Solicitation Announcement Biotech. Grants Program (fwd)

Ray Dobert rdobert at NALUSDA.GOV
Mon Sep 25 13:55:25 EST 1995


FYI
CONTACT Dr. Edward K. Kaleikau ONLY for more info.(ekaleikau at reeusda.gov)

Ray Dobert, Biotech Info Center,NAL/ARS/USDA

---------- Forwarded message ----------
Date: Tue, 19 Sep 1995 07:50:48 EST
From: Gary L. Jensen <GJENSEN at morrill.esusda.gov>
Subject: Solicitation Announcement Biotech. Grants Program

September 19, 1995

A Federal Register notice on the solicitation announcement for 
applications with the USDA grants program on Biotechnology Risk 
Assessment Research.  Please share this notice with others
who may have an interest in submitting a proposal.
The deadline for receipt of proposals is December 11, 1995.

Gary Jensen

DEPARTMENT OF AGRICULTURE (USDA) 
  Agricultural Research Service (ARS) 
  Cooperative State Research Service 
  Extension Service 
DEPARTMENT OF EDUCATION 
Purpose: Biotechnology Risk Assessment Research Grants Program; 
Fiscal Year 1996; Solicitation of Applications 
*Notices* 
(FEDREGISTER 60 FR 47236 09/11/95; 413 lines.) 

DEPARTMENT OF AGRICULTURE 
  
Agricultural Research Service; Cooperative State Research, Education 
and Extension Service 
  
Biotechnology Risk Assessment Research Grants Program; Fiscal 
Year 1996; Solicitation of Applications 
  
Purpose: 
     Applications are invited for competitive grant awards under the 
Biotechnology Risk Assessment Research Grants Program (the 
"Program") for fiscal year 1996. The authority for the Program is 
contained in section 1668 of Pub. L. No. 101-624 (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. 
  
   The purpose of the Program is to assist Federal regulatory 
agencies in making science-based decisions about the safety of 
introducing genetically modified plants, animals, and microorganisms 
into the environment. The Program accomplishes this purpose by 
providing scientific information derived from the risk assessment 
research conducted under it. Research proposals submitted to the 
Program must be applicable to the purpose of the Program to be 
considered. Awards will not be made for clinical trials, commercial 
product development, product marketing strategies, or other research 
not appropriate to risk assessment. 
  
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 fiscal year 1996 is $ 1.7 
million. 
  
   It is expected that Congress, in the final version of the 
Agriculture, Rural Development, Food and Drug Administration, and 
Related Agencies Appropriations Act, 1996 (H.R. 1976), will prohibit 
CSREES from using the funds available for fiscal year 1996 to pay 
indirect costs exceeding 14 per centum of the total Federal funds 
provided under each award on competitively-awarded research 
grants. 
  
   In addition, it is expected that, pursuant to the final version of 
the Agriculture, Rural Development, Food and Drug Administration, 
and Related Agencies Appropriations Act, 1996 (H.R. 1976), in the 
case of any equipment or product that may be authorized to be 
purchased with the funds provided under this Program, entities will be 
encouraged to use such funds to purchase only American-made 
equipment or products.   

Program Description: 
     Under the Program, USDA 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 to help regulators 
develop policies concerning such introduction. Proposals are invited 
in the area of biotechnology risk assessment research as appropriate 
to agricultural plants, animals and microbes. Proposals based upon 
field research and whole organism-population level studies are 
strongly encouraged. 

Although emphasis will be given to risk assessment research 
involving genetically modified organisms, model systems using 
nongenetically modified organisms also will be considered if they can 
provide information that could lead to improved assessment of 
potential risks associated with the introduction of genetically modified 
organisms into the environment. Proposals should be applicable to 
current regulatory issues surrounding the ecological impacts of 
genetically modified organisms. 

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 for current 
regulatory issues. 
  
Areas of Research to be Supported in Fiscal Year 1996: 
   Proposals addressing the following research topics are requested: 
  
   1. Development of new risk assessment methods (e.g., monitoring 
organism escape, measuring biological impacts), and risk 
assessment procedures (e.g. comparative analysis of ecosystems, 
models to predict risks) that could be used in risk assessment of 
genetically modified fungi, bacteria, viruses (including animal 
vaccines), plants, arthropods, fish, birds, and mammals. Applicants 
should address the need for, and development of, new risk 
assessment methods in the course of addressing a specific and 
defined risk assessment issue, especially as pertains to genetically 
modified organisms. The development of better risk assessment 
methods for field testing genetically modified organisms also will be 
considered. 
  
   2. Creation of information systems and computer models to support 
regulatory agency decision-making in regards to potential impacts to 
the environment over time (e.g., computer models to describe the 
interaction of environmental and organismal factors especially for 
establishment and dispersal of the organism). 
  
   3. Risk assessment of the environmental fate (e.g. survival, 
reproductive fitness, genetic stability, horizontal gene transfer) as 
correlated with effects (e.g., loss of genetic diversity, enhanced 
competition) of genetically modified fungi, bacteria, viruses, plants, 
arthropods, fish, birds, and mammals introduced into the environment 
(i.e., not in a contained laboratory, greenhouse or building); and 
studies or identification of traits which may influence fate and 
effects. 
  
   In response to requests to Program Directors and Federal 
regulatory agencies, as stipulated in the authorizing legislation for 
the Program, section 1668 of Public Law 101-624, the following 
specific areas of risk assessment research have been identified as 
eligible for competition as research topics for this year: 
  
   4. The bidirectional rates, effects of selection pressures, 
mechanisms and impact of gene transfer between currently 
genetically transformable crop species and existing North American 
weedy, free living relatives of those crops including studies of 
methods of mitigation of potential gene exchange. Research could 
rely on reanalysis of published information and/or laboratory/field 
studies. 
  
   5. The potential for recombination between plant viruses and plant- 
encoded noncapsid viral genes (e.g. replicase), especially for those 
viruses in supergroup B (carmovirus, tombusvirus, luteovirus, 
sobemovirus). Such studies should identify recombination potentials 
and, if demonstrated, define frequencies and effect on symptom 
expression. Comparisons with recombination frequencies between 
naturally occurring viral sequences are encouraged. 
  
   6. Changes in viral host ranges or the types of viral vectors as a 
result of the use of transgenic plants expressing viral genes. 
  
   7. The potential for nontarget effects of introduced plant-defense 
compounds expressed in genetically modified plant-associated 
microorganisms (e.g., compounds in phyllosphere or rhizosphere- 
inhabiting bacteria) or in  plants (e.g., Bacillus thuringiensis 
delta-endotoxin), especially in regard to persistence of the organisms 
and material in the environment.  [p47237] 
  
   8. Identification of genes which can confer additional 
pathogenicity to animal pathogens. 
  
   9. Environmental risk analysis of large scale deployment of 
genetically engineered organisms; especially commercial uses of 
such organisms, with special reference to consideration that may not 
be revealed through small scale evaluations and tests. 
  
   All research proposals submitted should include a statement 
describing the relevance of the proposed project to one or more of the 
research topics requested. When appropriate, detailed descriptions of 
statistical analyses to be done should be included in the proposal. 
The inclusion of statisticians as co-principal investigators or 
contractors is encouraged. 
  
   Note: Individual investigators whose research projects are funded 
under the Program will be required to attend, present data and 
provide a manuscript on the results of their research at an Annual 
Conference. Attendance costs at such a conference do not need to be 
included in the budgets of proposed research projects; such costs will 
be paid from funds provided under a cooperative agreement between 
CSREES and the University of Maryland for an annual risk 
assessment symposium Additionally, a final project report on 
research results will be required in a fixed protocol, electronic format, 
suitable for distribution by USDA. 
  
Applicable Regulations: 
     This Program is subject to the administrative provisions found in 7 
CFR part 3415 (58 FR 65646, December 15, 1993), 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 1.1-USDA implementation of the Freedom of Information 
Act;  7 CFR Part 1c-USDA implementation of the Federal Policy for the 
Protection of Human Subjects;  7 CFR Part 3-USDA implementation of 
OMB Circular A-129 regarding debt collection; 
  
   7 CFR Part 15, Subpart A-USDA implementation of Title VI of the 
Civil Rights Act of 1964;  7 CFR Part 520-ARS implementation of the 
National Environmental Policy Act;  7 CFR Part 3015-USDA Uniform 
Federal Assistance Regulations, implementing OMB directives (i.e., 
Circular Nos. A-110, A-21, and A- 122) and incorporating provisions of 
31 U.S.C. 6301-6308 (formerly, the Federal Grant and Cooperative 
Agreement Act of 1977, Pub. L. No. 95-224), as well as general policy 
requirements applicable to recipients of Departmental financial 
assistance;   
   7 CFR Part 3016-USDA Uniform Administrative Requirements for 
Grants and Cooperative Agreements to State and Local Governments; 
7 CFR Part 3017, as amended-USDA implementation of 
Governmentwide Debarment and Suspension (Nonprocurement) and 
Governmentwide Requirements for Drug-Free Workplace (Grants); 
   7 CFR Part 3018-USDA implementation of New Restrictions on 
Lobbying. Imposes new prohibitions and requirements for disclosure 
and certification related to lobbying on recipients of Federal contracts, 
grants, cooperative agreements, and loans; 7 CFR Part 3051-Audits of 
Institutions of Higher Education and Other Nonprofit Institutions; 
  
   7 CFR Part 3407-CSREES implementation of the National 
Environmental Policy Act; 29 U.S.C. 794, section 504-Rehabilitation 
Act of 1973, and 7 CFR Part 15B (USDA implementation of the statute), 
prohibiting discrimination based upon physical or mental handicap in 
federally assisted programs;   
   35 U.S.C. 200 et seq.-Bayh-Dole Act, controlling allocation of 
rights to inventions made by employees of small business firms and 
domestic nonprofit organizations, including universities, in Federally 
assisted programs (implementing regulations are contained in 37 
CFR part 401). 
  
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, Ag Box 2241, 
Washington, DC 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. 
  
How to Obtain Application Materials: 
     Copies of this solicitation, the administrative provisions for the 
Program (7 CFR Part 3415), and the Application Kit contains required 
forms, certifications, and instructions for preparing and submitting 
grant applications. The administrative provisions include guidelines 
for proposal format. 
  
   Copies of this solicitation, the administrative provisions, and the 
Application Kit may be obtained by contacting: 
  Proposal Services Branch, Awards Management Division, 
Cooperative State Research, Education and Extension Service, U.S. 
Department of Agriculture, Ag Box 2245, Washington, DC 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 psb at reeusda.gov which states that you wish to 
receive a copy of the application materials for the Fiscal Year 1996 
Biotechnology Risk Assessment Research Grants Program. The 
materials will then be mailed to you (not e-mailed) as quickly as 
possible. 
  
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 
fiscal year 1996. (Note that the Department elects not to solicit 
preproposals nor conference grant proposals in fiscal year 1996.) 
  
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. 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;  [p47238] 
  
   (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 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: 
  What to Submit 
     An original and 14 copies of a proposal must be submitted. 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 received by 4:30 p.m. eastern standard time on 
December 11, 1995. Proposals sent by First Class mail must be sent 
to the following address: 
  
Proposal Services Branch, Awards Management Division, 
Cooperative State Research, Education, and Extension Service, U.S. 
Department of Agriculture, Ag Box 2245, Washington, DC 20250-2245, 
Telephone: (202) 401-5048 
  
   Proposals that are delivered by Express mail, a courier service, or 
by hand must be submitted to the following address (note that the zip 
code differs from that shown above): Proposal Services Branch, 
Awards Management Division, Cooperative State Research, 
Education and Extension Service, U.S. Department of Agriculture, 
Room 303, Aerospace Center, 901 D Street, SW., Washington, DC 
20024, Telephone: (202) 401- 5048 
  
Supplementary 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 1980 (44 
U.S.C. 3504(h)), the collection of information requirements contained 
in this Notice have been approved under OMB Document No. 
0524-0022. 
  
   Done at Washington, DC, on this 1st day of September, 1995. 
  William D. Carlson, Acting Administrator, Cooperative State 
Research, Education, and Extension Service. 
  
Robert J. Reginato, 
  
Acting Administrator, Agricultural Research Service. 
  
[FR Doc. 95-22464 Filed 9-8-95; 8:45 am] 
  






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