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(5) For purposes of grants authorized in section 445 of the Act, an agency or institution (including university medical centers) which conducts basic and clinical research (including multidisciplinary research) into, training in, and demonstration of advanced diagnostic, prevention, and treatment methods for Alzheimer's disease;

(6) For purposes of grants authorized in section 445A of the Act, an agency or institution which conducts: (1) Research into the aging processes and into the diagnosis and treatment of diseases, disorders, and complications related to aging, including menopause, which research includes research on such treatments, and on medical devices and other medical interventions regarding such diseases, disorders, and complications, that can assist individuals in avoiding institutionalization and prolonged hospitalization and in otherwise increasing the independence of the individuals; and (ii) programs to develop individuals capable of conducting such research;

(7) For purposes of grants authorized in section 464C of the Act, a single institution or a consortium of cooperating institutions which conducts basic and clinical research into, training in, information and continuing education programs for the health community and the general public about, and demonstration of advanced diagnostic, prevention, and treatment methods for, disorders of hearing and other communication processes and complications resulting from such disorders; or

(8) For purposes of grants authorized in section 2316 of the Act, an entity for basic and clinical research into, and training in, advanced diagnostic, prevention, and treatment methods for acquired immunodeficiency.

As required in a section of the Act cited in this part or at the determination of the Director of the NIH awarding organizational component, a center may include the facilities of a single institution or a consortium of cooperating institutions and, if practical, may be part of an equitable geographical distribution of centers, or an environment with proven research capabilities.

NIH means the National Instituta Health and its organizational sex nents that award grants.

Nonprofit as applied to any agents institution means an agency or its tion which is a corporation or ciation, no part of the net earning which inures or may lawfully ints the benefit of any private shareb or individual. $52.3 Who is eligible to apply?

(a) Any public or private nOD-T: agency, institution, or consortie agencies or institutions is eligia apply for a grant under sections 422, 441, 445, and 445A and 2316d": Act.

(b) Any public or private non-F or for-profit agency, institution or sortium of agencies or institutio eligible to apply for a grant under ? tions 431 and 464C of the Act.

(c) Any applicant under this must be located in a state, the DS of Columbia, Puerto Rico, the T Islands, the Canal Zone, Guam, 11 ican Samoa, or the successor Sta* the Trust Territory of the past lands (the Federated States keine nesia, the Republic of the Marais lands, and the Republic of Palan) 852a.4 What information must ei

application contain? Each application under this? must include detailed informatio to the following:

(a) The personnel, facilities, other resources available to the 25 cant with which to initiate and Ti tain the proposed center grants gram;

(b) Any research, training, der onstration, or information dissemit tion activities in which the applican currently engaged; the sources of furt ing for these activities; and the evance of these activities

to the posed center grants program; onstration, and information dissemi

(c) Proposed research, training, der tion activities;

(d) The proposed structure of the center and the rest tionship of the proposed center to the mi applicant organization(s);

(e) The names and qualifications the center director and key staff mem De

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organizations 84

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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 con"ing the proposed activities; Proposed methods for monitoring

evaluating individual activities che overall center program;

Proposed methods for coordinat2-3 the 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 1,5 ct income from sources other than

to be used to further the purposes she center program. NIH encourages se efforts. Income may include, but s'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 in patients or third parties, where A copriate (the disposition of grantvan een ted income is governed by 45 CFR CALDI: 0 through 74.47 and 45 CFR 92.25); De The proposed budget for the center Dia justification for the amount of begrant funds requested; and BT) Any other information that the este ctor of the awarding institute may

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§ 52a.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)

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a.5 How will NIH evaluate applica

tions? a) NIH siders the following in aluating Center grant applications: 1) The scientific and technical merit the proposed program; 2) The qualifications and experience

the center director and other key rsonnel;

(3) The statutory and program purpses to be accomplished;

(4) The extent to which the various imponents of the proposed program

ould be coordinated into one multisciplinary effort within the center; (5) The extent to which the center's tivities would be coordinated with milar efforts by other organizations; (6) The administrative and manageal capability of the applicant;

(7) The reasonableness of the proosed budget in relation to the proosed program; and

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§ 52a.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.

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

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

52b.1 Applicability.

52b.2 efinitions. 42 CFR Part 50, Subpart A-Responsibilities of 52b.3 Eligibility.

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

52b.6 Other HHS regulations that apply. 42 CFR Part 50, Subpart D-Public Health 52b.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 46Protection of human sub- 52b.10 Additional conditions. jects

52b.11 Minimum standards of constructe 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. 3435 45 CFR Part 76Governmentwide debarment U.S.C. 286a); sec. 404(b)(9), 92 Stat. 3471 :

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

SOURCE: 45 FR 12243, Feb. 25, 1980, unlea 45 CFR Part 80—Nondiscrimination under

otherwise noted. programs receiving Federal assistance

852b.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() ! 45 CFR Part 81-Practice and procedure for the Public Health Service Act for 1 hearings under part 80 of this title

construction of centers for clinical 45 CFR Part 84Nondiscrimination 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 45 CFR Part 86—Nondiscrimination on the

award of grants under section $40KS

)

for construction of basic research labbasis of sex in education programs and activities receiving or benefiting from Fed

oratory facilities. eral financial assistance

852b.2 Definitions. 45 CFR Part 91-Nondiscrimination on the

basis of age in HHS programs or activities (a) Act means the Public Health Sem

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 of agreements to State and local govern

cer or employee of the National Cance ments

Institute to whom the authority * 45 CFR Part 93—New restrictions on lobbying

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

(c) Construction grant means a gre Molecules

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

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

and in accordance with these regult

tions. 852a.9 Additional conditions.

(d) Construction includes the com NIH may, with respect to any grant

struction of new buildings; acquisitire

of land or existing buildings provide award, impose additional conditions prior to or at the time of any award

such acquisition occurs after the filin

of the application; the expansion.com when, in NIH's judgment, the conditions are necessary to assure or protect

modeling, and alteration of existini advancement of the approved program,

buildings provided the cost of such es the interests of the public health, or

pansion, remodeling, and alteration is

not less than $75,000; and the initia the conservation of grant funds.

equipment of any such buildings, bui

excludes the cost of off-site improve with criteria of the Director, similar ments.

functions.

8 52b.3 Eligibility.

In order to be eligible for a construction grant under section 406(b) or section 404(b)(9) of the Act, the applicant must be:

(a) A public or private nonprofit agency or institution; and

(b) Located in a State, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Canal Zone, American Samoa, the Trust Territory of the Pacific Islands, or Guam.

(Sec. 215, Public Health Service Act, 58 Stat. 690, 67 Stat. 631 (42 U.S.C. 216); sec. 406(b), Public Health Service Act, 92 Stat. 3428 (42 U.S.C. 286a); sec. 404(b)(9), Public Health Service Act, 92 Stat. 3427 (42 U.S.C. 285)). (45 FR 12243, Feb. 25, 1980, as amended at 48 FR 29201, June 24, 1983; 48 FR 45558, Oct. 6, 1983]

352b.4 Application. 3

(a) Submittal. Applications for construction grants under section 406(b) or section 404(b)(9) of the Act, including both detailed narrative descriptions and detailed estimates of the cost of the respective projects, shall be made on an authorized form.

(b) Environmental impact. Each applicant shall furnish its analysis of the cenvironmental impact of the proposed

construction taking into account the consideration set forth in the National -Environmental Policy Act, Pub. L. 91– 190 ((42 U.S.C. 4321 et seq.), 83 Stat. 852).

(c) Flood hazards. Each applicant shall furnish its assessment of the project site in light of the considerations set forth in Executive Order 11296, 31 FR 10663 (August 10, 1966) concerning the evaluation of flood hazards in locating Federally supported facilities.

(d) Review by State and local comprehensive health planning agency. In the case of a project for the construction of a facility intended, at least in part, for the provision of health serv

ices, the applicant shall provide an op portunity for comment and approval with respect to such project to (1) the

State agency administering or supervising the administration of the State plan approved under section 314(a) of the Act, and (2) the public or nonprofit private agency or organization responsible for the plan or plans referred to in section 314(b) of the Act and covering the area in which such project is to be located or if there is no such agency, such other public or nonprofit private agency or organization (if any) as performs, as determined in accordance

852b.5 Evaluation.

In approving applications for construction grants under this part, the Director shall take into account, among other factors, the following:

(a) The relevance of the program for which construction is proposed to the objectives and priorities of the National Cancer Program (42 U.S.C. 286a),

(b) The scientific merits of the program for which construction is proposed,

(c) The scientific or professional standing or reputation of the agency or institution and of its existing or proposed officers and research staff,

(d) The availability, by affiliation or other association, of other scientific or health personnel and facilities to the extent necessary to carry out effectively the contemplated program, including the adequacy of an acceptable biohazard control and containment program where warranted,

(e) The need to accomplish appropriate geographical distribution of facilities, and

(f) The financial need of the applicant.

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852b.6 Other HHS regulations that

apply. Several other regulations apply to grants under this subpart. These include, but are not limited to: 42 CFR part 50, subpart D-Public Health

Service grant appeals procedure 45 CFR part 16-Procedures of the Depart

mental Grant Appeals Board 45 CFR part 74-Administration of grants 45 CFR part 75—Informal grant appeals pro

cedures 45 CFR part 80—Nondiscrimination under

programs receiving Federal assistance through the Department of Health and Human Services effectuation of title VI of

the Civil Rights Act of 1964 45 CFR part 81-Practice and procedure for

hearings under part 80 of this title

42 CFR Ch. I (10-1-95 Editor

45 CFR part 84—Nondiscrimination on the

basis of handicap in programs and activi-
ties receiving or benefiting from Federal

financial assistance
45 CFR part 91-Nondiscrimination on the

basis of age in HHS programs or activities

receiving Federal financial assistance (49 FR 38110, Sept. 27, 1984) 852b.7 Rate of Federal financial par

ticipation. (a) The amount of a construction grant may not exceed 75 percent of the necessary allowable cost of construction as determined by the Director, except that in situations where the Director finds good cause for waiving requirements, for example, in order to achieve sufficient geographical distribution of facilities, the amount of the construction grant may exceed 75 percent of the necessary allowable cost of construction.

(b) Subject to paragraph (a) of this section, the Director shall set the actual rate of Federal financial participation in the necessary allowable cost of construction taking into consideration the most effective use of available Federal funds to further the purposes of section 406(b) or section 404(b)(9).

will be obtained before the project is advertised or placed on the market ir bidding and that such approval she include a determination by the Dire tor that the final plans and specife tions conform to the minimum stasi ards of construction and equipment a set forth in $52b.11 of this part.

(c) Relocation assistance. That in 3 case of a public applicant with an a proved project which involves the d placement of persons or businesses : or after January 4, 1971, the applica will comply with the provisions of a Uniform Relocation Assistance a Real Property Acquisition Policies : of 1970 ((42 U.S.C. 4601 et seq.), 84 85 1984) and the applicable regulations ? sued thereunder (45 CFR part 15).

(d) Approval of changes in estimate cost. That the applicant will not este into any construction contract or ca tracts for the project or a part thereur the cost of which is in excess of the # timated cost approved in the apps tion for that portion of the work ® ered by the plans and specificatio without the prior approval of the D rector.

(e) Completion responsibility. That is applicant will construct the project

, or completion in accordance with the cause it to be constructed, to final grant application and approved plans and specifications.

(1) Construction inspection. That applicant will provide and mainta** competent and adequate architectura or engineering inspection at the e struction site to insure that the com pleted work conforms with the 38. proved plans and specifications.

(8) Non-Federal share. That sufficie funds will be available to meet , non-Federal share of the cost of a structing the facility.

(h) Funds for operation. That sur cient funds will be available when cor struction is completed for effective us : of the facility for the purposes for which it is being constructed.

(i) Inspection. That the Director and have access at all reasonable times to the Director's representatives shall work whereever it is in preparation progress, and the contractor shall pro vide proper facilities for such access and inspection.

$52b.8 Terms and conditions.

In addition to any other requirement imposed by law or determined by the Director to be reasonably necessary with respect to any particular grant to fulfill the purposes thereof, each construction grant shall be subject to the condition that the applicant provide certain evidences, supported by such documentation as the Director may reasonably require. The Director may for good cause shown approve exceptions to these conditions and evidences where the Director finds that such exceptions are not inconsistent with the Act and the purposes of the program:

(a) Title. That the applicant has a fee simple or such other estate or interest in the site, including necessary easements and rights-of-way sufficient to assure for the estimated useful life of the facility, as determined by the Director, undisturbed use and possession for the purpose of the construction and operation of the facility.

(b) Plans and specifications. That approval by the Director of the final working drawings and specifications

Or

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