80_FR_16459 80 FR 16400 - Criteria for Requesting Federal Travel Restrictions for Public Health Purposes, Including for Viral Hemorrhagic Fevers

80 FR 16400 - Criteria for Requesting Federal Travel Restrictions for Public Health Purposes, Including for Viral Hemorrhagic Fevers

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 59 (March 27, 2015)

Page Range16400-16402
FR Document2015-07118

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is publishing this Notice to inform the public of the criteria CDC considers for requesting federal travel restrictions for public health purposes, including for use of the Do Not Board (DNB) list and Public Health Border Lookout records. Individuals with communicable diseases that pose a public health threat to travelers can be placed on this list to restrict them from boarding commercial aircraft arriving into, departing from, or traveling within the United States. This notice further describes the factors that HHS/CDC will consider in evaluating whether to request that an individual who may have been exposed to a hemorrhagic fever virus be placed on the DNB list, which is administered by the Department of Homeland Security (DHS). It also contains information for individuals who have been placed on this list to respond to this decision in writing, if they believe the decision was made in error. This notice is effective immediately.

Federal Register, Volume 80 Issue 59 (Friday, March 27, 2015)
[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Notices]
[Pages 16400-16402]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07118]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Criteria for Requesting Federal Travel Restrictions for Public 
Health Purposes, Including for Viral Hemorrhagic Fevers

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

ACTION: Notice.

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SUMMARY: The Centers for Disease Control and Prevention (CDC) in the 
Department of Health and Human Services (HHS) is publishing this Notice 
to inform the public of the criteria CDC considers for requesting 
federal travel restrictions for public health purposes, including for 
use of the Do Not Board (DNB) list and Public Health Border Lookout 
records. Individuals with communicable diseases that pose a public 
health threat to travelers can be placed on this list to restrict them 
from boarding commercial aircraft arriving into, departing from, or 
traveling within the United States. This notice further describes the 
factors that HHS/CDC will consider in evaluating whether to request 
that an individual who may have been exposed to a hemorrhagic fever 
virus be placed on the DNB list, which is administered by the 
Department of Homeland Security (DHS). It also contains information for 
individuals who have been placed on this list to respond to this 
decision in writing, if they believe the decision was made in error. 
This notice is effective immediately.

DATES: This notice is effective on March 27, 2015.

FOR FURTHER INFORMATION CONTACT: For information regarding this Notice: 
Ashley A. Marrone, J.D., Division of Global Migration and Quarantine, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
E03, Atlanta, GA 30329. For information regarding CDC operations 
related to this Notice: Travel Restrictions and Intervention Activity, 
ATTN.: Francisco Alvarado-Ramy, M.D., Division of Global Migration and 
Quarantine, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE., MS-C-01, Atlanta, GA 30329. Either may also be reached by 
telephone 404-498-1600 or email [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Individuals with communicable diseases who travel on commercial 
aircraft can pose a risk for infection to the traveling public. In June 
2007, HHS/CDC and DHS developed a public health DNB list, enabling 
domestic and international public health officials to request that 
individuals with communicable diseases who meet specific criteria, 
including having a communicable disease that poses a public health 
threat to the traveling public, be restricted from boarding commercial 
aircraft arriving into, departing from, or traveling within the United 
States.\1\ The public health DNB list, administered by DHS and based on 
HHS/CDC's requests, is intended to supplement state and/or local public 
health measures to prevent individuals who are infectious, or 
reasonably believed to have been exposed to a communicable disease and 
may become infectious, from boarding commercial aircraft. Use of the 
list is limited to those communicable diseases that would pose a public 
health threat to travelers should the infected individual be permitted 
to board a flight. Once an individual is placed on the DNB list, 
airlines are instructed not to issue a boarding pass to the individual 
for any commercial domestic flight or for any commercial international 
flight arriving in or departing from the United States. An individual 
is typically removed from the DNB upon receipt by HHS/CDC of the 
treating physician's or public health authority's statement (or other 
medical documentation) that the individual is no longer considered 
infectious, or lapse of the period that the individual is at risk of 
becoming infectious without development of symptoms.
---------------------------------------------------------------------------

    \1\ CDC. Federal air travel restrictions for public health 
purposes--United States, June 2007-May 2008. MMWR 2008; 57:1009-12. 
Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5737a1.htm.
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    Individuals included on the DNB list are assigned a Public Health 
Border Lookout (``Lookout'') record that assists in ensuring that an 
individual placed on the DNB is detected if he or she attempts to enter 
or depart the United States through a port of entry. When this happens, 
officials from U.S. Customs and Border Protection (CBP), a component 
agency of DHS, notify HHS/CDC so that a thorough public health inquiry 
and evaluation can be conducted and appropriate public health action 
taken, as needed.
    Requests for an individual to be placed on the public health DNB 
list with an associated Lookout record happen through a number of 
means, including: State or local public health officials contact the 
CDC Quarantine Station of jurisdiction, health-care providers make 
requests by contacting their state or local public health departments, 
and foreign and U.S. government agencies contact the CDC's Emergency 
Operations Center (EOC) in Atlanta. HHS/CDC may also request that DHS 
place an individual on the public health DNB and Lookout lists if HHS/
CDC becomes independently aware of an individual who meets the 
placement criteria.\2\
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    \2\ CDC. Federal air travel restrictions for public health 
purposes--United States, June 2007-May 2008. MMWR 2008; 57:1009-12. 
Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5737a1.htm.
---------------------------------------------------------------------------

    HHS/CDC has refined the criteria that it initially considered, as 
published in the Morbidity and Mortality Weekly Report (MMWR) in 2008, 
and this notice describes the criteria CDC currently considers when 
making requests to DHS to include an individual on the DNB list and 
associated Lookout record. If an individual satisfies the first 
criteria and any of the three other criteria, then he/she may qualify 
to be placed on the list. Currently, HHS/CDC considers whether:
    (1) The individual is known or reasonably believed to be infectious 
or reasonably believed to have been exposed to a communicable disease 
and may become infectious with a communicable disease that would be a 
public health threat should the individual be permitted to board a 
commercial aircraft or travel in a manner that would expose the public; 
and

[[Page 16401]]

    (2) the individual is not aware of his or her diagnosis, has been 
advised regarding the diagnosis and is non-compliant with public health 
requests or has shown potential for non-compliance, or is unable to be 
located; or
    (3) the individual is at risk of traveling on a commercial flight 
or of traveling internationally by any means; or
    (4) the individual's placement on the DNB is necessary to 
effectively respond to outbreaks of communicable disease or other 
conditions of public health concern. For example, an individual's 
placement on the DNB may be considered when necessary to aid in the 
application of controlled movement \3\ or in the execution of a 
federal, state, or local quarantine, isolation, or conditional release 
order.
---------------------------------------------------------------------------

    \3\ See http://www.cdc.gov/vhf/ebola/exposure/monitoring-and-movement-of-persons-with-exposure.html.
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II. Authority

    The DNB list and Lookout record are based on requests made by HHS/
CDC regarding public health decisions and actions, and are administered 
by DHS. Under the Public Health Service Act, the Secretary of HHS is 
authorized to make and enforce regulations and take other actions 
necessary to prevent the introduction, transmission, or spread of 
communicable diseases from foreign countries into the United States or 
between states.\4\ Under its delegated authority, the HHS/CDC Division 
of Global Migration and Quarantine fulfills this responsibility through 
a variety of activities that may include operating quarantine stations 
at ports of entry, conducting routine public health screening, and 
administering quarantine regulations that govern the international and 
interstate movement of persons, animals, and cargo.\5\
---------------------------------------------------------------------------

    \4\ 42 U.S.C. 264-265. The Secretary has promulgated 
implementing regulations at 42 CFR parts 70 and 71, administered by 
the CDC.
    \5\ See generally U.S. Department of Health and Human Services 
Centers for Disease Control and Prevention, Public Health Screening 
at U.S. Ports of Entry: A Guide for Federal Inspectors (July 2007) 
(describing port of entry health screening procedures); 42 CFR part 
70 (interstate quarantine regulations); 42 CFR part 71 (foreign 
quarantine regulations).
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Authority of DHS

    Federal law authorizes CBP, U.S. Immigration and Customs 
Enforcement (ICE), and U.S. Coast Guard (USCG) officers to assist HHS 
by enforcing quarantine rules and regulations.\6\ In addition, other 
DHS Components such as the Transportation Security Administration 
(TSA), relying on their existing authorities, may provide supportive 
roles to federal screening efforts designed to prevent the introduction 
and spread of communicable disease.
---------------------------------------------------------------------------

    \6\ See 42 U.S.C. 97, 268(b).
---------------------------------------------------------------------------

    TSA has the authority to accept the services of, or otherwise 
cooperate with, other federal agencies including implementing the DNB 
list.\7\ Further, TSA may ``develop policies, strategies, and plans for 
dealing with the threats . . . including coordinating countermeasures 
with appropriate departments, agencies, and instrumentalities of the 
United States.'' \8\ Consistent with this authority, TSA may assist 
another Federal agency in carrying out its authority in order to 
address a threat to transportation. These threats may involve passenger 
safety.\9\ In administering the DNB list, TSA relies on CDC to make 
public health findings as the basis for its request. As the medical 
authority for DHS,\10\ the Office of Health Affairs reviews and 
approves the medical appropriateness of HHS/CDC's request prior to DHS 
implementing HHS/CDC's request by placing the person on the DNB list.
---------------------------------------------------------------------------

    \7\ 49 U.S.C. 106(l), (m), 114(m).
    \8\ 49 U.S.C. 114(f)(3), (4).
    \9\ See, e.g., 49 U.S.C. 114(h)(3).
    \10\ 6 U.S.C. 321e(c)(1).
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III. Operations

    Because of the urgency involved in restricting individuals with 
serious communicable diseases from boarding commercial aircraft, 
individuals might not be notified prior to their inclusion on the DNB 
list and associated Lookout record. When an individual is placed on the 
DNB list with an associated Lookout record, HHS/CDC advises in writing 
that the individual is temporarily restricted from traveling by 
commercial air carrier and provides the reasons why HHS/CDC has reached 
this decision. HHS/CDC interprets ``temporarily restricted'' to mean 
that the individual will remain on the lists until no longer considered 
to be infectious or at risk of becoming infectious. HHS/CDC's 
notification to the individual also explains that, while the individual 
is on these lists, travel by commercial aircraft is forbidden and any 
attempt to enter the United States through any port of entry will be 
stopped by CBP officials and that the individual will be referred for 
public health evaluation. If an individual cannot be located, HHS/CDC 
works with state and local public health officials to contact the 
individual through family or other contacts. HHS/CDC and DHS take great 
care to ensure personal medical information is safeguarded.
    As part of its notification process HHS/CDC also asks the 
appropriate state or local health department to notify the individual 
directly, state the reasons for the placement on the DNB list and 
associated Lookout record, and provide the medical or public health 
requirements that must be satisfied to be removed from the lists. The 
primary consideration for requesting removal from the DNB list and 
associated Lookout record is CDC's determination that the individual is 
no longer considered to be infectious or at risk of becoming 
infectious; however, other factors may be taken into consideration 
including the individual's return to treatment, if applicable, and 
following public health recommendations. Once HHS/CDC receives 
documentation that these medical and other stated requirements have 
been met, it sends a request to DHS to lift the travel restrictions 
(both the DNB list and the Lookout record).\11\ Once an individual is 
removed from the DNB list and the associated Lookout record is removed, 
a second notification letter is sent by HHS/CDC to the individual 
informing him or her that the public health travel restrictions have 
been removed and providing further recommendations on an as-needed 
basis (e.g., advising that the individual continue treatment, if 
applicable).
---------------------------------------------------------------------------

    \11\ In addition to contacting CDC, individuals seeking removal 
from the Public Health DNB may also seek assistance through the 
redress process established by DHS in 49 CFR 1560.205.
---------------------------------------------------------------------------

    HHS/CDC's letter informing individuals that they have been placed 
on the DNB list and associated Lookout records invites individuals who 
believe that HHS/CDC's public health decision was made in error to 
submit a written response to the Director of HHS/CDC's Division of 
Global Migration and Quarantine and provide any supporting facts or 
other evidence supporting their belief. These operations and procedures 
will not change as a result of this Notice.

IV. Requesting Travel Restrictions for Viral Hemorrhagic Fevers

    To date, the DNB list and associated Lookout records have been used 
primarily with respect to individuals with suspected or confirmed 
pulmonary tuberculosis (TB), including multidrug-resistant tuberculosis 
(MDR-TB), and a very small number with measles. However, travel 
restrictions are also applicable to other suspected or confirmed 
communicable diseases that could pose a public health threat during 
travel, including viral hemorrhagic fevers such as Ebola virus disease

[[Page 16402]]

(Ebola). Ebola is a type of viral hemorrhagic fever that is often fatal 
in humans and nonhuman primates. Ebola can spread through human-to-
human transmission, with infection resulting from direct contact 
(through broken skin or mucous membranes) with the blood, secretions, 
droplets, or other body fluids of infected people, and indirectly from 
contact with surfaces or items (such as needles) contaminated with such 
fluids.
    With respect to viral hemorrhagic fevers, placement on the DNB list 
and associated Lookout record is requested for people known or 
suspected to have a viral hemorrhagic fever. Placement may also be 
requested for people without symptoms who have been exposed to a viral 
hemorrhagic fever, particularly if these individuals intend to travel 
against public health recommendations. Even though people without 
symptoms are not infectious, these restrictions are requested because 
of the possibility that symptoms could develop during travel, 
particularly long international flights. Exposure is determined through 
a CDC risk factor assessment using information available from a variety 
of public health, medical and other official sources. Examples of types 
of potential exposure to viral hemorrhagic fevers contained within the 
CDC risk factor assessment include the following. It should be noted 
that not all of these exposures may result in travel restrictions.

 Having been in a country with widespread Ebola virus 
transmission within the past 21 days and, although having had no known 
exposures, is showing symptoms
 Percutaneous (e.g., needle stick) or mucous membrane exposure 
to blood or body fluids of a person with Ebola while the person was 
showing symptoms
 Exposure to the blood or body fluids (including but not 
limited to feces, saliva, sweat, urine, vomit, and semen) of a person 
with Ebola while the person was showing symptoms without appropriate 
personal protective equipment (PPE) (see http://www.cdc.gov/vhf/ebola/hcp/procedures-for-ppe.html)
 Laboratory processing of blood or body fluids of a person with 
Ebola while the person was showing symptoms without appropriate PPE or 
standard biosafety protections
 Direct contact with a dead body without appropriate PPE in a 
country with widespread Ebola virus transmission (see http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/distribution-map.html)
 Having lived in the immediate household and provided direct 
care to a person with Ebola while the person was showing symptoms
 In countries with widespread Ebola virus transmission: Direct 
contact while using appropriate PPE with a person with Ebola while the 
person was showing symptoms, or with the person's body fluids, or any 
direct patient care in other healthcare settings
 Close contact in households, healthcare facilities, or 
community settings with a person with Ebola while the person was 
showing symptoms
[cir] Close contact is defined as not wearing appropriate PPE within 
approximately 3 feet (1 meter) of a person with Ebola while the person 
was showing symptoms
 Having brief direct contact (e.g., shaking hands), while not 
wearing appropriate PPE, with a person with Ebola while the person was 
in the early stage of disease
 In countries without widespread Ebola virus transmission: 
Direct contact while using appropriate PPE with a person with Ebola 
while the person was showing symptoms
 Traveled on an aircraft with a person with Ebola while the 
person was showing symptoms

Exposure risk factors, such as those just described, will be considered 
by HHS/CDC in their totality when determining whether an individual 
meets the first criteria for placement on the DNB List, as described in 
Section I of this notice. HHS/CDC would also consider other facts and 
information it may have to make a decision with respect to the other 
criteria, as described in Section I of this notice. It should be noted 
that all facts are considered when applying the criteria. Again, with 
the exception of the first criteria, not all of the other criteria need 
to be present for HHS/CDC to make a request to DHS to have an 
individual placed on DNB and Lookout.
    HHS/CDC would also consider these risk factors when assessing an 
individual who has been in a country where outbreaks of viral 
hemorrhagic fevers were occurring and refuses to comply with a public 
health assessment, and otherwise meets the travel restriction criteria. 
Refusing to comply with a public health risk assessment in this 
situation could include refusing to provide relevant information that 
would allow public health officials to assess the exposure risk.

V. Provisions of This Notice

    HHS/CDC will make requests of DHS based on the criteria in this 
notice effective immediately. Individuals who have had their travel 
temporarily restricted as a result of placement on the DNB list and 
associated Lookout records may submit a written response to the 
Director, Division of Global Migration and Quarantine, if they believe 
that HHS/CDC has erred in its public health request to DHS. The 
response should be addressed to: Director, Division of Global Migration 
and Quarantine, ATTN: Travel Restriction and Intervention Activity, 
Centers for Disease Control and Prevention, 1600 Clifton Road, MS E-03, 
Atlanta, GA 30329. Responses may also be faxed to CDC at (404) 718-2158 
or emailed to [email protected].
    As part of the response, individuals should include the reference 
number listed in the notification letter they received and any facts or 
other evidence indicating why they believe that HHS/CDC's public health 
request was made in error.
    The policy and program operations described above will become 
effective on March 27, 2015.

    Dated: March 24, 2015.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2015-07118 Filed 3-26-15; 8:45 am]
 BILLING CODE 4163-18-P



                                                  16400                           Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices

                                                  www.fitness.gov when it has been                        individuals who have been placed on                   An individual is typically removed from
                                                  finalized.                                              this list to respond to this decision in              the DNB upon receipt by HHS/CDC of
                                                     The meeting that is scheduled to be                  writing, if they believe the decision was             the treating physician’s or public health
                                                  held on May 5, 2015, is open to the                     made in error. This notice is effective               authority’s statement (or other medical
                                                  public. Every effort will be made to                    immediately.                                          documentation) that the individual is no
                                                  provide reasonable accommodations for                   DATES: This notice is effective on March              longer considered infectious, or lapse of
                                                  persons with disabilities and/or special                27, 2015.                                             the period that the individual is at risk
                                                  needs who wish to attend the meeting.                                                                         of becoming infectious without
                                                                                                          FOR FURTHER INFORMATION CONTACT: For
                                                  Persons with disabilities and/or special                                                                      development of symptoms.
                                                                                                          information regarding this Notice:
                                                  needs should call (240) 276–9567 no                                                                              Individuals included on the DNB list
                                                                                                          Ashley A. Marrone, J.D., Division of
                                                  later than close of business on April 21,                                                                     are assigned a Public Health Border
                                                                                                          Global Migration and Quarantine,
                                                  2015, to request accommodations.                                                                              Lookout (‘‘Lookout’’) record that assists
                                                                                                          Centers for Disease Control and
                                                  Members of the public who wish to                                                                             in ensuring that an individual placed on
                                                                                                          Prevention, 1600 Clifton Road NE., MS–
                                                  attend the meeting are asked to pre-                                                                          the DNB is detected if he or she
                                                                                                          E03, Atlanta, GA 30329. For information
                                                  register by sending an email to                                                                               attempts to enter or depart the United
                                                                                                          regarding CDC operations related to this
                                                  rsvp.fitness@hhs.gov or by calling (240)                                                                      States through a port of entry. When this
                                                                                                          Notice: Travel Restrictions and
                                                  276–9567. Registration for public                                                                             happens, officials from U.S. Customs
                                                                                                          Intervention Activity, ATTN.: Francisco
                                                  attendance must be completed before                                                                           and Border Protection (CBP), a
                                                                                                          Alvarado-Ramy, M.D., Division of
                                                  close of business on April 28, 2015.                                                                          component agency of DHS, notify HHS/
                                                                                                          Global Migration and Quarantine,
                                                                                                                                                                CDC so that a thorough public health
                                                    Dated: March 20, 2015.                                Centers for Disease Control and
                                                                                                                                                                inquiry and evaluation can be
                                                  Shellie Y. Pfohl,                                       Prevention, 1600 Clifton Road NE., MS–
                                                                                                                                                                conducted and appropriate public
                                                  Executive Director, Office of the President’s           C–01, Atlanta, GA 30329. Either may
                                                                                                                                                                health action taken, as needed.
                                                  Council on Fitness, Sports, and Nutrition,              also be reached by telephone 404–498–                    Requests for an individual to be
                                                  U.S. Department of Health and Human                     1600 or email travelrestrictions@                     placed on the public health DNB list
                                                  Services.                                               cdc.gov.                                              with an associated Lookout record
                                                  [FR Doc. 2015–06999 Filed 3–26–15; 8:45 am]             SUPPLEMENTARY INFORMATION:                            happen through a number of means,
                                                  BILLING CODE 4150–35–P
                                                                                                          I. Background                                         including: State or local public health
                                                                                                                                                                officials contact the CDC Quarantine
                                                                                                             Individuals with communicable                      Station of jurisdiction, health-care
                                                  DEPARTMENT OF HEALTH AND                                diseases who travel on commercial                     providers make requests by contacting
                                                  HUMAN SERVICES                                          aircraft can pose a risk for infection to             their state or local public health
                                                                                                          the traveling public. In June 2007, HHS/              departments, and foreign and U.S.
                                                  Centers for Disease Control and                         CDC and DHS developed a public health                 government agencies contact the CDC’s
                                                  Prevention                                              DNB list, enabling domestic and                       Emergency Operations Center (EOC) in
                                                                                                          international public health officials to              Atlanta. HHS/CDC may also request that
                                                  Criteria for Requesting Federal Travel
                                                                                                          request that individuals with                         DHS place an individual on the public
                                                  Restrictions for Public Health
                                                                                                          communicable diseases who meet                        health DNB and Lookout lists if HHS/
                                                  Purposes, Including for Viral
                                                                                                          specific criteria, including having a                 CDC becomes independently aware of
                                                  Hemorrhagic Fevers
                                                                                                          communicable disease that poses a                     an individual who meets the placement
                                                  AGENCY: Centers for Disease Control and                 public health threat to the traveling                 criteria.2
                                                  Prevention (CDC), Department of Health                  public, be restricted from boarding                      HHS/CDC has refined the criteria that
                                                  and Human Services (HHS).                               commercial aircraft arriving into,                    it initially considered, as published in
                                                  ACTION: Notice.                                         departing from, or traveling within the               the Morbidity and Mortality Weekly
                                                                                                          United States.1 The public health DNB                 Report (MMWR) in 2008, and this notice
                                                  SUMMARY:   The Centers for Disease                      list, administered by DHS and based on                describes the criteria CDC currently
                                                  Control and Prevention (CDC) in the                     HHS/CDC’s requests, is intended to                    considers when making requests to DHS
                                                  Department of Health and Human                          supplement state and/or local public                  to include an individual on the DNB list
                                                  Services (HHS) is publishing this Notice                health measures to prevent individuals                and associated Lookout record. If an
                                                  to inform the public of the criteria CDC                who are infectious, or reasonably                     individual satisfies the first criteria and
                                                  considers for requesting federal travel                 believed to have been exposed to a                    any of the three other criteria, then he/
                                                  restrictions for public health purposes,                communicable disease and may become                   she may qualify to be placed on the list.
                                                  including for use of the Do Not Board                   infectious, from boarding commercial                  Currently, HHS/CDC considers whether:
                                                  (DNB) list and Public Health Border                     aircraft. Use of the list is limited to                  (1) The individual is known or
                                                  Lookout records. Individuals with                       those communicable diseases that                      reasonably believed to be infectious or
                                                  communicable diseases that pose a                       would pose a public health threat to                  reasonably believed to have been
                                                  public health threat to travelers can be                travelers should the infected individual              exposed to a communicable disease and
                                                  placed on this list to restrict them from               be permitted to board a flight. Once an               may become infectious with a
                                                  boarding commercial aircraft arriving                   individual is placed on the DNB list,                 communicable disease that would be a
                                                  into, departing from, or traveling within               airlines are instructed not to issue a                public health threat should the
                                                  the United States. This notice further                  boarding pass to the individual for any               individual be permitted to board a
                                                                                                          commercial domestic flight or for any                 commercial aircraft or travel in a
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  describes the factors that HHS/CDC will
                                                  consider in evaluating whether to                       commercial international flight arriving              manner that would expose the public;
                                                  request that an individual who may                      in or departing from the United States.               and
                                                  have been exposed to a hemorrhagic
                                                                                                            1 CDC. Federal air travel restrictions for public     2 CDC. Federal air travel restrictions for public
                                                  fever virus be placed on the DNB list,
                                                                                                          health purposes—United States, June 2007–May          health purposes—United States, June 2007–May
                                                  which is administered by the                            2008. MMWR 2008; 57:1009–12. Available at             2008. MMWR 2008; 57:1009–12. Available at
                                                  Department of Homeland Security                         http://www.cdc.gov/mmwr/preview/mmwrhtml/             http://www.cdc.gov/mmwr/preview/mmwrhtml/
                                                  (DHS). It also contains information for                 mm5737a1.htm.                                         mm5737a1.htm.



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                                                                                  Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices                                                  16401

                                                     (2) the individual is not aware of his               Administration (TSA), relying on their                   As part of its notification process
                                                  or her diagnosis, has been advised                      existing authorities, may provide                     HHS/CDC also asks the appropriate state
                                                  regarding the diagnosis and is non-                     supportive roles to federal screening                 or local health department to notify the
                                                  compliant with public health requests                   efforts designed to prevent the                       individual directly, state the reasons for
                                                  or has shown potential for non-                         introduction and spread of                            the placement on the DNB list and
                                                  compliance, or is unable to be located;                 communicable disease.                                 associated Lookout record, and provide
                                                  or                                                         TSA has the authority to accept the                the medical or public health
                                                     (3) the individual is at risk of                     services of, or otherwise cooperate with,             requirements that must be satisfied to be
                                                  traveling on a commercial flight or of                  other federal agencies including                      removed from the lists. The primary
                                                  traveling internationally by any means;                 implementing the DNB list.7 Further,                  consideration for requesting removal
                                                  or                                                      TSA may ‘‘develop policies, strategies,               from the DNB list and associated
                                                     (4) the individual’s placement on the                and plans for dealing with the threats                Lookout record is CDC’s determination
                                                  DNB is necessary to effectively respond                 . . . including coordinating                          that the individual is no longer
                                                  to outbreaks of communicable disease or                 countermeasures with appropriate                      considered to be infectious or at risk of
                                                  other conditions of public health                       departments, agencies, and                            becoming infectious; however, other
                                                  concern. For example, an individual’s                   instrumentalities of the United States.’’ 8           factors may be taken into consideration
                                                  placement on the DNB may be                             Consistent with this authority, TSA may               including the individual’s return to
                                                  considered when necessary to aid in the                 assist another Federal agency in                      treatment, if applicable, and following
                                                  application of controlled movement 3 or                 carrying out its authority in order to                public health recommendations. Once
                                                  in the execution of a federal, state, or                address a threat to transportation. These             HHS/CDC receives documentation that
                                                  local quarantine, isolation, or                         threats may involve passenger safety.9                these medical and other stated
                                                  conditional release order.                              In administering the DNB list, TSA                    requirements have been met, it sends a
                                                                                                          relies on CDC to make public health                   request to DHS to lift the travel
                                                  II. Authority                                           findings as the basis for its request. As             restrictions (both the DNB list and the
                                                    The DNB list and Lookout record are                   the medical authority for DHS,10 the                  Lookout record).11 Once an individual
                                                  based on requests made by HHS/CDC                       Office of Health Affairs reviews and                  is removed from the DNB list and the
                                                  regarding public health decisions and                   approves the medical appropriateness of               associated Lookout record is removed, a
                                                  actions, and are administered by DHS.                   HHS/CDC’s request prior to DHS                        second notification letter is sent by
                                                  Under the Public Health Service Act,                    implementing HHS/CDC’s request by                     HHS/CDC to the individual informing
                                                  the Secretary of HHS is authorized to                   placing the person on the DNB list.                   him or her that the public health travel
                                                  make and enforce regulations and take                   III. Operations                                       restrictions have been removed and
                                                  other actions necessary to prevent the                                                                        providing further recommendations on
                                                  introduction, transmission, or spread of                   Because of the urgency involved in                 an as-needed basis (e.g., advising that
                                                  communicable diseases from foreign                      restricting individuals with serious                  the individual continue treatment, if
                                                  countries into the United States or                     communicable diseases from boarding                   applicable).
                                                  between states.4 Under its delegated                    commercial aircraft, individuals might                   HHS/CDC’s letter informing
                                                  authority, the HHS/CDC Division of                      not be notified prior to their inclusion              individuals that they have been placed
                                                  Global Migration and Quarantine fulfills                on the DNB list and associated Lookout                on the DNB list and associated Lookout
                                                  this responsibility through a variety of                record. When an individual is placed on               records invites individuals who believe
                                                  activities that may include operating                   the DNB list with an associated Lookout               that HHS/CDC’s public health decision
                                                  quarantine stations at ports of entry,                  record, HHS/CDC advises in writing that               was made in error to submit a written
                                                  conducting routine public health                        the individual is temporarily restricted              response to the Director of HHS/CDC’s
                                                  screening, and administering quarantine                 from traveling by commercial air carrier              Division of Global Migration and
                                                  regulations that govern the international               and provides the reasons why HHS/CDC                  Quarantine and provide any supporting
                                                  and interstate movement of persons,                     has reached this decision. HHS/CDC                    facts or other evidence supporting their
                                                  animals, and cargo.5                                    interprets ‘‘temporarily restricted’’ to              belief. These operations and procedures
                                                                                                          mean that the individual will remain on               will not change as a result of this
                                                  Authority of DHS                                        the lists until no longer considered to be            Notice.
                                                     Federal law authorizes CBP, U.S.                     infectious or at risk of becoming
                                                  Immigration and Customs Enforcement                     infectious. HHS/CDC’s notification to                 IV. Requesting Travel Restrictions for
                                                  (ICE), and U.S. Coast Guard (USCG)                      the individual also explains that, while              Viral Hemorrhagic Fevers
                                                  officers to assist HHS by enforcing                     the individual is on these lists, travel by              To date, the DNB list and associated
                                                  quarantine rules and regulations.6 In                   commercial aircraft is forbidden and                  Lookout records have been used
                                                  addition, other DHS Components such                     any attempt to enter the United States                primarily with respect to individuals
                                                  as the Transportation Security                          through any port of entry will be                     with suspected or confirmed pulmonary
                                                                                                          stopped by CBP officials and that the                 tuberculosis (TB), including multidrug-
                                                    3 See http://www.cdc.gov/vhf/ebola/exposure/          individual will be referred for public                resistant tuberculosis (MDR–TB), and a
                                                  monitoring-and-movement-of-persons-with-                health evaluation. If an individual                   very small number with measles.
                                                  exposure.html.                                          cannot be located, HHS/CDC works with
                                                    4 42 U.S.C. 264–265. The Secretary has                                                                      However, travel restrictions are also
                                                  promulgated implementing regulations at 42 CFR
                                                                                                          state and local public health officials to            applicable to other suspected or
                                                  parts 70 and 71, administered by the CDC.               contact the individual through family or              confirmed communicable diseases that
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                                                    5 See generally U.S. Department of Health and         other contacts. HHS/CDC and DHS take                  could pose a public health threat during
                                                  Human Services Centers for Disease Control and          great care to ensure personal medical                 travel, including viral hemorrhagic
                                                  Prevention, Public Health Screening at U.S. Ports of    information is safeguarded.
                                                  Entry: A Guide for Federal Inspectors (July 2007)                                                             fevers such as Ebola virus disease
                                                  (describing port of entry health screening
                                                                                                            7 49 U.S.C. 106(l), (m), 114(m).
                                                  procedures); 42 CFR part 70 (interstate quarantine                                                              11 In addition to contacting CDC, individuals
                                                                                                            8 49 U.S.C. 114(f)(3), (4).
                                                  regulations); 42 CFR part 71 (foreign quarantine                                                              seeking removal from the Public Health DNB may
                                                  regulations).                                             9 See, e.g., 49 U.S.C. 114(h)(3).
                                                                                                                                                                also seek assistance through the redress process
                                                    6 See 42 U.S.C. 97, 268(b).                             10 6 U.S.C. 321e(c)(1).                             established by DHS in 49 CFR 1560.205.



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                                                  16402                           Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices

                                                  (Ebola). Ebola is a type of viral                          a person with Ebola while the person               restricted as a result of placement on the
                                                  hemorrhagic fever that is often fatal in                   was showing symptoms                               DNB list and associated Lookout records
                                                  humans and nonhuman primates. Ebola                     • In countries with widespread Ebola                  may submit a written response to the
                                                  can spread through human-to-human                          virus transmission: Direct contact                 Director, Division of Global Migration
                                                  transmission, with infection resulting                     while using appropriate PPE with a                 and Quarantine, if they believe that
                                                  from direct contact (through broken skin                   person with Ebola while the person                 HHS/CDC has erred in its public health
                                                  or mucous membranes) with the blood,                       was showing symptoms, or with the                  request to DHS. The response should be
                                                  secretions, droplets, or other body fluids                 person’s body fluids, or any direct                addressed to: Director, Division of
                                                  of infected people, and indirectly from                    patient care in other healthcare                   Global Migration and Quarantine,
                                                  contact with surfaces or items (such as                    settings                                           ATTN: Travel Restriction and
                                                  needles) contaminated with such fluids.                 • Close contact in households,                        Intervention Activity, Centers for
                                                     With respect to viral hemorrhagic                       healthcare facilities, or community                Disease Control and Prevention, 1600
                                                  fevers, placement on the DNB list and                      settings with a person with Ebola                  Clifton Road, MS E–03, Atlanta, GA
                                                  associated Lookout record is requested                     while the person was showing                       30329. Responses may also be faxed to
                                                  for people known or suspected to have                      symptoms                                           CDC at (404) 718–2158 or emailed to
                                                  a viral hemorrhagic fever. Placement                    Æ Close contact is defined as not                     travelrestrictions@cdc.gov.
                                                  may also be requested for people                           wearing appropriate PPE within                        As part of the response, individuals
                                                  without symptoms who have been                             approximately 3 feet (1 meter) of a                should include the reference number
                                                  exposed to a viral hemorrhagic fever,                      person with Ebola while the person                 listed in the notification letter they
                                                  particularly if these individuals intend                   was showing symptoms                               received and any facts or other evidence
                                                  to travel against public health                         • Having brief direct contact (e.g.,
                                                                                                                                                                indicating why they believe that HHS/
                                                  recommendations. Even though people                        shaking hands), while not wearing
                                                                                                                                                                CDC’s public health request was made
                                                  without symptoms are not infectious,                       appropriate PPE, with a person with
                                                                                                                                                                in error.
                                                  these restrictions are requested because                   Ebola while the person was in the
                                                                                                                                                                   The policy and program operations
                                                  of the possibility that symptoms could                     early stage of disease
                                                                                                          • In countries without widespread                     described above will become effective
                                                  develop during travel, particularly long                                                                      on March 27, 2015.
                                                  international flights. Exposure is                         Ebola virus transmission: Direct
                                                  determined through a CDC risk factor                       contact while using appropriate PPE                  Dated: March 24, 2015.
                                                  assessment using information available                     with a person with Ebola while the                 Sylvia M. Burwell,
                                                  from a variety of public health, medical                   person was showing symptoms                        Secretary.
                                                  and other official sources. Examples of                 • Traveled on an aircraft with a person               [FR Doc. 2015–07118 Filed 3–26–15; 8:45 am]
                                                  types of potential exposure to viral                       with Ebola while the person was                    BILLING CODE 4163–18–P
                                                  hemorrhagic fevers contained within the                    showing symptoms
                                                  CDC risk factor assessment include the                  Exposure risk factors, such as those just
                                                  following. It should be noted that not all              described, will be considered by HHS/                 DEPARTMENT OF HEALTH AND
                                                  of these exposures may result in travel                 CDC in their totality when determining                HUMAN SERVICES
                                                  restrictions.                                           whether an individual meets the first
                                                  • Having been in a country with                         criteria for placement on the DNB List,               Food and Drug Administration
                                                     widespread Ebola virus transmission                  as described in Section I of this notice.             [Docket No. FDA–2011–N–0908]
                                                     within the past 21 days and, although                HHS/CDC would also consider other
                                                     having had no known exposures, is                    facts and information it may have to                  Agency Information Collection
                                                     showing symptoms                                     make a decision with respect to the                   Activities; Proposed Collection;
                                                  • Percutaneous (e.g., needle stick) or                  other criteria, as described in Section I             Comment Request; Guidance for
                                                     mucous membrane exposure to blood                    of this notice. It should be noted that all           Clinical Trial Sponsors: Establishment
                                                     or body fluids of a person with Ebola                facts are considered when applying the                and Operation of Clinical Trial Data
                                                     while the person was showing                         criteria. Again, with the exception of the            Monitoring Committees
                                                     symptoms                                             first criteria, not all of the other criteria
                                                  • Exposure to the blood or body fluids                  need to be present for HHS/CDC to                     AGENCY:   Food and Drug Administration,
                                                     (including but not limited to feces,                 make a request to DHS to have an                      HHS.
                                                     saliva, sweat, urine, vomit, and                     individual placed on DNB and Lookout.                 ACTION:   Notice.
                                                     semen) of a person with Ebola while                     HHS/CDC would also consider these
                                                     the person was showing symptoms                      risk factors when assessing an                        SUMMARY:    The Food and Drug
                                                     without appropriate personal                         individual who has been in a country                  Administration (FDA) is announcing an
                                                     protective equipment (PPE) (see                      where outbreaks of viral hemorrhagic                  opportunity for public comment on the
                                                     http://www.cdc.gov/vhf/ebola/hcp/                    fevers were occurring and refuses to                  proposed collection of certain
                                                     procedures-for-ppe.html)                             comply with a public health assessment,               information by the Agency. Under the
                                                  • Laboratory processing of blood or                     and otherwise meets the travel                        Paperwork Reduction Act of 1995 (the
                                                     body fluids of a person with Ebola                   restriction criteria. Refusing to comply              PRA), Federal Agencies are required to
                                                     while the person was showing                         with a public health risk assessment in               publish notice in the Federal Register
                                                     symptoms without appropriate PPE or                  this situation could include refusing to              concerning each proposed collection of
                                                     standard biosafety protections                       provide relevant information that would               information, including each proposed
                                                  • Direct contact with a dead body
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                                                                                                          allow public health officials to assess               extension of an existing collection of
                                                     without appropriate PPE in a country                 the exposure risk.                                    information and to allow 60 days for
                                                     with widespread Ebola virus                                                                                public comment in response to the
                                                     transmission (see http://www.cdc.gov/                V. Provisions of This Notice                          notice. This notice solicits comments on
                                                     vhf/ebola/outbreaks/2014-west-africa/                   HHS/CDC will make requests of DHS                  the collection of information concerning
                                                     distribution-map.html)                               based on the criteria in this notice                  the establishment and operation of
                                                  • Having lived in the immediate                         effective immediately. Individuals who                clinical trial data monitoring
                                                     household and provided direct care to                have had their travel temporarily                     committees.


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Document Created: 2015-12-18 11:36:19
Document Modified: 2015-12-18 11:36:19
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThis notice is effective on March 27, 2015.
ContactFor information regarding this Notice: Ashley A. Marrone, J.D., Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS- E03, Atlanta, GA 30329. For information regarding CDC operations related to this Notice: Travel Restrictions and Intervention Activity, ATTN.: Francisco Alvarado-Ramy, M.D., Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-C-01, Atlanta, GA 30329. Either may also be reached by telephone 404-498-1600 or email [email protected]
FR Citation80 FR 16400 

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