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uation projects, means discrete, identiflable projects supported under this subpart and not to solely the provision of administrative and staff support for the Center.

$67.113 Control of data.

Except as otherwise provided in the terms and conditions of the award and subject to the confidentiality requirements of §67.112, all data collected or assembled for the purposes of carrying out health services research, demonstration, or evaluation projects directly supported under this subpart (as that term is defined in §67.112) shall be made available to the Secretary upon request.

367.114 Grantee accountability.

(a) Accounting for grant award payments. All payments made by the Secretary shall be recorded by the grantee in accounting records separate from the records of all other funds, including unds derived from other grant awards. With respect to each approved project he grantee shall account for the sum otal of all amounts paid by presenting or otherwise making available evidence atisfactory to the Secretary of exenditures for direct and indirect costs neeting the requirements of this subart; Provided however, That when the mount awarded for indirect costs was ased on a predetermined fixed perentage of estimated direct costs, the mount allowed for indirect costs shall e computed on the basis of such preetermined fixed-percentage rates aplied to the total, or a selected element hereof, of the reimbursable direct osts incurred.

(b) Accounting for royalties. Royalties eceived by grantees from copyrights n publications or other works develped under the grant, or from patents or inventions conceived or first actully reduced to practice in the course of or under such grant, shall be acounted for as follows:

(1) State and local governments. When he grantee is a State or local governnent as defined in 45 CFR 74.3, royaldies shall be accounted for as provided thn 45 CFR 74.44.

(2) Grantees other than State and local Jovernments. Where the grantee is not a State or local government as so de

fined, royalties shall be accounted for as follows:

(1) Patent royalties, whether received during or after the project period, shall be governed by agreements between the Assistant Secretary for Health, Department of Health and Human Services, and the grantee, pursuant to the Department's patent regulations (45 CFR parts 6 and 8).

(ii) Copyright royalties, whether received during or after the grant period, shall first be used to reduce the Federal share of the grant to cover the costs of publishing or producing the materials; and any royalties in excess of the costs of publishing or producing such materials shall be distributed in accordance with chapter 1-420 or the Department of Health and Human Services Grants Administration Manual. 2

(c) Grant closeout―(1) Date of final accounting. In addition to such other special and periodic accounting as the Secretary may require, a grantee shall render with respect to each Center a full account, as provided herein, as of the termination of grant support which shall be (i) the end of the project period, or (ii) the date of any termination of grant support pursuant to subpart M of 45 CFR part 74.

(2) Final settlement. There shall be payable to the United States as final settlement with respect to each approved project the total sum of (i) any amount not accounted for pursuant to paragraph (a) of this section and (ii) any other amounts due pursuant to subparts F, M, and O of 45 CFR part 74. Such total sum shall constitute a debt owed by the grantee to the United States and shall be recovered from the grantee or its successors or assignees by set-off or other action as provided by law.

$67.115 Reports.

Each grant awarded under this subpart shall be subject to the condition

2 The Department of Health and Human Services Grants Administration Manual is available for public inspection and copying at the Department's and Regional Offices' information centers listed in 45 CFR 5.31 and may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402.

that the grantee shall file written notification with the Secretary of each research, demonstration or evaluation project undertaken by the Center on the date that such project is initiated. Buch notification shall include:

(a) A description of the project, including the hypotheses to be tested or the objectives to be pursued;

(b) The names of the principal investigators and the principal staff members that will be assigned to the project; and

(c) A budget, including an identification of the source of funds.

$67.116 Human subjects.

No award may be made under this Subpart unless the applicant has complied with 45 CFR part 46 and other applicable requirements pertaining to the protection of human subjects.

$67.117 Applicability of 45 CFR part 74.

The provisions of 45 CFR part 74, establishing uniform administrative requirements and cost principles, shall apply to all grants under this subpart to States and local governments as

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SUBCHAPTER F-QUARANTINE, INSPECTION, LICENSING

PART 71-FOREIGN QUARANTINE

Sec.

Subpart A-Definitions and General Provisions

71.1 Scope and definitions.

71.2 Penalties.

71.3 Designation of yellow fever vaccination centers: Validation stamps.

Subpart B-Measures at Foreign Ports 71.11 Bills of health.

Subpart C-Notice of Communicable
Disease Prior to Arrival

1.21 Radio report of death or illness.

Subpart D-Health Measures at U.S. Ports: Communicable Diseases

1.31 General provisions.

1.32 Persons, carriers, and things. 1.33 Persons: Isolation and surveillance. 1.34 Carriers of U.S. military services. 1.35 Report of death or illness on carrier during stay in port.

Subpart E-Requirements Upon Arrival at U.S. Ports: Sanitary Inspection

1.41 General provisions.

1.42 Disinsection of imports.

1.43 Exemption for mails.

1.44 Disinsection of aircraft.

1.45 Food, potable water, and waste: U.S. seaports and airports.

1.46 Issuance of Deratting Certificates and Deratting Exemption Certificates.

1.47 Special provisions relating to airports: Office and isolation facilities.

11.48 Carriers in intercoastal and interstate traffic.

Subpart F-Importations

11.51 Dogs and cats.

1.52 Turtles, tortoises, and terrapins. 71.53 Nonhuman primates.

71.54 Etiological agents, hosts, and vectors. 71.55 Dead bodies.

AUTHORITY: Sec. 215 of Public Health Service (PHS) Act, as amended (42 U.S.C. 216); secs. 361-369, PHS Act, as amended (42 U.S.C. 264-272); E.O. 12452 of December 22, 1983, 48 FR 56927.

SOURCE: 50 FR 1519, Jan. 11, 1985, unless otherwise noted.

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 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.

use as a

Exhibition purpose means 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 a person who:

(1) Has a temperature of 100 °F. (or 38 °C.) or greater, accompanied by a rash, glandular swelling, or jaundice, or which has persisted for more than 48 hours; or

(2) Has diarrhea, defined as the occurrence in a 24-hour period of three or more loose stools or of a greater than normal (for the person) amount of loose stools.

International means the International Health Regulations of the World Health Organization, adopted by the Twenty-Second World Health Assembly in 1969, as amended by the Twenty-Sixth World Health Assembly in 1973, the ThirtyFourth World Health Assembly in 1981, and as may be further amended.

Health Regulations

International voyage means: (1) 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 (2) 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: (1) When applied to a person or group of persons, the separation of that person or group of persons from other persons, except the health staff on duty, in such a manner as to prevent the spread of infection; or (2) when applied to animals, the separation of an animal or group of animals from persons, other animals, or vectors of disease in such a manner as to prevent the spread of infection.

means

Military services the U.S. Army, the U.S. Air Force, the U.S.BI Navy, and the U.S. Coast Guard.

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.

Surveillance means the temporary su pervision of a person who may have or has been exposed to a communicable disease.

U.S. port means any seaport, airport, or border crossing point under the control of the United States.

United States means the several States, the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, American Samoa, and the Trust Territory of the Pacific Islands.

Vector means an animal (including insects) or thing which conveys or is capable of conveying infectious agents from a person or animal to another person or animal.

$71.2 Penalties.

Any person violating any provision of these regulations shall be subject to & fine of not more than $1,000 or to imprisonment for not more than 1 year, or both, as provided in section 368 of the Public Health Service Act (42 U.S.C. 271).

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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 E-certificates of vaccination. This responsibility is delegated by the Director to a State or territorial health de

partment 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. Desgnation may be made upon application and presentation of evidence satisfacory to a State or territorial health deartment that the applicant has adeuate facilities and professionally rained personnel for the handling, torage, and administration of a safe, otent, and pure yellow fever vaccine. Medical facilities of Federal agencies re authorized to obtain yellow fever accine without being designated as a ellow fever vaccination center by the irector.

(2) A designated yellow fever vaccinalon center shall comply with the intruction issued by the Director or by a elegated officer or employee of a tate or territorial health department ir the handling, storage, and administation of yellow fever vaccine. If a esignated center fails to comply with ach instruction, after notice to the enter, the Director or, for non-Federal enters, a State or territorial health epartment, may revoke designation. (b) Validation stamps. International ertificates of Vaccination against holera and yellow fever issued for vacInations performed in the United ates shall be validated by:

(1) The Seal of the Public Health ervice; or

(2) The Seal of the Department of tate; or

(3) The stamp of the Department of Jefense; or

(4) The stamp issued to the National Aeronautics and Space Administration;

(5) The stamp issued by a State or
erritorial health department; or
(6) An official stamp of a design and
ize approved by the Director for such

purpose.

Subpart B-Measures at Foreign Ports

871.11 Bills of health.

A carrier at any foreign port clearing or departing for any U.S. port shall not be required to obtain or deliver a bill of health.

Subpart C-Notice of Communicable Disease Prior to Arrival

§ 71.21 Radio report of death or illness. (a) The master of a ship destined for a U.S. port shall report immediately to the quarantine station at or nearest the port at which the ship will arrive, the occurrence, on board, of any death or any ill person among passengers or crew (including those who have disembarked or have been removed) during the 15-day period preceding the date of expected arrival or during the period since departure from a U.S. port (whichever period of time is shorter).

(b) The commander of an aircraft destined for a U.S. airport shall report immediately to the quarantine station at or nearest the airport at which the aircraft will arrive, the occurrence, on board, of any death or ill person among passengers or crew.

(c) In addition to paragraph (a) of this section, the master of a ship carrying 13 or more passengers must report by radio 24 hours before arrival the number of cases (including zero) of diarrhea in passengers and crew recorded in the ship's medical log during the current cruise. All cases of diarrhea that occur after the 24 hour report must also be reported not less than 4 hours before arrival.

(Approved by the Office of Management and Budget under control number 0920-0134)

Subpart D-Health Measures at U.S. Ports: Communicable Diseases

§ 71.31 General provisions.

(a) Upon arrival at a U.S. port, a carrier will not undergo inspection unless the Director determines that a failure to inspect will present a threat of introduction of communicable diseases

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