$52.4 How to apply for a grant.

A grant application must include the following information:

(a) Nature requested project period, purpose and plan of the project;

(b) Name and qualifications of the principal investigator and any other key personnel;

(c) Qualifications of the principal staff members to be responsible for the project;

(d) The total facilities and resources that will be available;

(e) Justification of the amount of grant funds requested; and

(f) Other pertinent information the Secretary may require to evaluate the proposed project.

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

$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 resources 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.

(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) General. Within the limits of funds available for such purpose, the 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]

$52.7 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 ques- ¤ tion 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 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. [45 FR 12240, Feb. 25, 1980]

$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

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

52a.2 Definitions.

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?

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

AUTHORITY: 42 U.S.C. 216, 285a-3, 285b-4, 285c-5, 285d-6, 2856-2, 285e-3, 285m-3, and 300cc-16.

SOURCE: 57 FR 61006, Dec. 23, 1992, unless otherwise noted.

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

(a) This part applies to grants by the National Institutes of Health and its organizational components to support the planning, establishment, expansion and operation of research and demonstration, multipurpose, and other centers. Specifically, this part applies to National Cancer Research and Demonstration Centers (including payments for construction), as authorized by section 414 of the Act; National Research and Demonstration Centers for Heart, Blood Vessel, Lung, and Blood Diseases, Sickle Cell Anemia, and Blood Resources (including payments for construction), as authorized by section 422 of the Act; Research and Training Centers (including diabetes

mellitus, and digestive, endocrine, metabolic, kidney and urologic diseases), as authorized by section 431 of the Act; Multipurpose Arthritis and Musculoskeletal Disease Centers (including payments for alteration, but not construction), as authorized by section 441 of the Act; Alzheimer's Disease Centers, as authorized by section 445 of the Act; Claude D. Pepper Older Americans Independence Centers, as authorized by section 445A of the Act; Multipurpose Deafness and Other Communication Disorders Centers, as authorized by section 464C of the Act; and Centers for Acquired Immunodeficiency Syndrome Research, as authorized by section 2316 of the Act.

This part does not apply to:

(1) Grants for construction (see 42 CFR part 52b), except as noted above;

(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) This part also applies 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."

§ 52a.2 Definitions.

As used in this part:

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

(1) For purposes of grants authorized in section 414 of the Act, an agency or institution which provides for planning and conducting basic and clinical research into, training in, and demonstration of advanced diagnostic, control, prevention and treatment methods for cancer;

(2) For purposes of grants authorized in section 422 of the Act, an agency or institution which provides for planning and basic and clinical research into, training in, and demonstration of, management of blood resources and advanced diagnostic, prevention, and treatment methods (including emergency medical services) for heart, blood vessel, lung, or blood diseases, including sickle cell anemia;

(3) For purposes of grants authorized in section 431 of the Act, a single institution or a consortium of cooperating institutions, which conducts research, training, information programs, epidemiological studies, data collection activities, and development of model programs in diabetes mellitus and related endocrine and metabolic diseases;

(4) For purposes of grants authorized in section 441 of the Act, a facility which conducts basic and clinical research as well as research into arthritis and musculoskeletal diseases, orthopedic procedures, training, and information programs for the health community and the general public;

(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.

NIH means the National Institutes of Health and its organizational components that award grants.

Nonprofit as applied to any agency or institution means an agency or institution which is a corporation or an association, no part of the net earnings of which inures or may lawfully inure to the benefit of any private shareholder or individual.

§ 52a.3 Who is eligible to apply?

(a) Any public or private non-profit agency, institution, or consortium of agencies or institutions is eligible to apply for a grant under sections 414, 422, 441, 445, and 445A and 2316 of the Act.

(b) Any public or private non-profit or for-profit agency, institution or consortium of agencies or institutions is eligible to apply for a grant under sections 431 and 464C of the Act.

(c) Any applicant under this part must be located in a State, the District of Columbia, Puerto Rico, the Virgin Islands, the Canal Zone, Guam, American Samoa, or the successor States of the Trust Territory of the Pacific Islands (the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau).

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

Each application 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 grants program;

proposed

organizational

(d) The 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 would 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; and

(1) 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 (the disposition of grantrelated income is governed by 45 CFR 74.40 through 74.47 and 45 CFR 92.25);

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

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

[Approved under OMB Control Number 09250001]

52a.5 How will NIH evaluate applications?

(a) NIH considers the following in evaluating Center grant 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 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.

(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 addi