§ 67.112 Confidentiality.

No information obtained by a Center in the course of its health services research activities directly supported under this subpart may be used for any purpose other than the purpose for which it was supplied (which shall include the disclosure of such information to the Secretary for carrying out his responsibilities under the Health Services Research, Health Statistics, and Medical Libraries Act of 1974 (Pub. L. 93-353), unless authorized under regulations of the Secretary. Further, such information may not be published or released in other than statistical form if the person who supplied the information or who is described in it is identifiable unless such person has signed a written consent on such forms and in such manner as the Secretary may prescribe. For purposes of this section and § 67.113, the term "directly supported", as it relates to health services research, demonstration, or evaluation projects, means discrete, identifiable 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 section 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. § 67.114 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 funds derived from other grant awards. With respect to each approved project the grantee shall account for the sum total of all amounts paid by presenting or otherwise making available evidence satisfactory to the Secretary of expenditures for direct and indirect costs meeting the requirements of this subpart; Provided however, That when the amount awarded for indirect costs was based on a predetermined fixed percentage of estimated direct costs, the amount allowed for indirect costs shall be computed on the basis of such predetermined

fixed-percentage rates applied to the total, or a selected element thereof, of the reimbursable direct costs incurred.

(b) Accounting for royalties. Royalties received by grantees from copyrights on publications or other works developed under the grant, or from patents or inventions conceived or first actually reduced to practice in the course of or under such grant, shall be accounted for as follows:

(1) State and local governments. When the grantee is a State or local government as defined in 45 CFR 74.3, royalties shall be accounted for as provided in 45 CFR 74.44.

(2) Grantees other than State and local governments. Where the grantee is not a State or local government as so defined, royalties shall be accounted for as follows:

(i) Patent royalties, whether received during or after the project period, shall be governed by agreements between the Assistant Secretary for Health, Department of Health, Education, and Welfare, 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, Education, and Welfare 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

2 The Department of Health, Education, and Welfare 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, D.C. 20402.

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 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. Such 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.

74.

Subpart C-Notice of Communicable Disease Prior to Arrival

71.31 Radio report of death or illness.

Subpart D-Vessels and Aircraft Subject to
Quarantine Inspection

Subpart A-Definitions and General Provisions

Sec.

71.47

Vessels and aircraft of armed services.

Exempt vessels and aircraft subject to sanitary regulations.

71.700 Appendix-Excerpts from International Sanitary Regulations (World Health Organization Regulations No. 2).

AUTHORITY: The provisions of this Part 71 issued under sec. 215, 58 Stat. 690, as amended; 42 U.S.C. 216; secs. 361-369, 58 Stat. 703-706; 42 U.S.C. 264–272, E.O. 9708, 11 F.R. 8241, 3 CFR 1943-1948 Comp.; E.O. 10399, 17 FR. 8648, 3 CFR, 1948-1953 Comp.; E.O. 10532, 19 FR. 3209, 3 CFR, 1954-1958 Comp., unless otherwise noted.

SOURCE: The provisions of this Part 71 appear at 21 FR. 9870, Dec. 12, 1956, unless otherwise noted.

NOTE: Information concerning forms called for in this part may be obtained from medical officers in charge of quarantine stations of the Public Health Service or from the Division of Foreign Quarantine, Washington D.C. Pertinent provisions of the International Sanitary Regulations (World Health Organization Regulations No. 2) which are referred to in this part are contained in § 71.700.

Subpart A-Definitions and General Provisions

As used in this part, terms shall have the following meaning:

(a) Certificate of vaccination. Certificate of vaccination or revaccination against cholera, smallpox or yellow fever conforming with the rules and models prescribed by the International Sanitary Regulations.

(b) Communicable disease. An illness due to an infectious agent or its toxic products which is transmitted directly or indirectly to a well person from an affected person, animal, or arthropod (including insecta and arachnida) or through the agency of an intermediate host, vector or the inanimate environment.

(c) Contamination. The presence of undesirable substance or material which may contain pathogenic microorganisms. (d) Day. A period of 24 hours.

(e) Deratting Certificate. A certificate issued with respect to a vessel by the competent health authority for a port, in the form prescribed by the International Sanitary Regulations, recording the inspection and deratting of the vessel.

(f) Deratting Exemption Certificate. A certificate issued with respect to a vessel by the competent health authority for a port, in the form prescribed by the International Sanitary Regulations, recording the inspection and exemption from deratting of the vessel which has a negligible number of rodents on board. (g) Disinfection. The act of rendering anything free from the causal agents of disease.

(h) Disinfestation. The act of destroying the vectors of a communicable disease.

(1) Disinsecting. The act of destroying insects or other arthropod vectors of a communicable disease.

(j) Immunity. The condition of being protected against a particular disease, either as a result of artificial immunization or through a previous attack of the disease in question.

(k) Incubation period. The period between the implanting of disease organisms in a susceptible person and the appearance of clinical manifestations of the disease.

(1) Infected local area. A local area (as defined in the International Sanitary Regulations) where:

(1) There is a nonimported case of cholera or smallpox; or

(2) There is a nonimported case of plague, or there is plague infection among rodents; or

(3) There is a nonimported case of yellow fever, or there is activity of yellow fever virus in vertebrates other than man; or

(4) There is an epidemic of typhus or relapsing fever.

(m) Infected person. Any person who is suffering from a quarantinable disease or who is considered by the medical offcer in charge to be infected with such a disease.

(n) Infestation. harboring vectors.

The condition of

(0) International Sanitary Regulations. The International Sanitary Regulations (World Health Organization

Regulations No. 2) adopted by the Fourth World Health Assembly on May 25, 1951.

See

(p) Infected vessel or aircraft. under particular quarantinable diseases in Subpart F of this part.

(q) Isolation. (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.

(2) When applied to animals, the separation of an animal or group of antmals from other animals or vectors of disease in such manner as to prevent the spread of infection.

(r) Medical officer in charge. The medical officer of the Public Health Service responsible for the application of these regulations at a designated place or in a designated area.

(s) Port under the control of the United States. Any seaport or airport in the United States, its territories or possessions other than the Canal Zone.

(t) Pratique. A certificate issued by a quarantine officer releasing or provisionally releasing a vessel or aircraft from quarantine.

(u) Quarantine. The detention of a person, vessel, aircraft or other conveyance, animal or thing, in such place and for such period of time as may be specified in the regulations in this part.

(v) Quarantine officer. A medical officer or other specially trained employee assigned to quarantine duty by the Surgeon General.

(w) Quarantinable diseases. The specific communicable diseases: cholers, plague, smallpox, and yellow fever.

(x) Relapsing fever. Louse-borne relapsing fever.

(y) Rodents. Gnawing mammals capable of transmitting or harboring quarantinable diseases.

(z) Surgeon General. The Surgeon General of the Public Health Service.

(aa) Surveillance. The temporary supervision of a person who has been released from quarantine by the medical officer in charge upon the condition that he will submit himself to further medical examination or inquiry as required.

(bb) Suspect. A person who is considered by the medical officer in charge as having been exposed to infection by a

quarantinable disease and to be capable of spreading that disease.

(cc) Suspected vessel or aircraft. See under particular quarantinable diseases in Subpart F of this part.

(dd) Typhus. Louse-borne typhus. (ee) Valid. (1) With respect to a Deratting Certificate or Deratting Exemption Certificate issued for a vessel, a certificate issued by the competent health authority for a port not more than 6 months before presentation of the Certificate to the quarantine officer, or if the vessel is proceeding to a port designated or approved for the issuance of such Certificates, not more than 7 months before such presentation.

(2) With respect to a certificate of vaccination, a certificate presented within the applicable period of immunity prescribed in § 71.3.

(ff) Vector. An animal (including insects), plant, or thing which conveys or is capable of conveying pathogenic organisms from a person or animal to another person or animal.

(gg) Yellow fever receptive area. An area where the yellow fever virus does not exist but where Aedes aegypti or any other domiciliary or peri-domiciliary vector of yellow fever is present and development of the disease, if introduced, would thus be possible.

[22 FR 6461, Aug. 13, 1957, as amended at 38 FR 16861, June 27, 1973]

§ 71.2 Periods of isolation and surveil

lance.

Except as otherwise provided with respect to infected persons, where isolation or surveillance is authorized in this part the period of such isolation or surveillance shall be reckoned as hereinafter provided and shall not exceed the following appropriate incubation period of the quarantinable diseases:

(a) Plague: 6 days.
(b) Cholera: 5 days.
(c) Yellow fever: 6 days.
(d) Smallpcx: 14 days.
(e) Typhus: 14 days.

(f) Relapsing fever: 8 days. § 71.3 Periods of immunity.

The following shall be the recognized period of immunity after successful immunization; in the case of yellow fever, the vaccine must be approved by the World Health Organization:

Cholera: 6 months, beginning 6 days after the first injection of the vaccine and on date