome-CoV and Middle East Respiratory Syndrome-CoV), 
hemorrhagic fever viruses (Lassa and Ebola), and highly pathogenic 
avian influenza viruses, A(H5N1) and A(H7N9) American Journal of 
Infection Control. 2016;44(5):e91-e100.
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    The first incident case of Ebola in the United States among a 
traveler exposed in West Africa was diagnosed in a foreign national at 
a hospital in Dallas, Texas. At the initial presentation, the hospital 
did not suspect Ebola and did not test the patient before releasing him 
back into the community. As the patient's health continued to 
deteriorate, he returned to the same hospital and was then diagnosed 
with Ebola. Fortunately, there was no transmission to others in the 
community during the time between the initial and follow-up visits. 
During treatment, two health care workers at the hospital contracted 
Ebola, one of which flew on an interstate flight to and from Cleveland, 
Ohio. This single case led to 516 contacts who underwent active 
monitoring by health departments in six states. Among the 516 contacts, 
147 were health care workers all of whom were exposed at the first 
hospital. All 147 health care workers had voluntary movement 
restrictions and 30 underwent voluntary home 
quarantine.118 119 In addition, there were 101 persons 
exposed in the community and who were actively monitored in Texas and 
Ohio of which 41 had restricted movement and 9 underwent home 
quarantine.120 121 122 Finally, there were 274 travelers 
exposed during interstate travel and actively monitored in 6 states. Of 
these, 20 travelers had movement restrictions.\123\ In Texas and Ohio, 
7 schools were closed for one day, and 2 students were asked not to go 
to school for 21 days after being on same flight as the infected health 
care worker.\124\
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    \118\ Chevalier MS, Chung W, Smith J, et al. Ebola virus disease 
cluster in the United States--Dallas County, Texas, 2014. MMWR Morb 
Mortal Wkly Rep 2014;63:1087-8.
    \119\ McCarty CL, Basler C, Karwowski M, et al. Response to 
importation of a case of Ebola virus disease--Ohio, October 2014. 
MMWR Morb Mortal Wkly Rep 2014;63:1089-91.
    \120\ Chevalier MS, Chung W, Smith J, et al. Ebola virus disease 
cluster in the United States--Dallas County, Texas, 2014. MMWR Morb 
Mortal Wkly Rep 2014;63:1087-8
    \121\ Chung WM, Smith JC, Weil LM, Hughes SM, Joyner SN, Hall 
EM, et al. Active Tracing and Monitoring of Contacts Associated With 
the First Cluster of Ebola in the United States. Ann Intern Med. 
2015;163:164-73.
    \122\ Chung WM, Smith JC, Weil LM, Hughes SM, Joyner SN, Hall 
EM, et al. Active Tracing and Monitoring of Contacts Associated With 
the First Cluster of Ebola in the United States. Ann Intern Med. 
2015;163:164-73.
    \123\ Regan JJ, Jungerman R, Montiel SH, et al. Public health 
response to commercial airline travel of a person with Ebola virus 
infection--United States, 2014. MMWR Morb Mortal Wkly Rep 
2015;64:63-6.
    \124\ Bever L. Chain reaction: concern about Ebola nurse's 
flight prompts school closings in two states. The Washington Post. 
October 16, 2014. https://www.washingtonpost.com/news/morning-mix/wp/2014/10/16/after-concern-about-ebola-patients-flight-schools-close-in-two-cities/.
---------------------------------------------------------------------------

    In contrast, the second incident case of Ebola among a traveler 
from West Africa in the United States occurred in New York City. 
However, the patient was a health care worker that volunteered in a 
treatment center in West Africa. Per CDC guidance, the patient had been 
self-monitoring his temperature and symptoms. The patient was quickly 
identified as at risk for Ebola and was transported to a hospital 
designated to be capable of accepting potential Ebola patients. This 
patient did not infect any healthcare workers and only 3 community 
contacts and zero health care workers had movement restrictions 
imposed.\125\ There were no school closures in New York.
---------------------------------------------------------------------------

    \125\ Yacisin K, Balter S, Fine A, et al. Ebola virus disease in 
a humanitarian aid worker--New York City, October 2014. MMWR Morb 
Mortal Wkly Rep 2015;64:321-3.
---------------------------------------------------------------------------

    A comparison of estimated costs incurred for the first versus 
second

[[Page 54290]]

incident cases of Ebola in the United States is presented in Tables 44 
and 45. The opportunity costs for health care workers placed under 
movement restrictions are estimated based on average health care worker 
salary reported in the 2015 Occupational and Employment Statistics 
Survey ($37.40 per hour, code 29-0000) assuming that each employee is 
unable to work for a period of 3 weeks (15 work days). The costs to 
public health departments are estimated based on the average salary of 
epidemiologists ($36.97 per hour, code 19-1041) assuming that 50 
epidemiologists spent a total of 30 days working on investigations for 
the three cases originating in Dallas. An overhead multiplier of 100% 
is used to estimate employee benefits and overhead costs.
    Persons placed under movement restrictions are usually not 
permitted to go to public areas such as grocery stores and pharmacies. 
In addition, homeless contacts may need to be provided with temporary 
housing to facilitate active monitoring.\126\ Some states posted police 
officers at specific addresses at an estimated cost of $1,000 per 
day.\127\ The estimated average cost for the services required to 
monitor and sustain persons with restricted movement is estimated to be 
$500 per person-day for 21 days. In addition, 7 one-day school closures 
were reported. HHS/CDC does not have any data on school sizes and 
assumes that the average school size is 300 students and that 
opportunity costs of a one-day school closure can be estimated based on 
a parent or guardian losing one half-day of work (4 hours) for every 
student. Parent and guardian opportunity costs are estimated using the 
average wage rate in the United States ($23.23 per hour).\128\ The cost 
to treat an Ebola patient has been reported to be about $650,000 \129\ 
at the Nebraska Medical Center and has been estimated to exceed $1 
million.\130\ HHS/CDC estimates the treatment cost to be the midpoint 
of these estimates $825,000 per case). It is not clear if this estimate 
includes the cost of waste disposal associated with Ebola treatment. 
The cost of waste disposal has been estimated to be as much as $100,000 
per Ebola patient-day.\131\ HHS/CDC assumes the cost of waste disposal 
is not included in the reported treatment costs and that waste disposal 
over a 10-20 period of treatment would add another $1 million to the 
cost of treatment. This results in an average cost of treatment and 
waste disposal of $1.825 million per patient.
---------------------------------------------------------------------------

    \126\ Smith CL, Hughes SM, Karwowski MP, Chevalier MS, Hall E, 
Joyner SN, et al. Addressing Needs of Contacts of Ebola Patients 
During an Investigation of an Ebola Cluster in the United States--
Dallas, Texas, 2014. Morbidity and Mortality Weekly Report (MMWR). 
2015;64(5).
    \127\ West, M.G. The high cost of quarantine The Wall Street 
Journal. October 29, 2014. http://www.wsj.com/articles/the-high-cost-of-quarantine-and-who-pays-for-it-1414546114. Accessed June 13, 
2016.
    \128\ http://www.bls.gov/oes/current/oes_nat.htm.
    \129\ Sun L.H. Cost to treat Ebola in the U.S.: $1.16 million 
for 2 patients. Washington Post November 18, 2014 https://www.washingtonpost.com/news/post-nation/wp/2014/11/18/cost-to-treat-ebola-in-the-u-s-1-16-million-for-2-patients/?utm_term=.283370dc6c47. Accessed 6/10/2016.
    \130\ Worstall T. The Free Market Won't Produce An Ebola Cure; 
So Should Government Instead? Forbes: August 8, 2014. http://www.forbes.com/sites/timworstall/2014/08/08/the-free-market-wont-produce-an-ebola-cure-so-should-government-instead/#f8f45d46cac5. 
Accessed June 13, 2016.
    \131\ LaMantia, J. Hospitals bleed money as they fight Ebola. 
Crain's New York Business. November 10, 2014. http://www.crainsnewyork.com/article/20141110/HEALTH_CARE/141119994/hospitals-bleed-money-as-they-fight-ebola. Accessed June 14, 2016.

                   Table 44--Costs Associated With First Incident Ebola Case in Texas and Ohio
----------------------------------------------------------------------------------------------------------------
                Category                            Number                 Cost                  Notes
----------------------------------------------------------------------------------------------------------------
Health care workers missing work........  147.......................        $659,736  Assume all persons with
                                                                                       travel restriction missed
                                                                                       time at work/productivity
                                                                                       (21 days).
Community...............................  41........................         114,292
Air travelers...........................  20........................          55,752
Restricted movement support costs.......  208.......................       2,184,000  Assume support costs for
                                                                                       movement restrictions or
                                                                                       home quarantine are 500
                                                                                       per person-day for 21
                                                                                       days.
Public health response..................  50 (assumed)..............         887,280  Assume 50 public health
                                                                                       workers worked full time
                                                                                       on response for 30 days.
School closure..........................  7.........................         195,132  7 schools for 1 day,
                                                                                       assume 300 students each
                                                                                       and one parent lost one
                                                                                       half day of productivity
                                                                                       per student.
Ebola treatment.........................  3.........................       5,475,000  Assume treatment cost =
                                                                                       1,825,000 per patient.
    Total...............................  ..........................       9,571,192
----------------------------------------------------------------------------------------------------------------



                     Table 45--Costs Associated With Second Incident Ebola Case in New York
----------------------------------------------------------------------------------------------------------------
                Category                            Number                 Cost                  Notes
----------------------------------------------------------------------------------------------------------------
Health care workers missing work........  0.........................              $0  Assume all persons with
                                                                                       travel restriction missed
                                                                                       time at work.
Community...............................  3.........................           8,363
Air travelers...........................  0.........................               0
Restricted movement support costs.......  3.........................          31,500  Assume support costs for
                                                                                       movement restrictions or
                                                                                       home quarantine are 500
                                                                                       per person-day for 21
                                                                                       days.
Public health response..................  5.........................          62,832  Assume 5 public health
                                                                                       workers worked full time
                                                                                       on response for 21 days.
School closure..........................  0.........................               0
Ebola treatment.........................  1.........................       1,825,000  Assume treatment cost =
                                                                                       1,825,000.

[[Page 54291]]

 
    Total...............................  ..........................       1,927,695
----------------------------------------------------------------------------------------------------------------

    The difference ($7.7 million) in total estimated costs associated 
with the first incident case in a traveler from West Africa ($9.6 
million) and the second incident case ($1.9 million) show the potential 
benefits associated with the Federal, state and local activities 
implemented to link patients to appropriate care to mitigate the 
transmission risk. HHS/CDC does not have any more data with which to 
estimate the costs associated with incident Ebola cases in the United 
States and solicits public comment to improve the above cost estimates.
    At the time the Ebola enhanced entry risk assessment and management 
program was put in place, HHS/CDC could not accurately estimate the 
expected number of travelers from West Africa that would become sick 
with Ebola after arrival in the United States. In retrospect, efforts 
to contain the transmission of Ebola from countries with widespread 
transmission were very effective at limiting risk. Among all 300,000 
travelers departing countries with widespread transmission via 
commercial airlines, only four Ebola cases were reported, none of which 
were symptomatic during travel. Although less than 20% of such 
travelers were destined for the United States, two of the four cases 
occurred in the United States.

Public Willingness To Pay for Ebola Prevention Measures

    HHS/CDC was unable to conduct a willingness to pay survey to assess 
the U.S. public's willingness to expend Federal resources to minimize 
Ebola risks. However, survey evidence suggests that the public would 
probably be willing to pay some amount to reduce risk from Ebola to as 
close to zero as possible. Soon after Ebola was transmitted to two 
health care workers in the U.S., a poll showed that Americas felt Ebola 
was an urgent health problem for the entire country. Among a list of 
health care issues facing the country, only health care costs and 
access to care ranked higher than Ebola in the public's mind. In 
comparison, both heart disease and cancer were ranked below Ebola 
despite a significantly greater probability that any individual would 
suffer from these conditions than contract Ebola.\132\
---------------------------------------------------------------------------

    \132\ SteelFisher GK, Blendon RJ, Lasala-Blanco N. Ebola in the 
United States--Public Reactions and Implications. N Eng J Med. 
2015;373:789-91.
---------------------------------------------------------------------------

    Public opinion related to disease outbreaks can influence policy 
leader attitudes related to the response of the outbreak--potentially 
redirecting the focus of activities and public funding to areas of 
limited public benefit. In a review of over 175 public opinion polls in 
2014, researchers highlighted several reasons for this public 
perception.
    Survey respondents did not understand or trust information provided 
regarding the mode of transmission and therefore they felt particularly 
vulnerable. About 45% were either somewhat worried or very worried that 
they or someone in their family could become sick with Ebola. The media 
also played a role in increasing the public's concern--three major news 
networks aired approximately 1000 Ebola-related segments between mid-
October to early November, 2014. According to the survey, public trust 
in scientists and government was at an all-time low.\133\
---------------------------------------------------------------------------

    \133\ SteelFisher GK, Blendon RJ, Lasala-Blanco N. Ebola in the 
United States -- Public Reactions and Implications. N Eng J Med. 
2015;373:789-91.
---------------------------------------------------------------------------

    Considering that the U.S. population as a whole (319 million), an 
average willingness to pay per person of $17 would be sufficient to 
justify the entire $5.4 billion Federal Ebola response. This amount 
would cover the costs of Federal government activities to reduce Ebola 
transmission in affected countries, to support exit screening at 
international airports, research programs for Ebola vaccines and 
medicines, to implement domestic programs to identify and prepare U.S. 
hospitals and laboratories for Ebola testing and treatment, to 
implement the Ebola enhanced entry risk assessment and management 
program at U.S. airports, and to provide Federal support for active 
monitoring activities in U.S. states. The $5.4 billion budget 
allocation included $1.147 billion for domestic Ebola response 
activities (other than research and development) including the $96 
million for the Ebola enhanced entry risk assessment and management 
program. Thus, if international, research, and development activities 
are excluded, U.S. public willingness to pay would have to be greater 
than $3.65 per person for all domestic activities or $0.34 for just the 
enhanced entry risk assessment and management program. HHS/CDC would 
like to solicit public comment on willingness to pay to reduce Ebola 
risk in the United States to near zero if another outbreak of Ebola 
occurs in the future.

Potential for Disease Transmission in the United States

    HHS/CDC believes that the risk of significant transmission of Ebola 
in the United States is low and that Federal, state, and local public 
health interventions reduced such risks to almost effectively zero. 
However, as discussed above, outbreaks of new diseases can lead to 
significant costs if disease-related anxiety leads to reduced 
productivity. Thanks in part to vigorous Federal responses to 
communicable disease threats, the United States has never experienced a 
time-limited introduction of a new communicable disease with 
significant transmission. This analysis would not apply to a 
communicable disease threat like the novel H1N1 influenza pandemic that 
would infect a significant number of U.S. citizen regardless of HHS/CDC 
efforts. However, other relatively high income countries have had to 
deal with very costly outbreaks of SARS and MERS.
    The 2003 SARS outbreak was initiated in Guandong, China in late 
2002 and led to the exportation of cases to multiple countries, 
including Australia, Canada, Hong Kong, Singapore and the United 
States. Significant transmission occurred in Hong Kong, Canada, and 
Singapore. The introduction of SARS led to reductions in the number of 
people traveling to these countries. Survey respondents indicated that 
they were less likely to engage in activities such as eating at 
restaurants or going to shopping malls. Forecasted Gross Domestic 
Product (GDP) in 2003 decreased by 3.7 billion US dollars in Hong Kong, 
3.2-6.4 billion US dollars in Canada, and 4.9 billion US dollars in 
Singapore due to the SARS outbreak.\134\ In Canada and Singapore, GDP 
growth was estimated to decrease by 1% for the year 2003. In the second

[[Page 54292]]

quarter of 2003, GDP growth in China and Hong Kong was estimated to 
have decreased by 3% and 4.75%, respectively.\135\ The estimated losses 
to the tourism industry alone in Beijing, China was around 1.4 billion 
US dollars.\136\
---------------------------------------------------------------------------

    \134\ Keogh-Brown M.R. and Smith R.D., The economic impact of 
SARS: How does the reality match the predictions? Health Policy. 
2008; 88: 110-120.
    \135\ Keogh-Brown M.R. and Smith R.D., The economic impact of 
SARS: How does the reality match the predictions? Health Policy. 
2008; 88: 110-120.
    \136\ Beutels P., Jia N, Zhou Q., et al., The economic impact of 
SARS in Beijing, China. Tropical Medicine and International Health, 
2009, 12 Suppl 1: 85-91.
---------------------------------------------------------------------------

    The MERS outbreak in South Korea started with a case in an 
international traveler returning from the Middle East at the end of May 
2015 and ended with the official announcement of the World Health 
Organization in December 2015. A total of 186 laboratory-confirmed 
infections, including 38 deaths, was reported, and more than 16,000 
people kept in-house quarantine.\137\ This outbreak represents an 
infectious disease outbreak associated with international travel in a 
high income country. Since this outbreak recently occurred in 2015, it 
may provide a useful extrapolation of what might happen if HHS/CDC does 
not act swiftly to contain a quarantinable communicable disease threat.
---------------------------------------------------------------------------

    \137\ Korea Centers for Disease Control and Prevention. Middle 
East Respiratory Syndrome Coronavirus Outbreak in the Republic of 
Korea, 2015. Osong Public Health Research Perspective. 
2015;6(4):269-78.
---------------------------------------------------------------------------

    HHS/CDC assumes an outbreak similar in magnitude to the Korean MERS 
outbreak is more likely to happen in the United States if HHS/CDC were 
to stop enforcing its quarantine and isolation authorities, stop 
conducting contact investigations among travelers exposed to 
quarantinable communicable diseases, and if it were unable to implement 
enhanced entry risk assessment and management programs if warranted by 
a quarantinable communicable disease outbreak in another country. HHS/
CDC cannot quantify the change in risk to the United States that would 
result, but believes the Korean MERS outbreak is a useful example of 
the unpredictable course of quarantinable communicable disease 
outbreaks in the United States.
    HHS/CDC estimates that all patients would be hospitalized resulting 
in treatment costs of around $2.9 million inpatient based on 186 
laboratory-confirmed infections and ten days of hospitalization per 
case. HHS/CDC assumes that the inpatient cost is $1,542 per day based 
on the costs of treating multidrug resistant tuberculosis in the United 
States (Table 46).\138\
---------------------------------------------------------------------------

    \138\ Marks S.M., Flood J., Seaworth, B., et al. Treatment 
practices, outcomes, and costs of multidrug-resistant and 
extensively drug-resistant tuberculosis, United States, 2005-2007. 
Emerging Infectious Disease. 2014; 20(5):812-820.

                        Table 46--Cost of Hospitalization MERS Outbreak Example, 2015 USD
----------------------------------------------------------------------------------------------------------------
                                                                           Median  duration
           Number of people who are infected             Daily inpatient          of                Cost of
                                                              costs         hospitalization     hospitalization
(A) \a\                                                         (B) \b\                   (C) \a\     (A x B x C)
----------------------------------------------------------------------------------------------------------------
186....................................................          $1,542                  10          $2,868,843
----------------------------------------------------------------------------------------------------------------
\a\ Korea Centers for Disease Control and Prevention. Middle East Respiratory Syndrome Coronavirus Outbreak in
  the Republic of Korea, 2015. Osong Public Health Research Perspective. 2015;6(4):269-78.
\b\ Marks S.M., Flood J., Seaworth, B., et al. Treatment practices, outcomes, and costs of multidrug-resistant
  and extensively drug-resistant tuberculosis, United States, 2005-2007. Emerging Infectious Disease. 2014;
  20(5):812-820.

    The costs associated with excess mortality of the outbreak are 
estimated at $357.2 million based on the 38 reported MERS-associated 
deaths reported and a $9.4 million estimate for the value of a value of 
statistical life. Using a range of $4.3 million to $14.2 million for 
the value of statistical life, the cost of MERS-associated deaths can 
be estimated at $163--$540 million (Table 47).

                            Table 47--Mortality Cost, MERS Outbreak Example, 2015 USD
----------------------------------------------------------------------------------------------------------------
                                     Best estimate        Lower bound         Upper bound         References
----------------------------------------------------------------------------------------------------------------
Number of deaths (A)............  38................  38................  38................  Korea CDC 2015.\a\
Value of statistical life (B)...  $9.4 million......  $4.3 million......  $14.20 million....  Value of
                                                                                               statistical life.
Mortality cost (A x B)..........  $357.2 million....  $163.4 million....  $539.6 million....  N/A.
----------------------------------------------------------------------------------------------------------------
\a\ Korea Centers for Disease Control and Prevention. Middle East Respiratory Syndrome Coronavirus Outbreak in
  the Republic of Korea, 2015. Osong Public Health Research Perspective. 2015;6(4):269-78.

    To arrest the progress of the Korean MERS outbreak as quickly as 
possible, at least 16,000 people underwent in-house quarantine in South 
Korea.\139\ HHS/CDC assumes that state and local public health 
departments may implement similar measures if faced with a large 
outbreak of a newly-introduced quarantinable communicable disease in 
the United States. The South Korean government recommended 14 days of 
in-house quarantine based on the incubation period of MERS coronavirus 
and HHS/CDC assumes that state and local health departments in the 
United States would implement similar measures. The average wage 
reported in the Bureau of Labor Statistics, May 2015 Occupational 
Employment Statistics is $23.23 per hour.\140\ Assuming the 
productivity losses associated with in-home quarantine can be estimated 
based on the average hourly wage, HHS/CDC estimates the productivity 
losses at $41.6 million (Table 48).
---------------------------------------------------------------------------

    \139\ Korea Centers for Disease Control and Prevention. Middle 
East Respiratory Syndrome Coronavirus Outbreak in the Republic of 
Korea, 2015. Osong Public Health Research Perspective. 
2015;6(4):269-78.
    \140\ Bureau of Labor Statistics (http://www.bls.gov/oes/current/oes_nat.htm.

[[Page 54293]]



                 Table 48--Cost of Quarantine, 2015 USD
------------------------------------------------------------------------
            Description                    N              Reference
------------------------------------------------------------------------
Number of people who undergo house          16,000  Korea CDC 2015.\a\
 quarantine (A).
Number of days undergo house                    14  Korea CDC 2015.\a\
 quarantine per person (B).
Working hours per day (C).........               8  Assumption.
Hourly labor cost (D).............          $23.23  Bureau of Labor
                                                     Statistics.\b\
Cost of quarantine (A x B x C x D)     $41,628,320  N/A.
------------------------------------------------------------------------
\a\ Korea Centers for Disease Control and Prevention. Middle East
  Respiratory Syndrome Coronavirus Outbreak in the Republic of Korea,
  2015. Osong Public Health Research Perspective. 2015;6(4):269-78.
\b\ Bureau of Labor Statistics (http://www.bls.gov/oes/current/oes_nat.htm.)

    As of June 10th 2015, a reported 918,000 students, under 19 years 
of age, were affected by school closure due to the MERS outbreak in 
South Korea.\141\ HHS/CDC cannot predict whether an outbreak with a 
magnitude similar to the MERS outbreak in South Korea would lead to 
significant school closures in the United States, but notes that school 
closures occurred in the United States after the initial Ebola cases in 
the United States were diagnosed.
---------------------------------------------------------------------------

    \141\ Cho K.Y., Yoo J.S. Forecasting Economic loss associated 
with MERS outbreak in South Korea, 2015. KERI Insight. 15-20.
---------------------------------------------------------------------------

    During the 2009 H1N1 pandemic in the United States, HHS/CDC 
initially recommended dismissal of students for at least seven days 
\142\ after the diagnosis of an H1N1 case in a student. Later, HHS/CDC 
revised the recommendation and school closing was no longer 
recommended.\143\ For the H1N1 outbreak, around 17% of households 
reported lost work time because of school closure in New York 
City.\144\ In the absence of better data, HHS/CDC assumes schools would 
be closed for an average of seven days and that each closed school day 
results in 0.17 missed workdays for a parent. HHS/CDC estimates the 
productivity loss of parents due to school closure at $203 million 
(Table 49).
---------------------------------------------------------------------------

    \142\ Cauchemez S., Van Kerkhove M.D., Archer B.N. et al. School 
closures during the 2009 influenza pandemic: national and local 
experiences. BMC Infectious Disease. 2014; 14: 207.
    \143\ Cauchemez S., Van Kerkhove M.D., Archer B.N. et al. School 
closures during the 2009 influenza pandemic: national and local 
experiences. BMC Infectious Disease. 2014; 14: 207.
    \144\ Borse H.R., Behravesh C.B., Dumanovsky T. et al., Closing 
schools in response to the 2009 pandemic influenza A H1N1 virus in 
New York City: Economic impact on households. Clinical Infectious 
Disease: 2011; 52 (Supple 1) S168-S172.

               Table 49--Cost of School Closure, 2015 USD
------------------------------------------------------------------------
            Description                    N              Reference
------------------------------------------------------------------------
Number of students under 18 years          918,000  KERI Insight
 old who were affected by school                     2015.\a\
 closure (A).
School closure days (B)...........               7  Assumption.
Number of loss days of parents per            0.17  Borse et al.
 children (C).                                       2011.\b\
Working hours per day (D).........               8  Assumption.
Hourly labor cost (E).............          $23.23  Bureau of Labor
                                                     Statistics.\c\
Cost of quarantine (A x B x C x D     $203,015,033  N/A.
 x E).
------------------------------------------------------------------------
\a\ Cho K.Y., Yoo J.S. Forecasting Economic loss associated with MERS
  outbreak in South Korea, 2015. KERI Insight. 15-20.
\b\ Borse H.R., Behravesh C.B., Dumanovsky T. et al., Closing schools in
  response to the 2009 pandemic influenza A H1N1 virus in New York City:
  Economic impact on households. Clinical Infectious Disease: 2011; 52
  (Supple 1) S168-S172.
\c\ Bureau of Labor Statistics (http://www.bls.gov/oes/current/oes_nat.htm).

    In addition to the measurable impacts directly tied to the MERS 
outbreak. South Korea experience a significant decrease in the number 
of foreign travelers. The outbreak started in May 2015, but the biggest 
impacts were observed from June to August when the number of travelers 
decreased by 26.5% to 53.5% relative to 2014 (Table 50).\145\ As the 
outbreak subsided, the number of travelers returned to previous trends. 
By September 2015, South Korea only received 10% fewer travelers 
compared to September 2014. HHS/CDC examined travel data to Dallas in 
October 2014 (corresponding to the time period in which three Ebola 
cases were reported), but found no significant difference relative to 
October 2013. This indicates that the Ebola cases in the United States 
were not as disruptive as the MERS outbreak cases in South Korea.
---------------------------------------------------------------------------

    \145\ Trends of foreign travelers, South Korean international 
travelers, tourism income, and tourism expenditure in December 2015, 
Korea Tourism Organization.
    \146\ Trends of foreign travelers, South Korean international 
travelers, tourism income, and tourism expenditure in December 2015, 
Korea Tourism Organization.

 Table 50--Number of Foreign Travelers Who Visited South Korea During the MERS Outbreak (2014 Versus 2015, 1,000
                                                Travelers) \146\
----------------------------------------------------------------------------------------------------------------
                                                                       2014            2015         Change  (%)
----------------------------------------------------------------------------------------------------------------
June............................................................           1,274             751           -41.0
July............................................................           1,355             630           -53.5
August..........................................................           1,454           1,069           -26.5
----------------------------------------------------------------------------------------------------------------


[[Page 54294]]

    Given all of the above information, South Korean economic modelers 
attempted to estimate the impact of the MERS outbreak on South Korean 
GDP in 2015 and estimated that the MERS outbreak alone reduced GDP by 
0.26%.\147\ If a similar size outbreak occurs in the United States and 
results in a 0.26% loss to GDP, the economic cost could be extrapolated 
to be 0.0026 x $17.95 trillion \148\ = $41.3 billion.
---------------------------------------------------------------------------

    \147\ Cho, K., Yoo, J., Forecasted economic losses due to MERS 
outbreak in South Korea, KERI Insight.
    \148\ U.S. Central Intelligence Agency. The World Factbook. 
United States Economy. https://www.cia.gov/library/publications/the-world-factbook/geos/us.html. Accessed June 13, 2016.
---------------------------------------------------------------------------

Summary Ebola Enhanced Entry Risk Assessment and Management Program

    The above summary demonstrates the types of analyses that HHS/CDC 
would undergo when deciding to implement enhanced entry risk assessment 
and management programs in the future. HHS/CDC will weigh the costs of 
such programs, the public willingness to accept risks associated with 
incident cases of quarantinable communicable diseases, the ability of 
enhanced entry risk assessment and management programs to reduce such 
risks, and the economic costs of a significant outbreak of a newly-
introduced quarantinable communicable disease in the United States. 
HHS/CDC cannot easily assess how the U.S. public will respond to 
communicable disease threats and how anxiety associated with 
communicable disease threats may impact the broader economy.
    At the time the Ebola risk assessment program was implemented, HHS/
CDC had already been supporting the implementation of exit screening in 
countries with widespread Ebola transmission for two months. HHS/CDC 
began support efforts after an ill traveler flew on a commercial flight 
and introduced Ebola to Nigeria in July 2014. The exit screening 
efforts in countries with widespread transmission may have resulted in 
a significant reduction in the number of exported Ebola cases. Only 
four cases of Ebola (among approximately 300,000 travelers from August 
2014) were exported by countries with widespread transmission after the 
implementation of exit screening and none of these Ebola patients were 
symptomatic during commercial travel. This can be compared to estimates 
of 2.8 infected travelers departing Liberia, Sierra Leone, and Guinea 
each month in the absence of an exit screening program.\149\
---------------------------------------------------------------------------

    \149\ Bogoch II, Creatore MI, Cetron MS, Brownstein JS, Pesik N, 
Miniota J, et al. Assessment of the potential for international 
dissemination of Ebola virus via commercial air travel during the 
2014 west African outbreak. Lancet. 2015;385:29-35.
---------------------------------------------------------------------------

    The willingness and ability of affected countries to implement 
effective exit screening will also be considered by HHS/CDC when 
deciding whether to implement an enhanced entry risk assessment and 
management program in the future. It will always be a challenge to 
weigh the costs of public health interventions to the benefits of 
avoiding a large outbreak of a newly-introduced quarantinable 
communicable disease. However, HHS/CDC intends to use available 
evidence such as that summarized above when making decisions.

More Restrictive Alternative: Suspension of Entry during Period West 
Africa Ebola Outbreak

    The more restrictive alternative relative to the NPRM would be for 
the United States to temporarily suspend the entry of travelers into 
the United States in the event of widespread transmission of 
quarantinable communicable diseases. A number of U.S. politicians 
advocated for this response to the 2014-16 Ebola outbreak in Liberia, 
Sierra Leone, and Guinea.\150\ Some states actively discouraged persons 
from visiting their states including one example in which prospective 
participants at a large tropical medicine scientific conference were 
advised not to travel to a particular state to attend the conference if 
they had been in one of the countries with widespread transmission 
within the previous 21 days.\151\ The costs and benefits of this 
alternative are difficult to weigh. Presumably, the costs incurred to 
implement the Ebola Enhanced entry risk assessment and management 
program would not have been incurred representing a potential savings 
(avoided costs) of about $109 million (Table 46). In addition, state 
and local health departments would not have incurred costs associated 
with active monitoring of individuals arriving from Ebola-affected 
countries for a period of 21 days. HHS/CDC does not have any data to 
estimate these costs, but the costs were probably at least twice the 
costs for HHS/CDC to implement the Ebola Enhanced entry risk assessment 
and management program. The costs of state-level active monitoring are 
estimated as a range from 2 to 4 times the cost of the Ebola enhanced 
entry risk assessment and management program. The benefits ($327 to 
$545 million) for the more restrictive alternative are summarized in 
Table 51.
---------------------------------------------------------------------------

    \150\ McAuliff M. Lawmakers ignore experts, push for Ebola 
travel ban. The Huffington Post. October 16, 2014. http://www.huffingtonpost.com/2014/10/16/congress-ebola_n_5997214.html.
    \151\ Olliaro P, Lasry E, Tiffany A. Out of (West) Africa--Who 
Lost in the End? Am J Trop Med Hyg 2015 Feb 4; 92(2): 242-243. 
2015;92(2):242-3.

                               Table 51--Benefits of More Restrictive Alternative
                                              [Suspension of entry]
----------------------------------------------------------------------------------------------------------------
                                                                 Best estimate    Lower bound     Upper bound
---------------------------------------------------------------------------------------------------------------
Ebola Enhanced entry risk assessment and management program...    $109,003,711    $109,003,711    $109,003,711
Avoided cost of state-level active monitoring.................     327,011,133     218,007,422     436,014,844
                                                               -------------------------------------------------
    Total benefits............................................     436,014,844     327,011,133     545,018,555
----------------------------------------------------------------------------------------------------------------

Effect on Ebola Risk in the United States

    HHS/CDC cannot fully quantify the impact of a travel suspension on 
the risk of incident Ebola cases in the United States. Modeling studies 
suggest that travel restrictions would likely have only delayed, but 
not prevented the spread of Ebola to new countries.\152\
---------------------------------------------------------------------------

    \152\ Poletto C, Gomes M, Pastore y Piontti A, Rossi L, Bioglio 
L, Chao D, et al. Assessing the impact of travel restrictions on 
international spread of the 2014 West African Ebola epidemic. Euro 
Surveill. 2014;19(42):pii: 20936.
---------------------------------------------------------------------------

    The implementation of travel suspensions would have delayed efforts 
to stop the outbreak in West Africa by requiring all U.S. volunteers as 
well as Federal employees to spend 21 days in a designated safe 
facility or other location outside the United States after working in 
countries with widespread Ebola transmission. This would surely have 
dis-incentivized participation in the response. In addition, HHS/CDC 
cannot predict whether other countries

[[Page 54295]]

would have followed the U.S. lead in suspending travel. However, HHS/
CDC believes that travel suspensions would have delayed outbreak 
response efforts and may have been more likely to lead to additional 
spread of Ebola especially to neighboring countries in Africa.
    Under this alternative, traveler opportunity costs would be much 
greater because any travelers to countries with widespread Ebola 
transmission would no longer be allowed to enter the United States for 
a period of 21 days. If there is no decline in travelers, each traveler 
loses approximately 21 days of productivity as a result of the 
suspension, traveler opportunity costs can be estimated by 38,334 
travelers x 8 hours per day x 21 days x $23.23 (average U.S. wage rate) 
= $150 million. These costs alone could more than offset the cost of 
Ebola Enhanced entry risk assessment and management program. The cost 
for those travelers to spend an additional 21 days at a secure location 
would probably be similar to the opportunity cost estimate from above 
or more depending of operating a designated safe facility or the cost 
of staying at another location outside the United States.
    However, this simplistic analysis probably does not accurately 
reflect the implications of a travel suspension. Suspension of entry 
would probably significantly reduce the number of U.S. volunteers 
willing to travel to West Africa to mitigate the Ebola outbreak closer 
to its sources. This would delay the progress made in suppressing the 
outbreak and increase risk of exportation to other countries. HHS/CDC 
cannot predict how other countries may have responded to the U.S. 
decision to suspend entry. If other countries implemented similar 
restrictions, there may have been a chain of reaction leading to a 
significant decrease in the number of global volunteers to the most 
affected countries. In this scenario, the 2014-16 Ebola outbreak in 
West Africa would have almost certainly persisted for a much longer 
period of time. HHS/CDC cannot estimate the long term impact for the 
affected countries, the West African region, or the costs to the U.S. 
government or its people.
    While HHS/CDC is not able to estimate a dollar value of diminished 
trade in general, the estimated trade volumes prior to the outbreak are 
available and summarized in Table 52. The total annual value of trade 
for the three Ebola-affected countries in West Africa is $574 million 
and ranges from $125 million with Sierra Leone to $270 million with 
Liberia.\153\
---------------------------------------------------------------------------

    \153\ https://ustr.gov/countries-regions/africa/west-africa/liberia; https://ustr.gov/countries-regions/africa/west-africa/guinea; https://ustr.gov/countries-regions/africa/west-africa/sierra-leone Accessed June 13, 2016.

                                     Table 52--Summary of U.S. Trade With Guinea, Liberia, Sierra Leone, and China a
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Value U.S.                               Value of U.S.                             Total value
               Country                     Trading       exports to      Description of  U.S.      imports to      Description of  U.S.      imports +
                                        partner  rank      country              exports              country             Imports              exports
--------------------------------------------------------------------------------------------------------------------------------------------------------
Guinea...............................             153            $80M  Vehicles, machinery.....            $99M  Metals and precious               $179M
                                                                                                                  stones.
Liberia..............................             142            173M  Machinery, iron/steel,               97M  Rubber, salt/sulfur,               270M
                                                                        vehicles.                                 precious stones.
Sierra Leone.........................             162             83M  Machinery, vehicles,                 42M  Ores, metals, precious             125M
                                                                        meat.                                     stones.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Data extracted from the U.S. Office of the Trade Representative \154\

     
---------------------------------------------------------------------------

    \154\ https://ustr.gov/countries-regions/africa/west-africa/liberia; https://ustr.gov/countries-regions/africa/west-africa/guinea; https://ustr.gov/countries-regions/africa/west-africa/sierra-leone Accessed June 13, 2016.
---------------------------------------------------------------------------

    It is likely that U.S. economic losses would be much less than the 
numbers reported in Table 53 because U.S.-based importers and exporters 
would still be able to import or export some goods or services while 
the temporary travel delay remains in place. There may also be some 
substitution of countries by U.S. firms, for example if a particular 
good is made or grown in more than one country, U.S. firms might shift 
their purchasing away from one trade partner to the other. However, 
once purchasing is shifted there may be future difficulties once the 
suspension of entry is lifted if there are negative political 
consequences.
    In the absence of data HHS/CDC assumes that the cost of lost trade 
for a one-year period can be estimated by a range of 0.1%, 1%, or 10% 
of lost trade (minimal to maximum, Table 53). Generally, the losses in 
the three countries with widespread Ebola transmission are estimated to 
range from about $0.55 million to $55 million.

                            Table 53--Hypothetical Trade Losses Due to a Travel Delay
----------------------------------------------------------------------------------------------------------------
                                                                   Assumed financial losses to U.S. stakeholders
                                                    Total value                 as % of total trade
                     Country                         imports +   -----------------------------------------------
                                                      exports           10%             1%             0.10%
----------------------------------------------------------------------------------------------------------------
Guinea..........................................           $179M          $17.9M          $1.79M         $0.179M
Liberia.........................................            270M           27.0M           2.70M          0.270M
Sierra Leone....................................            125M           12.5M           1.25M          0.125M
    Subtotal....................................            574M           57.4M           5.74M          0.547M
----------------------------------------------------------------------------------------------------------------



[[Page 54296]]



                Table 54--Quantified costs of More Restrictive Alternative (Suspension of Entry)
----------------------------------------------------------------------------------------------------------------
                                                                   Best estimate    Lower bound     Upper bound
----------------------------------------------------------------------------------------------------------------
Opportunity costs to travelers..................................    $149,643,000             \a\    $149,643,000
                                                                                     $74,821,500
Lodging costs for 21 days outside the United States or at a          149,643,000      74,821,500     149,643,000
 designated safe facility \b\...................................
Trade costs.....................................................       5,470,000         547,000      55,470,000
                                                                 -----------------------------------------------
    Total quantified costs......................................     304,756,000     150,190,000     354,756,000
----------------------------------------------------------------------------------------------------------------
\a\ This lower bound assumes that half of the travelers decided not to go to West Africa.
\b\ The estimated lodging costs are assumed to be similar in magnitude to the opportunity costs.

    Comparing the costs in Table 51 and benefits in Table 54, the most 
easily quantified benefits may be greater than the most easily 
quantified costs. However, given the potential other costs associated 
with prolonging the length of the Ebola outbreak in West Africa, the 
potential for other countries to implement travel restrictions after 
the United States, and the potential that delayed cessation of the 
Ebola outbreak could have led to serious political and economic 
outcomes in West Africa, HHS/CDC believes that the suspension of entry 
would have been a poor alternative to the implementation of the Ebola 
Enhanced entry risk assessment and management program to reduce the 
risk of Ebola transmission in the United States. Suspension of entry 
could enhance the United States future vulnerability to communicable 
disease threats if other countries would have observed this suspension 
of entry and tried to conceal communicable disease outbreaks within 
their borders. This potentially reduced ability to address future 
communicable disease threats in combination with the realization that 
only two Ebola cases associated with international commercial travel 
occurred in the United States under the status quo, HHS/CDC believes 
that implementation of travel suspensions will lead to more costs than 
benefits relative to the status quo. However, HHS/CDC cannot quantify 
all of the costs and benefits of travel suspensions. HHS/CDC solicits 
public comment about the costs and benefits of a suspending entry as an 
alternative to HHS/CDC's decision to implement the Ebola Entry Risk 
Assessment program.

Payment for Care and Treatment (Proposed 42 CFR 70.13/71.30)

    The revisions to 42 CFR 70.13/71.30: Payment for Care and Treatment 
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 
for individuals under Federal orders.
    The provisions included in the NPRM 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.
    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:
     In one case, HHS/CDC paid $7,000 for a patient's care 
after splitting the cost with a local health department.
     In a second case, HHS/CDC paid over $200,000 of the 
treatment costs.
     In a third case, HHS/CDC paid healthcare facilities 
directly for treatment and transport of an individual who had been 
paroled into the United States. In this situation, HHS/CDC paid 
approximately $80,000 for this patient's transport and treatment.
    HHS/CDC could not confirm whether it paid for treatment for any of 
the 9 other individuals under Federal orders in the previous 11.3 
years. It is possible that HHS/CDC did help pay for treatment for some 
of these individuals. 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).\155\ 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).
---------------------------------------------------------------------------

    \155\ Marks SM, Flood J, Seaworth B, Hirsch-Moverman Y, 
Armstrong L, Mase S, et al. Treatment Practices, Outcomes, and Costs 
of Multidrug-Resistant and Extensively Drug-Resistant Tuberculosis, 
United States, 2005-2007. Emerging Infectious Diseases. 
2014;20(5):812-20.
---------------------------------------------------------------------------

    To estimate the average annual payments for care and treatment by 
HHS/CDC, the average payment for the three cases with known payment 
information can be assumed to be incurred annually (corresponding to 
the average number of isolation orders that HHS/CDC issues each year). 
In this case, the average annual cost to the Federal government would 
be ($7,000 + $80,000 + $200,000)/3 years = ~$96,000 per year. If 
instead HHS/CDC assumes zero payments by CDC for the other nine cases 
for which it is unclear whether or not CDC paid any amount, the average 
annual cost would be ($7,000 + $80,000 + $200,000)/12 years = ~$24,000 
per year. HHS/CDC can estimate with some certainty that the current 
annual average costs to the Federal government are probably somewhere 
in the range of $24,000 to $100,000 and not likely to exceed $1,000,000 
in any one year.
    HHS/CDC has not incurred any costs for the care and treatment of 
any individuals besides for those under Federal isolation orders.
    When HHS/CDC assumes responsibility to pay for treatment as the 
payer of last resort, another entity, typically a healthcare facility 
or state/local health department, would incur a benefit exactly equal 
to the amount of the HHS/CDC payment. This is referred to as a transfer 
payment, because from the perspective of the U.S. economy, there is 
zero net cost or benefit, simply

[[Page 54297]]

a transfer from the Federal government to another entity.
    The codification of 42 CFR 70.13 and 42 CFR 71.30 is not expected 
to change HHS/CDC's policy to continue to act as the payer of last 
resort. However, it may be possible that in the absence of 
codification, a precedent-setting event may occur in which HHS/CDC must 
take on additional responsibility to pay for the care and treatment of 
individuals under Federal orders. HHS/CDC's best estimate (and lower 
bound) of the impact of the changes to 42 CFR 70.13 and 42 CFR 71.30 is 
zero net cost or benefit to HHS/CDC or to healthcare facilities. The 
upper bound estimate corresponds to a 50% increase in HHS/CDC's average 
cost estimate for payments for care and treatment (50% x $96,000 = 
$48,000). In this case, without the NPRM, HHS/CDC could incur 
additional costs of up to $48,000 per year. If HHS/CDC is incurring 
additional costs, healthcare facilities would receive a corresponding 
benefit in receiving payments from HHS/CDC. Thus, without the NPRM, 
healthcare facilities may receive up to an average $48,000 in 
additional payments from HHS/CDC for the care and treatment of 
individuals under Federal orders. Thus, with the NPRM, an upper bound 
estimate of benefits to HHS/CDC would be $48,000 from the 
implementation of the NPRM. The corresponding upper bound estimate of 
costs to healthcare facilities associated with implementation of the 
NPRM would be $48,000. An extreme upper bound economic impact of the 
NPRM for any one year would be a benefit to HHS/CDC of avoided payments 
equal to $500,000 and a corresponding cost to healthcare facilities of 
$500,000 representing losses associated with treatment costs incurred 
for one additional XDR-TB case \156\ (Table 55). XDR-TB is very 
expensive to treat, because it can take up to two years to resolve. 
This amount would be similar to the cost to treat one Ebola case. The 
cost to treat an Ebola patient has been reported to be about $650,000 
\157\ at the Nebraska Medical Center and has been estimated to exceed 
$1 million \158\ if the cost of Ebola waste disposal is not included. 
However, because of the severity of Ebola, it is unlikely than an Ebola 
patient would have to be placed under a Federal order to seek 
treatment. MERS or SARS are examples of other diseases for which it is 
possible that patients may be placed under Federal orders; however, the 
costs of treating these diseases are expected to be considerably less 
than for XDR-TB or Ebola.
---------------------------------------------------------------------------

    \156\ Marks S.M., Flood J., Seaworth, B., et al. Treatment 
practices, outcomes, and costs of multidrug-resistant and 
extensively drug-resistant tuberculosis, United States, 2005-2007. 
Emerging Infectious Disease. 2014; 20(5):812-820.
    \157\ Sun L.H. Cost to treat Ebola in the U.S.: $1.16 million 
for 2 patients. Washington Post November 18, 2014.
    \158\ Worstall T. The Free Market Won't Produce An Ebola Cure; 
So Should Government Instead? Forbes: August 8, 2014. http://www.forbes.com/sites/timworstall/2014/08/08/the-free-market-wont-produce-an-ebola-cure-so-should-government-instead/#f8f45d46cac5 
Accessed June 13, 2016.
---------------------------------------------------------------------------

    HHS/CDC specifically solicits public comment on cost estimates 
associated with changes to 42 CFR 70.13/71.30: Payment for care and 
treatment.

 Table 55--Estimated Marginal Costs and Benefits Associated With Changes to 42 CFR 70.13/71.30: Payment for Care
                                                  and Treatment
----------------------------------------------------------------------------------------------------------------
                                                                                   Marginal cost
                                                                     Marginal         to U.S.
                                                                    benefit to    individuals or
                                                                      HHS/CDC        healthcare      Net cost/
                                                                     resulting      facilities        benefit
                                                                     from NPRM       resulting
                                                                                     from NPRM
----------------------------------------------------------------------------------------------------------------
NPRM..................................  Best estimate...........              $0              $0              $0
                                        Lower bound.............               0               0               0
                                        Upper bound.............          48,000          48,000               0
                                        Extreme upper bound.....         500,000         500,000               0
Less Restrictive Alternative (Cost      Best estimate...........     (1,885,000)       1,885,000               0
 estimate to pay for all Travelers      Lower bound.............       (471,250)         471,250               0
 sent to hospitals for evaluation       Upper bound.............     (9,425,000)       9,425,000               0
 during a potential enhanced entry
 risk assessment and management
 program).
More Restrictive Alternative (HHS/CDC   Best estimate...........          48,000          48,000               0
 never pays for care or treatment for   Lower bound.............          24,000          24,000               0
 persons under Federal orders).         Upper bound.............          96,000          96,000               0
----------------------------------------------------------------------------------------------------------------

    HHS/CDC examines two alternatives to codification of its current 
policy that individuals under Federal orders will utilize third party 
resources first. Under the first, less restrictive alternative, HHS/CDC 
would pay for individuals to be tested at hospitals if referred from an 
enhanced entry risk assessment and management program at airports in 
the future (i.e., similar to the 2014-16 Ebola enhanced risk assessment 
program). Under the more restrictive alternative HHS/CDC would never 
offer to pay for treatment and care.
    Besides the NPRM analysis included in Table 55, the Federal burden 
to pay for care and treatment may have included persons sent to 
hospitals from airports for further evaluation during the Federal 
government's Ebola enhanced entry risk assessment and management 
program. Over the 16 month period of this program, a total of 29 
travelers out of 38,344 screened (0.08%) were recommended for transport 
from the airport to a hospital for further testing. All travelers 
complied voluntarily and Federal orders were not issued. HHS/CDC does 
not have any data to estimate the cost of transportation to and 
evaluation at hospitals. The cost to treat Ebola patients was reported 
to be about $30,000 per day at the Nebraska Medical Center and about 
$50,000 per day at the National Institutes of Health.\159\ If the daily 
cost of evaluation is estimated to be similar to the cost of treating 
Ebola patients (i.e., $30,000-$50,000 per day) and it is assumed that 
evaluation requires 24-48 hours, a lower bound cost estimate for 
evaluation would be

[[Page 54298]]

$30,000/day x 1 day = $30,000 and an upper bound cost estimate could be 
calculated from $50,000/day x 2 days = $100,000. The midpoint cost 
estimate is $65,000. For 29 patients at the midpoint cost estimate, the 
total cost is 29 patients x $65,000 per patient = $1,885,000.
---------------------------------------------------------------------------

    \159\ Sun L.H. Cost to treat Ebola in the U.S.: $1.16 million 
for 2 patients. Washington Post November 18, 2014 https://www.washingtonpost.com/news/post-nation/wp/2014/11/18/cost-to-treat-ebola-in-the-u-s-1-16-million-for-2-patients/?utm_term=.283370dc6c47. Accessed6/10/2016.
---------------------------------------------------------------------------

    For the less restrictive alternative, HHS/CDC assumes a best 
estimate that is the same as the expected cost for hospital follow-up 
as part of the 2014-16 Ebola enhanced risk assessment program. This is 
not an annual cost since HHS/CDC does not perceive that it is likely to 
implement enhanced risk assessment programs on an annual basis in the 
future. For the lower bound estimated cost in a one-year period if an 
enhanced risk assessment program is implemented, HHS/CDC assumes a cost 
equal to 25% of that estimated for the Ebola enhanced risk assessment 
program or $471,250. For an upper bound estimate in any one year, HHS/
CDC assumes that the program costs five times more than that estimate 
for the Ebola risk assessment program or $9,425,000.
    If HHS/CDC has to pay these costs, given its fixed budget, other 
HHS/CDC programs would have to receive less funding. One example of a 
program that HHS/CDC supports is an overseas vaccination program for 
refugees. This program was recently introduced by the Division of 
Global Migration and Quarantine with assistance from interagency 
partners. Since vaccination is often compulsory for children to attend 
public schools, most refugee children would have to be vaccinated after 
arrival in the United States even if HHS/CDC is unable to support 
overseas vaccination. According to unpublished data, the cost to 
provide vaccines in countries from which refugees travel to the United 
States is much lower than the U.S. vaccination costs even using 
Medicaid reimbursement rates. The 2015 price of measles mumps and 
rubella vaccine available from UNICEF, who supplies most countries from 
which U.S.-bound refugees travel, is $1.08--$3.25.\160\ In comparison, 
the same vaccine costs $19.90 when publicly procured in the United 
States.\161\ HHS/CDC estimates that the cost of vaccine procurement and 
delivery for refugees is at least half as expensive overseas compared 
to domestic vaccination after arrival. In addition, U.S.-bound refugees 
tend to be at much greater risk of communicable diseases than other 
international travelers. One study found that the costs associated with 
a single case imported by a refugee was $25,000.\162\
---------------------------------------------------------------------------

    \160\ http://www.unicef.org/supply/files/MMR.pdf. Accessed 6/15/
2016.
    \161\ http://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/2015/2015-07-01.html#modalIdString_CDCTable_0. 
Accessed 6/15/2016.
    \162\ Coleman M, Garbat-Welch L, Burke H, Weinberg M, Humbaugh 
K, Tindall A, et al. Direct costs of a single case of refugee-
imported measles in Kentucky. Vaccine. 2012;30(2):317-21.
---------------------------------------------------------------------------

    At the same time, U.S. healthcare payers or state/local health 
departments would not have to incur the marginal costs that would be 
paid by HHS/CDC. This could lead to reduced out-of-pocket payments by 
those that need to be tested or treated and reduced payments for their 
health insurers. In some situations, costs may be covered as charitable 
care by treatment facilities if patients are unable to pay.
    For the more restrictive alternative, HHS/CDC considers a scenario 
in which it would never have to pay for care and treatment. This would 
reduce HHS/CDC's current estimated payment of $48,000 per year to zero 
and healthcare treatment facilities or health departments would like 
have to pay an equivalent amount. The lower bound is half of the 
estimate of current payments ($24,000) and upper bound is double the 
average annual payments ($96,000). The societal cost of this 
alternative is difficult to measure and would depend on whether 
treatment facilities would begin to refuse to admit patients subject to 
Federal orders, but not in dire need of treatment (e.g., an 
undocumented immigrant with infectious tuberculosis with non-life-
threatening symptoms).

Sec.  71.63 Suspension of entry of animals, articles, or things from 
designated foreign countries and places into the United States

    In this NPRM, HHS/CDC is elucidating its authority to temporarily 
suspend entry of animals, articles or things from designated foreign 
countries and places into the United States. HHS/CDC cannot predict how 
often such authority may be used in the future or for what purpose. 
HHS/CDC 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).'' \163\ Simultaneously, 
but unrelated to provisions included in this NPRM, ``the Director of 
CDC and the Commissioner of Food and Drugs, under 42 CFR 70.2 and 21 
CFR 1240.30 respectively, issued a joint order prohibiting, until 
further notice, the transportation or offering for transportation in 
interstate commerce, or the sale, offering for sale, or offering for 
any other type of commercial or public distribution, including release 
into the environment, of:

    \163\ Federal Register 62353 Vol. 68, No. 213 Tuesday, November 
4, 2003. P. 62353-69.

 Prairie dogs (Cynomys sp.);
 Tree squirrels (Heliosciurus sp.);
 Rope squirrels (Funisciurus sp.);
 Dormice (Graphiurus sp.);
 Gambian giant pouched rats (Cricetomys sp.);
 Brush-tailed porcupines (Atherurus sp.); and
 Striped mice (Hybomys sp.).'' \164\
---------------------------------------------------------------------------

    \164\ Federal Register 62353 Vol. 68, No. 213 Tuesday, November 
4, 2003. P. 62353-69.

    Both provisions were necessary to prevent transmission of 
monkeypox, a rare, zoonotic, viral disease that occurs primarily in the 
rain forest countries in Central and West Africa. (A zoonotic disease 
is a disease of animals that can be transmitted to humans under natural 
conditions.) The illness was first noted in monkeys in 1958, but, in 
Africa, serologic evidence of monkeypox infection has been found in 
many other species, including some species of primates, rodents, and 
lagomorphs (which includes such animals as rabbits). African rodents 
are considered to be the most likely natural host of the monkeypox 
virus.\165\
---------------------------------------------------------------------------

    \165\ Khodakevich, L., Jezek, Z. and Messinger, D., ``Monkeypox 
Virus: Ecology and Public Health Significance,'' Bulletin of the 
World Health Organization, 66: 747-752, 1988. This reference 
identifies several species of squirrels as playing a major role as a 
reservoir for the monkeypox virus and Federal Register 62353 Vol. 
68, No. 213 Tuesday, November 4, 2003. P. 62353-69.
---------------------------------------------------------------------------

    The temporary ban was later codified as a permanent restriction on 
importation of African rodents and other animals that may carry the 
monkeypox virus with an exception, which allows importation for 
scientific, exhibition, or educational purposes if a written request 
for such importation is approved CDC (existing 42 CFR 71.56). This 
suspension of import was codified in an interim final rule published on 
November 4, 2003.\166\
---------------------------------------------------------------------------

    \166\ Federal Register 62353 Vol. 68, No. 213 Tuesday, November 
4, 2003. P. 62353-69.
---------------------------------------------------------------------------

    Since the African rodent embargo in 2003, HHS/CDC has implemented 
only one other embargo. On January 13, 2004, the Department of Health 
and Human Services (HHS) announced an immediate embargo on the 
importation of civets to the United States. At the time, civets had 
been identified as a possible link to SARS transmission in China.\167\
---------------------------------------------------------------------------

    \167\ https://www.ndhan.gov/data/health/CDC%20Advisory%2000183.pdf. Accessed on 5/2/2016.
---------------------------------------------------------------------------

    HHS/CDC does not have any data on the number of illegal imports of 
African rodents or civets during the time the temporary embargos have 
been in place

[[Page 54299]]

and no way to quantify the impact of codification of this authority. 
The African rodent embargo predated the implementation of HHS/CDC's 
Quarantine Activity Reporting System, which is used to document its 
activities. For civets, HHS/CDC has data on four attempted importations 
for the period from October 13, 2005 through June 10, 2016. Among the 
four attempted importations, three were allowed to enter the United 
States with a special permit for science, education or exhibition. The 
fourth shipment was for commercial purposes. This shipment was denied 
entry and the animals were returned to the source country. The importer 
was aware of the civet embargo, but did not realize the animal in 
question were part of the same family (Viverridae) that are prohibited. 
HHS/CDC would like to solicit public comment on how behaviors might 
change with proposed codification under 71.63 with this NPRM compared 
to HHS/CDC's reliance on existing 71.32b when implementing temporary 
animal importation embargos.
    The temporary embargo on African rodents implemented on June 11, 
2003 provides an example of how HHS/CDC has used existing regulatory 
authority under 42 CFR 71.32(b), which states that ``Whenever the (CDC) 
Director has reason to believe that any arriving carrier or article or 
thing on board the carrier is or may be infected or contaminated with a 
communicable disease, he/she may require detention, disinfection, 
disinfestation, fumigation, or other related measures respecting the 
carrier or article or thing as he/she considers necessary to prevent 
the introduction, transmission, or spread of communicable diseases.'' 
The proposed language under 71.63 would codify how this authority may 
be applied in the future. Since this provision does not impose any new 
regulatory burden, the mostly likely economic impact is no change from 
the current baseline. A qualitative benefit of the proposed 71.63 is 
improved understanding of how and why HHS/CDC may suspend entry of 
animals, articles, or things in the future. An estimate of the economic 
impact of the temporary embargo of African rodents provides an example 
of the potential economic impact of future restrictions that HHS/CDC 
may deem necessary to protect public health.

Costs of the African Rodent Embargo

    The costs associated with a suspension of imports can be estimated 
based on the lost value to consumers and producers associated with not 
being able to import, sell, barter, or exchange African rodents. At the 
time of prohibition, African rodents were imported primarily for 
commercial, or science, education and exhibition purposes. In 2002, a 
total of 11,587 live rodents were imported, and 1,378 of them (around 
12%) were from Africa.\168\ In 2013, the total number of imported live 
rodents were 173,761. During this period, there was a shift from wild-
caught species, including those of African origin, to other rodent 
species shipped from multiple countries outside of the African 
continent.\169\ The percentage of wild-captured imports declined from 
75% during 1999 to less than 1% during 2013.\170\ Although the total 
market for imported rodents increased by approximately 15 times 
(1500%), HHS/CDC believes that the market for African rodents would 
probably not have expanded at the same rate. One reason is that market 
for African rodents would likely be more of a niche market for exotic 
pets compared to the overall market for domestic rodents. As a point of 
comparison, imports from Asian countries experienced a smooth decline 
during 1999-2013.\171\ A second reason is that consumer demand for 
African rodents would likely decline after the association of African 
rodents with the risk of contracting monkeypox virus was clearly 
demonstrated in the U.S. market.
---------------------------------------------------------------------------

    \168\ Lankau E.W., Sinclair J.R. Schroeder B.A., Galland G.G., 
Marano N. Public health implications of changing rodent importation 
patterns--United States, 1999-2013, Transboundary and Emerging 
Diseases. 2015.
    \169\ Schroeder, B., J. McQuiston, R. Marquis, G. Galland, and 
N. Marano, 2008: Anticipating the next monkeypox: Trends in rodent 
importation, 1999-2006. International Conference on Emerging 
Infectious Diseases, Atlanta GA (abstract, 2008).
    \170\ Lankau E.W., Sinclair J.R., Schroeder B.A., Galland G.G., 
Marano N. Public health implications of changing rodent importation 
patterns--United States, 1999-2013, Transboundary and Emerging 
Diseases. 2015.
    \171\ Lankau E.W., Sinclair J.R., Schroeder B.A., Galland G.G., 
Marano N. Public health implications of changing rodent importation 
patterns--United States, 1999-2013, Transboundary and Emerging 
Diseases. 2015.
---------------------------------------------------------------------------

    To provide a conservative estimate of the economic cost of the 
prohibition on imports of African imports, HHS/CDC uses the average 
number of African rodent imports in the three years prior to the import 
suspension to estimate the number of imports as the baseline if the 
import embargo had not been implemented. On average, 959 African 
rodents per year were imported between 2000 and 2002.
    HHS/CDC assumes that the annual cost of the African rodent import 
embargo can be subdivided into the following three categories: (1) 
African rodents imported using a special permit from CDC, (2) African 
rodents that are replaced by other regions' imported substitutes, and 
(3) African rodents that cannot be imported with special permits or 
substituted. The summary of the costs for each category are included in 
Table 56 and summarized subsequently.

Table 56--Summary of the Annual Incremental Costs of the African Rodents
                            Embargo, 2015 USD
------------------------------------------------------------------------
                     Source of cost                            Costs
------------------------------------------------------------------------
Importing African rodents using a special permit from               $744
 CDC....................................................
Use of substitute rodents from other regions............          11,900
Lost consumer surplus due to African rodents                       6,390
 unavailability.........................................
    Total...............................................          19,034
------------------------------------------------------------------------

Incremental Costs of Importing African Rodents Using a Special Permit 
From CDC for Scientific, Educational, or Exhibition Purposes

    African rodents that otherwise would be prohibited are eligible for 
a special permit from the CDC director if they are imported for 
scientific, educational, or exhibition purposes. Approximately 65 
African rodents per year were imported from 2004 to 2013.\172\ The HHS/
CDC assumes that all these imported African rodents after the ban are 
used for scientific, educational, or exhibition purposes.
---------------------------------------------------------------------------

    \172\ Lankau E.W., Sinclair J.R., Schroeder B.A., Galland G.G., 
Marano N. Public health implications of changing rodent importation 
patterns--United States, 1999-2013, Transboundary and Emerging 
Diseases. 2015.
---------------------------------------------------------------------------

    HHS/CDC estimates that the permitting process imposes additional 
costs that would not be incurred in the absence of the embargo. On an 
annual basis, the annual cost to obtain a special

[[Page 54300]]

permit from CDC will result in about $372 in incremental costs based on 
an assumption that the average hourly wage importer's hourly wage is 
$31 and African rodents arrive in three separate shipments. Thus, HHS/
CDC assumes that around 20 African rodents are included in each 
shipment (Table 57). The analysis does not include costs to appeal a 
permit denial.

                          Table 57--Per-Animal Incremental Cost To Request Special Permits To Import African Rodents, 2015 USD
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Importer time per      Importer's hourly labor   Shipments imported with      Number of African                                  Importer cost to
  shipment (hours) \a\              cost                 special permit         rodents per shipment      Overhead multiplier    request special  permit
(A)                                        (B)                         (C)                     (D)                       (E)                (A x B x C x E)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                   4                       $31                         3                        20                      100%                     $744
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ The analysis assumes a greater time burden to request a special permit to import animals that are prohibited because more information is required as
  a part of this request, including detailed descriptions of travel conditions and other measures taken to prevent the spread of disease.

Incremental Costs Associated With the Use of Substitute Rodents

    Commercially imported African rodents are expected to be replaced 
either by imported rodents from other regions or by increased U.S. 
production of rodents. Most African rodents are exotic species, and are 
not commonly imported rodents relative to the more commonly imported 
hamsters, guinea pigs, or cavies.\173\ HHS/CDC assumes that all 
substitutes would be imported from countries other than Africa and 
would not be replaced by domestically produced substitutes.
---------------------------------------------------------------------------

    \173\ Lankau E.W., Sinclair J.R. Schroeder B.A., Galland G.G., 
Marano N. Public health implications of changing rodent importation 
patterns--United States, 1999-2013, Transboundary and Emerging 
Diseases. 2015.
---------------------------------------------------------------------------

    The estimated price of imported non-African rodents is $20. 
According to 2012 data contained in the U.S. Fish and Wildlife 
Service's (USFWS) Law Enforcement Management Information System 
(LEMIS), 75 percent of rodents imported in 2008 were hamsters, and 
another 3 percent were chinchillas. A sample of prices for rodents 
advertised online yielded an average cost of about $15 for hamsters and 
an average cost of $142 for chinchillas. The weighted average price of 
these animals is around $20. Since African rodents are exotic species, 
HHS/CDC assumes that the price of African rodents is higher than the 
average price of imported non-African rodents. Thus, HHS/CDC uses the 
average price of chinchillas, which is about seven times greater than 
the estimated price of more commonly purchased rodents. In addition to 
the potential price increase associated with imports from other 
regions, U.S. consumers may also derive less utility from substitutes 
for African rodents. HHS/CDC estimates substitution costs by assuming 
that these costs are 10% of the estimated price of African rodents 
(based on chinchillas). As a result, U.S. consumers would have to pay 
approximately $14 more or lose $14 in utility for each substituted 
rodent import in place of the African rodents that would be purchased 
in the absence of an embargo (Table 58).

 Table 58--Incremental Cost of Using Other Imported Substitutes in Place
                      of African Rodents, 2015 USD
------------------------------------------------------------------------
  Incremental cost per African    Number of  rodents  Total  incremental
           rodent \a\              \b\  substituted           cost
(A)                                             (B)             (A x B)
------------------------------------------------------------------------
$14.............................                850             $11,900
------------------------------------------------------------------------
\a\ $142 x 10%.
\b\ 894 of commercially imported African rodents x 95%.

Incremental Costs of Lost use due to African Rodents' Unavailability

    HHS/CDC assumes that substitutes are not available for 5% of 
commercially imported African rodents. The absence of these animals 
will result in lost profit for the affected importers and lost utility 
to the affected consumers. HHS/CDC assumes that the average price can 
be used to estimate these costs, although HHS/CDC acknowledges that 
this may be an underestimate because lost consumer surplus is likely to 
be greater than the average price. HHS/CDC estimates the cost of lost 
consumer surplus associated with the lack of acceptable substitutes for 
U.S. consumers who can no longer import African rodents at 45 x $142 = 
$6,390 (Table 59).

      Table 59--Incremental Cost of Lost Use Due to African Rodents
                        Unavailability, 2015 USD
------------------------------------------------------------------------
                                  Number of  African
Incremental cost per unavailable   rodents  becoming  Total  incremental
       African rodent \a\           unavailable \b\           cost
(A)                                             (B)             (A x B)
------------------------------------------------------------------------
$142............................                 45             $6, 390
------------------------------------------------------------------------
\a\ HHS/CDC adapted price of chinchillas for the price of unavailable
  African rodents
\b\ 894 commercially imported African rodents x 5%


[[Page 54301]]

Benefits of the African Rodent Embargo

    The economic benefits of the African rodent embargo are likely much 
greater than the estimated costs. The primary benefits are improvements 
to human and animal health in the United States, averted public health 
measures necessary to contain a monkeypox outbreak, and averted costs 
to other animal markets in case of transmission of monkeypox from 
African rodents to other species through intermingling in the pet 
industry. The 2003 monkeypox outbreak resulted in a total of 71 cases 
that were clinically or laboratory confirmed.\174\ Among the 71 total 
cases, 16 patients (23%) with monkeypox infections were admitted to 
hospitals for treatment or for isolation. Two patients had serious 
clinical illness, but subsequently recovered and no deaths associated 
with monkeypox were reported.\175\ The two severe cases occurred in 
children who required intensive care, one for severe monkeypox-
associated encephalitis (encephalitis is an inflammation of the brain), 
and one with profound painful cervical (neck) and tonsillar adenopathy 
(adenopathy refers to an enlargement of the glands) and diffuse pox 
lesions, including lesions in the throat.\176\ Otherwise, the clinical 
symptoms of monkeypox included skin lesions with fever (temperature 
above 38 [deg]C, 100.4 [deg]F), drenching sweats and severe chills, 
headache, sore throat and persistent coughing. Other less common 
symptoms included lymphadenopathy (swollen glands), mild chest 
tightness, tonsillar erosion, general body malaise, myalgia (muscle 
aches), back pain and nasal congestion.\177\
---------------------------------------------------------------------------

    \174\ Centers for Disease Control and Prevention (CDC). Update: 
Multistate outbreak of Monkeypox--Illinois, Indiana, Kansas, 
Missouri, Ohio, and Wisconsin, 2003. Morb Mort Weekly Rep, . 
2003;52:642-6.
    \175\ Centers for Disease Control and Prevention (CDC). Update: 
Multistate outbreak of Monkeypox--Illinois, Indiana, Kansas, 
Missouri, Ohio, and Wisconsin, 2003. Morb Mort Weekly Rep, . 
2003;52:642-6.
    \176\ Federal Register 62353 Vol. 68, No. 213 Tuesday, November 
4, 2003. P. 62353-69.
    \177\ Sejvar JJ, Chowdary Y, Schomogyi M, Stevens J, Patel J, 
Karem K, et al. Human Monkeypox Infection: A Family Cluster in the 
Midwestern United States. Journal of Infectious Diseases. 
2004;190:1833-40.
---------------------------------------------------------------------------

    The number of monkeypox cases was increasing over an approximately 
3-week period from the identification of the first case on May 15, 2003 
through the week ending June 8, 2003. The number of cases declined 
subsequently; the date of onset for the last case was June 20, 
2003.\178\ In the United States, individuals apparently began 
contracting monkeypox, primarily as a result of contact with prairie 
dogs that had contracted monkeypox from diseased African rodents. 
Investigations indicate that a Texas animal distributor imported a 
shipment of approximately 800 small mammals from Ghana on April 9, 
2003, and that shipment contained 762 African rodents, including rope 
squirrels (Funiscuirus sp.), tree squirrels (Heliosciurus sp.), Gambian 
giant pouched rats (Cricetomys sp.), brushtail porcupines (Atherurus 
sp.), dormice (Graphiurus sp.), and striped mice (Hybomys sp.). Some 
animals were infected with monkeypox, and CDC laboratory testing 
confirmed the presence of monkeypox in several rodent species, 
including one Gambian giant pouched rat, three dormice, and two rope 
squirrels. Of the 762 rodents from the original shipment, 584 were 
traced to distributors in six states. A total of 178 African rodents 
could not be traced beyond the point of entry in Texas because records 
were not available.\179\
---------------------------------------------------------------------------

    \178\ Centers for Disease Control and Prevention (CDC). Update: 
Multistate outbreak of Monkeypox--Illinois, Indiana, Kansas, 
Missouri, Ohio, and Wisconsin, 2003. Morb Mort Weekly Rep 
2003;52:642.
    \179\ Centers for Disease Control and Prevention (CDC). Update: 
Multistate outbreak of Monkeypox--Illinois, Indiana, Kansas, 
Missouri, Ohio, and Wisconsin, 2003. Morb Mort Weekly Rep, . 
2003;52:642-6.; Federal Register 62353 Vol. 68, No. 213 Tuesday, 
November 4, 2003. P. 62353-69.
---------------------------------------------------------------------------

    Non-native animal species, such as African rodents, can create 
serious public health problems when they introduce a new disease, such 
as monkeypox, to the native animal and human populations. The 
transportation, sale, or distribution of an infected animal, or the 
release of an infected animal into the environment can result in the 
further spread of disease to other animal species and to humans. 
Several States issued orders or emergency rules to prohibit the 
importation, sale, distribution, release, disposal, and/or display of 
prairie dogs and certain rodents.180 181 182 183 184 185
---------------------------------------------------------------------------

    \180\ State of Colorado, Wildlife Commission, ``Emergency 
Regulation,'' dated July 10, 2003.
    \181\ State of Illinois, ``Executive Order in Response to 
Orthopox Outbreak,'' dated June 7, 2003.
    \182\ State of Indiana, Board of Animal Health, Emergency Rule, 
dated June 9, 2003.
    \183\ State of Michigan, Department of Community Health, ``Order 
Finding Imminent Danger to the Public Health and Requiring 
Corrective Action,'' dated June 13, 2003, and later amended on June 
27, 2003.
    \184\ State of North Dakota, State Board of Animal Health, ``In 
the matter of: Monkeypox in Prairie Dogs and Gambian Giant pouched 
Rats,'' Order No. 2003-04, dated June 11, 2003.
    \185\ State of Wisconsin, Department of Agriculture, Trade, and 
Consumer Protection, ``Emergency Rule,'' dated June 9, 2003.
---------------------------------------------------------------------------

    The monkeypox outbreak was contained in the United States after CDC 
and the public health departments in the affected states, together with 
the U.S. Department of Agriculture, the Food and Drug Administration, 
and other agencies, participated in a variety of activities that 
prevented further spread of monkeypox.
    To assist with the investigation and outbreak response, CDC took 
the following steps in addition to the embargo on the importation of 
African rodents:
     Activated its Emergency Operations Center.
     Deployed teams of medical officers, epidemiologists, and 
other experts to several states to assist with the investigation.
     Conducted extensive laboratory testing on specimens from 
humans and animals thought to have been exposed to monkeypox.
     Issued interim U.S. case definitions for human monkeypox 
and for animal monkeypox.
     Issued interim guidelines on infection control and 
exposure management for patients in the health care and community 
settings.
     Issued an immediate embargo and prohibition on the 
importation, interstate transportation, sale, and release into the 
environment of certain rodents and prairie dogs.
     Provided ongoing assistance to state and local health 
departments in investigating possible cases of monkeypox in both humans 
and animals the United States.
     Worked with state and Federal agencies to trace the origin 
and distribution of potentially infected animals.
     Issued an interim guidance on the use of smallpox vaccine 
(which also can be used to protect people against monkeypox), cidofovir 
(an antiviral medication), and vaccinia immune globulin (an antibody 
product obtained from the blood of people who have received the 
smallpox vaccine) in the setting of an outbreak of monkeypox.
     Issued interim guidelines for veterinarians.
     Issued interim guidance for persons who have frequent 
contact with animals, including pet owners, pet shop employees, animal 
handlers, and animal control officers.\186\
---------------------------------------------------------------------------

    \186\ http://www.cdc.gov/poxvirus/monkeypox/outbreak.html. 
Accessed 5/2/2016.
---------------------------------------------------------------------------

    These activities suggest the scale of the response required to 
contain monkeypox and the potential threat posed by the importation of 
African rodents. The public health response is estimated to require at 
least 20 HHS/CDC employees over a 2.5 month

[[Page 54302]]

period. These employees are assumed to be compensated at the GS-13, 
step 5 level on average. In addition, the total number of personnel 
from public health departments in the six affected states are assumed 
to at least equal the number of HHS/CDC employees. The average wage 
rate for public health departments is estimated based on 2015 U.S. 
average wage rates for epidemiologists reported in the May 2015 
National Occupational Employment and Wage Estimates from the Bureau of 
Labor Statistics ($36.97, category 19-1041).\187\ Total costs for the 
public health response include a 100% multiplier to account for 
overhead costs for these employees, but do not include potential travel 
and per diem costs that may have been incurred to investigate the 
outbreak. The total costs to HHS/CDC and public health departments are 
summarized in Table 60.
---------------------------------------------------------------------------

    \187\ http://www.bls.gov/oes/current/oes_nat.htm. Accessed 5/2/
2016.

  Table 60--Estimated Costs of the Public Health Response for the 2003 Monkeypox Outbreak in the United States,
                                                    2015 USD
----------------------------------------------------------------------------------------------------------------
                                                                      Average
                                     Number of       Duration       hourly wage      Overhead       Total cost
                                     employees       (months)          rate       multiplier (%)
----------------------------------------------------------------------------------------------------------------
HHS/CDC employees...............              20             2.5          $47.36             100        $757,760
State or local health                         20             2.5           36.97             100         591,520
 departments....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............      $1,349,280
----------------------------------------------------------------------------------------------------------------

    The list of HHS/CDC activities referenced above include guidance 
provided to veterinarians, persons who have frequent contact with 
animals including pet owners, pet shop employees, animal handlers, and 
animal control officers. It is likely that all of these stakeholders 
incurred costs as a result of the monkeypox outbreak; however, HHS/CDC 
does not have data to quantify most of these costs. HHS/CDC does have 
some data for one set of affected stakeholders. The size of the prairie 
dog market was estimated to be approximately $4.5 million in 2003,\188\ 
which would correspond to $5.8 million in 2015 USD after adjustment 
using the U.S. Consumer Price Index. Considering only the disruption to 
the prairie dog market, HHS/CDC estimates that the cost to this market 
would be at least 25% of the total market size in any year in which 
monkeypox transmission was associated with sales of prairie dogs. This 
large cost is estimated because infection of prairie dogs led to 
significant restrictions on interstate transport of prairie dogs and 
because several states issued orders or emergency rules to prohibit the 
importation, sale, distribution, release, disposal, and/or display of 
prairie dogs. This one-time 25% reduction would correspond to an annual 
cost of about $1.5 million just to this one market in the event of a 
re-introduction of monkeypox to the United States and transmission 
within the prairie dog population.
---------------------------------------------------------------------------

    \188\ Federal Register 62353 Vol. 68, No. 213 Tuesday, November 
4, 2003. P. 62353-69.
---------------------------------------------------------------------------

    The treatment costs for individuals diagnosed with monkeypox or 
exposed to infected persons or animals include hospitalization, 
outpatient treatment, medications, vaccinations (with smallpox 
vaccine), laboratory diagnosis, and the opportunity costs to 
individuals who contract monkeypox and cannot undertake their normal 
daily activities. Laboratory diagnosis of monkeypox can involve 
multiple approaches including combined Polymerize Chain Reaction (PCR) 
tests, enzymes-linked immunosorbent assays (ELISA) tests, DNA 
extraction of tissues to perform molecular tests and others. Most of 
the patients with monkeypox disease were treated with antibiotics 
(ciprofloxacin and doxycycline) and a few patients received intravenous 
acyclovir and valacyclovir medications.\189\ The costs of treating 
monkeypox were not systematically documented.\190\
---------------------------------------------------------------------------

    \189\ Ligon BL. Monkeypox: A review of the history and emergence 
in the Western hemisphere. Seminars in Pediatric Infectious 
Diseases. 2004; 15:280-7.
    \190\ Kroeger T. Economic Impacts of Live Wild animal Imports in 
the United States. Defenders of Wildlife; 2004.
---------------------------------------------------------------------------

    Table 61 provides a rough estimate of potential illness costs 
associated with an outbreak of monkeypox of similar size to the 
outbreak that occurred in 2003. The documented costs include 56 cases 
treated on an outpatient basis in emergency rooms at an estimated cost 
of $1,455 per patient.\191\ This estimate is based on the U.S. average 
cost for an outpatient hospital visit for any illness and is probably a 
very conservative estimate of the outpatient cost of treating 
monkeypox. Hospitalization costs are estimated at $16,516 per patient 
for each of 16 cases based on the average cost of hospitalization for 
any illness.\192\ Again, this cost estimate is probably very 
conservative for monkeypox treatment.
---------------------------------------------------------------------------

    \191\ Healthcare Costs Institute. Healthcare Costs and 
Utilization Report. Washington DC: Health Care Costs Institute; 
2011.
    \192\ Healthcare Costs Institute. Healthcare Costs and 
Utilization Report. Washington DC: Health Care Costs Institute; 
2011.
---------------------------------------------------------------------------

    All individuals (outpatients and inpatients) who contract the 
disease are estimated to lose an average of 12 days of productive 
activity. This assumption is based on a clinical report that on average 
infected individuals were ill for between 3 to 24 days.\193\ To be 
conservative, HHS/CDC only includes lost productivity costs for adults. 
Among laboratory confirmed monkeypox cases, 11 out of 35 (31%) patients 
occurred in patients less than 18 years old. Applying this ratio to the 
total number of cases (71), approximately 49 adults would incur lost 
productivity costs. For each adult, average productivity costs are 
estimated based on the U.S. average hourly salary ($23.23) reported in 
the 2015 Occupational Employment Statistics from the U.S. Bureau of 
Labor Statistics \194\ and assuming an 8-hour workday. Productivity 
losses are then estimated based on the average wage rate x 12 days x 8 
hours per day x number of monkeypox patients ($108,531). The total 
illness are estimated to be about $453,000 (Table 61).
---------------------------------------------------------------------------

    \193\ Reed KD, Melski JW, Graham MB, Regnery RL, Sotir MJ, 
Wegner MV, et al. The detection of monkeypox in humans in the 
western hemisphere. N Engl J Med 2004; 350:342-50.
    \194\ http://www.bls.gov/oes/current/oes_nat.htm. Accessed 5/2/
2016.

[[Page 54303]]



                 Table 61--Illness Costs Associated With 2003 U.S. Monkeypox Outbreak, 2015 USD
----------------------------------------------------------------------------------------------------------------
                Activity                             Units                   Unit cost \a\          Total costs
(A)                                       (B).......................  A x B = (C)...............
----------------------------------------------------------------------------------------------------------------
Outpatient treatment, ER Visit Cost       \196\ 55..................  $1,455 per patient........         $80,025
 \195\.
Hospital stay \197\.....................  \198\ 16..................  16,516 per patient........         264,256
Lost productivity.......................  48.7 (69%) for 584 Days...  161.68 per patient-day....         108,531
                                                                                                 ---------------
    Total costs.........................  ..........................  ..........................         452,812
----------------------------------------------------------------------------------------------------------------
\a\ Unit costs updated to USD 2015 using the U.S. Consumer Price Index where appropriate.

    The total quantified costs associated with the 2003 monkeypox 
outbreak are summarized in Table 62. These include a partial accounting 
of the costs incurred to HHS/CDC and to local public health 
departments, a one-time estimate of the potential costs to the U.S. 
prairie dog market, and a conservative estimate of illness costs for 
persons infected with monkeypox ($3.3 million).
---------------------------------------------------------------------------

    \195\ Healthcare Costs Institute. Healthcare Costs and 
Utilization Report. Washington DC: Health Care Costs Institute; 
2011.
    \196\ Centers for Disease Control and Prevention (CDC). Update: 
Multistate outbreak of Monkeypox--Illinois, Indiana, Kansas, 
Missouri, Ohio, and Wisconsin, 2003. Morb Mort Weekly Rep,. 
2003;52:642--6.
    \197\ Healthcare Costs Institute. Healthcare Costs and 
Utilization Report. Washington DC: Health Care Costs Institute; 
2011.
    \198\ Centers for Disease Control and Prevention (CDC). Update: 
Multistate outbreak of Monkeypox--Illinois, Indiana, Kansas, 
Missouri, Ohio, and Wisconsin, 2003. Morb Mort Weekly Rep. 
2003;52:642-6.

     Table 62--Estimated Costs of 2003 Monkeypox Outbreak, 2015 USD
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Public health response costs............................      $1,349,280
One-time costs to prairie dog market in the United             1,500,000
 States.................................................
Illness costs...........................................         452,812
                                                         ---------------
  Total.................................................       3,302,092
------------------------------------------------------------------------

    The outbreak costs reported in Table 62 represent a very 
conservative estimate of the potential benefits of reducing the 
probability of a future re-introduction of the monkeypox virus into the 
United States. The total costs of such an outbreak would probably 
greatly exceed the conservative estimates presented in Table 62. Since 
the order to embargo the importation of African rodents in June 2003 
and subsequent permanent restriction on the importation of African 
rodents codified in existing 42 CFR 71.56, the monkeypox virus has not 
been reintroduced to the United States. Comparing the potential 
benefits of an averted monkeypox outbreak in Table 62 ($3.3 million) to 
the estimated costs to African rodent importers and potential consumers 
(Table 56, $19,000), it is extremely likely the benefits of the African 
rodent import prohibition would greatly exceed the costs. However, HHS/
CDC is not able to quantify the risk of re-introduction with and 
without the restrictions on African rodent imports. Although this NPRM 
only seeks to codify HHS/CDC's ability to 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), this example 
demonstrates the potential costs and benefits of one such action. 
Because this outbreak occurred about 13 years ago, HHS/CDC specifically 
solicits public comment on cost estimates associated with the 
prohibition of African rodent imports and the cost of the 2003 
monkeypox outbreak.

Evaluation of Alternatives

    Two potential alternatives are considered to codification of this 
provision in the NPRM. Under the first less restrictive alternative, 
HHS/CDC would not implement temporary embargos after it becomes aware 
of imminent risks to public health in the United States. Under this 
scenario, there would be no embargo on the importation of African 
rodents between June 11, 2003 and November 4, 2003. Under this 
scenario, the United States would have remained at risk for the re-
introduction of monkeypox virus and the need to eliminate the virus 
from the United States animal and human populations. This scenario is 
elaborated above.
    The more restrictive alternative would be for HHS/CDC to no longer 
consider special permits to allow importation for scientific, 
education, and display purposes. HHS/CDC believes that limiting 
importations to these purposes protects public health, while allowing 
importation to occur in very controlled environments. If special 
permits were discontinued, African rodent importers would no longer 
have to fill out import permits at an annual cost of $744 (Table 57). 
This is the cost to create three special permit applications per year.
    In comparison, civet shipments with special permits occur 
approximately once every three years, so the annual cost to create 
special permits is $744/9 = $83 for civets. However, importers would no 
longer be able to import African rodents or civets for science, 
education, or exhibition under the more restrictive alternative. Thus, 
the societal costs of disallowing importation of animals with special 
permits under temporary embargos would outweigh the potential cost 
savings associated with the time spent filing for special permits. HHS/
CDC would like to solicit public comment on the value of continuing to 
allow importation of animals under temporary embargos for science, 
education, and exhibition with special permits.
B. The 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. HHS/CDC finds that the NPRM is not 
expected to change the cost of compliance for small businesses, small 
governmental units, or small not-for-profit organizations.
C. Paperwork Reduction Act of 1995
    HHS/CDC has determined that this NPRM 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.

[[Page 54304]]

     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.
     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 travels 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), this NPRM is proposing updates to certain information 
collections within these control numbers.
    In a separate information collection request accompanying this 
NPRM, 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.
    CDC is taking public comment on the burden to the public outlined 
in the three information collection requests below.
    Written comments should be received within 60 days of the 
publication of this NPRM. Please send written comments to Information 
Collection Review Office, 1600 Clifton Road NE., Atlanta, GA 30333.

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 
part 70 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. 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) Radio 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 request from importers/
filers certain data elements to identify and clear HHS/CDC regulated 
imports via the Automated Commercial Environment and the International 
Trade Data System. These HHS/CDC Partner Government Agency Message Sets 
are currently limited to: HHS/CDC PGA Message Set for Importing Cats 
and Dogs, HHS/CDC PGA Message Set for Importing African Rodents, HHS/
CDC PGA Message Set for Importing African Rodent and All Family 
Viverridae Products.
    In this NPRM, HHS/CDC is proposing 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 proposing 
to update the definition of ``ill person'' by codifying 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 proposing to include 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 current definition of ill person, which applies to both 
airlines and maritime vessels, is anyone who:
    (1) Has a temperature of 100.4[emsp14][deg]F (or 38 [deg]C) or 
greater, accompanied by a rash, glandular swelling, or jaundice, or 
which has persisted for more than 48 hours; or
    (2) Has diarrhea, defined as the occurrence in a 24-hour period of 
three or more loose stools or of a greater than normal (for the person) 
amount of loose stools.
    The proposed definition of ill person in the context of aircraft is 
proposed as follows:
    (a) Who if onboard an aircraft:
    (1) Has a fever (a measured temperature of 100.4[emsp14][deg]F [38 
[deg]C] or greater; or feeling warm to the touch; or giving 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

[[Page 54305]]

(other than air sickness), headache with stiff neck, or appears 
obviously unwell; or
    (2) Has symptoms or other indications of communicable disease, as 
the CDC may announce through posting of a notice in the Federal 
Register.
    The proposed definition of ill person in the context of vessels is 
as follows:
    (b) Who if onboard a vessel:
    (1) Has a fever (a measured temperature of 100.4[emsp14][deg]F [38 
[deg]C] or greater; or feeling warm to the touch; or giving 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 vomiting (other than sea 
sickness), headache with stiff neck, or appears obviously unwell; or
    (2) 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); or
    (3) Has symptoms or other indications of communicable disease, as 
the CDC may announce through posting of a notice in the Federal 
Register.
    The NPRM proposes to update 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 seeking a change in the title of the information 
collection pertaining to reports of death and illness from vessels to 
CDC. The current title is Radio Report of death or illness--illness 
reports from ships. CDC seeks 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.
    (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 proposed 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
                                                                                            Number  of       Number of      burden per     Total burden
               Type of respondent                   Regulatory provision or form name       respondents    responses per   response  (in       hours
                                                                                                            respondent        hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maritime Vessel Operators......................  42 CFR 71.21(a) Report of illness or              2,000               1            2/60              67
                                                  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/Illness reports            1,700               1            2/60              57
                                                  from aircraft.
Maritime Vessel Operators......................  42 CFR 71.21(c) (MIDRS) Acute Gastro-            17,000               1            3/60             850
                                                  Enteritis reports (24 and 4 hours
                                                  before arrival).
Maritime Vessel Operators......................  42 CFR 71.21 (c) Recordkeeping--Medical          17,000               1            3/60             850
                                                  logs.
Isolated or Quarantined individuals............  42 CFR 71.33 Report by persons in                    11               1            3/60               1
                                                  isolation or surveillance.
Maritime Vessel Operators......................  42 CFR 71.35 Report of death/illness                  5               1           30/60               3
                                                  during stay in port.
Importer.......................................  42 CFR 71.51(c)(1), (d)--Valid Rabies           245,310               1           15/60          61,328
                                                  Vaccination Certificates.

[[Page 54306]]

 
Importer.......................................  CDC Form 75.37 Notice To Owners And               1,400               1           10/60             233
                                                  Importers Of Dogs: Requirement for Dog
                                                  Confinement.
Importer.......................................  42 CFR 71.51(c)(i), (ii), and (iii)              43,290               1           15/60          10,823
                                                  exemption criteria for the importation
                                                  of a dog without a rabies vaccination
                                                  certificate.
Importer.......................................  42 CFR 71.51(c)(2), (d) Application For            1400               1           15/60             350
                                                  Permission To Import A Dog
                                                  Inadequately Against Rabies.
Importer.......................................  42 CFR 71.51(b) (3) Dogs/cats: Record                20               1           15/60               5
                                                  of sickness or deaths.
Importer/Filer.................................  42 CFR 71.51_CDC Requested Data on               30,000               1           15/60           7,500
                                                  Regulated Imports: Domestic Dogs and
                                                  Cats (PGA Message Set).
Importer.......................................  42 CFR 71.52(d) Turtle Importation                    5               1           30/60               3
                                                  Permits.
Importers......................................  42 CFR 71.55, 42 CFR 71.32 Dead Bodies--              5               1               1               5
                                                  Death certificates.
Importer.......................................  42 CFR 71.56 (a)(2) African Rodents--                20               1               1              20
                                                  Request for exemption.
Importer.......................................  42 CFR 71.56(a)(iii) Appeal............               2               1               1               2
Importer/Filer.................................  42 CFR 71.56 CDC Requested Data on                   60               1           15/60              15
                                                  Regulation Imports: Live African
                                                  Rodents (PGA Message Set).
Importer/Filer.................................  42 CFR 71.32 Statements or                         2000               1            5/60             167
                                                  documentation of non-infectiousness.
Importer/Filer.................................  42 CFR 71.56, 42 CFR 71.32 CDC                    2,000               1           15/60             500
                                                  Requested Data on Regulated Imports:
                                                  Products of African Rodents; Products
                                                  of all Family Viverridae (PGA Message
                                                  Set).
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    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 NPRM, CDC is also proposing a nonmaterial/non-
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 NPRM, CDC is proposing to add 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, or another designated official, 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 not proposing changes to 
its 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 NPRM, pilots in command of an aircraft, operating on 
behalf of an airline, that submit the ill person or death report to 
HHS/CDC under proposed 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 7 will add 70.11 Report of death or illness onboard 
aircraft operated by airline.
    As a result of this proposal, 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

[[Page 54307]]

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 proposing to include 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 proposed 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
                                                                                             Number of       Number of      burden per     Total burden
               Type of respondent                               Form name                   respondents    responses per   response (in     (in hours)
                                                                                                            respondent        hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pilot in command...............................  42 CFR 70.11 Report of death or illness             190               1            7/60              22
                                                  onboard aircraft operated by airline.
Master of vessel or person in charge of          42 CFR 70.4 Report by the master of a                10               1            7/60               1
 conveyance.                                      vessel or person in charge of
                                                  conveyance of the incidence of a
                                                  communicable disease occurring while
                                                  in interstate travel.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    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 NPRM HHS/CDC is proposing a new information 
collection, Airline and Vessel and Traveler Information Collection (42 
CFR part 70 and 71). This information collection request accompanies 
the proposed 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. In order to the increase transparency with regard 
to CDC's authorities and manifest order process, CDC is proposing 
specific regulatory provisions that outline the particular data 
elements CDC requires to perform contact tracing investigations. As 
stated in the NPRM, CDC is not mandating the collection of additional 
data. Only that if the airlines or maritime operators have the data 
elements listed in proposed 71.4 and 71.5 in their possession, they 
must be provided to CDC within 24 hours.
    While not included in the text of this NPRM, CDC is also seeking to 
include two other information collections, as described in the 
Supporting Statement of the information collection request accompanying 
this NPRM.
    (1) To include the collection of airline and vessel information, 
and passenger and crew member manifest information, from airlines and 
vessels engaged in interstate travel. CDC is not codifying these 
domestic orders in the regulation at this time.
    (2) CDC is proposing to transition the Passenger Locator Form, 
previously approved under OMB Control Number 0920-0134 Foreign 
Quarantine Regulations, to this new information collection request and 
is proposing the ability to use the Passenger Locator Form for 
travelers on domestic flights.
    CDC is not including burden for manifest orders for maritime 
vessels in the Paperwork Reduction Act section of the NPRM because CDC 
anticipates fewer than 10 maritime vessel manifest orders per year. 
Additionally, while the domestic manifest orders and transition of the 
Passenger Locator Form from OMB Control Number 0920-0134 into this 
Information Collection Request are accounted for in the Supporting 
Statement for Airline and Vessel and Traveler Information Collection 
(42 CFR part 70 and 71), they are not included here, as this NPRM is 
only codifying current practice with regard to manifest orders related 
to international flights arriving into the United States. Please see 
the accompanying Supporting Statement for further information on these 
additional information collections.
    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 proposed rule changes.
    Description of Respondents.
    Respondents to this data collection include the Airline Medical 
Officer or Equivalent and a Computer and Information Systems Manager.

[[Page 54308]]



                                          Table 3--Estimate of Annual Burden Airline and Vessel Manifest Orders
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total burden
               Type of respondent                               Form name                   respondents    responses per   response (in     (in hours)
                                                                                                            respondent        hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Airline Medical Officer or Equivalent/Computer   International TB Manifest Template.....              67               1          360/60             402
 and Information Systems Manager.
Airline Medical Officer or Equivalent/Computer   International Non-TB Manifest Template.              29               1          360/60             174
 and Information Systems Manager.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total......................................  .......................................              96  ..............  ..............             576
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The total requested burden hours included in this NPRM for proposed 
are 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 proposed amendments to 42 CFR part 
70 and 71 will not have a significant impact on the human environment. 
Therefore, neither an environmental assessment nor an environmental 
impact statement is needed.
E. EO 12988: Civil Justice Reform
    HHS/CDC has reviewed this rule under Executive Order 12988 on Civil 
Justice Reform and determines that this NPRM meets the standard in the 
Executive Order.
F. EO 13132: Federalism
    Under Executive Order 13132, if the rulemaking would limit or 
preempt State authorities, then a Federalism analysis is required. The 
agency must consult with State and local officials to determine whether 
the rule would have a substantial direct effect on State or local 
Governments, as well as whether it would either preempt State law or 
impose a substantial direct cost of compliance on them.
    HHS/CDC has determined that this NPRM will not have sufficient 
Federalism implications to warrant the preparation of a Federalism 
summary impact statement.
G. 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 has attempted to use plain language in this rulemaking 
to make our intentions and rationale clear and requests input from the 
public in this regard.

List of Subjects in 42 CFR Parts 70 and 71

    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 propose to 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 adding, in alphabetical order the definitions of 
``Agreement,'' ``Airlines,'' ``Apprehension,'' ``Communicable stage,'' 
``Conditional release,'' ``Contaminated environment,'' ``Conveyance,'' 
``Electronic or Internet-based monitoring,'' ``Ill person,'' 
``Incubation Period,'' ``Master or operator,'' ``Medical examination,'' 
``Medical representative,'' ``Medical reviewer,'' ``Non-invasive,'' 
``Precommunicable stage,'' ``Public health emergency,'': Public health 
prevention measures,'' ``Qualifying stage,'' and ``Reasonably believed 
to be infected, as applied to an individual'' to read as follows:


Sec.  70.1  General definitions.

    Agreement means an agreement entered into between the CDC and an 
individual expressing a voluntary agreement between the parties that 
the individual will observe public health measures authorized under 
this part, as the CDC considers reasonably necessary to protect the 
public's health, including quarantine, isolation, conditional release, 
medical examination, hospitalization, vaccination, and treatment.
    Airline(s) means any air carrier(s) or foreign air carrier(s) 
providing air transportation, including scheduled or public charter 
passenger operations operating in air commerce within the United 
States, as these terms are defined in 49 U.S.C. 40102, (a)(2), (a)(3), 
(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 surveillance as defined under 42 CFR 71.1 
and includes public health supervision through in-person visits by a 
health official or designee, 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 electronic mail, 
SMS texts, video conference or 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:

[[Page 54309]]

    (1) Has a fever (a measured temperature of 100.4[emsp14][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. For a 
quarantinable communicable disease, incubation period means the 
precommunicable stage.
    Indigent means an individual whose annual family income is below 
150% 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.
* * * * *
    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 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 representative means a physician, nurse practitioner, or 
similar medical professional qualified in the diagnosis and treatment 
of infectious diseases who is appointed by the HHS Secretary or CDC 
Director and may include an HHS or CDC employee, to assist an indigent 
individual under Federal quarantine, isolation, or conditional release 
with a medical review under this part.
    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 HHS Secretary or CDC 
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 health 
worker or another individual with suitable training and includes the 
physical examination of the ear, nose, and mouth; temperature 
assessments using an ear, oral, cutaneous, or noncontact thermometer, 
or thermal imaging; auscultation; external palpation; external 
measurement of blood pressure; 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 Secretary pursuant to Sec.  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.
* * * * *
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, or agreement, of isolation, quarantine, or conditional 
release with regard to a quarantinable communicable disease or to any 
individual meeting the

[[Page 54310]]

requirements of subparagraph (d) or (e) of this section:
    (1) 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 HHS/CDC.
    (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 CDC to 
assess the individual's health condition and potential for communicable 
disease spread to others.
    (3) The CDC 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 CDC shall prescribe.
    (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. The appeal must be in writing, state 
the factual basis for the appeal, and be submitted to the Director 
within 10 calendar days of the denial, suspension, or revocation of the 
permit. The CDC will promptly issue a written response to the appeal, 
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 or 
agreement of isolation, quarantine, or conditional release, unless such 
an individual presents a permit issued by the CDC authorizing such 
travel;
    (2) Transport any individual whom the operator knows, or reasonably 
should know, to be under a Federal order or agreement of isolation, 
quarantine, or conditional release in violation of any of the terms or 
conditions prescribed in the travel permit issued by the CDC.
    (c) Whenever a conveyance operating in interstate traffic 
transports an individual under a Federal order, travel permit, or 
agreement of isolation, quarantine, or conditional release, CDC may 
require that the operator of the conveyance submit the conveyance to 
inspection, sanitary measures, and other measures, as the CDC deems 
necessary to prevent the possible spread of communicable disease.
    (d) CDC may additionally apply the provisions in paragraphs (a) 
through (c) of this section upon the request of a state or local health 
authority of jurisdiction or whenever the Director makes a 
determination under 42 CFR 70.2 that is based on the existence of 
inadequate local control such measures are needed to prevent the spread 
of any of the communicable diseases from such State or U.S. territory 
to any other State or U.S. territory.
    (e) CDC 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.
    (f) The CDC 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.

    CDC 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:
    (a) 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
    (b) 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.
0
5. Add Sec. Sec.  70.10 through 70.19 to read as follows:


Sec.  70.10  Public health prevention measures to detect communicable 
disease.

    (a) The CDC 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 CDC to 
detect the presence of communicable diseases.
    (b) As part of the public health prevention measures, CDC 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, and travel history.


Sec.  70.11   Report of death or illness onboard aircraft operated by 
airline.

    (a) The pilot in command of an aircraft operated on behalf of an 
airline who is conducting a commercial passenger flight in interstate 
traffic under a regular schedule shall report as soon as practicable to 
the CDC the occurrence onboard of any deaths or the presence of ill 
persons among passengers or crew and take such measures as the CDC 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 on behalf of an 
airline who reports in accordance with paragraph (a) shall be deemed to 
satisfy the reporting obligation under 42 CFR 70.4.


Sec.  70.12  Medical examinations.

    (a) The CDC 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 CDC shall promptly arrange for the medical examination to 
be conducted when one is required under this section.
    (c) As part of the medical examination, the CDC 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.

[[Page 54311]]

Sec.  70.13  Payment for care and treatment.

    (a) The CDC 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 CDC 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 
CDC 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 CDC refers the individual or group to the hospital 
or medical facility and ends when, as determined by the CDC, 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 CDC refers the individual to 
the hospital or medical facility and ends when the individual's 
condition is diagnosed, as determined by the CDC, 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 a CDC authorizing 
official, 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 CDC'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 CDC'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 of the process for reassessment and medical 
review of the Federal order pursuant to this part; and
    (6) An explanation of the criminal penalties for violating a 
Federal order of quarantine, isolation, or conditional release.
    (b) A Federal order authorizing quarantine, isolation, or 
conditional release shall be promptly served on the individual, 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.


Sec.  70.15  Mandatory reassessment of a Federal order for quarantine, 
isolation, or conditional release.

    (a) The CDC 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 CDC 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 CDC 
shall consider whether less restrictive alternatives would adequately 
serve to protect the public health.
    (d) At the conclusion of the reassessment, the CDC 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 CDC directs 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 CDC'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.


Sec.  70.16  Medical review of a Federal order for quarantine, 
isolation, or conditional release.

    (a) The CDC 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 CDC's 
mandatory reassessment under Sec.  70.15 and following the issuance 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 CDC has a reasonable belief that the individual is infected 
with a quarantinable communicable disease in a qualifying stage.
    (d) The CDC shall notify the individual in writing of the time and 
place of the medical review.
    (e) The CDC 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 a representative 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 CDC shall appoint a medical representative at its 
own 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 and cannot afford a medical 
representative.
    (g) Prior to the convening of the review, the individual or his/her 
authorized representative shall be provided a reasonable opportunity, 
to examine the available medical and other

[[Page 54312]]

records involved in the medical review that pertain to that individual.
    (h) The CDC shall take such measures that it determines to be 
reasonably necessary to allow an individual under Federal quarantine or 
isolation to communicate with an authorized representative 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) In the medical reviewer's discretion, the review may be 
conducted through written submission, by telephone, or through any 
other means that the medical reviewer determines to be acceptable.
    (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 as to 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 
be served on the individual and the individual's authorized 
representative.
    (m) The Director shall, as soon as practicable, review the written 
report and any objections that may be submitted by the individual or 
the individual's authorized representative that contest the findings 
and recommendation contained in the medical reviewer's written report. 
Upon conclusion of the review, the Director 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 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 CDC 
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 representative, 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 representative, or alternatively, if applicable to a group 
of individuals and individual service would be impracticable, it is 
published or posted.
    (o) The Director 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 CDC may issue additional instructions as may be necessary 
or desirable governing the conduct of medical reviews.


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 representative, 
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 an authorized representative;
    (5) Any agreements entered into between the CDC and the individual.
    (b) An individual subject to a Federal public health order will 
upon request be served with a copy of his or her own administrative 
record in its entirety.


Sec.  70.18  Agreements.

    CDC may enter into an agreement with an individual, upon such terms 
as the CDC considers to be reasonably necessary, indicating that the 
individual consents to any of the public health measures authorized 
under this part, including quarantine, isolation, conditional release, 
medical examination, hospitalization, vaccination, and treatment; 
provided that the individual's consent shall not be considered as a 
prerequisite to the exercise of any authority under this part.


Sec.  70.19  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 Public Health Service (PHS) Act, 
as amended (42 U.S.C. 216, 243); secs. 361-369, PHS Act, as amended 
(42 U.S.C. 264-272).

0
7. Amend Sec.  71.1 by adding, in alphabetical order the definitions of 
``Agreement,'' ``Airlines,'' ``Apprehension,'' ``Commander,'' 
``Conditional release,'' ``Contaminated environment,'' ``Electronic or 
Internet-based monitoring,'' ``Ill person,'' ``Indigent,'' ``Master or 
operator,'' ``Medical examination,'' ``Medical representative,'' 
``Medical reviewer,'' ``Non-invasive,'' and ``Public health prevention 
measures,'' to read as follows:


Sec.  71.1  General Definitions

* * * * *
    (b) * * *
    Agreement means an agreement entered into between the CDC and an 
individual expressing a voluntary agreement between the parties that 
the individual will observe public health measures authorized under 
this part, as the CDC considers reasonably necessary to protect the 
public's health, including quarantine, isolation, conditional release, 
medical examination, hospitalization, vaccination, and treatment.

[[Page 54313]]

    Airline(s) means any air carrier(s) or foreign air carrier(s) 
providing air transportation or foreign air transportation, 
respectively, including scheduled or public charter passenger 
operations operating in air commerce, as these terms are defined in 49 
U.S.C. 40102,(a)(2), (a)(3), (a)(5),(a)(21), and (a)(23).
    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 CDC.
    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 electronic mail, 
SMS texts, video conference or 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 CDC.
    Ill person means an individual:
    (1) Who if onboard an aircraft:
    (i) Has a fever (a measured temperature of 100.4[emsp14][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
    (ii) Fever that has persisted for more than 48 hours; or
    (iii) Has symptoms or other indications of communicable disease, as 
the CDC may announce through posting of a notice in the Federal 
Register.
    (2) Who if onboard a vessel:
    (i) Has a fever (a measured temperature of 100.4[emsp14][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
    (ii) Has diarrhea, defined as the occurrence in a 24-hour period of 
three or more loose stools or of a greater than normal (for the person) 
amount of loose stools; or
    (iii) Has symptoms or other indications of communicable disease, as 
the CDC may announce through posting of a notice in the Federal 
Register.
    Indigent means an individual whose annual family income is below 
150% 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.
* * * * *
    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 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 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 representative means a physician, nurse practitioner, or 
similar medical professional qualified in the diagnosis and treatment 
of infectious diseases who is appointed by the HHS Secretary or CDC 
Director and may include an HHS or CDC employee, to assist an indigent 
individual under Federal quarantine, isolation, or conditional release 
with a medical review under this part.
    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 HHS Secretary or CDC 
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 health 
worker or another individual with suitable training and includes the 
physical examination of the ear, nose, and mouth; temperature 
assessments using an ear, oral, cutaneous, or noncontact thermometer, 
or thermal imaging; auscultation; external palpation; external 
measurement of blood pressure; 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.
* * * * *
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 Sec.  71.4 to read as follows:


Sec.  71.4   Requirements relating to collection, storage and 
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

[[Page 54314]]

the data elements in paragraph (b) of this section available to the CDC 
for passengers or crew who, as determined by the CDC, 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 CDC and in a format available and acceptable to both the 
airline and the CDC.
    (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.
0
10. Add Sec.  71.5 to read as follows:


Sec.  71.5   Requirements relating to collection, storage and 
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) available to the CDC for 
passengers or crew who, as determined by the CDC, 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 CDC and in a format available and acceptable to both the operator 
and the CDC.
    (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.
0
11. Add Sec.  71.20 to read as follows:


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

    (a) The CDC may conduct public health prevention measures, at U.S. 
ports of entry or other locations, through non-invasive procedures as 
defined in 42 CFR 71.1 to detect the potential presence of communicable 
diseases.
    (b) As part of the public health prevention measures, CDC 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, and travel history.
0
12. Add Sec. Sec.  71.29 and 71.30 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 representative, 
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 individual under Federal quarantine, 
isolation, or conditional release, or by an authorized representative;
    (5) Any agreements entered into between the CDC and the individual.
    (b) An individual subject to a Federal public health order will 
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 CDC 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 (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 CDC 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 
CDC 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 CDC refers the individual to the hospital or medical facility 
and ends when, as determined by the CDC, the period of apprehension,

[[Page 54315]]

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 CDC refers the individual to 
the hospital or medical facility and ends when the individual's 
condition is diagnosed, as determined by the CDC, 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 paragraph (c) to read as follows:


Sec.  71.33  Persons: Isolation and surveillance.

* * * * *
    (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 CDC 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 CDC 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 71.40 to read as follows:


Sec.  71.36  Medical examinations.

    (a) The CDC 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 CDC shall promptly arrange for the medical examination to 
be conducted when one is required under this section.
    (c) As part of the medical examination, the CDC 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 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 a CDC authorizing 
official, 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 CDC's 
reasonable belief that the individual is exposed to or infected with a 
quarantinable communicable disease;
    (4) An explanation of the process for reassessment and medical 
review of the Federal order pursuant to this part; and
    (5) An explanation of the criminal penalties for violating a 
Federal order of quarantine, isolation, or conditional release.
    (b) A Federal order authorizing quarantine, isolation, or 
conditional release shall be promptly served on the individual, 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.


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

    (a) The CDC 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 CDC 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 CDC 
shall consider whether less restrictive alternatives would adequately 
serve to protect the public health.
    (d) At the conclusion of the reassessment, the CDC 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 CDC directs 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 CDC'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.


Sec.  71.39  Medical review of a Federal order for quarantine, 
isolation, or conditional release.

    (a) The CDC 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 CDC's 
mandatory reassessment under Sec.  71.38 and following the issuance 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 CDC has a reasonable belief that the individual is infected 
with a quarantinable communicable disease.
    (d) The CDC shall notify the individual in writing of the time and 
place of the medical review.
    (e) The CDC 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 a representative 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 CDC shall appoint a medical representative at its 
own 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 and cannot afford a medical 
representative.
    (g) Prior to the convening of the review, the individual or his/her 
authorized representative 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 CDC shall take such measures that it determines to be 
reasonably necessary to allow an individual under Federal quarantine or 
isolation to

[[Page 54316]]

communicate with an authorized representative 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) In the medical reviewer's discretion, the review may be 
conducted through written submission, by telephone, or through any 
other means that the medical reviewer determines to be acceptable.
    (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 as to whether, in the medical reviewer's professional 
judgment, the Federal quarantine, isolation, or conditional release 
should continue. The written report shall be served on the individual 
and the individual's authorized representative.
    (m) The Director shall, as soon as practicable, review the written 
report and any objections that may be submitted by the individual or 
the individual's representative that contest the findings and 
recommendation contained in the medical reviewer's written report. Upon 
conclusion of the review, the Director 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 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 CDC 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 representative, 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 representative, or alternatively, if applicable to a group 
of individuals and individual service would be impracticable, it is 
published or posted.
    (o) The Director 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 CDC may issue additional instructions as may be necessary 
or desirable governing the conduct of medical reviews.


Sec.  71.40  Agreements.

    CDC may enter into an agreement with an individual, upon such terms 
as the CDC considers to be reasonably necessary, indicating that the 
individual consents to any of the public health measures authorized 
under this part, including quarantine, isolation, conditional release, 
medical examination, hospitalization, vaccination, and treatment; 
provided that the individual's consent shall not be considered as a 
prerequisite to any exercise of any authority under this part.
0
15. Add Sec.  71.63 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 CDC 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. HHS/CDC 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: July 12, 2016.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2016-18103 Filed 8-12-16; 8:45 am]
 BILLING CODE 4163-18-P