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Sec. 52e.1 To what programs do these regula

tions apply? 52e.2 Definitions. 520.3 Who is eligible to apply? 52e.4 How to apply. 52e. What are the project requirements? 52.6 How will NIH evaluate applications? 52e.7 What are the terms and conditions of

awards? 52e.8 Other HHS regulations and policies

that apply. 52e.9 Additional conditions.

AUTHORITY: 42 U.S.C. 216, 285b-1.

$ 52e.2 Definitions.

As used in this part:

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

Council means the National Heart, Lung, and Blood Advisory Council, tablished under section 406 of the 1 (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 z services utilized in responding to a perceived individual need for im diate medical care in order to pret loss of life or aggravation of phys logical or psychological illness of 2 jury.

HHS means the Department of Heala and Human Services.

National program means the Natio Heart, Blood Vessel, Lung, and Ax Diseases and Blood Resources referred to in section 421 of the we U.S.C. 2856-3).

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

PHS means the Public Health Se ice.

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

(58 FR 54298, Oct. 21, 1993)

852e.1 To what programs do these reg.

ulations apply? (a) This part applies to grants under section 419 of the Act (42 U.S.C. 2856–1) 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 diseases.

(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)

8520.3 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 si FR 54298, Oct. 21, 1993) 8520.4 How to apply.

(a) Application for a grant under subpart shall be made on an authoris form.2 Arnliants shall submit cat pleted fc

9,fore the dates! Directo

2 Applic able front National National i Pike, Beth

b) Each private institution which found safe and effective in the research es not already have on file with the setting and, based upon research findtional Institutes of Health evidence ings, appear to have the potential for - nonprofit status, must submit with general applicability to the prevention, i application acceptable proof of such diagnosis, or treatment of heart, blood itus.

vessel, lung, or blood diseases; (c) In addition to any other pertinent

(2) With respect to applications relatformation that the Director may re

ing to projects covered by $52e.1(a)(2) ire each application shall set forth in

and g 52e.1(a)(3), the project will include tail:

development and evaluation of one or 1) The nature and purpose of the pro

more methods for educating health sed project and the methods to be

practitioners or the public concerning ployed in carrying it out;

advances in the prevention, diagnosis, 2) The relevance of the proposed

or treatment of such diseases; and oject to the National Program; 3) The defined population to partici

(3) The nature of the project is such te in the proposed project and the ra

that its completion may be anticipated snale for its selection;

within the project period, or such other (4) With respect to applications relat

period as may be specified in the appli3 to projects covered by $52e.1(a)(1),

cation. ior research findings on which the

(b) The project must, in the judgment is ;

of the Director, be necessary for co59° The personnel, e facilities, and

operation by the National Heart, Lung, aer resources, including community

and Blood Institute with one or more sources, available to carry out the other Federal Health agencies, State, oposed project;

local or regional public health agen(6) Current activities of the applicant cies, or nonprofit private health agen

volving prevention or control of cies in the diagnosis, prevention, or 'art, blood vessel, lung, and blood dis- treatment of heart, blood vessel, lung ses, the sources of funding for such or blood diseases. tivities, and the anticipated rela

(45 FR 12249, Feb. 25, 1980, as amended at 58 onship of these activities to the pro

FR 54298 and 54299, Oct. 21, 1993] ised project; (7) The names and qualifications of

$ 52e.6 How will NIH evaluate applicale project director and key staff mem

tions? irs who would be responsible for conicting the proposed project;

(a) Within the limits of funds avail(8) Proposed methods for monitoring

able, after consultation with the Coun

cil, the Director may award grants to id evaluating the project; and (9) The proposed project period; a de

applicants with proposed projects .iled budget for the first budget pe

which in the Director's judgment will od, including a list of other antici

best promote the purposes of section ated sources of support and antici

419 of the Act, taking into considerated total needs for each of the suc

ation among other pertinent factors: eeding budget periods of the requested

(1) The scientific and technical merit roject period; and a justification for

of the proposed project; he amount of grant funds requested. (2) The significance of the project in 5 FR 12249, Feb. 25, 1980, as amended at 58

relation to the goals of the National R 54298, Oct. 21, 1993)


(3) Whether the project appropriately 52e.5 What are the project require emphasizes the prevention, diagnosis,

or treatment of heart, blood vessel, (a ovable application must

lung, or blood diseases of children; PIT the satisfaction of the (4) The qualifications and experience

of the project director and other key applications relat- personnel; ag

ed by $52e.1(a)(1), (5) The administrative and manage

rocedures to be rial capability and fiscal responsibility en

lated have been of the applicant;

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(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 88 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, sup plemental, continuation,

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)

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

(b) The Director may permit uit gated grant funds remaining in 3 grant account at the close of a bore period to be carried forward for obes tion during a subsequent budget pera provided a continuation award is mi for that period and the NHLBI Dis tor's written approval is obtained. I amount of any subsequent award take into consideration unobligās grant funds remaining in the granti count. [45 FR 12249, Feb. 25, 1980, as amended $ FR 54298 and 54299, Oct. 21, 1993) 8520.8 Other HHS regulations

policies that apply. Several other regulations apple grants under this part. These in: but are not necessarily limited 42 CFR Part 50, Subpart A-Responsit

PHS awardee and applicant instituto
dealing with and reporting possible

conduct in science 42 CFR Part 50, Subpart D_Public Etsi

Service grant appeals procedure 45 CFR Part 16 Procedures of the Dera

mental Grant Appeals Board 45 CFR Part 46-Protection of human &

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

cedures 45 CFR Part 76 Governmentwide debarre

and suspension (nonprocurement) and
ernmentwide requirements for drag
workplace (grants)
45 CFR Part 80_Nondiscrimination

programs receiving Federal Assis
through the Department of Health
Human Services-Effectuation of Tile

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 ser ties receiving or benefiting from Fedra

financial assistance 45 CFR Part 86-Nondiscrimination on

basis of sex in education programs and
tivities receiving or benefiting from it!

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 ard
agreements to State and


852e.7 What are the terms and condi.

tions 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

CFR Part 93—New restrictions on lobbying 852h.1 Applicability.
FR 16958 or successor-NIH Guidelines for
cesearch Involving Recombinant DNA

The regulations in this part apply to: Tolecules

(a) Applications for grants for bioublic Health Service Policy on Humane medical and behavioral research, under are and Use of Laboratory Animals," Of- the Act to the National Institutes of ice for Protection from Research Risks, Health; the Alcohol, Drug Abuse, and IIH (Revised September 1986), or successor Mental Health Administration; or any FR 14508 (as republished March 28, 1994), as

of their components; or the Division of nay be amended, or its successor—NIH

Nursing, Bureau of Health Professions, fuidelines on the Inclusion of Women and

Health Resources and Services Adminlinorities as Subjects in Clinical Reearch.

istration. These regulations do not

apply to applications for: FR 54298, Oct. 21, 1993, as amended at 59

(1) Continuation funding for budget 59372, Nov. 17, 1994)

periods within an approved project peZe.9 Additional conditions.


(2) Supplemental funding to meet inThe Director, may with respect to creased administrative costs within a y grant award impose additional

project period; or nditions prior to or at the time of (3) Construction grants. sy award when in the Director's judg- (b) Biomedical and behavorial re

nt those conditions are necessary to search and development contract pure or protect advancement of the

projects administered by the National proved project, the interests of the Institutes of Health; the Alcohol, Drug blic health, or the conservation of

Abuse, and Mental Health Administraant funds.

tion; or any of their components; or 3 FR 12249, Feb. 25, 1980, as amended at 58

the Division of Nursing, Bureau of 3.54299, Oct. 21, 1993)

Health Professions, Health Resources

and Services Administration. ART 52h-SCIENTIFIC PEER REVIEW (c) Applications for grants and conOF RESEARCH GRANT APPLICA

tracts under section 2008 of the Act. TIONS AND RESEARCH AND DE- (Sec. 215, 58 Stat. 690, as amended (42 U.S.C. VELOPMENT


216); sec. 475, 88 Stat. 360, 89 Stat. 351, 92 Stat.

3436 (42 U.S.C. 2891-4) PROJECTS

[45 FR 35328, May 27, 1980, as amended at 47 3

FR 50261, Nov. 5, 1982; 49 FR 38111, Sept. 27, c.

1984) h.1 Applicability. h.2 Definitions.

$52b.2 Definitions. h.3 Establishment and operation of peer review groups.

As used in this part: h.4 Composition of peer review groups.

(a) Act means the Public Health Servh.5 Conflict of interest.

ice Act, as amended. h.6 Availability of information.

(b) Project period has the same meanh.7 Grants; matters to be reviewed. ing as in 42 CFR part 52. 2h.8 Grants; review criteria.

(c) Budget period means the interval 2h.9 Unsolicited contract proposals; mat

of time (usually 12 months) into which ters to be reviewed.

the project period is divided for budg2h.10 Contract projects involving solicited etary and reporting purposes.

contract proposals; matters to be re- (d) Awarding official means the Secviewed.

retary of Health and Human Services 2h.11 Contract projects and proposals; re- and any other officer or employee of view criteria.

the Department of Health and Human 2h.12 Applicability of other regulations.

Services to whom the authority inAUTHORITY: Sec. 215, 58 Stat. 690, as amend- volved has been delegated; Except that, d (42 U.S.C. 216); sec. 475, 88 Stat, 360, BO where the Act specifically authorizes tat. 351 (42 U.S.C. 2892–4); sec. 955(a). Puutiother official to make awards in con7-35, 95 Stat. 590 (42 U.S.C. 300z-7(e)).

Destion with a particular program, the SOURCE: 43 FR 7862, Feb. 24, 1978, unie Potricial" shall mean said therwise noted.

and any other officer or



employee of the Department of Health (1) Solicited contract proposal has and Human Services to whom the au- same meaning as in 41 CFR} thority involved has been delegated. 1.353(b)(2).

(e) Peer review group means a group of (m) Unsolicited contract proposal experts qualified by training and expe- the same meaning as in 41 CFR 345 rience in particular scientific or tech- (n) Request for proposals means a fer nical fields to give expert advice, in ac- ernment solicitation to prospects cordance with the provisions of this offerors, under procedures for part, on the scientific and technical tiated contracts, to submit a propos merit of grant applications or contract to fulfill specific agency requireme projects in those fields.

based on terms and conditions des (f) Research means systematic study in the request for proposals. The ! directed toward new or fuller knowl- quest for proposals contains inform edge and understanding of the subject tion sufficient to enable all offerin studied.

prepare competitive proposals, and (8) Development means the systematic as complete as possible with respect: use of knowledge and understanding Nature of work to be performed: 3 gained from research, directed toward scriptions and specifications of itz creating useful materials, devices, sys- to be delivered; performance schedu tems, or methods.

special requirements clauses, or oth (h) Research and development contract circumstances affecting the course project means identified, cir- format for cost proposals; and en cumscribed activity, involving a single

tion criteria by which the prov contract or two or more similar, relat

will be evaluated. ed, or interdependent contracts, intended and designed to acquire new or

852h.3 Establishment and operatia fuller knowledge and understanding of

peer review groups. a subject and/or to use such knowledge (a) To the extent applicable, the and understanding to develop useful eral Advisory Committee Act (5 US materials, devices, systems, or meth- App. I), Department of Health & ods. The terms include (but are not Human Services (45 CFR part 11.9 limited to) development and utilization plementing regulations and chaptı of resources, testing, demonstrations, of the Department of Health clinical trials, preparation of reports,

Human Services General Administ and production of experimental or test

tion Manual1 will govern the establis models necessary or incidental to a re- ment and operation of peer rett search and/or development activity,

groups, including that meetings si but exclude quantity production and

be open to the public except as routine product testing and quality

mined by the Secretary. control.

(b) Subject to $52h.5 and parama (1) Project concept means the basic (a) of this section, the Director of purpose, scope, and objectives of the

National Institutes of Health, the project.

ministrator of the Alcohol, Drug All (j) Project approach means the meth

and Mental Health Administration, odology to be followed and the re

the Administrator of the Health sources needed in carrying out the

sources and Services Administrat project.

will adopt procedures for the condo (k) Contract proposal means a written

of reviews and the formulation of is offer to enter into a contract, submitted to an awarding official by an indi- 1 The Department of Health and H vidual or non-Federal organization,

Services General Administration Manus and including as a minimum a descrip

available for public inspection and copri tion of the nature, purpose, duration,

at the Department's and Regional OM ces"

formation centers listed in 45 CFR 5.31.00 and cost of the project and the meth

nurchased from the Superintende ods, personnel, and facilities to be ut

nts, U.S. P lized in carrying it out.

Ordoe, Washia

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