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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: (i) 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.

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§ 52a.3 Who is eligible to apply? (a) Any public or private non-p agency, institution, or consortim agencies or institutions is eligi N apply for a grant under sections 422, 441, 445, and 445A and 2316 of Act.

(b) Any public or private non-p or for-profit agency, institution or of sortium of agencies or institution 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 Di of Columbia, Puerto Rico, the Islands, the Canal Zone, Guam, ican Samoa, or the successor Stat the Trust Territory of the Pat

lands (the Federated States
nesia, the Republic of the Mar
lands, and the Republic of Palan
§ 52a.4 What information must est
application contain?

Each application under this must include detailed information to the following:

(a) The personnel, facilities, other resources available to the & cant with which to initiate and m tain the proposed center grants F

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who would be responsible for coning the proposed activities;

Proposed methods for monitoring evaluating individual activities Che overall center program;

Proposed methods for coordinatthe center's activities, where apriate, with similar efforts by other ic and private organizations;

The availability of any commuresources 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 the center program. NIH encourages e efforts. Income may include, but ot limited to, that generated from sale or rental of products or servproduced by grant-supported acties, such as laboratory tests, com

time, and payments received patients or third parties, where ropriate (the disposition of grant

4ted income is governed by 45 CFR ated 50 through 74.47 and 45 CFR 92.25); PerThe proposed budget for the center

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a justification for the amount of grant funds requested; and

erika) Any other information that the ederated actor of the awarding institute may prtidest. Republica

informatio contain

tion

etailed

proved under OMB Control Number 0925

a.5 How will NIH evaluate applications?

a) NIH considers the following in

Oncelluating Center grant applications:

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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 pur

hich theses to be accomplished;

the s(4) The extent to which the various

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mponents of the proposed program ould be coordinated into one multi

pro Sciplinary 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 manage-

ter al capability of the applicant;

(7) The reasonableness of the proosed budget in relation to the pro

qualosed program; and

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(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 09250001]

§ 52a.7 For what purposes may a 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.

§ 52a.8 Other HHS regulations that apply.

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

42 CFR Part 50, Subpart A-Responsibilities of PHS awardee and applicant institutions for dealing with and reporting possible misconduct in science

42 CFR Part 50, Subpart D-Public Health Service grant appeals procedures

45 CFR Part 16-Procedures of the Departmental Grant Appeals Board

45 CFR Part 46-Protection of human subjects

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

45 CFR Part 76-Governmentwide debarment and suspension (nonprocurement) and governmentwide requirements for drug-free workplace (grants)

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

45 CFR Part 84-Nondiscrimination on the basis of handicap in programs and activities receiving or benefiting from Federal financial assistance

45 CFR Part 86-Nondiscrimination on the basis of sex in education programs and activities 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

45 CFR Part 92-Uniform administrative requirements for grants and cooperative agreements to State and local governments

45 CFR Part 93-New restrictions on lobbying 51 FR 16958 or successor-NIH Guidelines for Research Involving Recombinant DNA Molecules

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

§ 52a.9 Additional conditions.

NIH may, with respect to any grant award, impose additional conditions prior to or at the time of any award when, in NIH's judgment, the conditions are necessary to assure or protect advancement of the approved program, the interests of the public health, or the conservation of grant funds.

PART 52b-NATIONAL CANCER INSTITUTE CONSTRUCTION GRANTS

Sec.

52b.1 Applicability.

52b.2 Definitions. 52b.3 Eligibility. 52b.4 Application. 52b.5 Evaluation.

52b.6 Other HHS regulations that apply. 52b.7 Rate of Federal financial partici tion.

52b.8 Terms and conditions. 52b.9 Acquisition of facilities. 52b.10 Additional conditions. 52b.11 Minimum standards of constructi and equipment.

AUTHORITY: Sec. 215, 58 Stat. 690, as amen ed (42 U.S.C. 216); sec. 406(b), 92 Stat. 3428 U.S.C. 286a); sec. 404(b)(9), 92 Stat. 3427 U.S.C. 285).

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

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excludes the cost of off-site improvements.

§ 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.

§ 52b.4 Application.

(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. 91190 ((42 U.S.C. 4321 et seq.), 83 Stat. 852). (c) Flood hazards. Each applicant shall furnish its assessment of the projrect 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 services, the applicant shall provide an opportunity 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

with criteria of the Director, similar functions.

(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]

§52b.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.

§ 52b.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 Departmental Grant Appeals Board

45 CFR part 74-Administration of grants 45 CFR part 75-Informal grant appeals procedures

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

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§ 52b.7 Rate of Federal financial participation.

(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).

§ 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

will be obtained before the projects advertised or placed on the market fr bidding and that such approval shi include a determination by the Dire tor that the final plans and specific tions conform to the minimum stan ards of construction and equipment a set forth in §52b.11 of this part.

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

(d) Approval of changes in estimated cost. That the applicant will not ente into any construction contract or o tracts for the project or a part there the cost of which is in excess of the timated cost approved in the appli 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 the applicant will construct the project, cause it to be constructed, to final completion in accordance with the grant application and approved plan and specifications.

(f) Construction inspection. That the

applicant will provide and mainta competent and adequate architectur or engineering inspection at the co struction site to insure that the com pleted work conforms with the p proved plans and specifications.

(g) Non-Federal share. That sufficie funds will be available to meet non-Federal share of the cost of ct! structing the facility.

(h) Funds for operation. That suff cient funds will be available when co struction is completed for effective use I of the facility for the purposes for

which it is being constructed.

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

and inspection.

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