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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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45 CFR part 75— Informal grant appeals pro

cedures 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 Fed

eral 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 re

quirements for grants and cooperative agreements to State and local govern

ments 45 CFR part 93— New restrictions on lobbying 59 FR 14508 March 28,1994)-NIH Guidelines

on the Inclusion of Women and Minorities as Subjects in Clinical Research.

[NOTE: This policy is subject to change, and interested persons should contact the Office of Research on Women's Health, NIH, Room 201, MSC 0161, BETHESDA, MD 20892– 0601 (301–402–1770; not a toll-free number) to obtain references to the current version and any amendments.] 59 FR 34496 (July 5,1994)NIH Guidelines for

Research Involving Recombinant DNA Molecules.

(NOTE: This policy is subject to change, and interested persons should contact the Office of Recombinant DNA Activities, NIH, Suite 323, 6000 Executive Boulevard, MSA 7010, BETHESDA, MD 20892–7010 (301-496–9838; not a toll-free number) to obtain references to the current version and any amendments.) Public Health Service Policy on Humane

Care and Use of Laboratory Animals, Office for Protection from Research Risks, NIH (Revised September 1986).

[NOTE: This policy is subject to change, and interested persons should contact the Office for Protection from Research Risks, NIH, Suite 3B01, 6100 Executive Boulevard, MSC 7507, Bethesda, MD 20892–7507 (301-496– 7005; not a toll-free number) to obtain references to the current version and any amendments.) (57 FR 61006, Dec. 23, 1992, as amended at 61 FR 55109, Oct. 24, 1996)

[61 FR 55109, Oct. 24, 1996)

$52a.8 Other HHS regulations and

policies 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 mis

conduct in science 42 CFR part 50, Subpart D- Public Health

Service grant appeals procedures 42 CFR part 50, subpart F-Responsibility of

applicants for promoting objectivity in re

search for which PHS funding is sought 45 CFR part 16—— Procedures of the Depart

mental Grant Appeals Board 45 CFR part 46Protection of human subjects 45 CFR part 74-Uniform administrative re

quirements for awards and subawards to institutions of higher education, hospitals, other nonprofit organizations, and commercial organizations; and certain grants and agreements with states, local governments and Indian tribal governments

$ 52a.9 Additional conditions.

The Director may, with respect to any grant award, impose additional conditions prior to or at the time of any award when in the Director's judgment the conditions are necessary to assure the carrying out of the purposes of the award, the interests of the public health, or the conservation of grant funds.

and in accordance with these regulations.

(d) Construction includes the construction of new buildings; acquisition of land or existing buildings provided such acquisition occurs after the filing of the application; the expansion, remodeling, and alteration of existing buildings provided the cost of such expansion, remodeling, and alteration is not less than $75,000; and the initial equipment of any such buildings; but excludes the cost of off-site improvements.

[61 FR 55110, Oct. 24, 1996)

PART 52b-NATIONAL CANCER INSTITUTE CONSTRUCTION GRANTS

Sec. 52b.1 Applicability. 52b.2 Definitions. 52b.3 Eligibility. 52b.4Application. 525.5 Evaluation. 52b.6 Other HHS regulations that apply. 52b.7 Rate of Federal financial participa

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

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

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

$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.1 Applicability.

The provisions of this part apply to award of grants under section 406(b) of the Public Health Service Act for the construction of centers for clinical research, training and demonstration of advanced diagnostic and treatment methods relating to cancer, and to the award of grants under section 404(b)(9) for construction of basic research laboratory facilities.

$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 environmental 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 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 services, the applicant shall provide an opportunity for comment and approval with respect to such project to (1) the

$52b.2 Definitions.

(a) Act means the Public Health Service Act, as amended.

(b) Director means the Director of the National Cancer Institute and any officer or employee of the National Cancer Institute to whom the authority involved may be delegated.

(c) Construction grant means a grant of funds for construction pursuant to sections 406(b) and 404(b)(9) of the Act,

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.

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 75Informal 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 45 CFR part 84-Nondiscrimination on the

basis of handicap in 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 (49 FR 38110, Sept. 27, 1984)

(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 pro

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.

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).

852b.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

$52b.6 Other HHS regulations that

apply. Several other regulations apply to grants under this subpart. These include, but are not limited to:

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 project is advertised or placed on the market for bidding and at such approval shall include a determination by the Director that the final plans and specifications conform to the minimum standards of construction and equipment as set forth in 852b.11 of this part.

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

(d) Approval of changes in estimated cost. That the applicant will not enter into any construction contract or contracts for the project or a part thereof, the cost of which is in excess of the estimated cost approved in the application for that portion of the work covered by the plans and specifications, without the prior approval of the Director.

(e) Completion responsibility. That the applicant will construct the project, or cause it to be constructed, to final completion in accordance with the grant application and approved plans and specifications.

(f) Construction inspection. That the applicant will provide and maintain competent and adequate architectural or engineering inspection at the construction site to insure that the completed work conforms with the approved plans and specifications.

(g) Non-Federal share. That sufficient funds will be available to meet the

non-Federal share of the cost of constructing the facility.

(h) Funds for operation. That sufficient funds will be available when construction is completed for effective use of the facility for the purposes for which it is being constructed.

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

(j) Accessibility to handicapped. That, the facility shall be designed to comply with the Federal Accessibility Standard (41 CFR subpart 101–19.6) as modified by other standards prescribed by the Director or the Administrator of General Services. The applicant will be responsible for conducting inspections to insure compliance with these specifications by the contractor.

(k) Minimum standards of construction and equipment. That the plans and specifications for the project will conform to the minimum standards of construction and equipment as set forth in $52b.11 of this part.

(45 FR 12243, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980]

$52b.9 Acquisition of facilities.

In addition to the other requirements of this part, the following provisions are applicable to the acquisition of existing facilities.

(a) Minimum standards of construction and equipment. A determination by the Director that the facility conforms (or upon completion of any necessary construction will conform) to the minimum standards of construction and equipment as set forth in 852b.11 of this part, shall be obtained before entering into a final or unconditional contract for such acquisition. Where the Director finds that exceptions to or modification of any such minimum standards of construction and equipment would be consistent with the purposes of section 406(b) or section 404(b)(9) of the Act, the Director may authorize such exceptions or modifications;

(b) Estimated cost of acquisition and remodeling: Suitability of facility. Each application for a project involving the acquisition of existing facilities shall include in the detailed estimates of the cost of the project, the cost of acquiring such facilities, and any cost of remodeling, renovating or altering such facilities to serve the purposes for which they are acquired. Such application shall demonstrate to the satisfaction of the Director that the architectural, structural and other pertinent features of the facility, as modified by any proposed expansion, remodeling, renovation, or alteration, will be clearly suitable for the purposes of section 406(b) or section 404(b)(9) of the Act, and, to the extent of the costs in which Federal participation is requested, are not in excess of what is necessary for the services proposed to be provided in such facilities;

(c) Bona fide sale. Federal participation in the acquisition of existing facilities is on condition that such acquisition constitutes a bona fide sale involving an actual cost to the applicant and will result in additional or improved facilities for purposes of section 406(b) or section 404(b)(9) of the Act; and

(d) Facility which has previously received Federal grant. No grant for the acquisition of a facility which has previously received a Federal grant for construction, acquisition, equipment shall serve either to reduce or restrict the liability of the applicant or any other transferor or transferee from any obligation of accountability imposed by the Federal Government by reason of such prior grant.

852b.11 Minimum standards of con

struction and equipment. The standards set forth in this section have been determined by the Director to constitute minimum requirements for construction and equipment, including remodeling, renovation, or alteration of existing buildings, and shall apply to all projects for which Federal assistance is requested under section 406(b) or section 404(b)(9) of the Act. In accordance with 5 U.S.C. 552(a)(1), the publications to which reference is made in this section, unless otherwise indicated, are hereby incorporated by reference and made a part hereof. These documents are available for inspection at the Department and Regional Offices' Information Centers listed in 45 CFR 5.31 and copies of such documents may be purchased as specified. The Director may for good cause shown approve plans and specifications which contain deviations from the requirements prescribed, if the Director is satisfied that the purposes of such requirements have been fulfilled. In addition to these requirements, it is recognized that each project will have to meet the requirements of State and/or local codes and ordinances relating to construction.

(a) General. The structural design, construction, and fire safety provisions of all project facilities shall comply with the standards of the Uniform Building Code (available from International Conference of Building Officials, 5360 South Workman Road, Whittier, CA 90601) or with applicable State or local codes and ordinances, whichever is more restrictive.

(b) Mechanical. All installations of fuel burning equipment, steam, heating, air conditioning and ventilation, plumbing and other piping systems, incinerators, and boilers shall comply with the following standards:

(1) Handbook of Fundamentals: American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE), United Engineer Center, 345 East 47th Street, New York, NY 10017.

(2) National Standard Plumbing Code: National Association of Plumbing-Heating-Cooling Contractors, 1016 20th Street NW., Washington, DC 20036.

or

[45 FR 12243, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980)

852b.10 Additional conditions.

The Director may with respect to any grant award impose additional conditions consistent with these regulations prior to or at the time of any award when in the Director's judgment such conditions are necessary to assure or protect advancement of the approved project, the interests of the National Cancer Program, or the conservation of grant funds.

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