[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Rules and Regulations]
[Pages 6890-6978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00615]
[[Page 6889]]
Vol. 82
Thursday,
No. 12
January 19, 2017
Part IV
Department of Health and Human Services
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42 CFR Parts 70 and 71
Control of Communicable Diseases; Final Rule
Federal Register / Vol. 82 , No. 12 / Thursday, January 19, 2017 /
Rules and Regulations
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Parts 70 and 71
[CDC Docket No. CDC-2016-0068]
RIN 0920-AA63
Control of Communicable Diseases
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Final rule.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), within
the Department of Health and Human Services (HHS), is issuing this
final rule (FR) to amend its regulations governing its domestic
(interstate) and foreign quarantine regulations to best protect the
public health of the United States. These amendments have been made to
aid public health responses to outbreaks of new or re-emerging
communicable diseases and to accord due process to individuals subject
to Federal public health orders. In response to public comment
received, the updated provisions in this final rule clarify various
safeguards to prevent the importation and spread of communicable
diseases affecting human health into the United States and interstate.
DATES: This rule is effective February 21, 2017.
FOR FURTHER INFORMATION CONTACT: Director, Division of Global Migration
and Quarantine, Centers for Disease Control and Prevention, 1600
Clifton Road NE., MS-E03, Atlanta, GA 30329, or email
[email protected].
SUPPLEMENTARY INFORMATION: Based on public comment received to the
Notice of Proposed Rulemaking (NPRM) (81 FR 54230) this final rule,
among other things: Withdraws a provision regarding ``Agreements'' as
proposed in the NPRM, requires CDC to issue a federal order within 72
hours after apprehending an individual, increases the threshold for
those who may be considered ``indigent'' to 200% of the applicable
poverty guideline, adds a definition for ``Secretary,'' adds a
requirement for CDC to provide legal counsel for isolated or
quarantined individuals qualifying as indigent who request a medical
review, modifies the definition of ``non-invasive,'' includes ``known
or possible exposure'' in the list of information that may be collected
during a public health risk assessment, and strengthens due process
protections by ensuring that CDC will arrange for translation or
interpretation services for public health orders and medical reviews as
needed. In implementing quarantine, isolation, or other public health
measures under this Final Rule, HHS/CDC will seek to use the least
restrictive means necessary to prevent the spread of communicable
disease.
Table of Contents
I. Executive Summary
A. Purpose of the Action
B. Summary of Major Provisions
C. Summary of Costs and Benefits
II. Public Participation
III. Background
A. Legal Authority
B. Regulatory History
IV. Summary of the Final Rule
A. General References to ``CDC'' and ``Director'' in Parts 70
and 71
B. Definitions (Sec. Sec. 70.1 and 71.1(b))
C. Apprehension and Detention of Persons With Quarantinable
Communicable Diseases (70.6)
D. Medical Examinations (Sec. Sec. 70.12 and 71.36)
E. Requirements Relating to the Issuance of a Federal Order for
Quarantine, Isolation, or Conditional Release (Sec. Sec. 70.14 and
71.37)
F. Mandatory Reassessment of a Federal Order for Quarantine,
Isolation, or Conditional Release (Sec. Sec. 70.15 and 71.38)
G. Medical Review of a Federal Order for Quarantine, Isolation,
or Conditional Release (Sec. Sec. 70.16 and 71.39)
H. Administrative Records Relating to a Federal Order for
Quarantine, Isolation, or Conditional Release (Sec. Sec. 70.17 and
71.29)
I. Payment for Care and Treatment (70.13 and 71.30)
J. Agreements (Sec. Sec. 70.18 and 71.40)
K. Penalties (Sec. Sec. 70.18 and 71.2)
L. Public Health Prevention Measures To Detect Communicable
Disease (Sec. Sec. 70.10 and 71.20)
M. Requirements Relating to Travelers Under a Federal Order of
Isolation, Quarantine, or Conditional Release (Sec. 70.5)
N. Report of Death or Illness Onboard Aircraft Operated by an
Airline (Sec. 70.11)
O. Requirements Relating to Collection, Storage, and
Transmission of Airline and Vessel Passenger, Crew, and Flight and
Voyage Information for Public Health Purposes (Sec. Sec. 71.4 and
71.5)
P. Requirements Relating to Collection, Storage, and
Transmission of Airline and Vessel Passenger, Crew, and Flight and
Voyage Information for Public Health Purposes (Sec. Sec. 71.4 and
71.5)
Q. Report of Death or Illness (Sec. 71.21)
V. Overview of Public Comment to the 2016 NPRM
A. Provisions Applicable to Both Parts 70 and 71
a. General Comments
b. Scope and Authority
c. Definitions
d. Public Health Prevention Measures To Detect Communicable
Disease
e. Apprehension and Detention of Persons With Quarantinable
Communicable Diseases
f. Medical Examinations
g. Requirements Relating to Issuance of a Federal Order for
Quarantine, Isolation, or Conditional Release
h. Mandatory Reassessment of a Federal Order for Quarantine,
Isolation, or Conditional Release
i. Medical Review of a Federal Order for Quarantine, Isolation,
or Conditional Release
j. Administrative Records Relating to a Federal Order for
Quarantine, Isolation, or Conditional Release
k. Other Due Process Concerns
l. Privacy
m. Payment for Care and Treatment
n. Agreements
o. Penalties
p. Economic Impact
q. Paperwork Reduction Act
B. Provisions Applicable to Part 70 Only (Domestic)
a. General
b. Requirements Relating to Travelers Under a Federal Order of
Isolation, Quarantine, or Conditional Release
c. Report of Death or Illness Onboard Aircraft Operated by an
Airline
C. Provisions Applicable to Part 71 Only (Foreign)
a. Requirements Relating to Transmission of Airline and Vessel
Passenger, Crew, and Flight Information for Public Health Purposes
b. Suspension of Entry of Animals, Articles, or Things From
Designated Foreign Countries and Places Into the United States
VI. Alternatives Considered
VII. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
B. The Regulatory Flexibility Act
C. The Paperwork Reduction Act
D. National Environmental Policy Act (NEPA)
E. Executive Order 12988: Civil Justice Reform
F. Executive Order 13132: Federalism
G. The Plain Language Act of 2010
I. Executive Summary
A. Purpose of the Action
HHS/CDC has statutory authority (42 U.S.C. 264, 265) to promulgate
regulations that protect U.S. public health from communicable diseases,
including quarantinable communicable diseases as specified in an
Executive Order of the President. See Executive Order 13295 (April 4,
2003), as amended by Executive Order 13375 (April 1, 2005) and
Executive Order 13674 (July 31, 2014). The need for this rulemaking was
reinforced during HHS/CDC's response to the largest outbreak of Ebola
virus disease (Ebola) on record, followed by the recent outbreak of
Middle East Respiratory Syndrome (MERS), both quarantinable
communicable diseases, and repeated outbreaks and responses to measles,
a non-quarantinable communicable disease of public health concern. This
[[Page 6891]]
final rule will enhance HHS/CDC's ability to prevent the introduction,
transmission, and spread of communicable diseases into the United
States and interstate by clarifying and providing greater transparency
regarding its response capabilities and practices.
B. Summary of Major Provisions
Both the domestic and foreign portions of this regulation include
new proposed public health definitions; new regulatory language
implementing HHS/CDC's activities concerning non-invasive public health
prevention measures (i.e., traveler health screening) at U.S. ports of
entry and other U.S. locations (i.e., railway stations, bus terminals);
and provisions affording due process to persons served with a Federal
public health order (e.g., isolation, quarantine), including requiring
that HHS/CDC explain the reasons for issuing the order, administrative
processes for appealing the order, and a mandatory reassessment of the
order.
The domestic portion of this final rule includes a requirement that
commercial passenger flights report deaths or illnesses to the CDC. It
also includes a provision requiring that individuals apply for a travel
permit if they are under a Federal quarantine, isolation, or
conditional release order (unless the specific travel is authorized by
the Federal conditional release order) or if a State or local public
health department requests CDC assistance in enforcing a State or local
quarantine or isolation order. Additionally, the domestic portion of
this final rule includes new regulatory language clarifying when an
individual who is moving between U.S. states is ``reasonably believed
to be infected'' with a quarantinable communicable disease in a
``qualifying stage.'' These determinations are made when the CDC
considers the need to apprehend or examine an individual for potential
infection with a quarantinable communicable disease. The foreign
portion of this final rule includes new regulatory authority permitting
the CDC Director to prohibit the importation of animals or products
that pose a threat to public health.
HHS/CDC has also changed the text of the regulation to reflect
modern terminology, technology, and plain language used by private
industry, public health partners, and the public. The final rule also
authorizes public health monitoring through electronic or internet-
based means of communication for individuals under a Federal
conditional release order who are reasonably believed to be exposed to
or infected with a quarantinable communicable disease. This would
include communication through email and webcam application tools.
Finally, while neither modifying nor authorizing additional criminal
penalties for violations of quarantine rules and regulations, this
final rule updates regulatory language to align with existing criminal
penalties set forth in statute.
C. Summary of Costs and Benefits
The regulatory impact analysis quantitatively addresses the costs
and benefits associated with this final rule. The economic impact
analysis of this final rule is subdivided into two sections.
The first analysis summarizes the economic impact of changes to 42
CFR 70.1, 42 CFR 71.1/71.4/71.5 for which the primary costs for
submitting passenger and crew information to HHS/CDC are incurred by
airlines and vessel operators and the primary benefit is improved
public health responsiveness to assess and offer post-exposure
prophylaxis to travelers potentially exposed to communicable diseases
of public health concern. The most likely estimates of annual costs to
airlines, vessel operators, the United States government, and public
health departments are low ($32,622, range $10,959 to $430,839) because
the final rule primarily codifies existing practice or improves
alignment between existing regulatory text and the International Civil
Aviation Organization (ICAO)'s guidelines for symptoms to report. The
cost estimates in this final rule are based on (1) an anticipated small
increase in the number of illness reports delivered by airlines and
processed by HHS/CDC and (2) increased costs for airlines and vessel
operators to comply with HHS/CDC orders for traveler and crew contact
data, to the extent that such information is readily available and
already maintained, and not already transmitted to the U.S. Customs and
Border Protection (CBP). The cost estimate also includes an increase in
costs for public health departments to contact more exposed travelers
due to the availability of improved contact data.
The best estimate of the annual quantified benefits of the final
rule are $110,045 (range $26,337 to $297,393) and mostly result from
increased efficiencies for HHS/CDC and State and local public health
departments to conduct contact investigations among travelers on an
aircraft exposed to communicable diseases of public health concern,
especially for measles and tuberculosis. To the extent that improved
responsiveness of airlines to HHS/CDC traveler data orders may result
from the implementation of the provisions in this final rule, HHS/CDC
may become better able to respond to infectious diseases threats and
(1) reduce case-loads during infectious disease outbreaks, (2) reduce
public anxiety during disease outbreaks, (3) mitigate economic impacts
on businesses as a consequence of reduced public anxiety associated
with quarantinable communicable disease outbreaks initiated by
international travelers (such as have been observed during outbreak of
severe acute respiratory syndrome in Canada or Middle East respiratory
syndrome in South Korea), and (4) reduce the amount of personnel labor
time to conduct large-scale contact investigations in response to a new
infectious disease or one with larger scale public health and medical
consequences like Ebola.
The second analysis in this final rule is of a number of provisions
that aim to improve transparency of how HHS/CDC uses its regulatory
authorities to protect public health. HHS/CDC believes that improving
the quality of its regulations by providing clearer explanations of its
policies and procedures is an important public benefit. However, HHS/
CDC is not able to attach a dollar value to this added benefit in a
significant way.
II. Public Participation
On August 15, 2016, HHS/CDC published a notice of proposed
rulemaking (NPRM) (81 FR 54299) to amend 42 CFR part 70 (interstate)
and 42 CFR part 71 (foreign) quarantine regulations. The public was
invited to comment on these amendments. The comment period ended
October 14, 2016. In the NPRM, HHS/CDC specifically requested public
comment on the following:
Whether the use of the standard definition of ``indigent''
is an appropriate threshold to determine whether an individual cannot
afford representation and therefore should be appointed a medical
representative at the government's expense and whether the public
believes that there may be non-indigent individuals, as defined in the
NPRM, who may have difficulty affording a representative;
The definition of public health emergency and its utility
in identifying communicable diseases that ``would be likely to cause a
public health emergency if transmitted to other individuals'' under 42
U.S.C. 264(d)(2)(B);
Requirements relating to travelers under a Federal order
of isolation, quarantine, or conditional release; specifically, on
whether stakeholders
[[Page 6892]]
have concerns regarding the requirement imposed on conveyance operators
to not ``knowingly'' transport individuals under a Federal order and
the feasibility of this requirement and the application of this
provision to individuals under State/local order as well as individuals
traveling entirely within a State.
Public health prevention measures and whether the public
has any concerns regarding the mandatory health screening of passengers
using non-invasive means as defined in the proposal or the collection
of personal information from screened individuals for the purposes of
contact tracing;
Payment for care and treatment, and whether there are any
concerns that all third party payments be exhausted prior to the
Federal reimbursement of medical care or treatment for individuals
placed under a Federal order for quarantine, isolation, or conditional
surveillance;
The application of requirements relating to issuance of a
Federal order for quarantine, isolation or conditional release as it
applies to groups and whether this provision sufficiently informs the
public of the important details concerning circumstances during which
HHS/CDC would issue to groups or individuals Federal orders for
quarantine, isolation, and conditional release and the duration and
conditions of such orders;
Whether 72 hours is the necessary amount of time to
conduct a reassessment after a Federal order is first issued, or if the
reassessment should take place earlier or later;
Whether or not the public sees a role for the Federal
government to ensure that basic living conditions, amenities, and
standards are satisfactory when placing individuals under Federal
orders;
Whether the definition of ``non-invasive'' aligns with
common perceptions of what constitutes non-invasive procedures that may
be conducted outside of a traditional clinical setting;
Whether the penalties proposed, and the circumstances
under which such penalties may be imposed, were clearly explained;
The applicability of the December 13, 2007 system of
records notice (SORN) to the activities proposed (72 FR 70867), and
whether the SORN sufficiently addresses the public's concerns related
to maintenance and protection of the data elements proposed;
The request for a passenger and crew manifest within 24
hours and whether the provision grants operators of airlines sufficient
time for operators to respond to manifests orders;
The likelihood that the passenger and crew data elements
requested are already collected and maintained by airline operators for
transmission to CDC;
Any industry concerns regarding whether proposed section
71.63 sufficiently details the circumstances under which HHS/CDC may
impose an embargo on the importation of animals, articles, or things,
including how such an embargo would be implemented, as well as any
concerns regarding coordination with other Federal agencies.
The public comment period for the proposed rule ended on October
14, 2016 and HHS/CDC received 15,800 comments from individuals,
stakeholders, and groups. A summary of those comments and responses to
those comments are found at Section IV, below.
II. Background
A. Legal Authority
The primary legal authorities supporting this rulemaking are
sections 361 and 362 \1\ of the Public Health Service Act (42 U.S.C.
264, 265). HHS/CDC also believes that the following Public Health
Service Act sections are relevant with respect to this rulemaking:
section 311 (42 U.S.C. 243), section 321 (42 U.S.C. 248), section 322
(42 U.S.C. 249), section 365 (42 U.S.C. 268), and sections 367-69 (42
U.S.C. 270-72). A detailed explanation of these legal authorities was
provided in the NPRM published at 81 FR 54230 (Aug. 15, 2016).
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\1\ Section 3 of Executive Order 13295 (April 4, 2003) states
that the functions of the President under sections 362 and 364(a) of
the Public Health Service Act (42 U.S.C. 265 and 267(a) are assigned
to the HHS Secretary.
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B. Regulatory History
On August 15, 2016, HHS/CDC published a Notice of Proposed
Rulemaking to update 42 CFR 70 (domestic) and 42 CFR 71 (foreign)
quarantine regulations. These amendments were proposed to aid public
health responses to outbreaks of communicable disease, such as the
largest outbreak of Ebola virus disease (Ebola) on record, Middle East
Respiratory Syndrome (MERS), both quarantinable communicable diseases,
and repeated outbreaks of measles in the United States, a non-
quarantinable communicable disease of public health concern. (81 FR
54299). Communicable diseases of public health concern are those
diseases that because of their potential for spread, particularly
during travel, may require a public health intervention. The provisions
contained within the proposal were designed to enhance HHS/CDC's
ability to prevent the further importation and spread of communicable
diseases into the United States and interstate by clarifying HHS/CDC's
response capabilities, practices, and making them more transparent.
III. Summary of the Final Rule
Upon consideration of public comment, the following is a section-
by-section summary of the changes from the proposed text that HHS/CDC
made to parts 70 and 71:
A. General References to ``CDC'' and ``Director'' in Parts 70 and 71
Throughout the regulatory text in parts 70 and 71, references to
``CDC'' or ``HHS/CDC'' have been replaced with ``Director.'' This is in
keeping with the common practice that federal agencies act through
employees and officials to whom the authority involved has been
delegated. Director is currently defined in sections 70.1 and 71.1 to
mean ``the Director, Centers for Disease Control and Prevention,
Department of Health and Human Services, or another authorized
representative as approved by the CDC Director or the Secretary of
HHS.'' Where it is necessary to exclude CDC employees or officials from
undertaking certain functions this has been indicated by use of
parenthesis, e.g., ``Director (excluding the CDC official who issued
the quarantine, isolation, or conditional release order).'' This is a
stylistic change from the NPRM, but does not result in a substantive
change in the final rule.
B. Definitions (Sections 70.1 and 71.1(b))
The definition of Agreements has been removed.
The definition of Electronic or internet-based monitoring
has been modified to include ``communication through'' these means and
``audio'' conference.
The definition of Indigent has been modified to increase
the threshold to 200% of the applicable poverty guidelines.
The definition of Ill person under section 71.1 has been
modified to include a person who ``Has a fever that has persisted for
more than 48 hours'' or ``Has acute gastroenteritis, which means either
diarrhea, defined as three or more episodes of loose stools in a 24-
hour period or what is above normal for the individual, or vomiting
accompanied by one or more of the following: One or more episodes of
loose stools in a 24-
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hour period, abdominal cramps, headache, muscle aches, or fever
(temperature of 100.4[emsp14][deg]F [38[deg]C] or greater).'' This
language was quoted verbatim in the preamble of the NPRM at 81 FR 54305
but was inadvertently omitted from the proposed regulatory text.
The definition of Medical Examination has been modified to
indicate that the health worker conducting the assessment must be
``licensed.''
The definition of Medical Representative has been changed
to Representatives and now includes for an indigent individual the
additional appointment of ``an attorney who is knowledgeable of public
health practices'' if the indigent individual requests a medical
review.
The definition of Non-invasive has been modified to: (1)
Replace ``physical examination'' with ``visual examination;'' (2)
specify that the individual performing the assessment must be a
``public health worker (i.e., an individual with education and training
in the field of public health)''; and (3) remove ``auscultation,
external palpation, external measurement of blood pressure.''
A definition for Secretary has been added. Secretary means
the Secretary of Health and Human Services (HHS) or any other officer
or employee of that Department to whom the authority involved has been
delegated. We note that while the NPRM did not propose this definition,
the NPRM referenced the Secretary in defining Public Health Emergency.
Thus, HHS/CDC considers it useful to also define the term Secretary.
C. Apprehension and Detention of Persons With Quarantinable
Communicable Diseases (Section 70.6)
This provision is has been finalized as proposed, with the
exception that references to CDC have been replaced with Director
throughout this section. HHS/CDC has also added a requirement that the
Director arrange for adequate food and water, appropriate
accommodation, appropriate medical treatment, and means of necessary
communication, for individuals who are apprehended or held in
quarantine or isolation. Similar language has been added to an
analogous provision at Section 71.33(a).
D. Medical Examinations (Sections 70.12 and 71.36)
These provisions are finalized as proposed, with the exception that
references to CDC have been replaced with Director throughout this
section. HHS/CDC has also added a requirement that the Director, as
part of the Federal order, advise the individual that the medical
examination shall be conducted by an authorized and licensed health
worker with prior informed consent.
E. Requirements Relating to the Issuance of a Federal Order for
Quarantine, Isolation, or Conditional Release (Sec. Sec. 70.14 and
71.37)
Paragraphs (a)(5) and (a)(4) of these provisions have been
modified, respectively, to require that the Federal order include an
explanation that the Federal order will be reassessed no later than 72
hours after it has been served and an explanation of the right to
request a medical review, present witnesses and testimony at the
medical review, and to be represented at the medical review by either
an advocate (e.g., an attorney, family member, or physician) at the
individual's own expense, or, if indigent, to have representatives
appointed at the government's expense. Paragraph (b) of these
provisions has been modified to require that a Federal public health
order be served within 72 hours of an individual's apprehension.
Paragraph (c) has been modified to require that the Director arrange
for translation or interpretation services of the Federal order as
needed. References to CDC have been replaced with Director throughout
this section.
F. Mandatory Reassessment of a Federal Order for Quarantine, Isolation,
or Conditional Release (Sec. Sec. 70.15 and 71.38)
These provisions have been modified to include paragraph (g) which
states that the Director shall arrange for translation or
interpretation services of the Federal order as needed. References to
CDC have been replaced with Director throughout this section.
G. Medical Review of a Federal Order for Quarantine, Isolation, or
Conditional Release (Sec. Sec. 70.16 and 71.39)
Paragraph (f) of these provisions has been modified to reference
``Representatives,'' consistent with the change in definition.
Paragraph (f) of these provisions has also been modified to remove,
``and cannot afford a medical representative'' because this language is
duplicative and unnecessary if the individual has already qualified as
indigent. Paragraph (k) of these provisions has been modified to state:
``The medical review shall be conducted by telephone, audio or video
conference, or through other means that the medical reviewer determines
in his/her discretion are practicable for allowing the individual under
quarantine, isolation, or conditional release to participate in the
medical review.'' These provisions have also been modified to include
paragraph (q) which states that the Director shall arrange for
translation or interpretation services as needed for purposes of this
section. References to CDC have been replaced with Director throughout
this section.
H. Administrative Records Relating to a Federal Order for Quarantine,
Isolation, or Conditional Release (Sec. Sec. 70.17 and 71.29)
These sections have been modified to remove paragraphs (5)
regarding agreements between CDC and the individual.
I. Payment for Care and Treatment (Sec. Sec. 70.13 and 71.30)
These provisions have been finalized as proposed, with the
exception that references to CDC have been replaced with Director
throughout this section.
J. Agreements (Sec. Sec. 70.18 and 71.40)
These provisions have been removed.
K. Penalties (Sec. Sec. 70.18 and 71.2)
The content of these provisions has been finalized as proposed.
Proposed Sec. 70.19 Penalties has been moved to Sec. 70.18, since
proposed Sec. 70.18 Agreements has been removed from this final rule.
L. Public Health Prevention Measures To Detect Communicable Disease
(Sec. Sec. 70.10 and 71.20)
Paragraph (b) has been modified to include ``known or possible
exposure'' information to the list of information that may be
collected. References to CDC have been replaced with Director
throughout this section.
M. Requirements Relating to Travelers Under a Federal Order of
Isolation, Quarantine, or Conditional Release (Section 70.5)
Paragraph (a), (a)(4), (b)(1), (b)(2), and (c) of this provision
have been modified to remove ``agreements.'' Paragraph (d) has been
modified to add ``to individuals traveling entirely intrastate and to
conveyances that may transport such individuals.'' The language in
paragraph (d) was discussed in the NPRM at 81 FR 54243 and public
comment concerning intrastate application of this provision was
explicitly solicited. The language, however, was inadvertently omitted
from the regulatory text. References to CDC have also been replaced
with Director throughout this section. In response to public comments,
HHS/CDC
[[Page 6894]]
has included a requirement that the Director respond to a request for a
travel permit within five (5) business days and to an appeal under this
section within three (3) business days. Public comments concerning this
provision are addressed below.
N. Report of Death or Illness Onboard Aircraft Operated by an Airline
(Sec. 70.11)
This provision has been finalized as proposed, with the exception
that references to CDC have been replaced with Director throughout this
section.
O. Requirements Relating to Transmission of Airline and Vessel
Passenger, Crew, and Flight and Voyage Information for Public Health
Purposes (Sec. 71.4 and 71.5)
These provisions have been finalized as proposed, with the
exception that the title has been modified to remove references to
collection and storage of information to more accurately reflect the
requirements under this section and references to CDC have been
replaced with Director throughout this section.
P. Suspension of Entry of Animals, Articles, or Things From Designated
Foreign Countries and Places Into the United States (Sec. 71.63)
This provision has been finalized as proposed with the exception
that references to CDC have been replaced with Director throughout this
section.
Q. Report of Death or Illness (Sec. 71.21)
The title of this provision has been finalized as proposed, to
remove the word ``Radio.''
V. Overview of Public Comments to the 2016 NPRM
On August 15, 2016 HHS/CDC published a Notice of Proposed
Rulemaking proposing to amend the current interstate (domestic) and
foreign quarantine regulations for the control of communicable
diseases. The NPRM included a 60-day public comment period and during
this time, HHS/CDC received 15,800 comments from individuals, groups,
organizations, industry, and unions. Comments were both in support of
and in opposition to the regulation. Many public comments expressed
concern that these updated regulations sought to compel medical
treatment or vaccination without patient consent. One association
stated its strong objection ``to the coercive imposition of treatment,
including vaccination, without the genuine consent of the patient.''
HHS/CDC begins this section by stating that these regulations do
not compel vaccination or involuntary medical treatment. In keeping
with current practice, HHS/CDC will continue to recommend care and
treatment, including post-exposure prophylaxis when indicated, to
individuals who are either sick with or at risk of disease following
exposure to a communicable disease of public health concern.
HHS/CDC also received comments relating to immigration policy and
regulations, issues of citizenship, border security, religion, personal
testimony regarding adverse vaccine events, and requests to apply these
regulations only to individuals who are not citizens of the United
States. These comments are beyond the scope of this final rule and have
not been included in this discussion. However, HHS/CDC notes that it
will continue to apply communicable disease control and prevention
measures uniformly to all individuals in the United States, regardless
of citizenship, religion, race, or country of residency.
HHS/CDC also received public comment regarding disinsection (i.e.,
measures to control or kill insect vectors of disease) and fumigation
procedures, citing HHS/CDC's statutory authorities relating to
inspection, fumigation, and pest extermination. We note that while HHS/
CDC maintains regulations at 42 CFR 70.2 and 71.32(b) implementing this
statutory authority, such comments are outside of the scope of this
final rule, which did not include proposed changes to these regulatory
provisions.
The following is a discussion of public comments received that are
applicable and within the scope of the regulation. Topics including:
Accountability, Administrative Records, Agreements, Apprehension,
Authority (including Scope), Conditional Release, Constitutional Issues
(including Amendments, Court Cases, and Habeas Corpus), Data
Collection, Definitions, Detention, Due Process, Economic Impact,
Electronic Monitoring, Exposure, Informed Consent, Least Restrictive
Means, Minors, Medical Assessments, Examination, Notice, Penalties,
Privacy, Qualifying Stage, Quarantine, Quarantinable Communicable
Diseases List, and others are discussed.
A summary of comments and a response to those comments are found
below, organized by general and specific comments that apply to both
parts 70 and 71, comments that only apply to part 70 (interstate), and
comments that only apply to part 71 (foreign).
A. Provisions Applicable to Both Parts 70 and 71
a. General Comments
Since posting the proposed regulation on August 15, 2016, HHS/CDC
received 15,800 public comments. HHS/CDC received several comments from
individuals, groups, or industry requesting to extend the 60-day
comment period. In light of the number of comments submitted, HHS/CDC
has determined that a 60-day comment period was both fair and
sufficient to adequately inform the public of the contents of this
rulemaking, allow the public to carefully consider the rulemaking, and
receive informed public feedback. Thus, HHS/CDC declines to reopen the
comment period.
Several commenters requested that HHS/CDC withdraw the NPRM in its
entirety. A non-profit organization stated that the ``NPRM would be, if
adopted, a direct and onerous infringement of the personal liberties of
Americans and an unnecessary aggressive method of assisting in the
control of communicable disease.'' Another commenter said that the
``NPRM is premature.'' HHS/CDC disagrees and declines to withdraw the
proposal in its entirety because it contains important measures that
will aid the public health response to prevent the introduction,
transmission, and spread of communicable diseases into and within the
United States. Moreover, in the spirit of transparency, these measures,
which are largely current practice, are being published and codified to
make the public aware of their use.
HHS/CDC received a comment from a partnership of public health
legal scholars and organizations stating that it should promulgate a
separate rule guaranteeing humane conditions of confinement. HHS/CDC
disagrees that such a separate rule is needed and believes that the
current final rule adequately addresses these concerns, as discussed in
detail below.
HHS/CDC received a comment that the proposed rule does not comply
with Executive Order 12866 because there is no public need for the rule
and it did not adequately assess the costs and benefits of the rule,
including the alternative of not regulating. HHS/CDC disagrees. As
discussed in detail below, this rule describes the public health
measures that may be used in response to outbreaks of communicable
diseases, such as the recent largest recorded outbreak of Ebola. The
economic impact analysis has been clarified to more clearly
differentiate quarantinable and non-quarantinable diseases. The
[[Page 6895]]
economic impact analysis also examines the costs and benefits of the
Final Rule measured against current practices (i.e., a status quo
baseline). Both the costs and benefits of this Final Rule are small
because the provisions set forth are primarily a codification of
current practices, based on existing regulatory authorities.
A public health research center commented that there is no evidence
that measures employed at points of entry were effective during the
response to the 2014-2016 Ebola outbreak and that HHS/CDC is attempting
to codify these ineffective practices for use in future disease
outbreaks. They further noted that despite greater than 99% complete
monitoring, zero cases of Ebola were detected among those monitored.
HHS/CDC appreciates this comment and recognizes the challenges
presented by measuring the benefits of prevention in public health.
HHS/CDC disagrees that the measures employed in response to the
2014-16 Ebola outbreak were ineffective and that it is seeking to
codify ineffective measures. HHS/CDC considers more than 99% complete
monitoring a successful effort in State and Federal cooperation in
response to an unprecedented outbreak of Ebola. Second, rather than the
number of cases detected, HHS/CDC considers the key metrics of
effectiveness to be the number of people who were able to continue to
travel safely without fear of disease spread and the ability to
facilitate rapid isolation and evaluation of the approximately 1400
individuals who developed illness compatible with Ebola during the 21-
day monitoring period. Finally, we note that this commenter limited his
or her statement to HHS/CDC measures put into place at U.S. ports of
entry during the Ebola response.
The enhanced public health risk assessment protocol put into place
at U.S. ports of entry in response to the Ebola outbreak was one part
of a layered risk mitigation program to prevent the importation and
spread of Ebola within the United States, which included exit screening
in the affected countries as recommended by the World Health
Organization (WHO) (see Statement on the 1st meeting of the
International Health Regulations [IHR] Emergency Committee on the 2014
Ebola outbreak in West Africa 8/8/2014) and a reliance on air industry
partners for detection and reporting of potentially ill travelers prior
to arrival.
The enhanced entry risk assessment process was instituted after an
individual infected with Ebola entered the United States and
transmitted the disease. This case demonstrated that the processes then
in place to prevent departure of individuals exposed to or infected
with Ebola in affected West African countries could not detect persons
who were exposed but were unaware of or denied such exposure and were
potentially incubating the infection. To further reduce the risk of
introduction and spread, HHS/CDC recommended monitoring of all
potentially exposed individuals by a public health authority through
the 21-day risk period after potential exposure, rather than relying on
previously recommended self-monitoring. Monitoring was viewed as the
least restrictive alternative to widespread quarantine and travel bans
demanded by some members of the public that would ultimately have
hampered the response efforts in West Africa and domestically. HHS/CDC,
along with its Federal and State partners, implemented an entry process
by which individuals identified as having recently traveled to, from,
or through an affected country entered through five ports of entry
where public health staff and partners were stationed, submitted
accurate and complete contact information, were checked for symptoms,
and were provided answers to Ebola risk assessment questions.
This was done for several reasons:
To ensure that any individual entering the United States
who could have been exposed to or infected with Ebola in a country
experiencing an Ebola outbreak was identified and reported to the State
and local health department of final destination so that, if the
individual became ill, State or local health departments could rapidly
notify healthcare providers prior to the individual's arriving at a
hospital. This process was designed specifically to prevent unknowing
individuals from exposing others such as occurred in Texas when a
patient exposed two healthcare workers.
While HHS/CDC acknowledges that a public health worker may
be unlikely to encounter someone with symptoms at the moment of entry
because of the 21-day incubation period, individuals coming from the
outbreak countries frequently traveled for well over 24 hours and in
many cases had itineraries that involved interstate movement within the
United States. The odds of developing symptoms during that travel, and
potential onward travel, were considered non-trivial, and public health
measures to detect symptoms upon entry were considered warranted given
the serious morbidity and costs associated with Ebola.
The risk assessment at the limited ports of entry provided
an important opportunity for HHS/CDC to stratify the risk of developing
Ebola for every individual who entered from the affected countries. It
allowed HHS/CDC to work with State and local health departments in
implementing the least restrictive means of monitoring individuals for
development of symptoms. HHS/CDC notes that there were no Federal
quarantine orders issued because of the availability of monitoring
options provided by State and local authorities under the Interim U.S.
Guidance for Monitoring and Movement of Persons with Potential Ebola
Virus Exposure.
The encounter also provided an opportunity to provide
travelers with educational materials, orientate them to the monitoring
program (Check and Report Ebola (CARE)), and facilitate reporting of
the traveler's health status to State and local health departments.
The enhanced entry risk assessment and monitoring process described
above was developed in response to the epidemiological profile of Ebola
and the complexities of a 21-day incubation period. However, in the
event of an outbreak of a different communicable disease requiring
enhanced assessment or monitoring of travelers (whether quarantinable
or non-quarantinable), HHS/CDC, in concert with Federal and State
partners, may implement a different system of risk assessment and
monitoring. HHS/CDC would tailor the program in accordance with the
scientific evidence of the situation and the utility and feasibility of
the program given the availability of resources.
The same public health research center commented that employing
non-evidence-based measures is contrary to the United States'
international legal agreements, specifically mentioning the public
health measures implemented during the response to Ebola as they
pertain to the International Health Regulations (IHR 2005). The
commenter further stated that given the absence of evidence to support
the use of travel monitoring and quarantine, HHS/CDC should proceed
cautiously before employing these measures in the future.
Having addressed the commenter's concern regarding the evidence of
the effectiveness of public health measures at ports of entry above,
HHS/CDC concurs with the commenter that the use of quarantine and
travel restrictions, in the absence of evidence of their utility, is
detrimental to efforts to combat the spread of communicable disease.
However, HHS/CDC disagrees that it used non-evidence based measures in
contravention of the IHR.
[[Page 6896]]
To the contrary, HHS/CDC used the best available science and risk
assessment procedures in designing a port of entry risk assessment and
management program that took into account available resources,
circumstances in the countries with Ebola outbreaks, and principles of
least restrictive means to successfully ensure that measures to ban
travel between the United States and the affected countries were
unnecessary. These measures would have negatively impacted the efforts
to combat Ebola in the region and would have had dramatic negative
implications for travelers and industry.
Furthermore, the measures did not unduly affect travel or trade
beyond the voluntary changes made by industry and travelers. HHS/CDC
believes that CDC's entry risk assessment and management program was
appropriate, commensurate with the risk, and consistent with the
following WHO recommendation: ``[Member] States should be prepared to
detect, investigate, and manage Ebola cases; this should include
assured access to a qualified diagnostic laboratory for Ebola and,
where appropriate, the capacity to manage travelers originating from
known Ebola-infected areas who arrive at international airports or
major land crossing points with unexplained febrile illness.'' WHO
Statement on the 1st meeting of the IHR Emergency Committee on the 2014
Ebola outbreak in West Africa (Aug. 8, 2014). Travelers were assessed
for risk on an individual basis upon entry; and any individual who met
the pre-defined symptom threshold (based on exposure level) was
medically evaluated and referred to care as needed. No Federal
quarantine orders were issued for the duration of the response because
HHS/CDC in coordination with State and local public health authorities
was able to tailor its interventions to allow onward travel.
Future outbreaks may necessitate a different combination of public
health measures at ports of entry. In those circumstances, HHS/CDC will
use the best available science to assess the risk of importation and
spread within the United States.
One commenter suggested that if HHS/CDC were to apply the
``Precautionary Principle,'' it would not promulgate these regulations.
HHS/CDC notes first that the ``precautionary principle,'' often
described as the avoidance of harm when there is scientific uncertainty
about risks, originated in environmental contexts and remains largely
associated with environmental issues. Invoking the precautionary
principle in an environmental context, for instance, places the onus on
those considering a potentially harmful action, such as drilling or
mining near a watershed, to prove its safety in advance. The principle
may be used by policy makers to justify discretionary decisions in
situations where there is the possibility of harm from making a certain
decision (e.g. taking a particular course of action) when extensive
scientific knowledge on the matter is lacking.
HHS/CDC disagrees that this regulation will have harmful effect or
that these measures lack a scientific basis for protecting public
health. In fact, as described above regarding the response efforts to
the 2014-2016 Ebola response, HHS/CDC has successfully employed the
measures outlined in this regulation for many years. Again, the
provisions outlined through this regulation are not new practices, nor
new authorities, but a codification of HHS/CDC practice to protect
public health.
One commenter suggested that education on healthy practices would
be more effective than regulatory provisions. Another commenter stated
that our immune systems would ward off communicable disease if we
encourage clean water, adequate shelter, effective sewage treatment,
and nutritious food. HHS/CDC agrees that these necessities are
important to public health, and we rely on health communication often
to educate the public on how to protect themselves and others from
certain communicable diseases. For example, HHS/CDC routinely advises
people with seasonal influenza to stay home from work and school, to
cover their coughs and sneezes, and to wash their hands. HHS/CDC also
works with State, local, and airport authorities in posting health
education materials for the public. However, in certain circumstances,
when a communicable disease poses a severe health threat to others,
additional measures may be needed to protect the public's health. This
is particularly important in situations when the infectious individual
has disregarded public health recommendations by, for example, refusing
to take prescribed medications to treat infectious tuberculosis or
traveling while infectious. In such situations, it may be necessary to
use public health authorities to require the individual to remain in
isolation or to prevent travel to protect the public's health.
HHS/CDC received a few comments suggesting that publication of the
NPRM in the Federal Register was not sufficient to inform the public of
these proposed updates. One comment questioned why the proposed
regulations were not more widely disseminated through media outlets. In
response, HHS/CDC notes that Federal courts have long recognized that
publication in the Federal Register is legally sufficient for giving
affected persons notice of proposed rulemaking. See Federal Crop Ins.
Corp. v. Merrill, 332 U.S. 380, 385 (1947) (``Congress has provided
that the appearance of rules and regulations in the Federal Register
gives legal notice of their contents.''). The Federal Register, within
the National Archives and Records Administration, is the official
publication for all Federal agency rules, proposed rules, and notices
of Federal agencies and organizations, as well as for Executive Orders
and certain other presidential documents. Individuals interested in
obtaining more information regarding HHS/CDC's regulatory processes,
including input provided by persons and organizations, may examine the
regulatory docket or submit a request through the Freedom of
Information Act.
HHS/CDC received a comment stating that HHS/CDC should, by
regulation, provide sufficient public health justification for
screening practices to support its proposed public health prevention
measures at ports of entry. While HHS/CDC agrees that it should provide
sufficient public health justification for large-scale screening
practices, HHS/CDC disagrees that this justification should be
formalized in regulations. During the 2014-2016 Ebola epidemic, HHS/CDC
issued Interim U.S. Guidance for Monitoring and Movement of Persons
with Potential Ebola Virus Exposure to assist HHS/CDC staff and public
health partners engaged in the response. The guidance provided public
health authorities and partners with recommendations for monitoring
people potentially exposed to Ebola and for evaluating their intended
travel, including the application of movement restrictions when
necessary. From August 2014-December 2015, the guidance was accessed
online approximately 334,000 times, with more than 88,000 views during
the first 4 days after the October 2014 update that added
recommendations for active monitoring and clarified travel and movement
restriction recommendations. Updates to the guidance to accommodate new
information and changes in the outbreak situation continued through
2015. The guidance was retired on February 19, 2016, when more than 45
days had passed since Guinea was declared free of Ebola virus
transmission, signaling widespread human-to-human transmission in the
[[Page 6897]]
affected countries was at an end. Formalizing this guidance in
regulation would have deprived HHS/CDC of the needed flexibility to
respond to public health events as they occurred, would have proved
administratively burdensome and unnecessary, and would have potentially
delayed prevention measures therefore resulting in a less effective
response. HHS/CDC will consider the need for similar guidance during
future outbreaks taking into account the extent of the outbreak and the
risk of importation and spread of disease into the United States.
HHS/CDC received several comments suggesting that the proposed
regulations were not written in plain language and were therefore
difficult to understand. One commenter also noted errors in the
document such as hyperlinks, references, and footnotes. This commenter
also reviewed the NPRM for inconsistencies, conflicts, missing
definitions, misleading language, and ambiguities. HHS/CDC thanks these
commenters for the input. We have developed communication materials and
published them to our Web site to help facilitate the review and
comprehension of these documents. Interested persons should see http://www.cdc.gov/quarantine/notice-proposed-rulemaking-control-communicable-diseases.html.
One commenter opposed the rule because of a perceived negative
social impact upon individuals placed under a public health order. We
respond that one compelling reason for the publication of this final
rule is to make the public aware of these measures so that the words,
purposes, and meanings of ``quarantine'' and ``isolation'' become more
familiar and less likely to cause public anxiety and stigmatization.
HHS/CDC received comments suggesting that, to best prevent the
introduction of communicable diseases into the U.S., individuals who
travel to or originate in countries with high risk of communicable
disease should not be allowed to enter (or return to) the United
States. On March 27, 2015, HHS/CDC published a Notice in the Federal
Register titled Criteria for Recommending Federal Travel Restrictions
for Public Health Purposes, Including for Viral Hemorrhagic Fevers. See
80 FR 16400 (Mar. 27, 2015). The Notice describes the tools the Federal
government has to ensure that people who pose a public health risk do
not board flights or enter the United States without a public health
evaluation. See 80 FR 16400 (Mar. 27, 2015). It is the policy of HHS/
CDC to work with the Department of State, and any other relevant
Federal and State agencies to ensure infected U.S. citizens seeking to
return to the U.S. do so in a manner that does not place the public at
risk.
A few commenters expressed concern, as parents or guardians, about
their rights with respect to children or minors. Specifically, these
commenters wondered whether children/minors would be separated from
parents/guardians during a public health risk assessment. HHS/CDC
thanks the commenters for these questions and appreciates the
opportunity to respond. In response, HHS/CDC notes that these
regulations do not limit the rights that parents or guardians may have
over minor children, including the right to make medical decisions.
Notwithstanding, children are included in the definition of
``individuals'' as used in these regulations and thus minor children
may be subject to apprehension, detention, examination, and conditional
release for quarantinable communicable diseases to the same extent as
adults. In such rare circumstances, HHS/CDC will work with the child's
parent or guardian to ensure that the rights accorded to any individual
subject to Federal isolation or quarantine, such as the opportunity for
an administrative medical review, are adequately protected.
In addition, and in keeping with standard public health practice,
parents or guardians while in the presence of infected minor children
may be required to adhere to infection control precautions for their
own protection. Such protections may include wearing personal
protective equipment (such as a mask) while in close proximity to the
child/minor to avoid further transmission of the illness. In extremely
rare circumstances, such as a child infected with Ebola, the risk may
be too great to allow a parent to remain with a child; however, every
effort will be made to facilitate communication between a parent and a
minor child through the least restrictive means, for example, through
the use of technology.
One commenter asked about HHS/CDC obtaining the consent of a parent
or legal guardian prior to the medical examination, quarantine, or
treatment of minors. We respond that HHS/CDC will adhere to all
applicable laws regarding the medical examination or treatment of
minors. If minors are traveling unaccompanied by a parent or legal
guardian and are believed to be infected with or exposed to a
quarantinable communicable disease, HHS/CDC will use its best efforts
to contact a parent or guardian to obtain consent prior to medical
examination. In addition, HHS/CDC will not restrict a minor's ability
to communicate with family or legal counsel hired by the minor's parent
or legal guardian. As explained further below, HHS/CDC will appoint
representatives, including a medical representative and an attorney, if
the individual (including a minor's parent or legal guardian) is
indigent and requests a medical review. HHS/CDC clarifies, however,
that the public health measures included in this final rule, including
apprehension, examination, quarantine, and isolation, do not require a
parent or legal guardian's consent as a prerequisite to their
application. However, in response to concerns about informed consent,
HHS/CDC has added regulatory language requiring that the Director
advise the individual that if a medical examination is required as part
of a Federal order that the examination will be conducted by an
authorized and licensed health worker with prior informed consent.
b. Scope and Authority
HHS/CDC received comments from the public questioning whether HHS/
CDC is a part of the Federal government and has the authority to
propose and promulgate regulations, or whether the Agency is a private
entity. The ``Communicable Disease Center'' became part of the U.S.
Public Health Service on July 1, 1946 and is an Agency within the U.S.
Department of Health and Human Services. For more information on the
history of CDC, please see http://www.cdc.gov/museum/timeline/index.html.
HHS/CDC received numerous comments from the public seeking clarity
on the scope of authority the Agency has to take actions described in
this regulation. Specifically, HHS/CDC received comments questioning
whether the authority to detain an individual may be exercised by a
Federal agency of government, instead of the U.S. President or
Congress. Several commenters specifically questioned whether the
wording of the regulation was too ``general'' and expressed concern
over its potential for abuse. A public health organization recommended
that HHS/CDC's authority should be limited only to those diseases
listed by Executive Order as quarantinable communicable diseases. An
association suggested that the proposed rule would vastly increase the
authority of HHS/CDC. One individual stated that this regulation is an
attempt by HHS/CDC to evade Congress. One organization speculated that
HHS/CDC plans to request that the list of quarantinable communicable
diseases be expanded ``to include measles and other vaccine targeted
diseases for the purpose of
[[Page 6898]]
apprehending and quarantining travelers entering the US or traveling
between States, who have not been vaccinated with MMR (measles-mumps-
rubella vaccine) and other Federally recommended vaccines.''
In response, HHS/CDC first notes that it cannot--and will not--act
beyond the scope of authority granted by Congress in statute; HHS/CDC
offers the following clarifications. Under section 361(a) of the Public
Health Service Act (42 U.S.C. 264(a)), the HHS Secretary is authorized
to make and enforce regulations as in the Secretary's judgment are
necessary to prevent the introduction, transmission, or spread of all
communicable diseases from foreign countries into the States or
possessions of the United States and from one State or possession into
any other State or possession. Under section 361(b)(42 U.S.C. 264(b)),
the authority to issue regulations authorizing the apprehension,
examination, detention, and conditional release of individuals is
limited to those communicable diseases specified in an Executive Order
of the President, i.e., ``quarantinable communicable diseases.'' The
authority for carrying out these regulations has been delegated from
the HHS Secretary to the CDC Director, who in turn delegated these
authorities to HHS/CDC's Division of Global Migration & Quarantine
(DGMQ). These quarantinable communicable diseases are currently limited
to cholera, diphtheria, infectious tuberculosis (TB), plague, smallpox,
yellow fever, and viral hemorrhagic fevers (such as Marburg, Ebola,
Lassa fever, and Crimean-Congo), severe acute respiratory syndromes,
and influenza caused by novel or re-emergent influenza viruses that are
causing or have the potential to cause a pandemic. See Executive Order
13295 (April 4, 2003), as amended by Executive Order 13375 (April 1,
2005) and Executive Order 13674 (July 31, 2014). Changes to the list of
quarantinable communicable diseases are beyond the scope of this
regulation. And again, we reemphasize that HHS/CDC does not intend,
through these regulations, to mandate vaccination or compulsory medical
treatment of individuals.
One commenter supported the international proposals (part 71), but
urged HHS/CDC to remove the domestic portion (part 70) of this
regulation. We disagree. HHS/CDC's authorities apply to all travelers
in the United States, regardless of citizenship or residency, and are
intended to complement State authorities within their jurisdictions by
providing a mechanism to prevent importation of communicable disease
from other countries as well as spread of communicable disease between
States and between States and territories. Thus, HHS/CDC's and States'
authorities together create a comprehensive system to protect the
public from communicable disease threats including in situations such
as interstate travel when a single State's authorities may be
inadequate to address the communicable disease threat.
Several commenters suggested that HHS/CDC has the authority to
unilaterally change or update the list of quarantinable communicable
diseases. Other commenters requested that the list be narrowed to only
those diseases with a ``high mortality rate.'' HHS/CDC reemphasizes
that, as prescribed by statute, the list of quarantinable communicable
diseases may only be changed by Executive Order of the President and
that such suggestions are beyond the scope of this final rule.
HHS/CDC received several comments on the Agency's accountability
system, encouraging that a ``strong system of checks and balances''
should be in place for this regulation to be implemented. HHS/CDC
agrees that there should be accountability and oversight regarding the
agency's activities. We note that these regulations do not affect the
ability of Congress to conduct its oversight activities or affect the
jurisdiction of federal courts to review federal agency actions under
the Administrative Procedure Act (5 U.S.C. 704).
HHS/CDC received a comment that there is no court supervision of
HHS/CDC activities. We disagree. These regulations do not affect the
jurisdiction of the Federal courts or the statutory rights of
individuals to obtain judicial review of CDC's actions and decisions
through appropriate mechanisms such as the habeas corpus statute (28
U.S.C. 2241) or the Administrative Procedure Act (5 U.S.C. 704).
Some commenters questioned the need for HHS/CDC to use its
authorities if the threat of death is minimal compared with the size of
the population, listing illnesses such as chickenpox, pertussis, Zika,
the common cold and flu, and leprosy. One organization suggested that,
through the language of the NPRM, HHS/CDC was ``equating'' non-
quarantinable diseases with quarantinable diseases. Another commenter
suggested that HHS/CDC's authority to act should be based on the
mortality of the illness, rather than whether or not it appears on the
list of quarantinable communicable diseases. HHS/CDC thanks the
commenters for consideration of the proposal as well as the input
provided.
First, we note that HHS/CDC only has authority to quarantine or
isolate individuals who have illnesses that are listed by Executive
Order of the President as quarantinable communicable diseases. HHS/CDC
does not have the ability or authority to unilaterally modify the list
of quarantinable communicable diseases. Second, because HHS/CDC also
has statutory authority to prevent the ``introduction, transmission,
and spread'' of communicable diseases, HHS/CDC may take actions other
than quarantine or isolation to protect the public's health. These
other actions may include contact tracing investigations to notify
individuals to seek proper treatment if they have been exposed to a
communicable disease, even if the disease is not listed by Executive
Order as quarantinable. HHS/CDC does not seek to compel vaccination or
medical treatment. In keeping with current practice, HHS/CDC recommends
certain vaccines for post-exposure prophylaxis and individuals may
choose to follow these recommendations as they deem appropriate.
Other commenters questioned why diseases such as Ebola, measles,
and Zika--three very different diseases with three very different
effects on individuals--are used to support the same regulatory
provisions. One organization quoted the NPRM, citing correctly that
while measles is not a quarantinable communicable disease, it was used
in the NPRM to support the need for this updated regulation. HHS/CDC
welcomes the opportunity to provide further clarification.
The proposed rule provides HHS/CDC with a number of options for
public health interventions based on a public health risk assessment of
the communicable disease in question and the situation at hand. These
interventions could include conducting a contact investigation on an
airplane or vessel if a person with a serious communicable disease was
known to have traveled on the airplane or vessel. These contact
investigations are similar to those conducted by health departments in
community settings. In addition to these interventions, for the nine
communicable diseases currently designated by Executive Order as
quarantinable communicable diseases, HHS/CDC may apprehend, detain,
examine, quarantine, isolate, or conditionally release individuals for
purposes of preventing communicable disease spread. Ebola and
infectious tuberculosis are examples of quarantinable communicable
diseases.
[[Page 6899]]
HHS/CDC also provides the public with recommendations to address
other communicable diseases of public health concern. Zika is a good
example of a disease of public health concern because of the ways it
can be spread, e.g., through mosquitoes, sexual transmission, and
maternal-fetal transmission. Therefore, HHS/CDC has recommended
avoiding mosquito bites, protecting against sexual transmission, and
for pregnant women to avoid travel to areas where Zika is spreading.
Another example is seasonal influenza, which is very contagious but
also very common; therefore, HHS/CDC makes recommendations for people
sick with flu-like symptoms to stay home from work or school and take
basic precautions such as covering their coughs and sneezes and washing
their hands. In all situations, HHS/CDC considers how common and severe
the communicable disease is, how it is transmitted, and what
interventions are available and appropriate before making
recommendations or taking action to protect the health of the public.
One commenter questioned why HHS/CDC was not able to currently
control all communicable diseases, specifically leprosy. While HHS/CDC
works regularly and continuously with other Federal, State, local and
tribal health departments to eliminate the introduction, transmission
and spread of all communicable disease, outbreaks can and do still
occur. HHS/CDC staff have experienced first-hand the impact of
globalization on public health. The rapid speed and tremendous volume
of international and transcontinental travel, commerce, and human
migration enable microbial threats to disperse worldwide in 24 hours--
less time than the incubation period of most communicable diseases.
These and other forces intrinsic to modern technology and ways of life
favor the emergence of new communicable diseases and the reemergence or
increased transmission of known communicable diseases.
HHS/CDC received many comments regarding measles and the need to
apply public health measures to prevent the transmission and spread of
the disease. We note also that while measles may be transmissible
during travel, it is not one of the quarantinable communicable diseases
listed by Executive Order of the President. Therefore, while HHS/CDC
may recommend post-exposure prophylaxis, or other ways to manage and
prevent spread, we do not have the authority to apprehend, examine,
detain, or conditionally release individuals who may have measles, nor
those who may have been exposed. See 80 FR 16,400 (Mar. 27,
2015)(describing air travel restrictions that may be applicable to a
passenger who would represent a threat to public health).
HHS/CDC believes that requesting that DHS restrict the air travel
of persons with measles is warranted because measles is a serious and
highly contagious communicable disease that would pose a public health
threat during travel. People exposed to measles who are not immune to
the infection and have not been vaccinated following the exposure are
advised to delay their travel voluntarily until they are no longer at
risk of becoming infectious.
A number of commenters suggested that the proposed regulations are
unconstitutional or in violation of the ``Nuremberg Code,'' the United
Nations Educational, Scientific and Cultural Organization (UNESCO), the
Universal Declaration on Bioethics and Human Rights, the Geneva
Convention, human rights in general, and/or civil liberties in general
because they ostensibly authorize compulsory medical treatment without
informed consent. Commenters also cited numerous Supreme Court cases
purportedly in support of these claims, such as Mills v. Rogers, 457
U.S. 291 (1982), (curtailing the involuntary administration of anti-
psychotic drugs to mental patients); Vacco v. Quill, 521 U.S. 793
(1997) (constitutionality of an assisted suicide ban); Washington v.
Harper, 494 U.S. 210 (1990) (involuntary administration of anti-
psychotic drugs to prison inmates); Sell v. United States, 539 U.S. 166
(2003)(upholding certain strict due process protections before any
involuntary administration of anti-psychotic drugs to incarcerated
prisoners can be made); and Canterbury v. Spence, 409 U.S. 1064
(1972)(duty of doctors to obtain informed consent). HHS/CDC disagrees
and re-asserts that this final rule does not authorize compulsory
medical treatment, including compulsory vaccination, without informed
consent.
These regulations do not violate or take away any recognized rights
guaranteed by the U.S. Constitution or applicable international
agreements. While HHS/CDC has successfully responded to outbreaks of
communicable diseases, such as Ebola, these regulations will improve
HHS/CDC's future ability to prevent the introduction, transmission, and
spread of communicable diseases, through such mechanisms as improved
reporting of illnesses and public health prevention measures at
airports. While many of these activities have been carried out in the
past through internal operating procedures, these regulations improve
the public's awareness and understanding of HHS/CDC's activities to
protect the public's health.
One commenter expressed concerns about religious exemptions for
mandatory vaccination or treatment. In response, HHS/CDC notes that
these regulations do not authorize compulsory vaccinations or medical
treatment. While HHS/CDC will implement these regulations in a manner
consistent with respecting the religious rights of individuals,
religion is not a basis for exempting individuals from the provisions
of these regulations, including those provisions relating to quarantine
and isolation.
One commenter raised similar concerns that the regulations may lead
to apprehensions based on factors unrelated to public health such as
wearing of religious garb or reading of certain newspapers. HHS/CDC
agrees that public health actions should not be taken based on factors
unrelated to protecting the public's health and these regulations do
not authorize such actions. Additionally, these regulations strike the
appropriate balance between individual liberties and public health
protection.
Several commenters questioned whether quarantine and isolation may
be carried out consistent with the Fourth Amendment to the U.S.
Constitution. One commenter also suggested that implementation of
public health prevention measures at airports would lead to
``unreasonable searches and seizures'' under the Fourth Amendment. HHS/
CDC disagrees with these assertions. The Fourth Amendment protects the
rights of persons to be free in their persons, houses, papers, and
effects, against unreasonable government searches and seizures. HHS/CDC
notes that at ports of entry, routine apprehensions and examinations
related to quarantine and isolation may fall under the border-search
doctrine, which provides that, in general, searches conducted by CBP
officers at the border are not subject to the requirements of first
establishing probable cause or obtaining a warrant. See United States
v. Roberts, 274 F.3d 1007, 1011 (5th Cir. 2001); see also United States
v. Bravo, 295 F.3d 1002, 1006 (9th Cir. 2002) (noting that only in
circumstances involving extended detentions or intrusive medical
examinations have courts required that border searches be premised upon
reasonable suspicion). Similarly, apprehensions and examination of
persons traveling interstate under this rule are authorized under the
special-needs doctrine articulated by the
[[Page 6900]]
Supreme Court in Skinner v. Railway Labor Executives' Ass'n, 489 U.S.
602 (1989) because of the ``special need'' in preventing communicable
disease spread. Furthermore, to the extent that ``probable cause,''
rather than ``special needs,'' would be the applicable Fourth Amendment
standard, HHS/CDC contends that meeting the requirements of 42 U.S.C.
264 satisfies this standard. See Villanova v. Abrams, 972 F.2d 792, 795
(7th Cir.1992)(noting that probable cause for emergency civil
commitment exists where ``there are reasonable grounds for believing
that the person seized is subject to the governing legal standard.'').
HHS/CDC further acknowledges that any searches and seizures of
individuals must be reasonable under the circumstances. HHS/CDC
reiterates that this final rule does not authorize compulsory medical
treatment, including vaccination, without informed consent.
HHS/CDC received a comment citing Missouri v. McNeely, where the
U.S. Supreme Court ruled that police must generally obtain a warrant
before subjecting a drunken-driving suspect to a blood test, and that
the natural metabolism of blood alcohol does not establish a per se
exigency that would justify a blood draw without consent. In response,
HHS/CDC notes that courts have recognized that while the requirements
for probable cause and a warrant generally apply in a criminal context,
these standards do not apply when the government is conducting a non-
law enforcement related activity. See Nat'l Treasury Employees Union v.
Von Raab, 489 U.S. 665 (1989) (reaffirming the general principle that a
government search may be conducted without probable cause and a warrant
when there is a special governmental need, beyond the normal need for
law enforcement). HHS/CDC reiterates that the special-needs doctrine
articulated by the Supreme Court in Skinner v. Railway Labor
Executives' Ass'n., 489 U.S. 602 (1989) provides the appropriate legal
standard under the Fourth Amendment for apprehensions and detentions
under this final rule.
Several commenters also questioned whether the regulations are
consistent with the requirements of the Fifth and Sixth Amendments to
the U.S. Constitution. We note at the outset that the Sixth Amendment
only applies to criminal proceedings and thus would be inapplicable to
isolation and quarantine decisions which are public health protection
measures unrelated to the normal needs of law enforcement. Furthermore,
HHS/CDC asserts that this final rule is consistent with the
requirements of due process embodied in the Fifth Amendment to the U.S.
Constitution. Specifically, procedural safeguards contained in the
final rule include: (1) A requirement for written orders of quarantine,
isolation, or conditional release, including translation or
interpretation services as needed; (2) mandatory review of the Federal
order after the first 72 hours; (3) notifying individuals through the
written order of their right to request a medical review; (4) an
opportunity at the medical review for the detained individual to be
heard through an attorney or other advocate hired at their own expense,
present experts or other witnesses, submit documentary or other
evidence; and confront and cross-examine any government witnesses; (5)
a decision-maker independent of those who authorized the original
isolation, quarantine, or conditional release; (6) a written statement
by the fact-finder of the evidence relied upon and the reasons for the
decision; (7) appointment of representatives, including a medical
representative and an attorney, if the individual is indigent and
requests a medical review; and (8) timely notice of the preceding
rights. See Vitek v. Jones, 445 U.S. 480 (1980); Matthews v. Eldridge,
424 U.S. 319 (1976).
HHS/CDC also received a comment that quarantine violates the
guarantees of substantive due process under the 5th Amendment to the
U.S. Constitution. HHS/CDC disagrees. In addition to a guarantee of
fair procedures, the U.S. Supreme Court has interpreted the Fifth
Amendment's Due Process Clause as containing a substantive component
barring certain arbitrary, wrongful government actions regardless of
the fairness of the procedures used to implement them. See Zinermon v.
Burch, 494 U.S. 113, 125 (1990). HHS/CDC notes that the quarantine of
individuals who have been exposed to a communicable disease, but are
not yet capable of transmission is a well-known and accepted public
health strategy of long standing. See Jacobson v. Massachusetts, 197
U.S. 11, 25 (1905) (recognizing the power of States to issue
``quarantine laws and health laws of every description''); Compagnie
Francaise de Navigation a Vapeur v. State Bd. of Health, Louisiana, 186
U.S. 380, 396 (1902) (discussing the 1893 Federal quarantine statute).
The restrictions on individuals authorized under this regulation are
justified by the benefits to the public health.
HHS/CDC received a comment that quarantine and isolation are State
police powers that should not be exercised at the Federal level. While
HHS/CDC acknowledges that the States have primary authority for
quarantine and isolation within their borders, the Federal government
has an important and longstanding role in preventing communicable
disease spread at ports of entry and interstate. This authority is
reflected in 42 U.S.C. 264 and consistent with principles of
Federalism.
HHS/CDC received one comment stating that it should conduct a
Federalism analysis because implementing the rule will require working
with State health officials and resources. Under Executive Order 13132,
a Federalism analysis is required if a rulemaking has federalism
implications, would limit or preempt State or local law, or imposes
substantial direct compliance costs on State or local governments.
Under such circumstances, a Federal agency must consult with State and
local officials. Federalism implications is defined as having
substantial direct effects on State or local governments, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. Under 42 U.S.C. 264(e), Federal public health regulations
do not preempt State or local public health regulations, except in the
event of a conflict with the exercise of Federal authority. Other than
to restate this statutory provision, this rulemaking does not alter the
relationship between the Federal government and State/local governments
as set forth in 42 U.S.C. 264. While HHS/CDC acknowledges that portions
of this rule may involve HHS/CDC ``working with State health
officials'' to better coordinate public health responses, the rule is
consistent with 42 U.S.C. 264(e) and there are no provisions that
impose direct compliance costs on State and local governments. The
longstanding provision on preemption in the event of a conflict with
Federal authority (42 CFR 70.2) is left unchanged by this rulemaking.
Therefore, HHS/CDC believes that the rule does not warrant additional
consultation under Executive Order 13132.
HHS/CDC received several questions asking who would be responsible
for the enforcement of these regulations. One commenter questioned
whether HHS/CDC would use ``militarized police or create [an] armed
Federal police force to carry out these actions.'' As explained
elsewhere, in keeping with current practice and existing law, law
enforcement support for quarantine or isolation orders will generally
be provided by U.S. Customs and Border Protection, U.S. Coast Guard, or
other Federal law enforcement programs, but
[[Page 6901]]
HHS/CDC may also accept voluntary State and local assistance in
enforcing its Federal orders. HHS/CDC will also continue to enforce its
regulations in a manner consistent with the Fourth Amendment and other
provisions of the U.S. Constitution.
c. Definitions
Agreements
HHS/CDC received many comments on the definition of Agreement,
largely expressing confusion and concern that such agreements would not
be truly voluntary. The intent of this provision was to provide HHS/CDC
with an additional tool to facilitate cooperation from individuals in
regard to recommended public health actions. In response to public
comments, however, HHS/CDC has withdrawn this definition and will not
issue the proposed provisions on ``Agreements.''
Airline
HHS/CDC did not receive public comment on the proposed definition
of Airline. However, consistent with HHS/CDC's intent that this
definition apply to common air carriers, to improve clarity, we have
removed the phrase ``including scheduled or public charter passenger
operations operating in air commerce within the United States'' and
removed the reference to 49 U.S.C. 40102(a)(3).
Apprehension
HHS/CDC received many comments on the proposed definition and
provision regarding Apprehension; a discussion of these comments is in
the section below titled, ``Apprehension and Detention of Persons with
Quarantinable Communicable Diseases.'' The definition is finalized as
proposed.
Commander
HHS/CDC did not receive public comment on the proposed definition
of Commander. Therefore, this definition is finalized as proposed.
Communicable Stage
HHS/CDC received a comment seeking clarity regarding the definition
of Communicable Stage. The commenter stated that the definition for
communicable stage may unnecessarily restrict social distancing powers
because it appears limited to human-to-human transmission and does not
include human transmission via an intermediate vector, such as
mosquitoes or flea bites. HHS/CDC disagrees. The definition of
communicable stage includes transmission of an infectious agent either
``directly or indirectly from an infected individual to another
individual.'' Thus, HHS/CDC clarifies that indirect transmission of an
infectious agent may include transmission via an insect vector as
described by the commenter. This definition is finalized as proposed.
Conditional Release
HHS/CDC received many comments on the proposed definition and
provision regarding Conditional Release; a substantive discussion of
these comments is presented in the section below titled Requirements
Relating to Issuance of a Federal Order for Quarantine, Isolation, or
Conditional Release.
HHS/CDC is modifying the definition of Conditional Release under
section 70.1 to remove the cross-reference to the definition of
surveillance as that term appears in current section 71.1. The
definition of Conditional Release under section 70.1 tracks the
definition of surveillance under section 71.1 and means ``the temporary
supervision by a public health official (or designee) of an individual
or group, who may have been exposed to a quarantinable communicable
disease to determine the risk of disease spread and includes public
health supervision through in-person visits, telephone, or through
electronic or internet-based monitoring.'' HHS/CDC is making this
change to improve clarity and remove the need for the public to cross-
reference the definition of surveillance to understand the definition
of Conditional Release as used in section 70.1.
This definition of Conditional Release under section 71.1 is
finalized as proposed.
Contaminated Environment
HHS/CDC did not receive public comment on the proposed definition
of Contaminated Environment. Therefore, this definition is finalized as
proposed.
Conveyance
HHS/CDC did not receive public comment on the proposed definition
of Conveyance. Therefore, this definition is finalized as proposed.
Electronic or Internet-Based Monitoring
HHS/CDC received many comments on the proposed definition and
provision regarding Electronic or Internet-based monitoring. We have
modified this definition as follows: ``mechanisms or technologies
allowing for the temporary public health supervision of an individual
under conditional release and may include communication through
electronic mail, SMS texts, video or audio conference, webcam
technologies, integrated voice-response systems, or entry of
information into a web-based forum; wearable tracking technologies; and
other mechanisms or technologies as determined by the Director or
supervising State or local health authority.''
Several commenters expressed privacy concerns because conditional
release of exposed or ill individuals may be accomplished over the
internet or through electronic monitoring. Other commenters expressed
concerns about privacy, having misunderstood the proposed rule as
authorizing HHS/CDC to conduct invasive surveillance of personal
communications such as emails, text messages, and telephone calls.
Commenters also expressed concerns related to the use of webcams and
wearable tracking technologies as an option for monitoring of exposed
people. One association viewed this proposed provision as an expansion
of CDC's ``electronic monitoring of personal information, under the
guise of protecting the public against rare, isolated outbreaks of
disease.''
HHS/CDC appreciates the opportunity to address these concerns.
CDC's intent was to describe mechanisms that HHS/CDC or other public
health authorities can use to communicate with individuals for the
purpose of conducting monitoring following exposure to a quarantinable
communicable disease. These mechanisms are intended as alternatives to
in-person interviews because of the inconvenience and logistical
problems that may arise when meeting in-person.
During the 2014-2016 Ebola response, HHS/CDC recommended ``active
monitoring'' defined as daily communication between public health
authorities and the individuals being monitored. HHS/CDC did not
specify how this communication should occur, and health departments
used a variety of electronic technologies for this purpose including
those listed in the regulation. HHS/CDC also recommended ``direct
active monitoring'' for people with certain higher levels of exposure.
This involved having a public health official check in with the person
through direct observation rather than relying on phone calls or
electronic communications. Webcams were used by some health departments
as an alternative to in-person visits to observe the person taking his
or her temperature. The webcam was only operational during this
scheduled public health ``visit.'' The use of webcams proved convenient
for both
[[Page 6902]]
the health departments and the people being monitored, especially if
the people lived in remote areas. Webcams are also used routinely by
health departments for ``directly observed therapy'' for diseases like
tuberculosis (TB), in order to watch patients take their TB
medications. HHS/CDC has clarified the regulatory text to state that
these technologies will be used for communicating with the individual
and not as a means of monitoring the individual's personal
communications.
One commenter asked whether HHS/CDC would ``assist with payment for
internet services'' if webcam communications was required. In keeping
with current practice, if an individual does not have access to
internet services, HHS/CDC may use alternative methods to assist with
communication, such as the issuance of a cellular phone. Some
organizations also expressed concerns about the use of technologies
such as cellular phones or wearable tracking technologies for the
purpose of electronic monitoring. HHS/CDC acknowledges that the use of
wearable tracking technology may be necessary in rare situations when a
person does not comply with the required monitoring or when it is
necessary to know the physical whereabouts of the person to ensure that
they are not in a public place. While HHS/CDC acknowledges that public
health surveillance of ill or exposed individuals through electronic
monitoring may raise some privacy concerns, HHS/CDC believes that
protecting the public's health outweighs these concerns.
HHS/CDC is committed to protecting the privacy of personally
identifiable information collected and maintained under the Privacy Act
of 1974. As detailed in the preamble of the proposed rule, on December
13, 2007, HHS/CDC published a notice of a new system of records under
the Privacy Act of 1974 for its conduct of activities under this final
rule (72 FR 70867). HHS/CDC accepted public comment on its proposed new
system of records at that time. As required under the Privacy Act, HHS/
CDC described in its notice the proposed system of records, the purpose
for the collection of the system data, the proposed routine uses (i.e.,
disclosures of system data that are compatible to the purpose for the
data collection), the benefits and need for the routine use of this
data, our agency's policies, procedures, and restrictions on the
routine use disclosure of this information, and, most importantly, our
safeguards to prevent its unauthorized use.
Under this system of records, CDC will only release data collected
under this rule and subject to the Privacy Act to authorized users as
legally permitted. HHS/CDC will take precautionary measures including
implementing the necessary administrative, technical and physical
controls to minimize the risks of unauthorized access to medical and
other private records. In addition, HHS/CDC will make disclosures from
the system only with the consent of the subject individual or, in
accordance with the routine uses published at 72 FR 70867, or as
allowed under an exception to the Privacy Act. Furthermore, HHS/CDC
will apply the protections of the SORN to all travelers regardless of
citizenship or nationality. Finally, such records will be stored and
maintained in keeping with the official Records Control Schedule as set
forth by the National Archives and Records Administration. For more
information, please see https://www.archives.gov/records-mgmt/rcs.
Ill Person
We have modified the definition of Ill person under 71.1 to include
a person who ``(b)(2) Has a fever that has persisted for more than 48
hours; or (b)(3) Has acute gastroenteritis, which means either
diarrhea, defined as three or more episodes of loose stools in a 24-
hour period or what is above normal for the individual, or vomiting
accompanied by one or more of the following: One or more episodes of
loose stools in a 24-hour period, abdominal cramps, headache, muscle
aches, or fever (temperature of 100.4[emsp14][deg]F [38 [deg]C] or
greater).'' This language was quoted verbatim in the preamble of the
NPRM at 81 FR 54305 but was inadvertently omitted from the proposed
regulatory text.
HHS/CDC received comments regarding the updated definition of Ill
person which flight crews use to report to the CDC occurrences of
illnesses in passengers or crew during travel. Specifically, commenters
expressed concern that ``non-medical personnel'' such as flight
attendants would report such observations; others questioned whether
the definition is too broad and may result in over-reporting of non-
threatening illnesses; others worried that it could lead to unnecessary
apprehensions of individuals. One commenter claimed to be ``chemical
sensitive,'' and worried that he or she may be penalized for having a
reaction from sitting next to someone on a plane wearing a ``strong
fragrance.'' HHS/CDC thanks the commenters for considering the proposal
and providing feedback.
HHS/CDC clarifies that the purpose of the ill person definition is
to align with current global and accepted detection and reporting
practices so that onboard deaths and illnesses are reported by airlines
and, where necessary, investigated by HHS/CDC. We note that the ill
person definition in this final rule is consistent with the
internationally recognized and accepted illness reporting guidelines
published by the International Civil Aviation Organization (ICAO). This
practice is not new, but has been used successfully for many years by
aircraft and vessel crews to assist public health officials in
preventing further transmission and spread of communicable disease.
HHS/CDC also does not intend to apprehend individuals based solely
on their meeting the definition of an ill person. The purpose of an
illness report is to allow trained HHS/CDC public health and medical
officers to determine whether an illness occurring onboard a flight or
voyage necessitates a public health response. In contrast, an
apprehension of an individual is based on a variety of criteria in
addition to an illness report including: Clinical manifestations,
contact or suspected contact with infected individuals, host
susceptibility, travel to affected countries or places, or other
evidence of exposure to or infection with a quarantinable communicable
disease. Thus, HHS/CDC disagrees that the ill person definition will
lead to unnecessary apprehensions of individuals.
Several commenters noted that the symptoms listed in HHS/CDC's
definition of an ill person are common symptoms of many non-threatening
conditions, and thus questioned their inclusion in the definition. HHS/
CDC appreciates the opportunity to respond to these concerns. The
symptoms listed in HHS/CDC's ill person definition are provided for
airlines and vessels to report to HHS/CDC so that HHS/CDC can make a
public health risk assessment; the symptoms alone would not result in
issuance of a public health order. In making such an assessment, HHS/
CDC medical and public health officers consider the symptoms as well as
the medical history of the person and any possible exposures that could
indicate that the person may be infected with a quarantinable
communicable disease.
A few commenters stated that the definition of ill person appears
to expand the scope of HHS/CDC's authority beyond the list of
quarantinable communicable diseases specified through an Executive
Order of the President. HHS/CDC disagrees. The
[[Page 6903]]
purpose of the ill person definition is to help facilitate the
identification, particularly by flight crews, of communicable diseases
of public health concern. Thus, HHS/CDC has defined ill person in such
a way that the term may be understood by non-medically trained
crewmembers. While the reporting of an ill person onboard a flight may
trigger a public health evaluation by a trained quarantine officer in
consultation with an HHS/CDC medical officer, such reporting does not
expand the basis upon which an ill person may be subject to
apprehension, detention, or conditional release. As noted by the
commenter, such public health actions are limited to those
quarantinable communicable diseases specified through an Executive
Order of the President (e.g., cholera, diphtheria, infectious
tuberculosis, yellow fever, viral hemorrhagic fevers, Severe Acute
Respiratory Syndromes, and pandemic influenza).
A public health association suggested that any changes to the list
of signs and symptoms within the definition of ill person should be
made available for public comment. HHS/CDC assumes this comment is in
reference to section (3) of the definition which provides for reporting
of ``symptoms or other indications of communicable disease, as the HHS/
CDC may announce through posting of a notice in the Federal Register.''
HHS/CDC appreciates the opportunity to clarify the purpose of this
section. Section (3) of the ill person definition is intended to apply
only to new, emerging, and imminent threats to public health. We expect
it will only be relied on in emergency situations where a quick
response is required to protect the public. Other circumstances, where
the list of signs and symptoms may change due to evolving science or
technology, will be made available for public comment, through a
similar process as this rulemaking--Notices in the Federal Register--
and may also request input from the public.
A number of commenters noted that symptoms listed in HHS/CDC's
definition of an ill person are common symptoms of many conditions,
particularly ``appears obviously unwell'' which many commenters
requested be removed from the definition. HHS/CDC appreciates the
opportunity to clarify that, with the exception of acute
gastroenteritis on vessels, HHS/CDC only requires reporting of an ill
traveler on an aircraft or vessel if fever ``accompanied by one or more
of the following'' other symptoms listed are present. Therefore, as an
example, headache alone would not be sufficient to require reporting,
but rather fever plus headache, fever plus cough, fever plus persistent
vomiting, fever plus persistent diarrhea, etc. These symptoms combined
with fever are frequently seen in communicable diseases that could pose
a public health risk to others during travel. Because a person with
fever who also appears obviously unwell could have a serious
communicable disease, HHS/CDC feels it is appropriate to retain this
symptom, and further notes that its inclusion better aligns with Note 1
to the guidelines set forth by the International Civil Aviation
Organization in paragraph 8.15 of Annex 9 to the Convention on
International Civil Aviation.
One public health organization commented that the definition of ill
person was broad and would be better issued through agency guidance
rather than a rule. In response, HHS/CDC notes that the existing
regulation contains an outdated and overly narrow definition of ill
person that does not reflect current knowledge of communicable
diseases, and that the reporting of ill travelers has been managed
through a combination of regulation and agency guidance. This
combination of ``required'' and ``requested'' reporting has proven
confusing to some airline and vessel employees and this rule seeks to
mitigate such confusion by including all relevant symptom clusters in
the rule. Further, HHS/CDC notes that the change in the ill person
definition better aligns with guidelines set forth by the International
Civil Aviation Organization and is supported in comments received from
the airline industry.
One public health organization commented on the different
definitions of ill person for aircraft and vessels and recommended that
the definitions be combined and not depend on the mode of transport. In
response, HHS/CDC wishes to point out three crucial differences between
aircraft and vessels which HHS/CDC feels justify the different
definitions. One difference, additionally noted by the commenting
organization, is the difference in time that a traveler spends on an
aircraft and a vessel which makes the time frame (24 hours) specified
in the definition of acute gastroenteritis for vessels relevant and
minimizes the reporting of travelers with a single episode of loose
stool that subsequently resolves, a common occurrence. The second is
the high risk of spread of gastrointestinal infections onboard vessels
that is unlikely to occur on aircraft; for this reason, reporting of
diarrheal illnesses on aircraft includes the presence of fever which is
more likely to indicate a serious communicable disease, whereas the
definition on vessels includes diarrheal illness without fever to allow
for the reporting of viral gastrointestinal illnesses that typically do
not cause fever but have been known to cause large outbreaks on cruise
vessels. The third difference is the presence onboard cruise vessels of
medical facilities capable of making a diagnosis of pneumonia which
allows the inclusion of pneumonia in the vessel definition. In all
other respects, the definitions are the same. HHS/CDC adds that
combining the definitions would be confusing to industry professionals
responsible for conducting this reporting.
One public health organization provided a recommendation to modify
the description of the ``rash'' component in the definition of ill
person to ensure that the term fully encompassed the range of potential
skin rash symptoms. The organization's recommendation for revisions was
as follows: ``The individual has areas on the skin that are red or
purple, flat or bumps; with multiple red bumps; red, flat spots; or
blister-like bumps filled with fluid or pus that are intact, draining,
or partly crusted over; or dry and scaling patches. The rash may be
discrete or run together, and may include one area of the body, such as
the face, or more than one area.''
HHS/CDC responds that it will not change the regulatory text of the
ill person definition with this language because we are concerned that
this might add too much complexity to the regulatory definition.
However, consistent with the regulatory definition of ``ill person,''
HHS/CDC will update its reporting guidance for aircraft and vessels to
include this revised description. Current guidance may be found at:
http://www.cdc.gov/quarantine/air/reporting-deaths-illness/guidance-reporting-onboard-deaths-illnesses.html.
An air industry commenter suggested another change to the ill
person definition. The proposed definition included ``headache with
stiff neck,'' and the commenter suggested that this be modified to
``severe headache of recent onset with stiff neck.'' While HHS/CDC will
not change the regulatory definition of ill person to accommodate this
change, HHS/CDC believes this is a useful modification to make in ill
person reporting guidance to aircraft and vessels.
Incubation Period
HHS/CDC did not receive any comments on the proposed definition of
Incubation period. However, upon a
[[Page 6904]]
review of the definition, we have decided that the definition should
more closely track the definition of Precommunicable stage. For
quarantinable communicable diseases, the Incubation period is defined
as the Precommunicable stage of the disease. Thus, we have determined
that the two definitions should more closely align. A substantive
discussion of comments received concerning the definition of
Precommunicable stage appears below.
Accordingly, we have modified the definition of Incubation period
to add ``or, if signs and symptoms do not appear, the latest date signs
and symptoms could reasonably be expected to appear.'' Other aspects of
this definition are finalized as proposed.
Indigent
HHS/CDC received comments relating to the proposed definition of
Indigent which is used to determine whether a detained individual
qualifies for appointment at government expense of representatives to
assist him/her during a medical review. One comment from a public
health department suggested raising the threshold for indigent status
to at least 200% of the applicable poverty guideline. HHS/CDC agrees
and has made this change in the final regulation.
One commenter opposed including a definition for indigents and
indicated that HHS/CDC should assume all costs whenever an individual
is placed into Federal isolation or quarantine. HHS/CDC disagrees that
assuming such costs without regard to indigence is necessary or
appropriate.
Other substantive comments relating to the appointment at
government expense of representatives to assist detained indigent
individuals during a medical review are discussed below.
Master or Operator
HHS/CDC did not receive any comments on the definition of Master or
operator. Accordingly, this definition is finalized as proposed.
Medical Examination
In response to comments received regarding medical examinations
under sections 70.12 and 71.36, we have modified the definition of
Medical Examination to indicate that the health worker conducting the
assessment must be ``licensed.'' Comments regarding sections 70.12 and
71.36 are addressed below.
HHS/CDC received a comment regarding the definition of Medical
Examination. The commenter stated that the definition of medical
examination should include a mental health assessment because a mental
health condition may impact an individual's appreciation of his or her
public health risk to others. While HHS/CDC acknowledges that a mental
health assessment may be useful as part of an individual's medical care
and treatment and that such an assessment may be ordered as needed by a
treating clinician, HHS/CDC declines to make such assessments a formal
part of the medical examination process. Specifically, because a mental
health assessment is not generally needed to diagnose or confirm the
presence or extent of infection with a quarantinable communicable
disease, HHS/CDC disagrees that it is necessary or appropriate to
require such an assessment as part of a Federal public health order.
Medical Representative
HHS/CDC received several comments relating to the proposed
definitions of Medical Representative and Medical Reviewer as well as
the potential use of HHS/CDC employees as representatives or medical
reviewers. One commenter suggested that it would be less problematic
for HHS/CDC to allow and pay for outside participants to serve in these
capacities. First, HHS/CDC notes that the definition of Medical
representative has been changed to Representatives and revised as
detailed below. HHS/CDC disagrees with this comment and notes that the
definition of both Representatives and Medical reviewer would in fact
allow for the appointment of non-HHS/CDC employees in these capacities
as suggested by the commenter. For this reason, both Representatives
and Medical reviewer are broadly defined in terms of the occupational
qualifications of these individuals. HHS/CDC also does not consider it
problematic to rely on internal reviewers and notes that it is not
unusual, for instance, for hospitals to rely on internal decision-
makers when determining whether to commit a mental health patient on an
emergency basis.
HHS/CDC received a comment that the ``definition of medical
exemption is not apparent.'' In response, HHS/CDC notes that no
clarification of what is meant by ``medical exemption'' is provided by
the commenter and that HHS/CDC did not propose adding such a
definition. While these regulations do not authorize compulsory
vaccination or medical treatment, there is no recognized ``medical
exemption'' from quarantine, isolation, or conditional release and HHS/
CDC declines to create one.
Non-Invasive
HHS/CDC received several comments concerning the definition of Non-
invasive, including support from a public health association regarding
the definition. However, several individuals disagreed with the
proposed definition. In response to public comment that the definition
of ``non-invasive'' allowed too much physical contact between the
individual and public health officer, HHS/CDC has replaced ``physical''
with ``visual'' and removed ``auscultation; external palpation;
external measurement of blood pressure'' from the definition. While
HHS/CDC continues to believe that these procedures qualify as Non-
invasive under the definition, after considering public comment and a
review of standard operating procedures, HHS/CDC finds such procedures
to be unlikely to be conducted during a public health risk assessment.
Such procedures may be conducted at a port of entry by emergency
medical service personnel as part of a medical assessment to determine
the need for emergency medical care. We also modified the definition to
clarify that the individual conducting the public health risk
assessment will be a ``public health worker.'' Public health workers
are individuals who have education and training in the field of public
health.
One commenter mentioned that the new definition of Non-invasive
states that the HHS/CDC could order laboratory testing under certain
conditions. The commenter further asserted that forced laboratory
testing, without the option of quarantine instead, is an invasive
measure, and questioned how this could be in line with the concept of
non-invasive. HHS/CDC responds that the definition of non-invasive
applies to procedures conducted during a public health risk assessment
at a port of entry and that this definition does not authorize forcible
or invasive procedures to extract human biological samples for
laboratory testing. Should laboratory testing be needed for a person
reasonably believed to be infected with a quarantinable communicable
disease, such testing would be done as part of a medical examination
conducted at a healthcare facility and performed with the patient's
informed consent. HHS/CDC has added language to the regulatory text
requiring that the Director advise individuals of their right to have
medical testing and examination conducted by an authorized and licensed
health worker and with prior informed consent. While this regulation
does not authorize forcible testing,
[[Page 6905]]
HHS/CDC may require laboratory test results demonstrating that a
symptomatic individual is no longer infectious prior to rescinding a
Federal isolation order.
Precommunicable Stage
HHS/CDC received comments relating to the definition of
Precommunicable stage. One commenter suggested that persons in the
``precommunicable stage'' of a quarantinable communicable disease pose
no direct threat to the public's health. A public health organization
also stated that this definition should not apply to non-symptomatic
people who have been exposed to Ebola. HHS/CDC disagrees with both
comments. For instance, a patient diagnosed with multidrug-resistant or
extensively drug-resistant tuberculosis who is not currently
infectious, but who has not been adequately treated and is thus at high
risk for relapse would be considered to be in the ``precommunicable
stage'' of the disease and pose a direct threat to the public's health.
Similarly, an individual who is reasonably believed to have been
exposed to Ebola poses a direct threat.
Several public health organizations additionally expressed concerns
regarding the use of the ``precommunicable stage'' definition to
justify quarantine of healthcare workers caring for patients with
quarantinable communicable diseases such as Ebola or severe acute
respiratory syndromes, including healthcare workers providing care in
the United States or in other countries. One such organization further
requested clarification of whether the rule provides for the needs and
protection of healthcare workers who voluntarily self-quarantine while
providing care for patients with the quarantinable communicable
diseases noted above.
In response, HHS/CDC states that it does not recommend quarantine
or occupational restrictions of healthcare workers who follow
recommended infection control precautions while providing care for
patients with quarantinable communicable diseases. Healthcare workers
who do not follow infection control precautions or who have had
unprotected exposures to patients with a quarantinable communicable
disease may be subject to quarantine or occupational restrictions;
these individuals would be afforded the same due process protections as
other exposed individuals.
Several commenters also questioned CDC's proposed definition for
Precommunicable stage stating that it may result in an apprehension of
an individual who displays no symptoms of a communicable illness. In
response, HHS/CDC states that it has defined Precommunicable stage
consistent with the public health practice of quarantine. Quarantine
refers to the public health practice of separating and restricting the
movement of individuals who are reasonably believed to have been
exposed to a communicable disease, but are not yet ill. In contrast,
isolation refers to the public health practice of separating and
restricting the movement of individuals who have been exposed to a
communicable disease and are symptomatic from those who are not sick.
The definition of Precommunicable stage is finalized as proposed.
Public Health Emergency
HHS/CDC received several comments relating to the definition of
Public health emergency. One commenter stated that use of the term is
duplicative and unnecessary because the term is used elsewhere in the
Public Health Service Act (42 U.S.C. 247d) and appears in State-based
legislation based on the Model State Emergency Health Powers Act. This
commenter suggested that to avoid confusion the term should be renamed
``Public Health Exigency.'' HHS/CDC disagrees. Section 361(d) of the
Public Health Service Act (42 U.S.C. 264(d)(1)) authorizes the
apprehension and examination of individuals traveling interstate who
are in the ``precommunicable stage'' of a quarantinable communicable
disease, but only if the disease ``would be likely to cause a public
health emergency if transmitted to other individuals.'' Thus, section
361(d) is unique and differs from how the term public health emergency
is used in other statutes or provisions of the Public Health Service
Act because it authorizes application of specific public health
measures (apprehension and examination) to specific individuals (those
in the precommunicable stage of a quarantinable communicable disease),
but only if the disease would be likely to cause a public health
emergency. Thus, HHS/CDC considers it essential to define public health
emergency because the existence of such an emergency is a necessary
prerequisite to the apprehension and examination of individuals in the
precommunicable stage of a quarantinable communicable disease.
This commenter also suggested that the definition of public health
emergency contains an oversight because it does not mention the
potential for an infectious condition being highly likely to cause
``short- or long-term disability.'' HHS/CDC disagrees because the
definition includes infectious diseases that are highly likely to cause
``serious illness'' if not properly controlled. HHS/CDC clarifies that
``short- or long-term disability'' caused by an infectious agent would
be considered a ``serious illness.''
This commenter further suggested that in addition to referencing a
public health emergency declaration by the HHS Secretary, the
definition should also include similar declarations by the President
under the Stafford Act or under the National Emergencies Act. HHS/CDC
disagrees. We note first that the definition of public health emergency
is not limited to those emergencies declared by the HHS Secretary.
Second, in the event of a man-made or natural disaster that also
affects public health, the HHS Secretary may issue a separate
declaration under the Public Health Service Act as was done in response
to the terrorist attacks of September 11, 2001 and in response to
Hurricane Katrina. Thus, HHS/CDC does not see a need to also reference
Presidential declarations as suggested by the commenter.
This commenter also requested clarification concerning whether the
World Health Organization's (WHO) declaration of a Public Health
Emergency of International Concern (PHEIC) could continue to serve as
the basis for a ``public health emergency'' if the President or HHS
Secretary disagreed with the declaration of a PHEIC on legal,
epidemiologic, or policy grounds. In response, HHS/CDC notes that the
scenario proposed by the commenter is unlikely, but that CDC remains a
component of HHS, subject to the authority and supervision of the HHS
Secretary and President of the United States.
HHS/CDC also received a comment objecting to referencing the WHO's
declaration of a Public Health Emergency of International Concern
(PHEIC) in the definition of ``public health emergency'' because this
ostensibly relinquishes U.S. sovereignty. HHS/CDC disagrees. By
including references to a PHEIC, HHS/CDC is not constraining its
actions or makings its actions subject to the dictates of the WHO.
Rather, the declaration or notification of a PHEIC is only one way for
HHS/CDC to define when the precommunicable stage of a quarantinable
communicable disease may be likely to cause a public health emergency
if transmitted to other individuals. While HHS/CDC will give
consideration to the WHO's declaration of a PHEIC or the circumstances
under which a PHEIC may be notified to the
[[Page 6906]]
WHO, HHS/CDC will continue to make its own independent decisions
regarding when a quarantinable communicable disease may be likely to
cause a public health emergency if transmitted to other individuals.
Thus, HHS/CDC disagrees that referencing the WHO determination of a
PHEIC results in any relinquishment of U.S. sovereignty.
The International Health Regulations are an international legal
instrument that sets out the roles of WHO and State parties in
identifying, responding to, and sharing information about public health
emergencies of international concern. HHS/CDC believes that it would be
unlikely for the United States to formally object to the WHO's
declaration of a PHEIC, but that CDC remains a component of HHS,
subject to the authority and supervision of the HHS Secretary and
President of the United States.
Also regarding the definition of ``public health emergency,'' one
public health association expressed concern that any disease considered
to be a public health emergency may qualify it as quarantinable.
Another commenter noted that some PHEICs ``most certainly do not
qualify as public health emergencies'' under the proposed definition.
HHS/CDC appreciates the opportunity to clarify. Only those communicable
diseases listed by Executive Order of the President may qualify as
quarantinable communicable diseases. For example, Zika virus infection,
which although the current epidemic was declared a PHEIC by WHO, is not
a quarantinable communicable disease. The definition of Public health
emergency is finalized as proposed.
Public Health Prevention Measures
HHS/CDC received one comment relating to the definition of Public
health prevention measures. The commenter stated that the second use of
``and other non-invasive means'' should be deleted from the definition
of public health prevention measures as redundant. HHS/CDC disagrees
because ``observation, questioning, review of travel documents, and
records review'' as cited in the definition appears to materially
differ from ``other non-invasive means'' that may be used as a part of
public health prevention measures such as temperature checks, visual
observation, or visual examination of the ear, nose, or mouth.
Accordingly, HHS/CDC believes that the updated definition provides
greater clarity as written. Further information, including a discussion
regarding comments received on these proposed provisions, is discussed
in the section below titled Public Health Prevention Measures to Detect
Communicable Disease. The definition is finalized as proposed.
Qualifying Stage
HHS/CDC received several comments relating to Qualifying stage.
Several commenters, including one public health organization, expressed
concern that the definition was either too vague, too broad, or too
confusing. One commenter suggested that the definition for Qualifying
stage is confusing because it splits communicable diseases into a
``precommunicable stage'' and a ``communicable stage'' and that a
communicable disease would not be on the list of Federal quarantinable
communicable diseases if its spread did not already have some potential
to cause a public health emergency. In response, HHS/CDC notes that the
term ``qualifying stage'' is defined under 42 U.S.C. 264(d)(2) to
include both a ``precommunicable stage'' and a ``communicable stage''
and that this definition explicitly references diseases ``likely to
cause a public health emergency.'' Thus, while HHS/CDC may clarify and
explain statutory terms through regulation, it has no authority to
change the language of the statute.
One public health organization recommended that HHS/CDC policy
implementing the Qualifying stage definition acknowledge that a one-
size fits all protocol is not appropriate because different diseases
have different transmission patterns and the need for isolation and
quarantine may differ. HHS/CDC agrees that the need for isolation and
quarantine may differ based on the disease and adds that it conducts a
public health risk assessment before issuing Federal public health
orders. For example, HHS/CDC does not typically issue Federal public
health orders for cholera, a quarantinable communicable disease as
defined by Executive Order because the sanitation infrastructure in the
United States makes cholera transmission unlikely. HHS/CDC further
notes that it typically conducts the public health risk assessment in
coordination with the State or local health department of jurisdiction
before issuing a Federal public health order.
Public health organizations and other commenters cautioned against
apprehending individuals or issuing public health orders when the risk
of communicable disease spread during the precommunicable period is
low. HHS/CDC agrees and further adds that it will typically conduct a
public health risk assessment in coordination with State and local
public health officials to ensure that any restrictions imposed on an
individual are commensurate with the degree of risk and using the least
restrictive means available.
The definition of Qualifying stage is finalized as proposed.
Reasonably Believed To Be Infected, as Applied to Individuals
HHS/CDC received several comments regarding the definition of
Reasonably believed to be infected, as applied to an individual.
Several public health organizations expressed concern there could be
undue burden placed on healthcare facilities or health departments by
greatly expanding the number of individuals requiring health screening,
medical examination and testing, or placed under Federal isolation of
quarantine orders. HHS/CDC disagrees. This rule represents a
codification of current practice and decisions regarding the need for
medical examination of individuals suspected of being infected with a
quarantinable communicable disease, including during an outbreak or
public health emergency, will generally be based on published disease-
specific case definitions for PUIs (persons under investigation) that
incorporate clinical and epidemiologic factors. Furthermore, decisions
regarding the issuance of Federal public health orders or medical
examination for a suspected quarantinable communicable disease would
typically be made in coordination with a State or local health
department of jurisdiction. Therefore, HHS/CDC does not anticipate
placing an undue burden on healthcare facilities or health departments
as a result of these definitions.
One commenter stated that the Reasonably believed to be infected,
as applied to an individual definition allows for apprehension,
quarantine, or isolation based solely on reasonable inferences that the
person was exposed somehow or in some way to infectious agents. HHS/CDC
disagrees because as stated in the definition reasonable inferences may
only be drawn from ``specific articulable facts'' that an individual
has been exposed to an infectious agent such as through ``contact with
an infected person or an infected person's bodily fluids, a
contaminated environment, or through an intermediate host or vector.''
Thus, HHS/CDC disagrees that this standard does not comport with
standard public health practice.
HHS/CDC received a comment from a public health agency expressing
concern that travel to other countries where transmission of a
quarantinable
[[Page 6907]]
communicable disease has likely occurred would be the sole basis upon
which HHS/CDC would form a reasonable belief that an individual may be
infected with a quarantinable communicable disease. In response, HHS/
CDC clarifies that travel to other countries was simply used as an
illustrative example. The decision to place an individual into
isolation or quarantine will ordinarily be based on several factors,
including travel, contact with an infected person or an infected
person's bodily fluids, host susceptibility, and clinical
manifestations. HHS/CDC believes that this definition is clear and that
no further changes are necessary.
The definition of Reasonably believed to be infected as applied to
an individual is finalized as proposed.
Secretary
HHS/CDC has added a definition for Secretary meaning the Secretary
of Health and Human Services (HHS) or any other officer or employee of
that Department to whom the authority involved has been delegated. We
note that while the NPRM did not propose this definition, the NPRM
referenced the Secretary in defining Public Health Emergency. Thus,
HHS/CDC considers it useful to also define the term Secretary.
After consideration of comments regarding Definitions, HHS/CDC has
made the following changes in the final rule:
The definition of Agreements has been withdrawn.
The definition of Conditional Release under section 70.1
has been modified to remove the internal cross-reference to the
definition of surveillance under section 71.1. The definition of
Conditional Release under section 70.1 has been further modified to
align with the definition of surveillance under section 71.1 and means
``the temporary supervision by a public health official (or designee)
of an individual or group, who may have been exposed to a quarantinable
communicable disease to determine the risk of disease spread and
includes public health supervision through in-person visits, telephone,
or through electronic or internet-based monitoring.''
The definition of Electronic or internet-based monitoring
has been modified to indicate ``communication through'' such means, and
include ``audio'' conference.
The definition of Incubation period has been modified to
add ``or, if signs and symptoms do not appear, the latest date signs
and symptoms could reasonably be expected to appear.'' This aligns the
definition with the Precommunicable stage definition.
The definition of Indigent has been modified to increase
the threshold to 200% of the applicable poverty guidelines.
The definition of Medical Examination has been modified to
indicate that the health worker conducting the assessment must be
``licensed.''
The definition of Medical Representative has been changed
to Representatives and now includes in addition to the appointment of a
medical professional, the appointment of ``an attorney who is
knowledgeable of public health practices.''
The definition of Non-invasive has been modified to (1)
replace ``physical examination'' with ``visual examination,'' (2)
specify that the individual performing the assessment must be a
``public health worker (i.e., an individual with education and training
in the field of public health)'' and (3) remove ``auscultation,
external palpation, external measurement of blood pressure.''
A definition for Secretary has been added and means ``the
Secretary of Health and Human Services (HHS) or any other officer or
employee of that Department to whom the authority involved has been
delegated.''
d. Public Health Prevention Measures To Detect Communicable Disease
HHS/CDC received support from commenters on screening individuals
entering the U.S. from parts of the world where highly infectious
diseases are common. One such commenter requested to know the criteria
HHS/CDC uses when deciding whether to detain an individual. Another
commenter stated that travel history ``should be a prerequisite for
Federal orders to quarantine'' and ``medical exam should be a
prerequisite for Federal orders to isolate.'' HHS/CDC thanks these
commenters and welcomes the opportunity to explain this process.
HHS/CDC's decision to detain an individual is based on several
criteria, including: Clinical manifestations: Signs and symptoms
consistent with those of a quarantinable communicable disease; known or
suspected contact with cases, i.e., patients either confirmed or
suspected to be infected with a quarantinable communicable disease;
epidemiologic information/evidence (travel history, exposure to
animals); other documentary or physical evidence in the individual's
possession, such as a physician's note documenting infection with or
medication for treatment of a quarantinable disease; and/or public
health authorities having notified HHS/CDC that the individual is known
or suspected to be infected with a quarantinable communicable disease
and likely non-adherent with public health recommendations.
HHS/CDC has modified paragraph (b) of the provisions relating to
public health prevention measures to detect communicable disease
(Sec. Sec. 70.10 and 71.20) to include information about ``known or
possible exposure,'' in response to comments requesting further clarity
of CDC's criteria.
One organization from the airline industry was generally supportive
of 70.10 and 71.20, public health prevention measures to detect
communicable disease, and requested that any measures, such as
screening, occur prior to individuals boarding an aircraft, and
preferably prior to arrival at the gate. HHS/CDC thanks these
commenters for their support. In response, while an operational plan
for each location has not yet been finalized, HHS/CDC expects such
measures to occur prior to the boarding of an aircraft, and to the
extent possible, prior to arrival at the gate. One airline organization
insisted that airline operators should not be financially responsible
for any costs associated with screening. HHS/CDC responds that it does
not expect airlines and airline operators to assume direct costs
associated with public health screening, such as providing additional
personnel to conduct the screening. However, indirect costs such as
missed flights of passengers who are detained may occur.
Another airline organization requested that HHS/CDC ensure wait-
times in lines are not impacted by screening, and encouraged HHS/CDC to
take into account the needs of all stakeholders. HHS/CDC feels strongly
that in these rare circumstances, which would only occur should a
threat to public health exist, preventing airline employees and other
passengers from being exposed to a detained or delayed individual
provides a greater benefit than the monetary loss of airfare. In
keeping with current practice, HHS/CDC will work together with public
health partners, carriers, and all who have equities, to ensure insofar
as possible that the least restrictive and time-consuming measures are
implemented. Finally, commenters requested that individuals who refuse
to undergo a public health risk assessment prior to travel be denied
boarding of an aircraft. In response, HHS/CDC notes that individuals
may be denied boarding for public health reasons pursuant to the
criteria published at 80 FR 16,400 (Mar. 27, 2015) titled Criteria for
Requesting
[[Page 6908]]
Federal Travel Restrictions for Public Health Purposes, Including for
Viral Hemorrhagic Fevers.
HHS/CDC received a comment expressing concern about conducting
public health prevention measures at ``other locations'' besides U.S.
ports of entry because the commenter found this language vague. HHS/CDC
clarifies that this term is meant to include all locations where
individuals may enter the United States from a foreign country (i.e.,
border crossings) or gather for the purposes of engaging in interstate
travel (e.g., airports, seaports, railway stations, bus terminals),
regardless of whether such places are formally designated as such.
One public health organization requested clarification regarding
what information or event would justify triggering the screening of
travelers. CDC's response is that, while specific triggers cannot be
defined at this time, screening of travelers may generally be conducted
during a public health emergency if HHS/CDC determined that monitoring
of potentially exposed travelers was needed to protect the public's
health.
One public health organization and many individual commenters
asserted that people exposed to measles should not be ``tracked''
through the use of Federal public health orders. First, we reiterate
that because measles is not a quarantinable communicable disease, HHS/
CDC does not have the authority to issue a public health order for this
illness. Second, it is not HHS/CDC's policy to monitor people following
measles exposures. Rather, HHS/CDC notifies State or local health
departments regarding people in their jurisdictions who may have been
exposed to measles. The State or local health departments, in turn,
choose to notify people regarding their measles exposure, assess their
immunity to measles and, if they are not immune, offer vaccination with
MMR vaccine to prevent infection. State or local health authorities may
choose to monitor people following exposures to measles based on their
own criteria.
One commenter asked whether mandatory health screenings at airports
would be conducted privately, whether processes would comply with
HIPAA, and how data would be protected at airports. In response, HHS/
CDC states that, in all situations, HHS/CDC strives to protect the
privacy of individuals subject to screening, collection of information,
or the issuance of Federal public health orders under HHS/CDC's
authority. While some aspects of the entry risk assessment process
conducted during the 2014-2016 Ebola epidemic were performed in areas
of the airport that are not considered private, these were limited to
collection of contact information, noncontact temperature measurement,
observation for visible signs of illness, and superficial screening
questions that did not collect sensitive information. Any more detailed
public health assessment would be done in a private area.
HHS/CDC is bound by the Privacy Act to protect personally
identifiable data collected and maintained in accordance with that Act.
Furthermore, HHS/CDC will apply the protections of the SORN to all
travelers regardless of citizenship or nationality. Personally
identifiable data collected by HHS/CDC at airports are maintained in a
secure database and shared only for official purposes on a need to know
basis using secure methods as described in CDC's System of Records
Notice published at 72 FR 70867. HHS is also a hybrid entity under
HIPAA, but only those parts of HHS that have been determined to be
health care components are subject to the HIPAA Privacy Rule. CDC is
generally not a health care component treated as a ``covered entity''
under the HIPAA Privacy Rule. However, certain specific offices of HHS,
CDC, and the National Institute for Occupational Safety and Health
(NIOSH) performing activities related to the World Trade Center Health
Program are considered health care components of HHS and must comply
with HIPAA and the Privacy Rule.
One public health organization recommended that the rulemaking
specify that individuals undergoing a public health risk assessment
only be asked to provide contact tracing information if the risk
assessment leads to a reasonable belief that the individual may become
infected. It is CDC's policy to conduct conveyance-related contact
investigations for confirmed cases of communicable diseases. In
instances when confirmation cannot be obtained, HHS/CDC may investigate
contacts based on reasonable belief of infection following a public
health risk assessment which is typically conducted in coordination
with the State or local health department of jurisdiction. Such
operational details are generally defined in internal protocols. State
or local authorities may conduct community-based contact investigations
within their jurisdictions based on their own criteria.
After consideration of these comments, HHS/CDC has modified
paragraph (b) the provisions relating to Public Health Prevention
Measures to Detect Communicable Disease (Sec. Sec. 70.10 and 71.20) to
include information about ``known or possible exposure'' in the list of
information that may be collected.
e. Apprehension and Detention of Persons With Quarantinable
Communicable Diseases
HHS/CDC received several comments relating to the ``apprehension''
of an individual. One public health association and a public health
department suggested that HHS/CDC not use the term ``apprehension''
because this may create social stigma. HHS/CDC uses this term in these
regulations to align with the statutory terminology used in 42 U.S.C.
264(b) which authorizes the ``apprehension, detention, or conditional
release'' of individuals coming into a State or possession from a
foreign country or possession for purposes of preventing the
introduction, transmission, and spread of quarantinable diseases.
Similarly, 42 U.S.C. 264(d) authorizes the ``apprehension and
examination'' of any individual in the qualifying stage of a
quarantinable communicable disease who is moving or about to move
between States or constitutes a probable source of infection to
individuals moving between States. While HHS/CDC can clarify and
explain this term, only Congress has the authority to change statutory
language. In addition to being a term specifically used in statute
under 42 U.S.C. 264, HHS/CDC has determined that this term best conveys
that HHS/CDC may, based on public health grounds, assume physical
custody of individuals. Furthermore, using alternative terminology, may
reduce public understanding and transparency regarding HHS/CDC's legal
authorities.
One commenter stated that not every social distancing technique
needs to involve taking physical custody of individuals and that using
more voluntary-based options would be advisable. HHS/CDC agrees that
attempting to obtain voluntary compliance with public health measures
is more advisable than assuming legal custody, but believes that
maintaining the authority to apprehend individuals who may pose a
public health risk is a necessary tool to protect the public's health.
HHS/CDC received a comment regarding the ``burden of proof'' for an
apprehension. In response, HHS/CDC notes that the applicable standard
for an apprehension of an interstate traveler is ``reason to believe''
that the individual is in the qualifying stage of a quarantinable
communicable disease. HHS/CDC notes that Reasonably believed to be
infected as applied to an individual is defined under this final rule.
[[Page 6909]]
Several commenters expressed concern that because the
``apprehension'' period is not explicitly time-limited, that HHS/CDC
may ``apprehend'' an individual indefinitely without providing the
individual with a written public health order or a medical review. One
commenter noted that HHS/CDC used the term ``generally'' in the
preamble of the NPRM and felt it was too vague, stating ``setting a
firm timeframe is vital.'' A partnership of public health legal
scholars and organizations stated that because HHS/CDC did not
explicitly limit how long an individual could remain apprehended that
such apprehensions could turn into the functional equivalent of a
quarantine thus potentially raising Fourth and Fifth Amendment
concerns. In response to these concerns, HHS/CDC has added language
requiring that it serve an apprehended individual with a public health
order within 72 hours of that individual's apprehension.
HHS/CDC received several other comments relating to the sections
authorizing the apprehension and detention of persons with
quarantinable communicable diseases. A partnership of public health
legal scholars and organizations suggested two public health frameworks
for apprehension and detention, one for implementation during non-
exigent circumstances and a second for exigent circumstances. As
described, the primary distinction between the non-exigent and exigent
framework, is that in the former HHS/CDC would be required to hold a
due process hearing prior to the imposition of an isolation or
quarantine, while in the latter HHS/CDC may briefly detain the
individual prior to holding a hearing. While HHS/CDC appreciates the
input provided by this partnership, HHS/CDC declines to adopt this
suggestion. Importantly, unlike State and local public health
authorities who have primary responsibility for the imposition of
public health measures occurring within their jurisdictions, HHS/CDC
acts in time-sensitive circumstances to prevent communicable disease
spread, such as at ports of entry, upon the request of a State or local
public health authority of jurisdiction, or when State or local control
is inadequate. Furthermore, unlike State and local public health
authorities who generally have broad police-power authority to protect
the public's health, HHS/CDC's statutory authority with respect to
isolation and quarantine is limited to only those small, subset of
communicable diseases specified through an Executive Order of the
President as quarantinable. Accordingly, HHS/CDC does not foresee
sufficient ``non-exigent'' circumstances where it would be necessary
for it to issue a Federal isolation or quarantine order and thus
declines to establish the suggested alternative framework on this
basis.
The circumstances under which HHS/CDC may apprehend and detain
individuals is limited by the terms of 42 U.S.C. 264. HHS/CDC may only
isolate, quarantine, or conditionally release an individual if it
reasonably believes that the individual is infected with a
quarantinable communicable disease and the individual is either
arriving into the U.S. from a foreign country, moving between States,
or constitutes a probable source of infection to others who may then
move between States.
Accordingly, the circumstances under which CDC is would issue a
quarantine or isolation order are ``exigent'' because the individual
constitutes a communicable disease risk and is actively engaged in
travel or constitutes a source of infection to others engaged in
travel. It is thus unnecessary and impractical to provide a ``pre-
deprivation'' hearing prior to quarantining or isolating the individual
because he/she if released from custody may be lost to public health
follow-up and may expose others. HHS/CDC would not quarantine or
isolate an arriving traveler from a foreign country where a single case
of a communicable disease such as Ebola exists unless it reasonably
believes that the traveler arriving into the U.S. is infected with a
quarantinable communicable disease.
Commenters stated that individuals must receive notice of their
suspected exposure and be permitted to speak with legal counsel or have
legal counsel appointed to them. HHS/CDC agrees that individuals should
be adequately notified of the basis for their detention and directs
this commenter to sections 70.14 and 71.37, which detail the specific
factual content that must be included in a Federal order for
quarantine, isolation, or conditional release. We have also modified
these sections to explicitly require that the federal order include an
explanation of the right to request a medical review, present witnesses
and testimony at the medical review, and to be represented at the
medical review by either an advocate (e.g., family member, physician,
or attorney) at the individual's own expense, or, if indigent, to have
representatives appointed at the government's expense.
As previously stated, consistent with principles of preventing
communicable disease spread, HHS/CDC will also take measures (such as
ensuring phone access) to allow apprehended individuals to have contact
with family or legal counsel whom they hire at their own expense. As
explained further below, HHS/CDC will also appoint representatives,
including a medical representative and an attorney, if the individual
is indigent and requests a medical review. Individuals who do not
qualify as indigent may also choose to be represented at the medical
review by an advocate (e.g., an attorney, physician, family member) and
present a reasonable number of medical experts, of their own choosing
and at their own expense. HHS/CDC, however, rejects as impractical the
notion that indigent individuals should have representatives appointed
to them at the moment of apprehension because most illnesses of public
health concern can be ruled out based on a short interview with a
quarantine officer involving an assessment of symptoms and travel
history. Thus, the expected length of an apprehension will be very
short and not justify the appointment of representatives.
This commenter also requested clarity on what legal recourse may be
available to apprehended individuals. While HHS/CDC does not express an
opinion regarding what form of legal action an aggrieved individual
should pursue, we note that these regulations do not impact the
constitutional or statutory rights of individuals to seek judicial
redress for detention.
HHS/CDC received comments from the public regarding HHS/CDC's
authority to ``arrest'' individuals. One commenter stated that
individuals should only be detained when a crime has been committed.
One association objected to HHS/CDC's ``power to detain an individual
for 72 hours and longer without any Federal court order.'' Some
commenters also worried that any person showing signs of a ``common
cold'' may be held. To be clear, HHS/CDC is not a law enforcement
agency, it has no legal authority to ``arrest'' individuals, but rather
has been granted the authority by Congress to ``apprehend and detain''
individuals for the purposes of preventing the introduction,
transmission and spread of quarantinable communicable disease as
specified in an Executive Order of the President. 42 U.S.C. 264(b).
This provision further provides that ``regulations may provide that if
upon examination any such individual is found to be infected, he may be
detained for such time and in such manner as may be reasonably
necessary.'' 42 U.S.C. 264(d)(1). HHS/CDC strongly believes that these
[[Page 6910]]
authorities may be implemented in a manner consistent with the U.S.
Constitution. Furthermore, during the period of apprehension, HHS/CDC
will arrange for adequate food and water, appropriate accommodation,
appropriate medical treatment, and means of necessary communication.
HHS/CDC received comments from the public inquiring about the
criteria that HHS/CDC uses to determine whether an individual should be
detained and assessed. As provided for in the regulation, HHS/CDC may
apprehend, examine, isolate, and quarantine such individuals to protect
the public's health. In determining whether an individual poses a
threat to public health, HHS/CDC has developed and uses the following
criteria: Clinical manifestations: Signs and symptoms consistent with
those of a quarantinable disease; known or suspected contact with a
case, i.e., patients either confirmed or suspected to be infected with
a quarantinable disease; epidemiologic information/evidence (travel
history, exposure to animals); other documentary or physical evidence
in the individual's possession, such as a physician's note documenting
infection with or medication for treatment of a quarantinable
communicable disease; and/or public health authorities have notified
HHS/CDC that the individual is known or suspected to be infected with a
quarantinable communicable disease and non-adherent with public health
recommendations. This determination is typically made in consultation
and coordination with State and local public health authorities, as
well as the treating health care physician (when available). One public
health association agreed that travel history (entering the U.S. from a
country where quarantinable diseases occur) made sense for screening,
but not for a quarantine or isolation order. HHS/CDC responds that the
criteria listed above, as well as those within the NPRM, are examples
of factors that HHS/CDC takes into consideration when determining the
totality of the circumstances--not one criterion does, should, or will,
decide if the individual requires a public health order.
One commenter questioned whether, regarding the list of
quarantinable communicable diseases listed by Executive Order of the
President, a ``common cold'' would qualify as a ``severe acute
respiratory syndrome'' and therefore subject the ill individual to a
public health order. In response, we note that Executive Order 13295
(April 4, 2003), as amended by Executive Order 13375 (April 1, 2005)
and Executive Order 13674 (July 31, 2014), explicitly excludes
``influenza'' from the definition of severe acute respiratory syndrome.
HHS/CDC received several comments from a flight attendant union
relating to apprehension and detention of a flight crew. These comments
include that the flight attendant's employer should be made aware of
the apprehension, that HHS/CDC should limit the personal health
information that is shared with the employer, that the employer should
treat this information as confidential, and that those apprehended
should be able to notify families and their union. In response, HHS/CDC
notes that it works closely with the airline industry regarding
potential occupational exposures to communicable diseases. Furthermore,
HHS/CDC notes that personally identifiable health information collected
and maintained under the Privacy Act will be disclosed only with the
consent of the subject individual, in accordance with the routine uses
published in HHS/CDC's system of records notice (72 FR 70867), or under
an applicable exception to the Privacy Act. While these regulations do
not mandate how employers should treat the personal health information
of their employees, HHS/CDC agrees that such information should be
treated as confidential. Lastly, consistent with principles of
preventing communicable disease spread, HHS/CDC will allow persons
detained in accordance with these regulations to communicate with
family, union representatives, legal counsel whom they hire at their
own expense, and others of their choosing. HHS/CDC will also appoint
representatives, including a medical representative and an attorney, if
the individual is indigent and requests a medical review.
One commenter asked about provisions for people detained under HHS/
CDC's authority who require emergency medical care, and whether the
need to conduct a public health assessment could impede such care
resulting in harm to the individual. In response, HHS/CDC states that
public health officers at ports of entry work closely with emergency
medical service (EMS) personnel and that emergency medical care takes
precedence over the public health risk assessment. When an individual
suspected of being infected with a quarantinable communicable disease
requires emergency care, the individual would be transported
immediately by EMS to a medical facility, using appropriate infection
control precautions. The public health risk assessment would be
completed subsequently using information provided by the examining
health care provider in coordination with the health department of
jurisdiction.
After consideration of these comments, HHS/CDC has finalized the
Apprehension and Detention of Persons With Quarantinable Communicable
Diseases (Sec. 70.6) provision as proposed, with the exception that
Federal public health orders must be served on the individual within 72
hours of an apprehension. As further detailed below, the 72-hour period
was determined based on public comment from health departments familiar
with the process, as well as CDC's previous experience of the time
necessary to conduct a medical examination, collect and package
laboratory specimens, transport the specimens to an appropriate
laboratory (when necessary), and conduct the testing.
f. Medical Examinations
HHS/CDC received several comments relating to medical examinations.
HHS/CDC received a comment from a public health agency stating that
when an individual agrees to submit to a medical examination, it may be
more appropriate to medically examine the patient during the
``apprehension'' period. In response, HHS/CDC notes that these
regulations do not prohibit voluntary compliance with public health
recommendations in the absence of a public health order.
Notwithstanding, HHS/CDC believes that the ability to order a medical
examination as part of an order for isolation, quarantine, or
conditional release is an important tool to protect the public's
health. This agency also stated that the definitions of ``health
status'' and ``public health risk'' should be modified to ensure that
the medical examination contains the minimum requirements needed to
assess the communicable disease of public health concern. In response,
HHS/CDC clarifies that its sole purpose in ordering a medical
examination would be to determine the presence, absence, or extent of
infection with a quarantinable communicable disease. HHS/CDC notes,
however, that the medical examination is conducted by clinical staff
who have primary responsibility for the patient's medical care and
treatment and that a medical examination would thus ordinarily include
the taking of a medical history and physical examination. HHS/CDC
believes that this definition is clear and that no further
modifications are needed.
HHS/CDC received a comment expressing concern that an individual
would not be able to choose his or her own clinical healthcare provider
if
[[Page 6911]]
ordered to undergo a medical examination. One commenter raised concerns
about the possibility of medical examinations being conducted by
``unqualified'' or ``non-medical personnel.'' In response, HHS/CDC
clarifies that, in keeping with current practice, any medical
evaluation required by HHS/CDC would be conducted at a healthcare
facility by a licensed healthcare practitioner. Furthermore, HHS/CDC
has determined that it would be impractical to allow individuals to
choose their own medical examiners. HHS/CDC notes that among other
considerations, it must ensure that the healthcare facility where the
medical examination will be conducted has appropriate containment
facilities, that necessary laboratory samples will be properly
collected, and that it is HHS/CDC's practice to coordinate closely with
State and local public health authorities in the choosing of clinical
healthcare providers. Accordingly, we have concluded that the public
interest is best served by having HHS/CDC, in coordination with the
local health authority and EMS, choose the healthcare facility where
the medical examination will be conducted and not the detained
individual.
One commenter expressed concern that nonmedical personnel may be
allowed to make a determination of illness resulting in actions being
taken based on potential misdiagnosis. HHS/CDC appreciates the
opportunity to clarify this point. Decisions to issue Federal public
health orders are based on the assessment of qualified and licensed
physicians. These decisions are based on all available evidence,
including clinical presentation, medical and exposure history, and the
results of medical evaluation and laboratory testing. Treatment
decisions are made by the individual's treating physician with guidance
from public health subject-matter experts.
One commenter suggested that medical examinations should be
conducted only with the informed consent of the individual and should
not ``forcibly'' be required. HHS/CDC clarifies that it may require a
medical examination under 42 U.S.C. 264(d) because this section, among
other things, authorizes the ``apprehension and examination'' of
individuals reasonably believed to be infected with quarantinable
communicable diseases in a qualifying stage. CDC, however, agrees that
medical examinations may not be conducted ``forcibly.'' Furthermore,
because medical examinations will typically occur in a hospital setting
and be performed by clinical staff, it will be incumbent upon clinical
staff to obtain the patient's informed consent consistent with
established standards of medical practice.
Public health organizations provided several comments regarding
medical examinations, including that they be performed promptly so as
not to curtail liberty, include only minimal components necessary to
establish the diagnosis of or rule out the quarantinable communicable
disease of concern, and that specimens obtained during such
examinations not be used for purposes other than diagnostic testing
without informed consent. In response, HHS/CDC states that it agrees
with all of these points and that CDC, in keeping with current
practice, has a commitment to upholding the highest ethical standards
for both medical care and research.
One public health organization asked for clarification of whether
hospital staff would be involved in obtaining consent for medical
examinations authorized under this rule. In response, HHS/CDC states
that, while a public health order authorizes that a medical examination
be conducted, should any invasive procedures be determined by the
treating clinician to be necessary for diagnostic or treatment
purposes, consent for such procedures should be obtained by medical
staff in accordance with established standards.
One organization asked for clarification of the location where
medical examinations would be conducted, including whether inpatient or
ambulatory-care facilities would be included. HHS/CDC responds that it
will coordinate with State or local health departments of jurisdiction
concerning such operational details as the exact locations where
medical examinations may be conducted.
Several public health organizations commented on whether the
issuance of public health orders is needed prior to medical examination
if individuals agree voluntarily to such examinations, noting that a
requirement for the issuance of orders could impede or delay the
medical examination and that the examination, itself, could determine
whether such orders are needed. In response, HHS/CDC notes that it may
choose not to exercise its authority to issue public health orders if
an individual complies voluntarily with HHS/CDC's requirements,
including the requirement of a medical examination. However, HHS/CDC
retains the right to issue an order requiring a medical examination
should an individual not comply voluntarily. Of note, one public health
organization supported the use of Federal public health orders in
requiring medical examinations, stating that such orders had been used
effectively in the past to facilitate timely examination.
One public health organization requested that language be added to
the rule stating that medical examinations will be performed with
proper adherence to worker safety and health policies and protocols.
HHS/CDC responds that such occupational health protections are beyond
the scope of this regulation and are covered by regulations of the
Occupational Safety and Health Administration (OSHA).
HHS/CDC received several comments from a flight attendant union
relating to medical examinations. This organization stated that the
regulations should mandate that an employer pay a flight attendant's
salary and per diem and that no flight attendant should incur
discipline as a result of being absent from work. This organization
further commented that any changes in the employer-employee
relationship should be addressed through joint guidance between
government and industry groups. This group also commented that
``promptly'' should be defined in terms of the length of time that may
be needed to arrange for a medical exam and that no more than five
hours would be reasonable. This group further stated that ``reasonably
believed'' should be defined to require specific, articulable facts
that a trained medical professional can articulate.
HHS/CDC responds that these regulations do not alter, define, or
mandate the employer-employee relationship between flight attendants
and their employers. In regard to the timeframe for arranging a medical
examination, HHS/CDC rejects a specific 5-hour timeframe as too
prescriptive, but agrees that the medical examination should be
arranged as quickly as possible based on the circumstances of the
event. HHS/CDC further notes that the definition of ``reasonably
believed to be infected'' already requires the existence of ``specific
articulable facts'' articulated by a public health officer. Such
specific, articulable facts would, for instance, include ``contact with
an infected person or an infected person's bodily fluids, a
contaminated environment, or through an intermediate host or vector.''
HHS/CDC received a comment from a partnership of public health
legal scholars and organizations expressing concern that the
regulations do not appear to limit the invasiveness of a medical
examination, so long as the examination itself is needed to diagnose or
determine the presence or extent of infection with a quarantinable
communicable disease. HHS/CDC
[[Page 6912]]
welcomes this opportunity to provide further clarifications. HHS/CDC
notes that because medical examinations will occur in a hospital
setting and be performed by the hospital's clinical staff, it will be
incumbent upon clinical staff to obtain the patient's informed consent
consistent with established standards of medical practice prior to any
examination occurring and that such examinations may not be forcibly
conducted. HHS/CDC has also added a requirement that the Director, as
part of the Federal order, the individual that the medical examination
shall be conducted by an authorized and licensed health worker with
prior informed consent. Furthermore, HHS/CDC will implement this
provision consistent with U.S. constitutional requirements and Articles
23 and 31 of the International Health Regulations, which requires that
parties apply ``the least intrusive and invasive medical examination
that would achieve the public health objective.''
After consideration of these comments, HHS/CDC has finalized the
provisions relating to Medical Examination (Sec. Sec. 70.12 and 71.36)
as proposed, with the exception that the Director as part of the
Federal order must advise the individual that the medical examination
will be conducted by an authorized and licensed health worker with
prior informed consent.
g. Requirements Relating to Issuance of a Federal Order for Quarantine,
Isolation, or Conditional Release
HHS/CDC received several comments relating to the issuance of
Federal orders for isolation or quarantine. A flight attendant union
commented that crew lists should not be published as part of a
quarantine order posted in a conspicuous location. This group further
stated that quarantine orders for flight attendants should be treated
differently than those applicable to passengers or other airline
personnel because flight attendants are health and safety personnel
trained in how to perform CPR and operate defibrillators. In response,
HHS/CDC notes that if a public health order is publicly posted, the
order will be written to refer to a group of individuals, such as all
individuals onboard a particular affected interstate or international
flight. Under such circumstances, HHS/CDC expects that all members of
the group will receive individual copies of the public health order. In
some circumstances, CDC anticipates that issuance of a group federal
order to an individual may not be feasible--such as when the location
of the individual is unknown. Thus, HHS/CDC does not expect to publish
the names of individual passengers or crew as part of a publicly posted
quarantine order. Furthermore, while HHS/CDC agrees that flight
attendants provide an important public health and safety role, HHS/CDC
disagrees that acknowledging this role requires the issuance of
different public health orders than those issued to other affected
persons.
HHS/CDC received several comments requesting the ``least
restrictive'' means with respect to quarantine and isolation. HHS/CDC
agrees and clarifies that in all situations involving quarantine,
isolation, or other public health measures, it seeks to use the least
restrictive means necessary to prevent spread of disease. Regarding
quarantine, as an example, during the 2014-2016 Ebola epidemic, HHS/CDC
recommended monitoring of potentially exposed individuals rather than
quarantine. Most of these people were free to travel and move about the
community, as long as they maintained daily contact with their health
department. For some individuals with higher levels of exposure, HHS/
CDC recommended enhanced monitoring (involving direct observation) and,
in some cases restrictions on travel and being in crowded places, but
did not recommend quarantine. HHS/CDC has the option of ``conditional
release'' as a less restrictive alternative to issuance of an order of
quarantine or isolation. Under a conditional release order, the person
would not be confined as long as the terms of the order were followed.
Should a quarantine or isolation order be deemed necessary, home
quarantine or isolation would be considered as a less restrictive
option to confinement in a guarded facility as long as this was
determined to be safe for other household members, appropriate based on
the individual's ability and willingness to follow all necessary
precautions, and based on the individual's history of compliance with
public health recommendations.
One public health organization requested that HHS/CDC specify the
types of locations of Federal quarantine and asked clarification of
whether this would occur on lands or property under Federal
jurisdiction, and whether Federal or State standards would apply to an
individual quarantined on lands or property not under Federal control.
In response, HHS/CDC notes that operational issues such as the exact
location of a quarantine and whether Federal, State, and local orders
would be issued separately or concurrently would depend on individual
facts and circumstances unique to each case. HHS/CDC notes, however,
that it is not unusual for the Federal government to exercise
jurisdiction concurrently with State and local governments.
One public health organization noted the longstanding difficulties
faced by Federal, State and local authorities in identifying suitable
facilities for quarantining of large groups of people (approximately
350, representing the potential complement of travelers onboard an
international flight), including the immediate availability of such
facilities in the event of an emergency. HHS/CDC acknowledges these
difficulties and affirms that it is actively working with Federal
partners to identify suitable locations to accommodate large groups of
people while under a Federal public health order.
One commenter stated, ``If this is enacted . . . everyone who works
with diseases . . . CDC, WHO, Labs, Drs., nurses etc. would have to be
arrested as potential carriers.'' HHS/CDC disagrees with this
assertion. HHS/CDC is not a law enforcement agency and does not have
authority to arrest individuals. HHS/CDC's authority to issue Federal
public health orders is limited to those diseases defined by Executive
Order as quarantinable communicable diseases. Furthermore, HHS/CDC does
not recommend restriction of movement for healthcare workers,
laboratory workers, or others whose occupations involve working with
infectious pathogens as long as the recommended infection control
precautions are followed. Workers who do not take the necessary
precautions or have unprotected exposures to a quarantinable
communicable disease may be subject to restrictions if they meet the
requirements for issuance of Federal public health orders.
Some commenters indicated that vaccination or treatment should not
be ``conditions'' under ``conditional release.'' HHS/CDC confirms that
this final rule does not compel mandatory vaccination or medical
treatment of individuals. HHS/CDC clarifies that when medically
appropriate, vaccination or treatment, may be ``conditions'' of an
individual's release from quarantine or isolation. Individuals consent
to these conditions.
A public health agency commented that HHS/CDC should consider the
conditions of confinement to ensure that certain minimum requirements,
such as access to telephones, and reasonable accommodation of dietary
restrictions, are observed. Specifically, such conditions should be
considered at different stages including as part of the issuance of an
order, during the mandatory reassessment, and as a part
[[Page 6913]]
of the medical review. In response, HHS/CDC notes that in addition to
implementing these regulations consistent with U.S. constitutional
requirements, CDC's implementation will also be consistent with Article
32 of the International Health Regulations which, among other things,
requires that in implementing health measures under the IHR the gender,
sociocultural, ethnic and religious concerns of the traveler be taken
into consideration. Furthermore, Article 32 requires arranging for
adequate food and water, protection for baggage and other possessions,
appropriate accommodation, appropriate medical treatment, and means of
necessary communication for those subject to public health orders.
Furthermore, as stated in the regulations, as part of a mandatory
reassessment and medical review, HHS/CDC will consider whether the
least restrictive means are being used to protect the public health.
HHS/CDC, however, does not believe that it is necessary for
``conditions of confinement'' to be formally considered as part of an
administrative review because many conditions of confinement, such as
availability of entertainment or other amenities, may be raised through
informal means such as making one's concern known to the facility where
the individual is being housed.
HHS/CDC received a comment from a public health agency noting that
it should assume the responsibility of providing translation and
interpretation services when issuing an order for quarantine,
isolation, or conditional release, or when conducting a medical review.
HHS/CDC agrees and has incorporated these changes into the regulatory
text.
HHS/CDC received a comment from a partnership of public health
legal scholars and organizations requesting clarification as to whether
personal service will occur when a quarantine order is issued on a
group basis and posted in a conspicuous location. In response, HHS/CDC
notes that if a public health order is publicly posted, the order will
be written to refer to a group of individuals, such as all individuals
onboard a particular affected interstate or international flight. Under
such circumstances, HHS/CDC expects that all members of the group will
receive individual copies of the public health order, thus addressing
any concerns about adequacy of notice. Because HHS/CDC, however, cannot
foresee all of the circumstances that may arise in an emergency
situation, HHS/CDC believes that it is appropriate for these
regulations to authorize service through posting or publication, but
only when individual service is ``impracticable.''
After consideration of these comments, HHS/CDC has modified the
provisions regarding requirements relating to issuance of a Federal
order for quarantine, isolation, or conditional release (Sec. Sec.
70.14 and 71.37). Paragraphs (a)(5) and (4) of these provisions have
been modified, respectively, to require that the federal order include
an explanation of the right to request a medical review, present
witnesses and testimony at the medical review, and to be represented at
the medical review by either an advocate (e.g., family member,
physician, or attorney) at the individual's own expense, or, if
indigent, to have representatives appointed at the government's
expense. Paragraph (b) of these provisions has been modified to require
that a Federal public health order be served within 72 hours of an
individual's apprehension. A new provision, paragraph (c), has been
added requiring that the Director arrange for translation and
interpretation services of the Federal order as needed.
h. Mandatory Reassessment of a Federal Order for Quarantine, Isolation,
or Conditional Release
A number of commenters were confused regarding the 72-hour period,
believing this period referred to the period of apprehension pending
the issuance of a Federal public health order and asked why 72 hours
were needed. The 72-hour period proposed referred to the timeframe in
which HHS/CDC must conduct a mandatory reassessment of the continued
need for isolating or quarantining an individual following the service
of a Federal public health order. However, in response to public
comments HHS/CDC has also added in sections 70.14(b) and 71.37(b) a
requirement that it serve the individual with a Federal public health
order within 72 hours of that individual's apprehension.
Some commenters, including a public health association, supported
the mandatory 72-hour reassessment provision guaranteed by these
regulations. One of these commenters also suggested the time be re-
evaluated periodically in the event that technology provides a way of
speeding up the diagnosis process; another suggested the time frame be
expanded to five days to account for weekends; one more commenter noted
that circumstances may arise where an additional 72 hours may be
needed; and another commenter stated that a second 72-hour reassessment
should be required. HHS/CDC is committed to performing a reassessment
within 72 hours of the federal public health order being served on the
individual. If, at that time, HHS/CDC determines that the order was
properly issued and that a public health risk continues to exist, the
order would either be continued or HHS/CDC would work with the State
and local health department to transfer custody. In the event that HHS/
CDC continues the order, the individual may request a medical review at
that time.
A few commenters stated that the reassessment of HHS/CDC's orders
should be conducted in a shorter time period than 72 hours such as
within 12 hours, performed electronically and conducted by a 3rd party.
While HHS/CDC appreciates the input provided by these commenters, HHS/
CDC finds these suggestions impractical. Medical examination to confirm
or rule out infection with a quarantinable communicable disease may
require up to 72 hours to allow for laboratory testing. While some
communicable diseases (typically viral infections) may be diagnosed
using molecular tests such as polymerase chain reaction (PCR) that take
several hours to perform, others require that the organism be cultured
to make a confirmed diagnosis or to conduct antimicrobial sensitivity
testing in order to provide appropriate treatment. This is typically
needed for bacterial infections, such as diphtheria or plague, and may
take 48-72 hours (or longer) to complete. For some infectious
tuberculosis cases, laboratory confirmation may take several weeks
although preliminary molecular testing may assist in conducting an
assessment of risk sufficient to continue or rescind the order.
Specimen transportation time may also need to be factored in as testing
for certain diseases is only available at state public health
laboratories or CDC.
While HHS/CDC is required by this provision to reassess the need
for a Federal public health order within 72 hours, HHS/CDC will
immediately release individuals from detention if at any time it
receives information confirming the absence of infection with a
quarantinable communicable disease. We note that while the medical
assessment is intended primarily as a review of available medical
records and other relevant information, these regulations do not
prohibit HHS/CDC from conducting the review electronically, for
instance by relying on electronic medical records. Furthermore, HHS/CDC
disagrees that relying on internal decision-makers for the reassessment
is inappropriate or undesirable and thus does not consider
[[Page 6914]]
it necessary to rely on a ``3rd party.'' However, the CDC official or
employee conducts the reassessment will not be the same person who
issued the quarantine, isolation, or conditional release order.
Following the reassessment, the detained individual may also request a
medical review as described in these regulations.
HHS/CDC received a comment from a public health agency requesting
clarification as to whether all individuals within a group will receive
individual due process when a group order is issued. This agency also
questioned the feasibility of providing a mandatory reassessment and
medical review for large groups. In response, HHS/CDC confirms that if
a group order is issued, all individuals within that group will be
accorded due process. Furthermore, HHS/CDC has provided flexibility in
the regulations to allow for a mandatory reassessment of the group
order and consolidation of medical reviews where appropriate.
HHS/CDC received a comment from a partnership of public health
legal scholars and organizations stating that while the rule requires
consideration of least restrictive means upon reassessment of an order
and as part of the medical review, HHS/CDC must also consider least
restrictive means prior to the issuance of a quarantine or isolation
order. HHS/CDC agrees that all means short of assuming legal custody of
the individual including attempting to obtain voluntary compliance with
public health measures should be explored. HHS/CDC notes, however, that
an isolation or quarantine order is typically issued in time-sensitive
situations where because of the exigent circumstances surrounding the
risk of communicable disease spread it is not immediately possible to
explore all available less restrictive means, including the
appropriateness of a home environment, instead of a hospital. For this
reason, HHS/CDC has chosen the mandatory reassessment and medical
review as the appropriate time to conduct a formal assessment of least
restrictive means. To the extent that the commenters suggest that due
process requires more, we disagree. See Yin v. California, 95 F.3d 864,
870 (9th Cir. 1996) (recognizing that in searches and seizures
justified by special needs, the government does not have to use the
least restrictive means to further its interests); Stockton v. City of
Freeport, Texas, 147 F.Supp.2d 642, 647 (S.D. Tex. 2001) (recognizing
that the Fourth Amendment does not require that a search or seizure be
conducted through the least restrictive means, but rather that the
alleged personal invasion be reasonable under all of the
circumstances).
After consideration of these comments, HHS/CDC has finalized the
provisions relating to mandatory reassessment of a Federal order for
quarantine, isolation, or conditional release (Sec. Sec. 70.15 and
71.38) as proposed.
i. Medical Review of a Federal Order for Quarantine, Isolation, or
Conditional Release
HHS/CDC received several comments arguing that its proposed medical
review procedures are deficient. Specifically, one commenter stated
that assessment procedures should be clearly communicated to all
affected persons; that HHS/CDC should more clearly delineate ``less
restrictive alternatives;'' that affected individuals should have a
right to legal representation; and that access to independent judicial
review is essential.
HHS/CDC agrees that it should clearly communicate review procedures
to individuals subject to Federal isolation, quarantine, or conditional
release. We note that sections 70.14 and 71.37 have been modified to
require that the federal order authorizing isolation, quarantine, or
conditional release include an explanation that the federal order will
be reassessed 72 hours after it is served on the individual and of the
right to request a medical review, present witnesses and testimony at
the medical review, and to be represented at the medical review by
either an advocate (e.g., family member, physician, or attorney) at the
individual's own expense, or, if indigent, to have representatives
appointed at the government's expense. We further note that the
provisions relating to medical reviews, sections 70.16 and 71.39 have
been revised to include new paragraphs (q) which states that ``The
Director shall arrange for translation or interpretation services as
needed for purposes of this section.''
Similarly, in regard to minor children or adults with a cognitive
disability, HHS/CDC will work with a competent guardian to ensure that
procedures are clearly communicated. In regard to less restrictive
alternatives, HHS/CDC believes that it is not possible to delineate
with specificity all of the less restrictive options that may be
available because such determinations will inevitably be based on the
individual circumstances of each case, including the severity of the
particular disease-causing agent, availability of treatment options
should the disease not be adequately contained, the patient's
particular level of infectivity or communicability, appropriateness of
the home environment, and the individual patient's understanding,
ability, and willingness to comply with less restrictive alternatives.
For this reason, HHS/CDC has made consideration of less restrictive
alternatives a part of the medical review proceeding where evidence may
be submitted into the record, testimony obtained, and a recommendation
provided by the medical reviewer. As a general matter, however, HHS/CDC
clarifies that less restrictive alternatives would refer to reasonable
and available alternatives that are adequate to protect the public's
health other than confinement in a guarded facility, such as home
quarantine, directly observed therapy, or other forms of supervised
release.
In response to concerns about legal representation, HHS/CDC has
amended the definition of ``Medical representative'' to
``Representatives'' and will now appoint ``an attorney knowledgeable of
public health practices'' in addition to a ``physician, nurse
practitioner, or similar medical professional qualified in the
diagnosis and treatment of infectious diseases.'' HHS/CDC hopes that by
appointing both an attorney and a qualified medical professional for
indigent individuals it will alleviate concerns expressed by the public
regarding the medical review process. We note that an attorney may
become ``knowledgeable of public health practices'' in a number of
ways, for instance, through prior representation of a public health
agency or advocacy organization, training provided by a public health
or advocacy organization or other training that would ordinarily occur
through a Continuing Legal Education (CLE) event, law school
coursework, or through independent study. We further note that for
individuals qualifying as indigent, HHS/CDC intends to provide
independent legal counsel from outside of the agency. In doing so, HHS/
CDC may employ a variety of mechanisms, such as through agreements or
memorandums of understanding with law school legal clinics, State or
local bar associations, or public interest groups representing indigent
clients. Individuals who do not qualify as indigent may choose to be
represented at the medical review by an advocate (e.g., an attorney,
physician, family member) and present a reasonable number of medical
experts, of their own choosing and at their own expense.
HHS/CDC also agrees that access to independent judicial review is
essential and assures the public that this final rule does not affect
the constitutional or statutory rights of individual to seek
[[Page 6915]]
judicial review through such traditional mechanisms as a petition for a
writ of habeas corpus under 28 U.S.C. 2241. As a Federal agency,
however, HHS/CDC would lack the legal authority through regulation to
grant Federal courts with jurisdiction that they would not otherwise
possess because only Congress may expand a Federal court's
jurisdiction.
HHS/CDC received a comment from a partnership of public health
legal scholars and organizations stating that the CDC Director should
not have unfettered discretion to accept or reject the medical
reviewer's decision, but rather should only be allowed to reject a
decision based on lack of substantial evidence. HHS/CDC believes that
it would be inappropriate to mandate through regulation that the
decision of a medical reviewer (which may include an HHS or CDC
employee) should displace the decision of the CDC Director,
particularly where the statute and delegation of authority have
provided otherwise.
HHS/CDC received several comments stating that a medical
representative should be appointed to anyone regardless of their
ability to pay. HHS/CDC disagrees and notes that appointment of a
representative at the government's expense without regard to the
patient's indigence is not required. The status of ``indigent'' is
self-reported as HHS/CDC will not require access to an individual's
financial records. Those who self-identify as indigent may be required
to sign an affidavit or declaration under penalty of perjury stating
they meet the threshold of at least 200% of the applicable poverty
guidelines.
HHS/CDC received a comment from a non-profit organization
contending that the medical review does not comport with due process
because there is no limit on the number of reviews that may be
consolidated into a single proceeding, no access to legal counsel, no
independence of the reviewer from the initial decision-maker, no
confrontation or cross-examination of witnesses, no compulsory process
for obtaining evidence or testimony, and no judicial review. This group
contends that any detention that is non-exigent should occur only based
on the ``informed explicit written consent'' of the patient or
``utilize the existing legal procedures for involuntary commitment of
persons.''
HHS/CDC disagrees that the medical review as described and set
forth in the regulations does not comport with due process. While HHS/
CDC acknowledges that there is no numerical limit to the number of
medical reviews that may be consolidated, HHS/CDC believes that the
circumstances giving rise to the need for consolidation will be
exceedingly rare and that medical reviews will generally be conducted
on an individual basis.
HHS/CDC also disagrees that there is no access to legal counsel
because HHS/CDC will, consistent with principles of preventing
communicable disease spread, allow persons subject to public health
orders to communicate with family and legal counsel whom they hire at
their own expense. Furthermore, as described above, the regulations
have been amended to require the appointment of both an attorney and a
medical professional if the detained individual qualifies as an
indigent and requests a medical review. Individuals who do not qualify
as indigent may also choose to be represented at the medical review by
an advocate (e.g., an attorney, physician, family member) and present a
reasonable number of medical experts, of their own choosing and at
their own expense.
HHS/CDC further believes that reliance on internal reviewers does
not violate due process and notes that it is not unusual, for instance,
for hospitals to rely on internal decision-makers when determining
whether to commit a mental health patient on an emergency basis. The
regulations, moreover, explicitly state that the medical reviewer will
not be the same individual who initially authorized the quarantine or
isolation order. We note further that the definition of both
``representatives'' and ``medical reviewer'' would in fact allow for
the appointment of non-HHS/CDC employees in these capacities because
both terms are broadly defined in terms of the professional
qualifications and not employment status of these individuals. Thus,
these regulations do not prohibit the CDC Director from appointing
personnel from outside of the agency to assist in conducting a medical
review. For individuals qualifying as indigent, HHS/CDC intends,
generally, to provide independent legal counsel from outside of the
agency.
HHS/CDC also clarifies that during the course of a medical review,
a detained individual will be permitted to present witnesses and
question any witnesses offered by HHS/CDC. Any ``confrontation'' of
witnesses, however, will be conducted in a manner consistent with
principles of preventing communicable disease spread. HHS/CDC, as a
Federal agency, however lacks the legal authority to allow a detained
individual to use compulsory processes, such as a subpoena, to compel
the presence of witnesses. HHS/CDC will nevertheless make reasonable
efforts to produce any HHS/CDC employees that would be critical to a
detained individual's presentation of evidence during a medical review.
HHS/CDC also disagrees that there is no judicial review and notes
that these regulations do not impact an individual's constitutional or
statutory rights to contest their Federal detention through such
traditional mechanisms as a petition for a writ of habeas corpus under
28 U.S.C. 2241. To the extent, however, that the commenter contends
that HHS/CDC should follow legal procedures other than those set forth
through the Federal quarantine statute at 42 U.S.C. 264, we disagree.
HHS/CDC notes that as a Federal agency it lacks the ability to rewrite
Federal statutes or grant Federal courts with legal jurisdiction that
they do not already possess. HHS/CDC also rejects as impractical and as
insufficient to protect public health, the notion that isolation or
quarantine should only occur based upon the consent of the subject
individual.
HHS/CDC received a comment from a flight attendant union that as an
important ``safety net'' HHS/CDC should pay for ``second medical
opinions.'' HHS/CDC declines to extend payment to medical examinations
beyond those required as part of a public health order, but notes that
as part of a medical review individuals may submit additional evidence
into the record concerning their health status and potential public
health risk to others.
One commenter noted language in the NPRM stating that the ``medical
review is not intended to address the concerns of individuals who take
issue with amenities of their confinement . . .,'' interpreting this to
mean that ``no provision is made for those who must use a CPAP
(continuous positive airway pressure) at night or who need orthopedic
appliances, or who have food allergies, to name a few.'' In response,
HHS/CDC states that, when confinement of an individual under Federal
public health authorities is needed, HHS/CDC will ensure that such
confinement will occur in a location and with necessary amenities to
ensure the health and safety of the individual, including provision for
medical or dietary requirements. Issues related to health and safety
will be addressed at the time of the issuance of the order, or as soon
as HHS/CDC is made aware of them, but are beyond the scope of the
medical review which is intended to re-evaluate the continued need for
the Federal public health order based on a review of the medical and
other evidence submitted into the record.
[[Page 6916]]
HHS/CDC received a comment from a partnership of public health
legal scholars and organizations stating that it should provide for an
oral hearing whenever practical. HHS/CDC agrees that an oral hearing is
appropriate and has modified the language to state: ``The medical
review shall be conducted by telephone, audio or video conference, or
through other means that the medical reviewer determines in his/her
discretion are practicable for allowing the individual under
quarantine, isolation, or conditional release to participate in the
medical review.''
HHS/CDC received a comment from a partnership of public health
legal scholars and organizations that the CDC Director's written order,
which constitutes final agency action, must advise individuals of their
rights to appeal to Federal court. We note that the commenters
specifically cite the Administrative Procedures Act (APA, 5 U.S.C.
704), which provides that ``final agency action for which there is no
other adequate remedy in a court are subject to judicial review.''
While HHS/CDC agrees that independent judicial review of agency
decisions is available, it takes no position as to whether such reviews
should occur under the APA (as suggested by the commenters) or through
other traditional mechanisms as a petition for a writ of habeas corpus
under 28 U.S.C. 2241. For this reason, HHS/CDC believes that due
process is satisfied by designating the Director's written order as
``final agency action'' without further speculation as to the exact
form of further legal review. However, to clarify HHS/CDC's intended we
have added the following language to the regulatory text: ``Nothing in
these regulations shall affect the constitutional or statutory rights
of individuals to obtain judicial review of their federal detention.''
Accordingly, after consideration of these comments, HHS/CDC has
modified paragraph (f) of the provisions regarding medical review of a
Federal order for quarantine, isolation, or conditional release
(Sec. Sec. 70.16 and 71.39) to include the revised definition of
``Representatives,'' which now requires HHS/CDC to appoint both a
medical professional and an attorney ``to assist the individual for
purposes of the medical review upon a request and certification, under
penalty of perjury, by that individual that he or she is indigent and
cannot afford a representative.''
j. Administrative Records Relating to a Federal Order for Quarantine,
Isolation, or Conditional Release
HHS/CDC received a comment from a flight attendant union concerning
whether an overlap existed between CDC's maintenance of administrative
records relating to the issuance of Federal public health orders and an
employee's access to exposure and medical records under OSHA (29 CFR
1910.1020). We note that since HHS/CDC is not a flight attendant's
employer, HHS/CDC would not be covered by this particular OSHA standard
under these circumstances. Furthermore, because these regulations do
not alter, define, or mandate the employer-employee relationship
between flight attendants and their employers, to the extent that this
question seeks input regarding an employer's obligations under OSHA,
HHS/CDC views the question as outside the scope of the rulemaking.
HHS/CDC received a comment from a partnership of public health
legal scholars and organizations stating that the regulations should
require quarterly reporting to Congress to facilitate transparency and
oversight. While CDC recognizes the additional transparency that direct
reporting of details related to quarantine activities may provide to
the public, CDC notes that historically, the issuance of Federal orders
is rare (i.e., one to two orders issued per year). Thus, publication of
the specifics surrounding individual quarantine cases may raise
significant privacy concerns related to the individuals placed under
federal orders.
CDC does routinely describe its practices in published Morbidity
and Mortality Weekly Reports (MMWR) when new methods, technologies, or
other changes make it possible to revise and improve programs (e.g.
DNB, M&M guidance, change in air contact investigation algorithms),
which all serve to enhance transparency. Such information is also found
on CDC's Web site and publicly available standard operating procedures.
After consideration of comments received and as further explained
below, HHS/CDC has modified the provisions regarding Administrative
Records relating to a Federal order for quarantine, isolation, or
conditional release (Sec. Sec. 70.17 and 71.29) to remove paragraphs
(5) regarding agreements entered into between HHS/CDC and the
individual.
k. Other Due Process Concerns
HHS/CDC received many additional comments from the public concerned
over whether this regulation violates rights guaranteed by the U.S.
Constitution, such as Due Process and specifically during the medical
review process. HHS/CDC disagrees that the regulations are insufficient
to protect the constitutional rights of individuals. In regard to
medical reviews, HHS/CDC asserts that allowing individuals to choose at
the government's expense who will conduct the medical review is not
required by due process and that there is no conflict of interest in
allowing the CDC Director to appoint who will conduct the medical
review on the agency's behalf. HHS/CDC asserts, however, that
individuals will be allowed to submit relevant information, including
information provided by outside doctors or other medical specialists
during the medical review. HHS/CDC will further preserve relevant
agency documents for purposes of ensuring a competent legal review in
the event that the individual seeks judicial redress of their
quarantine or isolation. As explained elsewhere, law enforcement
support for quarantine or isolation orders will generally be provided
by U.S. Customs and Border Protection, U.S. Coast Guard, or other
Federal law enforcement programs, but HHS/CDC may also accept voluntary
state and local assistance in enforcing its Federal orders.
HHS/CDC received public comment expressing concern with regard to
potential language barriers experienced by foreign nationals during
travel. HHS/CDC responds that it has revised those sections of the
regulations dealing with issuance of Federal orders to require that
HHS/CDC arrange for translation or interpretation services of the
Federal order as needed. In circumstances where it would be impractical
to provide a line-by-line translation of the order, HHS/CDC may take
other steps to reasonably apprise individuals of the contents of the
order, for example, by arranging for oral translation services.
One public health organization questioned the feasibility of CDC's
conducting the mandatory reassessment or medical review of a group
quarantine order within the specified time frame. In response, HHS/CDC
states that a group quarantine order would be issued on the basis of a
shared exposure for all individuals in the group; therefore, the
mandatory reassessment or medical review could be conducted based on
the shared exposure, unless certain individuals in the group were
determined to be immune to the quarantinable communicable disease in
question. Part of the reassessment would include a determination of
whether the group order should be revised as individual orders.
[[Page 6917]]
HHS/CDC also received a comment that the duration of a quarantine,
isolation, or conditional release period is not adequately defined.
HHS/CDC disagrees because the regulations limit these actions to only
those who would pose a public health threat, for instance, by being in
the ``qualifying stage'' or a quarantinable communicable disease. The
``qualifying stage'' of the disease is defined as a communicable stage
of the disease or a precommunicable stage, but only if the disease
would be likely to cause a public health emergency if transmitted to
other individuals. We note that HHS/CDC's ``Health Information for
International Travel'' (also known as the Yellow Book) provides the
public with general guidance regarding the expected length of
communicability for many quarantinable communicable diseases. For more
information, please see http://wwwnc.cdc.gov/travel/yellowbook/2016/table-of-contents.
HHS/CDC received a comment that the qualifications of who may issue
a quarantine or isolation order are not defined leading to concerns
that such orders will be issued by non-medically trained personnel. In
regard to the qualifications of who may issue a Federal public health
order, HHS/CDC notes that all orders are issued under the authority of
the CDC Director, but that in practice such determinations are made
only by personnel trained in public health and licensed to practice
medicine in the United States.
One organization requested that HHS/CDC provide notification to the
appropriate embassy if a foreign national is placed under a Federal
order. In regard to non-resident foreign nationals, HHS/CDC clarifies
that it will coordinate closely with the U.S. Department of State to
ensure that all rights and obligations under the Vienna Convention on
Consular Relations and bilateral agreements will be observed. Because
of the complexity of this issue, including reliance on the
interpretation of treaties and bilateral agreements, HHS/CDC believes
that it is best to ensure compliance through operational procedures,
rather than to formalize such obligations through regulatory text.
One commenter requested that HHS/CDC clarify its handling of issues
relating to diplomatic immunity. HHS/CDC recognizes that under the
Vienna Convention on Diplomatic Relations, diplomats are not liable to
any form of ``detention.'' It is HHS/CDC's policy to coordinate closely
with the U.S. Department of State regarding any public health issues
arising in regards to diplomats and HHS/CDC will continue to do so
under these regulations.
One public health organization recommended that HHS/CDC include
written notification to individuals under public health orders of the
duration that the order will be in effect. HHS/CDC responds that it
will provide information on the incubation and communicability period
of the quarantinable communicable disease, if known, but that the
duration of the public health order may depend on a variety of factors,
such as demonstration of non-infectiousness through repeated laboratory
testing. Thus, HHS/CDC is unable to provide an exact numerical limit
(in terms of days or hours) that a public health order will remain in
effect.
HHS/CDC received a comment from a partnership of public health
legal scholars and organizations stating that in exigent circumstances
HHS/CDC may isolate or quarantine an individual, but should then be
required to hold a mandatory due process hearing within 48 hours before
a neutral decision-maker. At the outset, HHS/CDC agrees with the
commenters that the appropriate framework for determining the adequacy
of due process procedures are the factors articulated by the Supreme
Court in Matthews v. Eldridge, 424 U.S. 319 (1976). These factors
include: (1) The private interest affected by the government's actions;
(2) the risk of erroneous deprivation of such private interest through
the procedures used and the probable value, if any, of additional or
substitute procedures; and (3) the government's interest, including the
function involved and the fiscal and administrative burden of proposed
additional or substitute procedures. Concerning the private interest at
stake, HHS/CDC disagrees that this interest should be measured solely
in terms of the physical liberty of the individual, but notes that the
private interest also includes an interest in receiving medical
treatment and in not harming others, as would occur if the individual
was communicable. The Federal government's interest, moreover, is
particularly strong because it is not simply guarding the welfare of a
single individual or even a small group of individuals, but rather
protecting the public at large against the spread of a quarantinable
communicable disease. Most importantly, HHS/CDC believes that mandatory
administrative hearings are unlikely to significantly guard against
erroneous deprivations. Unlike subjective determinations of behavior
which typically form the basis of a mental health ``civil commitment,''
isolation and quarantine decisions are based on objective criteria such
as manifestations of physical illness or laboratory test results. Thus,
weighing these factors, HHS/CDC disagrees that due process requires it
to adopt a system of mandatory administrative hearings in the absence
of the individual requesting a medical review.
Regarding the use of a ``neutral'' decision maker, HHS/CDC restates
that the definition of both ``representatives'' and ``medical
reviewer'' would in fact allow for the appointment of non-HHS/CDC
employees in these capacities. The regulations, moreover, explicitly
state that the medical reviewer will not be the same individual who
initially authorized the quarantine or isolation order. Accordingly,
HHS/CDC has determined that the procedures it has adopted for medical
reviews comport with due process.
l. Privacy
Several people commented on the private nature of the doctor-
patient relationship. HHS/CDC appreciates the opportunity to respond to
this concern. HHS/CDC is charged with protecting the health of the
public. At times, this requires obtaining private information about
people's health or exposure history and taking certain actions to
protect others from becoming sick with a communicable disease. HHS/CDC
works closely with State and local health departments to ensure that
ill people detained or isolated under Federal orders receive
appropriate care and treatment. HHS/CDC is also bound by the Privacy
Act to protect personally identifiable information collected and
maintained under that Act. For a more detailed explanation of how such
information is protected, please see http://www.cdc.gov/sornnotice/09-20-0171.htm. For information on the retention and maintenance of such
records, please see https://www.archives.gov/records-mgmt/rcs.
HHS/CDC received a comment from a professor of public health law
and ethics stating that HHS/CDC should address how the HIPAA Privacy
Rule, Americans with Disabilities Act (ADA), and Administrative
Procedure Act (APA) counterbalance the powers set forth in the proposal
and reflect ``appropriate social distancing practices.'' The commenter
did not highlight which specific provisions of these laws HHS/CDC
should address or the relationship that these laws have to social
distancing. Notwithstanding, HHS/CDC may generally state that these
regulations will be carried out consistent with Federal law.
We note that HHS is a hybrid entity under HIPAA, but only those
parts of the Department that have been
[[Page 6918]]
determined to be health care components are subject to the HIPAA
Privacy Rule. CDC is generally not a health care component treated as a
``covered entity'' under the HIPAA Privacy Rule. However, certain
specific offices of HHS, CDC, and the National Institute for
Occupational Safety and Health (NIOSH) performing activities related to
the World Trade Center Health Program are considered health care
components of HHS and must comply with HIPAA and the Privacy Rule.
CDC most often acts as a public health authority under the HIPAA
Privacy Rule. During the course of a public health investigation it may
seek the support of a covered entity, such as a hospital or private
physician. The HIPAA Privacy Rule permits the disclosure of public
health information to public health authorities, such as the CDC, and
their authorized agents for public health purposes including but not
limited to public health surveillance, investigations, and
interventions. More information concerning the HIPAA Privacy Rule may
be found here: http://www.cdc.gov/mmwr/preview/mmwrhtml/m2e411a1.htm.
Similarly, we note that this final rule while formalizing
administrative policies and practices, does not affect the rights of
individuals under the ADA or APA, which are statutes enacted by
Congress. One commenter opined that collection of contact information
as part of public health prevention measures and maintenance of
administrative records raise privacy concerns and that HHS/CDC should
consider ``super-enhanced privacy protections'' consistent with the
Model State Public Health Privacy Act of 1999. HHS/CDC disagrees. As a
Federal agency, HHS/CDC must abide by the laws established by Congress
for the protection of records, specifically the Privacy Act of 1974, 5
U.S.C. 552. On December 13, 2007, HHS/CDC published a system of records
notice (72 FR 70867) under the Privacy Act describing, among other
things, safeguards for preventing the unauthorized use of information
collected from travelers. HHS/CDC will make disclosures from this
system only with the consent of the subject individual, in accordance
with routine uses published in its system notice, or in accordance with
an applicable exception under the Privacy Act.
m. Payment for Care and Treatment
HHS/CDC received several comments relating to payment for medical
expenses. One commenter stated that HHS/CDC should assume payment for
all related medical expenses, housing costs, and other necessities for
individuals or groups subject to deprivations of liberty and that it is
``ethically unfair'' for HHS/CDC to be the ``payer of last resort.''
Another commenter stated that ``CDC must guarantee financial help after
third party payments are exhausted.'' While HHS/CDC acknowledges that
it has an ethical, moral, and legal obligation to provide care and
treatment for individuals under a Federal quarantine or isolation
order, HHS/CDC disagrees that it is ``ethically unfair'' to excuse a
medical insurer or other entity with a contractual obligation from
paying for medical expenses. Accordingly, HHS/CDC has determined that
it is appropriate for it to maintain and affirm its status as a ``payer
of last resort.''
Two public health organizations asked whether nonmedical costs such
as training of staff, replenishing of personal protective equipment,
managing and disposing of biological waste and contaminated supplies,
etc., are also subject to HHS/CDC payment authorization. While the
costs of care and treatment of individual patients under Federal public
health orders are authorized by this rule, these additional costs to
the extent that they are unrelated to the individual patient's
treatment and care would not be covered by this rule.
HHS/CDC received a comment suggesting that the regulations allow
for charging detainees the medical and hospital costs of nonconsensual
treatment. HHS/CDC disagrees and first, clarifies that these
regulations do not authorize compulsory medical treatment. HHS/CDC
further acknowledges that constitutional principles and medical ethics
require that those detained under isolation or quarantine have access
to adequate nourishment, appropriate accommodation, and medical
treatment. However, HHS/CDC has determined that its obligation to pay
for medical care and treatment should be secondary to the obligation of
any third party, such as a medical insurer that may have a pre-existing
contractual obligation with the patient to pay for hospital expenses.
Accordingly, HHS/CDC declines to make any changes to the provisions
authorizing payment for medical care and treatment.
A flight attendant union commented that HHS/CDC should pay for any
outside costs that the flight attendant would normally incur relating
to medical treatment, e.g., copayments, deductibles. HHS/CDC declines
this suggestion and notes that while it is not HHS/CDC's intent to
unduly burden individuals with the costs of their own isolation or
quarantine, payment for expenses will be made consistent with
constitutional and ethical obligations to provide for the basic
necessities, e.g., food, medical treatment, for those subject to such
public health orders. Furthermore, these regulations do not alter,
define, or modify the contractual relationship between insurance
companies and the insured.
After consideration of these comments, HHS/CDC has finalized the
provisions relating to payment for care and treatment (Sec. Sec. 70.13
and 71.30) as proposed.
n. Agreements
HHS/CDC received comments relating to the intention and use of
agreements. Commenters worried that such ``agreements'' may be coerced,
and individuals would be compelled to submit to involuntary testing or
``research projects.'' One commenter stated that the definition of
agreement is circular and confusing because the word ``agreement''
appears in the definition. This commenter also suggested that what HHS/
CDC proposes should more aptly be labeled as an ``Affidavit'' or
``Affirmation'' because the definition as proposed by HHS/CDC lacks
bilateral obligations on both parties.
Due to the number of public comments received expressing confusion
over this public health measure, HHS/CDC has removed the provisions on
Agreements (70.18 and 71.40), and modified other provisions of the
final rule (70.1, 71.1(b), and 70.5) to remove references to
``agreements.''
o. Penalties
Many commenters expressed concern over the penalties provisions
contained within the proposed regulation. Specifically, one association
objected to ``CDC's proposed increase in penalties.'' Another stated
that ``CDC is not qualified to decide upon the punishment.'' HHS/CDC
takes this time to better explain that the penalties listed in today's
final rule, which have been codified as proposed, are set forth by
Congress via statutory language and codified into regulation to reflect
current practice. This regulation serves to notify the public of the
existing statutory penalties for violation of quarantine regulations,
which HHS/CDC has no authority to change.
One organization requested that language be added to rules
regarding the issuance of penalties if an employer provides an ``unsafe
work or unhealthful working condition.'' HHS/CDC responds that such
penalties are beyond the scope of this rule and refers
[[Page 6919]]
the commenter to regulations of the Occupational Safety and Health
Administration.
HHS/CDC received a comment from a flight attendant union regarding
criminal penalties stating that HHS/CDC should provide further
clarification as to what constitutes a violation and clarify that
flight attendants who act in accordance with their company's practices,
policies, or procedures should not be held criminally liable. In
response, HHS/CDC notes that while the text of the regulation is being
updated, these regulations do not increase the criminal penalties that
may be imposed for violations of quarantine regulations or alter the
manner in which liability may be assessed. Rather, these regulations
serve to inform the public of the criminal penalties that currently
exist in statute (42 U.S.C. 271 and 18 U.S.C. 3571). Furthermore, HHS/
CDC clarifies that criminal penalties, if any, would be assessed by a
court of law based on an indictment or information filed by an
Assistant U.S. Attorney based on individualized facts and
circumstances, and would not be determined administratively by the CDC.
HHS/CDC offers the following explanation to inform the public
regarding this section. As prescribed in section 368 (42 U.S.C. 271)
and under 18 U.S.C. 3559 and 3571(c), criminal sanctions exist for
violating regulations enacted under sections 361 and 362 (42 U.S.C. 264
and 265). 18 U.S.C. 3559 defines an offense (not otherwise classified
by letter grade) as a ``Class A misdemeanor'' if the maximum term of
imprisonment is ``one year or less but more than six months.'' 18
U.S.C. 3571 provides that individuals found guilty of an offense may be
sentenced to a fine. Specifically, an individual may be fined ``not
more than the greatest of''--(1) the amount specified in the law
setting forth the offense; or (2) for a misdemeanor resulting in death,
not more than $250,000; or (3) for a Class A misdemeanor that does not
result in death, not more than $100,000. Similarly, an organization,
found guilty of an offense may be fined ``not more than the greatest
of''--(1) the amount specified in the law setting forth the offense; or
(2) for a misdemeanor resulting in a death, not more than $500,000; or
(3) for a Class A misdemeanor that does not result in death, not more
than $200,000. 42 U.S.C. 271 sets forth statutory penalties of up to 1
year in jail and a fine of $1,000. Therefore, it is classified as a
Class A misdemeanor under 18 U.S.C. 3559. Because the alternate fines
set forth under 18 U.S.C. 3571 are greater than the $1,000 set forth
under 42 U.S.C. 271 (which sets a maximum penalty of not more than
$1,000 or one year of jail, or both for violation of quarantine laws),
and because 42 U.S.C. 271 does not exempt its lower penalties from 18
U.S.C. 3571(e), HHS/CDC has chosen to codify the greater penalties of
18 U.S.C. 3571(b)(5) and (c)(5) and to remove the lower penalties as
stated in 42 CFR 71.2 from the regulation.
After consideration of these comments, HHS/CDC has finalized the
provisions relating to Penalties (70.18 and 71.2) as proposed.
Penalties has been moved to section 70.18, since proposed 70.18
Agreements has been removed from this final rule.
p. Economic Impact
Within the analysis published with the NPRM, HHS/CDC solicited
public comment regarding the cost and benefit estimates for airlines
and vessel operators associated with improved provision of traveler
contact data. While HHS/CDC received support for the data collection
from two public health associations, HHS/CDC received a comment from
industry who misread the proposals to mean that aircraft operators
would be required to develop new capacity and processes to capture and
store a comprehensive set of sensitive data, archive this data, and
then provide it to CDC.
HHS/CDC restates and clarifies that today's final rule does not
impose any new burdens upon the airline industry but rather, codifies
the current practice of receiving a passenger manifest order (if
needed, as CDC currently collects passenger information from CBP via
APIS and PNR) and providing HHS/CDC with any data in an airline's
possession. This regulatory impact analysis has been revised to clarify
that the rule does not require an airline to solicit or store
additional data. Therefore, HHS/CDC does not expect that formalizing
its current data collection practices will increase costs. Neither
airlines nor U.S. Customs and Border Protection (CBP) will need to
develop new data systems nor will travelers need to provide data as
part of the ``check in process.''
The same industry organization also commented that they have been
complying effectively with the existing requirements, but have, on
occasion found it difficult to locate, extract, compile, format and
transmit available information within the timeframe specified in orders
from HHS/CDC. They note that delays sometimes arise because the
manifest order may contain incorrect flight or passenger information.
The discussion in the regulatory impact analysis section has been
revised to note that delays in compliance with manifest order
requirements may result from HHS/CDC having incorrect traveler
information in the manifest order.
The same industry organization also reports that all of the data
available to them related to passengers are currently transmitted as
Advance Passenger Information System (APIS), and potentially under
Passenger Name Record (PNR), data to the Department of Homeland
Security (DHS) and that there is no reason to burden airlines with an
order for passenger data. HHS/CDC recognizes that industry does submit
certain passenger data to DHS and it is not our intent to burden
industry with duplicative requirements, but rather to effectively and
efficiently protect public health. In the experience of the HHS/CDC,
queries from APIS/PNR rarely result in full sets of contact information
(i.e. the record includes all five additional data fields as outlined
in the final rule). The data fields that are most commonly missing from
the records are email addresses (missing 90 percent of the time),
secondary phone number (missing 90 percent of the time), and street
addresses (missing or insufficient for public health contact tracing up
to 50 percent of the time). These data elements are vital to a contact
tracing investigation. In looking at a random sample of 20% of the
compiled international air travel manifests for 2015, those including a
compiled data set from NTC and the airlines, 100% were missing at least
one of the 5 data fields. Email address and secondary phone number were
among those most frequently missing. For context, there were
approximately 760,000 scheduled flights that arrived into the United
States in 2015. In 2015, CDC issued passenger manifest requests for 64
international flights arriving into the United States. As noted in the
RIA of the final rule, from 2010 to 2015, CDC conducted an average of
77 contact investigations per year involving arriving international
flights.
Airlines are contacted for the majority of contact investigations
using a manifest order document. At a minimum, CDC needs to confirm the
ill traveler was on the flight and where the individual sat in relation
to other travelers to determine risk of exposure.
In CDC's experience the following has been true:
Only airlines can quickly and efficiently produce a
partial manifest targeting affected rows;
only airlines can confirm identity of ``babes in arms''
and their co-travelers (Parent); this is important for measles cases;
[[Page 6920]]
only airlines can quickly confirm whether an individual
actually flew (in instances where individuals deplane and do not re-
board during a layover); and
only airlines can confirm a plane's configuration if there
is a question with the provided row numbers. Different aircraft have
different seating arrangements depending on carrier and layout. It is
important to know if a certain seat is separated by a bulkhead or is a
window seat.
In addition, HHS/CDC only requires a partial manifest, e.g. 5 rows
for travelers with infectious tuberculosis, so that NTC and HHS/CDC
staff can limit the investigation to only those passengers at risk and
supplement/cross reference with APIS and PNR data. If a partial
manifest is not available from the airlines, then each passenger record
must be researched individually to find a seat number, and then the
configuration of an entire plane must be populated to determine where
the index case sat in relation to other at-risk passengers. For large
flights from Asia, this can pose a tremendous burden to NTC and CDC
staff while slowing the ability of CDC to provide important contact
information to state and local health departments. Manually populating
multiple 300+ person flights is not feasible in a timely manner.
As part of its plan for retrospective analysis under E.O. 13563,
HHS/CDC intends to synthesize, analyze, and report within the next two
years on strategies to reduce duplication of the collection of
passenger/crew manifest information in coordination with DHS/CBP. The
report will include any recommendations (e.g., IT systems improvements
to facilitate enhanced search capabilities of passenger data, increased
efficiency to relay passenger data, improvements to the existing CDC-
CBP MOU) to ensure that the collection of passenger or crew manifest
information do not unduly burden airlines, vessels, and other affected
entities. HHS/CDC intends to seek public comment on the report and any
recommendations regarding the costs and benefits of activities
implemented in 42 CFR parts 71.4 and 71.5. Estimates of both costs and
benefits in the NPRM regulatory impact analysis were not very large
because HHS/CDC is not implementing a new data collection requirement.
The regulatory impact analysis for the final rule has been revised to
reflect that HHS/CDC will work with CBP to search for responsive data
to avoid duplicative data requirements. Estimates of costs in the
revised regulatory impact analysis have not been revised because the
airline industry did not provide any new information regarding costs to
search for responsive data when receiving manifest orders. The benefit
estimate has been revised and is lower than the estimate for the NPRM
to indicate that the airlines may not have any more contact data than
is already provided in APIS or PNR data submitted to DHS.
HHS/CDC received a number of comments from the general public that
compared the relatively small number of measles cases in any given year
to the total numbers of vaccine-associated adverse events and health
department spending to contain measles outbreaks. Based on this
comparison, commenters believed that HHS/CDC and health departments
spend too much money on communicable disease control and that resources
would be better allocated to other activities. Some commenters
suggested that the costs of these adverse events should be included in
a Small Business Regulatory Enforcement Fairness Act analysis. In
general, this type of analysis is outside the scope of this regulatory
impact analysis because this final rule does not require measles
vaccination. HHS/CDC's recommended vaccine schedule will not be
affected by this final rule. Although HHS/CDC recommends that health
departments offer measles vaccine to non-immune individuals exposed
during travel, measles is not a quarantinable communicable disease and
this final rule does not require any individual to receive a measles
vaccine. Because health departments offer measles vaccines to exposed,
non-immune travelers, HHS/CDC estimates that the final rule will only
result in a small number (6) of additional measles vaccines. The costs
of procuring and administering these vaccines is included in the
analysis.
As noted in the regulatory impact analysis, there are only 564
travelers exposed to measles during international travel in a given
year. Most of these travelers will already have immunity to measles and
the final rule is only expected to have a small impact on the ability
of health departments to contact travelers. The total costs of all
measles vaccine-associated adverse events is outside the scope of the
analysis for this final rule as mentioned above.
One commenter suggested that the cost estimates for the NPRM were
too low because the analysis did not account for reduced willingness to
travel if vaccines against measles and other communicable diseases are
required to travel. HHS/CDC disagrees with this suggestion because
vaccination is not a requirement in this final rule. HHS/CDC has on
occasion requested that DHS/TSA restrict interstate or international
air travel for people known to be infectious with measles who were
noncompliant with public health recommendations not to travel. However,
HHS/CDC does not recommend restricting the air travel of persons who
have not received the measles vaccine.
One commenter questioned whether the estimated value of statistical
life ($9.4 million) should be multiplied by the total number of measles
vaccine-associated adverse events in the United States. HHS/CDC
appreciates this thoughtful comment. This would result in a larger
estimate in the cost of measles vaccine-associated adverse events.
However, this is not a correct usage of the value of statistical life,
which should only be multiplied by an estimated number of deaths. The
regulatory impact analysis has been revised to better explain this
distinction.
Another commenter suggested that public health department measles
response costs were overestimated by using a model-based approach
rather than estimating the cost of hiring of additional staff to deal
with measles outbreaks. HHS/CDC addressed the comment in the regulatory
impact analysis by clarifying that the analysis is a published model-
based analysis and that the cost estimate is based on the opportunity
cost of public health personnel and is not based on the cost of hiring
additional staff.
HHS/CDC received comments from the airline industry indicating that
the definition of ill person under 71.1 does align with Note 1 to
Standard 8.15 of ICAO's Annex 9 to the Convention on International
Civil Aviation. HHS/CDC also received comments from the airline
industry regarding the change to the definition of ill person under
70.1 for interstate flights contending that these changes would
increase costs. Specifically, the airline industry reported that not
only does the expansion of the definition of ill person place a greater
burden on airline staff, the ambiguity of that definition amplifies the
burden or at least raises questions as to the particular obligations of
the flight crew to determine if someone is an ``ill person.'' Moreover,
the airline industry wanted to know whether flight crews have an
obligation to conduct a physical examination of the passenger to
determine fever. The airline industry also noted that under the OSHA
blood borne pathogens standard, employers are prohibited from exposing
crewmembers to blood or other potentially infectious materials. The
airline industry also questioned whether the fever-related illness
[[Page 6921]]
reporting in the proposal would require that all carriers have the
equipment (thermometers) onboard to determine fever. The proposal, as
noted, has two other ways to identify fever (warm to touch or history
of fever) which the airline industry wanted to ensure would remain
viable options within the final rule.
HHS/CDC notes that there is no expectation that flight crews should
perform physical examinations as part of illness reporting. HHS/CDC
also notes that the non-thermometer (warm to touch or history of fever)
remain in the final rule. Regarding the potential for increased costs
associated with the change in illness reporting for interstate flights,
HHS/CDC notes that the current illness reporting requirements for
interstate travel appear in 42 CFR 70.4 and state that ``The master of
any vessel or person in charge of any conveyance engaged in interstate
traffic, on which a case or suspected case of a communicable disease
develops shall, as soon as practicable, notify the local health
authority at the next port of call, station, or stop, and shall take
such measures to prevent the spread of the disease as the local health
authority directs.'' Communicable disease is defined in current 42 CFR
70.1 as ``illnesses due to infectious agents or their toxic products,
which may be transmitted from a reservoir to a susceptible host either
directly as from an infected person or animal or indirectly through an
intermediate plant or animal host, vector, or the inanimate
environment.''
The changes in this final rule will not result in substantially
increased costs because airlines would either: (1) Be complying with
the current regulatory requirement and report all cases or suspected
cases of communicable disease to local health departments; or (2)
report illnesses according to HHS/CDC guidance available at http://www.cdc.gov/quarantine/air/reporting-deaths-illness/guidance-reporting-onboard-deaths-illnesses.html, which is codified in this final rule.
HHS/CDC notes that changes in this final rule align the symptoms
requested for international and interstate illness reporting. In
addition, according to guidance, reports received by HHS/CDC would be
considered sufficient to satisfy the requirement to report to local
health departments because HHS/CDC will coordinate response activities
with the local health department after receiving an illness report. In
response to these comments, HHS/CDC increased the expected number of
illness reports in the upper bound analysis regulatory impact analysis
for the final rule. This upper bound analysis finds that a 100%
increase in info-only reports and 50% increase in reports requiring
response would result in a marginal cost of $20,573 for airlines and
vessel operators. This cost is negligible compared to the annual
revenue of the international air and maritime travel markets. HHS/CDC
also received a comment to include the cost of training for illness
reporting in the regulatory impact analysis. HHS/CDC notes that illness
reporting is already required under existing regulations and the
changes in this final rule more closely align with ICAO guidance for
illness reporting for international flights and represent a reduction
in burden for interstate flights, where reporting of all cases or
suspected cases of communicable diseases is required. HHS/CDC added an
estimate of training costs to the upper bound cost analysis for
airlines (an annualized $356,000 per year).
HHS/CDC received a comment from a local health department
concerning the rationale for reporting all illnesses and deaths that
occur on interstate flights. This health department asked whether
evaluating illnesses and deaths that occur on interstate flights may
lead to an increase in costs for State and local health departments.
HHS/CDC does not anticipate an increase in costs for State and local
health departments because evaluating illnesses and deaths occurring on
interstate flights is consistent with existing HHS/CDC guidance and
represents a less restrictive alternative compared to the existing
reporting requirement in 42 CFR 70.4. Furthermore, the costs to State
and local health departments may decrease if HHS/CDC is able to filter
out reports that do not require a public health response, which
airlines would have previously reported directly to the health
departments under 42 CFR 70.4. If there is an increase in the number of
illness reports requiring a public health response, HHS/CDC believes
the costs to health departments may decrease if the health department
is notified earlier.
A public health research center questioned the value of nonmedical
personnel being able to differentiate Ebola, Middle East respiratory
syndrome (MERS) or measles from other medical issues. HHS/CDC
appreciates the concern and notes that the final rule aligns the
illness reporting requirement with international guidelines and
represents a reduced burden for illness reporting on interstate flights
compared to current regulatory language as mentioned above. The intent
of illness reporting is not to diagnose disease during flight, but
rather to identify a limited number of instances in which it would be
advantageous to follow up with ill travelers for an assessment upon
disembarkation. The current numbers of illness reports received are
summarized in the regulatory impact analysis and the number of reports
is not expected to increase significantly because the regulatory text
will better align with publically available HHS/CDC guidance.
A number of comments from the public questioned whether there would
be a huge cost resulting from the broad definition of ill person. These
commenters expressed concern that misdiagnosis by non-medically trained
personnel would lead to reduced travel based on the public's fear of
being wrongly detained by public health officials. HHS/CDC notes that
illness reporting is already required for both interstate and
international travel. We note that travelers are not placed under
public health orders simply as a result of an illness report. Rather,
orders are issued only if a licensed medical officer based on a public
health risk assessment has sufficient reason to believe that the
individual is infected with a quarantinable communicable disease. In
addition, the new definition is consistent with existing international
guidelines and HHS/CDC guidance. Thus, HHS/CDC does not believe the
changes to illness reporting will result in a large burden to the
general public. The cost analysis in the regulatory impact analysis has
been updated to include the cost to travelers involved in public health
follow-up after an illness report.
One commenter opposed the rule because of a perceived negative
economic and/or social impact upon individuals placed under a public
health order. Regarding the social impact of the individual who may be
ostracized, HHS/CDC notes that public health measures such as
quarantine and isolation are not new concepts or practices, HHS/CDC has
been implementing these measures to protect public health for many
years. We reemphasize that one compelling reason for the publication of
this final rule is to make ``quarantine'' and ``isolation'' better
understood by the public so that these terms, its purposes, and
meanings become more familiar and thereby decrease public anxiety over
these important protections. For the same reason, HHS/CDC does not
believe the provisions in the final rule will increase or decrease the
cost of isolation or quarantine. HHS/CDC does provide an estimate of
traveler cost in the sections describing Ebola entry enhanced risk
assessment and management and illness
[[Page 6922]]
reports in the regulatory impact analysis.
One commenter suggested that the costs incurred by airlines would
be passed along to the general U.S. population purchasing tickets for
air travel. HHS/CDC concurs and mentions this possibility in the
regulatory impact analysis. However, changes included in this final
rule are a codification of a current practice and estimated total costs
are only $11,000 to $431,000 per year. Thus, significant changes in
ticket prices are not expected.
One commenter suggested that changes in infectious disease
caseloads would not result in cost savings to public health agencies or
individuals because there is already a public health workforce in
place. HHS/CDC calculates such costs based on the opportunity cost of
public health staff under the presumption that such staff would be
involved in other productive activities if not spending time addressing
outbreaks.
HHS/CDC solicited comment from the public regarding potential
public willingness to pay to be contacted in the event of an exposure
to a communicable disease during travel. This was done to help estimate
the potential benefit to the public of HHS/CDC's efforts to work with
health departments to contact travelers exposed to meningococcal
disease, viral hemorrhagic fevers, MERS or other severe acute
respiratory syndromes, measles, and tuberculosis, among other diseases.
HHS/CDC received a number of comments from several individuals that
they believe public health measures to mitigate measles transmission
are unnecessary. Some individuals also noted that Ebola and MERS cases
in the United States have not led to widespread transmission. These
commenters either indicated or inferred that they would be unwilling to
pay to be informed of potential communicable disease exposures during
travel. The discussion in the regulatory impact analysis has been
updated to incorporate this feedback.
HHS/CDC solicited public comment on willingness to pay to reduce
Ebola risk in the United States to near zero if another international
outbreak of Ebola with widespread transmission occurs in the future.
HHS/CDC received comments from an organization representing flight
attendants indicating that they believe it is in the public interest to
reduce Ebola risk in the United States to near zero in the event of a
future outbreak. They indicated that there is no reason to believe that
achieving this objective would require unsustainable levels of funding.
HHS/CDC incorporated this comment regarding public willingness to pay
in the regulatory impact analysis.
HHS/CDC also received comments from several individuals regarding
the high cost of the measures taken to reduce the risk of Ebola
transmission in the United States during the 2014-2016 Ebola epidemic
in West Africa. Several of these commenters indicated they had zero
willingness to pay for future public health measures in the event of a
large Ebola outbreak.
Many commenters stressed the need to reassess whether to implement
such activities in the event of a future Ebola outbreak. An example of
such comments is provided by a research center studying international
response efforts to emerging infectious disease threats, who noted that
despite 99% complete active monitoring by health departments, there was
no evidence of incident Ebola cases among individuals traveling from
Ebola-affected countries. This does not include the two incident cases
that preceded active monitoring. The commenters state that given this
evidence it is not advisable for HHS/CDC to recommend active monitoring
in the event of future Ebola outbreaks.
In addition, a public health research center cautioned against
extrapolating costs and benefits calculation methods for measles and
tuberculosis to Ebola, MERS, and other rare diseases. The research
center further noted that countermeasures for Ebola and MERS do not
exist (other than isolation and quarantine). They suggest that this
would limit the effectiveness of point of entry measures. These
researchers also point to the fact that transmission of Ebola and MERS
has not occurred during air travel. They noted that point of entry risk
assessment programs may increase anxiety (and costs) if cases are
detected in the community after the implementation of point of entry
measures. Finally, the research center noted that the costs for State
and local health departments to actively monitor all arriving travelers
for 21 days were not included in the analysis.
In response to these comments, HHS/CDC concurs that it would not be
wise to directly extrapolate approaches for measles and tuberculosis to
rare diseases and has tried to provide as much information as possible
around the decision to implement the Ebola risk assessment program and
recommendations for active monitoring. HHS/CDC did not simply
extrapolate the analysis for measles and tuberculosis to Ebola.
HHS/CDC does not have data on State and local spending to achieve
the objective of the 21-day active monitoring program and concedes that
the cost of active monitoring would likely exceed the costs incurred at
the airports. However, HHS/CDC did provide an estimate of total Federal
spending for both domestic and international efforts to attempt to
quantify the cost of these efforts. Federal money was used to support
State/local surveillance efforts. Federal money was also used to
support improvements in laboratory capacity by States and hospital
infection control efforts, which should have benefits beyond the 2014-
2016 Ebola epidemic. In addition, Federal funding supported research
into potential Ebola vaccines and medicines. The cost for the Ebola
enhanced entry risk assessment program was just a portion of these
costs and HHS/CDC acknowledges that risk assessment program at airports
by itself would have limited potential to reduce risk. However, HHS/CDC
also notes that the costs of Ebola entry risk assessment at points of
entry included efforts to (1) stratify travelers by risk level so that
health departments could focus more intense monitoring efforts on
travelers at higher risk and (2) educate travelers on Ebola risk
factors and symptoms and provide informational materials, a
thermometer, and a telephone to all travelers to improve compliance
with active monitoring efforts. This led to a higher cost, but more
effective program relative to an alternative in which travelers would
only be screened once at the airport, such as occurred in other
countries implementing screening programs during the 2003 Severe Acute
Respiratory Syndrome (SARS) epidemic.
HHS/CDC believes that the risk of Ebola infection in the U.S.
population was potentially reduced because of the combination of
measures to protect against Ebola transmission in the United States,
including risk assessment at ports of entry. HHS/CDC acknowledges the
risk was probably very low in the absence of domestic activities.
HHS/CDC further notes that it recommended active monitoring of
travelers as a less restrictive alternative to more stringent measures
such as quarantines that were being demanded by some members of the
public. Widespread implementation of quarantine, particularly for
healthcare workers crucial to the response efforts in West Africa and
the United States, would have greatly hampered outbreak control
measures by providing a strong disincentive to healthcare workers
participating in the response.
To estimate the potential benefits of the Ebola risk assessment
program at ports of entry, HHS/CDC provided a cost comparison of the
incident Ebola cases
[[Page 6923]]
that occurred in Texas compared to New York to estimate the difference
in costs between an Ebola case that was detected quickly and treated in
a pre-selected hospital identified to be capable of Ebola treatment in
comparison to an Ebola infection that was not initially suspected to be
Ebola leading to community exposures and hospital exposures in a
hospital that was not a pre-selected hospital capable of Ebola
treatment.
HHS/CDC also examined the recent MERS outbreak in South Korea to
demonstrate that even relatively small outbreaks of rare diseases such
as MERS and Ebola can have large economic costs despite a relatively
small number of cases and deaths. HHS/CDC found that the number of
international travelers (non-Korean citizens traveling to South Korea)
decreased by 40-50% during the peak months of the 2015 MERS outbreak.
HHS/CDC further notes that these declines in travel occurred in the
absence of widespread travel restrictions. The costs incurred by South
Korea during the outbreak were used to demonstrate the potential costs
of a larger Ebola outbreak in the United States.
Given the evidence from the programs implemented to mitigate risk
during the 2014-16 Ebola epidemic, i.e., the small number of
international air travelers from countries with widespread Ebola
transmission that later developed Ebola and the very limited risk of
transmission by asymptomatic individuals with Ebola infection, HHS/CDC
may not elect to implement an Ebola entry risk assessment program in
the event of a future outbreak or to recommend 21-day active monitoring
of travelers from countries with widespread transmission.
HHS/CDC emphasizes that it will continue to consider cost and work
with multiple U.S. government agencies, as well as with airport
authorities and health departments in U.S. States and territories, to
apply the latest evidence to future decision-making. In addition, HHS/
CDC will try to employ the least restrictive measures to achieve public
health objectives. HHS/CDC notes that, during the period that the Ebola
entry risk assessment and monitoring program was in effect, only 0.08%
(29/38,344) of travelers assessed at U.S. airports were recommended for
medical evaluation at hospitals and that no Federal quarantine or
isolation orders were issued during the epidemic, although some States
did issue such orders under their own authorities. These considerations
have been added to the regulatory impact analysis in the final rule.
Since this analysis concerns a codification of existing authorities,
this analysis has been moved to a separate appendix after incorporating
public feedback.
A number of commenters suggested that HHS/CDC did not include the
cost for people participating in the Ebola enhanced risk assessment
program. However, HHS/CDC did provide such an analysis of these costs.
One public commenter suggested that the psychological cost of
quarantine should be considered in the economic impact analysis.
Although HHS/CDC generally concurs with the idea of accounting for all
of the costs associated with time spent in quarantine, HHS/CDC's
authority to issue quarantine orders will not change with the
publication of this final rule. Thus, this final rule does not incur
new psychological costs for persons under quarantine orders.
HHS/CDC notes the opportunity costs for persons undergoing risk
assessment at airports and/or evaluation at hospitals during the 2014-
16 Ebola entry risk assessment and management program. HHS/CDC
estimates their opportunity costs based on average wage rates, but did
not have additional data to estimate a marginal psychological cost.
Opportunity costs were also estimated for a more restrictive option
compared to the Ebola entry risk assessment and management program,
i.e. a suspension of entry for 21 days after having been in an Ebola-
affected country.
One commenter suggested that this rulemaking does not represent the
``least burden on society'' because HHS/CDC has failed to clearly
identify a ``compelling public need'' for the rule. HHS/CDC appreciates
the comment and responds that the regulatory impact analysis cites a
specific market failure addressed by this final rule. The market
failure is that the costs associated with the spread of communicable
diseases impacts the entire U.S. population, not just the group of
persons currently infected with communicable diseases. Since this final
rule is primarily implementing current practice, HHS/CDC does not
anticipate major new benefits or costs.
One commenter stated that the cost/benefit analyses was very vague,
meaning that there is no accountability or way to measure whether or
not the final rule will achieve its intended result of preventing the
spread of quarantinable communicable diseases via travel, which the
commenter stated was already an extremely low risk. HHS/CDC concurs
that there is uncertainty in the regulatory impact analysis. However,
HHS/CDC has tried to indicate that one of the reasons for this
uncertainty is that this final rule is primarily implementing current
practice. Thus, where possible, HHS/CDC tried to provide data on the
current burden of the provisions that are being updated in this final
rule. HHS/CDC does not expect any major changes in practice as a result
of this final rule.
One commenter suggests that the cost/benefit analyses was confusing
because quarantinable and non-quarantinable diseases were not clearly
identified. HHS/CDC appreciates this feedback and has updated the
analyses to more clearly differentiate quarantinable and non-
quarantinable diseases.
One commenter suggested that HHS/CDC took an unnecessarily extreme
position in analyzing an alternative of removing all enforcement of
current regulations. HHS/CDC used this as an alternative because this
final rule is a codification of current practice and does not impose
new regulatory burdens.
q. Paperwork Reduction Act
HHS/CDC published notices related to modifications and a new
information collection in the Notice of Proposed Rulemaking. Those
information collections are as follows:
(1) Foreign Quarantine Regulations (42 CFR part 71) (OMB Control
No. 0920-0134)--Nonmaterial/non-substantive change--National Center for
Emerging, and Zoonotic Infectious Diseases (NCEZID), Centers for
Disease Control and Prevention (CDC).
(2) Restrictions on Interstate Travel of Persons (42 CFR part 70)
(OMB Control No. 0920-0488)--Nonmaterial/non-substantive change--
National Center for Emerging, and Zoonotic Infectious Diseases
(NCEZID), Centers for Disease Control and Prevention (CDC).
(3) Airline and Vessel and Traveler Information Collection (42 CFR
part 71)--New Information Collection Request--National Center for
Emerging, and Zoonotic Infectious Diseases (NCEZID), Centers for
Disease Control and Prevention (CDC).
One commenter stated that there are no estimates of additional
information collection requirements resulting in a clear violation of
the Paperwork Reduction Act. The commenter further stated that
requesting information when HHS/CDC has no idea of the impact is not a
well thought out or planned rulemaking. This commenter further
questioned the value of providing comment when the agency purportedly
has no idea what additional burden it is imposing on the public. HHS/
CDC disagrees with these assessments.
The focus of the final rule is to codify current practices and to
update currently approved information collections to better align with
operational procedures and other
[[Page 6924]]
industry guidance related to illness reporting on aircraft and vessels.
Those information collections are currently approved under OMB control
numbers 0920-0134 (Foreign Quarantine Regulations), 0920-0488
(Restrictions on Interstate Travel of Persons), and the new information
collection request Airline and Vessel and Traveler Information
Collection (42 CFR part 71), which is currently pending OMB approval.
The estimates of the burden provided in the Paperwork Reduction Act
section of the NPRM were based on previous experience with particular
information collections solicited or required from the public or
industry in the past. In some cases, larger estimates of the burden to
account for an increased number of reports to HHS/CDC during disease
outbreaks or public health emergencies were included. There are no
information collections requirements that are wholly new, unreasonably
burdensome, or outside the scope of historical HHS/CDC practices
implemented to prevent the introduction or spread of communicable
disease into or within the United States.
Another commenter suggested that training in recognizing ill
travelers is a burden that was not adequately considered. HHS/CDC
disagrees because it does not mandate specific training for recognition
of ill travelers. HHS/CDC is seeking to better align the ill person
definition with the ICAO standard and thus is not the only organization
that has this requirement. HHS/CDC provides specific guidance for how
to recognize ill travelers and report to HHS/CDC on its Web site. HHS/
CDC also believes this training is most likely already part of the
training process for flight crews. An analysis of potential training
costs has been added to the upper bound cost analysis in the Regulatory
Impact Analysis. The upper bound annualized costs for additional
training are estimated at $356,000.
Finally, HHS/CDC is re-inserting ``Has a fever that has persisted
for more than 48 hours'' as a component in the definition of Ill person
in Sec. 70.1 General definitions and ``Has acute gastroenteritis,
which means either diarrhea, defined as three or more episodes of loose
stools in a 24-hour period or what is above normal for the individual,
or vomiting accompanied by one or more of the following: One or more
episodes of loose stools in a 24-hour period, abdominal cramps,
headache, muscle aches, or fever (temperature of 100.4 [deg]F [38
[deg]C] or greater)'' in Sec. 71.1 General definitions. This language
was quoted verbatim in the preamble of the NPRM at 81 FR 54305 but was
inadvertently omitted from the proposed regulatory text.
B. Provisions Applicable Only to Part 70 Only (Domestic)
a. General
HHS/CDC received comments from the public asserting that State and
local public health regulations already in place are sufficient to
protect individuals without the need for Federal involvement. HHS/CDC
agrees that State and local authorities play an integral role in
protecting public health, but disagrees that there is no Federal role.
HHS/CDC's DGMQ maintains quarantine stations at major U.S. ports of
entry that fulfill a primary purpose in preventing the introduction of
communicable diseases into the United States, but also play an
important role in containing the interstate spread of communicable
disease. There are several broad areas of cooperation between
quarantine field staff and State and local health agencies, such as
contact tracing, which provide a framework for responding to
communicable disease threats arising from interstate travel and at the
local level. It is through these networks and established partnerships,
in keeping with current practice, that the provisions of the final rule
will be successfully implemented.
HHS/CDC received a comment to the effect that quarantine
specifically should be left to the States. HHS/CDC received another
comment stating that Federal authority should not take precedence over
State authority. In contrast, a public health association suggested
that these regulations should indicate that Federal public health
measures ``supersede activities taken by States.'' We respond that
while HHS/CDC works closely with State and local public health
authorities, the Federal government has a traditional role in
preventing introductions and spread of communicable diseases at ports
of entry and interstate. HHS/CDC also disagrees with the suggestion
that it should not intervene in the event of inadequate local control
or lacks authority to protect the public's health within the authority
granted to it by Congress. Under 42 U.S.C. 264(e), Federal public
health regulations do not preempt State or local public health
regulations, except in the event of a conflict with the exercise of
Federal authority. Other than to restate this statutory provision, this
rulemaking does not alter the relationship between the Federal
government and State/local governments as set forth in 42 U.S.C. 264.
Under, 42 CFR 70.2, HHS/CDC make take action to prevent the interstate
spread of communicable diseases in the event that the CDC Director
determines that inadequate local control exists. This longstanding
provision on preemption in the event of a conflict with Federal
authority is left unchanged by this rulemaking.
One public health organization requested clarification of the
process to transfer an individual from Federal to State custody and
further stipulated that the State authority should require an
independent State assessment of risk under State law. In response, HHS/
CDC notes that the issuance of Federal public health orders is
coordinated with State and, when appropriate, local public health
authorities. Transfer of an individual from Federal to State custody
would be similarly coordinated such that the State would need to agree
to assume custody and the State's order would need to be in place prior
to HHS/CDC's rescinding the Federal order. When custody of an
individual is transferred to a State authority, the State may choose,
but would not be under a Federal mandate, to conduct an independent
assessment of risk pursuant to its own policies and procedures.
Furthermore, once the transfer of custody has occurred, the State's
laws and standards for due process would apply.
Another public health authority asked for clarification of how
jurisdictional issues regarding transfers of authority affecting more
than one State would be handled for individuals under Federal
quarantine. HHS/CDC responds that if more than one State is affected by
the transfer of authority, HHS/CDC will work with all relevant States
to determine the most appropriate State or local jurisdiction to accept
custody of the individual. If it is necessary to transport the
individual to another State, for example to the individual's State of
residence, HHS/CDC will work with the affected States to facilitate
such a transfer under Federal orders.
One public health organization requested clarification of the
procedures HHS/CDC would use to rescind a public health order. HHS/CDC
responds that it would issue the detained individual a written order
rescinding the isolation, quarantine, or conditional release. This
would be based on either one of two criteria: The individual is
determined to no longer pose a public health threat or custody of the
individual has been transferred to a State or local public health
authority.
HHS/CDC received a comment from a public health department stating
that the regulations should include language that HHS/CDC will
coordinate with
[[Page 6925]]
State and local public health authorities and law enforcement regarding
any intended surveillance and enforcement activities. HHS/CDC strongly
believes that coordination with State and local public health
authorities, as well as relevant law enforcement entities, is essential
to the public health response to individual cases as well as outbreaks
of communicable disease. On the few occasions that HHS/CDC has issued
Federal isolation orders for travelers with infectious tuberculosis,
HHS/CDC has worked closely with State and local health departments to
coordinate transportation, medical evaluation, and treatment of the ill
traveler, including law enforcement when needed. During the 2014-2016
Ebola epidemic, HHS/CDC issued guidance and alerted health care and EMS
workers to consider a diagnosis of Ebola if patients had compatible
symptoms and had visited an affected country within the previous three
weeks. HHS/CDC and State and local health departments worked closely to
assess any potentially exposed individuals with symptoms compatible
with Ebola to determine whether medical evaluation was needed and, if
so, to ensure safe transportation to a medical facility designated by
the health department. In light of HHS/CDC's history of close
coordination with State and local public health authorities, including
cooperating law enforcement entities when needed, HHS/CDC has
determined that specific regulatory language is unnecessary.
b. Requirements Relating to Travelers Under a Federal Order of
Isolation, Quarantine, or Conditional Release
Some commenters questioned HHS/CDC's authority, as well as the
need, to restrict the movement of individuals who are not ill but have
been exposed. HHS/CDC thanks these commenters for their review and
input. Some quarantinable communicable diseases, such as novel pandemic
influenza strains, may be contagious before the infected person becomes
symptomatic. Therefore, in these situations, it may be necessary to
restrict the movement of asymptomatic exposed people to make sure they
do not expose others inadvertently while they are not aware that they
are contagious. It may also be necessary to restrict movement of an
exposed person if public health authorities are unable to ensure
appropriate monitoring of the person, for example, if an individual is
known to have a history of noncompliance with public health
recommendations. Exposed people whose movement is restricted through
quarantine or other means may be offered vaccination, if a vaccine is
available, but only with informed consent.
One commenter noted that the regulation allows HHS/CDC to issue
interstate travel permits to an infected individual conditioned upon
the individual taking ``precautionary measures'' as prescribed by HHS/
CDC. This commenter requested that HHS/CDC clarify what precautionary
measures may be prescribed and stated that such conditions should not
be based on factors unrelated to the individual's health condition,
e.g., socio-economic, ethnic status. While HHS/CDC agrees that the
issuance of a travel permit should not be based on such factors as
race, gender, ethnicity, or socio-economic status, we note that the
issuance of a travel permit may be conditioned on such factors as the
individual's ability and willingness to comply with the terms of the
permit. Furthermore, while the exact precautionary measures prescribed
may vary based on the infectious agent, such measures, for instance,
may include: Agreeing to minimize time in congregate settings while
traveling; avoiding eating in restaurants or other enclosed public
places; traveling with no other people in the vehicle or, if other
people are needed to safely operate the vehicle, agreeing to wear a
mask and ensure good ventilation; and reporting to the local health
department upon arrival or on route as needed.
This commenter also requested clarification of the legal impact of
a person who is denied a permit or has had a permit revoked. We note
that per the terms of the regulation persons denied a travel permit or
who have had a travel permit revoked may submit a written appeal. The
right to a written appeal, as well as the means by which an appeal may
be requested, will be addressed in the written order denying the
request for a travel permit or revoking an existing permit. The appeal
will be decided by an HHS/CDC official who is senior to the employee
who denied or revoked the permit. HHS/CDC declines to speculate as to
what else this commenter may be referring to by the term ``legal
impact,'' but notes that the regulation does not impair the ability of
persons to seek judicial review of final agency actions through the
Administrative Procedure Act.
This commenter also requested clarification of how long an
individual may be restricted in his or her travel under a Federal
travel permit. We note first that the restriction only applies to those
under a Federal public health order or under a State or local order if
the State or local health department of jurisdiction requests Federal
assistance or there is inadequate local control. In further response,
HHS/CDC notes that the restriction would remain in place so long as the
individual is infected or capable of infecting others. This commenter
further requested clarification of the impact of a disagreement between
HHS/CDC and State or local public health authorities. We note that by
the terms of 42 U.S.C. 264(e), Federal public health regulations do not
preempt State or local public health regulations except in the event of
a conflict with the exercise of Federal authority. Moreover, per the
terms of 42 CFR 70.2, HHS/CDC may take action to prevent the interstate
spread of communicable diseases in the event that the CDC Director
determines that inadequate local control exists.
HHS/CDC received a comment from a flight attendant union requesting
clarification as to whether an employee could be held criminally liable
for knowingly transporting someone in violation of the terms of a
travel permit as specified under section 70.5. In response, HHS/CDC
clarifies that the term ``operator'' is defined under 70.1 consistent
with 14 CFR 1.1 and with respect to an aircraft means, ``any person who
uses, causes to use or authorizes to use an aircraft, with or without
the right of legal control (as owner, lessee, or otherwise).'' We
further note that criminal liability, if any, will be determined by a
court of law and not administratively by HHS/CDC. Accordingly, we
decline to speculate as to whether employees who knowingly violate the
terms of a travel permit may be held criminally liable.
One public health organization asked for clarification of how local
health departments would be engaged in conducting communicable disease
screening activities or enforcing Federal public health travel
restrictions for individuals traveling interstate, given that HHS/CDC
staff are not present at many points of interstate travel. HHS/CDC
acknowledges this limitation in their presence at some ports of entry
and in regard to interstate travel and intends to address this through
future guidance and discussion with stakeholders.
In regard to interstate air travel, HHS/CDC clarifies that the
Federal public health Do Not Board tool will deny boarding of persons
known to pose a public health risk to other air travelers. This tool is
applicable to persons boarding a commercial aircraft with an origin or
destination in the United States, including interstate travel. See 80
FR 16400 (Mar. 27, 2015).
For other modes of travel, HHS/CDC does not have a systematic
mechanism
[[Page 6926]]
of denying boarding and these situations may need to be addressed on a
case-by-case basis, either through direct communication with a
conveyance operator or through application of other movement
restrictions such as the issuance of State or Federal public health
orders. Such situations will likely require the participation of State
or local public health authorities; however, as noted by the commenting
organization, the Federal and State/local costs and resources required
during such operations are not known. The specific roles of State or
local health departments will be addressed through future guidance or
stakeholder discussion.
HHS/CDC received a comment contending that the extension of travel
permits to intrastate travel is in violation of the Commerce Clause.
HHS/CDC disagrees. We note that HHS/CDC will only require intrastate
travel permits when a State or local health authority of jurisdiction
requests federal assistance or in the event that State and local
actions are inadequate to prevent interstate communicable disease
spread. Under 42 U.S.C. 264, Congress acting pursuant to its Commerce
Clause jurisdiction, has authorized HHS/CDC to take measures to prevent
the foreign introduction and interstate spread of communicable
diseases. It is well established that the Federal government may act to
protect interstate commerce, even though the threat may come entirely
from intrastate activities. See United States v. Lopez, 514 U.S. 549,
558-559 (1995).
One commenter requested that HHS/CDC replace the word ``traveler''
with ``passenger'' with respect to mandatory public health assessments,
as a traveler could be taken to mean ``anybody in a private vehicle
lined up at a toll booth.'' In response, HHS/CDC states that the use of
the word ``traveler'' with respect to conveyances is intended to
include both passengers and crew. Furthermore, HHS/CDC states that its
authority extends to all individuals engaging in interstate travel
including those traveling by private vehicle, particularly if they are
in the ``qualifying stage'' of a quarantinable communicable disease.
HHS/CDC received a comment from a partnership of public health
legal scholars and organizations expressing concern that requiring
application for a travel permit may be unduly burdensome because
individuals who are served with a conditional release order at an
airport would then need to apply for a separate travel permit to travel
to their home State of residence. HHS/CDC disagrees because under such
circumstances the conditional release order itself would include
authorization for these individuals to continue travel to their home
State of residence provided that they subsequently report to public
health authorities as needed. For example, during the response to
Ebola, CDC worked with state public health authorities to allow certain
individuals who met certain risk thresholds to travel in private
vehicles to their place of residence while maintaining a focus on
protecting public health. This was done on a case by case basis,
depending on distance of travel and risk of exposure, and distance from
a health care facility with adequate capacity to treat and contain
Ebola. CDC would make similar assessments in the event that conditional
release orders are needed for other quarantinable communicable
diseases. We note that the conditional release order itself would
provide permission to travel and have added clarifying language to the
text.
HHS/CDC clarifies, however, that after arriving in their home
State, should the individuals wish to engage in further travel, a
travel permit may be needed at that time. In response to comments from
this partnership organization, HHS/CDC also clarifies that the travel
permit, as provided for in the regulations, will only be required under
circumstances where the individual is already under a Federal, State or
local order of quarantine, isolation, or conditional release. Because
the travel permit requirement is only applicable to individuals who are
already under a Federal, State, or local public health order, HHS/CDC
believes that this provision does not impermissibly restrict an
individual's right to travel.
In response to comments regarding the time with which CDC may
consider a travel permit request, the CDC Director shall respond to a
request for a travel permit within 5 business days Likewise, one public
health association suggested that, in the event a travel permit is
denied, these regulations should state the timeframe that HHS/CDC will
issue a response to the appeal; another proposed the time period for
CDC's response to be 72 hours. In response to these comments, HHS/CDC
has added a requirement in the regulation that in the event that a
request for a travel permit is denied, it must decide an appeal from
that denial within three (3) business days. HHS/CDC believes that this
timeframe is appropriate because this provision only applies to
individuals who already have had their travel restricted through the
issuance of a public health order and deciding an appeal may involve
coordination with affected state or local jurisdictions.
After consideration of comments received, HHS/CDC has modified
paragraphs (a), (b)(1), (b)(2), and (c) of the provision concerning
Requirements Relating to Travelers Under a Federal Order of Isolation,
Quarantine, or Conditional Release (Sec. 70.5) to remove
``agreements,'' referring to agreements entered into by the CDC. We
have also modified paragraph (a)(5) to require that HHS/CDC must issue
a written response to an appeal within three (3) business days. Other
provisions of this section are finalized as proposed.
c. Report of Death or Illness Onboard Aircraft Operated by an Airline
Several commenters expressed concern that the new regulations
remove the requirement for a local health authority to be notified when
a passengers falls ill or dies on board a flight. The commenters
insisted that this could interfere with effective local response to
important communicable disease threats. They propose that local
authorities should be notified in a timely manner, such as within one
hour of initial reporting, and that HHS/CDC should consult with local
health authorities on the necessary steps to contain the spread of
communicable diseases. In contrast, one airline supported the direct
reporting to HHS/CDC.
HHS/CDC carefully considered these comments and responds that it
will continue its long standing partnership with local authorities. The
rationale behind asking airlines to submit reports of deaths or
reportable illnesses directly to HHS/CDC as opposed to local
authorities is to simplify and streamline the reporting process for
these airlines. Under the final rule, airlines will not be required to
know the current points of contact for multiple local jurisdictions,
but rather may report to HHS/CDC as a single point of contact. HHS/CDC
will continue to share public health information with State and local
health departments through approved electronic disease reporting
networks such as the Epidemic Information Exchange (Epi-X), HHS/CDC's
secure, Web-based system. HHS/CDC may also notify State or local
authorities via phone calls.
Some commenters questioned whether HHS/CDC has adequate resources
to be the first responder at the local level. HHS/CDC responds that it
regularly coordinates with Federal, State and local agencies and other
partners in the airport environment. HHS/CDC intends to continue
working closely with Federal, State, and local partners,
[[Page 6927]]
including first responders such as EMS and State and local health
agencies, when assistance is needed.
One commenter suggested that the reporting of ill travelers ``would
be an invasion of our liberty and privacy.'' HHS/CDC disagrees. The
report of illness or death on board a carrier is a longstanding
regulatory provision and practice. This final rule only changes to whom
the report is made (directly to HHS/CDC), rather than to the local
health department of destination. We further note that personally
identifiable information collected and maintained under the Privacy Act
will be handled in accordance with that Act and CDC's system of records
notice published at 72 FR 70867.
Another commenter worried that ``having flight reservations require
health reports will significantly impede air travel.'' It is not HHS/
CDC practice, nor a requirement under this regulation, for individuals
to submit health reports prior to or after making a flight or vessel
reservation. The only instance when health documents may be required
prior to travel, is if a person is known to be infectious with a
communicable disease that could spread during travel and has been
placed on the Federal Public Health Do Not Board described in 80 FR
16400 (Mar. 27, 2015). Because this practice is not new, HHS/CDC
believes it will not impede air travel.
A flight attendant association suggested that HHS/CDC should adopt
training and awareness requirements for airline employers to provide to
flight attendants concerning ``what entails a qualifying stage.''
Industry also expressed concern that flight crews may be held
responsible and penalized for missed illness identification. HHS/CDC
understands that the statutory definition of ``qualifying stage'' may
be confusing to lay persons and does not expect air or vessel
crewmembers to be trained in the nuances of such language. Instead, we
have crafted a definition of ill person to focus, in plain language, on
the signs and symptoms of communicable diseases of public health
concern and quarantinable communicable diseases, while taking into
account the medical resources available to aircrew. HHS/CDC intends to
enforce this provision consistent with how reports of deaths and
illnesses are currently handled in regard to foreign arrivals. We note
that flight crews have not been penalized in the past for missed
reports of illness.
HHS/CDC received comments from industry that the report of death or
illness should not be limited only to the pilot in command, given the
many duties already under his/her responsibility. HHS/CDC disagrees. We
clarify first that this domestic provision was proposed to mirror the
current foreign provision under 42 CFR 71.21(b)--which HHS/CDC did not
propose to change--and which states ``the commander of an aircraft
destined for a U.S. airport shall report immediately . . . any death or
ill person among passengers or crew.'' While we acknowledge the many
duties of the pilot in command, because this individual is directly
responsible and has final authority over the operation of the aircraft,
in keeping with the practice already established through regulation
under 42 CFR 71.21(b), we believe that the responsibility for reporting
ill persons onboard should ultimately rest with the pilot in command as
stated in the regulation. Thus, the text of the regulation has not
changed from the proposal.
One industry group commented that the role of flight attendants in
identifying sick travelers on board should be addressed through
guidance developed in conjunction with HHS/CDC and industry. HHS/CDC
responds that it routinely issues guidance for flight crews, including
standard guidance for the recognition and reporting of ill travelers
and disease- or situation-specific guidance during outbreaks. Such
guidance is published on HHS/CDC's Web site and disseminated through
established list serves, industry associations, and any other available
means. HHS/CDC will coordinate with industry partners to determine
whether additional guidance may be needed and, if necessary, work with
these partners to develop such guidance.
One industry organization commented that the proposed rule failed
to recognize that airlines employ intermediary professional medical
personnel. HHS/CDC responds that it recognizes the role of intermediary
professional medical personnel in assisting flight crews in managing an
ill traveler onboard and references such personnel in industry guidance
issued at http://www.cdc.gov/quarantine/air/index.html.
It is not HHS/CDC's intent for the public health assessment
conducted by HHS/CDC public health officers to replace this role in
medical management. However, HHS/CDC restates that the reporting of ill
travelers to HHS/CDC is the ultimate responsibility of the pilot in
command as noted above.
One association requested that the report of deaths on board a
carrier be modified and limited to those deaths which resulted from a
possible communicable disease. HHS/CDC disagrees. In keeping with
current practice, HHS/CDC will continue to require and receive the
reports of all deaths that occur on board a carrier, regardless of the
suspected cause, to allow a public health official to conduct an
assessment.
One public health organization raised concerns about replacing
reporting to local health authorities with reporting to HHS/CDC. In
response, HHS/CDC notes that extensive input was sought in 2012 from
the Association of State and Territorial Health officers (ASTHO) and
National Association of County and City Health Officials (NACCHO).
Representatives from those organizations recommended that requirements
and protocols should be the same for international and interstate
flights and procedures should be outlined describing how this would
occur. These representatives recommended that airlines should report
ill persons on domestic flights to HHS/CDC and that HHS/CDC should
subsequently notify State or local health departments. Subsequently,
HHS/CDC posted guidance to this effect on its Web site and has
continued response planning and development of standard operating
procedures to implement these recommendations. Thus, this rulemaking
codifies the current practice and is consistent with recommendations
provided by ASTHO and NACCHO.
One commenter stated that it appears HHS/CDC is ``attempting to
move towards mandatory reporting by carriers and border personnel,
requiring reporting of persons with signs of illness as they cross
borders, as opposed to having to do large-scale individual contact
interviews and investigations after an outbreak occurs.'' In response,
HHS/CDC states that reporting by carriers is already required under the
existing regulations and that this regulation only codifies current
practice and guidance. In addition, DHS notifies HHS/CDC of ill
travelers detected by border personnel. HHS/CDC and DHS agreed to this
notification process in a memorandum of understanding and therefore
changes to this regulation are unnecessary. HHS/CDC additionally
coordinates notification and investigation of contacts during exposure
or outbreak situations when necessary based on a public health risk
assessment. Such investigations are standard public health practice and
not mutually exclusive of reporting by carriers or notifications by
border personnel.
After consideration of these comments, the title of the Radio
Report of Death or Illness (71.21) in the provision has been finalized
as
[[Page 6928]]
proposed to remove the word ``Radio,'' and now reads Report of Death or
Illness.
C. Provisions Applicable to Part 71 Only (Foreign)
One commenter questioned the seriousness of communicable disease
spread on aircraft and vessels. Another commenter noted an ``extreme
unlikeliness of contracting any communicable disease while traveling''
and that, therefore, HHS/CDC failed to prove a ``compelling need'' for
the proposed regulations. HHS/CDC appreciates the opportunity to
respond to these comments. The spread of communicable diseases on
aircraft and vessels is well documented. There are numerous reports in
the medical and public health literature of spread of measles,
tuberculosis, SARS-coronavirus, and influenza virus on aircraft.
Outbreaks of varicella (chickenpox), influenza, and gastrointestinal
viruses such as norovirus are common on cruise ships, and spread of
other diseases such as measles, rubella (German measles), tuberculosis,
and other gastrointestinal diseases has also been reported. Aircraft
and vessels have people together in confined spaces for prolonged
periods of time. Therefore, conducting contact investigations for
certain communicable diseases identified on aircraft or vessels is
standard public health practice, both in the United States and
internationally, similar to public health practice in community
settings.
HHS/CDC received comments from industry regarding ongoing efforts
with DHS/CBP to improve passenger data collection, as announced in the
NPRM. Several commenters stated that HHS/CDC should delay this final
rule until DHS/CBP has published a regulation to ensure that a
coordinated system is put in place. HHS/CDC thanks these commenters for
their input but disagrees that this final rule should be delayed. This
comprehensive regulation seeks to protect public health, by
implementing, among other things, current passenger and crew data
collection practices.
One commenter objected to the collection of health information
prior to using public transportation. Another commenter opposed the
idea of carriers being ``forced to collect and report 17 data elements
on American travelers.'' A public health association also insisted that
data elements should only be collected from people if there is a
reasonable belief that the person is infected. This final rule does not
require carriers to collect or transmit any data elements that are not
currently collected and transmitted to CBP via APIS and PNR as a result
of normal operating procedures. We also take this time to emphasize two
important points. First, passengers are not required by HHS/CDC to
submit specific data elements provided by passengers. Second, HHS/CDC
will only seek this information from CBP or the airline in the event of
a confirmed or suspected communicable disease on board a carrier which
requires contacting fellow passengers to inform them of possible
exposure.
While HHS/CDC received support for the data collection from two
public health associations, a commenter misread the proposals to mean
that aircraft operators would be required to develop new capacity and
processes to capture and store a comprehensive set of sensitive data,
archive this data, and then provide it to HHS/CDC. HHS/CDC takes this
opportunity to restate and clarify that these final regulations do not
impose any new burdens upon the airline industry but rather, codify the
current practice of receiving a passenger manifest order (as needed)
and providing HHS/CDC with any data in an airline's possession. This
rule places no requirement on the airline to solicit or store
additional data than current practices allow. Therefore, HHS/CDC does
not expect this formalization of current practice to have an impact on
operations, including ``check-in process.'' If an airline does not have
in its possession the five additional data elements, it is not required
to collect or submit them to CDC.
One airline industry group commented that the collection of
information from screened individuals for the purpose of contact
tracing should apply only to passengers because crewmember information
would be provided by the employer. HHS/CDC responds that this may be
the case operationally; however, HHS/CDC reserves the right to collect
information directly from crew members if necessary.
HHS/CDC received a comment expressing concern that individuals may
provide false contact information, e.g. emails and telephone numbers,
to airlines, and thus that HHS/CDC would lack the means of contacting
individuals. In response, HHS/CDC notes that airlines are not required
to verify the accuracy of information collected and HHS/CDC takes no
position on what consequences the airline may impose if a traveler
refuses to provide information or provides inaccurate information.
One public health organization commented on the scope of HHS/CDC's
protocols for when contact investigations are conducted and how exposed
contacts are defined following exposures to measles or varicella on
aircraft or vessels. HHS/CDC appreciates the comment but seeks to
clarify that these protocols were mentioned in the NPRM solely for the
purposes of providing context for the economic analysis and that the
content of the protocols themselves is beyond the scope of this
rulemaking.
One public health organization commented on the fact that buses and
trains typically do not maintain or have access to passenger manifests
that would allow for the collection of information by HHS/CDC for the
purpose of contact tracing. HHS/CDC agrees with this comment and notes
that these regulations do not require operators of buses or trains to
maintain passenger manifests for purposes of contact tracing. The
organization also commented on the utility of the requirement that
operators of buses or trains not knowingly transport individuals
subject to a Federal public health order. In response, HHS/CDC notes
that it is useful to prohibit conveyance operators from knowingly
transporting someone under a Federal public health order without a
travel permit or in violation of the terms of a permit because this may
limit communicable disease spread. This prohibition, however, would
only apply in circumstances where the operator would know or have
reason to know that a travel permit is required, for instance, if the
conveyance operator has been directly informed by the HHS/CDC or
another cooperating Federal, State, or local agency.
A non-profit organization also commented that requiring airlines to
disclose passenger information, upon request, but without a warrant,
for purposes of notifying passengers of their potential exposure to a
communicable disease violates the Fourth Amendment to the U.S.
Constitution. This organization also contends that HHS/CDC lacks the
legal authority to require that travelers provide certain contact
information, such as information concerning their intended destination,
health status, and travel history as part of a public health
investigation. Specifically, this group contends that ``examination''
as used in 42 U.S.C. 264(d)(1) should be understood as referring only
to an ``inspection'' not an ``interrogation.'' This group further
contends that because HHS/CDC lacks the legal authority to collect
information under 42 U.S.C. 264 it also lacks the authority to collect
information under the Privacy Act of 1974. Lastly, this group contends
that any compulsory questioning of travelers about ``acts of
[[Page 6929]]
assembly or association'' violates the First Amendment to the U.S.
Constitution.
HHS/CDC disagrees with these comments. HHS/CDC notes that the
requirement of a judicial warrant is not applicable to requiring
passenger and crew information from air carriers. Rather, this activity
is permitted without a warrant under the special-needs doctrine
articulated by the Supreme Court in Skinner v. Railway Labor
Executives' Ass'n, 489 U.S. 602 (1989) because of the ``special need''
in preventing communicable disease spread. Furthermore, requiring
passenger information from airlines and questioning travelers is
authorized under 42 U.S.C. 264(a), which allows for the promulgation of
regulations necessary for preventing the spread of communicable
diseases from foreign countries into the United States and interstate.
In carrying out and enforcing these regulations, 42 U.S.C. 264(a),
authorizes ``inspection'' and ``other measures'' as may be necessary
which allows for inspection of airline records and questioning of
travelers regarding their health status and travel history. While 42
U.S.C. 264(d)(1) is not directly implicated in questioning of travelers
because such questioning may occur without a specific reason to believe
that the individual traveler may be infected with a quarantinable
communicable disease, we note that the commenter's suggestion that an
``examination'' excludes ``interrogation'' is not supported by common
understanding or language usage. We note that Merriam Webster defines
``examination'' among other things as ``a formal interrogation.'' Thus,
this commenter's suggestion that because HHS/CDC purportedly lacks the
legal authority to collect traveler information under 42 U.S.C. 264 it
also lacks authority to collect information under the Privacy Act is
without merit.
HHS/CDC also rejects the suggestion that questioning of travelers
violates their rights to free association under the First Amendment.
The U.S. Supreme Court has recognized a ``freedom of association'' in
only two distinct areas: (1) Choices to enter into and maintain certain
personal human relationships (as an element of personal liberty); and
(2) a right to associate for the purpose of engaging in other
activities protected by the First Amendment, i.e., speech, assembly,
petition for redress of grievances, exercise of religious freedom. City
of Dallas v. Stanglin, 490 U.S. 19, 23-24 (1989). The purpose of this
proposed requirement is to protect the vital health interests of
passengers and crew so that individuals who have been exposed to a
communicable disease during travel may be contacted, informed, and
provided with appropriate public health follow-up. HHS/CDC measures to
prevent the introduction, transmission, or spread of communicable
diseases do not implicate any of these constitutionally-protected
areas.
HHS/CDC further notes that its purpose in collecting passenger
information is to notify passengers who have been potentially exposed
to communicable diseases of public health concern. For some of these
diseases, there are preventive medications or vaccines that the
individual may be made aware of and wish to obtain to keep from
becoming sick. Therefore, HHS/CDC considers the collection of passenger
locating information to be of benefit to these passengers and in
keeping with standard public health practice to prevent further
communicable disease transmission.
After considering these comments, HHS/CDC has finalized these
provisions (71.4 and 71.5) as proposed, with the exception that the
title has been modified to remove references to ``collection'' and
``storage'' of information to more accurately reflect the requirements
under this section. References to the CDC have also been replaced with
Director throughout these sections.
a. Suspension of Entry of Animals, Articles, or Things From Designated
Foreign Countries and Places Into the United States
Regarding provision 71.63 Suspension of entry of animals, articles,
or things from designated foreign countries and places into the United
States, one public health association proposed that the restriction of
animals should include an exception for ports of entry that could
provide for physical inspection. In response, HHS/CDC clarifies that if
the CDC Director determines an imported animal (or product) poses a
significant public health threat, this provision requires the Director
to designate the period of time and conditions under which entry into
the United States shall be suspended, which may include limiting
entries to certain ports where physical inspections are available. In
keeping with current practice, HHS/CDC will implement public health
protection measures that strike the appropriate balance between
protecting the public's health and continued importation and trade.
HHS/CDC received a comment that the term ``thing'' as used in 71.63
authorizing the suspension of ``animals, articles, or things,'' based
on the existence of communicable disease in a foreign country is unduly
vague. In response, we explain that HHS/CDC may take public health
measures in regard to animals, articles, or things, to prevent the
introduction, transmission, and spread of communicable diseases into
the United States and interstate. ``Article'' generally refers to an
article of commerce, such as a specific product that someone wishes to
import into the United States or move between States that poses a
public health risk. In contrast, a ``thing'' simply refers to a
material object that poses a public health risk regardless of whether
there is a specific intent to import or move between States. For
instance, on July 10, 2001, CDC issued an order under the authority of
section 71.32(b) requiring that imports of ``lucky bamboo'' (a
decorative plant) shipped in standing water be prohibited from entering
the United States because the water (i.e., the method of packing the
lucky bamboo) constituted a potential vector for mosquito-borne
illnesses. See 66 FR 35984 (July 10, 2001). In contrast, shipments of
``lucky bamboo'' that were packed dry (not in standing water) were
permitted entry into the United States. In this case, ``lucky bamboo''
(the decorative plant) would constitute the ``article'' and the
standing water would constitute the ``thing.''
HHS/CDC received a question regarding the fate of animals or
articles denied entry under this regulation, stating that ``articles
might presumably be forfeited and pets will be executed,'' and
questioning whether this provision aligns with due process,
particularly with respect to the right to appeal. In response, HHS/CDC
states that the provision authorizing temporary suspension of entry of
certain animals, articles and things based on the existence of a
communicable disease in a foreign country and to protect the public's
health is intended to prevent the arrival of these items at a U.S. port
of entry. Therefore, HHS/CDC will seek to ensure travelers are informed
of the restriction and will also work with carriers to prevent these
animals or items from being loaded onto aircraft or vessels traveling
to the United States. If such animals or items do arrive at a U.S. port
of entry, HHS/CDC will take measures as needed to protect the public's
health. Such measures will be determined on a case-by-case basis and
may include, at the owner's expense, confinement, re-exportation, or
destruction. Re-exportation may be considered if there is no public
health risk during travel. HHS/CDC would also consider euthanasia of
animals if there
[[Page 6930]]
are no other reasonable alternatives to protect the public's health.
In response to the concern expressed about an ``appeal,'' HHS/CDC
notes that the Director's suspension order would ordinarily constitute
``final agency action'' under the Administrative Procedure Act, 5
U.S.C. 704. However, HHS/CDC will consider the appropriateness of
offering an administrative appeal as it develops the relevant
suspension order.
After considering these comments, HHS/CDC has finalized the
Suspension of Entry of Animals, Articles, or Things From Designated
Foreign Countries and Places Into the United States (71.63) provision
as proposed.
VI. Alternatives Considered
Under Executive Order 13563 agencies are asked to consider all
feasible alternatives to current practice and the rulemaking as
drafted. One less restrictive alternative would be for HHS/CDC to stop
enforcing its regulations and make compliance with current regulations
voluntary. Under this scenario, HHS/CDC would not obtain contact data
from airlines or provide such data to health departments in order to
conduct contact investigations. HHS/CDC would not require illness and
death reports on aircraft or vessels, but would still follow-up with
airlines and vessel operators upon request. This alternative would put
travelers at greater risk of becoming infected with communicable
diseases, reduce the ability of public health departments to offer
post-exposure prophylaxis or other measures to prevent communicable
disease spread from travelers known to have been exposed, and generally
increase the risk of communicable disease transmission in the United
States.
Another alternative, is to extend the scope of the regulations by
closing U.S. borders and ports of entry to incoming traffic from
countries experiencing widespread transmission of quarantinable
communicable diseases to protect public health is also analyzed based
on the 2014-16 Ebola outbreak in West Africa as well as recent
importations of Middle East respiratory syndrome. HHS/CDC believes this
approach is neither practicable nor is it desirable.
In a separate appendix, alternatives are considered to increase or
decrease HHS/CDC's required payments for care and treatment for
individuals under Federal orders as specified in 42 CFR 70.13 and 42
CFR 71.30. Also in a separate appendix, alternatives are also
considered in which HHS/CDC does not implement temporary animal import
embargos (less restrictive) or does not allow importation of animals
under temporary embargos for science, education, and exhibition when
accompanied by a special permit.
We believe the regulations described above and set forth below in
text offer the best solutions for protecting U.S. public health while
allowing for continued travel. HHS/CDC believes that this rulemaking
complies with Executive Order 13563; all of these changes provide good
alternatives to the current baseline.
VII. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
HHS/CDC has examined the impacts of the final rule under Executive
Order 12866, Regulatory Planning and Review (58 FR 51735, October 4,
1993) \2\ and Executive Order 13563, Improving Regulation and
Regulatory Review, (76 FR 3821, January 21, 2011).\3\ Both Executive
Orders direct agencies to evaluate any rule prior to promulgation to
determine the regulatory impact in terms of costs and benefits to
United States populations and businesses. Further, together, the two
Executive Orders set the following requirements: Quantify costs and
benefits where the new regulation creates a change in current practice;
define qualitative costs and benefits; choose approaches that maximize
net benefits including potential economic, environmental, public health
and safety, and other advantages; support regulations that protect
public health and safety; and minimize the adverse impact of
regulation. HHS/CDC has analyzed the final rule as required by these
Executive Orders and has determined that it is consistent with the
principles set forth in the Executive Orders and the Regulatory
Flexibility Act,\4\ as amended by the Small Business Regulatory
Enforcement Fairness Act (SBREFA) \5\ and that, relative to the status
quo, the final rule will not be economically significant because the
sum of annualized costs and benefits are estimated to be much less than
$100 million in any given year.
---------------------------------------------------------------------------
\2\ Executive Order 12866 of September 30, 1993: Regulatory
Planning and Review. Federal Register. Monday, October 4, 1993;
58(190). http://www.archives.gov/federal-register/executive-orders/pdf/12866.pdf. Accessed January 2016.
\3\ Executive Order 13563 of January 18, 2011: Improving
Regulation and Regulatory Review. Federal Register. Friday, January
21, 2011; 76(14). http://www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/2011-1385.pdf. Accessed January 2016.
\4\ U.S. Small Business Administration. Regulatory Flexibility
Act. http://www.sba.gov/advocacy/823. Accessed January 2016.
\5\ Summary of the Unfunded Mandates Reform Act. 2 U.S.C. 1501
et seq. (1995). http://www2.epa.gov/laws-regulations/summary-unfunded-mandates-reform-act. Accessed January 2016.
---------------------------------------------------------------------------
However, there is uncertainty about the appropriate analytic
baseline, and relative to some possible baselines, the effects of the
rule are non-negligible. For example, if in the absence this rule, some
aspects of future HHS/CDC screening or risk assessment activities are
found to be legally impermissible, then the status quo baseline would
not represent a reasonable approximation of the state of the world
without the rule. Relative to a non-status quo baseline, the rule would
lead to activities (e.g., the 2014-16 Ebola risk assessment and
management program) that have both substantial costs and substantial
benefits. Analyses relative to this non-status quo baseline are
presented in a separate appendix.
This Regulatory Impact Analysis (RIA) section presents the
anticipated costs and benefits that are quantified where possible are
relative to the status quo baseline. Where quantification is not
possible, a qualitative discussion is provided of the costs and/or
benefits that HHS/CDC anticipates from issuing these regulations.
Need for Rule
The 2014-2016 Ebola response highlights the inadequacies and
limitations of the current regulatory provisions on the traveler data
collection process in which CDC must request traveler manifests from
airlines and manually search for contact data in order to know who
enters the United States, where they go, and how to contact them.
Airlines have been slow to respond to HHS/CDC requests for traveler
manifests:
[cir] 30% arrive more than three days after a request,
[cir] 15% arrive more than six days late.
In addition, available locating information is usually incomplete:
HHS/CDC receives only the name and seat number for 61% of travelers,
and one or more additional pieces of information for 39% of travelers.
This final rule clarifies HHS/CDC's existing authority to request any
available contact data from airlines and vessel operators, which may
improve the timeliness and completeness of future requests from
airlines or vessel operators for data not already submitted to the
Department of Homeland Security.
Some traveler contact data is available in the APIS/PNR dataset
already submitted by airlines to CBP. In the experience of the HHS/CDC,
queries from APIS/PNR rarely result in full sets
[[Page 6931]]
of contact information (i.e. the record includes all five additional
data fields as outlined in the final rule). The data fields that are
most commonly missing from the records are email addresses (missing 90
percent of the time), secondary phone number (missing 90 percent of the
time), and street addresses (missing or insufficient for public health
contact tracing up to 50 percent of the time). These data elements are
vital to a contact tracing investigation. In looking at a random sample
of 20% of the compiled international air travel manifests for 2015,
those including a compiled data set from NTC and the airlines, 100%
were missing at least one of the 5 data fields. Email address and
secondary phone number were among those most frequently missing. For
context, there were approximately 760,000 scheduled flights that
arrived into the United States in 2015. In 2015, HHS/CDC issued
passenger manifest requests for 64 international flights arriving into
the United States. As noted in the RIA of the final rule, from 2010 to
2015, HHS/CDC conducted an average of 77 contact investigations per
year involving arriving international flights.
Airlines are contacted for the majority of contact investigations
using a manifest order document. At a minimum, HHS/CDC needs to confirm
the ill traveler was on the flight and where the individual sat in
relation to other travelers to determine risk of exposure. Further, in
HHS/CDC's experience, only airlines can:
Quickly and efficiently produce a partial manifest
targeting affected rows
confirm identity of ``babes in arms'' and their co-
travelers (Parent); this is important for measles cases;
quickly confirm whether an individual actually flew (in
instances where individuals deplane and do not re-board during a
layover); and
confirm a plane's configuration if there is a question
with the provided row numbers. Different aircraft have different
seating arrangements depending on carrier and layout. It is important
to know if a certain seat is separated by a bulkhead or is a window
seat.
In addition, HHS/CDC only requires a partial manifest, e.g. 5 rows
for travelers with infectious tuberculosis, so that NTC and HHS/CDC
staff can limit the investigation to only those passengers at risk and
supplement/cross reference with APIS and PNR data. If a partial
manifest is not available from the airlines, then each passenger record
must be researched individually to find a seat number, and then the
configuration of an entire plane must be populated to determine where
the index case sat in relation to other at-risk passengers. For large
flights from Asia, this can pose a tremendous burden to NTC and CDC
staff while slowing the ability of CDC to provide important contact
information to state and local health departments. Manually populating
multiple 300+ person flights is not feasible in a timely manner.
Finally, CDC wishes to reiterate its desire for the above-described
operations to be published in regulation to provide the public, as well
as industry, with understanding of the efforts made by CDC to protect
public health.
The other change to the economic baseline that may result from this
final rule was the need to change the definition of an ``ill person''
to better match HHS/CDC guidance and the guidelines contained in Note 1
to paragraph 8.15 of Annex 9 to the Convention on International Civil
Aviation. Where possible, the marginal costs and benefits of these
changes relative to the status quo baseline are monetized.
In addition, HHS/CDC believes that there is a need to better
communicate to the public the actions that it has taken in accordance
with its regulatory authority under 42 CFR 70.6 Apprehension and
detention of persons with specific diseases, 42 CFR 71.32 Persons,
carriers, and things, and Sec. 71.33--Persons: Isolation and
surveillance. HHS/CDC believes it is necessary for the public to better
understand actions that may be taken to prevent the importation of
communicable diseases and to explain the due process available to
individuals under Federal orders for isolation, quarantine, or
conditional release. HHS/CDC also believes it is important to explain
when HHS/CDC may authorize payment for the care and treatment of
individuals subject to medical examination, quarantine, isolation and
conditional release.
Finally, HHS/CDC believes it is important to explain its regulatory
authority to suspend entry of animals, articles or things from
designated foreign countries and places into the United States when
importation increases the risk of the introduction and/or transmission
of a communicable disease within the United States.
The specific market failure addressed by these regulations is that
the costs associated with the spread of communicable diseases impacts
the entire U.S. population, not just the group of persons currently
infected with communicable diseases or with business interests in
providing interstate or international travel to persons or animals
infected with communicable diseases.
The economic impact analysis of this final rule is subdivided into
four sections:
1. An analysis of 42 CFR 70.1, 42 CFR 71.1/71.4/71.5, for which the
primary costs may be incurred by aircraft and vessel operators and the
primary benefit is improved public health responsiveness to assess and
provide post-exposure prophylaxis to travelers exposed to communicable
diseases of public health concern.
2. An analysis of a number of provisions that aim to improve
transparency of how HHS/CDC uses regulatory authorities to protect
public health. These changes are not intended to provide HHS/CDC with
new regulatory authorities, but rather to clarify the agency's standard
operating procedures and policies, and due process rights for
individuals. HHS/CDC believes that improving the quality of its
regulations by providing clearer explanations of its policies and
procedures is an important public benefit. However, HHS/CDC is not able
to attach a dollar value to this added benefit in a significant way. In
a separate appendix, HHS/CDC analyzes the costs and benefits associated
with the 2014-2016 Ebola enhanced risk assessment and management
program are used to illustrate the costs and benefits of implementation
of some of these authorities, and are especially relevant when
analyzing the effects of the rule relative to a non-status quo
baseline.
3. In a separate appendix, HHS/CDC provides an analysis of the
revisions to 42 CFR 70.13/71.30: Payment for care and treatment, which
are not expected to lead to a change in HHS/CDC policy under which HHS/
CDC may act as the payer of last resort for individuals subject to
medical examination, quarantine, isolation, and conditional release
under Federal orders. The primary benefit of codification is increased
transparency around HHS/CDC policies to assist in paying for treatment
or transportation for individuals under Federal orders. The analysis
for these provisions is an examination in potential transfer payments
between HHS/CDC and healthcare facilities that provide treatment to
individuals under Federal orders or to other payers.
4. In a separate appendix, HHS/CDC provides an analysis of 42 CFR
71.63: Suspension of entry of animals, articles, or things from
designated foreign countries and places into the United States. In this
final rule, HHS/CDC is
[[Page 6932]]
explaining its existing regulatory authority. HHS/CDC cannot predict
how often such authority may be used in the future or for what purpose.
HHS/CDC previously exercised this authority on June 11, 2003, when
under 42 CFR 71.32(b), HHS/CDC implemented an immediate embargo on the
importation of all rodents from Africa (order Rodentia).\6\ A simple
economic impact analysis of this embargo is performed to demonstrate
the costs and benefits of one example, but HHS/CDC does not anticipate
an increase in frequency of such actions based on the provisions
included in this final rule. The primary purpose of the analysis is to
demonstrate potential costs and benefits using a realistic example.
---------------------------------------------------------------------------
\6\ Federal Register 62353 Vol. 68, No. 213 Tuesday, November 4,
2003. P. 62353-69.
---------------------------------------------------------------------------
Table 1 provides a summary of whether quantitative or qualitative
analyses were performed for each of the provisions in the final rule.
Table 1--Summary of Provisions Included in This Final Rule
------------------------------------------------------------------------
Qualitative impacts Codification of
Provision only existing authority
------------------------------------------------------------------------
Sec. 70.1/Sec. 71.1 No \a\............. Yes (except
General Definitions. definition of
``ill person'').
Sec. 70.5 Requirements Yes................ Yes.
relating to travelers under a
federal order of isolation,
quarantine, or conditional
release.
Sec. 70.6 Apprehension and Yes................ Yes.
detention of persons with
specific diseases; Sec.
71.32 Persons, carriers, and
things (no change to title).
Sec. 70.10/Sec. 71.20 Yes \b\............ Yes.
Public health prevention
measures to detect
communicable disease.
Sec. 70.11 Report of death Yes................ Yes.
or illness onboard aircraft
operated by an airline.
Sec. 70.12/Sec. 71.36 Yes................ Yes.
Medical examinations.
Sec. 70.13/Sec. 71.30 Yes \c\............ Yes.
Payment for Care and
Treatment.
Sec. 70.14/Sec. 71.37 Yes................ Yes.
Requirements relating to the
issuance of a Federal order
for quarantine, isolation, or
conditional release.
Sec. 70.15/Sec. 71.38 Yes................ Yes.
Mandatory reassessment of a
federal order for quarantine,
isolation, or conditional
release.
Sec. 70.16/Sec. 71.39 Yes................ Yes.
Medical review of a federal
order for quarantine,
isolation, or conditional
release.
Sec. 70.17/Sec. 71.29 Yes................ Yes.
Administrative records
relating to federal
quarantine, isolation, or
conditional release.
Sec. 70.18/Sec. 71.2 Yes................ Yes.
Penalties.
Sec. 71.4 Requirements No \a\............. Yes.
relating to collection,
storage and transmission of
airline passenger, crew and
flight information for public
health purposes.
Sec. 71.5 Requirements No \a\............. Yes.
relating to collection,
storage and transmission of
vessel passenger, crew, and
voyage information for public
health purposes.
Sec. 71.33 Persons: Yes................ Yes.
Isolation and surveillance.
Sec. 71.63 Suspension of Yes \d\............ Yes.
entry of animals, articles,
or things from designated
foreign countries and places
into the United States.
------------------------------------------------------------------------
\a\ Analyzed in RIA.
\b\ The costs and benefits associated with the 2014-2016 Ebola enhanced
risk assessment and management program are used to illustrate the
costs and benefits in a separate appendix.
\c\ In a separate appendix, an analysis of previous HHS/CDC payments for
care and treatment is provided. However, the provisions in the Final
Rule are not expected to lead to a change in HHS/CDC policy under
which HHS/CDC may act as the payer of last resort for individuals
subject to medical examination, quarantine, isolation, and conditional
release under Federal orders.
\d\ In a separate appendix, HHS/CDC provides an analysis of this
provision based on past experience when HHS/CDC implemented an
immediate embargo on the importation of all rodents from Africa.
Executive Summary of the Costs and Benefits of 42 CFR 70.1, 42 CFR
71.1/71.4/71.5
Estimated Costs
The quantified costs and benefits of the final rule are estimated
for the following stakeholders: Air and maritime conveyance operators,
State and local public health departments (PHDs), individuals exposed
to communicable diseases during travel and United States Government
(USG). The most likely estimates of primary costs are low ($32,622,
range $10,959 to $430,839) because the final rule primarily codifies
existing practice or improves alignment between regulatory text and the
symptoms reporting guidelines provided by the International Civil
Aviation Organization (ICAO). The cost estimates are based on an
increase in:
The number of illness reports delivered by airlines and
vessel operators to CDC, relay of air illness reports to CDC by the
Federal Aviation Administration (FAA) when such reports are received by
FAA air traffic service units, illness reports processed by HHS/CDC and
time for travelers;
increased costs for airlines and vessel operators to
comply with HHS/CDC requests for traveler contact data;
increased costs for State and local public health
departments to follow up with a larger number of travelers exposed to
communicable diseases during travel;
The upper bound cost estimate also includes a substantial
increase in training costs for the changes to illness reporting.
Estimated Benefits
The best estimate of quantified benefits of the final rule is also
relatively small $110,045 (range $26,337 to $297,393). This estimate is
based on expected improvements in illness reporting and in the
timeliness, completeness, and accuracy of contact data. These
improvements should result in increased efficiencies for HHS/CDC and
State and local public health departments in conducting contact
investigations among travelers exposed to communicable diseases on
aircraft and vessels and reduced illness costs associated with the
reduced risk of measles and tuberculosis morbidity and mortality in
exposed travelers.
Other potential but non-quantified benefits of the final rule would
be associated with future outbreaks of
[[Page 6933]]
infectious disease cases for which improved compliance by airlines and
vessel operators to provide available traveler contact data would
reduce onward spread of disease in the destination communities of
exposed travelers. In addition, the change to the definition of ``ill
person'' may also increase reporting of communicable diseases of public
health concern onboard conveyances. Reduction in onward spread would
also lead to the ability of the public health establishment to reduce
effects of disease outbreaks, e.g., delay the spread of disease until a
vaccine is available or limit the numbers of outbreaks and cases or
reduce public anxiety associated with the risk of transmission. There
may also be a reduction in the economic costs of many business sectors
such as avoidance of costs to the travel and tourism industry
7 8 when a disease is contained in its early stages.
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\7\ Rassy D, Smith RD. The economic impact of H1N1 on Mexico's
tourist and pork sectors. Health Econ. 2013;22(7):824-34. doi:
10.1002/hec.2862. PubMed PMID: 23744805.
\8\ Keogh-Brown MR, Smith RD. The economic impact of SARS: How
does the reality match the predictions? Health Policy.
2008;88(1):110-20.
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Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of [$146,000,000 in 2015 USD] or more.'' Not only will
this final rule not cost State, local and tribal governments any
expenditure, it is possible that these stakeholders who might be
engaged in contact tracing may see a reduction in costs if the final
rule is implemented and there is an improvement in airline compliance
with HHS/CDC requests to provide traveler data.
The Final Rule
Traveler contact information will only be requested by HHS/CDC
after a case of serious communicable disease (index case) is reported
in a person who traveled on a commercial airline or vessel while
contagious. Examples of serious communicable diseases include measles,
novel influenzas, and viral hemorrhagic fevers such as Ebola among
others. This type of situation necessitates identifying and locating
passengers seated near the index case in order to conduct a contact
investigation (CI). This final rule would lead to better health
outcomes if public health departments are more quickly and effectively
able to contact persons potentially exposed to the index case on an
aircraft or vessel. These increased efficiencies should lead to smaller
infectious disease outbreaks and fewer public health resources needed
to control an outbreak.
There are multiple communicable diseases including quarantinable
(e.g., tuberculosis, MERS, and Ebola) and non-quarantinable (e.g.,
measles, varicella, pertussis, rabies, meningococcal, and rubella)
diseases that may necessitate a contact investigation to prevent spread
of disease in the community. HHS/CDC notes that for non-quarantinable
diseases, HHS/CDC efforts would primarily be limited to assisting
health departments to notify individuals of their potential exposures.
HHS/CDC was unable to quantify the benefits of preventing the spread of
all diseases as a group because of differences in the characteristics
of each disease. The differences with respect to potential spread and
impact make it difficult to assess the benefits that may accrue from
reduced spread of all diseases. The quantified analysis focuses on the
two diseases that generate the greatest number of contacts to follow
up: Measles and tuberculosis.
The ongoing persistence of measles in the United States provides a
good example of the need for this final rule. In 2000, measles was
declared no longer endemic in the United States due to high vaccination
rates. Cases and outbreaks of measles continue to occur, however, as a
result of importation from other countries and lack of adherence to the
recommendation for measles vaccination (http://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/mmr.html). The United States is currently
discovering the greatest number of measles cases that have been
identified since the declaration of measles elimination; 97% of recent
cases were associated with importations from other countries. Of 45
direct importations, 40 occurred in U.S. citizens after traveling
abroad.\9\
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\9\ Gasta[ntilde]aduy, P.A., S.B. Redd, A.P. Fiebelkorn, J.S.
Rota, P.A. Rota, W.J. Bellini, J.F. Seward and G.S. Wallace (2014).
``Measles--United States, January 1-May 23, 2014.'' MMWR 63(22):
496-499.
---------------------------------------------------------------------------
Among air travelers exposed to measles during flights, post-
exposure prophylaxis (PEP) with measles-containing vaccine (within 72
hours) or immune globulin (within 6 days) can prevent onset of
disease,\10\ halting outbreaks before they begin. However, without
accurate and timely contact data, it is frequently difficult to
intervene within these timelines. A recent analysis showed that 9 cases
likely occurred as a result of exposure during 108 flights with 74
case-travelers over 3 years. Although there was no onward transmission
from these 9 cases,\11\ future cases may lead to larger outbreaks.
---------------------------------------------------------------------------
\10\ Nelson, K., Marienau, K.J., Schembri, C. and Redd, S.
(2013). ``Measles transmission during air travel, United States.''
Travel Medicine and Infectious Disease (2013) 11, 81e89 11: 81-89.
\11\ Nelson, K., Marienau, K.J., Schembri, C. and Redd, S.
(2013). ``Measles transmission during air travel, United States.''
Travel Medicine and Infectious Disease (2013) 11, 81e89 11: 81-89.
---------------------------------------------------------------------------
Measles outbreaks can have substantial associated costs. One model-
based analysis showed that 16 outbreaks with 107 confirmed measles
cases cost an estimated $2.7 million to $5.3 million U.S. dollars for
public health departments to contain.\12\ The estimate is based on
outbreak-specific travel expenses and the opportunity cost of diverting
public health staff to outbreak response activities and is not based on
the cost of hiring additional staff. This corresponds to an average
cost per outbreak of about $250,000 in 2015 USD. In comparison, a total
of 125 cases occurring in 8 States and three countries were associated
with a single measles outbreak that originated in late December 2014 in
amusement theme parks in Orange County, California.\13\ Thus, the
number of cases in this one outbreak exceeded the total number of
outbreak-associated cases identified in 16 outbreaks during 2011. The
source of the initial exposure has not been identified so it is not
possible to determine where this index case was exposed. However, this
example demonstrates the speed with which communicable diseases can be
transmitted and the importance of quickly identifying persons that may
have been exposed during air or maritime travel. It is possible that
the costs of this one outbreak, which spread across 8 States, exceeded
the total costs of all 16 outbreaks that occurred in 2011 and were
estimated to cost public health departments a total of $2.7 million to
$5.4 million dollars.\14\
---------------------------------------------------------------------------
\12\ Ortega-Sanchez, I.R., M. Vijayaraghavan, A.E. Barskey and
G.S. Wallace (2012). ``The economic burden of sixteen measles
outbreaks on United States public health departments in 2011.''
Vaccine 32(11).
\13\ Jennifer Zipprich, Kathleen Winter, Jill Hacker, Dongxiang
Xia, James Watt, Kathleen Harriman. (2015) Measles Outbreak--
California, December 2014-February 2015. MMWR/February 20, 2015/Vol.
64/No. 6: 153-154.
\14\ Ortega-Sanchez, I.R., M. Vijayaraghavan, A.E. Barskey and
G.S. Wallace (2012). ``The economic burden of sixteen measles
outbreaks on United States public health departments in 2011.''
Vaccine 32(11).
---------------------------------------------------------------------------
In the absence of interventions by public health departments,
travelers
[[Page 6934]]
infected with measles during international travel would be as likely as
any other individuals to initiate a measles outbreak. In the absence of
HHS/CDC efforts to retrieve and transmit contact data, public health
departments would not be able to contact travelers to offer post-
exposure prophylaxis and to recommend self-monitoring for potential
measles symptoms.
Summary of Quantifiable and Qualitative Results of the Regulatory
Impact Analysis
The Summary Table provides estimated total monetary results for
stakeholders' costs and benefits of implementing the final rule. The
Summary Table (Table 2) includes estimates associated with changes to
the definition of `ill person' in 42 CFR 70.1/71.1 and the codification
of international traveler data collection processes of aircraft and
vessel contact investigations under 42 CFR 71.4/71.5. The best
estimates of annual costs are $32,622 compared to the best estimate of
annual benefits at $110,045. The upper bound annual quantified costs
are $430,839 and the upper bound quantified benefits are $297,393.
Lower bound quantified costs are $10,959 and benefits are $26,337.
The measles and tuberculosis examples should not be considered a
complete estimate of non-quantified benefits associated with this final
rule, because the impact of this final rule to mitigate many different
types of infectious disease outbreaks cannot be quantified. It just
provides examples based on the two diseases for which contact
investigations are most frequently undertaken. Besides communicable
diseases commonly reported in the United States (e.g., measles,
tuberculosis), this final rule may also improve HHS/CDC's ability to
respond to diseases that are infrequently diagnosed in the United
States (e.g., Ebola, novel influenza, Middle East Respiratory
Syndrome). For example, it is possible that HHS/CDC may need to prepare
to address both Ebola and another disease such as novel influenza or
Middle East Respiratory Syndrome (MERS) occurring in two separate
countries or regions during a given year. For example, in 2014, two
international travelers on commercial flights from the Middle East
arrived in the United States while infected with MERS and two
international travelers on commercial flights from West Africa arrived
while infected with Ebola. Regardless of the infectious disease
scenarios faced by HHS/CDC in a given year, this final rule should
improve HHS/CDC's ability to mitigate infectious diseases in the
future. To the extent that the final rule would lead to improved
responsiveness of airlines and vessel operators to HHS/CDC traveler
data requests via manifest orders, HHS/CDC may become better able to
respond to infectious diseases threats and (1) reduce case-loads during
infectious disease outbreaks, (2) reduce public anxiety during disease
outbreaks, (3) mitigate economic impacts on businesses as a consequence
of reduced public anxiety, and (4) reduce the amount of personnel labor
time to conduct large-scale contact investigations in response to a new
infectious disease or one with serious public health and medical
consequences like Ebola.
Table 2--Summary of Monetized and Qualitative Benefits and Costs of the Final Rule
[2015 USD]
----------------------------------------------------------------------------------------------------------------
Most likely Lower bound Upper bound Source citation (RIA,
Category estimate estimate estimate preamble, etc.)
----------------------------------------------------------------------------------------------------------------
BENEFITS
----------------------------------------------------------------------------------------------------------------
Annual monetized routine benefits $12,218 $0 $12,218 RIA.
from reduced effort by CDC and
health department to search for
exposed contacts (0% discount rate).
Annual monetized routine benefits $97,828 $26,337 $272,958 RIA.
from reduced illness (0% discount
rate).
Total annual monetized routine $110,045 $26,337 $285,175 RIA.
benefits (0% discount rate).
------------------------------------------------
Qualitative (unquantified benefits). To the extent that airlines or vessel RIA.
operators have data available and improve
responsiveness of airlines and vessel
operators to HHS/CDC traveler data requests
results from the implementation of the
provisions in this final rule, HHS/CDC may
become better able to respond to infectious
diseases threats and (1) reduce case-loads
during infectious disease outbreaks, (2)
reduce public anxiety during disease
outbreaks, (3) mitigate economic impacts on
businesses as a consequence of reduced public
anxiety, and (4) reduce the amount of
personnel labor time to conduct large-scale
CIs in response to a new infectious disease or
one with serious public health and medical
consequences like Ebola.
----------------------------------------------------------------------------------------------------------------
COSTS
----------------------------------------------------------------------------------------------------------------
Annual monetized costs for changes $0 $0 $376,554 RIA.
to illness reporting (airlines and
vessel operators, 0% discount rate)
*.
Annual monetized costs for changes $12,654 $0 $25,308 RIA.
to codification of manifest order
process (airlines and vessel
operators), 0% discount rate) *.
Annual monetized costs for $19,968 $10,959 $28,977 RIA.
additional activities by health
department contacting individuals
exposed to communicable diseases
during international travel (0%
discount rate).
Total annual monetized routine costs $32,622 $10,959 $430,839 RIA.
(0% discount rate).
------------------------------------------------
[[Page 6935]]
Annual quantified, but unmonetized, None RIA.
costs.
------------------------------------------------
Qualitative (unquantified) costs.... None RIA.
----------------------------------------------------------------------------------------------------------------
The second analysis in this final rule is of a number of provisions
that aim to improve transparency of how HHS/CDC uses its regulatory
authorities to protect public health. These changes are not intended to
provide HHS/CDC with new regulatory authorities, but rather to clarify
the agency's standard operating procedures and policies with regard to
pre-existing regulations in 42 CFR parts 70 and 71 including due
process rights for individuals under Federal orders. HHS/CDC believes
that improving the quality of its regulations by providing clearer
explanations of its policies and procedures is an important public
benefit. However, HHS/CDC is not able to attach a dollar value to this
added benefit in a significant way.
Economic Baseline
Regulated Entities: Airlines and Vessel Operators
The group of entities that may be affected by this final rule would
include international and interstate aircraft operators, vessel
operators, travelers, State or local health departments and the Federal
government agencies that interact with these groups. Since this final
rule primarily updates regulatory requirements to better match current
practice, the economic impacts are marginal changes to current practice
that result from codification of current practices.
The North American Industry Classification System (NAICS) is used
by Federal statistical agencies in classifying business establishments
for the purpose of collecting, analyzing, and publishing statistical
data related to the U.S. business economy. A summary of the total
numbers of each entity is summarized in Table 3.
Table 3--Summary of the Number of Firms Engaged in Interstate and International Air and Maritime Travel
----------------------------------------------------------------------------------------------------------------
Number of
NAICS codes NAICS description firms in
industry
----------------------------------------------------------------------------------------------------------------
481111............................... Scheduled Passenger Air Transportation................... 264
481112............................... Scheduled Freight Air Transportation..................... 212
481219............................... Other Nonscheduled Air Transportation.................... 516
483111............................... Deep Sea Freight Transportation.......................... 191
483112............................... Deep Sea Passenger Transportation........................ 54
483113............................... Coastal and Great Lakes Freight Transportation........... 337
483114............................... Coastal and Great Lakes Passenger Transportation......... 110
483211............................... Inland Water Freight Transportation...................... 318
483212............................... Inland Water Passenger Transportation.................... 193
----------------------------------------------------------------------------------------------------------------
Statistics of U.S. Businesses, 2013 U.S. all industries.\15\
2012 North American Industry Classification System (NAICS).\16\
According to a report by the Federal Aviation Administration, in
2012, U.S. civil aviation-related economic activity generated $1.5
trillion and supported 11.8 million jobs with $459.4 billion in
earnings.\17\ In 2015, the domestic U.S. market for air travel included
696 million passengers and the international market included another
198 million travelers.\18\
---------------------------------------------------------------------------
\15\ http://www.census.gov/econ/susb/.
\16\ https://www.census.gov/cgi-bin/sssd/naics/naicsrch.
\17\ U.S. Department of Transportation, Federal Aviation
Administration (January 2015) The Economic Impact of Civil Aviation
on the U.S. Economy: Economic Impact of Civil Aviation by State.
http://www.faa.gov/air_traffic/publications/media/2015-economic-impact-report.pdf (Accessed 5/2/2016).
\18\ Bureau of Transportation Statistics T-100 Market data.
http://www.transtats.bts.gov/Data_Elements.aspx?Data=1 (Accessed 5/
2/2016).
---------------------------------------------------------------------------
In 2011, there were approximately 11 million North American cruise
ship passengers spending 71.8 million passenger nights on board
vessels. The cruise ship market was highly concentrated with four firms
accounting for 98% of the total market.\19\ In total, approximately 18
million travelers enter the United States each year via cruise or cargo
ships.\20\
---------------------------------------------------------------------------
\19\ U.S. Department of Transportation Maritime Administration
(March 2012) North American Cruise Statistical Snapshot, 2011 http://www.marad.dot.gov/wp-content/uploads/pdf/North_American_Cruise_Statistics_Quarterly_Snapshot.pdf (Accessed 5/
2/2016).
\20\ According to the U.S. Department of Homeland Security,
54,236 passengers and crew arrive via vessel each day, which
correspond to approximately 18 million per year. https://www.transportation.gov/policy/aviation-policy/us-international-air-passenger-and-freight-statistics-report Accessed on 5/2/2106.
---------------------------------------------------------------------------
The domestic/international air carrier market is an ever-shifting
corporate landscape. Both U.S. and foreign airlines engage in ``code-
sharing'' arrangements, whereby the marketing carrier places its call
sign (or code) on the operating carrier's flight. For purposes of this
rule, reporting duty would require the operating carrier to report on
all passengers and crewmembers, whether traveling on the operator's
code or another carrier's.
The complexity of the domestic/foreign airline-corporations' legal
and financial arrangements makes it very difficult to ascertain exactly
how each and every domestic and foreign airline would be affected by
the implementation costs associated with this final rule; presumably,
some of the costs might be passed along to the carrier putting its code
on the operating carrier, pursuant to the particular terms of each
applicable contract.
[[Page 6936]]
Under this final rule, the operator of any airline operating a
flight arriving into the United States must make certain contact
information described below available within 24 hours of a request by
HHS/CDC, to the extent that such data are available to the operator.
This requirement also applies to the operator of any vessel carrying 13
or more passengers (excluding crew) and, which is not a ferry as
defined in under 46 U.S.C. 2101 and U.S. Coast Guard (USCG) regulations
(46 CFR 2.10-25). This requirement is a codification of current
practice, and applies to any of the data elements that the airline or
vessel operator may have available and authorizes the airline or vessel
operator to transmit the contact information in any format and through
any system available and acceptable to both the airline and HHS/CDC.
Again, because this is a codification of current practices, HHS/CDC
assumes airlines and vessel operators will continue to submit data
through current mechanisms, although HHS/CDC will accept others that
are mutually acceptable.
To simplify the analysis and to develop conservative cost
estimates, HHS/CDC assumed that all costs to airlines and vessel
operators would be passed along to U.S.-based airlines, vessel
operators, or U.S. consumers.
Diseases Affected by the Rule
HHS/CDC has gathered statistics, or reported information on, a
number of notifiable and quarantinable diseases (Table 4) that form the
basis for estimates of quantitative and qualitative benefits. The final
rule provides CDC with the authority to take certain actions with
regard to both quarantinable and non-quarantinable diseases. For non-
quarantinable diseases, efforts would be primarily limited to early
identification and notification of exposed individuals and transmission
of contact data to local and State health departments. For
quarantinable diseases, efforts could include issuance of Federal
orders for quarantine, isolation, or conditional release of exposed/
infected individuals.
Table 4--Diseases Analyzed
------------------------------------------------------------------------
Non-quarantinable Quarantinable
------------------------------------------------------------------------
Measles Tuberculosis.
Pertussis Viral Hemorrhagic Fevers.
Rabies Middle East Respiratory Syndrome
Meningococcal disease Coronavirus (MERS).
Varicella
Rubella
------------------------------------------------------------------------
In addition, these diseases for which HHS/CDC currently issues
manifest orders and conducts contact investigations can also be
subdivided to identify those encountered with some frequency (routine
diseases): Tuberculosis, measles, meningococcal disease, pertussis and
rubella. Among these diseases, only tuberculosis is a quarantinable
disease. The second class is a group of new or emerging diseases, or
diseases with serious public health and medical consequences, that are
not currently prevalent, but are foreseeable as a future threat, e.g.,
severe acute respiratory syndromes (including SARS and MERS), Ebola.
This second group only includes quarantinable diseases, which may be
updated in the future by Executive Order, but which are not being
updated as a part of the final rule. Although HHS/CDC may help identify
travelers ill with or exposed to measles, meningococcal disease,
pertussis, rubella, rabies, and varicella, HHS/CDC does not have the
authority to place any travelers with such illnesses or exposures under
Federal orders. For quarantinable diseases, illness reporting could
lead to issuance of Federal orders if travelers are reasonably believed
to be infected with a quarantinable communicable disease in a
qualifying stage. Such restrictions would not occur based simply on an
illness report by airline or vessel operator staff and would require a
medical assessment by a public health professional.
Contact Investigations and Diseases--Interstate and International
The number of travelers exposed to an index case that are subject
to a contact investigation (CI) varies by disease and may include only
the two passengers sitting adjacent to the index case (meningococcal
disease or pertussis) or as much as the entire aircraft (e.g., initial
investigations of cases of MERS or Ebola) (Table 5). The entire
aircraft or vessel may be subject to CI if the disease is new and
transmission patterns are not well understood (e.g., MERS) or if the
disease is felt to have serious medical or public health consequences
(e.g., Ebola). Some CIs are only initiated for long-duration travel
(e.g., tuberculosis for flights of 8 hours or longer). For other
diseases (e.g., measles, MERS), CIs are undertaken regardless of
duration.
The table also includes criteria to be considered a contact for
persons exposed on vessels. In contrast to air contact investigations,
most maritime contact investigations are undertaken before travelers
disembark from vessels. Another difference between air and maritime
contact investigations is that varicella contact investigations are
frequently undertaken among maritime travelers on vessels, but are not
pursued for air travelers. In addition, HHS/CDC has not yet had to
conduct a contact investigation for Middle East Respiratory Syndrome or
viral hemorrhagic fever for travelers exposed on vessels. The criteria
listed in Table 5 are current as of October 2016, but may be updated in
the future based on reviews of the effectiveness of contact
investigations. For example, HHS/CDC stopped providing contact data to
health departments for mumps investigations after reviewing evidence of
the effectiveness of mumps contact investigations.
Table 5--Contact Investigation Criteria by Disease, PHD Follow Up
----------------------------------------------------------------------------------------------------------------
Persons contacted, Persons contacted, Recommended
Disease CI initiated if aircraft vessels activities
----------------------------------------------------------------------------------------------------------------
Ebola (Quarantinable)........... All cases......... All passengers and Cruise vessel--any Monitoring for 21
crew as of April passenger or crew days after last
2016. In the who made have potential
future, the come into contact exposure.
recommendation with the index
may change to case's body
include fewer fluids while the
passengers and index case was
crew. symptomatic.
Cargo vessel--all
on board the
vessel while the
index case was
symptomatic.
[[Page 6937]]
Measles (Non-quarantinable)..... All cases if Passengers seated Direct face-to- Offer MMR
notification within 2 rows face contact or vaccination if
received within either direction shared confined non-immune and
21 days of flight. of the index space >1 hour <72 hrs. since
case, all babies- with symptomatic exposure; immune
in-arms, crew in case-patient. globulin if
same cabin. All indicated and
passengers and within 6 days of
crew on flights exposure.
with <50 seats.
Meningo-coccal disease (Non- Case meets the Passengers or crew Cruise vessels-- Post-exposure
quarantinable). definition of sitting directly Cabin mates of or chemoprophylaxis.
meningococcal to the left and potential for
disease within 14 right of the direct contact
days of travel. index case or with oral or
For air travel: with potential respiratory
Flight >8 hrs. for direct secretions of
(or shorter contact with oral case-patient
flights if direct or respiratory during the 7 days
exposure secretions. prior to symptom
reported). onset until 24
hours after
implementation of
effective
antimicrobial
therapy.
Cargo vessels--All
on board the
vessel during the
7 days prior to
symptom onset of
case-patient
until 24 hours
after
implementation of
effective
antimicrobial
therapy.
New or reemerging influenza All cases during All passengers and All crew and Monitoring for 10
viruses (Quarantinable). early stages of crew. passengers. days after last
international potential
spread. exposure;
possible
serologic
testing.
Pertussis (Non-quarantinable)... All cases if Passengers sitting Direct face-to- Post-exposure
notification is next to index face contact or chemoprophylaxis.
received within case. shared confined
21 days of travel. space >1 hour
with symptomatic
case-patient.
Rubella (Non-quarantinable)..... All cases if Passengers seated Direct face-to- Serologic testing
notification is within 2 rows + face contact or and guidance for
received within crew in same shared confined pregnant women.
60 days of travel. cabin. All space >1 hour
passengers and with symptomatic
crew on flights case-patient.
with <50 seats.
Severe Acute Respiratory All cases......... SARS-Coronavirus: Cruise vessel--any Monitoring for 10-
Syndromes (Quarantinable). All passengers passenger or crew 14 days after
and crew. who had direct last potential
MERS: All face-to-face exposure;
passengers and contact or shared potential
crew contacted confined space >1 serologic
during 2014 CIs. hour with testing.
Future CIs will symptomatic case-
include patient.
passengers seated Cargo vessel--all
within 2 rows of on board the
index case. vessel while the
index case was
symptomatic.
TB (Quarantinable).............. Notification Passengers seated Cargo vessel: All Aircraft: Testing
received within 3 within 2 rows. crew members for latent TB
months of travel, within 3 months infection; chest
clinical criteria of diagnosis who radiograph if the
met For air worked with case- LTBI test is
travel: Flight >8 patient. positive.
hrs. Cruise vessel: Vessels: Clinical
Passenger travel assessment for
companions or symptoms and
crew working in chest radiograph.
close proximity/
sharing living
quarters.
Varicella (Non-quarantinable)... All cases on NA................ Any person who has Varicella
vessels. had >=5 minutes vaccination if
of direct face-to- unvaccinated/non-
face contact with immune and <3
a varicella case days since
during the exposure
infectious period. (possibly up to 5
days). High-risk
contacts
evaluated
Varicella Zoster
immune globulin
if <10 days after
exposure.
----------------------------------------------------------------------------------------------------------------
The Quarantine Activity Reporting System (QARS), which contains,
among other data, information collected under OMB Control Numbers 0920-
0134, 0920-0488, 0920-0821, and 0920-0900, is a web-based and secure
electronic system that supports collection of data for ill persons on
inbound or interstate flights and vessels and at land border crossings;
infectious disease threats, and follow-up actions. Currently, HHS/CDC
Quarantine Stations at U.S. ports of entry are using the system to
record their daily activities. All CIs undertaken by HHS/CDC are
documented in QARS.
CIs for international flights from January 2010 through December
2015 are summarized in Table 6. More than half (73.2%) were initiated
as a result of tuberculosis cases. Measles is the next most common
disease (20.8%). The remaining 6% are subdivided across rubella,
pertussis, meningococcal
[[Page 6938]]
disease and other diseases. This table also includes CIs undertaken for
MERS.
Table 6--International Air Contact Investigations, Average Number of Annual Investigations and Contacts by
Disease, Jan 2010 Through Dec 2015
[QARS data] a
----------------------------------------------------------------------------------------------------------------
Average Average
Disease Total Total contacts investigations contacts per Percent of
investigations per year year total contacts
----------------------------------------------------------------------------------------------------------------
Influenza, avian.............. 0 0 0.0 0.0 0.0
MERS Coronavirus \b\.......... 2 270 0.3 45.0 1.7
Measles....................... 94 3,381 15.7 563.5 20.8
Meningococcal disease......... 8 9 1.3 1.5 0.1
Other......................... 3 97 0.5 16.2 0.6
Pertussis..................... 11 18 1.8 3.0 0.1
Rabies........................ 3 4 0.5 0.7 0.0
Rubella....................... 17 532 2.8 88.7 3.3
TB (clinically active)........ 318 11,928 53.0 1,988.0 73.2
Viral hemorrhagic fever....... 7 53 1.2 8.8 0.3
---------------------------------------------------------------------------------
Total..................... 463 16,292 77.2 2,715 ..............
----------------------------------------------------------------------------------------------------------------
\a\ In May 2011, CIs were discontinued for international outbound flights. To give a better picture of what CIs
will look like under this new protocol, flights from January 2010 to May 2011 have been excluded from the
above-reported counts. In addition, CIs for mumps have been discontinued. Prior to discontinuation, there were
approximately 25 contacts per year investigated for mumps.
\b\ For these CIs, contact information for the entire flight was required.
In rare instances, a disease is ruled out after a CI has happened.
HHS/CDC also requests traveler contact data to support contact
investigations for travelers exposed to infectious diseases on
interstate flights. The numbers of investigations and contacts during
2010-15 are summarized in Table 7. In contrast to international
flights, very few contact investigations for tuberculosis were
undertaken on interstate flights, because most interstate flights do
not meet the 8-hour time requirement for tuberculosis contact
investigations (Table 5). The majority of contacts were investigated
after exposure to measles cases (76%) followed by MERS (8.4%) and viral
hemorrhagic fevers including Ebola (8.0%).
Table 7--Interstate Air Contact Investigations, Average Number of Annual Investigations and Contacts by Disease,
January 2010 through December 2015
[QARS data]
----------------------------------------------------------------------------------------------------------------
Average number
Total of Average number Percent of
Disease investigations Total contacts investigations of contacts total contacts
per year per year
----------------------------------------------------------------------------------------------------------------
Measles....................... 72 3033 12.0 505.5 76.1
Meningococcal disease......... 1 1 0.2 0.2 0.0
MERS Coronavirus \a\.......... 2 334 0.3 55.7 8.4
Other......................... 0 0 0.0 0.0 0.0
Pertussis..................... 43 83 7.2 13.8 2.1
Rabies........................ 3 3 0.5 0.5 0.1
Rubella....................... 8 172 1.3 28.7 4.3
TB (clinically active)........ 2 40 0.3 6.7 1.0
Viral hemorrhagic fever....... 4 319 0.7 53.2 8.0
---------------------------------------------------------------------------------
Total..................... 135 3,985 22.5 664.2
----------------------------------------------------------------------------------------------------------------
Notes:
\a\ For these CIs, contact information for the entire flight was required.
In rare instances, a disease is ruled out after a CI has happened.
The numbers of contacts for maritime contact investigations are
summarized in Table 8. For maritime investigations, the majority of
contacts were investigated for varicella (~79%) followed by
tuberculosis (~13%) and measles (~6%). Most of the varicella and
measles contact investigations were initiated while travelers were
still on vessels. Besides the investigations listed in Table 8,
gastrointestinal illness cases on cruise vessels carrying 13 or more
passengers are reported to HHS/CDC's Vessel Sanitation Program and
cases of Legionnaires' disease are reported directly to HHS/CDC's
Respiratory Diseases Branch.
[[Page 6939]]
Table 8--Maritime Passenger Data Collection, Average Number of Annual Contacts by Disease
[January 2010-December 2015]
----------------------------------------------------------------------------------------------------------------
Average number
Total of Average number Percent of
Passengers per voyage investigations Total contacts investigations of contacts total contacts
per year per year
----------------------------------------------------------------------------------------------------------------
Measles....................... 5 288 0.83 48 6.3
Meningococcal disease......... 3 22 0.5 3.67 0.5
MERS Coronavirus **........... 0 0 0 0 0.0
Other......................... 1 9 0.17 1.5 0.2
Pertussis..................... 3 14 0.5 2.33 0.3
Rabies........................ 0 0 0 0 0.0
Rubella....................... 2 26 0.33 4.33 0.6
TB (clinically active)........ 50 585 8.3 97.5 12.8
Viral hemorrhagic fever....... 0 0 0 0 0.0
Varicella (chickenpox) \a\.... 206 3,627 34.3 604.5 79.3
---------------------------------------------------------------------------------
Total..................... 270 4,571 45 761.8 100.0
----------------------------------------------------------------------------------------------------------------
\a\ One CI for varicella involved entire crew of the vessel (1224).
Traveler Manifest Orders for Airlines
Contact tracing is most effective at reducing cases of communicable
disease at the early stages of a potential outbreak as soon after
initial exposure as possible. Therefore, if an efficient contact system
is not in place when the first ill travelers arrive, the benefits of
contact tracing are greatly diminished.
Contact data requests only occur after a case of serious
communicable disease (index case) is reported in a person who traveled
on a commercial airline or vessel while contagious. This type of
situation necessitates identifying and locating travelers seated near
the index case in order to conduct a CI.
At present, HHS/CDC uses a multi-step process to obtain traveler
contact information from airlines. HHS/CDC issues a written order to
the airline that requires the airline to provide HHS/CDC with contact
information about the index case and traveler contacts. The order cites
current regulatory language in 42 CFR 71.32(b), as authorized by 42
U.S.C. 264. HHS/CDC requires that the airline provide it with the
traveler's first and last name, seat number, two phone numbers and
email address. HHS/CDC instructs airlines and vessel operators to
provide data when available or to report when data are unavailable. The
time it takes for HHS/CDC to obtain the available traveler contact data
can range from a few hours to a few days. From 2010 through May 2015,
about 70% of manifests from airlines arrived within 3 days of the
request, 15% arrived between 3 and 6 days after a request, 15% arrived
after more than six days, and nine requests took more than a month or
were never received by HHS/CDC.
At present, HHS/CDC requests that airlines and vessels provide
available traveler contact data within 24 hours for ``urgent'' manifest
requests. In current practice, requests for contact data are only
considered ``non-urgent'' for contact investigations in which travelers
had rubella (for which there is no available prophylaxis) or
tuberculosis or for situations in which HHS/CDC is not notified of
travelers diagnosed with some communicable diseases until after a
certain amount of time during which prophylaxis would be effective
(e.g., for measles: 6 days). If the analysis is limited to diseases
where requests for traveler contact data are marked ``urgent'' by HHS/
CDC (measles, meningococcal disease, MERS, viral hemorrhagic fevers,
and rabies), performance improved such that 51% arrived within 24 hours
of a request, 33% arrived between 1-3 days after a request, 13% between
3-6 days and only 3% arrived after 6 days. HHS/CDC notes that there may
be instances where CDC may not have included the correct information in
a manifest order (e.g., flight number or port of entry). The provision
of incorrect flight information may have caused delay submission in
some of the instances cited above.
While HHS/CDC requires that all information be provided upon first
order for information, HHS/CDC has consistently seen that the
information provided by a majority of airlines appears limited to
frequent flyer information, or other limited contact information.
Overall, the completeness of data provided by airlines varied such that
airlines generally fell into two categories. Some airlines always
provided only the passenger name and seat number. Other airlines would
provide some additional contact information for passengers. However,
even among these airlines, contact data for some of the passengers only
included names and seat numbers. Considering all requests from 2014, at
least one additional piece of contact information was provided for only
about 39% of passengers. If the sample were restricted to only flights
for which any contact information was provided (1,270 out of 2,411
total passengers), the fraction of passengers with at least one piece
of contact information beyond name and seat number increased from 39%
to 73.9%. This contact information would include U.S. address for 41.7%
of passengers and one phone number for 45% of passengers. As a result
of HHS/CDC's use of available information and technology and its
partnerships with other Federal agencies, contact tracing of exposed
travelers can now be accomplished more rapidly than would be possible
if only the contact data provided by airlines were used. However, if
airlines or vessel operators have additional data relative to what is
currently provided to DHS, the efficiency of contact investigations
could improve.
Change to Definition of an ``Ill Person''
HHS/CDC is updating the definition of ``ill person'' in 42 CFR 70.1
and 71.1 to better facilitate identification of communicable diseases
of public health concern aboard flights and voyages. However, HHS/CDC
currently requests that aircraft and vessels report several of the
symptoms included in the revised definition of ill person. Besides
aircraft and vessel operators, quarantine stations also receive illness
reports from U.S. Customs and Border Protection, U.S. Coast Guard,
State and local health departments, and health facilities. These
reports are not included in this analysis, which focuses on reporting
during travel.
HHS/CDC has crafted the definition of ``ill person'' in such a way
that it should
[[Page 6940]]
be understood by non-medically trained crewmembers and used to discern
illnesses of public health interest that HHS/CDC would like to be made
aware of according to 42 CFR 70.4 from those that it does not (e.g.,
common cold), while more closely aligning the definition with the
symptoms reporting guidelines published by ICAO in Note 1 to paragraph
8.15 of Annex 9 to the Convention on International Civil Aviation. To
further assist flight crewmembers (and vessel crewmembers under part
71) in identifying individuals with a reportable illness, HHS/CDC
provides the following in-depth explanations and examples of the
communicable diseases that such signs and symptoms might indicate. Note
that these explanations also apply to the definition of ``ill person''
under part 71 and are discussed in the preamble of this final rule.
The current illness reporting requirements for interstate travel
are summarized in 42 CFR 70.4 and state that ``The master of any vessel
or person in charge of any conveyance engaged in interstate traffic, on
which a case or suspected case of a communicable disease develops
shall, as soon as practicable, notify the local health authority at the
next port of call, station, or stop, and shall take such measures to
prevent the spread of the disease as the local health authority
directs.'' Communicable disease is defined in 42 CFR 70.1 as
``illnesses due to infectious agents or their toxic products, which may
be transmitted from a reservoir to a susceptible host either directly
as from an infected person or animal or indirectly through the agency
of an intermediate plant or animal host, vector, or the inanimate
environment.''
Thus, the changes in this final rule would amount to fewer illness
reports than may be anticipated under the current regulation. However,
in practice, according to CDC guidance available at http://www.cdc.gov/quarantine/air/reporting-deaths-illness/guidance-reporting-onboard-deaths-illnesses.html, the symptoms requested for international and
interstate illness reporting are the same subset. In addition,
according to guidance, reports received by HHS/CDC would be considered
sufficient to satisfy the requirement to report to local health
departments since HHS/CDC would coordinate any response activities with
the local health department after receipt of the illness report.
This final rule would align the definition from CDC guidance with
regulatory text by requiring reports of ill travelers with fever and
persistent cough, persistent vomiting, difficulty breathing, headache
with stiff neck, decreased consciousness, travelers appearing obviously
unwell, or unexplained bleeding. In practice, the codification of such
guidance may increase costs to some or all airlines and vessel
operators who submit illness reports based only upon symptoms currently
identified in 42 CFR 71.1 and not based on HHS/CDC guidance. For
illness reports from aircraft, DOT/FAA may also incur additional costs
if the number of illness reports made by aircraft pilots in command to
air traffic control and reported to HHS/CDC via the Domestic Events
Network increases.
For aircraft, the updated definition better aligns with symptoms
reporting guidelines published by ICAO in Note 1 to paragraph 8.15 of
Annex 9 to the Convention on International Civil Aviation. Therefore,
HHS/CDC does not anticipate much additional burden on airlines and
vessel operators to report ill travelers during travel.
Although HHS/CDC estimates the net change will be no cost to
airline or vessel operators, it may be possible to examine the
potential increase using simple assumptions. Table 9 shows the number
of reports by pilots in command during flights and recorded in HHS/
CDC's Quarantine Activity Reporting System (QARS). These include
reports of illness that fit the illness definition specified in current
42 CFR 71.1, reports based on HHS/CDC's guidance for airlines and
vessel operators, reports made based on the guidelines in Note 1 to
paragraph 8.15 of Annex 9 to the Convention on International Civil
Aviation, or illness reports unrelated to current regulation or
guidance. Such reports can also be subdivided into reports requiring
HHS/CDC response (``response reports'') and reports that HHS/CDC
receives, but which do not require an HHS/CDC response (``info-only
reports''). Info-only reports may include symptoms included in HHS/CDC
guidance, but for which the underlying condition can easily be
diagnosed not to be a communicable disease of public health concern
(e.g., influenza-like illness on an aircraft). Info-only reports can
also be based on illnesses not requested by HHS/CDC guidance (e.g.,
motion sickness).
Table 9--Total Numbers of Reports Made During Flight by Aircraft Operators, 2011 to 2015
[HHS/CDC QARS data]
----------------------------------------------------------------------------------------------------------------
Reports not
Based on based on
symptoms Based on symptoms
Year Category included in symptoms included in Total
current included in either current
regulation final rule regulation or
final rule
----------------------------------------------------------------------------------------------------------------
2015......................... Info-only....... 30 55 43 128
Response........ 33 22 15 70
2014......................... Info-only....... 33 61 42 136
Response........ 19 36 12 67
2013......................... Info-only....... 31 46 29 106
Response........ 21 25 4 50
2012......................... Info-only....... 34 58 38 130
Response........ 12 18 2 32
2011......................... Info-only....... 27 39 25 91
Response........ 25 29 13 67
------------------------------------------------
Average, Info-only............................. 31 51.8 35.4 118.2
Average Response............................... 22 26 9.2 57.2
Average, total................................. 53 77.8 44.6 175.4
----------------------------------------------------------------------------------------------------------------
In addition to illness reports, HHS/CDC receives an average of 10 death reports during air travel each year.
Since death reporting requirements are not changing, these are not analyzed.
[[Page 6941]]
Table 9 shows that HHS/CDC already receives a number of reports
based on symptoms included in HHS/CDC guidance that will be codified
with this final rule. On average, among the total 175 illness reports
per year, about 78 annual reports are based on symptoms included in the
final rule, but not in current regulations compared to 53 reports based
on symptoms already listed in current regulations. The remaining 45
reports would include those based on fever alone or based on symptoms
not included either in current regulatory text or in this final rule.
The number of illness reports from master of vessels during voyages
is summarized in Table 10. Compared to the breakdown in reports for
aircraft, the vast majority of illness reports during voyages are for
response as opposed to info-only. There may be greater specificity in
reports from cruise vessels because of the presence of medical officers
onboard vessels. On average, there were about 208 reports requiring
follow-up and 10.6 info-only reports each year. In contrast to reports
from aircraft, most of the reporting for vessels pertains to symptoms
included in the current regulation (175 per year) as opposed to those
specified in this final rule (32 per year). Very few reports from
vessels (3.4 per year) were based on fever only or based on symptoms
not included in either current regulation or specified in this final
rule.
Table 10--Total Numbers of Illness Reports (Excluding Influenza-Like Illness) Made During Voyage by Masters of
Vessels, 2011 to 2015
[HHS/CDC QARS data]
----------------------------------------------------------------------------------------------------------------
Reports not
Based on based on
symptoms Based on symptoms
Year Type of report included in symptoms included in Total
current included in either current
regulation final rule regulation or
final rule
----------------------------------------------------------------------------------------------------------------
2015................. Info-only............... 5 4 4 13
Response................ 179 21 1 201
2014................. Info-only............... 6 3 3 12
Response................ 168 21 12 201
2013................. Info-only............... 1 1 3 5
Response................ 145 48 11 204
2012................. Info-only............... 5 7 3 15
Response................ 167 19 1 187
2011................. Info-only............... 1 3 4 8
Response................ 196 32 19 247
------------------------------------------------
Average, Info-only............................. 3.6 3.6 3.4 10.6
Average Response............................... 171 28.2 8.8 208
Average, total................................. 174.6 31.8 12.2 218.6
----------------------------------------------------------------------------------------------------------------
In addition to the illness reports reported in the table, HHS/CDC receives about 115 reports of death during
maritime travel each year. In addition, HHS/CDC requests, but not require reporting of influenza-like-illness
from cruise vessels (also not included in above table).
Baseline Contact Investigation Process for Routinely Imported Diseases
This section reports the primary steps of CIs for routine diseases:
A traveler (the index case) is identified as ill either
during the flight or voyage with a reportable illness or after with a
notifiable disease. The aircraft pilot in command or master of vessel
may report the illness directly to HHS/CDC. Illnesses on aircraft may
also be reported indirectly to HHS/CDC via air traffic control. The FAA
then passes the report to CDC through the Domestic Event Network. If
the report occurs after travel, a healthcare facility would then report
the illness either to HHS/CDC or public health departments (PHDs).
If CI criteria are met, HHS/CDC contacts the airlines for
[cir] a manifest to determine where the index case was seated in
relation to other passengers or crew members,
[ssquf] HHS/CDC then requests information available from DHS'
databases to verify or obtain passenger contact information not
included in the manifest.
[ssquf] If data are not available in DHS databases, HHS/CDC will
require (as part of the manifest order) for the airlines to provide any
available traveler contact information. The number of travelers for
which contact data will be requested is based on the disease-specific
criteria listed in Table 5.
Once HHS/CDC has the traveler contact information and flight-
seating chart, the CI begins. Current CI procedures are cumbersome, in
part because of the difficulties associated with obtaining traveler
contact information. HHS/CDC staff may contact airlines more than once
to obtain traveler contact data including email address, one or two
phone numbers, and address in the United States for U.S. citizens and
permanent residents.
When passenger contact information is delayed or partial, State/
local public health departments are delayed in starting CIs and,
depending on the disease, this delay could make it impossible to
prevent illness and/or the transmission of disease. Further, PHDs could
have improved success contacting passengers with more accurate or
timelier data.
The model for estimating the benefits of CIs is: Current number of
CIs x (reduction in HHS/CDC and health department staff time/resources
per contact) x value of staff time.
The rest of this section reports both the quantifiable benefits
arising from streamlining the CI process and a discussion of health
benefits. The differential impacts of the various diseases make it hard
to summarize the final rule's effects given uncertainty around future
probabilities of case(s) of multiple such notifiable disease(s). The
timeliness of contact investigations could also be improved if
improvements in illness reporting led to earlier diagnoses of
communicable diseases.
Estimating the Number of Infected Travelers
Most air travelers with illness are not identified in flight, but
rather seek medical care and are identified as an
[[Page 6942]]
index case after their travel is completed. Compared to air travelers,
maritime travelers spend more time on vessels during voyages and
medical officers may be employed on cruise vessels.
When communicable diseases are diagnosed after travel, the medical
practitioner should notify HHS/CDC or a PHD if the diagnosed disease is
on either the list of quarantinable communicable diseases or the list
of notifiable diseases. If HHS/CDC can draw upon improved contact
information based on the codification of requests for traveler contact
data to aircraft and vessel operators as set forth in this final rule,
the risk of onward disease transmission can be reduced. By contacting
ill travelers more quickly, HHS/CDC may slow the spread and the
severity of the outbreak. The benefits therefore depend on:
How many infected travelers are expected to enter the
United States;
How many quarantinable or notifiable diseases are detected
either on-board the aircraft/vessel or reported to HHS/CDC by PHDs;
How many exposed travelers will become ill as a result of
exposure during travel;
How the infection will be transmitted within the U.S.
population;
How effective public health agency contact tracing will be
with and without the final rule.
In addition to improved efficiencies associated with more timely or
more complete provision of traveler contact data by airlines and vessel
operators, there may also be an increase in the number of reports of
ill travelers during travel that require HHS/CDC follow-up. Under the
most likely scenario, there will not be a change in these reports,
since the new definition better corresponds to reporting guidelines
published by ICAO in Note 1 to paragraph 8.15 of Annex 9 to the
Convention on International Civil Aviation and current HHS/CDC
guidance. However, there may be an increase in illness reports
depending on whether airlines and vessel operators increase reporting
for required rather than recommended symptoms.
Contact Investigations Supported by CDC and Undertaken by Partners at
State and Local Health Departments
The change to the definition of an ``ill person'' for the purposes
of illness reporting and the codification of HHS/CDC requests from
airlines and vessel operators for traveler contact data may improve
HHS/CDC's ability to respond effectively and mitigate infectious
disease outbreaks. There are a number of intermediate steps between
either an illness report or receiving more complete or timelier
traveler data and stopping an infectious disease outbreak. For example,
the travelers exposed to the infectious disease would have to be
contacted by health departments and comply with recommended public
health measures, which could include some form of public health or
medical follow up to mitigate their risk of becoming ill, or self-
monitoring/quarantine to mitigate the risk of transmitting that disease
to other individuals.
The amount of time HHS/CDC staff spend per air or maritime contact
varies with the size of the CI because some tasks are CI-specific, such
as filling out reports or obtaining manifests, and some are contact-
specific such as determining a specific traveler's contact information.
The CI-specific labor time costs less per contact when an investigation
includes more contacts, e.g., a manifest that takes 60 minutes of HHS/
CDC staff time to obtain for 2 contacts is the equivalent of 30
minutes-staff-time-per-contact while the same manifest listing 30
contacts is the equivalent of 2 minutes-staff-time-per-contact. On the
other hand, the traveler-specific time tends to increase-per-contact
with less information and decrease-per-contact with more
information.\21\ Further, the QARS system used to document and follow
up on CIs requires full-time personnel to maintain the system, pull
regular reports, and monitor follow-up of travelers contacted during
CIs. Finally, HHS/CDC has two full-time persons regularly assigned as
liaisons to DHS whose duties include gathering contact information from
DHS systems. Therefore, for HHS/CDC staff time to initiate and follow
up on different sized CIs, to track down traveler contact information
from multiple sources, to work with PHDs, document and report on CIs,
update and train in systems, and manage the staff involved in CIs, a
cost of $180 per contact is estimated. This is the equivalent of 2
hours of a HHS/CDC staff person's being paid the salary of a GS-13,
step 4 plus 100% for benefits and employee overhead costs (Table 11).
---------------------------------------------------------------------------
\21\ Margaret S. Coleman, unpublished data.
---------------------------------------------------------------------------
For PHD resources, HHS/CDC also estimated a cost-per-contact of
$180, which is consistent with HHS/CDC costs and a recent publication
adjusted to 2015 dollars.\22\ PHD processes vary greatly from State to
State and at the local level within a State. A couple of examples:
---------------------------------------------------------------------------
\22\ Coleman, M.S., Marienau, K.J., Marano, N., Marks, S.M.,
Cetron, M.S. (2014). ``Economics of United States tuberculosis
airline contact investigation policies: a return on investment
analysis.'' TMAID 12(1):63-71.
---------------------------------------------------------------------------
One State assigns 2 registered nurses (RNs) who perform 5
CIs or fewer per year for the entire State another State assigns 3 RNs,
a Public Health Service Medical Officer, a physician, and a data
analyst and conducts about 25 CIs a year.\23\
---------------------------------------------------------------------------
\23\ Personal communication from states to Dr. Margaret S.
Coleman 2010.
---------------------------------------------------------------------------
When one State receives information about passenger
contacts from HHS/CDC, the State epidemiologist creates several
documents to fax to the relevant county health departments, a team of
an epidemiologist and RNs at the county then either call or visit the
contacts if there is an address. But the State epidemiologist will make
every effort to locate travelers even if their final destination is
unclear.\24\
---------------------------------------------------------------------------
\24\ Discussion between Dr. Brian Maskery, Dr. Margaret S.
Coleman and State and County Health Department contacts 11/21/2014.
---------------------------------------------------------------------------
Finally, different diseases may elicit different levels of response
at the PHD level, with a more rapid response for highly infectious
diseases like measles that can be prevented with timely post-exposure
prophylaxis and a more measured response for less infectious diseases
like TB. By using the same cost for HHS/CDC and for PHDs, HHS/CDC
believes the potential reductions in cost from reduced effort for PHDs
to locate infectious disease contacts are conservatively estimated.
Table 11--Cost-per-Contact
------------------------------------------------------------------------
CDC PHD
------------------------------------------------------------------------
$180................................................... $180
------------------------------------------------------------------------
Infectious Disease Transmission During International Travel
For some diseases, there is empirical data from which onboard
transmission can be estimated. According to a published analysis of the
outcomes of measles contact investigations (74 case-travelers on 108
flights resulting in 3,399 contacts) in the United States between
December 2008 and December 2011, HHS/CDC could not assign 9% of measles
contacts (322) to a health department due to insufficient contact data.
Another 12% of these contacts (397) were believed to be outside the
United States.\25\ After HHS/CDC provides contact data to State health
departments, HHS/CDC requests, but does not require health departments
to
[[Page 6943]]
provide data on the outcomes of their attempts to follow-up with
travelers. Among the 2,673 contacts assigned to U.S. public health
departments in 2008-11, HHS/CDC only received outcome data for 1,177
out of the 2,673 assigned contacts. This outcome data included reports
from State health departments that 225 out of the 1,177 assigned
contacts could not be located (19%). Among the 952 contacts for which
HHS/CDC received measles outcome data from health departments, there
were 9 lab-confirmed measles cases (1%). Since there may be reporting
bias from health departments (i.e. health departments would be more
likely to report outcome data for contacts that developed measles than
for other exposed travelers that did not develop measles, HHS/CDC
considers a range of measles incidence rates among exposed travelers
from 9 cases/2,673 contacts assigned to health departments (0.34%) to 9
cases/952 exposed contacts with outcome data reported to HHS/CDC
(0.95%). This probability could overstate or understate the true
transmission rate depending on the length of the flight and seating
configuration. On the other hand, it may understate the probability if
cases were not reported or occurred overseas.
---------------------------------------------------------------------------
\25\ Nelson, K., Marienau, K.J., Schembri, C. and Redd, S.
(2013). ``Measles transmission during air travel, United States.''
Travel Medicine and Infectious Disease (2013) 11, 81e89 11: 81-89.
---------------------------------------------------------------------------
The majority of travelers exposed to measles on aircraft (~74%) had
pre-existing immunity based on past measles immunization, past measles
illness, or being born prior to 1957 and thus likely to have measles
immunity even if they do not recall experiencing the disease.\26\ Among
the 952 exposed travelers, 8 cases occurred in the 247 contacts (3.2%)
without known pre-existing immunity compared to 1 case in the 705
contacts with past history of vaccination or measles illness (0.1%).
The median age of measles cases in exposed air traveler contacts was
1.6 years.
---------------------------------------------------------------------------
\26\ Nelson, K., Marienau, K.J., Schembri, C. and Redd, S.
(2013). ``Measles transmission during air travel, United States.''
Travel Medicine and Infectious Disease (2013) 11, 81e89 11: 81-89.
---------------------------------------------------------------------------
Intervention by public health departments mitigates the risk of
measles transmission in two ways. First, exposed travelers without
measles immunity may be offered voluntary post-exposure prophylaxis
with measles-containing vaccine (within 72 hours) or immune globulin
(within 6 days),\27\ which can prevent onset of disease, halting
outbreaks before they begin. Under the status quo, relatively few
exposed travelers receive post-exposure prophylaxis (just 11 out of 248
travelers with no history of measles immunization or infection).
Second, exposed travelers would be counseled by health departments to
self-isolate and seek treatment if they started to experience symptoms
consistent with measles onset. For example infants exposed during
travel and too young to be vaccinated could arrange for special
precautions if they visit a pediatrician after becoming ill with
measles-like symptoms to minimize the transmission to other
unvaccinated infants. Both activities will limit the possibility of
measles transmission to family members or others in the community. The
attack rate for measles is estimated to be 90%, but the high background
immunization rate and high efficacy of measles vaccine attenuates the
burden of measles outbreaks in the United States.
---------------------------------------------------------------------------
\27\ Nelson, K., Marienau, K.J., Schembri, C. and Redd, S.
(2013). ``Measles transmission during air travel, United States.''
Travel Medicine and Infectious Disease (2013) 11, 81e89 11: 81-89.
---------------------------------------------------------------------------
In summary, the potential size of a measles outbreak occurring
depends on:
The number of persons contacted by the infectious measles
patient
Background immunity among persons contacted
[cir] Survey estimates have shown considerable heterogeneity in
background vaccination rates such that 80% of unvaccinated children
live in counties comprising 40% of the total population.\28\
---------------------------------------------------------------------------
\28\ Smith P, Marcuse E, Seward J, Zhao Z, WA O. Children and
Adolescents Unvaccinated Against Measles: Geographic Clustering,
Parents' Beliefs, and Missed Opportunities. Public Health Rep.
2015;5:485-504.
---------------------------------------------------------------------------
For tuberculosis, it is difficult to estimate the transmission rate
on an aircraft or vessel. A modeling study suggests that the risk of
infection is about 1/1000 on an 8.7 hour flight and that persons seated
closer to the index case are at greater risk of infection.\29\ Only 5-
10% of persons infected with the bacteria Mycobacterium tuberculosis
will go on to develop active, infectious disease and the risk of
progression is greatest within the first two years after infection.\30\
---------------------------------------------------------------------------
\29\ Ko G, Thompson KM, Nardell EA. Estimation of tuberculosis
risk on a commercial airliner. Risk Anal 2004;24:379e88.
\30\ Marienau KJ, Cramer EH, Coleman MS, Marano N, Cetron MS.
Flight related tuberculosis contact investigations in the United
States: comparative risk and economic analysis of alternate
protocols. Travel Med Infect Dis. 2014;12(1):54-62.
---------------------------------------------------------------------------
An analysis of the epidemiology and outcomes of HHS/CDC-led flight-
related tuberculosis contact investigations conducted in the United
States from January 2007 to June 2008 examined 131 case-travelers and
4,550 passenger-contacts.\31\ Among 3,375 (74%) passenger-contacts
whose information was provided to health departments, HHS/CDC received
results for 861 (26%). HHS/CDC found that 103/861 (12%) had a previous
history of a positive TB screening test result or treatment for latent
tuberculosis or active disease and were not re-tested. Of the remaining
758 passenger contacts, 182 (24%) tested positive. The majority of
travelers with data about TB risk factors (other than exposure to cases
during air travel) had at least one risk factor (130/142 or 92%). Risk
factors included having been born or lived in a country with high TB
prevalence (prevalence >100 per 100,000 population). Although
passenger-contacts with risk factors were more likely to have pre-
existing latent tuberculosis infection, the authors could not exclude
the possibility that infection was acquired during the flights when the
travelers were exposed. Furthermore, because outcomes data were
reported for only 26% of passenger contacts forwarded to U.S. health
departments (19% of all passenger contacts) the precise determination
of in-flight transmission risk of M. tuberculosis was not feasible.\32\
---------------------------------------------------------------------------
\31\ Marienau KJ, Burgess GW, Cramer E, et al. Tuberculosis
investigations associated with air travel: US Centers for Disease
Control and Prevention, January 2007-June 2008. Travel Med Infect
Dis 2010;8:104e12.
\32\ Marienau KJ, Burgess GW, Cramer E, et al. Tuberculosis
investigations associated with air travel: US Centers for Disease
Control and Prevention, January 2007-June 2008. Travel Med Infect
Dis 2010;8:104e12.
---------------------------------------------------------------------------
The results from this investigation were used in a cost-
effectiveness study to estimate the return on investment for
tuberculosis CIs. The authors examined a range of latent tuberculosis
prevalence rates among exposed travelers that varied between 19% and
24% for two different HHS/CDC CI protocols for flight-related TB
investigations. The return on investment was calculated based on the
likelihood that travelers with latent tuberculosis infection would
initiate and complete a treatment regimen to clear the infection, the
average cost of tuberculosis treatment, a tuberculosis case fatality
rate of 5% and a conservative value of statistical life estimate of
$4.2 million (in 2009 USD) to account for the value of mortality risk
reduction from avoided tuberculosis disease. The return on investment
depended on the probability assumed for persons with latent TB
infection to develop active disease (5-10%) and variation in the costs
to health departments to locate exposed travelers ($28 to $164). Using
the expected latent tuberculosis prevalence rate of 19% in travelers
identified for contact investigations on flights and a health
department cost per contact of $164, the return on investment was
estimated to
[[Page 6944]]
vary between $1.01 and $3.20. The return on investment formula was
calculated based on (Expected benefits-Expected costs)/Expected costs.
Thus, for each $1 in Federal and State resources spent on contact
investigations and offering treatment to persons infected with latent
tuberculosis infections would result in benefits in excess of costs
equal to $1.01 to $3.20 33 34 on average. At the upper bound
latent tuberculosis prevalence estimate (24%), the return on investment
was estimated to vary between $1.35 and $3.92.
---------------------------------------------------------------------------
\33\ Coleman M, Marienau K, Marano N, Marks S, Cetron M, Dis
TMI. Economics of United States Tuberculosis Airline Contact
Investigation Policies. Travel Medicine and Infectious Disease.
2014;12:63-71.
\34\ Marienau KJ, Burgess GW, Cramer E, et al. Tuberculosis
investigations associated with air travel: US Centers for Disease
Control and Prevention, January 2007-June 2008. Travel Med Infect
Dis 2010;8:104e12.
---------------------------------------------------------------------------
There is also empirical data for SARS infections occurring on an
aircraft. A study reported that 37 infections resulted from 40 flights
with infectious passengers on board. Of the 40 flights, four have
documented aircraft sizes. They average 127 passengers per plane.\35\
Therefore the on board transmission rate could be estimated to be 0.73%
among all travelers. In comparison, there is no evidence of
transmission of MERS Coronavirus or viral hemorrhagic fevers during
travel on aircraft or vessels. However, there have not been enough
observations to determine that there is no risk.
---------------------------------------------------------------------------
\35\ Mangili A, Gendreau MA. Transmission of infectious diseases
during commercial air travel. Lancet. 2005;365:989-96.
---------------------------------------------------------------------------
For the remainder of the diseases, empirical data does not exist.
Like measles, immunizations are recommended to prevent pertussis,
rubella, and meningococcal disease. Since meningococcal conjugate
vaccine was more recently added to the United States vaccination
schedule, it is likely that background immunity is much lower relative
to measles, rubella or pertussis.
In the absence of data for some diseases, the infection rate of
measles is used to estimate the infection rates by using the ratio of
basic reproduction numbers (R0). The basic reproduction
number is a measure of disease infectiousness. Specifically, it is an
estimate of new infections in a completely susceptible population. For
example, rubella has an R0 of 9 to 10 while measles has an
R0 of 15 to 17.\36\ The infection rate of measles is
multiplied (0.0034 to 0.0095) by the ratio of the average basic
reproductive numbers (9.5/16) to arrive at a transmission rate (0.002
to 0.006) for rubella on airplanes. This rate is approximately 60% of
the rate for measles. The estimated transmission rates for some
diseases are reported in Table 12. The exceptions are for meningococcal
disease and tuberculosis. For meningococcal disease, the risk of
transmission in household contacts 0.002 to 0.004 \37\ is used in the
absence of other data and taking account that CIs are only performed
for travelers sitting adjacent to the index case or in the event of
other known exposures. For tuberculosis, the probability that exposed
travelers have latent tuberculosis \38\ (19%-24%) is used, although
infection may have occurred prior to air travel. For the purposes of
evaluating the economic impact of tuberculosis investigations, it does
not matter if travelers were infected during travel or before.
---------------------------------------------------------------------------
\36\ Anderson RM. The concept of herd immunity and the design of
community-based immunization programmes. Vaccine. 1992;10(13):928-
35.
\37\ Chapter 14. Meningococcal Disease, The Pink Book, CDC
http://www.cdc.gov/vaccines/pubs/pinkbook/mening.html Accessed 5/2/
2016.
\38\ Marienau KJ, Burgess GW, Cramer E, et al. Tuberculosis
investigations associated with air travel: US Centers for Disease
Control and Prevention, January 2007-June 2008. Travel Med Infect
Dis 2010;8:104e12.
Table 12--Estimated Transmission Rate on Plane for Exposed Travelers
----------------------------------------------------------------------------------------------------------------
Estimated transmission rate on
aircraft to exposed passengers
Disease R0 ---------------------------------
Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Diphtheria (quarantinable)................ 11 to 14.......................... 0.0026 0.0074
Measles (non-quarantinable)............... 15 to 17.......................... 0.0034 0.0095
Meningococcal Disease (non-quarantinable). NA................................ <2/1000 <4/1000
Pertussis (non-quarantinable)............. 4 to 5............................ 0.001 0.003
Rubella (non-quarantinable)............... 9 to 10........................... 0.002 0.006
TB (quarantinable)........................ NA................................ 0.19 0.24
----------------------------------------------------------------------------------------------------------------
Estimated Number of Cases in Traveler Contacts
The number of potential contacts for each disease can be multiplied
by the estimated transmission rate by disease in Table 12 to generate a
rough estimate of the annual number of cases among traveler contacts.
These numbers of contacts for each disease are summarized in Tables 6
and 7 for interstate and international CIs respectively. Contact
investigations on vessels are excluded for this analysis. Based on this
analysis, tuberculosis (19 to 48) and measles cases (3.6 to 10.1) are
the most likely diseases that will be diagnosed among contacts exposed
during travel (Table 13). Tuberculosis contact investigations only
occur for international flights with the very rare exception of a
domestic flight with a duration greater than 8 hours. The numbers of
contacts and outcomes are much more uncertain for other diseases. The
number of tuberculosis cases are adjusted from the number of contacts
with tuberculosis by assuming that only 5% (lower bound) to 10% (upper
bound) of infected contacts will go on to develop clinical disease.\39\
---------------------------------------------------------------------------
\39\ Coleman M, Marienau K, Marano N, Marks S, Cetron M, Dis
TMI. Economics of United States Tuberculosis Airline Contact
Investigation Policies. Travel Medicine and Infectious Disease.
2014;12:63-71.
---------------------------------------------------------------------------
For viral hemorrhagic fevers and MERS, there is no evidence of
transmission, but there have not been very many observations.
[[Page 6945]]
Table 13--Annual Estimated Number of Cases Among International Passenger Contacts by Disease
----------------------------------------------------------------------------------------------------------------
Expected Expected
incidence incidence Expected Expected
Passengers per flight Number of among among number of new number of new
contacts contacts contacts cases (lower cases (upper
(lower bound) (upper bound) bound) bound)
----------------------------------------------------------------------------------------------------------------
MERS Coronavirus (quarantinable)... 101 Insufficient data
---------------------------------------------------------------
Measles (non-quarantinable)........ 1,069 0.0034 0.0095 3.6 10.1
Meningococcal Disease (non- 1.7 0.00200 0.00400 0.0033 0.0067
quarantinable)....................
Pertussis (non-quarantinable)...... 16.8 0.001 0.003 0.02 0.04
Rubella (non-quarantinable)........ 117 0.002 0.006 0.2 0.7
TB \a\ (quarantinable)............. 1,995 \b\ 0.19 \b\ 0.24 \c\ 18.9 \c\ 47.90
---------------------------------------------------------------
Viral Hemorrhagic Fever 62.0 Insufficient data
(quarantinable)...................
----------------------------------------------------------------------------
Total.......................... 3,362 .............. .............. 22.8 58.7
----------------------------------------------------------------------------------------------------------------
\a\ For tuberculosis, travelers contacts are typically found to test positive for infection, but do not have
active disease.
\b\ These probabilities indicate the likelihood that a contact will test positive for infection.
\c\ The expected numbers of cases adjust for the finding that only 5-10% of individuals that test positive for
infection will go on to develop clinical disease.
These estimates of cases may be a lower bound, because potential
cases resulting from flights in which contact investigations were not
performed are not included. Especially for tuberculosis cases, many
international travelers may return to their home countries before
seeking treatment and such cases may not lead to contact investigations
if HHS/CDC is not informed.
Marginal Costs of Final Rule
Data Collection
Since the final rule does not change the timeframe or amount of
data requested from airlines or vessel operators, the most likely
economic impact is a small change in the amount of effort for airlines
to provide more complete and timely information. To the extent that
airlines would respond more quickly or with additional data, it would
require some airline information technology staff to expedite requests
or to search in more depth for available data. HHS/CDC estimates this
may require one hour of staff time per request. HHS/CDC has no way to
predict how much more complete, timely, or accurate contact from
airlines would become as a result of this final rule. On average, HHS/
CDC acted upon 77 requests per year to airlines for international
traveler contact data between 2010 and 2015 (Table 6). In addition,
HHS/CDC made 22.5 requests per year for interstate traveler data (Table
7) over the same period. There were 45 contact investigations per year
among travelers on vessels (Table 8); however, most of these were
undertaken before travelers disembarked vessels in which case contact
data could be collected directly from exposed travelers as part of the
investigation. The number of maritime contact investigations requiring
manifest requests after disembarkation is estimated to be less than 10
per year.
Overall, including international air and maritime activities, the
estimated number of contact data requests after disembarkation was
estimated at 100 to account for the fact that HHS/CDC sometimes
requests traveler contact data for infectious disease events prior to
confirmed diagnoses. On occasion, it turns out that travelers are not
infected with diseases that require a public health response. This
rounding up should also account for a year in which there is a
significant increase in the number of contact investigations among
exposed air or maritime travelers. HHS/CDC notes the manifest order
process for interstate flights is not codified in the final rule. The
data is provided here for completeness.
The average wages for computer and information systems managers
(occupation code 11-3021) reported in the Bureau of Labor Statistics,
May 2015 Occupational Employment Statistics \40\ were $63.27 per hour.
On average, under the baseline, HHS/CDC assumes that it would require 6
hours of work by airlines to search databases and provide data. For the
final rule, HHS/CDC assumes that a management-level computer specialist
will spend additional time to provide the best possible contact data
for potentially exposed travelers. The base salary is multiplied by an
overhead multiplier of 100% to account for non-wage benefits and other
overhead costs for supporting each employee (Table 14). The lower bound
estimate ($0) is no change from current practice, while the upper bound
estimate assumes 2 hours of time instead of one ($25,308). These costs
are applied to an estimated 100 manifest requests per year.
---------------------------------------------------------------------------
\40\ http://www.bls.gov/oes/current/oes_nat.htm.
Table 14--Estimate of Costs for Airlines and Vessel Operators To Improve Compliance With HHS/CDC Requests for
Traveler Contact Data, 2015 USD
----------------------------------------------------------------------------------------------------------------
Increased
effort to
Average provide more Average hourly
number of complete or wage rate of Overhead
manifest timelier IT staff (2015 multiplier (%) Total cost
requests per passenger USD)
year contact data
(hrs.)
----------------------------------------------------------------------------------------------------------------
Baseline...................... 100 6 $63.27 100 $75,924
Best estimate................. 100 1 63.27 100 12,654
[[Page 6946]]
Lower bound................... 100 0 63.27 100 0
Upper bound................... 100 2 63.27 100 25,308
----------------------------------------------------------------------------------------------------------------
Illness Reporting Costs
When reports are received, public health officers at Quarantine
Stations perform case assessments, may request follow-up information,
and may consult with HHS/CDC medical officers to determine if
additional action such as a contact investigation, onboard response, or
notification to State and local health departments is warranted. Under
one assumed upper bound scenario, the change in the definition of ``ill
person'' included in the final rule could result in a 100% increase in
the number of info-only reports from airlines and a 25% increase from
vessels. On average, there are 129 info-only reports for aircraft and
vessels each year and these increases would correspond to an annual
increase of 119 info-only reports on aircraft and 3 info-only reports
on vessels (Table 15). If the average time for each report is estimated
to be 2 minutes for aircraft pilots in command or masters of vessels to
make the report, 10 minutes for a traveler to discuss the illness with
public health officer, and 60 minutes for HHS/CDC to document the info-
only report, the estimated cost of the additional reports can be
estimated based on the opportunity cost of time for each type of
personnel. In addition to the time required for aircraft pilots in
command and masters of vessels to make reports, the personnel in the
Department of Transportation's Federal Aviation Administration (DOT/
FAA) may incur additional costs to relay reports of suspected cases of
communicable disease received by air traffic control to CDC through the
Domestic Events Network. The amount of DOT/FAA staff time is estimated
at 26 minutes for a government employee at GS-level 15, step 6 based in
Washington, DC. In reality, there would be three DOT/FAA employees
involved including 1 GS-15/16 level employee at air traffic control (10
minutes), 1 GS-15 level employee at the Domestic Events Network (10
minutes), and 1 GS-14 level employee at DOT/FAA's Washington Operations
Center Complex (6 minutes).\41\
---------------------------------------------------------------------------
\41\ Personal communication between Dr. Brian Maskery and DOT/
FAA.
---------------------------------------------------------------------------
For aircraft pilots in command or masters of vessels (occupation
codes 53-2011 and 53-5021) and travelers (average across all
occupations code 00-0000), their opportunity cost is estimated from
Bureau of Labor Statistics, May 2015 Occupational Employment Statistics
\42\ based on the average salary of aircraft pilots or copilots ($57.35
per hour), traveler ($23.23 per hour) or vessel captain, mate, or pilot
($39.95 per hour). For HHS/CDC employees, the average wage rate is
based on the Federal government's general salary scale for a GS-12,
step 5 employee based in Atlanta, GA). Base salaries are multiplied by
an overhead multiplier of 100% to account for non-wage benefits and
other overhead costs for supporting each employee. Travelers do not
have overhead costs. The annual quantified costs of 122 additional
info-only reports would be $17,471.
---------------------------------------------------------------------------
\42\ http://www.bls.gov/oes/current/oes_nat.htm.
Table 15--Changes in Numbers of Info-Only Reports and Associated Costs for the Final Rule Upper Bound, 2015 USD
----------------------------------------------------------------------------------------------------------------
Amount of Estimated
Change in time required wage rate Overhead Estimated
Employee type number of info- per report (2015 USD per multiplier (%) cost
only reports (min) hr.)
----------------------------------------------------------------------------------------------------------------
Aircraft:
Aircraft Pilots or Copilots. 119 2 $57.35 100 $455
CDC employee................ 119 60 39.83 100 9,480
DOT/FAA employees........... 119 26 70.57 100 7,278
Traveler.................... 119 10 23.23 0 461
-------------------------------------------------------------------------------
Air total............... .............. .............. .............. .............. 17,213
Vessels:
Air or maritime conveyance .............. .............. .............. .............. ..............
officer....................
Captains, Mates, and Pilots 3 2 39.95 100 8
of Water Vessels...........
CDC employee................ 3 60 439.83 100 239
Traveler.................... 3 10 23.23 0 12
-------------------------------------------------------------------------------
Maritime total.......... .............. .............. .............. .............. 259
-------------------------------------------------------------------------------
Total costs, aircraft and .............. .............. .............. .............. 17,471
vessels....................
----------------------------------------------------------------------------------------------------------------
Notes: Assumes 100% increase in info-only reports from airlines and 25% from vessel operators.
[[Page 6947]]
Besides the possible change in costs of info-only reports, the
other potential change would be an increase in the number of reports
that require HHS/CDC follow-up. Under the most likely scenario, there
will not be a change in these reports since the new definition better
corresponds to HHS/CDC guidance and to reporting guidelines published
by ICAO in Note 1 to paragraph 8.15 of Annex 9 to the Convention on
International Civil Aviation. However, there may be an increase in the
number of reports requiring a response. Under this scenario, there may
be an increase in costs for air or masters of vessels to report
illnesses. The upper bound increase in reports requiring response is
assumed to be 50% of the average annual illness reports from airlines
and a 10% increase from vessels (refer to Tables 10 and 11 for baseline
number of reports): 29 reports per year on aircraft and 21 reports per
year on vessels. HHS/CDC assumes that the time required to submit
illness reports and for DOT/FAA staff to relay reports requiring
responses is the same as for info-only reports (2 minutes for pilots in
command and masters of vessels and 26 minutes for DOT/FAA to relay
reports, Table 16). Further, HHS/CDC assumes that travelers could spend
up to 60 minutes talking to HHS/CDC and/or State and local public
health officers for reports requiring response. The upper bound
estimate of total costs associated with the increase in the number of
illness reports requiring response is estimated to be $3,102.
There would likely be no change or a decrease in HHS/CDC costs
because earlier reporting would lead to a more efficient HHS/CDC
response relative to an alternative in which the illness was not
reported during travel, but instead was later reported by a public
health department to HHS/CDC. In addition, the public health response
to the illness would likely be more efficient because exposed travelers
could be contacted earlier. In rare situations, such travelers may
potentially be informed of their potential exposure at the gate after
disembarking the aircraft or vessel. Such actions should not result in
significant delays by holding travelers on board.
HHS/CDC did not include any training costs because the change in
the ``ill person'' definition in this final rule is consistent with the
internationally recognized and accepted illness reporting guidelines
published by ICAO for international travelers and represents a reduced
burden compared to the previous illness reporting regulations for
interstate travelers.
Table 16--Changes in Annual Numbers of Reports Requiring Response and Associated Costs for the Final Rule Upper
Bound, 2015 USD
----------------------------------------------------------------------------------------------------------------
Amount of Estimated
Change in time required wage rate Overhead Estimated
Employee type number of per report (2015 USD per multiplier (%) cost (2015
reports (min) hr.) USD)
----------------------------------------------------------------------------------------------------------------
Aircraft:
Aircraft Pilots or Copilots. 29 2 $57.35 100 $111
CDC employee................ 29 0 39.83 100 0
DOT/FAA employee............ 29 26 70.57 100 1,774
Traveler.................... 29 60 23.23 0 674
-------------------------------------------------------------------------------
Total................... .............. .............. .............. .............. 2,558
Vessels:
Captains, Mates, and Pilots 21 2 39.95 100 56
of Water Vessels...........
CDC employee................ 21 0 39.83 100 0
Traveler.................... 21 60 23.23 0 488
-------------------------------------------------------------------------------
Total................... .............. .............. .............. .............. 544
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 3,102
----------------------------------------------------------------------------------------------------------------
Notes: Assume 50% increase in air illness and a 10% increase in maritime illness reports requiring response
(international and interstate).
There may also be a one-time cost associated with updating training
to reflect the new regulatory text. As noted above, HHS/CDC reiterates
that the change to regulatory text is a codification of HHS/CDC
guidance and better aligns with international guidance (Note 1 to
paragraph 8.15 of Annex 9 to the Convention on International Civil
Aviation). Further for interstate travel, these changes result in
relaxed illness reporting compared to status quo regulatory text. Thus
any airlines using either ICAO or HHS/CDC guidance to support training
efforts for illness reporting should not need to change training
materials. At most, it may be necessary to clarify that some symptoms
that were previously requested are now required. However, for some
airlines or vessel operators, it may be necessary to revise training
materials.
The cost of training was estimated based on the number of pilots
and flight attendants and their average wage rates as reported in the
Bureau of Labor Statistics, May 2015 Occupational Employment
Statistics.\43\ HHS/CDC assumes that the opportunity cost of employee
time spent in training would be the primary cost as opposed to the cost
of developing training materials. As an upper bound, HHS/CDC assumed
the cost of training could be estimated based on assuming that all
employees would require 10 minutes of training to summarize the
changes. As noted above, since this change aligns regulatory text with
existing HHS/CDC and ICAO guidance documents, this change may not
result in a new training requirement for all airlines since some
presumably already use HHS/CDC guidance in training. This 10 minute
estimate does not necessarily mean all 230,000 pilots and flight
attendants each require 10 minutes of training. For example, 50% of
each could require 20 minutes of training, while the other 50% may
already conduct training in accordance with either CDC or ICAO
guidance. The total cost of the one-time change in training is about
$3.1 million. If this cost is annualized over 10 years, the average
annual cost depends on the discount rate assumed and varies from
$313,000 per year (7% discount rate) to $416,000 (0% discount rate).
These
[[Page 6948]]
results are summarized in Table 17. These costs (3% discount rate) are
added to the upper bound cost estimate for illness reporting. The lower
bound and best estimates are $0 since the changes to the definition
better align with existing CDC and ICAO guidance.
---------------------------------------------------------------------------
\43\ http://www.bls.gov/oes/current/oes_nat.htm.
Table 17--Estimated Costs for One-Time Training About Changes in Illness Reporting for Airlines, 2015 USD
----------------------------------------------------------------------------------------------------------------
Amount of
time required Estimated Estimated
Employee type Number of for training wage rate Overhead cost or
employees per employee (2015 USD per multiplier (%) benefit (2015
(minutes) hr.) USD)
----------------------------------------------------------------------------------------------------------------
Aircraft Pilots or Copilots..... 121,110 10 57.35 100 2,315,220
Flight attendants............... 108,510 10 22.46 100 812,465
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 3,127,685
----------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized cost over 10-year 3% discount rate........... $355,981 0% discount rate........... $416,179 7% discount rate........... $312,768
time horizon.
--------------------------------------------------------------------------------------------------------------------------------------------------------
The monetized annual costs resulting from the change in the
definition of ``ill person'' are summarized in Table 18. The benefits
in regard to reductions in communicable disease transmission are
summarized in a subsequent section.
Table 18--Best Estimate, Lower Bound and Upper Bound of the Changes in Annual Monetized Benefits and Costs as a
Result of the Change to the Reportable Illness Definition, 2015 USD
----------------------------------------------------------------------------------------------------------------
Best estimate Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Costs
----------------------------------------------------------------------------------------------------------------
Final Rule:
Aircraft.................................................... $0 $0 $375,751
Vessels..................................................... 0 0 802
-----------------------------------------------
Total................................................... 0 0 376,554
----------------------------------------------------------------------------------------------------------------
The total costs of the final rule are summarized in Table 19 and
include the costs of the change to the definition of an ``ill person''
and the codification of the requirement for airlines to provide
passenger contact data for the final rule.
Table 19--Total Costs and Benefits Resulting From Codification of Traveler Data Collection (71.4 and 71.5) and
Change to Definition of ``Ill Person'' (70.1 and 71.1)
----------------------------------------------------------------------------------------------------------------
Best estimate Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Costs
----------------------------------------------------------------------------------------------------------------
Final Rule:
71.4 and 71.5 Passenger data collection..................... $12,654 $0 $25,308
70.1 and 71.1 Change in definition of an ``ill person''..... 0 0 376,554
-----------------------------------------------
Total costs............................................. 12,654 0 401,862
----------------------------------------------------------------------------------------------------------------
Benefits From Streamlining the CI Process for Routinely Imported
Diseases
This section reports the benefits that HHS/CDC anticipates from
implementation of the final rule in avoiding the costs incurred
annually for CIs of infectious diseases. The model for estimating the
benefits of CIs is: Current number of CIs x (reduction in HHS/CDC and
health department staff time/resources per contact) x value of staff
time.
HHS/CDC obtained the total number of contacts traced (2,715 per
year, Table 6) for all diseases reported on international flights.
International flight data were extracted for this analysis because the
codification of the requirements to provide timelier and more complete
contact data is limited to international arrivals. In comparison, HHS/
CDC requests contact information for approximately 664 contacts per
year on interstate flights (Table 7). HHS/CDC also supports contact
investigations affecting an average of 762 contacts per year for
illnesses on board vessels (Table 8); however, many of these
investigations occur before travelers disembark vessels. By limiting
the analysis to contacts on international flights, HHS/CDC
conservatively estimates the potential benefits associated with this
final rule. HHS/CDC multiplied the average annual number of contacts on
international flights by the cost-per-contact for HHS/CDC and PHDs
(Table 11) to estimate the costs of CIs under the current baseline.
To estimate the benefits (Tables 20 and 21), HHS/CDC assumed a
percent reduction in staff time for CIs at HHS/CDC (0-3%) and PHD
levels (0-2%)
[[Page 6949]]
based on internal conversations with personnel directly involved in the
CI process. The reduction in staff time that would result from
implementation of this final rule would arise from the ability of HHS/
CDC to have a better starting point with which to provide traveler
contact data to State and local health departments as a result of the
receipt of more complete and timely traveler contact data from
airlines. The impact of codification is expected to be limited and
would depend on instances in which airlines have more data than what is
currently provided to DHS. Better data would improve HHS/CDC's ability
to transmit information to destination States more quickly and for
States to contact exposed travelers earlier. This would allow States to
start their investigations more quickly, contact more travelers faster
to conduct public health assessments and potentially offer preventive
medications or vaccines in a more timely fashion or to recommend self-
monitoring to mitigate onward transmission. In addition, it would be
less likely that HHS/CDC would send incorrect contact data to States.
With all of the preceding factors in mind, HHS/CDC estimated that the
final rule would reduce labor time by between 0% to 3% at HHS/CDC, and
0% to 2% at PHDs. The higher percentage of avoided costs at HHS/CDC
reflect reduced efforts by HHS/CDC to search for accurate contact data
for travelers due to untimely or inaccurate data. The lower percentage
of avoided costs at PHDs reflects a more diffuse (e.g., multiple local
PHDs in a State) infrastructure and the more labor-intensive tasks of
following up on individuals. These estimates are small because the
change is a clarification and codification of a current practice
authorized under broad statutory and regulatory authority rather than a
new regulatory requirement. In addition, the change to the definition
of ``ill person'' may lead to the earlier diagnoses of some travelers
with communicable disease, which may lead to earlier and more efficient
public health responses.
HHS/CDC annual costs to engage in international air, interstate
air, and maritime CIs are about $745,000 or roughly the equivalent of
3.8 HHS/CDC full-time employees (FTEs) at the wage level of GS-13, step
4 plus benefits and overhead (Table 21). The final rule should have the
greatest effect on the international air CIs. The annual reduction in
contact tracing costs from implementing the final rule (Table 22) for
HHS/CDC ranged from $0 to $14,661 based on a 0-3% reduction in effort
on international CIs. For PHDs, the reduction in costs ranged from $0
at the lower bound to $9,774 at the upper bound (Table 22).
Table 20--Annually for HHS/CDC and PHD: Baseline Costs
----------------------------------------------------------------------------------------------------------------
Annual number
contacts HHS/CDC PHD costs Total costs
----------------------------------------------------------------------------------------------------------------
HHS/CDC and PHD Baseline Costs (Current Practice)
----------------------------------------------------------------------------------------------------------------
International air contacts...................... 2,715 $488,700 $488,700 $977,400
Interstate air contacts......................... 664 119,520 119,520 239,040
Maritime contacts............................... 762 137,160 137,160 274,320
----------------------------------------------------------------------------------------------------------------
Total baseline costs........................ 4,141 745,380 745,380 1,490,760
Viral hemorrhagic fever, MERS, and SARS contacts 163 29,340 29,340 58,680
----------------------------------------------------------------------------------------------------------------
Table 21--Annual For HHS/CDC and PHDs: Baseline Costs, Final Rule Costs, Benefits With the Final Rule (Number
Contacts Annualized From January 2010 to December 2015), 2015 USD
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
HHS/CDC and PHD Baseline Costs (Current Practice)
----------------------------------------------------------------------------------------------------------------
Annual number HHS/CDC PHD
contacts
-----------------------------------------------------------------------
International contacts.................. 2,715 $488,700 $488,700
----------------------------------------------------------------------------------------------------------------
HHS/CDC and PHD Costs With the Final Rule
----------------------------------------------------------------------------------------------------------------
Estimated Costs for HHS/CDC After
Efficiency Improvement with Final
Rule
Estimated Costs for PHDs After
Efficiency Improvement with Final
Rule
-----------------------------------------------------------------------
0%, Lower bound 3%, Upper bound 0%, Lower bound 2%, Upper bound
-----------------------------------------------------------------------
International contacts costs assuming $488,700 $474,039 $488,700 $478,926
reduction in time (2,715)..............
----------------------------------------------------------------------------------------------------------------
Benefits From Implementing the Final Rule
----------------------------------------------------------------------------------------------------------------
HHS/CDC 0% and 3% Reduction in
effort
PHD (0% and 2% Reduction in
effort)
-----------------------------------------------------------------------
Benefits (Reduced costs)................ $0 $14,661 $0 $9,774
----------------------------------------------------------------------------------------------------------------
The best estimate of benefits are the midpoint of the lower bound
and upper bound estimates for both HHS/CDC and PHDs ($12,218). The
lower bound ($0) and upper bound estimates ($24,435) for both entities
are also reported in Table 22.
[[Page 6950]]
Table 22--Best Estimate, Lower Bound and Upper Bound of Benefits From Increased Efficiencies for HHS/CDC and
PHDs To Conduct Contact Investigations With Provision of Better Data From Airlines (Final Rule), 2015 USD
----------------------------------------------------------------------------------------------------------------
HHS/CDC
benefits PHD benefits Total
----------------------------------------------------------------------------------------------------------------
Best estimate................................................... $7,331 $4,887 $12,218
Lower bound..................................................... 0 0 0
Upper bound..................................................... 14,661 9,774 24,435
----------------------------------------------------------------------------------------------------------------
The total annual monetized benefits by stakeholder from the
potential reduced effort for contact investigations are summarized in
Table 23.
Table 23--Best Estimate, Lower Bound and Upper Bound of Benefits From Increased Efficiencies for HHS/CDC and
PHDs to Conduct Contact Investigations With Provision of Better Data From Airlines, 2015 USD
----------------------------------------------------------------------------------------------------------------
HHS/CDC PHD benefits,
benefits, USD USD Airlines, USD Total
----------------------------------------------------------------------------------------------------------------
Best estimate................................... $7,331 $4,887 $0 $12,218
Lower bound..................................... 0 0 0 0
Upper bound..................................... 14,661 9,774 0 24,435
----------------------------------------------------------------------------------------------------------------
Marginal Impact of Final Rule--Measles Health Outcome Benefits
On average, HHS/CDC identified 564 travelers exposed to measles
cases on international flights during 2010-2015 (Table 6). The final
rule may affect the cost for health departments to implement public
health measures in two ways: (1) Health departments may contact exposed
travelers more quickly and (2) health departments may be able to
contact a higher percentage of exposed travelers. For the first set of
travelers that are contacted earlier with the final rule than under the
status quo, the cost to both the contacted travelers and to health
departments should be less than under the status quo. For measles
contacts, earlier follow-up with public health departments should lead
to more travelers being offered voluntary measles vaccines within 72
hours. This would potentially reduce the cost of following up with
exposed travelers at which time health departments could offer to
administer immune globulin or health departments may monitor travelers
that have been located after the 72-hour window in which measles
vaccination would reduce their risk of developing symptomatic measles.
At present, very few travelers receive post-exposure prophylaxis, 11/
248 or 4.4%.\44\ In addition, health departments have implemented
quarantine (usually voluntary) for unvaccinated, high risk measles
exposures.\45\ HHS/CDC notes that measles is not a quarantinable
communicable disease under Federal regulations, but may be
quarantinable under a State's authorities. HHS/CDC also notes that
measles vaccine is recommended for all persons lacking immunity. Thus,
the costs of vaccination for exposed travelers as part of the contact
investigation may have been incurred at a later date if travelers'
health care providers recommended measles vaccination at a more routine
health care visit in the future.\46\ However, to be conservative, HHS/
CDC includes the full additional cost to administer such vaccines to
persons contacted.
---------------------------------------------------------------------------
\44\ Nelson K, Marienau K, Schembri C, Redd S. Measles
transmission during air travel, United States. Travel Medicine and
Infectious Disease (2013) 11, 81e89. 2013;11:81-9.
\45\ P Kutty, J Rota, W Bellini, SB Redd, A Barskey, G Wallace.
(2014) Manual for the Surveillance of Vaccine-Preventable Diseases:
Chapter 7 Measles. http://www.cdc.gov/vaccines/pubs/surv-manual/chpt07-measles.html Accessed 5/8/2016.
\46\ CDC (2015) Epidemiology and Prevention of Vaccine-
Preventable Diseases: Measles. http://www.cdc.gov/vaccines/pubs/pinkbook/meas.html Accessed 5/8/2016.
---------------------------------------------------------------------------
Among the contacts, HHS/CDC estimates that approximately 25% (141
contacts per year) cannot be located by public health departments
(Table 24), either because HHS/CDC cannot assign the contacts to health
departments or because the information provided by HHS/CDC is not
sufficient to enable health departments to locate contacts after
assignment from HHS/CDC. Among these contacts, HHS/CDC assumes that 10%
of all contacts (56) are not located because HHS/CDC cannot assign
contacts to State health departments due to insufficient data. For
these contacts, health departments would not incur any contact tracing
costs because such contacts would not be assigned. HHS/CDC assumes a
15% improvement from baseline as a result of this final rule (Table
24). This would result in 8.5 additional contacts per year assigned to
health departments for contact tracing. As shown in Table 11, HHS/CDC
estimates that health departments incur an estimated cost of $180 per
contact. The marginal cost incurred from this final rule for additional
measles contacts assigned to health departments would be $180 x 8.5 =
$1,530 per year (Table 25).
Table 24--Estimated Marginal Improvement in the Numbers of Measles Contacts Who Could Be Treated With Final Rule
----------------------------------------------------------------------------------------------------------------
Description n Reference
----------------------------------------------------------------------------------------------------------------
Average contacts per year for measles, (a).. 564 Table 6.
Estimated number of contacts for which HHS/ 56 Nelson et al. 2013.\47\
CDC cannot assign to a health department,
(b) = 10% x (a).
[[Page 6951]]
Estimated improvement in HHS/CDC's ability 8.5 Assumption.
to assign contacts to health department (c)
= 15% x (b).
Numbers of people who are not currently 141 Nelson et al. 2013.
contacted due to lack of contact
information, (d) = (a) x 25%.
Expected numbers of people who could be 21 Assumption.
contacted with final rule, (e) = (d) x 15%.
Among those contacted, 70% would have 15 Nelson et al. 2013 (Table 2).
evidence of measles immunity (f) = (e) x
70%.
Among those contacted, 30% may be 6 Nelson et al. 2013 (Table 2).
susceptible to measles (g) = (e) x 30%.
----------------------------------------------------------------------------------------------------------------
\47\ Nelson, K., Marienau, K.J., Schembri, C. and Redd, S. (2013). ``Measles transmission during air travel,
United States.'' Travel Medicine and Infectious Disease (2013) 11, 81e89 11: 81-89.
Table 25--Estimated Marginal Costs for Health Departments To Contact
Exposed Travelers and Offer Measles Post-Exposure Prophylaxis
(Vaccination), 2015 USD
------------------------------------------------------------------------
------------------------------------------------------------------------
Number of additional names sent to health department, 8.5
(c)....................................................
Additional cost per contact to health department to $180
search for and examine contacts (USD per contact) (h)..
Additional cost to health department to search for $1,530
contacts, total (USD), (i) = (c) x (h).................
MMR vaccine price per dose (USD) (j).................... $39
Vaccine administration (k).............................. $31
Estimated cost prophylactic measles vaccine per person $70
(USD), (l) = (j) + (k).................................
Number of individuals who may receive measles vaccine, 6
(g)....................................................
Cost of measles vaccination, total (USD) (m) = (g) x (l) $420
Total additional annual cost to follow up with more $1,950
contacts (USD), (i) + (m)..............................
------------------------------------------------------------------------
In addition, HHS/CDC assumes that the final rule could improve
health departments' abilities to contact 15% of those who could not be
currently contacted because of insufficient contact information (21
contacts per year). HHS/CDC does not have any data to measure the
magnitude of improvement and applies a range of 10% to 20% to calculate
lower and upper bounds. If airlines and vessel operators do not have
any additional data besides what is already transmitted to DHS, there
will be very little improvement. Among the 21 additional exposed
travelers that would be contacted, 70% of them (15 per year) are
expected to have measles immunity because they were born before 1957,
had history of measles, or received one or more doses of measles
vaccine. The remaining 6 travelers per year without proven measles
immunity would incur additional costs if they are vaccinated (vaccine
costs + vaccine administration, Table 25).
To be conservative, HHS/CDC assumes that all 6 exposed travelers
would be adults and would be vaccinated with the measles-mumps-rubella
(MMR) vaccine. The vaccine price for adults is estimated from the
Vaccines for Children vaccine price archives (July 2014 and July 2015)
\48\ based on the public sector price for the vaccine. Vaccine
administration costs are estimated from Healthcare Solutions' 2015
Physicians' Fee & Coding Guide (CPT 90471).\49\ Total costs resulting
from the final rule are summarized in Table 26.
---------------------------------------------------------------------------
\48\ http://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/archive.html Accessed 5/2/2016.
\49\ InGauge Healthcare Solutions. 2015 Physicians' Fee & Coding
Guide. Atlanta GA2013.
Table 26--Marginal Impact of Final Rule To Improve Contact Investigations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average
Additional names Addition contacts travelers provided Number of travelers probability that
Marginal cost for measles investigations provided to health reached by health post-exposure identified earlier contact is
departments departments prophylaxis infected
--------------------------------------------------------------------------------------------------------------------------------------------------------
$1,950.................................... 8.5 21 6 Unknown..................... 0.0035-0.0095
--------------------------------------------------------------------------------------------------------------------------------------------------------
In the absence of interventions by public health departments,
travelers infected with measles during international travel would be as
likely as any other individuals to spark a measles outbreak. In the
absence of HHS/CDC efforts to retrieve and transmit contact data,
public health departments would not be able contact travelers to offer
post-exposure prophylaxis and/or to recommend self-monitoring for
potential measles symptoms.
For measles in 2011, 16 outbreaks occurred leading to 107 cases. An
outbreak was defined based on 3 or more cases in a cluster.\50\ The
remaining 113 cases reported in 2011 resulted in one or two cases per
cluster. Thus, the probability that any individual measles index case
leads to an outbreak was between 16/(16+113) = 12.4% and 16/(16+57) =
20.1%. The lower bound represents an assumption that all of the 113
cases unassociated with outbreaks of 3 or more cases occurred in
clusters with just one case each. The upper bound represents a scenario
with 56 clusters of two cases each with one cluster with one case.
Thus, the probability that any individual measles case could spark an
outbreak of 3 or more cases is 12.4% to 20.1%. The
[[Page 6952]]
average cost to public health departments per measles outbreak is
$250,000 and the upper bound cost is $1 million.\51\
---------------------------------------------------------------------------
\50\ Ortega-Sanchez IR, Vijayaraghavan M, Barskey AE, Wallace
GS. The economic burden of sixteen measles outbreaks on United
States public health departments in 2011. Vaccine. 2012;32(11).
\51\ Ortega-Sanchez IR, Vijayaraghavan M, Barskey AE, Wallace
GS. The economic burden of sixteen measles outbreaks on United
States public health departments in 2011. Vaccine. 2012;32(11).
---------------------------------------------------------------------------
HHS/CDC assumes that the probability that a measles case resulting
from exposure during travel and that is not contacted by a public
health department is as likely as any other measles case to initiate a
measles outbreak of 3 or more cases, which occurs at an approximate
probability of 12.4% to 21.9%. The average cost to health departments
is $250,000 for each of these outbreaks and the average outbreak size
is about 7 cases (107 cases/16 outbreaks).
The estimated illness costs for measles are $300 ($86-$515) for
outpatient cases and $24,500 ($3,900-$45,052) for inpatient cases.\52\
The probability of hospitalization is estimated to be 44.3%.\53\ A
range of hospitalization rates is estimated based on 50% to 150% of
this base case estimate (22%-66%). The measles case fatality rate has
been estimated to be 0.2%.\54\ HHS/CDC assumes that the value of
statistical life is $9.4 million (range $4.3 million to $14.2 million).
This value is an estimate of the average willingness to pay to reduce
one's mortality risk by a small increment not an estimate of the value
of any specific person's life. For example if 1,000 people were willing
to pay $1,000 each to reduce their risk of death by 1/1,000, the value
of statistical life would be equal to $1,000/0.001 change in risk of
death = $1 million. Alternatively 1,000 people each experiencing a
mortality risk reduction of 0.001 would correspond to 1,000 people x
0.001 mortality risk reduction = 1 statistical life; 1,000 people each
willing to pay $1,000 = 1,000 x $1,000 = $1 million to avert that one
statistical death. Using these estimates, the average illness costs
associated with a measles case (Table 27) is about $30,000 ($9,500 to
$58,000).
---------------------------------------------------------------------------
\52\ Zhou F, Shefer A, Wenger J, Messonnier M, Wang LY, Lopez A,
et al. Economic Evaluation of the Routine Childhood Immunization
Program in the United States, 2009. Pediatrics. 2014;133:577-85.
\53\ Mason WH, Ross LA, Lanson J, Wright HT. Epidemic measles in
the postvaccine era: evaluation of epidemiology, clinical
presentation, and complications during an urban outbreak. Pediatr
Infect Dis J. 1993;12:42-8.
\54\ Centers for Disease Control and Prevention. Epidemiology
and Prevention of Vaccine-Preventable Diseases, 13th Edition--
Measles April 2015 http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/meas.pdf. Accessed 6/13/2016.
Table 27--Estimated Illness and Mortality Costs per Measles Case
----------------------------------------------------------------------------------------------------------------
Best estimate Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Outpatient cost, a..................................... $300 $86 $515
Inpatient cost, b...................................... $24,500 $3,943 $45,052
Hospitalization rate, c................................ 44.30% 22.0% 66.0%
Case fatality rate, d.................................. 0.2% 0.2% 0.2%
VSL, e................................................. $9,400,000 $4,300,000 $14,200,000
Total cost per case (b x c + a x (1-c) + d x e)........ $29,821 $9,535 $58,309
----------------------------------------------------------------------------------------------------------------
The estimated number of measles cases that will occur in contacts
exposed during travel (3.6 to 10.1) can be multiplied by the
probability of an outbreak with 3 or more cases (12.4% to 21.7%) to
estimate the expected number of outbreaks in the absence of public
health intervention to conduct contact investigations in exposed
travelers. For each outbreak, HHS/CDC assumes that an average of 6
additional cases occur with associated morbidity and mortality costs.
The estimated costs of measles outbreaks in the absence of contact
investigations for exposed travelers is presented in Table 28.
Table 28--Estimated Illness, Mortality, Public Health Response Costs Associated with Measles Outbreaks
----------------------------------------------------------------------------------------------------------------
Best estimate Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Estimated number of measles cases among contacts, a.... 6.85 3.6 10.1
Probability of measles outbreak, b..................... 17 12.4 21.9
Number of additional cases per outbreak, c............. 6 6 6
Estimated number of outbreaks, d = a x b............... 1.18 0.45 2.22
Estimated number of outbreak cases, e = a x b x c...... 7.06 2.68 13.29
Estimated health department costs per outbreak, f...... 250,000 250,000 250,000
Estimated health department costs, g = f x d........... 293,989 111,607 553,758
Average cost per case, h............................... 29,821 9,535 58,309
Estimated illness costs, I = h x e..................... 210,406 25,539 774,944
Estimated total costs, g + i........................... 504,395 137,146 1,328,703
----------------------------------------------------------------------------------------------------------------
HHS/CDC has not received any reports of large measles outbreaks
associated with measles cases in patients exposed during travel and
contacted by State or local public health departments. As a result,
HHS/CDC believes that when measles cases occur in contacts reached by
health departments, the probability of an outbreak is significantly
mitigated by pre-warning of exposure before disease outset. Given that
HHS/CDC estimates that health departments are able to reach
approximately 75% of contacts under the status quo, HHS/CDC assumes
that the risk of an outbreak has been reduced by at least 60% under the
status quo. Further, HHS/CDC assumes that the provisions in the final
rule further improve health departments' ability to prevent measles
outbreaks in cases that occur among travelers exposed during flights. A
modest improvement of 15% is assumed (range 10%-20%) resulting in
estimated benefits of about $45,000 ($8,000 to $159,000) in Table 29.
[[Page 6953]]
Table 29--Estimated Benefits Associated With Improvement of Measles Contact Investigations as a Result of This
Final Rule
----------------------------------------------------------------------------------------------------------------
Best estimate Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Estimated total costs without intervention, j = g + i.. $504,395 $137,146 $1,328,703
Estimated effectiveness of outbreak prevention 60% 60% 60%
baseline, k...........................................
Estimated cost of measles outbreaks under baseline, j x $201,758 $54,858 $531,481
(1-k).................................................
Estimated effectiveness of outbreak prevention with 69% 66% 72%
final rule, l.........................................
Estimated cost of measles outbreaks with final rule, m $156,363 $46,630 $372,037
= j x (1-l)...........................................
Estimated benefit associated with final rule, n = j-m.. $45,396 $8,229 $159,444
----------------------------------------------------------------------------------------------------------------
Marginal Impact on Tuberculosis Investigations
Although measles is not a quarantinable disease and tuberculosis is
a quarantinable disease, HHS/CDC's and health departments' approaches
to contact investigations are relatively similar. However, HHS/CDC may
issue isolation orders for individuals with active tuberculosis in some
situations, but would not have authority to issue isolation (or
quarantine orders) for individuals with measles. The expected benefits
associated with reduced tuberculosis morbidity and mortality of contact
investigations for exposed travelers are based on a previous analysis,
which estimated a return on investment of $1.01 to $3.20 for the
baseline situation in which an estimated 19% of exposed contacts are
found to have latent tuberculosis infection.\55\ The contact rate for
exposed tuberculosis contacts is probably higher than for measles
because the vast majority of tuberculosis contacts are exposed during
international travel as exposed to measles contacts, which are
approximately evenly divided between interstate and international
travel.
---------------------------------------------------------------------------
\55\ Coleman M, Marienau K, Marano N, Marks S, Cetron M, Dis
TMI. Economics of United States Tuberculosis Airline Contact
Investigation Policies. Travel Medicine and Infectious Disease.
2014;12:63-71.
---------------------------------------------------------------------------
The estimated costs to provide testing and treatment to contacts
that test positive for latent tuberculosis infection are estimated to
be $1,044 for infected contacts that complete a full course of
treatment and $591 for infected contacts that discontinue treatment
after 30 days.\56\ Following the assumptions in the article, an
estimated 28% of persons who test positive for latent tuberculosis
infection do not start treatment. An estimated 46% start and complete
treatment and the remaining 26% start, but do not complete treatment.
The authors estimated that the risk of progression to active
tuberculosis is reduced by 80% for those that complete treatment. The
authors assumed that there is no effect for individuals that start, but
do not complete treatment. HHS/CDC assumes that under the status quo
that health departments are able to contact 75% of exposed travelers
(based on the reported outcomes from measles contact
investigations).\57\
---------------------------------------------------------------------------
\56\ Coleman M, Marienau K, Marano N, Marks S, Cetron M, Dis
TMI. Economics of United States Tuberculosis Airline Contact
Investigation Policies. Travel Medicine and Infectious Disease.
2014;12:63-71.
\57\ Nelson K, Marienau K, Schembri C, Redd S. Measles
transmission during air travel, United States, December 1, 2008-
December 31, 2011. Travel Med Infect Dis. 2013;11(2):81-9.
---------------------------------------------------------------------------
The costs to provide treatment for latent tuberculosis infections
under the status quo are summarized in Table 30. In total, the costs
are almost $900,000 including about $720,000 to locate contacts and
about $180,000 to provide treatment to individuals with latent
tuberculosis infection.
Table 30--Baseline Estimated Costs To Conduct Tuberculosis Contact Investigations and To Provide Treatment
----------------------------------------------------------------------------------------------------------------
Number of Estimated cost
contacts per contact Estimated cost Notes
----------------------------------------------------------------------------------------------------------------
Estimated cost of contact 1,995 $360 $718,092 Number of contacts from
investigations. Table 13 and cost per
contact from Table 11.
Estimated number of contacts reached 1,496 NA .............. Estimated at 75% similar
by health departments (75%). to measles from Table
24.
Estimated number of contacts reached 284 NA .............. Estimated 19% of
by health departments and have latent contacts have LTBI
TB infection (19% of 75%). (Table 13).
Number of contacts that never start 79.6 0 0 28% of 284 contacts with
treatment (28%). LTBI.
Number of contacts that complete 130.8 1,044 136,506 46% of 284 contacts with
treatment (46%). LTBI.
Number of contacts that start, but not 73.9 591 43,677 26% of 284 contacts with
compete treatment, (26%). LTBI.
------------------------------------------------
Total cost........................ .............. .............. 898,275 ........................
----------------------------------------------------------------------------------------------------------------
The benefits associated with tuberculosis contact investigations
are estimated from a published article, which reported a range of $1.01
to $3.20. This analysis did not include the potential benefits from
reduced onward transmission of tuberculosis among averted cases,
potentially resulting in a conservative estimate of the return on
investment. The formula used to derive estimated benefits from the
return on investment (ROI) is Estimated Benefits = Estimated Costs x
ROI + Estimated Costs. The estimated benefits are $2.6 million and are
shown in Table 31 (range: $1.8 million to $3.8 million).
[[Page 6954]]
Table 31--Baseline Estimated Costs and Benefits for Tuberculosis Contact Investigations, 2015 USD
----------------------------------------------------------------------------------------------------------------
Best estimate Lower bound Upper bound Notes
----------------------------------------------------------------------------------------------------------------
Estimate costs for contact $898,260 $898,260 $898,260 Table 30.
investigations and treatment.
Return on investment from tuberculosis 1.91 1.01 3.20 Coleman et al.
contact investigations.
Estimated benefits.................... 2,613,936 1,805,502 3,772,691 = Cost x ROI + Costs.
----------------------------------------------------------------------------------------------------------------
The provisions in the final rule should result in a small increase
(assumed baseline of 10%, range: 5-15%) in the number of contacts
reached by health departments and offered treatment for latent
tuberculosis infection. This estimated improvement is less than that
assumed for measles because tuberculosis usually involves a much longer
period of latent infection prior to active disease; thus, tuberculosis
contact investigations are less time sensitive relative to measles
contact investigations. The estimated costs associated with this
marginal improvement to reach more contacts can be estimated by
multiplying the costs of providing latent tuberculosis ($180,000) by
this range of improvement (5%-15%) as shown in Table 32. This results
in marginal increased costs associated with the final rule of $18,000
(range: $9,000 to $27,000). The estimated benefits (Table 32)
associated with the final rule are $52,000 (range: $18,000 to
$114,000).
Table 32--Estimated Costs and Benefits for Tuberculosis Contact Investigations Associated With This Final Rule,
2015 USD
----------------------------------------------------------------------------------------------------------------
Best estimate Lower bound Upper bound Notes
----------------------------------------------------------------------------------------------------------------
Baseline contact investigation costs.. $718,080 $718,080 $718,080 ........................
Baseline latent tuberculosis treatment $180,180 $180,180 $180,180 Table 30 costs for
costs. latent tuberculosis
treatment and testing.
Estimated improvement in health 10% 5% 15% Assumed.
departments' abilities to contact
exposed travelers.
Estimated increased cost for latent $18,018 $9,009 $27,027 Estimated cost for
tuberculosis treatment under final improvement in contact
rule. rate as result of final
rule.
Estimated costs under final rule...... $916,278 $907,269 $925,287 Estimated baseline cost
+ increased cost as
result of final rule.
Estimated ROI......................... $1.91 $1.01 $3.20 Table 30.
Estimated benefits for final rule..... $2,666,368 $1,823,610 $3,886,204 = Cost x ROI + Costs.
Estimated costs associated with final $18,018 $9,009 $27,027. Calculated from the
rule. difference in costs for
the final rule--
Baseline costs.
Estimated benefits associated with $52,432 $18,108 $113,513 Calculated from the
final rule. difference in benefits
for the final rule--
Baseline benefits.
----------------------------------------------------------------------------------------------------------------
Total Costs and Benefits for Measles and Tuberculosis Contact
Investigations
The total costs for measles and tuberculosis contact investigation
activities are estimated by summing the costs and benefits of measles
contact investigations (Table 29) and tuberculosis contact
investigations (Table 32). The results are summarized in Table 33.
Table 33--Changes in Measles and Tuberculosis Contact Investigations Costs and Benefits Relative to Baseline,
2015 USD
----------------------------------------------------------------------------------------------------------------
Best estimate Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Final rule benefits.................................... $97,828 $26,337 $272,958
Final rule costs....................................... 19,968 10,959 28,977
----------------------------------------------------------------------------------------------------------------
Note: This table includes the sum of results in Tables 29 and 32.
Total Annual Benefits Resulting From Codification of Traveler Data
Collection (71.4 and 71.5) and Change to Definition of ``Ill Person''
(70.1 and 71.1) Leading to Improved Contact Investigations and Health
Outcomes for Measles and Tuberculosis
The total quantified benefits (Table 34) resulting from the
improvement of the quality and timeliness of traveler contact data or
the improvement of illness reporting is summarized by summing the
improved efficiency for HHS/CDC to provide contact data to health
departments and improved efficiency for health departments to contact
exposed travelers (Table 23) and the reductions associated with measles
and tuberculosis morbidity and mortality (Table 33).
[[Page 6955]]
Table 34--Total Annual Costs and Benefits Associated With Improved Efficiency Public Health Response Activities,
2015 USD
----------------------------------------------------------------------------------------------------------------
Best estimate Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Final rule benefits.................................... $110,045 $26,337 $297,393
Final rule costs....................................... 19,968 10,959 28,977
----------------------------------------------------------------------------------------------------------------
The benefits and costs associated with improved effectiveness of
contact investigations (Table 34) can be combined with the increased
costs to airlines, vessel operators, DOT/FAA, and HHS/CDC to submit and
respond to illness reports or to provide more timely and complete
traveler contact data for manifest requests (Table 19) to estimate the
total annual costs and benefits of the final rule (Table 35).
Table 35--Total Annual Costs and Benefits of the Final Rule, 2015 USD
----------------------------------------------------------------------------------------------------------------
Best estimate Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Final rule benefits.................................... $110,045 $26,337 $297,393
Final rule costs....................................... 32,622 10,959 430,839
----------------------------------------------------------------------------------------------------------------
Other Diseases (Besides Measles and Tuberculosis)
HHS/CDC does not have sufficient data to quantify the health impact
of contact investigations for pertussis, rubella, varicella (vessels
only), viral hemorrhagic fevers (including Ebola), MERS, or SARS. HHS/
CDC attempts to continuously update its contact investigation protocols
based on available evidence. In the past few years, HHS/CDC has stopped
requesting data to conduct mumps contact investigations \58\ and has
modified its protocol to reduce the number of tuberculosis contacts
investigated.\59\
---------------------------------------------------------------------------
\58\ Nelson KR, Marienau KJ, Barskey AE, Schembri C. No evidence
of mumps transmission during air travel, United States, November 1,
2006-October 31, 2010. Travel Medicine and Infectious Disease.
2012;10:165-71.
\59\ Marienau KJ, Cramer EH, Coleman MS, Marano N, Cetron MS.
Flight related tuberculosis contact investigations in the United
States: comparative risk and economic analysis of alternate
protocols. Travel Med Infect Dis. 2014;12(1):54-62.
---------------------------------------------------------------------------
Experience from interstate flight contact investigations suggest
that travelers may want to know when they have been exposed to
communicable diseases during flights. The first Ebola contact
investigation conducted in the United States occurred in October, 2014,
and found that 60 travelers out of 164 had no contact information on
the manifest that was provided by the airline. A second request was
made to the airline after it was announced to the media that the
airline had contacted over 800 travelers, including travelers who had
flown on the same plane subsequent to the flight with the Ebola. At
that time the airline was able to provide HHS/CDC more complete
information for all travelers.
It is likely that the need for CDC to put out media requests for
travelers to contact the Agency created a level of fear in the general
population that may not have been necessary if better contact data were
available. In addition, this fear may have led to non-health costs
(such as fear of airplane travel) that would have been mitigated if the
Agency were able to contact all passengers without the media request.
However, when HHS/CDC solicited public comment about perceived
willingness to pay to be contacted in the event of an exposure to a
communicable disease during, HHS/CDC only received a few public
comments, all of which indicated that they had zero willingness to pay
in the event of an exposure to a communicable disease.
In summary, improved alignment between regulatory text and HHS/
CDC's publicly available guidance should reduce compliance costs for
airlines and vessel operators while improving HHS/CDC's ability to
respond to public health threats associated with international and
interstate travel. To the extent that airlines and vessel operators
improve responsiveness to HHS/CDC traveler data requests, HHS/CDC may
become better able to respond to infectious diseases threats and (1)
reduce case-loads during infectious disease outbreaks, (2) reduce
public anxiety during disease outbreaks, (3) mitigate economic impacts
on businesses as a consequence of reduced public anxiety, and (4)
reduce the amount of personnel labor time to conduct large-scale CIs in
response to a new infectious disease or one with serious public health
and medical consequences like Ebola. HHS/CDC will make all reasonable
efforts to work with DHS/CBP via CDC's liaison located at the National
Targeting Center, as provided through internal Memorandum of
Understanding, to search and obtain data collected from their APIS and
PNR data sets prior to contacting airlines or vessel operators with
duplicate data requests.
Analysis of Alternatives
Traveler Contact Data Alternatives
For the less restrictive alternative, HHS/CDC assumes that the
process of requesting contact data from airlines and vessel operators
would be discontinued. Thus, the cost to provide such data can be
modeled as a benefit to airlines and vessel operators equal to their
costs under the baseline. For the more restrictive alternative, HHS/CDC
assumes that suspension of entry may be implemented for travelers from
countries experiencing widespread transmission of quarantinable
communicable diseases. HHS/CDC notes that suspension of entry would not
be considered for non-quarantinable diseases (refer to Table 4).
Specifically, HHS/CDC assumes that persons traveling from affected
countries are not permitted entry to the United States unless such
persons spend an amount of time equivalent to the incubation period for
the target disease at a location where they are not at risk of exposure
and are also screened for symptoms of the disease prior to travel to
the United States. During the 2014-2016 Ebola epidemic, travelers from
Liberia, Sierra Leone or Guinea would not be able to enter until 21
days in another country or within the affected country but separated
from others in a manner that excludes the possibility of interaction
with potentially infected individuals.
On average, HHS/CDC has conducted about 2.5 contact investigations
for viral hemorrhagic fevers and MERS coronavirus over the past six
years. HHS/CDC assumes that if suspensions
[[Page 6956]]
of entry may be in place, some fraction of these contact investigations
may not be conducted.
Thus, the cost to airlines and vessel operators to provide traveler
contact data would decrease for the less restrictive alternative
resulting in estimated benefits of $75,924. For the more restrictive
scenario, the costs are relatively similar as for the final rule except
for the reduction in cost associated with providing contact data for
2.5 investigations ($12,338 vs. $12,654) and calculating the cost
reduction of doing 2.5 fewer contact investigations each year ($1,898)
(Table 36).
Table 36--Estimate of the Costs and Benefits to Airlines and Vessel Operators To Provide Traveler Contact Data,
2015 USD
----------------------------------------------------------------------------------------------------------------
Less More
restrictive restrictive
Baseline Final rule alternative alternative
\a\ \b\
----------------------------------------------------------------------------------------------------------------
Baseline number of contact investigations....... 100 100 0 97.5
----------------------------------------------------------------------------------------------------------------
Costs
----------------------------------------------------------------------------------------------------------------
Best estimate................................... NA $12,654 $0 $12,338
Lower bound..................................... NA 0 0 0
Upper bound..................................... NA 25,308 0 24,802
----------------------------------------------------------------------------------------------------------------
Benefits
----------------------------------------------------------------------------------------------------------------
Best estimate................................... NA $0 $75,924 $1,898
Lower bound..................................... NA 0 75,924 1,898
Upper bound..................................... NA 0 75,924 1,898
----------------------------------------------------------------------------------------------------------------
\a\ The less restrictive alternative is less expensive than the status quo, because HHS/CDC does not request
data from airlines and attempt to provide data to health departments to follow up with exposed travelers.
\b\ The more restrictive alternative also could potentially reduce costs to airlines and vessel operators
because HHS/CDC would restrict travel to countries undergoing widespread transmission of quarantinable
communicable diseases such as viral hemorrhagic fevers, MERS or SARS.
Illness Reporting Alternatives
HHS/CDC examines two alternatives: A less restrictive alternative
in which HHS/CDC relaxes its regulatory authorities to make illness
reporting compliance voluntary rather than compulsory. Under the more
restrictive alternative HHS/CDC may enforce the current requirement
that airlines report all persons with communicable diseases to local
health departments in addition to reporting to HHS/CDC.
The current status quo for illness reporting is summarized in
Tables 9 and 10. Reports can be subdivided by illnesses that fit (1)
the ill person definition specified in current 42 CFR 71.1, (2) reports
based on HHS/CDC's guidance for airlines and vessel operators, or (3)
illness reports unrelated to current regulation or guidance. As shown
in Table 9, only about 53 out of 175.4 (30%) illness reports during air
travel appear to be based on symptoms included in the current
definition of an ill person in existing 71.1. The remaining 70% of
reports are based on symptoms currently requested by HHS/CDC, but not
required. In addition, only 67% of illness reports during air travel
require HHS/CDC response and follow-up. In comparison, illness reports
from vessels are much more likely to be based on the definition of ill
person as defined in current 71.1 (174.6/218.6 or 80%). In addition, a
much greater proportion of reports require an HHS/CDC follow-up (>95%).
This may result from differences in the types of illnesses observed on
vessels relative to aircraft or because of the presence of medical
officers on cruise vessels, who may be better able to identify
communicable diseases of public health concern during travel relative
to aircraft personnel.
If illness reporting were entirely voluntary, HHS/CDC assumes the
number of reports (both info-only and reports requiring response) would
decrease by 50% from both airlines and vessel operators (refer to
Tables 9 and 10) from the current status quo. HHS/CDC does not have any
data to estimate the magnitude of decrease in reporting. HHS/CDC
believes that both HHS/CDC and DOT/FAA would continue to maintain their
current infrastructure to effectively respond to public health
emergencies either on aircraft or vessels. Thus, relative to the status
quo, the primary impact of voluntary reporting would be reduced
incremental time costs for pilots in command and masters of vessels,
travelers, DOT/FAA, and HHS/CDC, especially for info-only illness
reports. This 50% reduction in illness reporting would generate
benefits from cost reductions for airlines and vessel operators, HHS/
CDC, travelers, and DOT/FAA of approximately $14,700 (Tables 37 and
38).
The adverse impact for the less restrictive alternative relative to
the baseline would be reduced capacity for HHS/CDC to respond quickly
to communicable disease threats occurring during travel. This is
analyzed in a subsequent section on the health impact of regulated
activities.
Table 37--Less Restrictive Alternative for Illness Reporting
[Effect on info-only reports, 2015 USD]
----------------------------------------------------------------------------------------------------------------
Change in Amount of time Estimated Estimated
Employee type number of info- required per wage rate Overhead benefit (cost
only reports report (min) (per hr.) multiplier (%) reduction)
----------------------------------------------------------------------------------------------------------------
Aircraft:
Aircraft Pilots or 60 2 $57.35 100 $229
Copilots.................
[[Page 6957]]
CDC employee.............. 60 60 39.83 100 4,780
DOT/FAA employees......... 60 26 70.57 100 3,670
Traveler.................. 60 10 23.23 0 232
---------------------------------------------------------------------------------
Air total............. .............. .............. .............. .............. 8,911
Vessels:
Captains, Mates, and 6 2 39.95 100 16
Pilots of Water Vessels..
CDC employee.............. 6 60 39.83 100 478
Traveler.................. 6 10 23.23 0 23
---------------------------------------------------------------------------------
Maritime total........ .............. .............. .............. .............. 517
---------------------------------------------------------------------------------
Total (Air + .............. .............. .............. .............. 9,428
Maritime)........
----------------------------------------------------------------------------------------------------------------
Assume 50% reduction in reports.
Table 38--Less Restrictive Alternative for Illness Reporting
[Effect on reports requiring response, 2015 USD]
----------------------------------------------------------------------------------------------------------------
Change in Amount of
number of time required Estimated Overhead Estimated
Employee type info-only per report wage rate multiplier (%) benefit (cost
reports (min) (per hr.) reduction)
----------------------------------------------------------------------------------------------------------------
Aircraft:
Aircraft pilots or 29 2 $57.35 100 $111
copilots.................
CDC employee.............. 29 0 39.83 100
DOT/FAA employee.......... 29 26 70.57 100 1,774
Traveler.................. 29 60 23.23 0 674
---------------------------------------------------------------------------------
Total................. .............. .............. .............. .............. 2,558
Vessels:
Captains, mates, and 104 2 39.95 100 277
pilots (masters) of
vessels..................
CDC employee.............. 104 0 39.83 100
Traveler.................. 104 60 23.23 0 2,416
---------------------------------------------------------------------------------
Total................. .............. .............. .............. .............. 2,693
---------------------------------------------------------------------------------
Total (Air + .............. .............. .............. .............. 5,251
Maritime)........
----------------------------------------------------------------------------------------------------------------
Notes: Assume 50% reduction in air illness reports and 15% of maritime illness reports (response, international
and interstate).
Under the more restrictive alternative, HHS/CDC would require
duplicate illness reporting both to HHS/CDC and to local health
departments with jurisdiction upon arrival for interstate flights and
voyages. This alternative is based upon the existing regulatory text
under 42 CFR 70.4. HHS/CDC assumes that 50% of illness reports occur
during interstate (relative to international) air travel and that 15%
of maritime illness reports occur during interstate travel. The time
required for pilots in command and masters of vessels is assumed to be
about 4 minutes. This duration is greater than the amount of time
estimate for reporting to HHS/CDC because pilots in command and masters
of vessels may have to search for contact information for local health
departments and because local health departments may have less
experience dealing with illness reports than HHS/CDC. The costs to
airlines and vessel operators is estimated to be $848 per year (Table
39). Since HHS/CDC would coordinate responses to illness reports with
local health departments under the status quo, there are no additional
costs or benefits to requiring duplicative reports to local health
departments. These costs would be added to the costs of the changes
resulting from the final rule.
Table 39--More Restrictive Alternative (Illness Reporting in Duplicate to HHS/CDC and to Local Health
Departments), 2015 USD
----------------------------------------------------------------------------------------------------------------
Change in Amount of Estimated
number of time required wage rate Overhead Estimated
Employee type info-only per report (2015 USD per multiplier (%) cost ($2015
reports (min) hr.) USD)
----------------------------------------------------------------------------------------------------------------
Aircraft pilots or copilots..... 88 4 $57.35 100 $673
[[Page 6958]]
Captains, mates, and pilots 33 4 39.83 100 175
(masters) of vessels...........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 848
----------------------------------------------------------------------------------------------------------------
The total costs and benefits associated with the more and less
restrictive illness reporting scenarios as compared to the final rule
are summarized in Table 40.
Table 40--Best Estimate, Lower Bound and Upper Bound of the Changes in Annual Monetized Benefits and Costs as a
Result of the Change to the Reportable Illness Definition, 2015 USD
----------------------------------------------------------------------------------------------------------------
Best estimate Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Costs
----------------------------------------------------------------------------------------------------------------
Final Rule:
Aircraft.................................................... $0 $0 $375,751
Vessels..................................................... 0 0 802
-----------------------------------------------
Total................................................... 0 0 376,554
Less Restrictive Alternative: \a\
Aircraft.................................................... 0 0 0
Vessels..................................................... 0 0 0
-----------------------------------------------
Total................................................... 0 0 0
More Restrictive Alternative:
Aircraft.................................................... 673 673 376,424
Vessels..................................................... 175 175 978
-----------------------------------------------
Total................................................... 848 848 377,402
----------------------------------------------------------------------------------------------------------------
Benefits
----------------------------------------------------------------------------------------------------------------
Final Rule:
Aircraft.................................................... 0 0 0
Vessels..................................................... 0 0 0
-----------------------------------------------
Total................................................... 0 0 0
Less Restrictive Alternative: \a\
Aircraft.................................................... 11,469 11,469 11,469
Vessels..................................................... 3,210 3,210 3,210
-----------------------------------------------
Total................................................... 14,679 14,679 14,679
More Restrictive Alternative:
Aircraft.................................................... 0 0 0
Vessels..................................................... 0 0 0
-----------------------------------------------
Total................................................... 0 0 0
----------------------------------------------------------------------------------------------------------------
\a\ For the less restrictive scenario, the current reporting requirement is relaxed leading to a reduction in
costs.
The total costs of the alternatives compared to the final rule are
summarized in Table 41 and include the costs of the change to the
definition of an ``ill person'' and the codification of the requirement
for airlines to provide passenger contact data for the final rule, the
less restrictive alternative, and the more restrictive alternative.
Table 41--Total Costs and Benefits Resulting From Codification of Traveler Data Collection (71.4 and 71.5) and
Change to Definition of ``Ill Person'' (70.1 and 71.1)
----------------------------------------------------------------------------------------------------------------
Best estimate Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Costs
----------------------------------------------------------------------------------------------------------------
Final Rule:
71.4 and 71.5 Passenger data collection..................... $12,654 $0 $25,308
[[Page 6959]]
70.1 and 71.1 Change in definition of an ``ill person''..... 0 0 376,554
-----------------------------------------------
Total costs............................................. 12,654 0 401,862
Less Restrictive Alternative:
71.4 and 71.5 Passenger data collection..................... 0 0 0
70.1 and 71.1 Change in definition of an ``ill person''..... 0 0 0
-----------------------------------------------
Total costs............................................. 0 0 0
More Restrictive Alternative:
71.4 and 71.5 Passenger data collection..................... 12,338 0 24,802
70.1 and 71.1 Change in definition of an ``ill person''..... 848 848 377,402
-----------------------------------------------
Total costs............................................. 13,186 848 402,204
----------------------------------------------------------------------------------------------------------------
Benefits
----------------------------------------------------------------------------------------------------------------
Final Rule:
71.4 and 71.5 Passenger data collection..................... 0 0 0
70.1 and 71.1 Change in definition of an ``ill person''..... 0 0 0
-----------------------------------------------
Total benefits.......................................... 0 0 0
Less Restrictive Alternative:
71.4 and 71.5 Passenger data collection..................... 75,924 75,924 75,924
70.1 and 71.1 Change in definition of an ``ill person''..... 14,679 14,679 14,679
-----------------------------------------------
Total benefits.......................................... 90,603 90,603 90,603
More Restrictive Alternative:
71.4 and 71.5 Passenger data collection..................... 1,898 1,898 1,898
70.1 and 71.1 Change in definition of an ``ill person''..... 0 0 0
-----------------------------------------------
Total benefits.......................................... 1,898 1,898 1,898
----------------------------------------------------------------------------------------------------------------
Staff Time for Contact Investigations
For the less restrictive alternative, the change relative to
baseline is equal to the current cost of performing Cis for travelers
exposed on international flights ($745,000 each for HHS/CDC and local
health departments or a total of about $1.5 million, Table 20). Under
the more restrictive alternative (i.e. implementing travel restrictions
immediately upon evidence of widespread transmission of viral
hemorrhagic fevers, SARS or MERS, the costs of these contact
investigations are assumed to be avoided (potential cost reductions of
about $29,000 each to HHS/CDC and health departments or $58,000 in
total). The benefits of the avoided contacted investigations are then
added to the cost savings for the remaining contacts assuming a 0-3%
improvement in HHS/CDC efficiency and a 0-2% improvement in PHD
efficiency as for the final rule (Table 42).
Table 42--Estimated Benefits Associated With Reduced Costs To Conduct Contact Investigations
----------------------------------------------------------------------------------------------------------------
HHS/CDC
benefits PHD benefits Total
----------------------------------------------------------------------------------------------------------------
Final Rule:
Best estimate............................................... $7,331 $4,887 $12,218
Lower bound................................................. 0 0 0
Upper bound................................................. 14,661 9,774 24,435
Less Restrictive Alternative:
Best estimate............................................... 745,380 745,380 1,490,760
Lower bound................................................. 745,380 745,380 1,490,760
Upper bound................................................. 745,380 745,380 1,490,760
More Restrictive Alternative:
Best estimate............................................... 36,671 34,227 70,898
Lower bound................................................. 29,340 29,340 58,680
Upper bound................................................. 44,001 39,114 83,115
----------------------------------------------------------------------------------------------------------------
Measles Contact Investigation Health Outcomes--Alternatives
For this analysis, under the less restrictive alternative, HHS/CDC
assumes that no contact investigations are performed for measles. As a
result, the probability of onward transmission from 3.6 to 10.1 measles
patients exposed each year during travel greatly increases and is
modeled based on the estimated costs of measles in the absence of
intervention $504,000 (range: $137,000 to $1.3 million) (Table 28).
Measles outcomes for the more restrictive alternative are the same as
estimated for the final rule since there is no difference in measles
efforts between the final rule and the more
[[Page 6960]]
restrictive alternative because measles is not a quarantinable disease.
The comparative benefits relative to the status quo baseline are shown
in Table 43. For the less restrictive alternative, costs are estimated
based on an increase in measles outbreak costs relative to the
baseline.
Table 43--Estimated Benefits Associated With Averted Costs From Measles Outbreaks Relative to Baseline, 2015 USD
----------------------------------------------------------------------------------------------------------------
Best estimate Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Benefits
----------------------------------------------------------------------------------------------------------------
Final Rule...................................................... $45,396 $8,229 $159,444
Less Restrictive Alternative.................................... 0 0 0
More Restrictive Alternative.................................... 45,396 8,229 159,444
----------------------------------------------------------------------------------------------------------------
Costs
----------------------------------------------------------------------------------------------------------------
Final Rule...................................................... 1,950 1,950 1,950
Less Restrictive Alternative \a\................................ 201,758 54,858 531,481
More Restrictive Alternative.................................... 1,950 1,950 1,950
----------------------------------------------------------------------------------------------------------------
\a\ For the less restrictive alternative, contact investigations are not performed so the cost can be estimated
based on the estimated public health benefit of contact investigations performed under the baseline (Table
29).
Tuberculosis Contact Investigations Health Outcomes--Alternatives
Under the less restrictive alternative, tuberculosis contact
investigation are no longer conducted for persons exposed during
travel. Relative to the baseline, there are neither costs to conduct
such investigations (resulting in benefits of about $180,000 to forego
providing treatment for latent tuberculosis treatment) or benefits
associated with reduced tuberculosis morbidity and mortality. Relative
to the baseline, the estimated cost of increased tuberculosis morbidity
and mortality is estimated to be $2.6 million (range: $1.8 million to
$3.8 million). Under the more restrictive alternative in which
suspension of entry is enforced in response to quarantinable
communicable disease outbreaks, there is no change relative to the
final rule results because it is unlikely that a tuberculosis outbreak
would cause suspension of entry. Results are summarized in Table 44.
Table 44--Changes in Tuberculosis Contact Investigations Costs and Benefits Relative to Baseline, 2015 USD
----------------------------------------------------------------------------------------------------------------
Best estimate Lower bound Upper bound Notes
----------------------------------------------------------------------------------------------------------------
Benefits
----------------------------------------------------------------------------------------------------------------
Final Rule............................ $52,432 18,108 113,513 Table 32.
Less Restrictive Alternative.......... 180,180 180,180 180,180 Assumed to be the cost
to provide LTBI
treatment under the
baseline (Table 32).
More Restrictive Alternative.......... 52,432 18,108 113,513 The more restrictive
alternative has the
same effect on TB
contact investigations
as the final rule.
----------------------------------------------------------------------------------------------------------------
Costs
----------------------------------------------------------------------------------------------------------------
Final Rule............................ 18,018 9,009 27,027 Table 32.
Less Restrictive Alternative.......... $2,613,936 $1,805,502 $3,772,691 Estimated based on the
benefits of avoided TB
morbidity and mortality
resulting from contact
investigations under
the baseline.
More Restrictive Alternative.......... 18,018 9,009 27,027 The more restrictive
alternative has the
same effect on TB
contact investigations
as final rule.
----------------------------------------------------------------------------------------------------------------
The total costs and benefits of changes in health outcomes
associated with the more and less restrictive alternatives compared to
the provisions included in the Final Rule are summarized in Table 45.
The less restrictive alternative in which contact investigations are no
longer pursued shows a large increase in costs relative to the baseline
and in comparison to the provisions in the final rule. In addition,
there are some benefits, but not enough to offset the costs. The more
restrictive alternative does not change health outcomes for
tuberculosis and measles in comparison to the final rule.
[[Page 6961]]
Table 45--Changes in Measles and Tuberculosis Contact Investigations Costs and Benefits Relative to Baseline,
2015 USD
----------------------------------------------------------------------------------------------------------------
Best estimate Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Benefits
----------------------------------------------------------------------------------------------------------------
Final Rule...................................................... $97,828 $26,337 $272,958
Less Restrictive Alternative.................................... 180,180 180,180 180,180.
More Restrictive Alternative.................................... 97,828 26,337 272,958
----------------------------------------------------------------------------------------------------------------
Costs
----------------------------------------------------------------------------------------------------------------
Final Rule...................................................... 19,968 10,959 28,977
Less Restrictive Alternative.................................... 2,815,694 1,860,360 4,304,172
More Restrictive Alternative.................................... 19,968 10,959 28,977
----------------------------------------------------------------------------------------------------------------
Note: This table includes the sum of results in Tables 43 and 44.
The total quantified costs and benefits (Table 46) resulting from
the additional data provision and timeliness of traveler contact data
or the improvement of illness reporting for alternatives to the
provisions included in the final rule is summarized by summing the
improved efficiency for HHS/CDC to provide contact data to health
departments and improved efficiency for health departments to contact
exposed travelers (Table 42) and the reductions associated with measles
and tuberculosis morbidity and mortality (Table 45).
Table 46--Total Annual Costs and Benefits Associated With Improved Efficiency Public Health Response Activities,
2015 USD
----------------------------------------------------------------------------------------------------------------
Best estimate Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Benefits
----------------------------------------------------------------------------------------------------------------
FR.............................................................. $110,045 $26,337 $297,393
Less Restrictive Alternative.................................... 1,670,940 1,670,940 1,670,940
More Restrictive Alternative.................................... 168,725 85,017 356,073
----------------------------------------------------------------------------------------------------------------
Costs
----------------------------------------------------------------------------------------------------------------
FR.............................................................. 19,968 10,959 28,977
Less Restrictive Alternative.................................... 2,815,694 1,860,360 4,304,172
More Restrictive Alternative.................................... 19,968 10,959 28,977
----------------------------------------------------------------------------------------------------------------
The total annual costs and benefits for the alternatives compared
to the final rule are summarized in Table 47. Although the benefits for
the more restrictive alternative in which suspensions of entry would be
implemented for countries experiencing outbreaks of quarantinable
communicable diseases are greater than the quantified annual benefits
of the final rule, the costs are underestimated. HHS/CDC does not have
sufficient data to quantify the long term costs of implementing
suspensions of entry for countries experiencing outbreaks of
quarantinable diseases; however, such costs would probably exceed the
$100,000 in estimated benefits associated with suspensions of entry
that may result in fewer contact investigations for quarantinable
diseases such as Ebola and MERS. Refer to the appendix for some details
of potential costs associated with hypothetical suspensions of entry
for the countries with widespread Ebola transmission during the 2014-
2016 global Ebola epidemic.
Table 47--Total Annual Costs and Benefits of the Final Rule, Less Restrictive and More Restrictive Alternatives,
2015 USD
----------------------------------------------------------------------------------------------------------------
Best estimate Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Benefits
----------------------------------------------------------------------------------------------------------------
Final Rule...................................................... $110,045 $26,337 $297,393
Less Restrictive Alternative.................................... 1,780,524 1,780,524 1,780,524
More Restrictive Alternative.................................... 170,623 86,915 357,971
----------------------------------------------------------------------------------------------------------------
Costs
----------------------------------------------------------------------------------------------------------------
Final Rule...................................................... 32,622 10,959 430,839
Less Restrictive Alternative.................................... 2,815,694 1,860,360 4,304,172
More Restrictive Alternative.................................... 33,154 11,807 431,181
----------------------------------------------------------------------------------------------------------------
[[Page 6962]]
Codification of Current Practice (Multiple Provisions in Final Rule)
HHS/CDC does not expect that most of the provisions included in the
final rule will result in measurable changes relative to the economic
baseline. The primary purpose of the provisions summarized in list
below is to explain how HHS/CDC interprets its current statutory and
regulatory authority under the Public Health Service Act (42 U.S.C.
264, 265) and regulations at 42 CFR parts 70 and 71. HHS/CDC is
grouping the complementary provisions in part 70 and part 71 in the
list below, when they align, to facilitate public review of the current
provisions as well as those included in the final rule. These changes
are intended to clarify the agency's standard operating procedures and
policies, and due process rights for individuals. HHS/CDC believes that
such clarity is an important qualitative benefit of the provisions in
this final rule, but is not able to monetize this impact in a
significant way.
New Provisions: Sec. 70.5 Requirements relating to
travelers under a Federal order of isolation, quarantine, or
conditional release.
[cir] Baseline and Current Regulatory Provision: Sec. 70.5 Certain
communicable disease; special requirements.
[ssquf] Without the final rule, HHS/CDC may issue Federal orders to
restrict travel for persons infected or exposed to quarantinable
communicable diseases. However, this process is less transparent and
efficient than allowing travel (i.e. issue travel permits to allow
interstate travel to persons under Federal orders for diseases not
currently identified under existing 42 CFR 70.5.) Under current
practice, HHS/CDC issues approximately one Federal order per year, most
frequently for tuberculosis, which is a disease not included in the
current 70.5.
[cir] Change relative to baseline as result of final rule
[ssquf] With the final rule, HHS/CDC is aligning the list of
diseases for which individuals under Federal orders may be allowed to
travel with the quarantinable communicable diseases specified in
Executive Order. A potential future qualitative benefit would be to
reduce uncertainty by the individual subject to the order, carrier
operators, and cooperating health and law enforcement entities about
whether HHS/CDC could issue a travel permit to an individual under a
Federal order and quantifiable benefit would be the avoided cost of
potential legal challenge.
[cir] Qualitative benefit/cost of final rule
[ssquf] Improved transparency for HHS/CDC's ability to allow
individuals under Federal orders to issue travel permits to allow
individuals to travel (interstate). HHS/CDC may allow persons under
Federal orders to travel interstate for whom there is greater
uncertainty regarding HHS/CDC restricting their travel.
[cir] Monetized benefit/cost of final rule
[ssquf] Increased clarity around due process may result in fewer
resources and time expended by individuals under orders and HHS/CDC in
disagreements over HHS/CDC's authority to issue Federal public health
orders that limit an individual's movement. This includes the potential
costs of litigation and associated activities.
New provisions: Sec. 70.6 Apprehension and detention of
persons with specific diseases; Sec. 71.32 Persons, carriers, and
things (no change to title)
[cir] Baseline and Current Regulatory Provision:
[ssquf] Under current 42 CFR 70.6 and Sec. 71.32, HHS/CDC has
regulatory authority to apprehend and detain individuals with
quarantinable communicable diseases.
[cir] Change relative to baseline as result of final rule
[ssquf] As a result of these new provisions, the major change would
be improved transparency of HHS/CDC's regulatory authority with regard
to the issuance of Federal quarantine, isolation, or conditional
release orders of individuals traveling interstate.
[cir] Qualitative benefit/cost of final rule
[ssquf] ;Improved transparency and compliance with Federal orders.
[cir] Monetized benefit/cost of final rule
[ssquf] Increased clarity around due process may result in fewer
resources and time expended by individuals under orders, cooperating
entities, and CDC in disagreements over HHS/CDC's authority to issue
Federal public health orders that limit an individual's movement. This
includes the potential costs of litigation and associated activities.
New Provisions: Sec. 70.10 Public health prevention
measures to detect communicable disease; Sec. 71.20 Public health
prevention measures to detect communicable disease.
[cir] Baseline and Current Regulatory Provisions: No explicit
regulatory provision.
[ssquf] In the absence of the final rule and under existing
statutory authority provided in the Public Health Service Act and
regulatory authority provided by 42 CFR 70.2 and 71.32(b), HHS/CDC
could still implement public health measures at locations where
individuals may gather for interstate travel or at U.S. ports of entry.
However, without more transparent regulatory authority to require such
measures, travelers may be less likely to comply, either by refusing to
answer risk assessment questions or providing false information. This
lack of compliance may require that HHS/CDC, if it reasonably believes
that the individual is infected with or has been exposed to a
quarantinable communicable disease, to quarantine, isolate, or place
the individual under surveillance under 42 CFR 70.6 or 71.32 and 71.33.
HHS/CDC has not implemented public health measures at locations where
individuals may congregate for the purposes of interstate travel in at
least 50 years and cannot predict if or how often it may implement
measures in the future.
[cir] Change relative to baseline as result of final rule
[ssquf] Improved transparency and potentially improved compliance
in the event that HHS/CDC implements such measures in the future.
[cir] Qualitative benefit/cost of final rule
[ssquf] Improved transparency and public understanding of HHS/CDC's
rationale and authority to conduct such measures and require
individuals to comply.
[cir] Monetized benefit/cost of final rule
[ssquf] Increased clarity around due process procedures may result
in fewer resources and time expended by individuals under orders and
HHS/CDC in disagreements over HHS/CDC's authority to issue Federal
public health orders that limit an individual's movement. This includes
the potential costs of litigation and associated activities.
New Provisions: Sec. 70.12 Medical examinations; Sec.
71.36 Medical Examinations
[cir] Baseline and Current Regulatory Provisions: 71.33 Persons:
Isolation and Surveillance.
[ssquf] This is carried out under statutory authority and under the
regulatory authorities in 42 CFR 70.6 and 71.32(a), 71.33, which would
allow for medical examinations of individuals under Federal orders.
[cir] Change to baseline as result of final rule
[ssquf] With the final rule, the major change would be an alignment
between the statutory language in the Public Health Service Act and
improved transparency of HHS/CDC's regulatory authority.
[cir] Qualitative benefit/cost of final rule
[ssquf] Improved transparency and public understanding of HHS/CDC's
rationale and authority to conduct such measures and require
individuals to comply.
[cir] Monetized benefit/cost of final rule
[ssquf] Increased clarity around due process procedures may result
in fewer
[[Page 6963]]
resources and time expended by individuals under orders, cooperating
entities, and HHS/CDC in disagreements over HHS/CDC's authority to
issue Federal public health orders that limit an individual's movement.
This includes the potential costs of litigation and associated
activities.
New Provisions: Sec. 70.13 Payment for Care and
Treatment; Sec. 71.30 Payment for Care and Treatment
[cir] Baseline and Current Regulatory Provisions: No current
explicit regulatory provision.
[ssquf] This addition is not expected to lead to a change in HHS/
CDC policy under which HHS/CDC may act as the payer of last resort for
individuals subject to medical examination, quarantine, isolation, and
conditional release under Federal orders. The provisions included in
the final rule are similar to a Memorandum of Agreement between a
number of hospitals and HHS/CDC. Under the terms of the Memorandum of
Agreement, the hospital can be reimbursed for incurred medical expenses
subject to HHS/CDC's discretion, availability of appropriations, and
limited to what a hospital would bill Medicare. The Memorandum of
Agreement also indicates that HHS/CDC should be the payer of last
resort.
[ssquf] HHS/CDC issued 12 isolation orders between Jan 1, 2005 and
May 10, 2016, which would correspond to an average of about 1 order per
year over the past 11.3 years. HHS/CDC has information on payments made
for 3 of the 12 cases. In most cases, HHS/CDC makes payment directly to
healthcare facilities, sometimes in lieu of payments that would be made
by State or local health departments. Among the three instances for
which HHS/CDC has some data on payments for treatment, care, and
transportation of individuals under Federal orders:
[ssquf] HHS/CDC's expected annual payments for care and treatment
are estimated to be between $0 and $1,000,000 in any given year under
the current baseline. This upper bound cost would correspond to a year
in which HHS/CDC would have to incur the costs of two patients at
$500,000 per patient. This roughly corresponds to the average cost to
treat an extremely drug-resistant tuberculosis case (XDR-TB).
Alternatively, this could represent a situation in which HHS/CDC may
have to pay a significant fraction of the total costs for one very
complicated illness associated with a quarantinable communicable
disease not endemic to the United States (e.g., Ebola).
[ssquf] HHS/CDC has not incurred any costs for the care and
treatment of any individuals besides for those under Federal isolation
orders.
[cir] Change to baseline as result of final rule
[ssquf] Improved transparency around HHS/CDC's authority for, and
requirements and processes related to payment for care and treatment.
[cir] Qualitative benefit/cost of final rule
[ssquf] Improved transparency and public knowledge of HHS/CDC's
procedures and regulatory requirements.
[cir] Monetized benefit/cost of final rule
[ssquf] None. This is a clarification of HHS/CDC's current
practice. (For more details, please refer to separate RIA Appendix)
New Provisions: Sec. 70.14 Requirements relating to the
issuance of a Federal order for quarantine, isolation, or conditional
release; Sec. 71.37 Requirements relating to the issuance of a Federal
order for quarantine, isolation, or conditional release
[cir] Baseline and Current Regulatory Provisions: No current
explicit regulatory provision
[ssquf] Without the final rule, HHS/CDC can under current statutory
provided by the Public Health Service Act and regulatory authority
under 42 CFR 70.6 and 71.32(a), 71.33 continue to issue Federal
quarantine, isolation, or condition release orders. However, the
issuance of federal orders is implemented through internal policies and
standard operating procedures that are not as transparent to the public
as detailed regulations outlining requirements.
[cir] Change to baseline as result of final rule
[ssquf] Improved transparency around HHS/CDC's authority for, and
requirements and processes related to, the issuance of Federal
quarantine, isolation, and conditional release orders.
[cir] Qualitative benefit/cost of final rule
[ssquf] Improved transparency and public knowledge of HHS/CDC's
procedures and regulatory requirements.
[cir] Monetized benefit/cost of final rule
[ssquf] None. This is a clarification of HHS/CDC's current
practice.
New Provisions: Sec. 70.15 Mandatory reassessment of a
Federal order for quarantine, isolation, or conditional release; Sec.
71.38 Mandatory reassessment of a Federal order for quarantine,
isolation, or conditional release
[cir] Baseline and Current Regulatory Provisions: No current
explicit regulatory provision.
[ssquf] Without the final rule, HHS/CDC can under current statutory
authority provided by the Public Health Service Act and regulatory
authority under 42 CFR 70.6 and 71.32(a), 71.33 continue to issue
Federal quarantine, isolation, or conditional release orders. However,
the process for reassessing a Federal order is implemented through
internal policy and standard operating procedures that are not as
transparent to the public as detailed regulations outlining
requirements.
[cir] Change to baseline as result of final rule:
[ssquf] With the final rule, individuals under Federal order may be
more aware of the mandatory reassessment of a Federal quarantine,
isolation, or conditional release order.
[cir] Qualitative benefit/cost of final rule
[ssquf] Improved transparency and understanding of due process
protections under a Federal public health order.
[cir] Monetized benefit/cost of final rule
[ssquf] Increased clarity around due process protections may result
in fewer resources and time expended by individuals under orders and
HHS/CDC in disagreements over HHS/CDC's authority to issue Federal
public health orders that limit an individual's movement. This includes
the potential costs of litigation and associated activities.
New Provisions: Sec. 70.16 Medical review of a Federal
order for quarantine, isolation, or conditional release; Sec. 71.39
Medical review of a Federal order for quarantine, isolation, or
conditional release
[cir] Baseline and Current Regulatory Provisions: No current
explicit regulatory provision.
[ssquf] Without the final rule, HHS/CDC can under current statutory
authority provided by the Public Health Service Act and regulatory
authority under 42 CFR 70.6 and 71.32, 71.33 continue to issue Federal
quarantine, isolation, or conditional release orders. However, the
process for a medical review of a Federal order is outlined in internal
policy and standard operating procedures that are not as transparent to
the public as detailed regulations outlining requirements.
[cir] Change to baseline as result of final rule:
[ssquf] With the final rule, individuals under Federal order may
become aware of their right to a medical review, and exercise that
right, under this due process provision.
[cir] Qualitative benefit/cost of final rule
[ssquf] Improved transparency and understanding of due process
afforded to individuals under a Federal order
[cir] Monetized benefit/cost of final rule
[ssquf] Increased clarity around due process protections may result
in fewer resources and time expended by individuals under orders and
HHS/CDC
[[Page 6964]]
in disagreements over HHS/CDC's authority to issue Federal public
health orders that limit an individual's movement. This includes the
potential costs of litigation and associated activities.
[ssquf] One potential change that could have an economic effect is
the requirements to appoint medical and legal representatives for
individuals that qualify as ``indigent''. The status of ``indigent'' is
self-reported as HHS/CDC will not require access to an individual's
financial records. Those who self-identify as indigent may be required
to sign an affidavit or declaration under penalty of perjury stating
they meet the threshold of at least 200% of the applicable poverty
guidelines. HHS/CDC notes that in practice it has never denied a
request for a representative. HHS/CDC estimates the cost of providing
one medical representative and one legal representative based on the
average hourly wage for physicians and surgeons ($97.33, occupation
code 29-1060) and lawyers ($65.51, occupation code 23-1011) as reported
from the Bureau of Labor Statistics' May 2015 National Occupational
Employment and Wage Estimates. Assuming that it takes about 40 hours of
physician time and 40 hours of lawyer time per review and an overhead
cost multiplier of 100%, the expected cost is about $13,000 per review.
HHS/CDC notes that public health orders are issued on average once per
year. The need for HHS/CDC to pay for medical and legal representatives
will depend on the income level for persons placed under federal
orders, but should not exceed this $13,000 estimate in most years and
will be $0 in many years. Without the new regulatory provision, as part
of current practice, HHS/CDC would still attempt to appoint legal and
medical representatives if requested for the medical review by
individuals unable to afford the cost of such representation. Thus,
relative to current practice, there should be minimal costs associated
with this provision.
New Provisions: Sec. 70.17 Administrative records
relating to Federal quarantine, isolation, or conditional release;
Sec. 71.29 Administrative records relating to Federal quarantine,
isolation, or conditional release
[cir] Baseline and Current Regulatory Provisions: No current
explicit regulatory provision.
[ssquf] Without the final rule, HHS/CDC can issue under current
statutory provided by the Public Health Service Act and regulatory
authority under 42 CFR 70.6 and 71.32(a), 71.33 continue to issue
Federal quarantine, isolation, or conditional release orders. However,
the process for documenting the administrative record is implemented
internal policy and standard operating procedures that are not as
transparent to the public as a detailed regulation outlining this
requirement.
[cir] Change to baseline as result of final rule
[ssquf] The requirement, with which HHS/CDC is already complying,
will clarify for the public that certain documents must be retained for
the administrative record.
[cir] Qualitative benefit/cost of final rule
[ssquf] Improved transparency
[cir] Monetized benefit/cost of final rule
[ssquf] Not applicable. This is a codification of an administrative
activity within HHS/CDC.
New Provisions: Sec. 70.18 Penalties/Sec. 71.2 Penalties
[cir] Baseline and Current Regulatory Provision: Sec. 71.2
Penalties. Part 70 currently has no penalties provision.
[ssquf] Without the final rule, individuals may not be aware that
18 U.S.C. 3559 and 3571 increased the maximum penalties for violations
of regulations under 42 CFR part 70 and part 71. And it may not be
clear to individuals that violating quarantine regulation under 42 CFR
part 70 may result in criminal penalties.
[cir] Change to baseline as result of final rule
[ssquf] With the NRPM, there will be less confusion about the
maximum criminal penalties for a violation of regulations under 42 CFR
70 and 71.
[cir] Qualitative benefit/cost of final rule
[ssquf] Improved transparency and alignment with current law under
18 U.S.C. 3559 and 3571.
[cir] Monetized benefit/cost of final rule
No individual or organization has been assessed criminal
penalties for violating these regulations, so monetizing this benefit
or cost is not feasible. This is simply an effort to align the domestic
and foreign quarantine penalties provisions, and updates outdated
regulatory language so that it reflects current statutory language
concerning criminal penalties.
New Provisions: Sec. 71.63 Suspension of entry of
animals, articles, or things from designated foreign countries and
places into the United States
[cir] Baseline and Current Regulatory Provision: Sec. 71.32(b) has
previously been used to justify the temporary embargo of imported
African rodents prior to the codification of this as a requirement in
existing 42 CFR 71.56.
[ssquf] Without the final rule, individuals may not be aware that
HHS/CDC's authority to temporarily suspend entry of animals, articles
or things from designated foreign countries and places into the United
States based on existing 42 CFR 71.32(b).
[cir] Change to baseline as result of final rule
[ssquf] With the NRPM, there will be less confusion about HHS/CDC's
ability to temporarily restrict importations associated with
communicable disease risks.
[cir] Qualitative benefit/cost of final rule
[ssquf] Improved transparency.
[cir] Monetized benefit/cost of final rule
[ssquf] Refer to the appendix for an analysis of the temporary
embargo of African rodents implemented in 2003.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act, as amended by the Small
Business Regulatory Enforcement Fairness Act (SBREFA), agencies are
required to analyze regulatory options to minimize significant economic
impact of a rule on small businesses, small governmental units, and
small not-for-profit organizations. We have analyzed the costs and
benefits of the final rule, as required by Executive Order 12866, and a
preliminary regulatory flexibility analysis that examines the potential
economic effects of this rule on small entities, as required by the
Regulatory Flexibility Act. Based on the cost benefit analysis, we
expect the rule to have little or no economic impact on small entities.
C. The Paperwork Reduction Act
HHS/CDC has determined that this final rule contains proposed
information collections that are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520). A description of these proposed provisions
is given below with an estimate of the annual reporting and
recordkeeping burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information. Comments are invited on the following
subjects.
Whether the proposed collection of information is
necessary for the proper performance of the functions of HHS/CDC,
including whether the information will have practical utility.
The accuracy of HHS/CDC's estimate of the burden of the
collection of information.
Ways to enhance the quality, utility, and clarity of the
information to be collected.
[[Page 6965]]
Ways to minimize the burden of the collection of
information on respondents, including by using information technology.
While HHS/CDC currently has approval to collect certain information
concerning illnesses and travelers under OMB Control Numbers 0920-0134
(Foreign Quarantine Regulations, expiration date 05/31/2019) and 0920-
0488 (Restrictions on Interstate Travel of Persons, expiration date 05/
31/2019), CDC is requesting updates to certain information collections
within these control numbers.
In another information collection request associated with this
final rule, CDC is also requesting approval to require that airlines
and vessels provide certain data elements to CDC, as described in
proposed 71.4 and 71.5, for the purposes of contact tracing. This
information is used to locate individuals, both passengers and
crewmembers, who may have been exposed to a communicable disease during
travel and to provide them with appropriate public health follow-up.
Written comments should be received within 30 days of the
publication of this final rule. Please send written comments to CDC
Desk Officer, Office of Management and Budget, Washington, DC 20503 or
by fax to (202) 395-5806.
Proposed Projects
(1) Foreign Quarantine Regulations (42 CFR part 71) (OMB Control
No. 0920-0134)--Nonmaterial/non-substantive change--National Center for
Emerging, and Zoonotic Infectious Diseases (NCEZID), Centers for
Disease Control and Prevention (CDC).
(2) Restrictions on Interstate Travel of Persons (42 CFR part 70)
(OMB Control No. 0920-0488)--Nonmaterial/non-substantive change--
National Center for Emerging, and Zoonotic Infectious Diseases
(NCEZID), Centers for Disease Control and Prevention (CDC)
(3) Airline and Vessel and Traveler Information Collection (42 CFR
and 71)--New Information Collection Request--National Center for
Emerging, and Zoonotic Infectious Diseases (NCEZID), Centers for
Disease Control and Prevention (CDC).
Description
Section 361 of the Public Health Service (PHS) Act (42 U.S.C. 264)
authorizes the Secretary of Health and Human Services to make and
enforce regulations necessary to prevent the introduction,
transmission, or spread of communicable diseases from foreign countries
into the United States and interstate. Legislation and existing
regulations governing foreign and interstate quarantine activities (42
CFR parts 70 and 71) authorize quarantine officers and other personnel
to inspect and undertake necessary control measures in order to protect
the public health. Currently, with the exception of the CDC's Vessel
Sanitation Program, inspections are performed only on those vessels and
aircraft that report illness before arriving or when illness is
discovered upon arrival. Other inspection agencies assist quarantine
officers in public health risk assessment and management of persons,
pets, and other importations of public health importance. These
practices and procedures ensure protection against the introduction and
spread of communicable diseases into the United States with a minimum
of recordkeeping and reporting as well as a minimum of interference
with trade and travel. The information collection burden is associated
with these recordkeeping and reporting requirements.
At present, HHS/CDC has approval from OMB to collect certain
information and impose recordkeeping requirements related to foreign
quarantine responsibilities under OMB Control Number 0920-0134
(expiration 05/31/2019). The specific provisions within 42 CFR part 71
that include information collection under are as follows:
42 CFR 71.21(a), (b), and (c) Report of death and illness.
42 CFR 71.33(c) Report of persons held in isolation or
surveillance.
42 CFR 71.35 Report of death or illness on carrier during stay in
port.
42 CFR 71.51 Dogs and cats.
42 CFR 71.52 Turtles, terrapins, tortoises.
42. CFR 71.56 African Rodents
HHS/CDC has also used its authority under 42 CFR 71.32 to require
importers to submit statements or documentation of non-infectiousness
for those items that may constitute a public health risk if not
rendered non-infectious.
Finally, HHS/CDC has approval from OMB to collect from importers/
filers certain documents and data elements to identify and clear HHS/
CDC regulated imports via the Automated Commercial Environment and the
International Trade Data System using the Document Imaging System and
Partner Government Agency Message Sets. These CDC Partner Government
Agency Message Sets are currently limited to: CDC PGA Message Set for
Importing Cats and Dogs, CDC PGA Message Set for Importing African
Rodents, CDC PGA Message Set for Importing African Rodent and All
Family Viverridae Products.
In this final rule, CDC is requesting approval from OMB for 4 non-
substantive changes to OMB Control Number 0920-0134 Foreign Quarantine
Regulations (42 CFR part 71):
(1) Updating the definition of ``ill person,'' which relates to the
illness reporting requirements under 42 CFR 71.21(a), (b), and (c) for
airlines and vessels arriving into the United States. CDC is updating
the definition of ``ill person'' by implementing current practice with
the anticipated effect of better facilitating identification of
communicable diseases of concern and quarantinable communicable
diseases aboard flights and maritime voyages to the United States,
diseases such as measles, viral hemorrhagic fevers, active
tuberculosis, and influenza caused by novel or re-emergent influenza
viruses that are causing or have the potential to cause a pandemic. CDC
is also including a provision to allow the Director to add new symptoms
to the definition of ill person to respond to unknown communicable
diseases that may emerge as future concerns.
The final rule updates the current definition of ill person to
better focus on the signs and symptoms of communicable diseases of
public health concern and quarantinable communicable diseases. The
changes define an ill person in the context of the medical resources
available to the operator of an airline or vessel.
CDC already requests from pilots in command of aircraft and
commanders of vessels several of the symptoms included in the revised
definition of ill person through publicly available guidance to
airlines and vessels. Moreover, for airlines, the updated definition
also better aligns with symptoms reporting guidelines published by ICAO
in Note 1 to paragraph 8.15 of Annex 9 to the Convention on
International Civil Aviation, and the definition of ``acute
gastroenteritis'' is used by the WHO and is currently included in
reporting guidance from CDC's Vessel Sanitation Program. Therefore, CDC
does not anticipate additional burden on airlines or vessel operators
to respond to these information collections.
(2) CDC is requesting a change in the title of the information
collection pertaining to reports of death and illness from vessels to
CDC. The former title is Radio Report of death or illness--illness
reports from ships. CDC sought a change to remove ``Radio'' from the
title. This change reflects the fact that reports to CDC primarily via
means other than radio, such as the Maritime Illness and Death
Reporting System, managed by CDC's Vessel Sanitation Program. CDC
[[Page 6966]]
did not receive any public comments to this change, and it is therefore
finalized as proposed.
(3) CDC is seeking a change in the title of a specific information
collection pertaining to reports of gastro-intestinal illness to CDC.
CDC is updating the definition of ill person and is replacing the term
``gastro-intestinal'' with ``acute gastroenteritis''; therefore, the
title change is requested to align with the definition.
(4) CDC is seeking a change in title of respondents from ``Maritime
Conveyance Operator'' to ``Maritime Vessel Operator'' and from
``Airline Commander or Operator'' to ``Pilot in Command.''
Table 1 below presents estimates of annual burden (in hours)
associated with each reporting and recordkeeping requirement under this
OMB control number, accounting for the rule changes.
Description of Respondents. Respondents to this data collection
include pilots in command of aircraft, maritime vessel operators,
importers/filers, and travelers/general public. The nature of the
response to HHS/CDC dictates which forms are completed and by whom. The
total requested burden hours are 82,779.
There is no burden to respondents other than the time taken to
complete the reports to CDC, maintain recordkeeping of illness aboard
vessels and records of sickness or death in imported cats and dogs, as
outlined in the table below. If a cat or dog is ill upon arrival, or
dies prior to arrival, an exam is required, the initial exam fee may be
between $100 and $200. Rabies testing on a dog that dies may be between
$50 and $100. The expected number of ill or dead dogs arriving into the
United States for which CDC may require an examination is estimated at
less than 30 per year.
Table 1--Estimated Annual Reporting Burden 0920-0134
----------------------------------------------------------------------------------------------------------------
Average
No. of burden
Regulatory provision or No. of responses per Total
Type of respondent form name respondents per response burden
respondent (in hours
hours)
----------------------------------------------------------------------------------------------------------------
Maritime Vessel Operators............. 42 CFR 71.21(a) Report 2,000 1 2/60 67
of illness or death
from ships--Maritime
Vessel Illness or Death
Investigation Form/
Cumulative Influenza/
Influenza-Like Illness
(ILI) Form/Radio report
or transcribed email.
Pilot in Command...................... 42 CFR 71.21 (b) Death/ 1,700 1 2/60 57
Illness reports from
aircraft.
Maritime Vessel Operators............. 42 CFR 71.21(c) (MIDRS) 17,000 1 3/60 850
Acute Gastro-Enteritis
reports (24 and 4 hours
before arrival).
Maritime Vessel Operators............. 42 CFR 71.21 (c) 17,000 1 3/60 850
Recordkeeping-Medical
logs.
Isolated or Quarantined individuals... 42 CFR 71.33 Report by 11 1 3/60 1
persons in isolation or
surveillance.
Maritime Vessel Operators............. 42 CFR 71.35 Report of 5 1 30/60 3
death/illness during
stay in port.
Importer.............................. 42 CFR 71.51(c)(1), (d)-- 245,310 1 15/60 61,328
Valid Rabies
Vaccination
Certificates.
Importer.............................. CDC Form 75.37 Notice To 1,400 1 10/60 233
Owners And Importers Of
Dogs: Requirement for
Dog Confinement.
Importer.............................. 42 CFR 71.51(c)(i), 43,290 1 15/60 10,823
(ii), and (iii)
exemption criteria for
the importation of a
dog without a rabies
vaccination certificate.
Importer.............................. 42 CFR 71.51(c)(2), (d) 1,400 1 15/60 350
Application for a
Permit to Import A Dog
Inadequately Immunized
Against Rabies.
Importer.............................. 42 CFR 71.51(b) (3) Dogs/ 20 1 15/60 5
cats: Record of
sickness or deaths.
Importer/Filer........................ 42 CFR 71.51_CDC 30,000 1 15/60 7,500
Requested Data on
Regulated Imports:
Domestic Dogs and Cats
(PGA Message Set).
Importer.............................. 42 CFR 71.52(d) Turtle 5 1 30/60 3
Importation Permits.
Importers............................. 42 CFR 71.55, 42 CFR 5 1 1 5
71.32 Dead Bodies--
Death certificates.
Importer.............................. 42 CFR 71.56 (a)(2) 20 1 1 20
African Rodents--
Request for exemption.
Importer.............................. 42 CFR 71.56(a)(iii) 2 1 1 2
Appeal.
Importer/Filer........................ 42 CFR 71.56 CDC 60 1 15/60 15
Requested Data on
Regulation Imports:
Live African Rodents
(PGA Message Set).
Importer/Filer........................ 42 CFR 71.32 Statements 2,000 1 5/60 167
or documentation of non-
infectiousness.
Importer/Filer........................ 42 CFR 71.56, 42 CFR 2,000 1 15/60 500
71.32 CDC Requested
Data on Regulated
Imports: Products of
African Rodents;
Products of all Family
Viverridae (PGA Message
Set).
-----------------------------------------------
Total............................. ........................ ........... ........... ......... 82,779
----------------------------------------------------------------------------------------------------------------
The estimates are based on experience to date with current
recordkeeping and reporting requirements of 42 CFR part 71, with
additional burden included to account for the potential for increased
reports of illness during an outbreak and for reports of disease that
may have been missed by airlines or vessels and are reported to CDC
after travel.
Under this final rule, CDC is also requesting a nonmaterial/non-
[[Page 6967]]
substantive change to Restrictions on Interstate Travel of Persons (42
CFR part 70) (OMB Control No. 0920-0488). The regulations at 42 CFR
part 70 are intended to prevent the interstate spread of disease, and
include a requirement that the master of vessel or person in charge of
conveyance to report the occurrence on board of communicable disease.
Under this regulation and control number, CDC has approval to collect
the following information:
42 CFR 70.4 Report by the master of a vessel or person in
charge of conveyance of the incidence of a communicable disease
occurring while in interstate travel.
Through this final rule, CDC is adding the provision 70.11 Report
of death or illness onboard aircraft operated by airline, which
specifies that the pilot in command of an aircraft operating on behalf
of an airline who conducts a commercial passenger flight in interstate
traffic under a regular schedule shall report as soon as practicable to
HHS/CDC the occurrence onboard of any deaths or ill persons among
passengers or crew and take such measures as HHS/CDC may direct to
prevent the potential spread of the communicable disease. HHS/CDC notes
that it is changing the existing regulatory requirement at 42 CFR 70.4,
which states that the master of a vessel or person in charge of any
conveyance engaged in interstate traffic on which a case or suspected
case of communicable disease develops shall, as soon as practicable,
notify the local health authority.
Under the final rule, pilots in command of an aircraft, operating
on behalf of an airline, that submit the ill person or death report to
HHS/CDC under new 70.11 will not be required to also submit a report to
the local health authority under current 70.4. HHS/CDC will continue to
share public health information with State and local health departments
through electronic disease reporting networks. It is unlikely that HHS/
CDC would request follow-up reports of illnesses that are reported to
the local health authorities, unless there was an urgent public health
need. Therefore, CDC does not anticipate any additional burden to the
respondents; however, the accounting for burden in Table 2 will add
70.11 Report of death or illness onboard aircraft operated by airline.
As a result of this final rule, CDC does not anticipate a change in
total burden. CDC is instead allocating 95% of the reports of illness
or death within the proposed 70.11 Report of death or illness onboard
aircraft operated by airline. The remains 5% will remain within 70.4
Report by the master of a vessel or person in charge of conveyance of
the incidence of a communicable disease occurring while in interstate
travel, in the event that some reports are still made to State health
authorities.
In addition to the requirement to report directly to HHS/CDC, HHS/
CDC is updating the definition of ``ill person'' for the purposes of
illness reports to HHS/CDC in 42 CFR part 70. HHS/CDC has, as a matter
of agency guidance, communicated with airlines that the same current
set of required and requested signs and symptoms of disease, as well as
any death, apply to domestic as well as international flights. This
guidance is similar to that of the guidelines issued by ICAO under Note
1 to paragraph 8.15 of Annex 9 to the Convention on International Civil
Aviation. Therefore, the new proposed definition of ill person should
not affect standard practice, and no change in burden is anticipated.
Table 2 below presents estimates of annual burden (in hours)
associated with each reporting and recordkeeping requirement under this
OMB control number, accounting for the rule changes.
Description of Respondents
Respondents to this data collection include masters of vessels or
persons in charge of conveyance and pilots in command of aircraft.
Table 2--Estimated Annual Reporting Burden 0920-0488
----------------------------------------------------------------------------------------------------------------
Average
No. of burden Total
No. of responses per burden
Type of respondent Form name respondents per response (in
respondent (in hours)
hours)
----------------------------------------------------------------------------------------------------------------
Pilot in command...................... 42 CFR 70.11 Report of 190 1 7/60 22
death or illness
onboard aircraft
operated by airline.
Master of vessel or person in charge 42 CFR 70.4 Report by 10 1 7/60 1
of conveyance. the master of a vessel
or person in charge of
conveyance of the
incidence of a
communicable disease
occurring while in
interstate travel.
-------------------------------------------------------------------------
Total............................. ........................ 200 ........... ......... 23
----------------------------------------------------------------------------------------------------------------
The total requested burden hours are 23. There is no burden to
respondents other than the time taken to complete the reports. The
estimates are based on experience to date with current recordkeeping
and reporting requirements of 42 CFR part 70, and take into account the
potential for additional burden from increased reports of illness
during an outbreak and for reports of disease that may have been missed
by respondents during travel and are reported to CDC by other means.
Finally, under this final rule HHS/CDC is requesting approval for a
new information collection, Airline and Vessel and Traveler Information
Collection (42 CFR part 71). This information collection request
accompanies the codification of issuing orders to airlines and vessel
operators for the provision to CDC of airline and vessel and traveler
information (aka manifests) in the event that a quarantinable
communicable disease or a communicable disease of public health
concern, or a death caused by a quarantinable communicable disease or
communicable disease of public health concern, occurs during travel to
the United States and public health follow-up is warranted. These
proposed provisions are found in 42 CFR 71.4 for airlines and 71.5 for
vessels.
The ordering of manifests from airlines and vessel operators
arriving into the United States is an ongoing activity executed under
CDC's broad regulatory authority found at 42 CFR 71.32 Persons,
carriers, and things. To increase transparency with regard to CDC's
authorities and manifest order process, CDC is proposing specific
[[Page 6968]]
regulatory provisions that outline the particular data elements CDC
requires to perform contact tracing investigations. As stated in the
final rule, CDC is not mandating the collection of additional data.
Only that if the airlines or maritime operators have the data elements
listed in 71.4 and 71.5 in their possession, they must be provided to
CDC within 24 hours.
Table 3 below presents estimates of annual burden (in hours)
associated with each reporting and recordkeeping requirement under this
OMB control number, accounting for the final rule changes.
Description of Respondents
Respondents to this data collection include the Airline Medical
Officer or Equivalent and a Computer and Information Systems Manager.
Table 3--Estimate of Annual Burden Airline and Vessel Manifest Orders
----------------------------------------------------------------------------------------------------------------
Average
No. of burden Total
No. of responses per burden
Type of respondent Form name respondents per response (in
respondent (in hours)
hours)
----------------------------------------------------------------------------------------------------------------
Airline Medical Officer or Equivalent/ International TB 67 1 360/60 402
Computer and Information Systems Manifest Template.
Manager.
Airline Medical Officer or Equivalent/ International Non-TB 29 1 360/60 174
Computer and Information Systems Manifest Template..
Manager.
-----------------------------------------------
Total............................. ........................ 96 ........... ......... 576
----------------------------------------------------------------------------------------------------------------
The total requested burden hours included in this final rule is
576. There is no burden to respondents other than the time taken to
complete the manifest information and send to CDC. The estimates are
based on experience to date with current manifest order process.
D. National Environmental Policy Act (NEPA)
HHS/CDC has determined that the amendments to 42 CFR parts 70 and
71 will not have a significant impact on the human environment.
E. Executive Order 12988: Civil Justice Reform
HHS/CDC has reviewed this rule under Executive Order 12988 on Civil
Justice Reform and determines that this final rule meets the standard
in the Executive Order.
F. Executive Order 13132: Federalism
Under Executive Order 13132, a Federalism analysis is required if a
rulemaking has Federalism implications, would limit or preempt State or
local law, or impose substantial direct compliance costs on State or
local governments. Under such circumstances, a Federal agency must
consult with State and local officials. Federalism implications is
defined as having substantial direct effects on State or local
governments, on the relationship between the national government and
the States, or on the distribution of power and responsibilities among
the various levels of government. Under 42 U.S.C. 264(e), Federal
public health regulations do not preempt State or local public health
regulations, except in the event of a conflict with the exercise of
Federal authority. Other than to restate this statutory provision, this
rulemaking does not alter the relationship between the Federal
government and State/local governments as set forth in 42 U.S.C. 264.
The longstanding provision on preemption in the event of a conflict
with Federal authority (42 CFR 70.2) is left unchanged by this
rulemaking. Additionally, there are no provisions in these regulations
that impose direct compliance costs on State and local governments.
Therefore, HHS/CDC believes that the rule does not warrant additional
consultation under Executive Order 13132.
G. The Plain Language Act of 2010
Under 63 FR 31883 (June 10, 1998), Executive Departments and
Agencies are required to use plain language in all proposed and final
rules. HHS/CDC received several comments suggesting that the proposed
regulation was not written in plain language and was therefore
difficult to understand. Prior to publication, this final rule was
reviewed by specialists in health communication and education to ensure
the content and intention, as well as substance, were clear and
accurate.
List of Subjects in 70.1, 70.5, 70.6, 70.10-70.18, 71.1, 71.2,
71.4, 71.5, 71.12, 71.20, 71.29, 71.30, 71.36-71.39, 71.63
Apprehension, Communicable diseases, Conditional release, CDC, Ill
person, Isolation, Non-invasive, Public health emergency, Public health
prevention measures, Qualifying stage, Quarantine, Quarantinable
Communicable Disease.
For the reasons discussed in the preamble, we amend 42 CFR parts 70
and 71 as follows:
PART 70--INTERSTATE QUARANTINE
0
1. The authority citation for part 70 continues to read as follows:
Authority: Secs. 215 and 311 of the Public Health Service (PHS)
Act, as amended (42 U.S.C. 216, 243) section 361-369, PHS Act, as
amended (42 U.S.C. 264-272); 31 U.S.C. 9701.
0
2. Amend Sec. 70.1 by--
0
a. Adding in alphabetical order definitions for ``Airline'',
``Apprehension'', and ``Communicable stage'';
0
b. Revising the definition of ``Conditional release'';
0
c. Adding in alphabetical order a definitions for ``Contaminated
environment;''
0
d. Revising the definition of ``Conveyance'';
0
e. Adding in alphabetical order definitions for ``Electronic or
Internet-based monitoring'' and ``Ill person'';
0
f. Revising the definition of ``Incubation period'';
0
g. Adding in alphabetical order a definition for ``Indigent'';
0
h. Revising the definition of ``Interstate traffic'';
0
i. Revising the definition of ``Master or operator'';
0
j. Adding in alphabetical order definitions for ``Medical
examination'', ``Medical reviewer'', ``Non-invasive'',
``Precommunicable stage'', ``Public health emergency'', ``Public health
[[Page 6969]]
prevention measures'', ``Qualifying stage'', ``Reasonably believed to
be infected, as applied to an individual'', and ``Representatives''.
The additions and revisions read as follows:
Sec. 70.1 General definitions.
Airline means any air carrier or foreign air carrier providing air
transportation as that term is defined in 49 U.S.C. 40102(a)(2),
(a)(5), and (a)(21).
Apprehension means the temporary taking into custody of an
individual or group for purposes of determining whether Federal
quarantine, isolation, or conditional release is warranted.
* * * * *
Communicable stage means the stage during which an infectious agent
may be transmitted either directly or indirectly from an infected
individual to another individual.
Conditional release means the temporary supervision by a public
health official (or designee) of an individual or group, who may have
been exposed to a quarantinable communicable disease to determine the
risk of disease spread and includes public health supervision through
in-person visits, telephone, or through electronic or Internet-based
monitoring.
Contaminated environment means the presence of an infectious agent
on a surface, including on inanimate articles, or in a substance,
including food, water, or in the air.
Conveyance means an aircraft, train, road vehicle, vessel (as
defined in this section) or other means of transport, including
military.
* * * * *
Electronic or Internet-based monitoring means mechanisms or
technologies allowing for the temporary public health supervision of an
individual under conditional release and may include communication
through electronic mail, SMS texts, video or audio conference, webcam
technologies, integrated voice-response systems, entry of information
into a Web-based forum, wearable tracking technologies, and other
mechanisms or technologies as determined by the Director or supervising
health authority.
Ill person means an individual who:
(1) Has a fever (a measured temperature of 100.4 [deg]F [38 [deg]C]
or greater, or feels warm to the touch, or gives a history of feeling
feverish) accompanied by one or more of the following: Skin rash,
difficulty breathing, persistent cough, decreased consciousness or
confusion of recent onset, new unexplained bruising or bleeding
(without previous injury), persistent diarrhea, persistent vomiting
(other than air sickness), headache with stiff neck, appears obviously
unwell; or
(2) Has a fever that has persisted for more than 48 hours; or
(3) Has symptoms or other indications of communicable disease, as
the CDC may announce through posting of a notice in the Federal
Register.
Incubation period means the time from the moment of exposure to an
infectious agent that causes a communicable disease until signs and
symptoms of the communicable disease appear in the individual or, if
signs and symptoms do not appear, the latest date signs and symptoms
could reasonably be expected to appear. For a quarantinable
communicable disease, incubation period means the precommunicable
stage.
Indigent means an individual whose annual family income is below
200% of the applicable poverty guidelines updated periodically in the
Federal Register by the U.S. Department of Health and Human Services
under the authority of 42 U.S.C. 9902(2) or, if no income is earned,
liquid assets totaling less than 15% of the applicable poverty
guidelines.
Interstate traffic (1) Means:
(i) The movement of any conveyance or the transportation of persons
or property, including any portion of such movement or transportation
that is entirely within a State or possession--
(ii) From a point of origin in any State or possession to a point
of destination in any other State or possession; or
(iii) Between a point of origin and a point of destination in the
same State or possession but through any other State, possession, or
contiguous foreign country.
(2) Interstate traffic does not include the following:
(i) The movement of any conveyance which is solely for the purpose
of unloading persons or property transported from a foreign country, or
loading persons or property for transportation to a foreign country.
(ii) The movement of any conveyance which is solely for the purpose
of effecting its repair, reconstruction, rehabilitation, or storage.
* * * * *
Master or operator with respect to a vessel, means the sea crew
member with responsibility for vessel operation and navigation, or a
similar individual with responsibility for a conveyance. Consistent
with the definition of ``operate'' in 14 CFR 1.1, ``operator'' means,
with respect to aircraft, any person who uses, causes to use, or
authorizes to use an aircraft, for the purpose (except as provided in
14 CFR 91.13) of air navigation including the piloting of an aircraft,
with or without the right of legal control (as owner, lessee, or
otherwise).
Medical examination means the assessment of an individual by an
authorized and licensed health worker to determine the individual's
health status and potential public health risk to others and may
include the taking of a medical history, a physical examination, and
collection of human biological samples for laboratory testing as may be
needed to diagnose or confirm the presence or extent of infection with
a quarantinable communicable disease.
Medical reviewer means a physician, nurse practitioner, or similar
medical professional qualified in the diagnosis and treatment of
infectious diseases who is appointed by the Secretary or Director to
conduct medical reviews under this part and may include an HHS or CDC
employee, provided that the employee differs from the CDC official who
issued the Federal order for quarantine, isolation, or conditional
release.
Non-invasive means procedures conducted by an authorized public
health worker (i.e., an individual with education and training in the
field of public health) or another individual with suitable public
health training and includes the visual examination of the ear, nose,
and mouth; temperature assessments using an ear, oral, cutaneous, or
noncontact thermometer, or thermal imaging; and other procedures not
involving the puncture or incision of the skin or insertion of an
instrument or foreign material into the body or a body cavity excluding
the ear, nose, and mouth.
* * * * *
Precommunicable stage means the stage beginning upon an
individual's earliest opportunity for exposure to an infectious agent
and ending upon the individual entering or reentering the communicable
stage of the disease or, if the individual does not enter the
communicable stage, the latest date at which the individual could
reasonably be expected to have the potential to enter or reenter the
communicable stage.
Public health emergency as used in this part means:
(1) Any communicable disease event as determined by the Director
with either documented or significant potential for regional, national,
or international communicable disease spread or that is highly likely
to cause death or serious illness if not properly controlled; or
(2) Any communicable disease event described in a declaration by
the
[[Page 6970]]
Secretary pursuant to 319(a) of the Public Health Service Act (42
U.S.C. 247d (a)); or
(3) Any communicable disease event the occurrence of which is
notified to the World Health Organization, in accordance with Articles
6 and 7 of the International Health Regulations, as one that may
constitute a Public Health Emergency of International Concern; or
(4) Any communicable disease event the occurrence of which is
determined by the Director-General of the World Health Organization, in
accordance with Article 12 of the International Health Regulations, to
constitute a Public Health Emergency of International Concern; or
(5) Any communicable disease event for which the Director-General
of the World Health Organization, in accordance with Articles 15 or 16
of the International Health Regulations, has issued temporary or
standing recommendations for purposes of preventing or promptly
detecting the occurrence or reoccurrence of the communicable disease.
Public health prevention measures means the assessment of an
individual through non-invasive procedures and other means, such as
observation, questioning, review of travel documents, records review,
and other non-invasive means, to determine the individual's health
status and potential public health risk to others.
Qualifying stage is statutorily defined (42 U.S.C. 264(d)(2)) to
mean:
(1) The communicable stage of a quarantinable communicable disease;
or
(2) The precommunicable stage of the quarantinable communicable
disease, but only if the quarantinable communicable disease would be
likely to cause a public health emergency if transmitted to other
individuals.
* * * * *
Reasonably believed to be infected, as applied to an individual,
means specific articulable facts upon which a public health officer
could reasonably draw the inference that an individual has been
exposed, either directly or indirectly, to the infectious agent that
causes a quarantinable communicable disease, as through contact with an
infected person or an infected person's bodily fluids, a contaminated
environment, or through an intermediate host or vector, and that as a
consequence of the exposure, the individual is or may be harboring in
the body the infectious agent of that quarantinable communicable
disease.
Representatives means a physician, nurse practitioner, or similar
medical professional qualified in the diagnosis and treatment of
infectious diseases, and an attorney who is knowledgeable of public
health practices, who are appointed by the Secretary or Director and
may include HHS or CDC employees, to assist an indigent individual
under Federal quarantine, isolation, or conditional release with a
medical review under this part.
* * * * *
Secretary means the Secretary of Health and Human Services (HHS) or
any other officer or employee of that Department to whom the authority
involved has been delegated.
* * * * *
0
3. Revise Sec. 70.5 to read as follows:
Sec. 70.5 Requirements relating to travelers under a Federal order
of isolation, quarantine, or conditional release.
(a) The following provisions are applicable to any individual under
a Federal order of isolation, quarantine, or conditional release with
regard to a quarantinable communicable disease or to any individual
meeting the requirements of paragraph (d), (e), or (f) of this section:
(1) Except as specified under the terms of a Federal conditional
release order, no such individual shall travel in interstate traffic or
from one State or U.S. territory to another without a written travel
permit issued by the Director.
(2) Requests for a travel permit must state the reasons why the
travel is being requested, mode of transportation, the places or
individuals to be visited, the precautions, if any, to be taken to
prevent the potential transmission or spread of the communicable
disease, and other information as determined necessary by the Director
to assess the individual's health condition and potential for
communicable disease spread to others.
(3) The Director will consider all requests for a permit and,
taking into consideration the risk of introduction, transmission, or
spread of the communicable disease, may condition the permit upon
compliance with such precautionary measures as the Director shall
prescribe. The Director shall respond to a request for a permit within
5 business days.
(4) An individual to whom a permit has been issued shall retain it
in his/her possession throughout the course of his/her authorized
travel and comply with all conditions prescribed therein, including
presentation of the permit to the operators of conveyances, as required
by its terms.
(5) An individual who has had his/her request for a permit denied,
or who has had a travel permit suspended or revoked, may submit a
written appeal to the Director (excluding the CDC official who denied,
suspended, or revoked the permit). The appeal must be in writing, state
the factual basis for the appeal, and be submitted to the Director
(excluding the CDC official who denied, suspended, or revoked the
permit) within 10 calendar days of the denial, suspension, or
revocation of the permit. The Director (excluding the CDC official who
denied, suspended, or revoked the permit) will issue a written response
to the appeal within 3 business days, which shall constitute final
agency action.
(b) The operator of any conveyance operating in interstate traffic
shall not:
(1) Accept for transportation any individual whom the operator
knows, or reasonably should know, to be under a Federal order of
isolation, quarantine, or conditional release, unless such an
individual presents a permit issued by the Director or a copy of the
Federal conditional release order authorizing such travel;
(2) Transport any individual whom the operator knows, or reasonably
should know, to be under a Federal order of isolation, quarantine, or
conditional release in violation of any of the terms or conditions
prescribed in the travel permit or conditional release order issued by
the Director.
(c) Whenever a conveyance operating in interstate traffic
transports an individual under a Federal order or travel permit, the
Director may require that the operator of the conveyance submit the
conveyance to inspection, sanitary measures, and other measures, as the
Director deems necessary to prevent the possible spread of communicable
disease.
(d) The Director may additionally apply the provisions in
paragraphs (a) through (c) of this section to individuals traveling
entirely intrastate and to conveyances that transport such individuals
upon the request of a State or local health authority of jurisdiction.
The Director shall consider the State or local health authority's
request for assistance and taking into consideration the risk of
introduction, transmission, or spread of the communicable disease,
grant or deny, in his/her discretion, the request for assistance.
(e) The Director may additionally apply the provisions in
paragraphs (a) through of this section (c) to individuals traveling
interstate or entirely intrastate and to conveyances that transport
such individuals whenever the Director makes a determination under 42
CFR 70.2 that based on the existence of inadequate local control such
measures are needed to prevent the spread of any
[[Page 6971]]
of the communicable diseases from such State or U.S. territory to any
other State or U.S. territory.
(f) The Director may additionally apply the provisions in
paragraphs (a) through (c) of this section to individuals under a State
or local order, or written agreement, for quarantine, isolation, or
conditional release and to conveyances that may transport such
individuals, upon the request of a State or local health authority of
jurisdiction or whenever the Director makes a determination of
inadequate local control under 42 CFR 70.2. The Director shall consider
the State or local health authority's request for assistance and taking
into consideration the risk of introduction, transmission, or spread of
the communicable disease, grant or deny, in his/her discretion, the
request for assistance.
(g) The Director may exempt individuals and non-public conveyances,
such as ambulances, air ambulance flights, or private vehicles, from
the requirements of this section.
0
4. Revise Sec. 70.6 to read as follows:
Sec. 70.6 Apprehension and detention of persons with quarantinable
communicable diseases.
(a) The Director may authorize the apprehension, medical
examination, quarantine, isolation, or conditional release of any
individual for the purpose of preventing the introduction,
transmission, and spread of quarantinable communicable diseases, as
specified by Executive Order, based upon a finding that:
(1) The individual is reasonably believed to be infected with a
quarantinable communicable disease in a qualifying stage and is moving
or about to move from a State into another State; or
(2) The individual is reasonably believed to be infected with a
quarantinable communicable disease in a qualifying stage and
constitutes a probable source of infection to other individuals who may
be moving from a State into another State.
(b) The Director will arrange for adequate food and water,
appropriate accommodation, appropriate medical treatment, and means of
necessary communication for individuals who are apprehended or held in
quarantine or isolation under this part.
0
5. Add Sec. Sec. 70.10 through 70.18 to read as follows:
Sec.
* * * * *
70.10 Public health prevention measures to detect communicable
disease.
70.11 Report of death or illness onboard aircraft operated by an
airline.
70.12 Medical examinations.
70.13 Payment for care and treatment.
70.14 Requirements relating to the issuance of a Federal order for
quarantine, isolation, or conditional release.
70.15 Mandatory reassessment of a Federal order for quarantine,
isolation, or conditional release.
70.16 Medical review of a Federal order for quarantine, isolation,
or conditional release.
70.17 Administrative records relating to Federal quarantine,
isolation, or conditional release.
70.18 Penalties.
Sec. 70.10 Public health prevention measures to detect communicable
disease.
(a) The Director may conduct public health prevention measures at
U.S. airports, seaports, railway stations, bus terminals, and other
locations where individuals may gather to engage in interstate travel,
through non-invasive procedures determined appropriate by the Director
to detect the presence of communicable diseases.
(b) As part of the public health prevention measures, the Director
may require individuals to provide contact information such as U.S. and
foreign addresses, telephone numbers, email addresses, and other
contact information, as well as information concerning their intended
destination, health status, known or possible exposure history, and
travel history.
Sec. 70.11 Report of death or illness onboard aircraft operated by
an airline.
(a) The pilot in command of an aircraft operated by an airline who
is conducting a commercial passenger flight in interstate traffic under
a regular schedule shall report as soon as practicable to the Director
the occurrence onboard of any deaths or the presence of ill persons
among passengers or crew and take such measures as the Director may
direct to prevent the potential spread of the communicable disease,
provided that such measures do not affect the airworthiness of the
aircraft or the safety of flight operations.
(b) The pilot in command of an aircraft operated by an airline who
reports in accordance with paragraph (a) of this section shall be
deemed to satisfy the reporting obligation under 42 CFR 70.4.
Sec. 70.12 Medical examinations.
(a) The Director may require an individual to undergo a medical
examination as part of a Federal order for quarantine, isolation, or
conditional release for a quarantinable communicable disease.
(b) The Director shall promptly arrange for the medical examination
to be conducted when one is required under this section and shall as
part of the Federal order advise the individual that the medical
examination shall be conducted by an authorized and licensed health
worker, and with prior informed consent.
(c) As part of the medical examination, the Director may require an
individual to provide information and undergo such testing as may be
reasonably necessary to diagnose or confirm the presence or extent of
infection with a quarantinable communicable disease.
(d) Individuals reasonably believed to be infected based on the
results of a medical examination may be isolated, or if such results
are inconclusive or unavailable, individuals may be quarantined or
conditionally released in accordance with this part.
Sec. 70.13 Payment for care and treatment.
(a) The Director may authorize payment for the care and treatment
of individuals subject to medical examination, quarantine, isolation,
and conditional release, subject to paragraphs (b) through (h) of this
section.
(b) Payment for care and treatment shall be in the CDC's sole
discretion and subject to the availability of appropriations.
(c) Payment shall be secondary to the obligation of the United
States or any third-party (i.e., any State or local governmental
entity, private insurance carrier, or employer), under any other law or
contractual agreement, to pay for such care and treatment, and shall be
paid by the Director only after all third-party payers have made
payment in satisfaction of their obligations.
(d) Payment may include costs for providing ambulance or other
medical transportation when such services are deemed necessary by the
Director for the individual's care and treatment.
(e) Payment shall be limited to those amounts the hospital, medical
facility, or medical transportation service would customarily bill the
Medicare system using the International Classification of Diseases,
Clinical Modification (ICD-CM), and relevant regulations promulgated by
the Centers for Medicare and Medicaid Services in existence at the time
of billing.
(f) For quarantinable communicable diseases, payment shall be
limited to costs for services and items reasonable and necessary for
the care and treatment of the individual or group for the time period
beginning when the Director refers the individual or group to the
hospital or medical facility and ends when, as determined by the
Director,
[[Page 6972]]
the period of apprehension, quarantine, isolation, or conditional
release expires.
(g) For diseases other than those described in paragraph (f) of
this section, such payment shall be limited to costs for services and
items reasonable and necessary for care and treatment of the individual
for the time period that begins when the Director refers the individual
to the hospital or medical facility and ends when the individual's
condition is diagnosed, as determined by the Director, as an illness
other than a quarantinable communicable disease.
(h) For ambulance or other medical transportation, payment shall be
limited to the costs for such services and other items reasonable and
necessary for the individual's safe medical transport.
Sec. 70.14 Requirements relating to the issuance of a Federal order
for quarantine, isolation, or conditional release.
(a) A Federal order authorizing quarantine, isolation, or
conditional release shall be in writing, signed by the Director, and
contain the following information:
(1) The identity of the individual or group subject to the order;
(2) The location of the quarantine or isolation or, in the case of
conditional release, the entity to who and means by which the
individual shall report for public health supervision;
(3) An explanation of the factual basis underlying the Director's
reasonable belief that the individual is in the qualifying stage of a
quarantinable communicable disease;
(4) An explanation of the factual basis underlying the Director's
reasonable belief that the individual is moving or about to move from
one State into another or constitutes a probable source of infection to
others who may be moving from one State into another;
(5) An explanation that the Federal order will be reassessed no
later than 72 hours after it has been served and an explanation of the
medical review of the Federal order pursuant to this part, including
the right to request a medical review, present witnesses and testimony
at the medical review, and to be represented at the medical review by
either an advocate (e.g., an attorney, family member, or physician) at
the individual's own expense, or, if indigent, to have representatives
appointed at the government's expense;
(6) An explanation of the criminal penalties for violating a
Federal order of quarantine, isolation, or conditional release; and
(7) An explanation that if a medical examination is required as
part of the Federal order that the examination will be conducted by an
authorized and licensed health worker, and with prior informed consent.
(b) A Federal order authorizing quarantine, isolation, or
conditional release shall be served on the individual no later than 72
hours after the individual has been apprehended, except that the
Federal order may be published or posted in a conspicuous location if
the Federal order is applicable to a group of individuals and
individual service would be impracticable.
(c) The Director shall arrange for translation or interpretation
services of the Federal order as needed.
(d) Nothing in this section shall affect the constitutional or
statutory rights of individuals to obtain judicial review of their
Federal detention.
Sec. 70.15 Mandatory reassessment of a Federal order for quarantine,
isolation, or conditional release.
(a) The Director (excluding the CDC official who issued the
quarantine, isolation, or conditional release order) shall reassess the
need to continue the quarantine, isolation, or conditional release of
an individual no later than 72 hours after the service of the Federal
order.
(b) As part of the reassessment, the Director (excluding the CDC
official who issued the quarantine, isolation, or conditional release
order) shall review all records considered in issuing the Federal
order, including travel records, records evidencing exposure or
infection with a quarantinable communicable disease, as well as any
relevant new information.
(c) As part of the reassessment, and where applicable, the Director
(excluding the CDC official who issued the quarantine, isolation, or
conditional release order) shall consider and make a determination
regarding whether less restrictive alternatives would adequately serve
to protect the public health.
(d) At the conclusion of the reassessment, the Director (excluding
the CDC official who issued the quarantine, isolation, or conditional
release order) shall promptly issue and serve a written Federal order
directing that the quarantine, isolation, or conditional release be
continued, modified, or rescinded.
(e) In the event that the Director orders that the quarantine,
isolation, or conditional release be continued or modified, the written
Federal order shall explain the process for requesting a medical review
under this part.
(f) The Director's written Federal order shall be promptly served
on the individual, except that the Federal order may be served by
publication or by posting in a conspicuous location if the Federal
order is applicable to a group of individuals and individual service
would be impracticable.
(g) The Director shall arrange for translation or interpretation
services of the Federal order as needed.
Sec. 70.16 Medical review of a Federal order for quarantine,
isolation, or conditional release.
(a) The Director shall, as soon as practicable, arrange for a
medical review upon a request by an individual under Federal
quarantine, isolation, or conditional release.
(b) A request for a medical review may only occur after the
Director's mandatory reassessment under section 70.15 and following the
service of a Federal order continuing or modifying the quarantine,
isolation, or conditional release.
(c) The medical review shall be for the purpose of ascertaining
whether the Director has a reasonable belief that the individual is
infected with a quarantinable communicable disease in a qualifying
stage.
(d) The Director shall notify the individual in writing of the time
and place of the medical review.
(e) The Director (excluding the CDC official who issued the
quarantine, isolation, or conditional release order) shall designate a
medical reviewer to review the medical or other evidence presented at
the review, make medical or other findings of fact, and issue a
recommendation concerning whether the Federal order for quarantine,
isolation, or conditional release should be rescinded, continued, or
modified.
(f) The individual under Federal quarantine, isolation, or
conditional release may authorize an advocate (e.g., an attorney,
family member, or physician) at his or her own expense to submit
medical or other evidence and, in the medical reviewer's discretion, be
allowed to present a reasonable number of medical experts. The Director
(excluding the CDC official who issued the quarantine, isolation, or
conditional release order) shall appoint representatives at government
expense to assist the individual for purposes of the medical review
upon a request and certification, under penalty of perjury, by that
individual that he or she is indigent.
(g) Prior to the convening of the review, the individual or his/her
authorized advocate or representatives shall be provided a reasonable
opportunity to examine the available medical and other records involved
in
[[Page 6973]]
the medical review that pertain to that individual.
(h) The Director shall take such measures that he/she determines to
be reasonably necessary to allow an individual under Federal quarantine
or isolation to communicate with any authorized advocate or
representatives in such a manner as to prevent the possible spread of
the quarantinable communicable disease.
(i) The medical reviewer may order a medical examination of an
individual when, in the medical reviewer's professional judgment, such
an examination would assist in assessing the individual's medical
condition.
(j) As part of the review, and where applicable, the medical
reviewer shall consider and accept into the record evidence concerning
whether less restrictive alternatives would adequately serve to protect
public health.
(k) The medical review shall be conducted by telephone, audio or
video conference, or through other means that the medical reviewer
determines in his/her discretion are practicable for allowing the
individual under quarantine, isolation, or conditional release to
participate in the medical review.
(l) At the conclusion of the review, the medical reviewer shall,
based upon his or her review of the facts and other evidence made
available during the medical review, issue a written report to the
Director (excluding the CDC official who issued the quarantine,
isolation, or conditional release order) concerning whether, in the
medical reviewer's professional judgment, the Federal quarantine,
isolation, or conditional release should be rescinded, continued, or
modified. The written report shall include a determination regarding
whether less restrictive alternatives would adequately serve to protect
public health. The written report shall be served on the individual and
the individual's authorized advocate or representatives.
(m) The Director (excluding the CDC official who issued the
quarantine, isolation, or conditional release order) shall, as soon as
practicable, review the written report and any objections that may be
submitted by the individual or the individual's authorized advocate or
representatives that contest the findings and recommendation contained
in the medical reviewer's written report. Upon conclusion of the
review, the Director (excluding the CDC official who issued the
quarantine, isolation, or conditional release order) shall promptly
issue a written Federal order directing that the quarantine, isolation,
or conditional release be continued, modified, or rescinded. In the
event that the Director (excluding the CDC official who issued the
quarantine, isolation, or conditional release order) continues or
modifies the Federal quarantine, isolation, or conditional release, the
Director's written order shall include a statement that the individual
may request that the Director rescind the Federal quarantine,
isolation, or conditional release, but based only on a showing of
significant, new or changed facts or medical evidence that raise a
genuine issue as to whether the individual should continue to be
subject to Federal quarantine, isolation, or conditional release. The
written Federal order shall be promptly served on the individual and
the individual's authorized advocate or representatives, except that
the Federal order may be served by publication or by posting in a
conspicuous location if applicable to a group of individuals and
individual service would be impracticable.
(n) The Director's written order shall not constitute final agency
action until it has been served on the individual and the individual's
authorized advocate or representatives, or alternatively, if applicable
to a group of individuals and individual service would be
impracticable, it is published or posted.
(o) The Director (excluding the CDC official who issued the
quarantine, isolation, or conditional release order) may order the
consolidation of one or more medical reviews if the number of
individuals or other factors makes the holding of individual medical
reviews impracticable.
(p) The Director may issue additional instructions as may be
necessary or desirable governing the conduct of medical reviews.
(q) The Director shall arrange for translation or interpretation
services as needed for purposes of this section.
Sec. 70.17 Administrative records relating to Federal quarantine,
isolation, or conditional release.
(a) The administrative record of an individual under Federal
quarantine, isolation, or conditional release shall, where applicable,
consist of the following:
(1) The Federal order authorizing quarantine, isolation, or
conditional release, including any subsequent Federal orders continuing
or modifying the quarantine, isolation or conditional release;
(2) Records of any available medical, laboratory, or other
epidemiologic information that are in the agency's possession and that
were considered in issuing the Federal quarantine, isolation, or
conditional release order, or any subsequent Federal orders;
(3) Records submitted by the individual under quarantine,
isolation, or conditional release, or by an authorized advocate or
representatives, as part of a request for rescission of the Federal
quarantine, isolation, or conditional release or as part of a medical
review;
(4) The written findings and report of the medical reviewer,
including any transcripts of the medical review and any written
objections submitted by the individual under Federal quarantine,
isolation, or conditional release, or by any authorized advocate or
representatives;
(b) An individual subject to a Federal public health order shall
upon request be served with a copy of his or her own administrative
record in its entirety.
Sec. 70.18 Penalties.
(a) Persons in violation of this part are subject to a fine of no
more than $100,000 if the violation does not result in a death or one
year in jail, or both, or a fine of no more than $250,000 if the
violation results in a death or one year in jail, or both, or as
otherwise provided by law.
(b) Violations by organizations are subject to a fine of no more
than $200,000 per event if the violation does not result in a death or
$500,000 per event if the violation results in a death or as otherwise
provided by law.
PART 71--FOREIGN QUARANTINE
0
6. The authority citation for part 71 continues to read as follows:
Authority: Secs. 215 and 311 of the Public Health Service (PHS)
Act, as amended (42 U.S.C. 216, 243) section 361-369, PHS Act, as
amended (42 U.S.C. 264-272).
0
7. Amend Sec. 71.1, paragraph (b), by--
0
a. Adding in alphabetical order definitions for ``Airline'' and
``Apprehension'';
0
b. Revising the definition of ``Commander'';
0
c. Adding in alphabetical order definitions for ``Conditional
release'', ``Contaminated environment'', and ``Electronic or Internet-
based monitoring'';
0
d. Revising the definition of ``Ill person'';
0
e. Adding in alphabetical order a definition for ``Indigent'';
0
f. Revising the definition of ``International voyage'';
0
g. Adding in alphabetical order definitions for ``Master or operator'',
``Medical examination'', ``Medical reviewer'', ``Non-invasive'',
``Public health prevention measures'', ``Representatives'', and
``Secretary''.
[[Page 6974]]
The additions and revisions read as follows:
Sec. 71.1 General definitions.
* * * * *
(b) * * *
Airline means any air carrier or foreign air carrier providing air
transportation, as that term is defined in 49 U.S.C. 40102(a)(2),
(a)(5), and (a)(21).
Apprehension means the temporary taking into custody of an
individual or group for purposes of determining whether quarantine,
isolation, or conditional release is warranted.
* * * * *
Commander means the pilot in command of an aircraft as defined in
14 CFR 1.1.
* * * * *
Conditional release means surveillance as defined under this part
and includes public health supervision through in-person visits by a
health official or designee, telephone, or through any electronic or
internet-based means as determined by the Director.
Contaminated environment means the presence of an infectious agent
on a surface, including on inanimate articles, or in a substance,
including food, water, or in the air.
* * * * *
Electronic or internet-based monitoring means mechanisms or
technologies allowing for the temporary public health supervision of an
individual under conditional release and may include communication
through electronic mail, SMS texts, video or audio conference, webcam
technologies, integrated voice-response systems, entry of information
into a web-based forum, wearable tracking technologies, and other
mechanisms or technologies as determined by the Director.
Ill person means an individual:
(i) Who if onboard an aircraft:
(A) Has a fever (a measured temperature of 100.4 [deg]F [38 [deg]C]
or greater, or feels warm to the touch, or gives a history of feeling
feverish) accompanied by one or more of the following: Skin rash,
difficulty breathing, persistent cough, decreased consciousness or
confusion of recent onset, new unexplained bruising or bleeding
(without previous injury), persistent diarrhea, persistent vomiting
(other than air sickness), headache with stiff neck, appears obviously
unwell; or
(B) Has a fever that has persisted for more than 48 hours; or
(C) Has symptoms or other indications of communicable disease, as
the Director may announce through posting of a notice in the Federal
Register.
(ii) Who if onboard a vessel:
(A) Has a fever (a measured temperature of 100.4 [deg]F [38 [deg]C]
or greater; or feels warm to the touch; or gives a history of feeling
feverish) accompanied by one or more of the following: Skin rash,
difficulty breathing or suspected or confirmed pneumonia, persistent
cough or cough with bloody sputum, decreased consciousness or confusion
of recent onset, new unexplained bruising or bleeding (without previous
injury), persistent vomiting (other than sea sickness), headache with
stiff neck; or
(B) Has a fever that has persisted for more than 48 hours; or
(C) Has acute gastroenteritis, which means either diarrhea, defined
as three or more episodes of loose stools in a 24-hour period or what
is above normal for the individual, or vomiting accompanied by one or
more of the following: One or more episodes of loose stools in a 24-
hour period, abdominal cramps, headache, muscle aches, or fever
(temperature of 100.4 [deg]F [38 [deg]C] or greater); or
(D) Has symptoms or other indications of communicable disease, as
the Director may announce through posting of a notice in the Federal
Register.
Indigent means an individual whose annual family income is below
200% of the applicable poverty guidelines updated periodically in the
Federal Register by the U.S. Department of Health and Human Services
under the authority of 42 U.S.C. 9902(2) or, if no income is earned,
liquid assets totaling less than 15% of the applicable poverty
guidelines.
* * * * *
International voyage means:
(i) In the case of a carrier, a voyage between ports or airports of
more than one country, or a voyage between ports or airports of the
same country if the ship or aircraft stopped in any other country on
its voyage; or
(ii) In the case of a person, a voyage involving entry into a
country other than the country in which that person begins his/her
voyage.
* * * * *
Master or operator with respect to a vessel, means the sea crew
member with responsibility for vessel operation and navigation, or a
similar individual with responsibility for a carrier. Consistent with
the definition of ``operate'' in 14 CFR 1.1, ``operator'' means, with
respect to aircraft, any person who uses, causes to use or authorizes
to use aircraft, for the purpose (except as provided in 14 CFR 91.13)
of air navigation including the piloting of aircraft, with or without
the right of legal control (as owner, lessee, or otherwise).
Medical examination means the assessment of an individual by an
authorized and licensed health worker to determine the individual's
health status and potential public health risk to others and may
include the taking of a medical history, a physical examination, and
collection of human biological samples for laboratory testing as may be
needed to diagnose or confirm the presence or extent of infection with
a quarantinable communicable disease.
Medical reviewer means a physician, nurse practitioner, or similar
medical professional qualified in the diagnosis and treatment of
infectious diseases who is appointed by the Secretary or Director to
conduct medical reviews under this part and may include an HHS or CDC
employee, provided that the employee differs from the CDC official who
issued the Federal order for quarantine, isolation, or conditional
release.
* * * * *
Non-invasive means procedures conducted by an authorized public
health worker (i.e., an individual with education and training in the
field of public health) or another individual with suitable public
health training and includes the visual examination of the ear, nose,
and mouth; temperature assessments using an ear, oral, cutaneous, or
noncontact thermometer, or thermal imaging; and other procedures not
involving the puncture or incision of the skin or insertion of an
instrument or foreign material into the body or a body cavity excluding
the ear, nose, and mouth.
* * * * *
Public health prevention measures means the assessment of an
individual through non-invasive procedures and other means, such as
observation, questioning, review of travel documents, records review,
and other non-invasive means, to determine the individual's health
status and potential public health risk to others.
Representatives means a physician, nurse practitioner, or similar
medical professional qualified in the diagnosis and treatment of
infectious diseases, and an attorney who is knowledgeable of public
health practices, who are appointed by the Secretary or Director and
may include HHS or CDC employees, to assist an indigent individual
under Federal quarantine, isolation, or conditional release with a
medical review under this part.
* * * * *
Secretary means the Secretary of Health and Human Services (HHS) or
[[Page 6975]]
any other officer or employee of that Department to whom the authority
involved has been delegated.
* * * * *
0
8. Revise Sec. 71.2 to read as follows:
Sec. 71.2 Penalties.
(a) Persons in violation of this part are subject to a fine of no
more than $100,000 if the violation does not result in a death or one
year in jail, or both, or a fine of no more than $250,000 if the
violation results in a death or one year in jail, or both, or as
otherwise provided by law. (b) Violations by organizations are subject
to a fine of no more than $200,000 per event if the violation does not
result in a death or $500,000 per event if the violation results in a
death or as otherwise provided by law.
0
9. Add 71.4 to subpart A to read as follows:
Sec. 71.4 Requirements relating transmission of airline passenger,
crew and flight information for public health purposes.
(a) Any airline with a flight arriving into the United States,
including any intermediate stops between the flight's origin and final
destination, shall make the data elements in paragraph (b) of this
section available to the Director for passengers or crew who, as
determined by the Director, may be at risk of exposure to a
communicable disease, to the extent that such data are already
available and maintained by the airline, within 24 hours of an order by
the Director and in a format available and acceptable to both the
airline and the Director.
(b) The data elements referred to in paragraph (a) of this section
include:
(1) Full name (last, first, and, if available, middle or others);
(2) Date of birth;
(3) Sex;
(4) Country of residence;
(5) If a passport is required: Passport number, passport country of
issuance, and passport expiration date;
(6) If a travel document other than a passport is required: Travel
document type, travel document number, travel document country of
issuance and travel document expiration date;
(7) Address while in the United States (number and street, city,
State, and zip code), except that U.S. citizens and lawful permanent
residents will provide address of permanent residence in the U.S.
(number and street, city, State, and zip code);
(8) Primary contact phone number to include country code;
(9) Secondary contact phone number to include country code;
(10) Email address;
(11) Airline name;
(12) Flight number;
(13) City of departure;
(14) Departure date and time;
(15) City of arrival;
(16) Arrival date and time; and
(17) Seat number.
(c) No later than February 18, 2019, the Secretary or Director will
publish and seek comment on a report evaluating the burden of this
section on affected entities and duplication of activities in relation
to mandatory passenger data submissions to DHS/CBP. The report will
specifically recommend actions that streamline and facilitate use and
transmission of any duplicate information collected.
0
10. Add Sec. 71.5 to subpart A to read as follows:
Sec. 71.5 Requirements relating transmission of vessel passenger,
crew, and voyage information for public health purposes.
(a) The operator of any vessel carrying 13 or more passengers
(excluding crew) and, which is not a ferry as defined under 46 U.S.C.
2101 and U.S. Coast Guard (USCG) regulations (46 CFR 2.10-25), shall
make the data elements in paragraph (b) of this section available to
the Director for passengers or crew who, as determined by the Director,
may be at risk of exposure to a communicable disease, to the extent
that such data are already in the operator's possession, within 24
hours of an order by the Director and in a format available and
acceptable to both the operator and the Director.
(b) The data elements referred to in paragraph (a) of this section
include:
(1) Full name (last, first, and, if available middle or others);
(2) Date of birth;
(3) Sex;
(4) Country of residence;
(5) If a passport is required: Passport number, passport country of
issuance, and passport expiration date;
(6) If a travel document other than a passport is required: Travel
document type, travel document number, travel document country of
issuance and travel document expiration date;
(7) Address while in the United States (number and street, city,
State, and zip code), except that U.S. citizens and lawful permanent
residents will provide address of permanent residence in the United
States (number and street, city, State, and zip code; as applicable);
(8) Primary contact phone number to include country code;
(9) Secondary contact phone number to include country code;
(10) Email address;
(11) Vessel operator;
(12) Vessel name;
(13) Voyage number;
(14) Embarkation port and date;
(15) Disembarkation port and date;
(16) All port stops; and
(17) Cabin number.
(c) No later than February 21, 2019, the Secretary or Director will
publish and seek comment on a report evaluating the burden of this
section on affected entities and duplication of activities in relation
to mandatory passenger data submissions to DHS/CBP. The report will
specifically recommend actions that streamline and facilitate use and
transmission of any duplicate information collected.
0
11. Add Sec. 71.20 to subpart C to read as follows:
Sec. 71.20 Public health prevention measures to detect communicable
disease.
(a) The Director may conduct public health prevention measures, at
U.S. ports of entry or other locations, through non-invasive procedures
as defined in section 71.1 to detect the potential presence of
communicable diseases.
(b) As part of the public health prevention measures, the Director
may require individuals to provide contact information such as U.S. and
foreign addresses, telephone numbers, email addresses, and other
contact information, as well as information concerning their intended
destination, health status, known or possible exposure history, and
travel history.
0
12. Add Sec. Sec. 71.29 and 71.30 to subpart D to read as follows:
Sec. 71.29 Administrative records relating to quarantine, isolation,
or conditional release.
(a) The administrative record of an individual under quarantine,
isolation, or conditional release shall, where applicable, consist of
the following:
(1) The Federal order authorizing quarantine, isolation, or
conditional release, including any subsequent Federal orders continuing
or modifying the quarantine, isolation or conditional release;
(2) Records of any available medical, laboratory, or other
epidemiologic information that are in the agency's possession and that
were considered in issuing the Federal quarantine, isolation, or
conditional release order, or any subsequent Federal orders;
(3) Records submitted by the individual under quarantine,
isolation, or conditional release, or by an authorized advocate or
representatives, as part of a request for rescission of the quarantine,
isolation, or conditional release or as part of a medical review;
(4) The written findings and report of the medical reviewer,
including any transcripts of the medical review and any written
objections submitted by the
[[Page 6976]]
individual under Federal quarantine, isolation, or conditional release,
or by an authorized advocate or representatives;
(b) An individual subject to a Federal public health order shall,
upon request, be served with a copy of his or her own administrative
record in its entirety.
Sec. 71.30 Payment for care and treatment.
(a) The Director may authorize payment for the care and treatment
of individuals subject to medical examination, quarantine, isolation,
and conditional release, subject to paragraphs (b) through (h) of this
section.
(b) Payment for care and treatment shall be in the Director's sole
discretion and subject to the availability of appropriations.
(c) Payment shall be secondary to the obligation of the United
States or any third-party (including any State or local governmental
entity, private insurance carrier, or employer), under any other law or
contractual agreement, to pay for such care and treatment, and shall be
paid by the Director only after all third-party payers have made
payment in satisfaction of their obligations.
(d) Payment may include costs for providing ambulance or other
medical transportation when such services are deemed necessary by the
Director for the individual's care and treatment.
(e) Payment shall be limited to those amounts the hospital, medical
facility, or medical transportation service would customarily bill the
Medicare system using the International Classification of Diseases,
Clinical Modification (ICD-CM), and relevant regulations promulgated by
the Centers for Medicare and Medicaid Services in existence at the time
of billing.
(f) For quarantinable communicable diseases, payment shall be
limited to costs for services and items reasonable and necessary for
the care and treatment of the individual for the time period beginning
when the Director refers the individual to the hospital or medical
facility and ends when, as determined by the Director, the period of
apprehension, quarantine, isolation, or conditional release expires.
(g) For diseases other than those described in paragraph (f) of
this section, such payment shall be limited to costs for services and
items reasonable and necessary for care and treatment of the individual
for the time period that begins when the Director refers the individual
to the hospital or medical facility and ends when the individual's
condition is diagnosed, as determined by the Director, as an illness
other than a quarantinable communicable disease.
(h) For ambulance or other medical transportation, payment shall be
limited to the costs for such services and other items reasonable and
necessary for the safe medical transport of the individual.
0
13. Amend Sec. 71.33 by revising paragraphs (a) and (c) to read as
follows:
Sec. 71.33 Persons: Isolation and surveillance.
(a) The Director will arrange for adequate food and water,
appropriate accommodation, appropriate medical treatment, and means of
necessary communication for persons who are apprehended or held in
isolation or quarantine under this subpart.
* * * * *
(c) Every person who is placed under surveillance by authority of
this subpart shall, during the period of surveillance:
(1) Give information relative to his/her health and his/her
intended destination and submit to surveillance, including electronic
and internet-based monitoring as required by the Director or by the
State or local health department having jurisdiction over the areas to
be visited, and report for such medical examinations as may be
required.
(2) Inform the Director prior to departing the United States or
prior to traveling to any address other than that stated as the
intended destination.
* * * * *
0
14. Add Sec. Sec. 71.36 through 71.39 to subpart D to read as follows:
Sec.
* * * * *
71.36 Medical examinations.
71.37 Requirements relating to the issuance of a Federal order for
quarantine, isolation, or conditional release.
71.38 Mandatory reassessment of a Federal order for quarantine,
isolation, or conditional release (surveillance).
71.39 Medical review of a Federal order for quarantine, isolation,
or conditional release.
Sec. 71.36 Medical examinations.
(a) The Director may require that an individual arriving into the
United States undergo a medical examination as part of a Federal order
for quarantine, isolation, or conditional release.
(b) The Director shall promptly arrange for the medical examination
to be conducted when one is required under this section and shall as
part of the Federal order advise the individual that the medical
examination shall be conducted by an authorized and licensed health
worker, and with prior informed consent.
(c) As part of the medical examination, the Director may require
that an individual provide information and undergo such testing, as may
be reasonably necessary, to diagnose or confirm the presence, absence,
or extent of infection with a quarantinable communicable disease.
(d) Individuals reasonably believed to be infected, based on the
results of a medical examination, may be isolated, or if such results
are inconclusive or unavailable, individuals may be quarantined or
conditionally released in accordance with this part.
Sec. 71.37 Requirements relating to the issuance of a Federal order
for quarantine, isolation, or conditional release.
(a) A Federal order authorizing quarantine, isolation, or
conditional release shall be in writing, signed by the Director, and
contain the following information:
(1) The identity of the individual or group subject to the order;
(2) The location of the quarantine or isolation or, in the case of
conditional release, the entity to who and means by which the
individual shall report for public health supervision;
(3) An explanation of the factual basis underlying the Director's
reasonable belief that the individual is exposed to or infected with a
quarantinable communicable disease;
(4) An explanation that the Federal order will be reassessed no
later than 72 hours after it has been served and an explanation of the
medical review of the Federal order pursuant to this part, including
the right to request a medical review, present witnesses and testimony
at the medical review, and to be represented at the medical review by
either an advocate (e.g., an attorney, family member, or physician) at
the individual's own expense, or, if indigent, to have representatives
appointed at the government's expense;
(5) An explanation of the criminal penalties for violating a
Federal order of quarantine, isolation, or conditional release; and
(6) An explanation that if a medical examination is required as
part of the Federal order that the examination will be conducted by an
authorized and licensed health worker, and with prior informed consent.
(b) A Federal order authorizing quarantine, isolation, or
conditional release shall be served on the individual no later than 72
hours after the individual has been apprehended, except that the
Federal order may be published or posted in a conspicuous location if
applicable to a group of individuals and individual service would be
impracticable.
[[Page 6977]]
(c) The Director shall arrange for translation or interpretation
services of the Federal order as needed.
(d) Nothing in these regulations shall affect the constitutional or
statutory rights of individuals to obtain judicial review of their
federal detention.
Sec. 71.38 Mandatory reassessment of a Federal order for quarantine,
isolation, or conditional release (surveillance).
(a) The Director (excluding the CDC official who issued the
quarantine, isolation, or conditional release order) shall reassess the
need to continue the quarantine, isolation, or conditional release of
an individual no later than 72 hours after the service of the Federal
order.
(b) As part of the reassessment, the Director (excluding the CDC
official who issued the quarantine, isolation, or conditional release
order) shall review all records considered in issuing the Federal
order, including travel records, records evidencing exposure or
infection with a quarantinable communicable disease, as well as any
relevant new information.
(c) As part of the reassessment, and where applicable, the Director
(excluding the CDC official who issued the quarantine, isolation, or
conditional release order) shall consider and make a determination
regarding whether less restrictive alternatives would adequately serve
to protect the public health.
(d) At the conclusion of the reassessment, the Director (excluding
the CDC official who issued the quarantine, isolation, or conditional
release order) shall promptly issue a written Federal order directing
that the quarantine, isolation, or conditional release be continued,
modified, or rescinded.
(e) In the event that the Director orders that the quarantine,
isolation, or conditional release be continued or modified, the written
Federal order shall explain the process for requesting a medical review
under this part.
(f) The Director's written Federal order shall be promptly served
on the individual, except that the Federal order may be served by
publication or by posting in a conspicuous location if applicable to a
group of individuals and individual service would be impracticable.
(g) The Director shall arrange for translation or interpretation
services of the Federal order as needed.
Sec. 71.39 Medical review of a Federal order for quarantine,
isolation, or conditional release.
(a) The Director shall, as soon as practicable, arrange for a
medical review upon a request by an individual under Federal
quarantine, isolation, or conditional release.
(b) A request for a medical review may only occur after the
Director's mandatory reassessment under 71.38 and following the
issuance and service of a Federal order continuing or modifying the
quarantine, isolation, or conditional release.
(c) The medical review shall be for the purpose of ascertaining
whether the Director has a reasonable belief that the individual is
infected with a quarantinable communicable disease.
(d) The Director shall notify the individual in writing of the time
and place of the medical review.
(e) The Director (excluding the CDC official who issued the
quarantine, isolation, or conditional release order) shall designate a
medical reviewer to review the medical or other evidence presented at
the review, make medical or other findings of fact, and issue a
recommendation concerning whether the Federal order for quarantine,
isolation, or conditional release should be rescinded, continued, or
modified.
(f) The individual subject to Federal quarantine, isolation, or
conditional release may authorize an advocate (e.g., an attorney,
family member, or physician) at his or her own expense to submit
medical or other evidence and, in the medical reviewer's discretion, be
allowed to present a reasonable number of medical experts. The Director
shall appoint representatives at government expense to assist the
individual for purposes of the medical review upon a request and
certification, under penalty of perjury, by that individual that he/she
is indigent.
(g) Prior to the convening of the review, the individual or his/her
authorized advocate or representatives shall be provided a reasonable
opportunity to examine the available medical and other records involved
in the medical review pertaining to that individual.
(h) The Director shall take such measures that he/she determines to
be reasonably necessary to allow an individual under Federal quarantine
or isolation to communicate with any authorized advocate or
representatives in such a manner as to prevent the possible spread of
the quarantinable communicable disease.
(i) The medical reviewer may order a medical examination of an
individual when, in the medical reviewer's professional judgment, such
an examination would assist in assessing the individual's medical
condition.
(j) As part of the review, and where applicable, the medical
reviewer shall consider and accept into the record evidence concerning
whether less restrictive alternatives would adequately serve to protect
public health.
(k) The medical review shall be conducted by telephone, audio or
video conference, or through other means that the medical reviewer
determines in his/her discretion are practicable for allowing the
individual under quarantine, isolation, or conditional release to
participate in the medical review.
(l) At the conclusion of the review, the medical reviewer shall,
based upon his or her review of the facts and other evidence made
available during the medical review, issue a written report to the
Director (excluding the CDC official who issued the quarantine,
isolation, or conditional release order) concerning whether, in the
medical reviewer's professional judgment, the Federal quarantine,
isolation, or conditional release should continue. The written report
shall include a determination regarding whether less restrictive
alternatives would adequately serve to protect public health. The
written report shall be served on the individual and the individual's
authorized advocate or representatives.
(m) The Director (excluding the CDC official who issued the
quarantine, isolation, or conditional release order) shall, as soon as
practicable, review the written report and any objections that may be
submitted by the individual or the individual's advocate or
representatives that contest the findings and recommendation contained
in the medical reviewer's written report. Upon conclusion of the
review, the Director (excluding the CDC official who issued the
quarantine, isolation, or conditional release order) shall promptly
issue a written Federal order directing that the quarantine, isolation,
or conditional release be continued, modified, or rescinded. In the
event that the Director (excluding the CDC official who issued the
quarantine, isolation, or conditional release order) continues or
modifies the Federal quarantine, isolation, or conditional release, the
Director's written order shall include a statement that the individual
may request that the Director rescind the Federal quarantine,
isolation, or conditional release, but based only on a showing of
significant, new or changed facts or medical evidence that raise a
genuine issue as to whether the individual should continue to be
subject to Federal quarantine, isolation, or conditional release. The
written Federal order shall be promptly served on the individual and
the individual's authorized advocate or
[[Page 6978]]
representatives, except that the Federal order may be served by
publication or by posting in a conspicuous location if applicable to a
group of individual's and individual service would be impracticable.
(n) The Director's written order shall not constitute final agency
action until it has been served on the individual or the individual's
authorized advocate or representatives, or alternatively, if applicable
to a group of individuals and individual service would be
impracticable, it is published or posted.
(o) The Director (excluding the CDC official who issued the
quarantine, isolation, or conditional release order) may order the
consolidation of one or more medical reviews if the number of
individuals or other factors makes the holding of individual medical
reviews impracticable.
(p) The Director may issue additional instructions as may be
necessary or desirable governing the conduct of medical reviews.
(q) The Director shall arrange for translation or interpretation
services as needed for purposes of this section.
0
15. Add Sec. 71.63 to subpart F to read as follows:
Sec. 71.63 Suspension of entry of animals, articles, or things from
designated foreign countries and places into the United States.
(a) The Director may suspend the entry into the United States of
animals, articles, or things from designated foreign countries
(including political subdivisions and regions thereof) or places
whenever the Director determines that such an action is necessary to
protect the public health and upon a finding that:
(1) There exists in a foreign country (including one or more
political subdivisions and regions thereof) or place a communicable
disease the introduction, transmission, or spread of which would
threaten the public health of the United States; and
(2) The entry of imports from that country or place increases the
risk that the communicable disease may be introduced, transmitted, or
spread into the United States.
(b) The Director shall designate the foreign countries or places
and the period of time or conditions under which the introduction of
imports into the United States shall be suspended. The Secretary or
Director will coordinate in advance with other Federal agencies that
have overlapping authority in the regulation of entry of animals,
articles, or other things, as may be necessary to implement and enforce
this provision.
Dated: January 9, 2017.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2017-00615 Filed 1-12-17; 4:15 pm]
BILLING CODE 4163-18-P