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

1CDC. 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. 

2CDC. 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. 

www.fitness.gov when it has been 

finalized. 

The meeting that is scheduled to be 

held on May 5, 2015, is open to the 

public. Every effort will be made to 

provide reasonable accommodations for 

persons with disabilities and/or special 

needs who wish to attend the meeting. 

Persons with disabilities and/or special 

needs should call (240) 276–9567 no 

later than close of business on April 21, 

2015, to request accommodations. 

Members of the public who wish to 

attend the meeting are asked to preregister by sending an email to 

rsvp.fitness@hhs.gov or by calling (240) 

276–9567. Registration for public 

attendance must be completed before 

close of business on April 28, 2015. 

Dated: March 20, 2015. 

Shellie Y. Pfohl, 

Executive Director, Office of the President’s 

Council on Fitness, Sports, and Nutrition, 

U.S. Department of Health and Human 

Services. 

[FR Doc. 2015–06999 Filed 3–26–15; 8:45 am] 

BILLING CODE 4150–35–P 

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. 

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 travelrestrictions@

cdc.gov. 

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. 

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

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 

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

3See http://www.cdc.gov/vhf/ebola/exposure/

monitoring-and-movement-of-persons-withexposure.html. 

4 42 U.S.C. 264–265. The Secretary has 

promulgated implementing regulations at 42 CFR 

parts 70 and 71, administered by the CDC. 

5See 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). 

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

7 49 U.S.C. 106(l), (m), 114(m). 

8 49 U.S.C. 114(f)(3), (4). 

9See, e.g., 49 U.S.C. 114(h)(3). 

10 6 U.S.C. 321e(c)(1). 

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. 

(2) the individual is not aware of his 

or her diagnosis, has been advised 

regarding the diagnosis and is noncompliant with public health requests 

or has shown potential for noncompliance, 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. 

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

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. 

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. 

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). 

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 multidrugresistant 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 

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

(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 

Æ 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 

travelrestrictions@cdc.gov. 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0908] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Clinical Trial Sponsors: Establishment 

and Operation of Clinical Trial Data 

Monitoring Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the collection of information concerning 

the establishment and operation of 

clinical trial data monitoring 

committees. 

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