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ral grant for construction, acquisi- public, and safety from electronic prod

or equipment shall serve either to uct radiation, as authorized by section ce or restrict the liability of the 356 of the Act (42 U.S.C. 263d); icant or any other transferor or (3) Medical library science and relatsferee from any obligation of ac- ed activities, and for the development tability imposed by the Federal or dissemination of new knowledge, ernment by reason of such prior techniques, systems, and equipment for _t.

processing, storing, retrieving, and disR 5700, Dec. 30, 1976)

tributing information pertaining to health sciences, as authorized by sec

tion 394 of the Act (42 U.S.C. 280b-5); ARTS 510-51g (RESERVED)

(4) Emergency medical techniques,

methods, devices, and delivery, as auRT 52-GRANTS FOR RESEARCH

thorized by section 1205 of the Act (42 PROJECTS

U.S.C. 300d-4);

(5) The behavioral and biomedical

etiology, treatment, mental and physTo which programs do these regula- ical health consequences, and social ions apply?

and economic consequences, of alcohol Definitions.

abuse and alcoholism, as authorized by Who is eligible to apply for a grant? How to apply for a grant.

section 501 of the Comprehensive AlcoEvaluation and disposition of applica

hol Abuse and Alcoholism Prevention, Lions.

Treatment, and Rehabilitation Act of Grant awards.

1970 (42 U.S.C. 4585); Use of funds; changes.

(6) The improvement of drug mainteOther HHS regulations that apply.

nance techniques or programs, as auOther conditions.

thorized by section 410 of the Drug THORITY: Sec. 215, 58 Stat. 690, as amend- Abuse Office and Treatment Act of 1972 3 Stat. 835 (42 U.S.C. 216); sec. 301, 58 (21 U.S.C. 1177); 691, as amended, 60 Stat. 423, 62 Stat.

(7) Research in the biomedical, con501, 1017, 70 Stat. 490, 74 Stat. 1053, 85

traceptive development, behavioral, 785, 86 Stat. 687, 88 Stat. 346, 360 (42 C. 241); sec. 303, 70 Stat 929, as amended,

and program implementation fields reat. 1241, 88 Stat. 132, 346 (42 U.S.C. 242a);

lated to family planning and popu356, 82 Stat. 1174 (42 U.S.C. 263d); sec. 394,

lation, as authorized under section 1004 tat. 1062, as amended, 84 Stat. 63, 64, 66, of the Act; and 7 Stat. 92, 88 Stat. 372 (42 U.S.C. 2806-5); (8) Health care technology assess1004, 89 Stat. 306, 352, as amended, 91 ments, including studies of the safety, 389 (42 U.S.C. 300a-2); sec. 1006, 89 Stat.

efficacy, effectiveness, and cost effec12 U.S.C. 300a-4); sec. 501, 90 Stat. 1038 (42

tiveness of particular technologies, C. 4585); sec. 1205, 87 Stat. 597 (42 U.S.C.

their social, ethical, and economic im4); sec. 410, 68 Stat. 84, as amended, 90 1, 247, 90 Stat. 1040 (21 U.S.C. 1177); sec.

pacts, as well as studies of methods of »), 92 Stat. 3447 (42 U.S.C. 242n); sec.

dissemination of information about ), Pub. L. 97-35, 95 Stat. 589 (42 U.S.C. technologies, and factors affecting the -7(a)(1)).

use of technologies as authorized by

section 309(b) of the Act (42 U.S.C. .1 To which programs do these reg- 242n). ulations apply?

(9) Research on the causes,

con..) The regulations of this part apply sequences and approaches to coping grants for the support of health-re- with adolescent sexual relations, cond research projects in programs re- traceptive use, pregnancy and parentng to:

hood authorized by section 2008 of the ) The cause, diagnosis, treatment, Act. trol, or prevention of the physical (b) These regulations do not apply to nental diseases, injuries, or impair- general research support grants, grants its to human life, as authorized by for the construction of research faciliions 301, 303, and related provisions ties (see part 57 of this chapter), for the he Act (42 U.S.C. 241, 242a);

construction of hospital or other medi:) Electronic product radiation con- cal facilities (see part 53 of this chap

programs designed to protect the ter), or the award of fellowships (see part 61 of this chapter), traineeships shall be eligible for a grant award! (see part 63 of this chapter), training cept: grants (see part 64 of this chapter), or (1) An individual or entity when to the support of research training otherwise ineligible for an awards under the National Research Service applicable law or regulation, and Awards program (see part 66 of this (2) Federal agencies or instite chapter).

unless specifically authorized by (45 FR 12240, Feb. 25, 1980; 45 FR 20096, Mar.

receive the grant. 27, 1980, as amended at 46 FR 4919, Jan. 19,

(3) Any individual, corporation 1981; 47 FR 50261, Nov. 5, 1982)

tution, agency or other entity :

having previously received a { $52.2 Definitions.

award, has failed willfully and Di As used in this part:

ally in the judgment of the Seas (a) Secretary means the Secretary of

to comply with accounting or other Health and Human Services and any

quirements applicable to that other officer or employee of the De

award. Ineligibility for a grants partment of Health and Human Sery

under this paragraph continues

terminated in the public interes ices to whom the authority involved

the Secretary. may be delegated.

(b) Permissible activities within pre (b) Principal investigator means a sin- Any project found by the Secreta? gle individual designated by the grantee in the grant application and ap ing of $52.1 shall be eligible for a

be a research project within the si proved by the Secretary, who is respon- award. Eligible projects may con sible for the scientific and technical di

laboratory, clinical, population, rection of the project.

statistical, basic, applied or (c) Act means the Public Health Serv

types of investigations, studies a ice Act (42 U.S.C. 201 et seq.).

periments, or combinations they (d) Department means the Department and may either be limited to me of Health and Human Services.

particular aspect of a problez (e) Grantee means the institution, or- ject, or may consist of two of ganization, individual or other person lated problems or subjects for sa designated in the grant award docu- rent or consecutive investigation ment as the responsible legal entity to involving multiple disciplines

, * whom a grant is awarded under this ties and resources. part. (1) Research project grant means the

[45 FR 12240, Feb. 25, 1980, as amended!

FR 58675, Dec. 3, 1981) award by the Secretary of funds to a grantee to assist in meeting the costs 852.4 How to apply for a grant. of conducting for the benefit of the public health an identified project following information:

A grant application must include which is intended and designed to establish, discover, develop, elucidate or purpose and plan of the project:

(a) Nature requested project Deco confirm information or the underlying mechanisms relating to a program set principal investigator and any of

(b) Name and qualifications of forth in 852.1.

key personnel; (8) Project means the particular ac

(c) Qualifications of the prind tivity within the scope of one or more

staff members to be responsible for of the programs set forth in $ 52.1 which

project; is supporte by a grant award under this part.

(d) The total facilities and resources De

that will be available; (45 FR 12240, Feb. 25, 1980)

(e) Justification of the amount 14 grant funds requested; and

27, 852.3 Who is eligible to apply fa (1) Other pertinent information grant?


retary may require to evaluate (a) Persons eligible. Any ind

used proleot. corporation, public or private

25. 1980; 45 FR 20096, MA AVE tion or agency, or other lega

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2.5 Evaluation and disposition of plicants whose approved projects will applications.

in the Secretary's judgment best pro(a) Evaluation. All applications filed

mote the purposes of $52.1. The date accordance with $52.4 shall be evalu

specified by the Secretary as the begined by the Secretary through such of

ning of the project period shall be no Pers and employees and such experts

later than 9 months following the date consultants engaged for this purpose

of any initial or new award statement į the Secretary determines are spe

unless the Secretary finds that because ally qualified in the areas of research

of the nature of a project or the grantivolved in the project, including re

ee's particular circumstances earlier ew by an appropriate National Advi

assurance of grant support is required ry Council or other body as may be

to initiate the project. Any funds

granted under this part shall be exquired by law. The Secretary's evalLtion shall take into account among

pended solely for the purposes for her pertinent factors the scientific

which the funds were granted in acerit and significance of the project,

cordance with the approved application le competency of the proposed staff in

and budget, the regulations of this slation to the type of research in

part, the terms and conditions of the olved, the feasibility of the project,

award and the applicable cost prinle likelihood of its producing mean

ciples prescribed in subpart Q of 45 CFR igful results, the proposed project pe

part 74. od, and the adequacy of the appli

(b) Notice of grant award. (1) The nount's resources available for the

tice of grant award specifies how long roject and the amount of grant funds

HHS intends to support the project

without ecessary for completion, and in the

requiring the project ase of applications for support of re

recompete for funds. This period, called earch in emergency medical services,

the project period, will usually be for pecial consideration shall be given to

1-5 years. pplications for grants for research re

(2) Generally, the grant will initially iting to the delivery of emergency

be for one year and subsequent coniedical services in rural areas.

tinuation awards will also be for one (b) Disposition. On the basis of the

year at a time. A grantee must submit Secretary's evaluation of an applica

a separate application to have the supion in accordance with paragraph (a)

port continued for each subsequent of this section and subject to approv

year. Decisions regarding continuation Lls, recommendations or consultations

awards and the funding level of such

awards will be made after consider-y the appropriate National Advisory

ation of such factors as the grantee's Council or other body as may be reuired by law, the Secretary will (1) ap

progress and management practices, rove, (2) defer because of either lack

and the availability of funds. In all of funds or a need for further evalua

cases, continuation awards require a Lion, or (3) disapprove support of the

determination by HHS that continued proposed project in whole or in part.

funding is in the best interest of the With respect to approved projects, the

government. Secretary will determine the project

(3) Neither the approval of any appliperiod (subject to extension as provided

cation nor the award of any grant comn $52.7(c)) during which the project

mits or obligates the United States in nay be supported. Any deferral and

any way to make any additional, suplisapproval of an application will not

plemental, continuation,

other reclude its reconsideration

award with respect to any approved apeapplication.

plication or portion of an approved ap

plication. 45 FR 12240, Feb. 25, 1980; 45 FR 20096, Mar. (c) Multiple, concurrent, initial awards. 7, 1980)

Whenever a reseach project involves a

number of different but related prob52.6 Grant awards.

lems, activities or disciplines which re(a) General. Within the limits of funds quire evaluation by different groups, or available for such purpose, the Sec- whenever support for a project could be cetary shall award a grant to those ap more effectively administered by sepa




retary, with or without additio
grant support, for such an additio
period as the Secretary determiss
may be required to complete, or ft
the purposes of, the approved project
(45 FR 12240, Feb. 25, 1980)

rate 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 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)

852.8 Other HHS regulations

apply. Several other HHS regulations ap; to grants under this part. These : clude, but are not limited to: 42 CFR part 50, subpart D-Public Es

Service grant appeals procedure
45 CFR parts 6 and 8Inventions and
45 CFR part 16–Procedures of the Dean

mental Grant Appeals Board
45 CFR part 46–Protection of human

45 CFR part 74Administration of STEDT
45 CFR part 75—Informal grant appears F

45 CFR part 80—Nondiscrimination

programs receiving Federal assisk
through the Department of Health,
Human Services effectuation of title"

the Civil Rights Act of 1964
45 CFR part 81–Practice and process

hearings under part 80 of this tits
45 CFR part 84-Nondiscriminatis a the
basis of handicap in programs and scot
ties receiving or benefiting from Fedez

financial assistance
45 CFR part 86-Nondiscrimination of

basis of sex in education programs and
tivities receiving or benefiting from
eral financial assistance

C 45 CFR part 91-Nondiscrimination of

B basis of age in HHS programs or activi

fc receiving Federal financial assistance ti 48 FR 24556-Guidelines for Research IDF

T ing Recombinant DNA Molecules,

lished by the National Institutes of Hea* [49 FR 38110, Sept. 27, 1984)

ti 852.9 Other conditions.

M The Secretary may with respect C) any grant award or class of awards it 207 pose additional conditions prior to

tio at the time of any award when in der Secretary's judgment such condition the are necessary to assure or protect the can vancement of the approved project, the Bled interests of the public health, or be pure conservation of grant funds. (45 FR 12240, Feb. 25, 1980; 45 FR 20096, Mar! 27, 1980)

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852.7 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 Sec


ART 520-NATIONAL INSTITUTES as authorized by section 2316 of the OF HEALTH CENTER GRANTS Act.

This part does not apply to:

(1) Grants for construction (see 42 To which programs do these regula

CFR part 52b), except as noted above; tions apply?

(2) Grants covered by 42 CFR part 52 .2 Definitions.

(grants for research projects); or .3 Who is eligible to apply?

(3) Grants for general research sup...4 What information must each applica- port under section 301(a)(3) of the Act tion contain?

(42 U.S.C. 241(a)(3)). ..5 How will NIH evaluate applications? (b) This part also applies to coopera.6 Information about grant awards.

tive agreements made to support the .7 For what purposes may a grantee centers specified in paragraph (a) of spend grant funds?

this section. When a reference is made .8 Other HHS regulations that apply.

in this part to "grants," the reference .9 Additional conditions.

shall include "cooperative agreeUTHORITY: 42 U.S.C. 216, 285a-3, 285b-4, ments." C-5, 2850-6, 285e-2, 2850-3, 285m-3, and cc-16.

852a.2 Definitions. SOURCE: 57 FR 61006, Dec. 23, 1992, unless As used in this part: ierwise noted.

Act means the Public Health Service

Act, as amended (42 U.S.C. 201 et seq.). 2a.1 To which programs do these

Center means: regulations apply?

(1) For purposes of grants authorized a) This part applies to grants by the in section 414 of the Act, an agency or itional Institutes of Health and its institution which provides for planning ganizational components to support and conducting basic and clinical ree planning, establishment, expansion search into, training in, and demd operation of research and dem- onstration of advanced diagnostic, constration, multipurpose, and other trol, prevention and treatment methaters. Specifically, this part applies ods for cancer; National Cancer Research and Dem- (2) For purposes of grants authorized stration

Centers (including pay- in section 422 of the Act, an agency or ents for construction), as authorized institution which provides for planning

' section 414 of the Act; National Re- and basic and clinical research into, arch and Demonstration Centers for training in, and demonstration of, sart, Blood Vessel, Lung, and Blood management of blood resources and adiseases, Sickle Cell Anemia, and vanced diagnostic, prevention, and ood Resources (including payments treatment methods (including emerr construction), as authorized by sec- gency medical serv ces) for heart, on 422 of the Act; Research and blood vessel, lung, or blood diseases, inraining Centers (including diabetes cluding sickle cell anemia; Tellitus, and digestive, endocrine, (3) For purposes of grants authorized etabolic, kidney and urologic dis- in section 431 of the Act, a single instiises), as authorized by section 431 of tution or a consortium of cooperating ne Act; Multipurpose Arthritis and institutions, which conducts research, susculoskeletal Disease Centers (in- training, information programs, epideluding payments for alteration, but miological studies, data collection acot construction), as authorized by sec- tivities, and development of model prohon 441 of the Act; Alzheimer's Disease grams in diabetes mellitus and related centers, as authorized by section 445 of endocrine and metabolic diseases; he Act; Claude D. Pepper Older Ameri- (4) For purposes of grants authorized ans Independence Centers, as author- in section 441 of the Act, a facility zed by section 445A of the Act; Multi- which conducts basic and clinical reurpose Deafness and Other Commu- search as well as research into arthriucation Disorders Centers, as author- tis and musculoskeletal diseases, orzed by section 464C of the Act; and thopedic procedures, training, and inCenters


Acquired formation programs for the health immunodeficiency Syndrome Research, community and the general public;

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