(a) The regulations of this part apply to the award of grants to support programs for basic research and training directed towards understanding, assessing, and attenuating the adverse effects on human health resulting from exposure to hazardous substances, as authorized under section 311(a) of the Act (42 U.S.C. 9660(a)). The purpose of these programs is to carry out coordinated, multi-component, interdisciplinary research consisting of at least three or more biomedical research projects relating to hazardous substances and at least one non-biomedical research project in the fields of ecology, hydrogeology, and/or engineering, and including the training of investigators as part of the grantee's overall program.

(b) The regulations of this part also apply to cooperative agreements awarded to support the programs described in paragraph (a) of this section. References to “grant(s)” shall include “cooperative agreement(s).”

(c) The regulations of this part do not apply to:

(1) Research training support under the National Research Service Awards Program (see part 66 of this chapter),

(2) Research, demonstration, and training support under the NIH Center Grants programs (see part 52a of this chapter),

(3) Research training support under traineeship programs (see parts 63 and 64a of this chapter), or

(4) Research training support under the NIH AIDS Research Loan Repayment Program authorized under section 487A of the Public Health Service Act, as amended (42 U.S.C. 288-1).

As used in this part:

Act means the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended (42 U.S.C. 9601 et seq.).

Award or grant means a grant or cooperative agreement awarded under section 311(a) of the Act (42 U.S.C. 9660(a)).

Director means the Director of the National Institute of Environmental Health Sciences, or the Director's delegate.

HHS means the Department of Health and Human Services.

Institution of higher education means an educational institution in any state which (1) admits as regular students only persons having a certificate of graduation from a school providing secondary education, or the recognized equivalent of such a certificate, (2) is legally authorized within the state to provide a program of education beyond secondary education, (3) provides an educational program for which it awards a bachelor's degree or provides not less than a two-year program which is acceptable for full credit toward a bachelor's degree, (4) is a public or other nonprofit institution, and (5) is accredited by a nationally recognized accrediting agency or association or, if not so accredited, (i) is an institution with respect to which the Secretary of Education has determined that there is satisfactory assurance, considering the resources available to the institution, the period of time, if any, during which it has operated, the effort it is making to meet accreditation standards, and the purpose for which this determination is being made, that the institution will meet the accreditation standards of a nationally recognized accrediting agency or association within a reasonable time, or (ii) is an institution whose credits are accepted, on transfer, by not less than three institutions which are so accredited, for credit on the same basis as if transferred from an institution so accredited. The term also includes any school which provides not less than a one-year program of training to prepare students for gainful employment in a recognized occupation and which meets the provisions of paragraphs (1), (2), (4), and (5) of this definition. The term also includes a public or nonprofit private educational institution in any state which, in lieu of the requirement in paragraph (1), admits as regular students persons who are beyond the age of compulsory school attendance in the state in which the institution is located and who meet the requirements of section 1091(d) of title 20 U.S. Code, as amended. For purposes of this definition, the Secretary of Education publishes a list of nationally recognized accrediting agencies or associations which that official determines to be reliable authority as to the quality of training offered. This list is found in the brochure, “Nationally Recognized Accrediting Agencies and Associations Criteria and Procedures for Listing by the U.S. Secretary of Education and Current List.”

NIEHS means the National Institute of Environmental Health Sciences, an organizational component of the National Institutes of Health, as authorized under sections 401(b) and 463 of the Public Health Service Act, as amended (42 U.S.C. 281(b) and 185l).

NIH means the National Institutes of Health.

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

PHS means the Public Health Service.

Program means the activity to carry out research and training supported by a grant under this part.

Program director means the single individual designated by the grantee in the grant application and approved by the Director, who is responsible for the scientific and technical direction of the research component and the conduct of the training component under a program.

Project period means the period of time, from one to five years, specified in the notice of grant award that NIEHS intends to support a proposed program without requiring the program awardee to recompete for funds.

Secretary means, unless the context otherwise requires, the Secretary of Health and Human Services or other official of HHS to whom the authority involved is delegated.

(a) Except as otherwise prohibited by law, any public or private nonprofit institution of higher education may apply for an award under this part.

(b) Awardee institutions may carry out portions of the research or training components of an award through contracts with appropriate organizations, including:

(1) Generators of hazardous wastes;

(2) Persons involved in the detection, assessment, evaluation, and treatment of hazardous substances;

(3) Owners and operators of facilities at which hazardous substances are located; and

(4) State and local governments.

The applicant shall include the following in its proposed program for which support is requested under this part:

(a) Basic research component. The program shall include three or more meritorious biomedical research projects, including epidemiologic studies relating to the study of the adverse effects of hazardous substances on human health, and at least one meritorious project involving hydrogeologic or ecologic research which shall cumulatively address:

(1) Methods and technologies to detect hazardous substances in the environment;

(2) Advanced techniques for the detection, assessment, and evaluation of the effects of these substances on human health;

(3) Methods to assess the risks to human health presented by these substances; and

(4) Basic biological, chemical, and/or physical methods to reduce the amount and toxicity of these substances.

(b) Training component. The program shall include the following kinds of training, as part of or in conjunction with the basic research component:

(1) Graduate training in environmental and occupational health and safety and in public health and engineering aspects of hazardous waste control; and/or

(2) Graduate training in the geosciences, including hydrogeology, geological engineering, geophysics, geochemistry, and related fields, necessary to meet professional personnel needs in the public and private sectors and to carry out the purposes of the Act; and

(3) Worker training relating to handling hazardous substances, which includes short courses and continuing education for state and local health and environmental agency personnel and other personnel engaged in the handling of hazardous substances, in the management of facilities at which hazardous substances are located, and in the evaluation of the hazards to human health presented by these facilities.

Each institution desiring a grant under this part must submit an application at the time and in the form and manner as the Secretary may require.

The Director shall evaluate applications through the officers and employees, experts, consultants, or groups engaged by the Director for that purpose, including review by the National Advisory Environmental Health Sciences Council in accordance with peer review requirements set forth in part 52h of this chapter. The Director's first level of evaluation will be for technical merit and shall take into account, among other pertinent factors, the significance of the program, the qualifications and competency of the program director and proposed staff, the adequacy of the applicant's resources available for the program, and the amount of grant funds necessary for completion of its objectives. A second level of review will be conducted by the National Advisory Environmental Health Sciences Council.

Criteria. Within the limits of available funds, the Director may award grants to carry out those programs which:

(a) Are determined by the Director to be meritorious; and

(b) In the judgment of the Director, best promote the purposes of the grant program, as authorized under section 311(a) of the Act and the regulations of this part, and best address program priorities.

(a) The notice of grant award specifies how long NIEHS intends to support the project without requiring the grantee to recompete for funds. This period, called the project period, may 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 at the time and in the form and manner as the Secretary may require to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of these 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 Director 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.

(d) Any balance of federally obligated grant funds remaining unobligated by the grantee at the end of a budget period may be carried forward to the next budget period, for use as prescribed by the Director, provided a continuation award is made. If at any time during a budget period it becomes apparent to the Director that the amount of Federal funds awarded and available to the grantee for that period, including any unobligated balance carried forward from prior periods, exceeds the grantee's needs for that period, the Director may adjust the amounts awarded by withdrawing the excess.

In addition to being subject to other applicable regulations (see § 65a.11), grants awarded under this part are subject to the following terms and conditions:

(a) Material changes. Except as otherwise provided by 45 CFR 75.308, the grantee may not materially change the quality, nature, scope, or duration of the program unless the written approval of the Director is obtained prior to the change.

(b) Additional conditions. The Director may impose additional conditions prior to the award of any grant under this part if it is determined by the Director that the conditions are necessary to carry out the purpose of the grant or assure or protect advancement of the approved program, the interests of the public health, or the conservation of grant funds.

A grantee shall spend funds it receives under this part solely 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.

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