[Federal Register Volume 63, Number 242 (Thursday, December 17, 1998)]
[Notices]
[Pages 69986-69989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33550]
[[Page 69985]]
_______________________________________________________________________
Part V
Department of Agriculture
_______________________________________________________________________
Agricultural Research Service
_______________________________________________________________________
Cooperative State Research, Education, and Extension Service, USDA
_______________________________________________________________________
Biotechnology Risk Assessment Research Grants Program for Fiscal Year
1999; Solicitation of Applications; Notice
Federal Register / Vol. 63, No. 242 / Thursday, December 17, 1998 /
Notices
[[Page 69986]]
DEPARTMENT OF AGRICULTURE
Agricultural Research Service
Cooperative State Research, Education, and Extension Service
Biotechnology Risk Assessment Research Grants Program for Fiscal
Year 1999; Solicitation of Applications
AGENCY: Agricultural Research Service; Cooperative State Research,
Education, and Extension Service.
ACTION: Notice of Biotechnology Risk Assessment Research Grants
Program; Fiscal Year 1999 Solicitation of Applications.
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SUMMARY: Applications are invited for competitive grant awards under
the Biotechnology Risk Assessment Research Grants Program (the
``Program'') for fiscal year (FY) 1999. 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, 1999.
FOR FURTHER INFORMATION CONTACT: Dr. Edward K. Kaleikau, USDA/CSREES,
(202) 401-1901, Dr. Robert M. Faust, USDA/ARS, (301) 504-6918, or Dr.
Deborah Sheely, USDA/CSREES, (202) 401-1924.
SUPPLEMENTARY INFORMATION:
Table of Contents
Stakeholder Input
Purpose
Applicant Eligibility
Available Funding
Program Description
Proposal Evaluation
Areas of Research to be Supported in Fiscal Year 1999
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
Stakeholder Input
CSREES is soliciting comments regarding this solicitation of
applications from any interested party. These comments will be
considered in the development of the next request for proposals for the
Program. Such comments will be forwarded to the Secretary or his
designee for use in meeting the requirements of section 103(c)(2) of
the Agricultural Research, Extension, and Education Reform Act of 1998,
7 U.S.C. 7613(c)(2). Written comments should be submitted by first-
class mail to: Office of Extramural Programs; Competitive Research
Grants and Awards Management; USDA-CSREES; STOP 2299; 1400 Independence
Avenue, S.W., Washington, D.C. 20250-2299, or via e-mail to: RFP-
[email protected].
In your comments, please include the name of the program and the
fiscal year solicitation of applications to which you are responding.
Comments are requested within six months from the issuance of the
solicitation of applications. Comments received after that date will be
considered to the extent practicable.
Purpose
The purpose of the Program is to assist Federal regulatory agencies
in making science-based decisions about the effects of introducing into
the environment genetically modified organisms, including plants,
microorganisms, fungi, bacteria, viruses, arthropods, fish, birds,
mammals and other animals excluding humans. Investigations of effects
on both managed and natural environments are relevant. 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 1999 is $1.5 million. The
agency intends to award these funds for project proposals in the
targeted areas with no more than two awards for conference proposals.
CSREES is prohibited from paying indirect costs exceeding 19
percent of the total Federal funds provided under each award on
competitively awarded research grants (7 U.S.C. 3310). However, Section
711 of the Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies Appropriations Act, 1999, Sec.
107(a), Pub. L. No. 105-277 prohibits CSREES from using the funds
available for the Program for FY 1999 to pay indirect costs exceeding
14 percent of the total Federal funds provided under each award on
competitively awarded research grants.
Program Description
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 emphasis is on risk assessment, which is defined as
the science-based evaluation and interpretation of factual information
in which a given hazard, if any, is identified, and the consequences
associated with the hazard are explored. Investigators are encouraged
to design studies in which answers to three general questions are
sought: 1) what is the risk (potential risk identification)?; 2) how
likely is the risk to occur (quantifying the probability of
occurrence)?; and 3) what is the severity and extent of the effect if
it occurs (quantifying the effects)? Proposals that address all three
questions are preferred. However, studies of a single question will
also be considered if developed within the broader context of risk
assessment. The Program does not support risk management research,
which is defined as (1) research aimed primarily at reducing risks of
specific 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 research topics requested in
this solicitation. In addition, proposals should include detailed
descriptions of the experimental design and appropriate statistical
analyses to be done.
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 Administrators of ARS and CSREES
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. Proposals for funding a scientific research
conference grant will
[[Page 69987]]
be evaluated on the following criteria: 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. All proposals are considered together in making
award decisions. However, no more than two conference grants will be
awarded.
Areas of Research To Be Supported in Fiscal Year 1999
Proposals addressing the following topics are requested:
1. Research relevant to assessing the risk of the introduction into
the environment of genetically engineered organisms. Potential subject
areas include but are not limited to: research on the potential for
recombination between plant viruses and plant-encoded viral transgenes;
research on the potential for nontarget effects of introduced plant-
defense compounds expressed in genetically modified plant-associated
microorganisms (e.g., compounds in the phyllosphere or rhizosphere-
inhabiting bateria) or in plants (e.g., Bacillus thuringiensis delta-
endotoxin), especially in regard to persistence of the organisms and
material in the environment; changes in ecosystem or agro-ecosystem
function and composition; or research on gene flow from transgenic
crops to related plants. 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 excluding humans. As long as the data gathered are relevant to
the assessment of the risk of genetically modified organisms, the
experiments need not utilize genetically engineered organisms. When
feasible, measure of risk should include estimates of expected
frequency and impact, and address the availability of effective
mitigation measures to reduce or avoid impacts.
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. Studies should attempt to project impacts
over as large a spatial and temporal scale as feasible. Of particular
interest are studies that survey transgenic insect and virus resistant
plants for insects and viral strains that have overcome the resistance
phenotype. This may be done by monitoring locations where such plants
are grown on a commercial scale or in large scale production. The
analysis of resistance-breaking viral 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
data relevant to risk assessment of genetically modified organisms
released into the environment. The scientific steering committee for
the conference should include representatives from a variety of
relevant disciplines, such as ecology, population biology, pathology,
production and resource management science, and others, as appropriate.
The Program will fund a maximum of two conference proposals.
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--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. Robert M. Faust, Agricultural Research Service, U.S. Department of
Agriculture, Room 338, Building 005, BARC-West, Beltsville, MD 20705,
Telephone: (301) 504-6918,
or
Dr. Deborah Sheely, 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) 401-1924
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, 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 also may be requested via Internet by sending
a message with your name, mailing address (not e-mail) and telephone
number to [email protected] which states that you wish to receive a copy
of the application materials for the FY 1999 Biotechnology Risk
Assessment Research Grants Program. The materials will then be mailed
to you (not e-mailed) as quickly as possible.
This Solicitation and other application information and materials
also are available at the Program's website (http://www.reeusda.gov/
crgam/biotechrisk/biotech.htm).
Proposal Format
The format guidelines for full research proposals, found in the
administrative provisions for the Program at Sec. 3415.4(d), should be
followed for the preparation of proposals under the Program in FY 1999.
In addition, please note the following items: (1) The Department elects
not to solicit preproposals in FY 1999; (2) a proposal's project
summary may not exceed one single-or double-spaced page. Include on
this page the proposal title, as well as names and institutions of each
investigator; and (3) a separate conflict of interest list must be
submitted with the proposal for each investigator for whom a curriculum
vitae (C.V.) is required. This list is
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necessary to assist program staff in excluding from proposal review
those individuals who have conflicts of interest with the project
personnel in the grant proposal.
For each investigator (and other personnel as described in the
program description), list alphabetically the full names of only the
individuals in the following categories. It is not necessary to list
individuals in each category separately; rather, a single alphabetized
list for each investigator is preferred. Additional pages may be used
as necessary. A conflict of interest list must be submitted before a
proposal is considered complete. Inclusion of a C.V. or publication
list in lieu of a conflict of interest list is not sufficient. Other
investigators working in the applicant's specific research area are not
in conflict of interest with the applicant unless those investigators
fall within one of the categories listed below:
(A) All collaborators on research projects within the past five
years, including current and planned collaborations;
(B) All co-authors on publications within the past five years,
including pending publications and submissions;
(C) All persons in your field with whom you have had a consulting
or financial arrangement within the past five years; and
(D) All thesis or postdoctoral advisees/advisors within the past
five years.
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 short-term 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 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 therefore. 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 sent by First Class, an express mail service, or courier
service must be postmarked on or by March 24, 1999, to be eligible for
the program. Proposals hand-delivered must be received on or by March
24, 1999. Proposals received after the deadline date of March 24, 1999,
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 sent via First Class must be sent to the
following address: Biotechnology Risk Assessment Research Grants
Program, c/o Proposal Services Unit, 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, express mail, or overnight courier
must be sent to the following address (note that the zip code differs
from that shown above): Biotechnology Risk Assessment Research Grants
Program, c/o Proposal Services Unit, 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
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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 third day of December, 1998.
Colien Hefferan,
Acting Administrator, Cooperative State Research, Education, and
Extension Service.
Floyd Horn,
Administrator, Agricultural Research Service.
[FR Doc. 98-33550 Filed 12-16-98; 8:45 am]
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