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.

140 FR 19314, May 2, 1975; 40 FR 20953, May 14, 1975]

§ 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

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. 2897-1(a) (1) (B)), to non-Federal 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 disease (or diseases) or other health problems to which the activities of the National Institutes of Health and the Alcohol, Drug Abuse, and Mental Health Administration are directed.

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 non-Federal 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. 2891-2);

(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

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.

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 assistance.

(c) Grant funds used for alterations and renovations shail 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.

(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, diseminate and dispose of such materials, and to authorize others to do so.

§ 66.215 Additional conditions.

The Secretary, may with respect to any grant award impose additional conditions prior to or at the time of any award when in his judgment such conditions are necessary to assure or protect

AUTHORITY: Sec. 215, 58 Stat. 690 (42 U.S.C. 216); sec. 305(d), as amended, 88 Stat. 364; (42 U.S.C. 242c (d)).

SOURCE: 41 FR 5226, Feb. 4, 1976, unless otherwise noted.

§ 67.101 Purpose and scope.

(a) The regulations of this subpart are applicable to the award of grants under section 305(d) of the Public Health Service Act, as amended, to assist in meeting the costs of planning, establish– ing and operating multidisciplinary Health Services Research Centers by providing support for both permanent staff composed of experts from different disciplines and the administrative costs of carrying out multidisciplinary health services research, evaluations and demonstrations respecting:

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

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

(3) The design, construction, utilization, and cost of facilities and equipment.

(b) Additional support awarded under this subpart, for National Special Emphasis Centers is intended to support staff, research, demonstration, and evaluation projects, training programs, and

As used in this subpart:

(a) "Act" means the Public Health Service Act, as amended.

(b) "Secretary" means the Secretary of Health, Education, and Welfare and any other officer or employee of the Department of Health, Education, and Welfare to whom the authority involved has been delegated.

(c) "Nonprofit" as applied to a private entity, means that no part of the net earnings of such entity inures or may lawfully inure to the benefit of any shareholder or individual.

(d) "Project period" means the total period of time for which support for a project has been approved as specified in the grant award document. Such approval does not commit or obligate the Federal government to any additional, supplemental or continuation support beyond the current budget period.

(e) "Budget period" means the interval of time (usually 12 months) into which the project has been divided for budgetary and reporting purposes and for which the Government has made a financial commitment to fund a particular project.

(f) "Center" means a Health Services Research Center supported under this subpart.

(g) "National Special Emphasis Center" mean a Center which directs a substantial portion of its efforts in research training, technical assistance, and other appropriate activities to a particular aspect of health care delivery specified by the Secretary and requiring a particular kind of scientific expertise. Such Centers shall include:

(1) A Health Care Technology Center, which shall focus on all forms of technology, including computers and electronic devices, and its applications in health care delivery;

(2) A Health Care Management Center, which shall focus on the improvement of administration and organization in the health field, the training and retraining of administrators of health care enterprises, and the development of leaders, planners and policy analysts in the health field; and

(3) Such other Centers as the Secretary shall deem appropriate, provided that formal notification of the competi

66-019-76-32

tion for a grant award and designation as a National Special Emphasis Center under this subpart shall be made at least ninety (90) days prior to the closing date for filing applications for Center grants.

(h) "State" means one of the 50 States, the District of Columbia, Puerto Rico, Guam, Virgin Islands, American Samoa, and the Trust Territory of the Pacific Islands.

(i) "Grantee" means the public or nonprofit private entity that receives a grant under section 305(d) of the Act and this subpart and assumes legal and financial responsibility for the funds awarded and for the performance of the grant supported activity.

(j) "Director" means a single individual, designated by the grantee in the grant application and approved by the Secretary, who is responsible for the scientific, technical, and administrative direction of the Center.

§ 67.103 Eligibility.

Any public or nonprofit private entity located in a State is eligible to apply for a grant under this subpart; Provided, That no entity is eligible for assistance for more than one Center at any one time.

§ 67.104 Application.

(a) An application for a grant under this subpart shall be submitted to the Secretary at such time and in such manner as the Secretary may prescribe.1

(b) The 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 Act, the regulations of this subpart and the terms and conditions of any grant award.

(c) In addition to such other pertinent information as the Secretary may require, an application for a grant under this subpart shall contain the following:

(1) A description of the manner in which the applicant intends to plan and establish a Center, including a timetable for making the proposed Center operational;

1 Applications and instructions are available from the Director, Review and Advisory Services, National Center for Health Services Research, Health Resources Administration, 5600 Fishers Lane, Rockville, Maryland 20852, Room 15-35.