(3) Any individual, corporation, institution, agency or other entity that, having previously received a grant award, has failed willfully and materially in the judgment of the Secretary to comply with accounting or other requirements applicable to that prior award. Ineligibility for a grant award under this paragraph continues until terminated in the public interest by the Secretary.

(b) Permissible activities within projects. Any project found by the Secretary to be a research project within the meaning of § 52.1 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 subjects for concurrent or consecutive investigation and involving multiple disciplines, facilities and re

sources.

[45 FR 12240, Feb. 25, 1980, as amended at 46 FR 58675, Dec. 3, 1981]

§ 52.4 How to apply for a grant.

A grant application must include the following information:

(a) Nature requested project period, purpose and plan of the project;

(b) Name and qualifications of the principal investigator and any other key personnel;

(c) Qualifications of the principal staff members to be responsible for the project;

(d) The total facilities and resources that will be available;

(e) Justification of the amount of grant funds requested; and

(f) Other pertinent information the Secretary may require to evaluate the proposed project.

[45 FR 12240, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980]

§ 52.5 Evaluation and disposition of appli

cations.

(a) Evaluation. All applications filed in accordance with § 52.4 shall be evaluated by the Secretary through such officers and employees and such ex

perts or consultants engaged for this purpose as the Secretary 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, and in the case of applications for support of research in emergency medical services, special consideration shall be given to applications for grants for research relating to the delivery of emergency medical services in rural

areas.

(b) Disposition. On the basis of the Secretary's evaluation of an application in accordance with paragraph (a) of this section and subject to approvals, recommendations or consultations by the appropriate National Advisory Council or other body as may be required by law, the Secretary will (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 will determine the project period (subject to extension as provided in § 52.7(c)) during which the project may be supported. Any deferral and disapproval of an application will not preclude its reconsideration or a reapplication.

[45 FR 12240, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980]

§ 52.6 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 the Secretary's judgment best promote the purposes of § 52.1. 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. 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.

(b) Notice of grant award. (1) 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.

(2) 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.

(3) 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.

(c) Multiple, concurrent, initial awards. Whenever a reseach project involves a number of different but related problems, activities or disciplines which 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 speci

fied aspects of the project, and the Secretary may make two or more concurrent grant awards with respect to such a project.

(d) Unobligated balances. The Secretary 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 Secretary's written approval is obtained.

(e) Award for continuation of project under new grantee. The Secretary, upon application in accordance with the provisions of § 52.4 and without further action by a Council or other body, may make a grant to any institution or other person eligible under § 52.3 for continuation of a currently supported project for which a grant was previously made to another institution or person, provided the Secretary finds that the change in the conduct of the project is consonant with the previous evaluation and approval of the project under § 52.5.

[45 FR 12240, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980]

§ 52.7 Use of funds; changes.

(a) Delegation of fiscal responsibility. The grantee may not in whole or in part delegate or transfer to another person responsibility for the use or expenditure of grant funds.

(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 to expedite achievement of the project's research objectives, including changes that grow out of the approved project and serve the best scientific strategy. If the grantee and the principal investigator are uncertain whether a change complies with this provision, the question must be referred to the Secretary for a final determination.

(c) Changes in project period. The project period determined pursuant to § 52.5(b) may be extended by the Secretary, with or without additional grant support, for such an additional period as the Secretary determines

may be required to complete, or fulfill the purposes of, the approved project.

§ 52.8 Other HHS regulations that apply.

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

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

45 CFR Parts 6 and 8-Inventions and patents

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 48 FR 24556-Guidelines for Research involving Recombinant DNA Molecules, published by the National Institutes of Health

[49 FR 38110, Sept. 27, 1984]

852.9 Other conditions.

The Secretary may with respect to any grant award or class of awards impose additional conditions prior to or at the time of any award when in the Secretary's judgment such conditions are necessary to assure or protect advancement of the approved project, the interests of the public health, or the conservation of grant funds.

[45 FR 12240, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980]

(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

§ 52a.3 Eligibility.

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

(a) A public or nonprofit private hospital or school of medicine, or other public or nonprofit private agency or 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.

§ 52a.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 personnel, facilities, and other resources currently available to the applicant with which to initiate and maintain the proposed center program;

(2) Any basic or clinical research, training, or demonstration activities in which the applicant is currently engaged relating to the management of blood resources or advanced diagnostic prevention, or treatment methods for heart, blood vessel, lung, or blood diseases; the sources of funding for such

'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.

activities; and the relevance of these activities to the National Program;

(3) The major area or areas (i.e., heart disease, blood vessel disease, lung disease, blood disease, or management of blood resources) on which the applicant would concentrate if awarded a grant under this part;

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

(5) The proposed center program, including proposed research and demonstration projects and information and education activities, and the relevance of each to the National Program;

(6) The opportunities that would be available for training of professional personnel, including allied health professions personnel;

(7) The availability of community resources necessary to carry out the proposed activities;

(8) The organizational structure of the applicant;

(9) The proposed support project period (not to exceed five years); 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 (not exceeding $5,000,000 in the aggregate for costs other than indirect costs in any year, plus any added amounts attributable to increases in such year in appropriate costs as reflected in the Consumer Price Index published by the Bureau of Labor Statistics);

(10) Proposed methods for monitoring and evaluating individual activities and the overall program; and

(11) Proposed methods for coordination of center activities with the National Heart, Lung, and Blood Institute and the National Program.

[45 FR 12242, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980]

§ 52a.5 Program requirements.

An approvable application must include information indicating that:

(a) The proposed program will include all of the following components:

basic and clinical research relating to the major areas on which the applicant would concentrate; plans for demonstrating the applicability of clinical research findings in such areas; information and education activities pertaining to such areas; and opportunities for training, including training of allied health professions personnel;

(b) The center will be an identifiable organizational unit of the applicant headed by a center director responsible for the center program; and

(c) The applicant will have staff, facilities, and other resources available with which to initiate the proposed program.

(a) Within the limits of funds available, after consultation with the Council, the Director, NHLBI, may award grants to applicants with proposed programs which in the Director's judgment best promote the purposes of section 415(b) of the Act, taking into consideration among other pertinent factors:

(1) The scientific and technical merit of the overall proposed program and its individual components;

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

(3) The qualifications and experience of the center director and other key personnel;

(4) The extent to which the center activities would be coordinated with the National Heart, Lung, and Blood Institute and the National Program;

(5) The extent to which the various components of the proposed program would be coordinated into one multidisciplinary effort within the center;

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

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

(8) The adequacy of the methods for monitoring and evaluating the overall program and its components; and

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

(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.

(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.

(e) An initial project period may be extended by the Director, NHLBI, for additional periods not in excess of five years each, after review of the operations of the grantee by an appropriate scientific review group established by the Director, NHLBI, and consultation with the Council, except that if an additional period of support involves only the expenditure of funds previously awarded, consultation with the Council is not required.

[45 FR 12242, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980]

§ 52a.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 award, and the applicable cost principles prescribed by Subpart Q of 45 CFR Part 74.

(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 con