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prior approval any changes that substantially alter the scope of the function, utilities, or safety of the facility.

(2) Competitive bids. (i) Obtain the approval of the Secretary before the project is advertised or placed on the market for bidding; such approval must include a determination by the Secretary that the final plans and specifications conform to the standards set forth in 3510.503(a)(7)(iii) of these regulations.

(ii) Except as otherwise provided by State or local law, contract for construction (including the purchase and installation of built-in equipment) on a lump sum fixed-price basis, and award contracts on the basis of competitive bidding obtained by public advertising with award of the contracts to the lowest responsive and responsible bidders. The provision for exceptions based on State and local law shall not be invoked to give local contractors or suppliers a percentage preference over non-local contractors bidding for the same contract. Such practices are precluded by this paragraph.

(3) Construction contracts. (i) Include the following conditions and provisions in all construction contracts for the modernization project:

(A) The provisions set forth in "DHHS Requirements for Federally Assisted Construction Contracts Regarding Labor Standards and Equal Employment Opportunities," Form DHHS 514 (rev. 7/76) (issued by the Office of Grants Administration Policy, U.S. Department of Health and Human Services) pertaining to the Davis-Bacon Act, the Contract Work Hours Standards Act, and the Copeland Act (AntiKickback) Regulations, except in the case of contracts in the amount of $2,000 or less; and pertaining to Executive Order 11246, 30 FR 12319 (September 24, 1965), as amended, relating to nondiscrimination in construction contract employment, except in the case of contracts in the amount of $10,000 or less;

(B) That the contractor shall furnish performance and payment bonds each of which shall be in the full amount of the contract price, and shall maintain, during the life of the contract, adequate fire, workmen's compensation, public liability, and property damage

insurance: Provided, however, That in the case of a State or local unit of government which enters into a construction contract of less than $100,000, State or local provisions with respect to performance and payment bonds shall be deemed to meet the requirements of this paragraph; and

(C) That the Secretary shall have access at all reasonable times to work wherever it is in preparation progress, and the contractor shall provide proper facilities for such access and inspection.

(ii) Executive Order 11246. Comply with the applicable requirements of Executive Order 11246, 30 FR 12319 (September 24, 1965) as amended, relating to nondiscrimination in construction contract employment, and the applicable rules, regulations, and procedures prescribed pursuant thereto.

(4) Modernization supervision. Provide and maintain competent and adequate architectural or engineering supervision and inspection at the modernization site to insure that the completed work conforms with the plans and specifications.

(5) Completion responsibility. Complete the modernization in accordance with the grant application and the approved plans and specifications.

(6) Progress reports. Furnish progress reports and such other information concerning the modernization as the Secretary may require.

(d) The Secretary may at any time approve exceptions to the provisions of this section where he finds that such exceptions are not inconsistent with section 330 of the Act, other requirements of law, or the purposes of the program. (41 FR 57000, Dec. 30, 1976, as amended at 43 FR 5352, Feb. 7, 1978)

$51c.505 Determination of cost.

The cost of acquisition and/or modernization of existing buildings for which funds may be granted under this part will be determined by the Secretary, utilizing such documentation submitted by the applicant as the Secretary may prescribe (including the reports of such real estate appraisers as the Secretary may approve) and other relevant factors, taking into consideration only that portion of the existing building necessary for the operation of the approved project. [41 FR 5700, Dec. 30, 1976)

$51c.506 Use of grant funds.

Grant funds may be used to amortize the principal of or pay interest on a loan or mortgage on an existing building acquired under this part, including a building purchased by a grantee prior to the promulgation of this part, but only if the building is being used for the purposes of section 330 and complies with the applicable provisions of this subpart and only to the extent the Secretary finds such principal amounts and interest rates to be reasonable.

the PHS or its components, except for grants for health services research, demonstration, and evaluation projects administered by the Agency for Health Care Policy and Research. These regulations do not apply to research grants that are not for the support of an identified research project (sometimes referred to as general research support grants), grants for the construction or operation of research facilities, grants for prevention or educational programs, demonstration grants, traineeships, training grants, or to the support of research training under the National Research Service Awards program.

(b) Specific programs covered. From time to time the Secretary will publish a list of the research project grant programs covered by this part. The list is for informational purposes only and is not intended to restrict the statement of applicability in paragraph (a) of this section. In addition, information on particular research project grant programs, including applications and instructions, may be obtained from the component of the PHS that administers the program. [61 FR 55105, Oct. 24, 1996.)

(41 FR 5700, Dec. 30, 1976)

$51c.507 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, or 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.

(41 FR 5700, Dec. 30, 1976)

PARTS 510-51g (RESERVED]

PART 52-GRANTS FOR RESEARCH

PROJECTS

Sec. 52.1 To which programs do these regula

tions apply? 52.2 Definitions. 52.3 Who is eligible to apply for a grant? 52.4 How to apply for a grant. 52.5 Evaluation and disposition of applica

tions. 52.6 Grant awards. 52.7 Use of funds; changes. 52.8 Other HHS policies and regulations

that apply. 52.9 Additional conditions.

AUTHORITY: 42 U.S.C. 216.

852.2 Definitions.

As used in this part:

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

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. The term shall also mean the recipient of a cooperative agreement awarded under this part.

HHS means the Department of Health and Human Services.

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.

Project means the particular activity for which funding is sought under this part as described in the application for grant award.

Public Health Service and PHS means the operating division of the Department that consists of the Agency for

$ 52.1 To which programs do these reg.

ulations apply? (a) General. The regulations of this party apply to all health-related research project grants administered by

Health Care Policy and Research, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Health Resources and Services Administration, the Indian Health Service, the National Institutes of Health, the Office of the Assistant Secretary for Health, the Substance Abuse and Mental Health Administration, and the Agency for Toxic Substances and Disease Registry.

Research means a systematic investigation, study or experiment designed to contribute to general knowledge relating broadly to public health by establishing, discovering, developing, elucidating or confirming information about, or the underlying mechanisms relating to, the biological functions, diseases, or related matters to be studied.

Secretary means the Secretary of HHS and any other officer or employee of the HHS to whom the authority involved may be delegated. (61 FR 55105, Oct. 24, 1996)

vestigation and involving multiple disciplines, facilities and resources.

(c) Preferences. In the award of grants for international research relating to the development and evaluation of vaccines and treatments for AIDS under section 2315 of the Act, preference shall be given to:

(1) Activities conducted by, or in cooperation with, the World Health Organization, and

(2) With respect to activities in the Western Hemisphere, activities conducted by, or in cooperation with, the Pan American Health Organization or the World Health Organization.

[61 FR 55105, Oct. 24, 1996)

$52.4 How to apply for a grant.

Each institution interested in applying for a grant under this part must submit an application at such time and in such form and manner as the Secretary may prescribe. [61 FR 55105, Oct. 24, 1996)

$52.3 Who is eligible to apply for a

grant? (a) Persons eligible. Any individual, corporation, public or private institution or agency, or other legal entity shall be eligible for a grant award, except:

(1) An individual or entity which is otherwise ineligible for an award under applicable law or regulation;

(2) Federal agencies or institutions, unless specifically authorized by law to receive the grant; or

(3) Individuals, corporations, institutions, agencies, and other entities during the period they are debarred or suspended from eligibility for Federal financial assistance (see 45 CFR part 76).

(b) Permissible activities within research projects. Any project found by the Secretary to be a research project within the meaning of this part shall be eligible for a grant award. Eligible projects may consist of laboratory, clinical, population, field, statistical, basic, applied or other types of investigations, studies or experiments, or combinations thereof, and may either be limited to one, or a particular aspect of a problem or subject, or may consist of two or more related problems or subjects for concurrent or consecutive in

$52.5 Evaluation and disposition of

applications. (a) Evaluation. All applications filed in accordance with $52.4 shall be evaluated by the Secretary through such officers and employees and such experts or consultants engaged for this purpose as the Secretary determines are specially qualified in the areas of research involved in the project, including review by an appropriate National Advisory Council or other body as may be required by law. The Secretary's evaluation shall take into account among other pertinent factors the scientific merit and significance of the project, the competency of the proposed staff in relation to the type of research involved, the feasibility of the project, the likelihood of its producing meaningful results, the proposed project period, and the adequacy of the applicant's

available for the project and the amount of grant funds necessary for completion, and in the case of applications for support of research in emergency medical services, special consideration shall be given to applications for grants for research relating to the delivery of emergency medical services in rural areas.

resources

(b) Disposition. On the basis of the Secretary's evaluation of an application 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) Within the limits of funds available for that purpose, the Secretary will award a grant to those applicants whose approved projects will in the Secretary's judgment best promote the purposes of the statute authorizing the grant and the regulations of this part. 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) Evaluation of unapproved drug treatments for AIDS. Grants under section 2314 of the Act to support research relating to the evaluation of drug treatments for AIDS not approved by the Commissioner of Food and Drugs, shall be subject to appropriate scientific and ethical guidelines established by the Secretary for each project, pursuant to section 2314(c) of

the Act. In order to receive a grant, the applicant must agree to comply with those guidelines.

(c) 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 an application at the time and in the form and manner as the Secretary may prescribe to have support continued for each subsequent year.

(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.

(d) Multiple or concurrent awards. Whenever a research 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 separate handling of separate aspects of the project, the Secretary may evaluate, approve and make awards pursuant to two or more concurrent applications, each dealing with one or more specified aspects of the project.

(e) 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.

(f) 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; 61 FR 55105, Oct. 24, 1996)

852.7 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 Secretary, with without additional grant support, for such an additional period as the Secretary determines may be required to complete, or fulfill the purposes of, the approved project. (45 FR 12240, Feb. 25, 1980)

45 CFR part 74-Administration of grants 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 activi

ties receiving 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 changes, and interested persons should contact the Office of Research on Women's Health, NIH. Room 201, Building 1, MSC 0161, BETHESDA, MD 20892-0161 (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 changes, and interested persons should contact the Office of Recombinant DNA Activities, NIH, Suite 323, 6000 Executive Boulevard, MSC 7010, Bethesda, MD 20892–7010 (301-496-9838; not a toll-free number) to obtain references to the current version and any amendments.) "PHS Grants Policy Statement," DHHS

Publication No. (OASH) 94-50,000 (Rev.) April 1, 1994.

NOTE: This policy is subject to changes, and interested persons should contact the Grants Policy Branch, OASH, Room 17A45, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857 (301-443–1874; 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).

or

$ 52.8 Other HHS regulations and poli

cies that apply. Several other HHS policies and regulations apply to grants under this part. These include, but are not necessarily limited to: 37 CFR part 401--Rights to inventions made

by nonprofit organizations and small business firms under government grants, con

tracts, and cooperative agreements 42 CFR part 50, subpart A-Responsibility 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 procedure 42 CFR part 50, subpart F-Responsibility of

applicants for promoting objectively in re

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

mental Grant Appeals Board 45 CFR part 46--Protection of human sub

jects

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