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

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

(10) The adequacy of the methods for monitoring and evaluating the program on a continuing basis; and

(11) The degree to which the application adequately provides for the requirements set forth in § 52d.5.

(b) The notice of grant award specifies how long HHS intends to support the program without requiring the program to recompete for funds. This period, called the project period, will usually be for 1-5 years.

(c) Generally, the grant will initially be for one year and subsequent continuation awards will also be for one year at a time. A grantee must submit a separate application to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of such awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require a determination by HHS that continued funding is in the best interest of the government.

(d) Neither the approval of any application nor the award of any grant commits or obligates the United States in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.

§ 52d.7 Expenditure of grant funds.

(a) Any funds granted pursuant to this part 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 part, the terms and conditions of the awards, and the applicable cost principles prescribed by Subpart Q of 45 CFR Part 74, except that grant funds may not be used for costs incurred in connection with activities which, prior to the grant, were part of the grantee's standard curriculum.

(b) The Director, NCI, may permit unobligated grant funds remaining in the grant account at the close of a budget period to be carried forward

for obligation during a subsequent budget period, provided a continuation award is made for that period and the NCI Director's written approval is obtained. The amount of any subsequent award will take into consideration unobligated grant funds remaining in the grant account.

§ 52d.8 Other HHS regulations that apply.

Several other regulations apply to grants under this subpart. These include, but are not limited to:

42 CFR Part 50, Subpart D-Public Health Service grant appeals procedure

45 CFR Part 16-Procedures of the Departmental Grant Appeals Board

45 CFR Part 74-Administration of grants 45 CFR Part 75-Informal grant appeals procedures

45 CFR Part 80-Nondiscrimination under programs receiving Federal assistance through the Department of Health and Human Services effectuation of Title VI of the Civil Rights Act of 1964

45 CFR Part 81-Practice and procedure for hearings under Part 80 of this Title 45 CFR Part 84-Nondiscrimination on the basis of handicap in programs and activities receiving or benefiting from Federal financial assistance

45 CFR Part 86-Nondiscrimination on the basis of sex in education programs and activities receiving or benefiting from Federal financial assistance

45 CFR Part 91-Nondiscrimination on the basis of age in HHS programs or activities receiving Federal financial assistance [49 FR 38111, Sept. 27, 1984]

Sec.

52e.4 Application.

52e.5 Project requirements.

52e.6 Grant awards.

52e.7 Expenditure of grant funds.

52e.8 Other HHS regulations that apply. 52e.9 Additional conditions.

AUTHORITY: Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216); sec. 414, 86 Stat. 682 (42 U.S.C. 287c).

SOURCE: 45 FR 12249, Feb. 25, 1980, unless otherwise noted.

§ 52e.1 Applicability.

(a) The regulations in this part apply to grants under section 414 of the Public Health Service Act (42 U.S.C. 287c) for projects: (1) To demonstrate and evaluate the effectiveness of new techniques or procedures for the prevention, diagnosis, or treatment of heart, blood vessel, lung, and blood diseases, (2) to develop and evaluate methods of educating health practitioners concerning the prevention and control of these diseases, and (3) to develop and evaluate methods of educating the public concerning the prevention and control of these dis

eases.

(b) For purposes of this part, treatment may include emergency medical services.

[45 FR 12249, Feb. 25, 1980; 45 FR 20097, Mar. 27, 1980]

§ 52e.2

Definitions.

As used in this part:

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

(b) "Director, NHLBI," means the Director of the National Heart, Lung, and Blood Institute and any other officer or employee of said Institute to whom the authority involved has been delegated.

(c) "Nonprofit" as applied to any agency or institution means an agency or institution which is a corporation or an association no part of the net earnings of which inures or may lawfully inure to the benefit of any private shareholder or individual.

(d) “Council" means the National Heart, Lung, and Blood Advisory Council, established by section 417(a) of the Act (42 U.S.C. 287f(a)).

(e) "National Program" means the National Heart, Blood Vessel, Lung,

and Blood Diseases and Blood Resources Program referred to in section 413 of the Act (42 U.S.C. 287b).1

(f) "Emergency medical services" means the services utilized in responding to the perceived individual need for immediate medical care in order to prevent loss of life or aggravation of physiological or psychological illness or injury.

§ 52e.3 Eligibility.

To be eligible for a grant under this part, an applicant must be a public or nonprofit private agency or institution.

§ 52e.4 Application.

(a) Application for a grant under this subpart shall be made on an authorized form.2 Applicants shall submit completed forms on or before the dates the Director, NHLBI, may prescribe.

(b) Each private institution which does not already have on file with the National Institutes of Health evidence of nonprofit status, must submit with its application acceptable proof of such status.

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

(1) The nature and purpose of the proposed project and the methods to be employed in carrying it out;

(2) The relevance of the proposed project to the National Program;

(3) The defined population to participate in the proposed project and the rationale for its selection;

(4) With respect to applications relating to projects covered by

§ 52e.1(a)(1), prior research findings on which the proposed project is based;

'Single copies of the National Program are available upon request from the Division of Extramural Affairs, National Heart, Lung, and Blood Institute, National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland 20205.

Applications and instructions are available from the Division of Extramural Affairs, National Heart, Lung, and Blood Institute, National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland 20205.

73-147 0-86-9

(5) The personnel, facilities, and other resources, including community resources, available to carry out the proposed project;

(6) Current activities of the applicant involving prevention or control of heart, blood vessel, lung, and blood diseases, the sources of funding for such activities, and the anticipated relationship of these activities to the proposed project;

(7) The names and qualifications of the project director and key staff members who would be responsible for conducting the proposed project;

(8) Proposed methods for monitoring and evaluating the project; and

(9) The proposed project period; a detailed budget for the first budget period, including a list of other anticipated sources of support and anticipated total needs for each of the succeeding budget periods of the requested project period; and a justification for the amount of grant funds requested.

§ 52e.5 Project requirements.

(a) An approvable application must demonstrate to the satisfaction of the Director, NHLBI, that:

(1) With respect to applications relating § 52e.1(a)(1), the techniques or procedures to be demonstrated and evaluated have been found safe and effective in the research setting and, based upon research findings, appear to have the potential for general applicability to the prevention, diagnosis, or treatment of heart, blood vessel, lung, or blood diseases;

to projects covered by

the

(2) With respect to applications relating to projects covered § 52e.1(a)(2) and § 52e.1(a)(3), project will include development and evaluation of one or more methods for educating health practitioners or the public concerning advances in the prevention, diagnosis, or treatment of such diseases; and

(3) The nature of the project is such that its completion may be anticipated within the project period, or such other period as may be specified in the application.

(b) The project must, in the judgment of the Director, NHLBI, be necessary for cooperation by the National

Heart, Lung, and Blood Institute with one or more other Federal Health agencies, State, local or regional public health agencies, or nonprofit private health agencies in the diagnosis, prevention, or treatment of heart, blood vessel, lung or blood diseases.

§ 52e.6 Grant awards.

(a) Within the limits of funds available, after consultation with the Council, the Director, NHLBI, may award grants to applicants with proposed projects which in the NHLBI Director's judgment best promote the purposes of section 414 of the Act, taking into consideration among other pertinent factors:

(1) The scientific and technical merit of the proposed project;

(2) The significance of the project in relation to the goals of the National Program;

(3) Whether the project appropriately emphasizes the prevention, diagnosis, or treatment of heart, blood vessel, lung, or blood diseases of children;

(4) The qualifications and experience of the project director and other key personnel;

(5) The administrative and managerial capability and fiscal responsibility of the applicant;

(6) The reasonableness of the proposed budget in relation to the proposed project;

(7) The adequacy of the methods proposed for monitoring and evaluating the proposed project; and

(8) The degree to which the application adequately provides for the requirements set forth in §§ 52e.5(a) and 52e.5(b).

(b) The notice of grant award specifies how long HHS intends to support the project without requiring the project to recompete for funds. This period, called the project period, will usually be for 1-5 years.

ation of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require a determination by HHS that continued funding is in the best interest of the government.

(e) Any funds granted under this part 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 part, the terms, and conditions of the award, and the applicable cost principles prescribed in Subpart Q of 45 CFR Part 74.

§ 52e.7 Expenditure of grant funds.

(b) The Director, NHLBI, may permit unobligated grant funds remaining in the grant account at the close of a budget period to be carried forward for obligation during a subsequent budget period, provided a continuation award is made for that period and the NHLBI Director's written approval is obtained. The amount of any subsequent award will take into consideration unobligated grant funds remaining in the grant account.

§ 52e.8 Other HHS regulations that apply.

Several other regulations apply to grants under this subpart. These include, but are not limited to:

42 CFR Part 50, Subpart D-Public Health Service grant appeals procedure

45 CFR Part 16-Procedures of the Departmental Grant Appeals Board

45 CFR Part 46-Protection of human subjects

45 CFR Part 74—Administration of grants 45 CFR Part 75-Informal grant appeals procedures

45 CFR Part 80-Nondiscrimination under programs receiving Federal assistance through the Department of Health and Human Services effectuation of Title VI of the Civil Rights Act of 1964 45 CFR Part 81-Practice and procedure for hearings under Part 80 of this Title 45 CFR Part 84-Nondiscrimination on the basis of handicap in programs and activities receiving or benefiting from Federal financial assistance

45 CFR Part 86—Nondiscrimination on the basis of sex in education programs and activities receiving or benefiting from Federal financial assistance

45 CFR Part 91-Nondiscrimination on the basis of age in HHS programs or activities receiving Federal financial assistance [49 FR 38111, Sept. 27, 1984]

AUTHORITY: Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216); sec. 475, 88 Stat. 360, 89 Stat. 351 (42 U.S.C. 2891-4); sec. 955(a), Pub. L. 97-35, 95 Stat. 590 (42 U.S.C. 300z-7(e)).

SOURCE: 43 FR 7862, Feb. 24, 1978, unless otherwise noted.

§ 52h.1 Applicability.

The regulations in this part apply to:

(a) Applications for grants for biomedical and behavioral research, under the Act to the National Institutes of Health; the Alcohol, Drug Abuse, and Mental Health Administration; or any of their components; or the Division of Nursing, Bureau of Health Professions, Health Resources and Services Administration. These regulations do not apply to applications for:

(1) Continuation funding for budget periods within an approved project period;

(2) Supplemental funding to meet increased administrative costs within a project period; or

(3) Construction grants.

(b) Biomedical and behavorial research and development contract projects administered by the National Institutes of Health; the Alcohol, Drug Abuse, and Mental Health Administration; or any of their components; or the Division of Nursing, Bureau of Health Professions, Health Resources and Services Administration.

(c) Applications for grants and contracts under section 2008 of the Act. (Sec. 215, 58 Stat. 690, as amended (42 U.S.C. 216); sec. 475, 88 Stat. 360, 89 Stat. 351, 92 Stat. 3436 (42 U.S.C. 2891-4))

[45 FR 35328, May 27, 1980, as amended at 47 FR 50261, Nov. 5, 1982; 49 FR 38111, Sept. 27, 1984]

(d) "Awarding official" means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom the authority involved has been delegated; Except that, where the Act specifically authorizes another official to make awards in connection with a particular program, the "awarding official" shall mean said other official and any other officer or employee of the Department of Health and Human Services to whom the authority involved has been delegated.

(e) "Peer review group" means a group of experts qualified by training and experience in particular scientific or technical fields to give expert advice, in accordance with the provisions of this part, on the scientific and technical merit of grant applications or contract projects in those fields.

(f) "Research" means systematic study directed toward new or fuller knowledge and understanding of the subject studied.

(g) "Development" means the systematic use of knowledge and understanding gained from research, directed toward creating useful materials, devices, systems, or methods.

(h) "Research and development contract project" means an identified, circumscribed activity, involving a single contract or two or more similar, related, or interdependent contracts, intended and designed to acquire new or fuller knowledge and understanding of a subject and/or to use such knowledge and understanding to develop useful materials, devices, systems, or methods. The terms include (but are not limited to) development and utilization of resources, testing, demonstrations, clinical trials, preparation of reports, and production of experimental or test models necessary or incidental to a research and/or development activity, but exclude quantity production and routine product testing and quality control.

(i) "Project concept" means the basic purpose, scope, and objectives of the project.

(j) "Project approach" means the methodology to be followed and the resources needed in carrying out the project.

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