Att4a.42CFR71.1bii

Public Health Service, HHS

§ 71.1

AUTHORITY: Secs. 215 and 311 of Public
Health Service (PHS) Act. as amended (42
U.S.C. 216, 243); secs. 361–369, PHS Act, as
amended (42 U.S.C. 264–272).
SOURCE: 50 FR 1519, Jan. 11, 1985, unless
otherwise noted.

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Subpart A—Definitions and
General Provisions
§ 71.1 Scope and definitions.
(a) The provisions of this part contain the regulations to prevent the introduction, transmission, and spread of
communicable disease from foreign
countries into the States or territories
(also known as possessions) of the
United States. Regulations pertaining
to preventing the interstate spread of
communicable diseases are contained
in 21 CFR parts 1240 and 1250 and 42
CFR part 70.
(b) As used in this part the term:
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.
Carrier means a ship, aircraft, train,
road vehicle, or other means of transport, including military.
Commander means the pilot in command of an aircraft as defined in 14
CFR 1.1.
Communicable disease means an illness
due to a specific infectious agent or its
toxic products which arises through
transmission of that agent or its products from an infected person or animal
or a reservoir to a susceptible host, either directly, or indirectly through an
intermediate animal host, vector, or
the inanimate environment.
Conditional release means surveillance
as defined under this part and includes
public health supervision through inperson 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.

Contamination means the presence of
undesirable substances or material
which may contain infectious agents or
their toxic products.
Controlled Free Pratique means permission for a carrier to enter a U.S.
port, disembark, and begin operation
under certain stipulated conditions.
Deratting Certificate means a certificate issued under the instructions of
the Director, in the form prescribed by
the International Health Regulations,
recording the inspection and deratting
of the ship.
Deratting Exemption Certificate means
a certificate issued under the instructions of the Director, in the form prescribed by the International Health
Regulations, recording the inspection
and exemption from deratting of the
ship which is rodent free.
Detention means the temporary holding of a person, ship, aircraft, or other
carrier, animal, or thing in such place
and for such period of time as may be
determined by the Director.
Director means the Director, Centers
for Disease Control, Public Health
Service, Department of Health and
Human Services, or his/her authorized
representative.
Disinfection means the killing of infectious agents or inactivation of their
toxic products outside the body by direct exposure to chemical or physical
agents.
Disinfestation means any chemical or
physical process serving to destroy or
remove undesired small animal forms,
particularly arthropods or rodents,
present upon the person, the clothing,
or the environment of an individual, or
upon animals and carriers.
Disinsection means the operation in
which measures are taken to kill the
insect vectors of human disease present
in carriers and containers.
Educational purpose means use in the
teaching of a defined educational program at the university level or equivalent.
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-

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§ 71.1

42 CFR Ch. I (10–1–17 Edition)

response systems, entry of information
into a web-based forum, wearable
tracking technologies, and other mechanisms or technologies as determined
by the Director.
Exhibition purpose means use as a
part of a display in a facility comparable to a zoological park or in a
trained animal act. The animal display
must be open to the general public at
routinely scheduled hours on 5 or more
days of each week. The trained animal
act must be routinely scheduled for
multiple performances each week and
open to the general public except for
reasonable vacation and retraining periods.
Ill person means an individual:
(i) Who if onboard an aircraft:
(A) Has a fever (a measured temperature of 100.4 °F [38 °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 °F [38 °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 24hour 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 °F [38 °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 Health Regulations or
IHR means the International Health
Regulations of the World Health Organization, adopted by the Fifty-Eighth
World Health Assembly in 2005, as may
be further amended, and subject to the
United States’ reservation and understandings.
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.
Isolation means the separation of an
individual or group who is reasonably
believed to be infected with a quarantinable communicable disease from
those who are healthy to prevent the
spread of the quarantinable communicable disease.
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

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Public Health Service, HHS

§ 71.1

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.
Military services means the U.S.
Army, the U.S. Air Force, the U.S.
Navy, and the U.S. Coast Guard.
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.
Possession means U.S. territory.
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.
Quarantine means the separation of
an individual or group reasonably believed to have been exposed to a quar-

antinable communicable disease, but
who is not yet ill, from others who
have not been so exposed, to prevent
the possible spread of the quarantinable communicable disease.
Quarantinable communicable disease
means any of the communicable diseases listed in an Executive Order, as
provided under § 361 of the Public
Health Service Act (42 U.S.C. § 264). Executive Order 13295, of April 4, 2003, as
amended by Executive Order 13375 of
April 1, 2005, contains the current revised list of quarantinable communicable diseases, and may be obtained
at
http://www.cdc.gov
and
http://
www.archives.gov/federallregister.
If
this Order is amended, HHS will enforce that amended order immediately
and update that Web site.
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.
Scientific purpose means use for scientific research following a defined
protocol and other standards for research projects as normally conducted
at the university level. The term also
includes the use for safety testing, potency testing, and other activities related to the production of medical
products.
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.
Surveillance 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.
U.S. port means any seaport, airport,
or border crossing point under the control of the United States.
U.S. territory means any territory
(also known as possessions) of the
United States, including American
Samoa, Guam, the Northern Mariana

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§ 71.2

42 CFR Ch. I (10–1–17 Edition)

Islands, the Commonwealth of Puerto
Rico, and the U.S. Virgin Islands.
United States means the 50 States,
District of Columbia, and the territories (also known as possessions) of
the United States, including American
Samoa, Guam, the Northern Mariana
Islands, the Commonwealth of Puerto
Rico, and the U.S. Virgin Islands.
Vector means any animals (vertebrate
or invertebrate) including arthropods
or any noninfectious self-replicating
system (e.g., plasmids or other molecular vector) or animal products that
are known to transfer, or are capable of
transferring, an infectious biological
agent to a human.
[50 FR 1519, Jan. 11, 1985, as amended at 77
FR 75890, Dec. 26, 2012; 82 FR 6973, Jan. 19,
2017]

§ 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.
[82 FR 6975, Jan. 19, 2017]

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§ 71.3 Designation of yellow fever vaccination centers; Validation stamps.
(a) Designation of yellow fever vaccination centers. (1) The Director is responsible for the designation of yellow fever
vaccination centers authorized to issue
certificates of vaccination. This responsibility is delegated by the Director to a State or territorial health department with respect to yellow fever
vaccination activities of non-Federal
medical, public health facilities, and licensed physicians functioning within
the respective jurisdictions of a State
or territorial health department. Designation may be made upon application
and presentation of evidence satisfactory to a State or territorial health department that the applicant has adequate facilities and professionally
trained personnel for the handling,

storage, and administration of a safe,
potent, and pure yellow fever vaccine.
Medical facilities of Federal agencies
are authorized to obtain yellow fever
vaccine without being designated as a
yellow fever vaccination center by the
Director.
(2) A designated yellow fever vaccination center shall comply with the instruction issued by the Director or by a
delegated officer or employee of a
State or territorial health department
for the handling, storage, and administration of yellow fever vaccine. If a
designated center fails to comply with
such instruction, after notice to the
center, the Director or, for non-Federal
centers, a State or territorial health
department, may revoke designation.
(b) Validation stamps. International
Certificates of Vaccination against
cholera and yellow fever issued for vaccinations performed in the United
States shall be validated by:
(1) The Seal of the Public Health
Service; or
(2) The Seal of the Department of
State; or
(3) The stamp of the Department of
Defense; or
(4) The stamp issued to the National
Aeronautics and Space Administration;
or
(5) The stamp issued by a State or
territorial health department; or
(6) An official stamp of a design and
size approved by the Director for such
purpose.
§ 71.4 Requirements relating to the
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.

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