make a grant award for an additional budget period for any previously approved Center where the Secretary finds on the basis of such progress and accounting reports as may be required that the Center's activities during the current budget period justify continued support of the project for an additional budget period. Where the Secretary determines to continue support, the amount of grant award shall be determined in accordance with paragraph (b) of this section. Where the Secretary determines not to continue a project for an additional budget period, the grantee will be notified in writing before the end of the current budget period. In addition, where he determines such support is necessary, the Secretary may provide financial support for the orderly phase-out of the supported activity.

$67.107 Operational requirements.

(a) Any Center supported under this subpart shall:

(1) Have a full-time Director who possesses a demonstrated capacity for sustained productivity and leadership in health services research, demonstrations, and evaluations. The Director shall oversee the research program and the general operation of the Center and shall to the extent practicable directly participate in research activities.

Where the Director of a Center becomes unable to function in such capacity, the grantee shall so inform the Secretary as quickly as possible. Within five (5) days, the grantee shall designate an Interim Director and inform the Secretary of the name of such individual. Within ninety (90) days, the grantee shall nominate an Acting Director who, if approved by the Secretary, shall serve in that capacity until the end of the budget period. The failure to obtain Secretarial approval of a new Director in the prescribed period of time shall result in immediate suspension of the grant;

(2) Have such additional full-time professional staff representing various disciplines relevant to health services research as necessary to plan, establish and operate the proposed Center and to carry out or administer research projects undertaken with the Center. The number and expertise of the staff

shall be determined by the size of the proposed Center, the availability to it of staff resources other than its own immediate staff, and the nature and scope of the problems which its research will address:

(3) Be located within an established academic or research institution with available resources appropriate to the proposed activities to be conducted by the Center;

(4) Have written agreements with clinical settings which provide for settings appropriate for the initiation and evaluation of experiments in health services research;

(5) Select problems in health services for research, demonstrations and evaluations respecting:

(i) The accessibility, acceptability, planning, organization, distribution. technology, utilization, quality, and financing of health services and systems;

(ii) The supply and distribution, education and training, quality, utilization, organization, and cost of health manpower; and

(iii) The design, construction, utilization, organization, and cost of facilities and equipment on the basis of (A) their regional or national importance, (B) the unique potential for definitive research on the problem, (C) the opportunities for local application of the research findings;

(6) Provide educational opportunities, through formal mechanisms, for university students, health professionals or other appropriate individuals;

(7) Provide for the dissemination of its research findings, subject to the requirements for confidentiality as set forth in section 308(d) of the Act and § 67.112;

(8) Provide, through a formal mechanism, for consultations and technical assistance to concerned individuals and groups of the geographical area in which the Center will be located.

(b) National Special Emphasis Centers shall, in addition to the requirements of paragraph (a) of this section:

(1) Provide for the dissemination of its research findings on a national scale to groups and individuals particularly concerned with the area of special inquiry;

(2) Select problems in its area of special emphasis for research, demonstration and evaluation on the basis of the national importance of the problem being addressed and the unique potential for definitive research;

(3) Provide, through a formal mechaInism, for consultations and technical assistance appropriate to its area of special expertise to concerned individuals and groups on a national scale; and

(4) Employ all of the resources made available to the Center by virtue of its National Special Emphasis designation in planning, conducting and monitoring research, training, technical assistance, and other appropriate activities solely in its area of special emphasis.

$67.108 Grant payments.

The Secretary shall from time to time make payments to the grantee of all or a portion of any grant award, either by way of reimbursement for expenses incurred in the budget period, or in advance for expenses to be incurred, to the extent he determines such payments are necessary to promote prompt initiation and advancement of the approved Center. The amounts otherwise payable to any grantee shall be reduced by:

(a) Amounts equal to the fair market value of any equipment or supplies furnished to such grantee at their request by the Secretary for the purpose of planning, establishing or operating the Center; and

(b) Amounts equal to the pay, allowances, traveling expenses, and related personnel expenses attributable to the performance of services by an officer or employee of the government in connection with such Center, if such officer or employee was assigned or detailed by the Secretary at the request of the grantee to perform such services.

$67.109 Use of project funds.

(a) Any funds granted pursuant to this subpart shall be expended by the grantee solely for planning, establishing or operating the approved Center in accordance with the Act, the regulations of this subpart, the terms and conditions of the award, and the applicable cost principles prescribed in subpart Q of 45 CFR part 74.

(b) The grantee may not in whole or in part delegate or transfer this responsibility for the use of such funds to any other person, or other legal entity, without the specific prior written approval of the Secretary.

(c) Prior approval by the Secretary is required whenever there is to be a significant change in the scope or nature of the Center's approved activities.

§67.110 Nondiscrimination.

(a) Attention is called to the requirements of title VI of the Civil Rights Act of 1964 (78 Stat. 252, 42 U.S.C. 2000d et seq.) and in particular section 601 of such Act which provides that no person in the United States shall on account of race, color, or national origin be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance. Regulations implementing title VI which applies to grants made under this subpart have been issued by the Secretary with the approval of the President (45 CFR part 80).

(b) Attention is called to the requirements of section 504 of the Rehabilitation Act of 1973, as amended, which provides that no otherwise qualified handicapped person in the United States shall, solely by reason of his handicap, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance.

(c) Grant funds used for remodeling, alteration or repairs shall be subject to the conditions that the grantee shall comply with the requirements of Executive Order 11246, 30 FR 12319 (September 24, 1965), as amended, and with the applicable rules, regulations, and procedures prescribed pursuant thereto.

§ 67.111 Publications and copyright.

(a) Copyright. Except as may otherwise be provided under the terms and conditions of the award, the grantee is free to copyright any book or other copyrightable materials developed under the grant, subject to a royaltyfree, nonexclusive and irrevocable license of the Department to reproduce, publish, alter or otherwise use, and to authorize others to use the work for

Government purposes. In any case in which a copyright has been obtained, the Secretary shall be so notified.

(b) Publications. Any reports, papers, statistics, or other materials developed from work supported in whole or in part by an award made under this subpart shall be submitted to the Secretary. The Secretary may make such materials available and disseminate the material on as broad a basis as practicable and in such form as to make such materials understandable.

§ 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 §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 2 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 ap plied 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, royal- | ties 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, Depart ment 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 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;

"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.

(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 those terms are defined in subpart A of that part 74. The relevant provisions of the following subparts of part 74 shall also apply to grants to other grantee organizations under this subpart:

PART 71-FOREIGN QUARANTINE

71.31 General provisions.

71.32 Persons, carriers, and things. 71.33 Persons: Isolation and surveillance. 71.34 Carriers of U.S. military services. 71.35 Report of death or illness on carrier during stay in port.

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

71.41 General provisions.
71.42 Disinsection of imports.

71.43 Exemption for mails.

71.44 Disinsection of aircraft. 71.45 Food, potable water, and waste: U.S. seaports and airports.

71.46 Issuance of Deratting Certificates and Deratting Exemption Certificates.

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

71.48 Carriers in intercoastal and interstate traffic.

Subpart F-Importations

71.51 Dogs and cats.

71.52 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