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leral grant for construction, acquisin, or equipment shall serve either to uce or restrict the liability of the licant or any other transferor or nsferee from any obligation of acntability imposed by the Federal vernment by reason of such prior nt.

FR 5700, Dec. 30, 1976]

PARTS 51d-51g (RESERVED)

RT 52-GRANTS FOR RESEARCH PROJECTS

To which programs do these regulaions apply?

- Definitions.

Who is eligible to apply for a grant?

How to apply for a grant.

Evaluation and disposition of applica

ions.

Grant awards.

Use of funds; changes.

Other HHS regulations that apply.
Other conditions.

THORITY: Sec. 215, 58 Stat. 690, as amend3 Stat. 835 (42 U.S.C. 216); sec. 301, 58 691, as amended, 60 Stat. 423, 62 Stat. 301, 1017, 70 Stat. 490, 74 Stat. 1053, 85 785, 86 Stat. 687, 88 Stat. 346, 360 (42 C. 241); sec. 303, 70 Stat 929, as amended, bat. 1241, 88 Stat. 132, 346 (42 U.S.C. 242a); 356, 82 Stat. 1174 (42 U.S.C. 263d); sec. 394, tat. 1062, as amended, 84 Stat. 63, 64, 66, 7 Stat. 92, 88 Stat. 372 (42 U.S.C. 280b-5); 1004, 89 Stat. 306, 352, as amended, 91 .389 (42 U.S.C. 300a-2); sec. 1006, 89 Stat. 12 U.S.C. 300a-4); sec. 501, 90 Stat. 1038 (42 C. 4585); sec. 1205, 87 Stat. 597 (42 U.S.C. 4); sec. 410, 68 Stat. 84, as amended, 90 . 247, 90 Stat. 1040 (21 U.S.C. 1177); sec. »), 92 Stat. 3447 (42 U.S.C. 242n); sec. ), Pub. L. 97-35, 95 Stat. 589 (42 U.S.C. -7(a)(1)).

.1 To which programs do these regulations apply?

.) The regulations of this part apply rants for the support of health-red research projects in programs reng to:

) The cause, diagnosis, treatment, trol, or prevention of the physical nental diseases, injuries, or impairits to human life, as authorized by ions 301, 303, and related provisions he Act (42 U.S.C. 241, 242a);

) Electronic product radiation conI programs designed to protect the

public, and safety from electronic product radiation, as authorized by section 356 of the Act (42 U.S.C. 263d);

(3) Medical library science and related activities, and for the development or dissemination of new knowledge, techniques, systems, and equipment for processing, storing, retrieving, and distributing information pertaining to health sciences, as authorized by section 394 of the Act (42 U.S.C. 280b-5);

(4) Emergency medical techniques, methods, devices, and delivery, as authorized by section 1205 of the Act (42 U.S.C. 300d-4);

(5) The behavioral and biomedical etiology, treatment, mental and physical health consequences, and social and economic consequences, of alcohol abuse and alcoholism, as authorized by section 501 of the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970 (42 U.S.C. 4585);

(6) The improvement of drug maintenance techniques or programs, as authorized by section 410 of the Drug Abuse Office and Treatment Act of 1972 (21 U.S.C. 1177);

(7) Research in the biomedical, contraceptive development, behavioral, and program implementation fields related to family planning and population, as authorized under section 1004 of the Act; and

(8) Health care technology assessments, including studies of the safety, efficacy, effectiveness, and cost effectiveness of particular technologies, their social, ethical, and economic impacts, as well as studies of methods of dissemination of information about technologies, and factors affecting the use of technologies as authorized by section 309(b) of the Act (42 U.S.C. 242n).

(9) Research on the causes, consequences and approaches to coping with adolescent sexual relations, contraceptive use, pregnancy and parenthood authorized by section 2008 of the Act.

(b) These regulations do not apply to general research support grants, grants for the construction of research facilities (see part 57 of this chapter), for the construction of hospital or other medical facilities (see part 53 of this chapter), or the award of fellowships (see

part 61 of this chapter), traineeships (see part 63 of this chapter), training grants (see part 64 of this chapter), or to the support of research training under the National Research Service Awards program (see part 66 of this chapter).

[45 FR 12240, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980, as amended at 46 FR 4919, Jan. 19, 1981; 47 FR 50261, Nov. 5, 1982]

$52.2 Definitions.

As used in this part:

(a) Secretary 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 may be delegated.

(b) Principal investigator means a single individual designated by the grantee in the grant application and approved by the Secretary, who is responsible for the scientific and technical direction of the project.

(c) Act means the Public Health Service Act (42 U.S.C. 201 et seq.).

(d) Department means the Department of Health and Human Services.

(e) Grantee means the institution, organization, individual or other person designated in the grant award document as the responsible legal entity to whom a grant is awarded under this part.

(f) Research project grant means the award by the Secretary of funds to a grantee to assist in meeting the costs of conducting for the benefit of the public health an identified project which is intended and designed to establish, discover, develop, elucidate or confirm information or the underlying mechanisms relating to a program set forth in §52.1.

(g) Project means the particular activity within the scope of one or more of the programs set forth in §52.1 which is supported by a grant award under this part.

[45 FR 12240, Feb. 25, 1980]

§ 52.3 Who is eligible to apply fo grant?

(a) Persons eligible. Any ind corporation, public or private tion or agency, or other lega

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shall be eligible for a grant award cept:

(1) An individual or entity whit. otherwise ineligible for an award applicable law or regulation, and

(2) Federal agencies or institut unless specifically authorized by l receive the grant.

(3) Any individual, corporation, 1 tution, agency or other entity: having previously received a í award, has failed willfully and m ally in the judgment of the Secr to comply with accounting or othe award. Ineligibility for a grant quirements applicable to that under this paragraph continues terminated in the public interes the Secretary.

(b) Permissible activities within prog Any project found by the Secretary be a research project within the ing of §52.1 shall be eligible for a award. Eligible projects may co laboratory, clinical, population, statistical, basic, applied or types of investigations, studies periments, or combinations and may either be limited to particular aspect of a proble ject, or may consist of two or lated problems or subjects for rent or consecutive investigation involving multiple disciplines, ties and resources.

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

§ 52.4 How to apply for a grant. A grant application must include" following information:

(a) Nature requested project per purpose and plan of the project; (b) Name and qualifications of principal investigator and any of key personnel;

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

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

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

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(f) Other pertinent information cretary may require to evaluate the posed project.

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Evaluation and disposition of applications.

(a) Evaluation. All applications filed accordance with §52.4 shall be evalued by the Secretary through such ofcers and employees and such experts consultants engaged for this purpose the Secretary determines are speally qualified in the areas of research volved in the project, including reew by an appropriate National Adviry Council or other body as may be quired by law. The Secretary's evaltion shall take into account among her pertinent factors the scientific erit and significance of the project, le competency of the proposed staff in lation to the type of research in→olved, the feasibility of the project, he likelihood of its producing meangful results, the proposed project peod, and the adequacy of the appliant's resources available for the *roject and the amount of grant funds ecessary for completion, and in the ase of applications for support of reSearch in emergency medical services, pecial consideration shall be given to pplications for grants for research reting to the delivery of emergency hedical services in rural areas.

(b) Disposition. On the basis of the Secretary's evaluation of an applicaion 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 ap

plicants 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 sepa

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]

$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 Sec

retary, with or without addition grant support, for such an addition period as the Secretary determi may be required to complete, or full the purposes of, the approved project [45 FR 12240, Feb. 25, 1980]

$52.8 Other HHS regulations apply.

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

42 CFR part 50, subpart D-Public Ha Service grant appeals procedure 45 CFR parts 6 and 8-Inventions and pa 45 CFR part 16-Procedures of the Dep mental Grant Appeals Board

45 CFR part 46-Protection of human st jects

45 CFR part 74—Administration of grant 45 CFR part 75-Informal grant appeals

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section 414 of the Act; National Rearch and Demonstration Centers for eart, Blood Vessel, Lung, and Blood iseases, Sickle Cell Anemia, and lood Resources (including payments r construction), as authorized by secon 422 of the Act; Research and raining Centers (including diabetes Mellitus,

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and digestive, endocrine, etabolic, kidney and urologic disases), as authorized by section 431 of he Act; Multipurpose Arthritis and Iusculoskeletal Disease Centers (inluding payments for alteration, but ot construction), as authorized by secion 441 of the Act; Alzheimer's Disease enters, as authorized by section 445 of he Act; Claude D. Pepper Older AmeriMans Independence Centers, as authorzed by section 445A of the Act; Multiurpose Deafness and Other Commulication Disorders Centers, as authorzed by section 464C of the Act; and Centers for Acquired "mmunodeficiency Syndrome Research,

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as authorized by section 2316 of the Act.

This part does not apply to:

(1) Grants for construction (see 42 CFR part 52b), except as noted above; (2) Grants covered by 42 CFR part 52 (grants for research projects); or

(3) Grants for general research support under section 301(a)(3) of the Act (42 U.S.C. 241(a)(3)).

(b) This part also applies to cooperative agreements made to support the centers specified in paragraph (a) of this section. When a reference is made in this part to "grants," the reference shall include "cooperative agreements."

§ 52a.2 Definitions.

As used in this part:

Act means the Public Health Service Act, as amended (42 U.S.C. 201 et seq.). Center means:

(1) For purposes of grants authorized in section 414 of the Act, an agency or institution which provides for planning and conducting basic and clinical research into, training in, and demonstration of advanced diagnostic, control, prevention and treatment methods for cancer;

(2) For purposes of grants authorized in section 422 of the Act, an agency or institution which provides for planning and basic and clinical research into, training in, and demonstration of, management of blood resources and advanced diagnostic, prevention, and treatment methods (including emergency medical services) for heart, blood vessel, lung, or blood diseases, including sickle cell anemia;

(3) For purposes of grants authorized in section 431 of the Act, a single institution or a consortium of cooperating institutions, which conducts research, training, information programs, epidemiological studies, data collection activities, and development of model programs in diabetes mellitus and related endocrine and metabolic diseases;

(4) For purposes of grants authorized in section 441 of the Act, a facility which conducts basic and clinical research as well as research into arthritis and musculoskeletal diseases, orthopedic procedures, training, and information programs for the health community and the general public;

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