[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