National Institute of Environmental Health Sciences Hazardous Substances Basic Research and Training Grants

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