[Federal Register Volume 60, Number 44 (Tuesday, March 7, 1995)]
[Proposed Rules]
[Pages 12525-12529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5433]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

42 CFR Part 65a

RIN 0905-AD46


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: Notice of proposed rulemaking.

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SUMMARY: The National Institutes of Health (NIH) proposes to issue new 
regulations to govern grants for research [[Page 12526]] and training 
awarded by the National Institute of Environmental Health Sciences 
(NIEHS) for the purpose of understanding, assessing, and attenuating 
the adverse effect 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.

DATES: Comments must be received on or before May 8, 1995. The final 
rule would become effective on April 6, 1995.

ADDRESSES: Comments should be sent to Mr. Jerry Moore, NIH Regulatory 
Affairs Officer, National Institutes of Health, Building 31, Room 3B11, 
9000 Rockville Pike, Bethesda, Maryland 20892.

FOR FURTHER INFORMATION CONTACT: Mr. Jerry Moore at the address above, 
or telephone (301) 496-4606 (not a toll-free number).

SUPPLEMENTARY INFORMATION: Section 311(a) of CERCLA, enacted on October 
17, 1986, authorizes the Secretary of the Department of Health and 
Human Services, 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 on 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 on October 21, 1991 (56 
FR 53327).
    Further, PHS 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 that receive Federal funds in which education, 
library, day care, health care, and early childhood development 
services are provided to children.
    The purpose of this notice is to invite public comment on the 
proposed regulations.
    The following statements are provided as information for the 
public.

Regulatory Impact Statement

    Executive Order 12866 of September 30, 1993, Regulatory Planning 
and Review, requires the Department to prepare an analysis for any rule 
that meets one of the E. O. 12866 criteria for a significant regulatory 
action; that is, that may--

    Have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal, governments or 
communities;
    Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    Materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or the rights and obligations of 
recipients thereof; or
    Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
E.O. 12866.

    In addition, the Department prepares a regulatory flexibility 
analysis, in accordance with the Regulatory Flexibility Act of 1980 (5 
U.S.C. chapter 6), if the rule is expected to have a significant impact 
on a substantial number of small entities.
    For the reasons outlined below, we do not believe this proposed 
rule is economically significant nor do we believe that it will have a 
significant impact on a substantial number of small entities. In 
addition, this proposed rule is not inconsistent with the actions of 
any other agency.
    This proposed rule merely codifies internal policies and procedures 
of the Federal government currently used by 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 proposed rule would only 
affect those qualified public and private non-profit 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, the Secretary certifies this proposed rule 
will not have a significant economic impact on a substantial number of 
small entities, and that a Regulatory Flexibility Analysis, as defined 
under the Regulatory Flexibility Act of 1980, is not required.

Paperwork Reduction Act

    The proposed 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 1980 (44 U.S.C. 
chapter 35).

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance (CFDA) numbered program 
affected by this proposed rule is: 93.143.

List of Subjects in 42 CFR Part 65a

    Grant programs--health, Health, Medical research, Hazardous 
substances.

    Dated: October 28, 1994.
Philip R. Lee,
Assistant Secretary for Health.
    Approved: February 28, 1995.
Donna E. Shalala,
Secretary.
    For reasons set forth in the preamble, we propose amending title 42 
of the Code of Federal Regulations 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 awards?
65a.10  For what purposes may grant funds be spent?
65a.11  Other HHS policies and regulations 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 [[Page 12527]] Act (42 U.S.C. 9660(a)). The 
purpose of these programs is to carry out coordinated, multicomponent, 
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) These regulations also apply to cooperative agreements awarded 
to support the programs specified 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 Services 
Awards Program (see part 66 of this chapter),
    (2) Research training support under the NIH Center Grant 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 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 such 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 such a 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 such an 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.
    (6) 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.
    (7) The term also includes a public or nonprofit private 
educational institution in any State which, in lieu of the requirement 
in paragraph (1) of this definition, 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.
    (8) For purposes of this definition, the Secretary of Education 
shall publish a list of nationally recognized accrediting agencies or 
associations which that official determines to be reliable authority as 
to the quality of training offered.
    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)(1)(L) and 285l).
    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 inures 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.


Sec. 65a.3  Who is eligible to apply for a grant?

    (a) Public and private nonprofit institutions of higher education 
may apply for awards 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 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 [[Page 12528]] 
    (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 environment 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 shall submit an 
application at such time and in such form and manner as the Secretary 
may prescribe.


Sec. 65a.6  How will applications be evaluated?

    The Director shall evaluate applications through the officers and 
employees, and experts and consultants 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 project 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 such time and in such 
form and manner as the Secretary may prescribe 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 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 of this part), grants awarded under this part are subject 
to the following terms and conditions:
    (a) Material changes. The grantee may not materially change the 
quality, nature, scope, or duration of the program unless the 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 expend 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 in 45 CFR 74.27.


Sec. 65a.11  Other HHS policies and regulations that apply.

    Several other HHS policies and regulations 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 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--Administration of grants
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 51 FR 16958 (May 7, 
1986)--NIH Guidelines for Research Involving Recombinant DNA Molecules 
[[Page 12529]] 
``Public Health Service Policy on Humane Care and Use of Laboratory 
Animals,'' Office for Protection from Research Risks, NIH (Revised 
September 1986) 59 FR 14508 (as republished March 28, 1994)--NIH 
Guidelines on the Inclusion of Women and Minorities as Subjects in 
Clinical Research

[FR Doc. 95-5433 Filed 3-6-95; 8:45 am]
BILLING CODE 4140-01-P