Code of Federal Regulations: Containing a Codification of Documents of ...

(c) The prohibition against discrimination against the handicapped imposed by section 504 of the Rehabilitation Act of 1973, as amended (29 U.S.C. 794).

§ 66.113 Human subjects; animal welfare.

Where the application is for research or training at a public or nonprofit private institution, no Award may be made under this subpart unless said institution has complied with:

(a) 45 CFR Part 46 and any other applicable requirements pertaining to the protection of human subjects.

(b) Chapter 1-43 of the Department of Health, Education, and Welfare Grants Administration Manual' and any other applicable requirements concerning animal welfare.

§ 66.114 Publications.

Publication, distribution, and disposition of all manuscripts and other materials resulting from an Award shall be subject to the conditions that all such materials shall bear appropriate acknowledgement of Department of Health, Education, and Welfare support and that the awardee shall furnish such copies of these manuscripts or other materials as the Secretary may reasonably request.

§ 66.115 Copyright.

Where the work accomplished under an Award results in a book or other copyrightable material, the author is free to copyright the work, but the United States reserves a royalty-free, nonexclusive, and irrevocable license to reproduce, publish, or otherwise use, and to authorize others to use, all copyrightable or copyrighted material resulting from the Award.

§ 66.116 Inventions and discoveries.

(a) Any Award is subject to the regulations of the Department of Health, Education, and Welfare set forth in 45

'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.

CFR Parts 6 and 8, as amended. Such regulations shall apply to any activity for which Award funds are in fact used, whether within the scope of the Award as approved or otherwise. Each such invention or discovery shall be promptly and fully reported to the Assistant Secretary for Health, Department of Health, Education, and Welfare.

(b) Determination as to ownership and disposition of rights to such invention or discovery, including whether a patent application shall be filed, and, if so, the manner of obtaining, administering, and disposing of rights under any patent application or patent which may issue shall be made either: (1) By the Assistant Secretary for Health, whose decision shall be final,

(2) Where an Award is made to an individual for research or training at a non-Federal public or nonprofit private institution having a separate formal institutional patent agreement with the Department of Health, Education, and Welfare, by the institution in accordance with that agreement.

§ 66.117 Additional conditions.

The Secretary may with respect to any Award or class of Awards impose additional conditions prior to or at the time of any Award when in his judgment such conditions are necessary to assure the carrying out of the purposes of the Award, the interests of the public health, or the conservation of funds awarded.

Subpart B-Institutional Grants

§ 66.201 Applicability.

The regulations in this subpart are applicable to grants under section 472(a)(1)(B) of the Public Health Service Act, as amended (42 U.S.C. 28911(a)(1)(B)), to public institutions and to nonprofit private institutions to enable such institutions to make to individuals selected by them National Research Service Awards for research and predoctoral and postdoctoral training to undertake such research in matters relating to the cause, diagnosis, prevention, and treatment of the diseases or other health problems.

§ 66.202 Definitions.

The definitions in § 66.102 of Subpart A of this part shall apply as well to this subpart.

§ 66.203 Eligibility.

To be eligible for a grant under this subpart, an applicant must be:

(a) A public or nonprofit private institution; and

(b) Located in a State, the District of Columbia, Puerto Rico, the Virgin Islands, the Canal Zone, Guam, American Samoa, or the Trust Territory of the Pacific Islands.

§ 66.204 Application.

(a) Each institution desiring a grant under this subpart shall submit an application on a form approved for that purpose by the Secretary, on or before such dates as the Secretary may prescribe. Such application shall be executed by an individual authorized to act for the applicant and to assume on behalf of the applicant the obligations imposed by the terms and conditions of the grant, including the regulations of this subpart.

(b) In addition to any other pertinent information that the Secretary may require, each application shall set forth in detail:

(1) The subject area or areas in which the proposed research or training will be conducted;

(2) The resources and facilities available to the applicant for use by recipients of Awards in carrying out such research or training;

(3) The names, qualifications, and experience of the program director and principal staff members who will be responsible for the proposed program;

(4) The criteria to be employed in selecting individuals to be recipients of Awards;

(5) The estimated number of recipients of Awards under the grant;

(6) The proposed period of support and a detailed budget and justification for the amount of grant funds requested; and

(7) Proposed methods for monitoring and evaluating the performance of individual recipients of Awards, as well as the overall program.

§ 66.205 Requirements.

(a) No Award shall be made to an individual under a grant pursuant to this subpart unless:

(1) The individual has submitted to the Secretary a written assurance (in such form as the Secretary may prescribe) that he or she will satisfy the requirements of §§ 66.110 (a) and (b) of Subpart A of this part;

(2) Effective July 1, 1975, such Award is for research or training in a subject area for which there is a need for personnel, as determined under section 473 of the Act (42 U.S.C. 28912);

(3) The individual is a citizen or noncitizen national of the United States or has been lawfully admitted to the United States for permanent residence at the time of application;

(4) The Award includes a provision for termination in the event the recipient is found by the institution to have materially failed to comply with the terms and conditions of the Award or to carry out the purpose for which it was made; and

(5) The Award is not to be used to support a residency.

(b) No Award shall be made to an individual under such grant which exceeds three years in the aggregate unless the Secretary for good cause shown as provided in § 66.106(d) of Subpart A of this part, waives the application of this limitation to such individual.

(c) The provisions of §§ 66.110 and 66.111 of Subpart A of this part constitute terms and conditions of any Award made under a grant pursuant to this subpart.

§ 66.206 Grant awards.

(a) Within the limits of funds available, the Secretary shall award grants to those applicants:

(1) Whose applications have been reviewed and recommended for approval by appropriate advisory councils within NIH and ADAMHA;

(2) Who have satisfied the requirements of § 66.205 of this subpart; and

(3) Whose proposed programs would, in the judgment of the Secretary, best promote the purposes of section 472(a)(1)(B) of the Act, taking into

consideration among other pertinent factors:

(i) The scientific, technical, or educational merit of the proposed program;

(ii) The adequacy of the resources and facilities available to the applicant;

(iii) The qualifications and experience of the program director and principal staff members;

(iv) The degree of the need for personnel in the subject area or areas of the proposed research or training;

(v) The administrative and managerial capability of the applicant;

(vi) The reasonableness of the proposed budget in relation to the proposed program; and

(vii) The adequacy of the methods for monitoring and evaluating the performance of individual recipients and the overall program.

(b) All grant awards shall be in writing and shall specify the period of support, the total recommended amount of funds for the entire period of support, the approved budget for the initial budget period, and the amount awarded for the initial budget period.

(c) Neither the approval of any application nor any grant award shall commit or obligate the United States in any way to make any additional, supplemental, continuation, or other grant award with respect to any approved application or portion thereof.

(d) The amount of any grant award shall be determined by the Secretary on the basis of his estimate of the sum necessary during the budget period: (1) To provide stipends and allowances to individual recipients of Awards and payments to the institution, as determined in accordance with §§ 66.107(a) and 66.108(a) of Subpart A of this part, and (2) otherwise to carry out the grant award.

§ 66.207 Payment.

The Secretary shall from time to time make payments to a grantee of all or a portion of any grant award, either in advance or by way of reimbursement, for expenses incurred or to be incurred in accordance with its approved application.

§ 66.208 Expenditure of grant funds.

(a) Any funds granted pursuant to this subpart shall be expended solely for the purposes for which the funds were granted in accordance with the approved application and budget, the regulations of this subpart, the terms and conditions of the award, and the applicable cost principles prescribed by Subpart Q of 45 CFR Part 74.

(b) Any unobligated grant funds remaining in the grant account at the close of a budget period may, with prior approval by the Secretary, be carried forward and remain available for obligation during the remainder of the period of support, subject to such limitations as the Secretary may prescribe. The amount of any subsequent award will take into consideration unobligated grant funds remaining in the grant account. At the end of the period of support any unobligated grant funds remaining in the grant account must be refunded to the United States.

§ 66.209 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.) which provides that no person in the United States shall, on the grounds 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. A regulation implementing such Title VI, which is applicable to grants made under this subpart, has been issued by the Secretary of Health, Education, and Welfare with the approval of the President (45 CFR Part 80).

(b) Attention is also called to the requirements of Title IX of the Education Amendments of 1972 and in particular to section 901 of such Act (20 U.S.C. 1681) which provides that no person in the United States shall, on the basis of sex, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any education program or activity receiving Federal financial assist

ance.

(c) Grant funds used for alterations and renovations shall be subject to the condition 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.

(d) Attention is called to the requirements of section 504 of the Rehabilitation Act of 1973, as amended (29 U.S.C. 794), which provides that no otherwise qualified handicapped individual 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.

§ 66.210 Human subjects; animal welfare.

No grant award may be made under this subpart unless the applicant has complied with:

(a) 45 CFR Part 46 and any other applicable requirements pertaining to the protection of human subjects.

(b) Chapter 1-43 of the Department of Health, Education, and Welfare Grants Administration Manual1 and any other applicable requirements concerning animal welfare.

§ 66.211 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 State 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 all other grantee organizations under this subpart:

§ 66.212 Progress and fiscal records and reports.

Each grant award shall require that the grantee maintain such progress and fiscal records and file with the Secretary, such progress and fiscal reports relating to the conduct and results of the approved grant and the use of grant funds as the Secretary may find necessary to carry out the purposes of this subpart.

§ 66.213 Grantee accountability.

(a) All payments made by the Secretary shall be recorded by the grantee in accounting records separate from the records of all other grant funds, including funds derived from other grant awards. With respect to each approved program the grantee shall account for the sum total of all amounts paid by presenting or otherwise making available to the Secretary, satisfactory evidence of expenditures for direct and indirect costs meeting the requirements of this subpart.

(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. Where the grantee is a State or local government as those terms are defined in Subpart A of 45 CFR Part 74, 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

those terms are defined in Subpart A of 45 CFR Part 74, royalties shall be accounted for as follows:

(i) Patent royalties, whether received during or after the grant 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 the materials shall be distributed in accordance with Chapter 1-420 of the Department of Health, Education, and Welfare Grants Administration Manual.

§ 66.214 Publications and copyright.

(a) State and local governments. Where the grantee is a State or local government as those terms are defined in Subpart A of 45 CFR Part 74, the Department of Health, Education, and Welfare copyright requirement set forth in 45 CFR 74.140 shall apply with respect to any book or other copyrightable materials developed or resulting from an activity supported by a grant under this subpart.

(b) Grantees other than State and local governments. Where the grantee is not a State or local government as those terms are defined in Subpart A of 45 CFR Part 74, except as may otherwise be provided under the terms and conditions of the grant award, the grantee may copyright without prior approval any publications, films, or similar materials developed or resulting from an activity supported by a grant under this subpart, subject to a royalty-free nonexclusive, and irrevocable license or right in the United States to reproduce, translate, publish, use, disseminate and dispose of such materials, and to authorize others to do so.

« Previous Continue »

Books