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

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 the individual(s) judged by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program supported by the grant and who is or are 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 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.

(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 investigation 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.

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.

(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.

(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 45 CFR part 75, subpart E.

(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 one or more awards pursuant to one or more applications. When making more than one award in response to a single application, the Secretary shall consult with the applicant organization(s), as appropriate.

(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.

(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 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.

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

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.