sources for carrying out services to be provided under the approved State plan for the fiscal year;

(2) The amount of expenditures by such nonprofit agency which may be included for any fiscal year does not exceed the amount of the funds made available to such agency by the State under the plan plus not more than an equal amount of expenditure by such agency from nongovernmental funds;

(3) The records of the expenditure by a nonprofit private agency, in carrying out the State plan, shall be maintained and be available for inspection and audit for the period specified in § 51.104(j) (3).

(d) Equipment. When equipment purchased from funds spent in carrying out the approved State plan is sold, a proportionate share of any receipts realized from the sale of such equipment shall be deducted from the gross expenditures claimed for Federal participation for the year in which the receipts were received. Such share will be in the same proportion as participation of the Federal funds was in the expenditures under the State plan in the year in which the equipment was purchased. In addition, when any equipment purchased from funds spent in carrying out the approved State plan is transferred or otherwise disposed of to an activity which would not be eligible for support under this subpart, its then market value shall be deducted (in the same proportion as above) from the gross expenditures claimed for Federal participation for the year in which the transfer is made.

[32 F.R. 8245, June 8, 1967, as amended at 33 F.R. 11360, Aug. 9, 1968; 33 F.R. 13026, Sept. 14, 1968]

§ 51.108 Equipment, supplies or personnel in lieu of cash.

At the request of and for the convenience of a State authority, the Secretary may, in lieu of cash payments, furnish to such authority equipment or supplies or detail officers or employees of the Public Health Service when he finds that such equipment, supplies, or personnel would be used in carrying out the approved State plan for public health services. In such cases, the Secretary shall reduce the payments to which such State authority would otherwise be entitled from its allotment for the fiscal year by an amount which equals the fair market value of the equipment or supplies furnished and by the amount of the pay, allowances, traveling expen

ses, and other costs in connection with such detail of officers or employees. For purposes of determining the amount of the expenditures for any fiscal year made in carrying out the approved State plan and the Federal share of such expenditures, the costs incurred by the Secretary in furnishing such equipment or supplies and in detailing such personnel to the State agency during the fiscal year shall be considered as expenditures made by and funds paid to the State.

[32 F.R. 8246, June 8, 1967, as amended at 33 F.R. 13026, Sept. 14, 1968]

§ 51.109 Nondiscrimination on account of race, color, or national origin. Attention is called to the requirements of Title VI of the Civil Rights Act of 1964 (78 Stat. 252; P.L. 88-352) which provides that no person in the United States shall, on the ground 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 (sec. 601). A regulation implementing such Title VI has been issued by the Secretary of Health, Education, and Welfare with the approval of the President (45 CFR Part 80). Such regulation is applicable to services and programs provided under approved State plans for public health services receiving Federal assistance under section 314(d) of the Act, and requires receipt and acceptance by the Secretary of the applicable documentation set forth therein.

[32 F.R. 8246, June 8, 1967, as amended at 33 F.R. 13026, Sept. 14, 1968]

52.44 Project net income. 52.45 Final settlement.

AUTHORITY: The provisions of this Part 52 issued under secs. 215, 58 Stat. 690; 633 (a), 60 Stat. 1041; 5, 69 Stat. 322; and 10(a), 70 Stat. 506; 42 U.S.C. 216, 291k, 1857d; 33 U.S.C. 4661. Secs. 301, 58 Stat. 691; 636, 63 Stat. 900; 5, 69 Stat. 322; 4(a), 70 Stat. 499; and sec. 303, 70 Stat. 929; 42 U.S.C. 241, 291n, 1857d; 33 U.S.C. 466c; 42 U.S.C. 242a.

SOURCE: The provisions of this Part 52 appear at 28 F.R. 10420, Sept. 26, 1963, unless otherwise noted.

For technical changes in nomenclature see 33 F.R. 9821, July 9, 1968.

Subpart A Applicability and
Definitions

§ 52.1 Applicability.

The regulations of this part apply to grants for the support of health related research projects as set forth in § 52.10. They do not apply to general research support grants, demonstration grants, grants for studies in providing services outside hospitals, or other grants as may be authorized by law, such as grants for the construction of research facilities (see Part 57 of this chapter), for the construction of hospital or other medical facilities (see Part 53 of this chapter), or the award of fellowships (see Part 61 of this chapter), traineeships (see Part 63 of this chapter), or training grants (see Part 64 of this chapter).

[28 F.R. 10420, Sept. 26, 1963, as amended at 33 F.R. 9821, July 9, 1968]

§ 52.2 Definitions.

As used in this part:

(a) “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 may be delegated.

(b) "Project period” means the period of time, not exceeding 7 years, which the Secretary finds is reasonably required to initiate and conduct a research project meriting support by means of one or more research project grants within the scope of § 52.10, except that such period may be extended by the Secretary beyond 7 years solely to permit continuation or completion of the same approved project by use of funds previously awarded but remaining unencumbered by the grantee at the end of such 7 years. The project period may include the time required for initial staffing and acquisition of facilities and for the preparation and publication of the results of the project. The approval and support of a research project for the maximum project period shall not preclude additional support of that project beyond such period if such support of the continued project is requested, evaluated and approved on the same basis as a new or initial application in accordance with §§ 52.12 and 52.13.

[28 F.R. 10420, Sept. 26, 1963, as amended at 33 F.R. 9821, July 9, 1968]

Subpart B-Eligibility, Award and Termination

§ 52.10 Nature and purpose of research project grant.

A research project grant is the award by the Secretary of funds to an institution, organization or other person, hereinafter called the "grantee", to meet in whole or in part the costs of conducting for the benefit of the public health an identified activity or program, hereinafter termed the "project", that is intended and designed to establish, discover, develop, elucidate or confirm information or the underlying mechanisms relating to:

(a) The cause, diagnosis, treatment, control or prevention of the physical or mental diseases injuries, or impairments of man as authorized by sections 301, 303 and related provisions of the Public Health Service Act, as amended (42 U.S.C. 241, 242(a));

(b) The causes, effects, control or prevention of water pollution or air pollution, as authorized by section 301 of the Public Health Service Act, as amended (42 U.S.C. 241), and section 5 of Public Law 159, 84th Congress, as amended (42 U.S.C. 1857d);

(c) The development, ultilization and coordination of services, facilities and resources of hospitals or other medical

facilities agencies or institutions as authorized by section 636 of the Public Health Service Act as amended (42 U.S.C. 291n); or

(d) Improved methods of operation and administration of State institutions for the mentally ill as authorized by section 303 of the Public Health Service Act, as amended (42 U.S.C. 242a).

(e) Medical library science and related activities and for the development and/ or dissemination of new knowledge, techniques, systems and equipment for processing, storing, retrieving, and distributing information pertaining to sciences related to health, as authorized by section 396 of the Public Health Service Act.

[28 F.R. 10420, Sept. 26, 1963, as amended at 31 F.R. 5758, Apr. 14, 1966; 31 F.R. 9504, July 13, 1966]

§ 52.11 Eligibility for grant.

(a) Persons eligible. Except where otherwise prohibited by law, any individual, corporation, public or private institution or agency, or other legally accountable person found by the Secretary to be authorized and qualified by scientific or other relevant competence to carry out a proposed research project in accordance with the regulations of this part shall be eligible for a grant award except:

(1) Federal agencies or institutions not specifically authorized by law to receive such a grant;

(2) Any corporation, institution, agency or other such person, other than an individual, that is organized or operated for profit; and

(3) Any individual, corporation, institution, agency or other such person who, having previously received a grant award has failed wilfully and materially in the judgment of the Secretary to comply with accounting or other requirements applicable to such prior award, such disqualification to continue until terminated in the public interest by the Secretary.

(b) Projects eligible. Any project found by the Secretary to be a research project within the meaning of § 52.10 shall be eligible for a grant award. Eligible projects may consist of laboratory, clinical, population, field, statistical, basic, applied or other types of investigations, studies or experiments, or combinations thereof, and may either be limited to one, or a particular aspect of a, problem or subject, or may consist of two or more related problems or sub

jects for concurrent or consecutive investigation and involving multiple disciplines, facilities and resources.

[28 F.R. 10420, Sept. 26, 1963, as amended at 33 F.R. 9821, July 9, 1968]

§ 52.12

Application for grant.

Any person eligible for a grant award under § 52.11 may file application therefor with the Secretary on such forms as he may prescribe. Such application shall set forth adequately the nature, duration, purpose and plan of the research project, the qualifications of the principal staff members to be responsible for the project, the total facilities and resources that will be available, a justification of the amount of grant funds requested, and such other pertinent information as the Secretary may require. The application shall be executed by an individual authorized to act for the institution or other applicant and to assume on behalf of the applicant the obligations imposed by the terms and conditions of any award, including the regulations of this part.

§ 52.13 Evaluation and disposition of applications.

(a) Evaluation. All applications filed in accordance with § 52.12 shall be evaluated by the Secretary through such officers and employees and such experts or consultants engaged for this purpose as he determines are specially qualified in the areas of research involved in the project, including review by an appropriate National Advisory Council or other body as may be required by law. The Secretary's evaluation shall take into account among other pertinent factors the scientific merit and significance of the project, the competency of the proposed staff in relation to the type of research involved, the feasibility of the project, the likelihood of its producing meaningful results, the proposed project period, and the adequacy of the applicant's resources available for the project and the amount of grant funds necessary for completion.

(b) Disposition. On the basis of his evaluation of an application pursuant to paragraph (a) of this section and subject to such approvals, recommendations or consultations by the appropriate National Advisory Council or other body as may be required by law, the Secretary shall (1) approve, (2) defer because of either lack of funds or a need for further evaluation, or (3) disapprove support of the proposed project in whole or in

part. With respect to approved projects, the Secretary shall determine the project period during which the project may be supported. Any deferral or disapproval of an application shall not preclude its reconsideration or a reapplication.

[28 F.R. 10420, Sept. 26, 1963, as amended at 33 F.R. 9821, July 9, 1968]

§ 52.14 Grant awards.

(a) General. Within the limits of funds available for such purpose, the Secretary shall award a grant to those applicants whose approved projects will in his judgment best promote the purposes of § 52.10. The date specified by the Secretary as the beginning of the project period shall be no later than 9 months following the date of any initial or new award statement unless the Secretary finds that because of the nature of a project or the grantee's particular circumstances earlier assurance of grant support is required to initiate the project. All grant awards shall be in writing, shall set forth the amount of funds granted, which may include an estimated provisional amount for indirect costs or for designated direct costs (such as hospital per diem rates or fringe benefit rates) subject to adjustment as set forth below, and shall constitute for such amounts the encumbrance of Federal funds available for such purpose on the date of the award. Within the limits of available funds, provisional amounts shall be subject to upward as well as downward adjustment to actual costs when the amount properly expended by the grantee for provisional items has been determined by the Secretary. All amounts awarded, whether provisional or otherwise, remain subject to accountability as provided under Subpart E of this part.

Secretary from making upward adjustments to actual costs as to amounts awarded on a provisional basis as provided in paragraph (a) of this section. (c) Multiple, concurrent, initial awards. Whenever a research project involves a number of different but related problems, activities or disciplines so as to require evaluation by different groups, or whenever support for a project could be more effectively administered by separate handling of separate aspects of the project, the Secretary may evaluate and approve two or more concurrent applications each dealing with one or more specified aspects of the project, and he may make two or more concurrent grant awards with respect to such a project.

(d) Supplemental and continuation awards. The Secretary may from time to time within the project period make additional grant awards with respect to any approved project continued without change except as provided in § 52.20 (b) and (c) where he finds, on the basis of such progress and accounting reports as he may require, either that (1) the amount of any prior award was less than the amount necessary to carry out the approved project within the period used for estimating the amount of such prior award (a supplemental grant), or (2) the progress made within the period with respect to which any prior awards were made justifies support for an additional, specified portion, or the remainder, of the project period (a continuation grant). The amount of any supplemental or continuation grant shall be determined as provided in paragraph (b) of this section.

(e) Payments. 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 to be incurred or incurred in the project period, to the extent he determines such payments necessary to promote prompt initiation and advancement of the approved project. All such payments shall be recorded by the grantee in accounting records separate from all other fund accounts, including funds derived from other grant awards. Amounts paid shall be available for expenditure by the grantee in accordance with the regulations of this part throughout the project period subject to such limitations as the Secretary may prescribe.

(f) Award for continuation of project new grantee. The Secretary,

upon application in accordance with the provisions of § 52.12 and without further action by a Council or other body, may make a grant to any institution or other person eligible under § 52.11 for continuation of a currently supported project for which a grant was previously made to another institution or person, provided he finds that the change in the conduct of the project is consonant with the previous evaluation and approval of the project under § 52.13.

[28 F.R. 10420, Sept. 26, 1963, as amended at 29 F.R. 9831, July 22, 1964; 33 F.R. 9821, July 9, 1968]

§ 52.15 Termination.

agreement.

(a) Discontinuance by Whenever in the judgment of the Secretary and the grantee, continuation of an approved project would produce results of no value in furthering the purposes of § 52.10, grant support shall be terminated.

(b) Termination by Secretary. Any grant award may be revoked or terminated by the Secretary in whole or in part at any time within the project period whenever he finds that in his judgment the grantee has failed in a material respect to comply with the regulations of this part. The grantee shall be promptly notified of such finding in writing and given the reasons therefor.

(c) Termination by the grantee. A grantee may at any time terminate or cancel its conduct of an approved project by notifying the Secretary in writing setting forth the reasons for such termination.

(d) Accounting. Upon any termination, the grantee shall render an accounting pursuant to Subpart E of this part: Provided, however, That to the extent the termination is due in the judgment of the Secretary to no fault of the grantee, credit shall be allowed for the amount required to settle at minimum costs any noncancellable obligations properly incurred by the grantee prior to receipt of notice of termination. Subpart C-Grant ConditionsObligations of Grantee

may not in whole or in part delegate or transfer this responsibility for the use of such funds to any other person.

(b) Changes in project. The permissible changes by the principal investigator in the approved project shall be limited to changes in methodology, approach or other aspects of the project that would expedite achievement of the project's research objectives, including changes that grow out of the approved project and serve the best scientific strategy. Whenever the grantee and the principal investigator are uncertain as to whether a change complies with these provisions, the question shall be referred to the Secretary for a final determination.

(c) Changes in project period. The project period determined pursuant to § 52.13(b) may be extended by the Secretary, with or without additional grant support, for such an additional period as he determines may be required to complete, or fulfill the purposes of, the approved project provided the total period as extended does not exceed 7 years except with respect to the grantee's unencumbered balances as provided in § 52.2(b).

[28 F.R. 10420, Sept. 26, 1963, as amended at 33 F.R. 9822, July 9, 1968]

§ 52.21 Principal investigators.

All grant awards shall be subject to the condition that the principal investigator designated in the application as responsible for the conduct of the approved project shall continue responsible for the duration of the project period. Whenever any such investigator shall become unavailable for any reason to discharge this responsibility, the grant shall be terminated and an accounting rendered as provided in § 52.15 unless the grantee replaces such investigator with another person found by the Secretary to be qualified to direct and conduct the approved project.