Secretary shall award a grant to those applicants whose approved projects will in the Secretary's judgment best promote the purposes of § 52.1. 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) 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 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 HHS that continued funding is in the best interest of the government.

(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.

(c) Multiple, concurrent, initial awards. Whenever a reseach 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 and approve two or more concurrent applications each dealing with one or more specified aspects of the project, and the Secretary may make two or more concurrent grant awards with respect to such a project.

(d) 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.

(e) 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]

(c) Changes in project period. The project period determined pursuant to § 52.5(b) may be extended by the Secretary, with or 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. § 52.8 Other HHS regulations that apply.

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

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

45 CFR Parts 6 and 8-Inventions and patents

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 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 48 FR 24556-Guidelines for Research involving Recombinant DNA Molecules, published by the National Institutes of Health

[49 FR 38110, Sept. 27, 1984]

§ 52.9 Other conditions.

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

[45 FR 12240, Feb. 25, 1980; 45 FR 20096, Mar. 27, 1980]

52a.3 Who is eligible to apply?

52a.4 What information must each application contain?

52a.5 How will NIH evaluate applications? 52a.6 Information about grant awards. 52a.7 For what purposes may a grantee spend grant funds?

52a.8 Other HHS regulations that apply. 52a.9 Additional conditions.

AUTHORITY: Sec. 215, 58 Stat. 690, as amended, 63 Stat. 835 (42 U.S.C. 216): Sec. 415(b), 86 Stat. 683, as amended, 88 Stat. 347, 90 Stat. 403, 91 Stat. 387, 92 Stat. 3421, 3432 (42 U.S.C. 287d(b)); Sec. 435, 88 Stat. 376, as amended, 90 Stat. 376, 90 Stat. 2650, 94 Stat. 3185, 3186 (42 U.S.C. 289c-2); Sec. 439, 88 Stat. 2222, as amended, 90 Stat. 414, 90 Stat. 2646, 92 Stat. 3436, 94 Stat. 3189 (42 U.S.C. 298c-6).

SOURCE: 50 FR 49693, Dec. 4, 1985, unless otherwise noted.

§ 52a.1 To which programs do these regulations apply?

(a) These regulations apply to grants by the National Institutes of Health and its bureaus, institutes, and divisions to supply the establishment, expansion, and operation of research and demonstration centers. Specifically, these regulations apply to National Research and Demonstration Centers for Heart, Blood Vessel, Lung and Blood Diseases and Blood Resources, as authorized by section 415(b) of the Act, Diabetes Research and Training Centers, as authorized by section 435 of the Act, and Multipurpose Arthritis Centers, as authorized by section 439 of the Act. The regulations do not apply to:

(1) Grants for construction;

(2) Grants covered by 42 CFR Part 52 (grants for research projects); or

(3) Grants for general research support under section 301(a)(3) of the Act (42 U.S.C. 241(a)(3)).

(b) These regulations also apply to cooperative agreements made to support the centers specified in paragraph (a) of this section. When a reference is made in this part to "grants," the reference shall include "cooperative agreements."

(a) For purposes of the grants authorized by subsection (b) of section 415 of the Act, a facility which provides, or a combination of facilities which together provide, a research, training, and demonstration program as prescribed by that subsection and, if the grant is to a center developed under subsection (a) of section 415, the additional programs prescribed by that subsection.

(b) For purposes of the grants authorized by section 435 of the Act, a facility which provides, or a combination of facilities which together provide, the research, training, and information programs prescribed by that section.

(c) For purposes of the grants authorized by section 439 of the Act, a facility which provides, or a combination of facilities which together provide, a program for basic and clinical research, training, information and continuing education for professionals, and the dissemination of information to the public, as prescribed by that section.

"NIH" means the National Institutes of Health and its bureaus, institutes, and divisions.

§ 52a.3 Who is eligible to apply?

(a) To be eligible for a grant under this part, an applicant must be:

(1) An agency, institution, or consortium of agencies or institutions; and

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

(b) An applicant for a grant to support a research and demonstration center for heart, blood vessel, lung, blood diseases and blood resources

must also be a public or nonprofit private agency, institution or consortium of such agencies or institutions.

§ 52a.4 What information must each application contain?

Each application for a grant under this part must include detailed information as to the following:

(a) The personnel, facilities, and other resources available to the applicant with which to initiate and maintain the proposed center program;

(b) Any research, training, demonstration, or information dissemination activities in which the applicant is currently engaged; the sources of funding for these activities; and the relevance of these activities to the proposed center program;

(c) Proposed research, training, demonstration, and information dissemination activities;

(d) The proposed

organizational

structure of the center and the relationship of the proposed center to the applicant organization(s);

(e) The names and qualifications of the center director and key staff members who will be responsible for conducting the proposed activities;

(f) Proposed methods for monitoring and evaluating individual activities and the overall center program;

(g) Proposed methods for coordinating the center's activities, where appropriate, with similar efforts by other public and private organizations; (h) The availability of any community resources necessary to carry out proposed activities;

(i) Efforts to be made to generate and collect income from sources other than NIH to be used to further the purposes of the center program (NIH encourages these efforts). Income may include but is not limited to that generated from the sale or rental of products or services produced by grant-supported activities, such as laboratory tests, computer time, and payments received from patients or third parties, where appropriate. (Disposition grant-related income is governed by 45 CFR 74.40-74.47);

or

(j) The proposed budget for the center and a justification for the amount of grant funds requested; and

(k) Any other information that the Director of the awarding institute may request.

(Approved by the Office of Management and Budget control number 0925-0259)

§ 52a.5 How will NIH evaluate applications?

(a) NIH considers the following in evaluating applications:

(1) The scientific and technical merit of the proposed program;

(2) The qualifications and experience of the center director and other key personnel;

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

(4) The extent to which the various components of the proposed program would be coordinated into one multidisciplinary effort within the center;

(5) The extent to which the center's activities would be coordinated with similar efforts by other organizations;

(6) The administrative and managerial capability of the applicant;

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

(8) Other factors which the awarding bureau, institute, 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.

§ 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 contin

ued 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.

§ 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 the regulations of this part.

§ 52a.8 Other HHS regulations that apply.

Several other regulations apply to grants under this part. 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 46-Protection of human subjects

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

45 CFR Part 76-Debarment and suspension from eligibility for financial assistance 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 49 FR 46266 or successor-NIH Guidelines for Research Involving Recombinant DNA Molecules

(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.

§ 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 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