[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

[[Page 55115]]

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 ([email protected]) 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