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$52e.1 To what programs do these regulations apply?

(a) This part applies to grants under section 419 of the Act (42 U.S.C. 285b-1) for projects to:

(1) Demonstrate and evaluate the effectiveness of new techniques or procedures for the prevention and control of heart, blood vessel, lung, and blood diseases, with special consideration given to the prevention and control of these diseases in children, and in populations that are at increased risk with respect to such diseases;

(2) Develop and evaluate methods of educating health practitioners concerning the prevention and control of these diseases; and

(3) Develop and evaluate methods of educating the public concerning the prevention and control of these dis

eases.

(b) For purposes of this part, prevention and control projects shall include community-based and population-based programs carried out in cooperation with other Federal agencies, with public health agencies of State or local governments, with nonprofit private entities that are community-based health agencies, or with other appropriate public or nonprofit private entities.

[45 FR 12249, Feb. 25, 1980; 45 FR 20097, Mar. 27, 1980, as amended at 58 FR 54298, Oct. 21, 1993; 59 FR 59372, Nov. 17, 1994]

§ 52e.2 Definitions.

As used in this part:

Act means the Public Health Servis Act, as amended (42 U.S.C. 201 et

Council means the National Ha Lung, and Blood Advisory Council, + tablished under section 406 of the (42 U.S.C. 284a).

Director means the Director of National Heart, Lung, and Blood In tute and any official to whom the thority involved may be delegated.

Emergency medical services means services utilized in responding to perceived individual need for in diate medical care in order to pre loss of life or aggravation of phys logical or psychological illness or jury.

HHS means the Department of Healt and Human Services.

National program means the Nati Heart, Blood Vessel, Lung, and Diseases and Blood Resources referred to in section 421 of the U.S.C. 285b-3).

Nonprofit as applied to any agenc institution means an agency or inst tion which is a corporation or an ciation, no part of the net earning! which inures or may lawfully inure the benefit of any private sharehold or individual.

PHS means the Public Health Ser ice.

[58 FR 54298, Oct. 21, 1993]

§ 52e.3 Who is eligible to apply?

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

[45 FR 12249, Feb. 25, 1980, as amended &í FR 54298, Oct. 21, 1993]

§ 52e.4 How to apply.

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(a) Application for a grant under th subpart shall be made on an authoris form.2 Ap nts shall submit com pleted fo before the dates Directo

2 Applic able from National National i Pike, Bethe

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b) Each private institution which es not already have on file with the tional Institutes of Health evidence nonprofit status, must submit with application acceptable proof of such

atus.

xc) In addition to any other pertinent formation that the Director may reire each application shall set forth in stail:

1) The nature and purpose of the prosed project and the methods to be ployed in carrying it out;

2) The relevance of the proposed oject to the National Program;

3) The defined population to particite in the proposed project and the raonale for its selection;

4) With respect to applications relatto projects covered by §52e.1(a)(1), ior research findings on which the oposed project is based;

5) The personnel, facilities, and her resources, including community sources, available to carry out the oposed project;

(6) Current activities of the applicant volving prevention or control of art, blood vessel, lung, and blood disses, the sources of funding for such tivities, and the anticipated relaonship of these activities to the prosed project;

(7) The names and qualifications of le project director and key staff memers who would be responsible for conicting the proposed project; (8) Proposed methods for monitoring id evaluating the project; and

(9) The proposed project period; a deiled budget for the first budget peod, including a list of other anticiated sources of support and anticiated total needs for each of the suceeding budget periods of the requested project period; and a justification for he amount of grant funds requested.

5 FR 12249, Feb. 25, 1980, as amended at 58 R. 54298, Oct. 21, 1993]

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;

(2) With respect to applications relating to projects covered by §52e.1(a)(2) and § 52e.1(a)(3), the 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, 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.

[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298 and 54299, Oct. 21, 1993]

§ 52e.6 How will NIH evaluate applications?

(a) Within the limits of funds available, after consultation with the Council, the Director may award grants to with applicants proposed projects which in the Director's judgment will best promote the purposes of section 419 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

526.5 What are the project require- emphasizes the prevention, diagnosis, ments?

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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.

(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) 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.

[45 FR 12249, Feb. 25, 1980, as amended at 58 FR 54298, Oct. 21, 1993]

§ 52e.7 What are the terms and conditions of awards?

(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 reg

ulations of this part, the terms a conditions of the award, and the app cable cost principles prescribed by su part Q of 45 CFR part 74.

(b) The Director may permit unsti gated grant funds remaining in 3 grant account at the close of a bude period to be carried forward for ob tion during a subsequent budget per provided a continuation award is me for that period and the NHLBI D tor's written approval is obtained. amount of any subsequent award take into consideration unoblig grant funds remaining in the grant count.

[45 FR 12249, Feb. 25, 1980, as amended sti FR 54298 and 54299, Oct. 21, 1993]

$52e.8 Other HHS regulations

policies that apply.

Several other regulations apply i grants under this part. These in but are not necessarily limited t 42 CFR Part 50, Subpart A-Responsi PHS awardee and applicant institutio dealing with and reporting possible

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cedures

45 CFR Part 76-Governmentwide debar and suspension (nonprocurement) and f ernmentwide requirements for drug workplace (grants)

45 CFR Part 80-Nondiscrimination programs receiving Federal assista through the Department of Health Human Services Effectuation of Title of the Civil Rights Act of 1964 45 CFR Part 81-Practice and procedure hearings under Part 80 of this title 45 CFR Part 84-Nondiscrimination on basis of handicap in programs and act ties receiving or benefiting from Fed

financial assistance

45 CFR Part 86-Nondiscrimination on basis of sex in education programs and tivities receiving or benefiting from F

eral financial assistance

45 CFR Part 91-Nondiscrimination
basis of age in HHS programs
receiving Federal financial as
45 CFR Part 92-Uniform admi
quirements for grants and
agreements to State and
ments

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CFR Part 93-New restrictions on lobbying FR 16958 or successor-NIH Guidelines for tesearch Involving Recombinant DNA Molecules

ablic Health Service Policy on Humane Care and Use of Laboratory Animals," Ofice for Protection from Research Risks, ETIH (Revised September 1986), or successor

FR 14508 (as republished March 28, 1994), as may be amended, or its successor-NIH uidelines on the Inclusion of Women and Minorities as Subjects in Clinical Reearch.

FR 54298, Oct. 21, 1993, as amended at 59 59372, Nov. 17, 1994]

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$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]

$52h.2 Definitions.

As used in this part:

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

(b) Project period has the same meaniming as in 42 CFR part 52.

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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.

(1) 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.

(k) Contract proposal means a written offer to enter into a contract, submitted to an awarding official by an individual or non-Federal organization, and including as a minimum a description of the nature, purpose, duration, and cost of the project and the methods, personnel, and facilities to be ut lized in carrying it out.

(1) Solicited contract proposal has th same meaning as in 41 CFR } 1.353(b)(2).

(m) Unsolicited contract proposal the same meaning as in 41 CFR 345

(n) Request for proposals means a Gaj ernment solicitation to prospecti offerors, under procedures for rep tiated contracts, to submit a propos to fulfill specific agency requiremen based on terms and conditions defin in the request for proposals. The quest for proposals contains inform tion sufficient to enable all offers! prepare competitive proposals, and as complete as possible with respect Nature of work to be performed; $ scriptions and specifications of it to be delivered; performance schedu special requirements clauses, or ot circumstances affecting the cont format for cost proposals; and en tion criteria by which the pro will be evaluated.

§ 52h.3 Establishment and operatio peer review groups.

(a) To the extent applicable, the eral Advisory Committee Act (5 US App. I), Department of Health Human Services (45 CFR part 11)* plementing regulations and chapte of the Department of Health & Human Services General Administ tion Manual1 will govern the establis ment and operation of peer reve groups, including that meetings be open to the public except as det mined by the Secretary.

(b) Subject to §52h.5 and paragni (a) of this section, the Director of National Institutes of Health, the ministrator of the Alcohol, Drug A and Mental Health Administration, the Administrator of the Health sources and Services Administra will adopt procedures for the cond of reviews and the formulation of

1 The Department of Health and Hu Services General Administration Manual available for public inspection and copy at the Department's and Regional Offices formation centers listed in 45 CFR 5.31 purchased from the Superintende its, U.S. Pr Office, Washin

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