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(5) For purposes of grants authorized NIH means the National Instituta in section 445 of the Act, an agency or Health and its organizational com institution (including university medi- nents that award grants. cal centers) which conducts basic and Nonprofit as applied to any agency clinical research (including multidisci

institution means an agency or ist plinary research) into, training in, and tion which is a corporation or an u demonstration of advanced diagnostic, ciation, no part of the net earnins prevention, and treatment methods for

which inures or may lawfully ins: Alzheimer's disease;

the benefit of any private sharebi (6) For purposes of grants authorized

or individual. in section 445A of the Act, an agency or

852a.3 Who is eligible to apply? institution which conducts: (i) Research into the aging processes and

(a) Any public or private noninto the diagnosis and treatment of

agency, institution, or consortiv diseases, disorders, and complications

agencies or institutions is eligib related to aging, including menopause,

apply for a grant under sections which research includes research on

422, 441, 445, and 445A and 2316 such treatments, and on medical de

Act. vices and other medical interventions

(b) Any public or private nonregarding such diseases, disorders, and

or for-profit agency, institution or complications, that can assist individ

sortium of agencies or institutio

eligible to apply for a grant under 4 uals in avoiding institutionalization

tions 431 and 464C of the Act. and prolonged hospitalization and in

(c) Any applicant under this otherwise increasing the independence must be located in a State, the Ds of the individuals; and (ii) programs to of Columbia, Puerto Rico, the develop individuals capable of conduct- Islands, the Canal Zone, Guam, 4 ing such research;

ican Samoa, or the successor St** (7) For purposes of grants authorized the Trust Territory of the Past in section 464C of the Act, a single in- lands (the Federated States stitution or a consortium of cooperat- nesia, the Republic of the Marat ing institutions which conducts basic lands, and the Republic of Palau and clinical research into, training in, information and continuing education

852a.4 What information muster programs for the health community

application contain? and the general public about, and dem- Each application under this onstration of advanced diagnostic, pre

must include detailed information vention, and treatment methods for, to the following: disorders of hearing and other commu

(a) The personnel, nication processes and complications

other resources available to the app resulting from such disorders; or

cant with which to initiate and (8) For purposes of grants authorized

tain the proposed center grants : in section 2316 of the Act, an entity for

gram; basic and clinical research into, and

(b) Any research, training,

onstration, or information dissem training in, advanced diagnostic, pre

tion activities in which the applicar vention, and treatment methods for ac

currently engaged; the sources of ft quired immunodeficiency.

ing for these activities; and the As required in a section of the Act

evance of these activities to the cited in this part or at the determina- posed center grants program; tion of the Director of the NIH award

(c) Proposed research, training, ing organizational component, a center onstration, and information dissemi may include the facilities of a single tion activities; institution or a consortium of cooper- (d) The proposed

proposed organizatio

: ating institutions and, if practical, structure of the center and the re may be part of an equitable geographi- tionship of the proposed center to ! cal distribution of centers, or an envi- applicant organization(s); ronment with proven research capabili- (e) The names and qualifications ties.

the center director and key staff me'

facilities,

de

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(8) Other factors which the awarding institute, center, or division considers appropriate in light of its particular statutory mission.

(b) Where required by statute or NIH policy, applications are reviewed by appropriate national advisory councils or boards before awards are made. NIH grants may be awarded generally only after approval recommendations from both appropriate scientific peer review groups and national advisory councils or boards.

who would be responsible for coning the proposed activities; Proposed methods for monitoring

evaluating individual activities She overall center program;

Proposed methods for coordinatthe center's activities, where ap riate, with similar efforts by other ic and private organizations; » The availability of any commu

resources necessary to carry out osed activities; and Efforts to be made to generate and ct income from sources other than to be used to further the purposes le center program. NIH encourages e efforts. Income may include, but ot limited to, that generated from sale or rental of products or serv

produced by grant-supported accies, such as laboratory tests, com

time, and payments received 2 patients or third parties, where copriate (the disposition of grantted income is governed by 45 CFR o through 74.47 and 45 CFR 92.25);

The proposed budget for the center a justification for the amount of grant funds requested; and -) Any other information that the octor of the awarding institute may iest. proved under OMB Control Number 0925– ]

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a.5 How will NIH evaluate applications? L) NIH considers the following in luating Center grant applications: 1) The scientific and technical merit he proposed program; 2) The qualifications and experience the center director and other key sonnel; 3) The statutory and program purses to be accomplished; 4) The extent to which the various nponents of the proposed program uld be coordinated into one multiciplinary effort within the center; 5) The extent to which the center's ivities would be coordinated with nilar efforts by other organizations; 6) The administrative and manage1 capability of the applicant; 7) The reasonableness of the prosed budget in relation to the prosed program; and

852a.6 Information about grant

awards. (a) The notice of grant award specifies how long NIH 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.

(b) 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 the NIH that continued funding is in the best interest of the Federal Government.

(c) Neither the approval of any application, nor the award of any grant commits or obligates the Federal Government in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application. (Approved under OMB Control Number 0925– 0001) 852a.7 For what purposes may

grantee spend grant funds? A grantee shall only spend funds it receives under this part according to the approved application and budget, the authorizing legislation, the terms and conditions of the award, the applicable cost principles prescribed in subpart Q of 45 CFR part 74 and 45 CFR 92.22, and the regulations of this part.

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852a.8 Other HHS regulations that PART 52b-NATIONAL CANCER apply.

INSTITUTE CONSTRUCTION GRANT Several other regulations and policies apply to this part. These include, Sec. but are not necessarily limited to:

52b.1 Applicability.

526.2 Definitions. 42 CFR Part 50, Subpart A-Responsibilities of 526.3 Eligibility.

PHS awardee and applicant institutions for 52b.4 Application. dealing with and reporting possible mis- 526.5 Evaluation. conduct in science

526.6 Other HHS regulations that apply. 42 CFR Part 50, Subpart D_Public Health 526.7 Rate of Federal financial partici Service grant appeals procedures

tion. 45 CFR Part 16 Procedures of the Depart- 52b.8 Terms and conditions. mental Grant Appeals Board

52b.9 Acquisition of facilities. 45 CFR Part 46–Protection of human sub- 52b.10 Additional conditions. jects

52b.11 Minimum standards of construct 45 CFR Part 74-Administration of grants

and equipment. 45 CFR Part 75—Informal grant appeals pro- AUTHORITY: Sec. 215, 58 Stat. 690, as ames cedures

ed (42 U.S.C. 216); sec. 406(b), 92 Stat. 343 45 CFR Part 76—Governmentwide debarment U.S.C. 286a); sec. 404(b)(9), 92 Stat. 34274

and suspension (nonprocurement) and gov- U.S.C. 285).
ernmentwide requirements for drug-free
workplace (grants)

SOURCE: 45 FR 12243, Feb. 25, 1980, unles

otherwise noted. 45 CFR Part 80Nondiscrimination under programs receiving Federal assistance

$52b.1 Applicability. through the Department of Health and Human Services Effectuation of Title VI The provisions of this part apply of the Civil Rights Act of 1964

award of grants under section 406(b)! 45 CFR Part 81-Practice and procedure for the Public Health Service Act for the hearings under part 80 of this title

construction of centers for clinical 45 CFR Part 84-Nondiscrimination on the search, training and demonstration of

basis of handicap in programs and activi- advanced diagnostic and treatment ties receiving or benefiting from Federal methods relating to cancer, and to the financial assistance

award of grants under section 440X9) 45 CFR Part 86—Nondiscrimination on the for construction of basic research lab

basis of sex in education programs and activities receiving or benefiting from Fed

oratory facilities. eral financial assistance 45 CFR Part 91-Nondiscrimination on the

852b.2 Definitions. basis of age in HHS programs or activities (a) Act means the Public Health Ser

receiving Federal financial assistance ice Act, as amended. 45 CFR Part 92-Uniform administrative re- (b) Director means the Director of the

quirements for grants and cooperative National Cancer Institute and any agreements to State and local govern

cer or employee of the National Cancer ments 45 CFR Part 93—New restrictions on lobbying

Institute to whom the authority

volved may be delegated. 51 FR 16958 or successor-NIH Guidelines for Research Involving Recombinant DNA

(c) Construction grant means a 87 Molecules

of funds for construction pursuant sections 406(b) and 404(b)(9)

of the As Public Health Service Policy on Humane Care and Use of Laboratory Animals.

and in accordance with these regulit

tions. 852a.9 Additional conditions.

(d) Construction includes the core

struction of new buildings; acquisitio NIH may, with respect to any grant of land or existing buildings provided award, impose additional conditions prior to or at the time of any award

such acquisition occurs after the filin when, in NIH's judgment, the condi

of the application; the expansion, it

modeling, and alteration of existing advancement of the approved program, the interests of the public health, or

pansion, remodeling, and alteration is the conservation of grant funds.

not less than $75,000; and the initial

equipment of any such buildings, but

xcludes the cost of off-site improve with criteria of the Director, similar nents.

functions. 52b.3 Eligibility.

(Sec. 215, Public Health Service Act, 58 Stat.

690, 67 Stat. 631 (42 U.S.C. 216); sec. 406(b), In order to be eligible for a construc- Public Health Service Act, 92 Stat. 3428 (42 cion grant under section 406(b) or sec- U.S.C. 286a); Sec. 404(b)(9), Public Health ion 404(b)(9) of the Act, the applicant

Service Act, 92 Stat. 3427 (42 U.S.C. 285)). must be:

(45 FR 12243, Feb. 25, 1980, as amended at 48 (a) A public or private nonprofit FR 29201, June 24, 1983; 48 FR 45568, Oct. 6, agency or institution; and

1983) (b) Located in a State, the District of

852b.5 Evaluation. Columbia, the Commonwealth of Puer-o Rico, the Virgin Islands, the Canal In approving applications for conZone, American Samoa, the Trust Ter- struction grants under this part, the itory of the Pacific Islands, or Guam.

Director shall take into account,

among other factors, the following: 52b.4 Application.

(a) The relevance of the program for

which construction is proposed to the (a) Submittal. Applications for con

objectives and priorities of the Nastruction grants under section 406(b) or

tional Cancer Program (42 U.S.C. 286a), section 404(b)(9) of the Act, including

(b) The scientific merits of the proboth detailed narrative descriptions

gram for which construction is pround detailed estimates of the cost of

posed, che respective projects, shall be made

(c) The scientific or professional on an authorized form.

standing or reputation of the agency or (b) Environmental impact. Each appli- institution and of its existing or procant shall furnish its analysis of the

posed officers and research staff, environmental impact of the proposed

(d) The availability, by affiliation or construction taking into account the

other association, of other scientific or consideration set forth in the National

health personnel and facilities to the Environmental Policy Act, Pub. L. 91

extent necessary to carry out effec190 ((42 U.S.C. 4321 et seq.), 83 Stat. 852).

tively the contemplated program, in(c) Flood hazards. Each applicant cluding the adequacy of an acceptable shall furnish its assessment of the proj- biohazard control and containment ect site in light of the considerations

program where warranted, set forth in Executive Order 11296, 31 (e) The need to accomplish approFR 10663 (August 10, 1966) concerning priate geographical distribution of fahe evaluation of flood hazards in lo- cilities, and ating Federally supported facilities. (f) The financial need of the appli

(d) Review by State and local com- cant. prehensive health planning agency. In the case of a project for the construc- $52b.6 Other HHS regulations that tion of a facility intended, at least in apply. part, for the provision of health serv- Several other regulations apply to ices, the applicant shall provide an op- grants under this subpart. These inportunity for comment and approval clude, but are not limited to: with respect to such project to (1) the State agency administering or super

42 CFR part 50, subpart D-Public Health

Service grant appeals procedure rising the administration of the State

45 CFR part 16-Procedures of the Departplan approved under section 314(a) of mental Grant Appeals Board he Act, and (2) the public or nonprofit 45 CFR part 74-Administration of grants private agency or organization respon- 45 CFR part 75—Informal grant appeals proible for the plan or plans referred to in cedures ection 314(b) of the Act and covering

45 CFR part 80—Nondiscrimination under he area in which such project is to be

programs receiving Federal assistance ocated or if there is no such agency,

through the Department of Health and

Human Services effectuation of title VI of iuch other public or nonprofit private

the Civil Rights Act of 1964 gency or organization (if any) as per- 45 CFR part 81-Practice and procedure for orms, as determined in accordance hearings under part 80 of this title

45 CFR part 84-Nondiscrimination on the will be obtained before the project basis of handicap in programs and activi. advertised or placed on the market te ties receiving or benefiting from Federal bidding and that such approval sha

financial assistance 45 CFR part 91-Nondiscrimination on the include a determination by the Dire basis of age in HHS programs or activities

tor that the final plans and specifix receiving Federal financial assistance tions conform to the minimum stan (49 FR 38110, Sept. 27, 1984)

ards of construction and equipment i

set forth in $52b.11 of this part. 852b.7 Rate of Federal financial par (c) Relocation assistance. That ind ticipation.

case of a public applicant with an a (a) The amount of a construction proved project which involves the di grant may not exceed 75 percent of the placement of persons or businesses ? necessary allowable cost of construc- or after January 4, 1971, the applica: tion as determined by the Director, ex- will comply with the provisions of a cept that in situations where the Di- Uniform Relocation Assistance a rector finds good cause for waiving re- Real Property Acquisition Policies quirements, for example, in order to of 1970 ((42 U.S.C. 4601 et seq.), 84 Ste achieve sufficient geographical dis- 1984) and the applicable regulations i tribution of facilities, the amount of sued thereunder (45 CFR part 15). the construction grant may exceed 75

(d) Approval of changes in estimate percent of the necessary allowable cost

cost. That the applicant will not este of construction.

into any construction contract or com (b) Subject to paragraph (a) of this tracts for the project or a part there section, the Director shall set the ac- the cost of which is in excess of the * tual rate of Federal financial participation in the necessary allowable cost of

timated cost approved in the appis construction taking into consideration

tion for that portion of the work as the most effective use of available Fed

ered by the plans and specificatio

without the prior approval of the 2 eral funds to further the purposes of rector. section 406(b) or section 404(b)(9).

(e) Completion responsibility. That the 852b.8 Terms and conditions.

applicant will construct the project

, or In addition to any other requirement

cause it to be constructed, to final imposed by law or determined by the

grant application and approved plass

completion in accordance with the Director to be reasonably necessary with respect to any particular grant to

and specifications. fulfill the purposes thereof, each con

(1) Construction inspection. That the struction grant shall be subject to the

applicant will provide and mainta condition that the applicant provide

competent and adequate architectura certain evidences, supported by such

or engineering inspection at the com documentation as the Director may

struction site to insure that the cor reasonably require. The Director may

pleted work conforms with the # for good cause shown approve excep

proved plans and specifications. tions to these conditions and evidences

(8) Non-Federal share. That sufficie where the Director finds that such ex

funds will be available to meet ceptions are not inconsistent with the non-Federal share of the cost of all Act and the purposes of the program:

structing the facility. (a) Title. That the applicant has a fee (h) Funds for operation. That suits simple or such other estate or interest cient funds will be available when com in the site, including necessary ease

struction is completed for effective 2 ments and rights-of-way sufficient to of the facility for the purposes for assure for the estimated useful life of which it is being constructed. the facility, as determined by the Director, undisturbed use and possession

(i) Inspection. That the Director and for the purpose of the construction and

the Director's representatives shall operation of the facility.

have access at all reasonable times to

work whereever it is in preparation (b) Plans and specifications. That approval by the Director of the final

progress, and the contractor shall proworking drawings and specifications

vide proper facilities for such access and inspection.

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