67488 Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Notices

DEPARTMENT OF AGRICULTURE

Agricultural Research Service

Cooperative State Research,

Education, and Extension Service

Biotechnology Risk Assessment

Research Grants Program for Fiscal

Year 1998; Solicitation of Applications

AGENCY: Agricultural Research Service;

Cooperative State Research, Education,

and Extension Service, USDA.

ACTION: Notice of Biotechnology Risk

Assessment Research Grants Program;

Fiscal Year 1998 solicitation of

applications.

SUMMARY: Applications are invited for

competitive grant awards under the

Biotechnology Risk Assessment

Research Grants Program (the

‘‘Program’’) for fiscal year (FY) 1998.

The authority for the Program is

contained in section 1668 of the Food,

Agriculture, Conservation, and Trade

Act of 1990 (7 U.S.C. 5921). The

Program is administered by the

Cooperative State Research, Education,

and Extension Service (CSREES) and the

Agricultural Research Service (ARS) of

the U.S. Department of Agriculture.

DATES: Proposals are due March 24,

1998.

FOR FURTHER INFORMATION CONTACT: Dr.

Edward K. Kaleikau, USDA/CSREES,

(202) 401–1901, Dr. Daniel D. Jones,

USDA/CSREES, (202) 401–6854, or Dr.

Robert M. Faust, USDA/ARS, (301) 504–

6918.

SUPPLEMENTARY INFORMATION:

Table of Contents

Purpose

Applicant Eligibility

Available Funding

Program Description

Proposal Evaluation

Areas of Research to be Supported in Fiscal

Year 1998

Applicable Regulations

Programmatic Contact

How to Obtain Application Materials

Proposal Format

Compliance with the National Environmental

Policy Act (NEPA)

Proposal Submission and Due Date

Additional Information

Purpose

The purpose of the Program is to

assist Federal regulatory agencies in

making science-based decisions about

the safety of introducing into the

environment genetically modified

organisms, including plants,

microorganisms, fungi, bacteria, viruses,

arthropods, fish, birds, mammals and

other animals. The Program

accomplishes this purpose by providing

scientific information derived from the

risk assessment research that it funds.

Research proposals submitted to the

Program must be applicable to the

purpose of the Program to be

considered.

Applicant Eligibility

Proposals may be submitted by any

United States public or private research

or educational institution or

organization.

Available Funding

Subject to the availability of funds,

the anticipated amount available for

support of the Program in FY 1998 is

$1.5 million.

Section 712 of the Agriculture, Rural

Development, Food and Drug

Administration, and Related Agencies

Appropriations Act, 1998 (Pub. L. 105–

86), prohibits CSREES from using the

funds available for the Program for FY

1998 to pay indirect costs exceeding 14

per centum of the total Federal funds

provided under each award on

competitively awarded research grants.

Section 716 of the Agriculture, Rural

Development, Food and Drug

Administration, and Related Agencies

Appropriations Act, 1998, encourages

entities to use grant funds to purchase

only American-made equipment or

products in the case of any equipment

or product that may be authorized to be

purchased with the funds provided

under this program.

CSREES and ARS will competitively

award research grants to support

science-based biotechnology regulation

and thus help address concerns about

the effects of introducing genetically

modified organisms into the

environment and help regulators in

developing policies regarding such

introduction.

The Program’s research emphasis is

on risk assessment and not risk

management. The Program defines risk

assessment research as the sciencebased evaluation and interpretation of

factual information in which a given

hazard, if any, is identified, and the

consequences associated with the

hazard are explored. The Program

defines risk management as (1) research

aimed primarily at reducing risks of

biotechnology-derived agents and (2) a

policy and decision-making process that

uses risk assessment data in deciding

how to avoid or mitigate the

consequences identified in a risk

assessment. Proposals must be relevant

to risk assessment to be eligible for this

Program.

Proposals must include a statement

describing the relevance of the proposed

project to one or more of the topics

requested in this solicitation. In

addition, proposals must include

detailed descriptions of the

experimental design and appropriate

statistical analyses to be done. The

Program strongly encourages the

inclusion of statisticians and risk

analysis researchers as co-principal

investigators or contractors.

Awards will not be made for clinical

trials, commercial product

development, product marketing

strategies, or other research deemed not

appropriate to risk assessment.

Proposal Evaluation

Proposals will be evaluated by the

Administrator assisted by a peer panel

of scientists for scientific merit,

qualifications of project personnel,

adequacy of facilities, and relevance to

both risk assessment research and

regulation of agricultural biotechnology.

Areas of Research To Be Supported in

Fiscal Year 1998

Proposals addressing the following

topics are requested:

1. Research on the introduction into

the environment (not in a contained

facility) of genetically engineered

organisms. The data collected may

include: survival; reproductive fitness;

genetic stability; genetic recombination;

horizontal gene transfer; loss of genetic

diversity; or enhanced competitiveness.

The organisms may include: fungi;

bacteria; viruses; microorganisms;

plants; arthropods; fish; birds;

mammals; and other animals.

2. Research on large-scale deployment

of genetically engineered organisms;

especially commercial uses of such

organisms, with special reference to

considerations that may not be revealed

through small-scale evaluations and

tests. This may include monitoring

locations where transgenic virus

resistant plants (expressing viral

transgenes) are grown on a commercial

scale or in large-scale production for

viral strains which overcome the

resistance phenotype. The analysis of

resistance-breaking strains should

include analyzing whether the strain

arose via recombination between viral

transgenes and the viral genome. Such

projects should survey the production

sites for two to three years.

3. Research to develop statistical

methodology and quantitative measures

of risks associated with field testing of

genetically modified organisms.

4. The Program will, subject to

resource availability, provide partial

funding to organize a scientific research

conference that brings together

scientists and regulators to review the

science-based evidence, if any, that the
Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Notices 67489

introduction of a pest resistance gene

into a crop plant poses the risk of

increasing the fitness of weedy, sexually

compatible relatives of the crop plant.

Data considered should include the

introduction of pest resistance genes by

conventional breeding or by a process

involving recombinant DNA. The

conference should provide an

opportunity to address how experiments

could be designed to test whether a pest

resistance gene increases the fitness of

weeds in the field. The scientific

steering committee for the conference

should include a broad representation of

disciplines, including ecology,

population biology, plant pathology,

entomology, plant breeding, and others

as appropriate. Evaluation criteria of

submitted proposals will include:

choice of topics and selection of

speakers; general format of the

conference, especially with regard to its

appropriateness for fostering scientific

exchange; provisions for wide

participation from the scientific and

regulatory community and others as

appropriate; qualifications of the

organizing committee and

appropriateness of invited speakers to

the topic areas being covered; and

appropriateness of the budget requested

and qualifications of the project

personnel.

Applicable Regulations

This Program is subject to the

administrative provisions found in 7

CFR part 3415, which set forth

procedures to be followed when

submitting grant proposals, rules

governing the evaluation of proposals,

the awarding of grants, and post-award

administration of such grants. Several

other Federal statutes and regulations

apply to grant proposals considered for

review or to grants awarded under this

Program. These include but are not

limited to:

7 CFR Part 3019, as amended by 62

FR 45934—USDA implementation of

OMB Circular A–110, Uniform

Administrative Requirements for Grants

and Agreements with Institutions of

Higher Education, Hospitals and Other

Nonprofit Organizations.

Programmatic Contact

For additional information on the

Program, please contact:

Dr. Edward K. Kaleikau, Cooperative

State Research, Education, and

Extension Service, U.S. Department of

Agriculture, STOP 2241, 1400

Independence Avenue, S.W.,

Washington, D.C. 20250–2241,

Telephone: (202) 401–1901

or

Dr. Daniel D. Jones, Cooperative State

Research, Education, and Extension

Service, U.S. Department of

Agriculture, STOP 2220, 1400

Independence Avenue, S.W.,

Washington, D.C. 20250–2220,

Telephone: (202) 401–6854

or

Dr. Robert M. Faust, Agricultural

Research Service, U.S. Department of

Agriculture, Room 338, Building 005,

BARC-West, Beltsville, MD 20705,

Telephone: (301) 504–6918

How To Obtain Application Materials

Copies of this solicitation, the

administrative provisions for the

Program (7 CFR Part 3415), and the

Application Kit, which contains

required forms, certifications, and

instructions for preparing and

submitting applications for funding,

may be obtained by contacting: Proposal

Services Unit, Grants Management

Branch, Office of Extramural Programs,

Cooperative State Research, Education,

and Extension Service, U.S. Department

of Agriculture, STOP 2245, 1400

Independence Avenue, S.W.,

Washington, D.C. 20250–2245,

Telephone Number: (202) 401–5048.

Application materials may also be

requested via Internet by sending a

message with your name, mailing

address (not e-mail) and telephone

number to psb@reeusda.gov which

states that you wish to receive a copy of

the application materials for the FY

1998 Biotechnology Risk Assessment

Research Grants Program. The materials

will then be mailed to you (not emailed) as quickly as possible.

Proposal Format

The format guidelines for full research

proposals, found in the administrative

provisions for the Program at

§ 3415.4(d), should be followed for the

preparation of proposals under the

Program in FY 1998. (Note that the

Department elects not to solicit

preproposals in FY 1998.)

Compliance With the National

Environmental Policy Act (NEPA)

As outlined in 7 CFR Part 3407 and

7 CFR Part 520 (the CSREES and ARS

regulations implementing the National

Environmental Policy Act of 1969),

environmental data for any proposed

project is to be provided to CSREES and

ARS so that CSREES and ARS may

determine whether any further action is

needed. Form CSREES–1234, ‘‘NEPA

Exclusions Form’’ (copy in Application

Kit), indicating the applicant’s opinion

of whether or not the project falls within

one or more categorical exclusions,

along with supporting documentation,

must be included in the proposal. The

applicant shall review the following

categorical exclusions and determine if

the proposed project may fall within

one of the categories:

(1) Department of Agriculture

Categorical Exclusions (7 CFR 1b.3)

(i) Policy development, planning and

implementation which are related to

routine activities such as personnel,

organizational changes, or similar

administrative functions;

(ii) Activities which deal solely with

the funding of programs, such as

program budget proposals,

disbursements, and transfer or

reprogramming of funds;

(iii) Inventories, research activities,

and studies, such as resource

inventories and routine data collection

when such actions are clearly limited in

context and intensity;

(iv) Educational and informational

programs and activities;

(v) Civil and criminal law

enforcement and investigative activities;

(vi) Activities which are advisory and

consultative to other agencies and

public and private entities; and

(vii) Activities related to trade

representation and market development

activities abroad.

(2) CSREES and ARS Categorical

Exclusions (7 CFR 3407.6 and 7 CFR

520.5)

Based on previous experience, the

following categories of CSREES and

ARS actions are excluded because they

have been found to have limited scope

and intensity and to have no significant

individual or cumulative impacts on the

quality of the human environment:

(i) The following categories of

research programs or projects of limited

size and magnitude or with only shortterm effects on the environment:

(A) Research conducted within any

laboratory, greenhouse, or other

contained facility where research

practices and safeguards prevent

environmental impacts;

(B) Surveys, inventories, and similar

studies that have limited context and

minimal intensity in terms of changes in

the environment; and

(C) Testing outside of the laboratory,

such as in small, isolated field plots,

which involves the routine use of

familiar chemicals or biological

materials.

(ii) Routine renovation, rehabilitation,

or revitalization of physical facilities,

including the acquisition and

installation of equipment, where such

activity is limited in scope and

intensity.

In order for CSREES and ARS to

determine whether any further action is
67490 Federal Register / Vol. 62, No. 247 / Wednesday, December 24, 1997 / Notices

needed with respect to NEPA, pertinent

information regarding the possible

environmental impacts of a particular

project is necessary; therefore, a

separate statement must be included in

the proposal indicating whether the

applicant is of the opinion that the

project falls within a categorical

exclusion and the reasons therefor. If it

is the applicant’s opinion that the

project proposed falls within the

categorical exclusions, the specific

exclusions must be identified. The

information submitted shall be

identified as ‘‘NEPA Considerations’’

and the narrative statement shall be

placed after the coversheet of the

proposal.

Even though a project may fall within

the categorical exclusions, CSREES and

ARS may determine that an

Environmental Assessment or an

Environmental Impact Statement is

necessary for an activity, if substantial

controversy on environmental grounds

exists or if other extraordinary

conditions or circumstances are present

which may cause such activity to have

a significant environmental effect.

Proposal Submission and Due Date

What To Submit

An original and 14 copies of a

proposal must be submitted. Proposals

should be typed on one side of the page

only. Each copy of each proposal must

be stapled securely in the upper

lefthand corner (DO NOT BIND). All

copies of the proposal must be

submitted in one package.

Where and When To Submit

Proposals must be postmarked by

March 24, 1998 to be eligible for the

program. Proposals received after the

deadline date of March 24, 1998, as

indicated either by the postmark date on

First Class or express mail, or by the

date on a courier bill of lading, will be

returned without review. Proposals

must be sent to the following address:

Biotechnology Risk Assessment

Research Grants Program, c/o Proposal

Services Unit, Grants Management

Branch, Office of Extramural Programs,

Cooperative State Research, Education,

and Extension Service, U.S. Department

of Agriculture, STOP 2245, 1400

Independence Avenue, S.W.,

Washington, D.C. 20250–2245,

Telephone: (202) 401–5048.

Proposals delivered by hand must be

received at the following address by

March 24, 1998 (note that the zip code

differs from that shown above):

Biotechnology Risk Assessment

Research Grants Program, c/o Proposal

Services Unit, Grants Management

Branch, Office of Extramural Programs,

Cooperative State Research, Education,

and Extension Service, U.S. Department

of Agriculture, Room 303, Aerospace

Center, 901 D Street, S.W., Washington,

D.C. 20024, Telephone: (202) 401–5048.

Additional Information

The Biotechnology Risk Assessment

Research Grants Program is listed in the

Catalog of Federal Domestic Assistance

under No. 10.219. For reasons set forth

in the final rule-related Notice to 7 CFR

part 3015, subpart V (48 FR 29115, June

24, 1983), this Program is excluded from

the scope of Executive Order No. 12372

which requires intergovernmental

consultation with State and local

officials.

Under the provisions of the

Paperwork Reduction Act of 1995 (44

U.S.C. chapter 35), the collection of

information requirements contained in

this Notice have been approved under

OMB Document No. 0524–0022.

Done at Washington, D.C., on this 15 day

of December, 1997.

Colien Hefferan,

Associate Administrator, Cooperative State

Research, Education, and Extension Service.

Edward B. Knipling,

Associate Administrator, Agricultural

Research Service.

[FR Doc. 97–33500 Filed 12–23–97; 8:45 am]

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