PART 65a—NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES HAZARDOUS SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS Authority: 42 U.S.C. 216, 9660(a). Source: 61 FR 55114, Oct. 24, 1996, unless otherwise noted. § 65a.1 To what programs do these regulations apply? (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). § 65a.2 Definitions. As used in this part: Act et seq. Award grant Director HHS Institution of higher education Note: This brochure is subject to change, and interested persons should contact the U.S. Department of Education Office of Post-Secondary Education, Accreditation and State Liaison Division, ROB 3, 7th and D Streets, S.W., Room 37-15, Washington, DC 20202-5244 (202-708-7417; not a toll-free number) to obtain a current version of the brochure and any amendments. NIEHS l NIH Nonprofit, PHS Program Program director Project period Secretary § 65a.3 Who is eligible to apply for a grant? (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. § 65a.4 What are the program requirements? The applicant shall include the following in its proposed program for which support is requested under this part: (a) Basic research component. (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. (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. § 65a.5 How to apply. 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. § 65a.6 How will applications be evaluated? 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. § 65a.7 Awards. Criteria. (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. § 65a.8 How long does grant support last? (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. § 65a.9 What are the terms and conditions of awards? 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. (b) Additional conditions. [61 FR 55114, Oct. 24, 1996, as amended at 81 FR 3010, Jan. 20, 2016; 89 FR 80068, Oct. 2, 2024] § 65a.10 For what purposes may grant funds be spent? 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 2 CFR parts 200 and 300, subpart E. [61 FR 55114, Oct. 24, 1996, as amended at 81 FR 3010, Jan. 20, 2016; 89 FR 80068, Oct. 2, 2024] § 65a.11 Other HHS regulations and policies that apply. Several other HHS regulations and policies apply to awards under this part. These include but are not necessarily limited to: 2 CFR parts 200 and 300—Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. 42 CFR part 50, subpart A—Responsibility of PHS awardee and applicant institutions for dealing with and reporting possible misconduct 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 objectivity in research for which PHS funding is sought 42 CFR part 52h—Scientific peer review of research grant applications and research and development contract projects 45 CFR part 16—Procedures of the Departmental Grant Appeals Board 45 CFR part 46—Protection of human subjects 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 activities receiving 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 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 change, 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 change, 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 (Revised April 1, 1994), as amended by Addendum, dated January 24, 1995. Note: This policy is subject to change, and interested persons should contact the Extramural Outreach and Information Resources Office (EOIRO), Office of Extramural Research, 6701 Rockledge Drive, Room 6208, MSC 7910, Bethesda, MD 20892-7910 (301-435-0714; not a toll-free number) to obtain references to the current version and any amendments. Information may also be obtained by contacting the EOIRO via its e-mail address ( [email protected] http://www.nih.gov “Public Health service Policy on Humane Care and Use of Laboratory animals,” Office for Protection from Research Risks, HIH (Revised September 1986). Note: This policy is subject to change, and interested persons should contact the Office for Protection for Research Risks, NIH, Suite 3B01, 6100 Executive Boulevard, MSC 7507, Rockville, MD 20852-7507 (301-496-7005; not a toll-free number) to obtain references to the current version and any amendments.] [61 FR 55114, Oct. 24, 1996, as amended at 81 FR 3010, Jan. 20, 2016; 89 FR 80068, Oct. 2, 2024]