96-26973. National Institute of Environmental Health Sciences Hazardous Substances Basic Research and Training Grants  

  • [Federal Register Volume 61, Number 207 (Thursday, October 24, 1996)]
    [Rules and Regulations]
    [Pages 55113-55116]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-26973]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    42 CFR Part 65a
    
    RIN 0925-AA03
    
    
    National Institute of Environmental Health Sciences Hazardous 
    Substances Basic Research and Training Grants
    
    AGENCY: National Institutes of Health, Public Health Service, 
    Department of Health and Human Services.
    
    ACTION: Final rule.
    
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    SUMMARY: The National Institutes of Health (NIH) is issuing new 
    regulations to govern grants for research and training awarded by the 
    National Institute of Environmental Health Sciences (NIEHS) for the 
    purpose of understanding, assessing, and attenuating the adverse 
    effects on human health of exposure to hazardous substances. The grants 
    are authorized by section 311(a) of the Comprehensive Environmental 
    Response, Compensation, and Liability Act of 1980 (CERCLA), as added by 
    section 209 of the Superfund Amendments and Reauthorization Act of 
    1986.
    
    EFFECTIVE DATE: This final rule is effective on November 25, 1996.
    
    FOR FURTHER INFORMATION CONTACT: Mr. Jerry Moore, NIH Regulatory 
    Affairs Officer, National Institutes of Health, Building 31, Room 1B25, 
    31 CENTER DRIVE MSC 2075, BETHESDA, MD 20892-2075, telephone (301-496-
    4606; not a toll-free number). For further information about the grant 
    program contact: Dr. William A. Zuk, Chemical Exposures and Molecular 
    Biology Branch, NIEHS, Division of Extramural Research and Training, 
    104 T. W. Alexander Drive, P.O. Box 12233, Research Triangle Park, NC 
    27709, telephone (919-541-1403; not a toll-free number).
    
    SUPPLEMENTARY INFORMATION: Section 311(a) of CERCLA, enacted on October 
    17, 1986, authorizes the Secretary of Health and Human Services 
    (Secretary), acting through the Director of the National Institute of 
    Environmental Health Sciences (NIEHS) and, in consultation with the 
    Administrator of the Environmental Protection Agency, to administer a 
    program of grants for basic research and training directed towards 
    understanding, assessing, and attenuating the adverse effects on human 
    health resulting from exposure to hazardous substances. Grants made 
    under this program are for coordinated, multi-component, 
    interdisciplinary projects linking biomedical research with related 
    engineering, hydrologic, and ecologic research, and concomitant 
    training. NIH published a full description of the program in the 
    Federal Register of November 21, 1986 (51 FR 43089), and invited the 
    public to attend an open meeting on the program which was held on 
    December 19, 1986. Subsequently, NIH announced its intention to issue 
    regulations to implement this program in the ``Unified Agenda of 
    Federal Regulations'' published in the Federal Register of October 21, 
    1991 (56 FR 53327), and published proposed regulations in a notice of 
    proposed rulemaking (NPRM) in the Federal Register of March 7, 1995 (60 
    FR 12525). The public was given 60 days in which to comment on the 
    proposed regulations. The NIH received one comment which supported the 
    regulations. Except for minor editorial and clarifying changes, the 
    final regulations are the same as those published in the NPRM.
        The following statements are provided as information for the 
    public.
        The Department of Health and Human Services (HHS) strongly 
    encourages all grant recipients to provide a smoke-free workplace and 
    to promote the nonuse of all tobacco products, and Public Law 103-227, 
    the Pro-Children Act of 1994, prohibits smoking in certain facilities
    
    [[Page 55114]]
    
    that receive Federal funds in which education, library, day care, 
    health care, and early childhood development services are provided to 
    children.
    
    Executive Order 12866
    
        Executive Order 12866 requires that all regulatory actions reflect 
    consideration of the costs and benefits they generate and that they 
    meet certain standards, such as avoiding the imposition of unnecessary 
    burdens on the affected public. If a regulatory action is deemed to 
    fall within the scope of the term ``significant regulatory action,'' as 
    defined in section 3(f) of the Order, prepublication review by the 
    Office of Management and Budget's Office of Information and Regulatory 
    Affairs (OIRA) is necessary. This rule was reviewed under Executive 
    Order 12866 by OIRA and was determined to be not significant.
    
    Regulatory Flexibility Act
    
        The Regulatory Flexibility Act of 1980 (5 U.S.C. chapter 6) 
    requires that regulatory actions be analyzed to determine whether they 
    create a significant impact on a substantial number of small entities. 
    This rule merely codifies internal policies and procedures of the 
    Federal Government currently used by the NIH to administer the NIEHS 
    Hazardous Substances Basic Research and Training Grants program. The 
    grants do not have a significant economic or policy impact on a broad 
    cross-section of the public. Furthermore, this rule would only affect 
    those qualified public and private nonprofit institutions of higher 
    education; generators of hazardous waste; persons involved in the 
    detection, assessment, evaluation, and treatment of hazardous 
    substances; owners and operators of facilities at which hazardous 
    substances are located; and state and local governments interested in 
    participating in the program. No individual or institution is obligated 
    to participate in the grant program.
        For these same reasons, this rule will not have a significant 
    economic impact on a substantial number of small entities and that a 
    regulatory flexibility analysis is not required under the Regulatory 
    Flexibility Act of 1980.
    
    Paperwork Reduction Act
    
        The rule does not contain information collection requirements 
    subject to review and approval by the Office of Management and Budget 
    (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35).
    
    Catalog of Federal Domestic Assistance
    
        The Catalog of Federal Domestic Assistance (CFDA) numbered program 
    affected by this rule is: 93.143.
    
    List of Subjects in 42 CFR Part 65a
    
        Grant programs--health; Health; Medical research; Hazardous 
    substances.
    
        Dated: August 8, 1996.
    Harold Varmus,
    Director, NIH.
    
        For the reasons set forth in the preamble, title 42 of the Code of 
    Federal Regulations is amended by adding a new part 65a, as follows.
    
    PART 65a--NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES 
    HAZARDOUS SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS
    
    Sec.
    65a.1 To what programs do these regulations apply?
    65a.2 Definitions.
    65a.3 Who is eligible to apply for a grant?
    65a.4 What are the program requirements?
    65a.5 How to apply.
    65a.6 How will applications be evaluated?
    65a.7 Awards.
    65a.8 How long does grant support last?
    65a.9 What are the terms and conditions of award?
    65a.10 For what purposes may grant funds be spent?
    65a.11 Other HHS regulations and policies that apply.
    
        Authority: 42 U.S.C. 216, 9660(a).
    
    
    Sec. 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).
    
    
    Sec. 65a.2  Definitions.
    
        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
    
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    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.''
    
        [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 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.
    
    
    Sec. 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.
    
    
    Sec. 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. 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.
    
    
    Sec. 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.
    
    
    Sec. 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.
    
    
    Sec. 65a.7  Awards.
    
        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.
    
    
    Sec. 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.
    
    [[Page 55116]]
    
        (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.
    
    
    Sec. 65a.9  What are the terms and conditions of awards?
    
        In addition to being subject to other applicable regulations (see 
    Sec. 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 74.25, 
    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.
    
    
    Sec. 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 45 CFR 74.27.
    
    
    Sec. 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:
    
    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 74--Uniform administrative requirements for awards and 
    subawards to institutions of higher education, hospitals, other 
    nonprofit organizations, and commercial organizations; and certain 
    grants and agreements with states, local governments and Indian tribal 
    governments
    45 CFR part 75--Informal grant appeals procedures
    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 92--Uniform administrative requirements for grants and 
    cooperative agreements to state and local governments
    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 (asknih@odrockm1.od.nih.gov) and by 
    browsing the NIH Home Page site on the World Wide Web (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.]
    
    [FR Doc. 96-26973 Filed 10-23-96; 8:45 am]
    BILLING CODE 4140-01-M
    
    
    

Document Information

Effective Date:
11/25/1996
Published:
10/24/1996
Department:
Health and Human Services Department
Entry Type:
Rule
Action:
Final rule.
Document Number:
96-26973
Dates:
This final rule is effective on November 25, 1996.
Pages:
55113-55116 (4 pages)
RINs:
0925-AA03: Hazardous Substances Basic Research and Training Grants
RIN Links:
https://www.federalregister.gov/regulations/0925-AA03/hazardous-substances-basic-research-and-training-grants
PDF File:
96-26973.pdf
CFR: (12)
42 CFR 65a.11)
42 CFR 65a.1
42 CFR 65a.2
42 CFR 65a.3
42 CFR 65a.4
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