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uation projects, means discrete, identi- fined, royalties shall be accounted for fiable projects supported under this as follows: subpart and not to solely the provision (1) Patent royalties, whether received of administrative and staff support for during or after the project period, shall the Center.
be governed by agreements between the
Assistant Secretary for Health, Depart$67.113 Control of data.
ment of Health and Human Services, Except as otherwise provided in the and the grantee, pursuant to the Determs and conditions of the award and partment's patent regulations (45 CFR zubject to the confidentiality require- parts 6 and 8). nents of $67.112, all data collected or (11) Copyright royalties, whether reissembled for the purposes of carrying ceived during or after the grant period, put health services research, dem- shall first be used to reduce the FedOnstration, or evaluation projects di- eral share of the grant to cover the cectly supported under this subpart (as costs of publishing or producing the Chat term is defined in $67.112) shall be materials; and any royalties in excess nade available to the Secretary upon
of the costs of publishing or producing request.
such materials shall be distributed in
accordance with chapter 1-420 or the 67.114 Grantee accountability.
Department of Health and Human (a) Accounting for grant awurd pay
Services Grants Administration Manrents. All payments made by the Sec
ual.2 etary shall be recorded by the grantee
(c) Grant closeout-(1) Date of final aco accounting records separate from
counting. In addition to such other spehe records of all other funds, including
cial and periodic accounting as the unds derived from other grant awards.
Secretary may require, a grantee shall With respect to each approved project
render with respect to each Center a he grantee shall account for the sum
full account, as provided herein, as of otal of all amounts paid by presenting
the termination of grant support which r otherwise making available evidence
shall be (i) the end of the project peatisfactory to the Secretary of ex
riod, or (ii) the date of any termination enditures for direct and indirect costs
of grant support pursuant to subpart M
of 45 CFR part 74. deeting the requirements of this subart; Provided however, That when the
(2) Final settlement. There shall be mount awarded for indirect costs was
payable to the United States as final ased on a predetermined fixed per
settlement with respect to each apentage of estimated direct costs, the
proved project the total sum of (i) any
amount not accounted for pursuant to mount allowed for indirect costs shall e computed on the basis of such pre
paragraph (a) of this section and (ii) etermined fixed-percentage rates ap
any other amounts due pursuant to lied to the total, or a selected element
subparts F, M, and 0 of 45 CFR part 74.
Such total sum shall constitute a debt hereof, of the reimbursable direct osts incurred.
owed by the grantee to the United
States and shall be recovered from the (b) Accounting for royalties. Royalties Eceived by grantees from copyrights
grantee or its successors or assignees en publications or other works devel
by set-off or other action as provided ped under the grant, or from patents
by law. I inventions conceived or first actu
8 67.115 Reports. lly reduced to practice in the course for under such grant, shall be ac
Each grant awarded under this subcounted for as follows:
part shall be subject to the condition (1) State and local governments. When he grantee is a State or local govern
2 The Department of Health and Human nent as defined in 45 CFR 74.3, royal
Services Grants Administration Manual is ies shall be accounted for as provided
available for public inspection and copying
at the Department's and Regional Offices' in2 45 CFR 74.44.
formation centers listed in 45 CFR 5.31 and (2) Grantees other than State and local
may be purchased from the Superintendent overnments. Where the grantee is not a of Documents, U.S. Government Printing Ofstate or local government as so de- fice, Washington, DC 20402.
that the grantee shall file written noti- those terms are defined in subpart A of fication with the secretary of each re that part 74. The relevant provisions of search, demonstration or evaluation the following subparts of part 74 shall project undertaken by the Center on also apply to grants to other grantee the date that such project is initiated. organizations under this subpart: Bach notification shall include: (a) A description of the project, in
45 CFR PART 74 cluding the hypotheses to be tested or Subpart: the objectives to be pursued;
A General (b) The names of the principal inves- B Cash Depositories. tigators and the principal staff mem- C Bonding and Insurance. bers that will be assigned to the
D Retention and Custodial Requirements
for Records. project, and
F Grant-Related Income. (c) A budget, including an identifica
G Matching and Cost Sharing. tion of the source of funds.
K Grant Payment Requirements.
L Budget Revision Procedures. 467.116 Human subjects.
M Grant Closeout, Suspension, and Termi. No award may be made under this nation. Bubpart unless the applicant has com- O Property. plied with 45 CFR part 46 and other ap Q Cost Principles. plicable requirements pertaining to the protection of human subjects.
867.118 Additional conditions.
The Secretary may, with respect to $87.117 Applicability of 46 CFR part any grant awarded under this subpart, 74.
impose additional conditions prior to The provisions of 45 CFR part 74, es- or at the time of any award when in his tablishing uniform administrative re- judgment such conditions are neoquirements and cost principles, shall essary to assure or protect advance apply to all grants under this subpart ment of the approved Center or the to States and local governments as conservation of grant funds.
SUBCHAPTER F-QUARANTINE, INSPECTION, LICENSING
PART 71-FOREIGN QUARANTINE
Subpart A-Definitions and General
dec. 1.1 Scope and definitions. 1.2 Penalties. 1.3 Designation of yellow fever vaccination
centers: Validation stamps.
Subpart B-Measures at Foreign Ports
L11 Bills of health.
Subpart c-Notice of Communicable
Disease Prior to Arrival
.21 Radio report of death or illness.
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 possessions of the United States. Regulations pertaining to preventing the interstate spread of communicable diseases are contained in 21 CFR parts 1240 and 1250.
(b) As used in this part the term:
Carrier means a ship, aircraft, train, road vehicle, or other means of transport, including military.
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.
Contamination means the presence of undesirable substances 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 Eremption 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
ubpart D-Health Measures of U.S. Ports:
Communicable Diseases .31 General provisions. 32 Persons, carriers, and things. .33 Persons: Isolation and surveillance. 34 Carriers of U.S. military services. -35 Report of death or illness on carrier
during stay in port. lubpart E-Requirements Upon Arrival at
U.S. Ports: Sanitary Inspection 41 General provisions. 42 Disinsection of imports. 43 Exemption for malls. 44 Disinsection of aircraft. 45 Food, potable water, and waste: U.S.
seaports and airports. 46 Issuance of Deratting Certificates and
Deratting Exemption Certificates. 17 Special provisions relating to airports:
Office and isolation facilities. 48 Carriers in intercoastal and interstate traffic.
Subpart F-Importations 51 Dogs and cats. 52 Turtles, tortoises, and terrapins. 53 Nonhuman primates. 54 Etiological agents, hosts, and vectors. 55 Dead bodies. KUTHORITY: Sec. 215 of Public Health Serv
(PHS) Act, as amended (42 U.S.C. 216); 8. 361-369, PHS Act, as amended (42 U.S.C. -272); E.O. 12452 of December 22, 1983, 48 56927. JOURCE: 50 FR 1519, Jan. 11, 1985, unless verwise noted.
Human Services, or his/her authorized or aircraft stopped in any other counrepresentative.
try on its voyage; or (2) in the case of Disinfection means the killing of in- a person, a voyage involving entry into fectious agents or inactivation of their
a country other than the country in toxic products outside the body by di- which that person begins his/her voyrect exposure to chemical or physical
Isolation means: (1) When applied to & Disinfestation means any chemical or
person or group of persons, the separaphysical process serving to destroy or
tion of that person or group of persons remove undesired small animal forms,
from other persons, except the health particularly arthropods or rodents,
staff on duty, in such a manner as to present upon the person, the clothing,
prevent the spread of infection; or (2) or the environment of an individual, or
when applied to animals, the separaupon animals and carriers. Disinsection means the operation in
tion of an animal or group of animals which measures are taken to kill the
from persons, other animals, or vectors
of disease in such a manner as to pre insect vectors of human disease present in carriers and containers.
vent the spread of infection.
Military services means the U.S. Educational purpose means use in the teaching of a defined educational pro
Army, the U.S. Air Force, the U.S. gram at the university level or equiva
Navy, and the U.S. Coast Guard. lent.
Scientific purpose means use for sciExhibition purpose means use as a
entific research following a defined part of a display in a facility com
protocol and other standards for reparable to a zoological park or in a
search projects as normally conducted trained animal act. The animal display at the university level. The term also must be open to the general public at includes the use for safety testing, poroutinely scheduled hours on 5 or more tency testing, and other activities re days of each week. The trained animal lated to the production of medical act must be routinely scheduled for products. multiple performances each week and Surveillance means the temporary suopen to the general public except for pervision of a person who may have or reasonable vacation and retraining pe- has been exposed to a communicable riods.
disease. Il person means a person who:
U.S. port means any seaport, airport (1) Has a temperature of 100 °F. (or 38
or border crossing point under the con°C.) or greater, accompanied by a rash, trol of the United States. glandular swelling, or jaundice, or
United States means the several which has persisted for more than 48
States, the District of Columbis. hours; or
Guam, the Commonwealth of Puerto (2) Has diarrhea, defined as the occur
Rico, the Northern Mariana Islands, rence in a 24-hour period of three or
the Virgin Islands, American Samoa, more loose stools or of a greater than
and the Trust Territory of the Pacific normal (for the person) amount of
Islands. loose stools.
Vector means an animal (including International Health Regulations
insects) or thing which conveys or is means the International Health Regulations of the World Health Organiza
capable of conveying infectious agents
from a person or animal to another tion, adopted by the Twenty-Second World Health Assembly in 1969, as
person or animal. amended by the Twenty-Sixth World
871.2 Penalties. Health Assembly in 1973, the ThirtyFourth World Health Assembly in 1981, Any person violating any provision of and as may be further amended.
these regulations shall be subject to a International voyage means: (1) In the fine of not more than $1,000 or to imcase of a carrier, a voyage between prisonment for not more than 1 year, ports or airports of more than one or both, as provided in section 368 of country, or a voyage between ports or the Public Health Service Act (42 airports of the same country if the ship U.S.C. 271).
171.3 Designation of yellow fever vac- Subpart B-Measures at Foreign cination centers; Validation stamps.
Ports (a) Designation of yellow fever vaccinaion centers. (1) The Director is respon- 871.11 Bills of health. ible for the designation of yellow fever A carrier at any foreign port clearing accination centers authorized to issue or departing for any U.S. port shall not ertificates of vaccination. This re
be required to obtain or deliver a bill of ponsibility is delegated by the Direc- health. or to a State or territorial health deartment with respect to yellow fever Subpart C-Notice of Commuuccination activities of non-Federal
nicable Disease Prior to Arrivledical, public health facilities, and liinsed physicians functioning within
al le respective jurisdictions of a State territorial health department. Des
$71.21 Radio report of death or illness. nation may be made upon application (a) The master of a ship destined for Id presentation of evidence satisfac- a U.S. port shall report immediately to ry to a State or territorial health de- the quarantine station at or nearest rtment that the applicant has ade- the port at which the ship will arrive, ate facilities and professionally the occurrence, on board, of any death uined personnel for the handling, or any ill person among passengers or vrage, and administration of a safe, crew (including those who have distent, and pure yellow fever vaccine. embarked or have been removed) durdical facilities of Federal agencies ing the 15-day period preceding the ? authorized to obtain yellow fever date of expected arrival or during the ccine without being designated as a period since departure from a U.S. port llow fever vaccination center by the (whichever period of time is shorter). rector
(b) The commander of an aircraft des 2) A designated yellow fever vaccina- tined for a U.S. airport shall report imn center shall comply with the in- mediately to the quarantine station at uction issued by the Director or by a or nearest the airport at which the airlegated officer or employee of a
craft will arrive, the occurrence, on ite or territorial health department
board, of any death or ill person among the handling, storage, and adminis- passengers or crew. tion of yellow fever vaccine. If a (c) In addition to paragraph (a) of ignated center fails to comply with
this section, the master of a ship carryh instruction, after notice to the ing 13 or more passengers must report iter, the Director or, for non-Federal by radio 24 hours before arrival the iters, a State or territorial health number of cases (including zero) of diartment, may revoke designation. arrhea in passengers and crew recorded 5) Validation stamps. International in the ship's medical log during the tificates of Vaccination against current cruise. All cases of diarrhea lera and yellow fever issued for vac- that occur after the 24 hour report ations performed in the United must also be reported not less than 4 tes shall be validated by:
hours before arrival. 1 The Seal of the Public Health
(Approved by the Office of Management and 'vice; or
Budget under control number 0920-0134) 1) The Seal of the Department of ite; or » The stamp of the Department of Subpart D-Health Measures at lense; or
U.S. Ports: Communicable Dis1) The stamp issued to the National eases ronautics and Space Administration;
871.31 General provisions. 5) The stamp issued by a State or (a) Upon arrival at a U.S. port, a carritorial health department; or
rier will not undergo inspection unless B) An official stamp of a design and the Director determines that a failure e approved by the Director for such to inspect will present a threat of inpose.
troduction of communicable diseases