Biotechnology Risk Assessment Research

 

The purpose of the BRAG program Assistance Listing 10.219, is to support the generation of new information that will assist Federal regulatory agencies [USDAs Animal and Plant Health Inspection Service - Biotechnology Regulatory Services (APHIS-BRS), Environmental Protection Agency (EPA), and Department of Health and Human Services (DHHS) Food and Drug Administration (FDA)] in making science-based decisions about the environmental effects of introducing genetically engineered (GE) organisms by techniques that use recombinant, synthesized, or amplified nucleic acids to modify or create a genome. The organisms include plants, microorganisms (including fungi, bacteria, and viruses), arthropods, fish, birds, livestock, and other animals these include related wild and agricultural organisms. The statutory program goals and objectives are to authorize and support environmental assessment research to help identify and analyze environmental effects of biotechnology and to authorize research to help regulators develop long-term policies concerning the introduction of such technology. The BRAG program supports applied and/or fundamental research relevant to environmental risk assessment, including biological risk, and the Federal regulatory process. When evaluating GE organisms, Federal regulators must answer the following four general questions: 1. Is there a hazard? (Potential hazard identification.) 2. How likely is the hazard to occur? (Quantifying the probability of occurrence; identifying likely exposure scenarios.) 3. What is the severity and extent of the hazard if it occurs? (Quantifying the effects) and 4. Is there an effect beyond what might occur with an unmodified organism or an organism that has similar traits, but was developed using other technologies?

Active 10.219 National Institute of Food and Agriculture, Department of Agriculture B - Project Grants Fiscal Year 2016 For the FY 2016 award cycle, the (Payment to States) amount available for awards was $ 2,433,375. A total of 44 applications requesting a total of $ 23,790,339 were received in this year’s competition. In June 2016, a 14-member peer review panel will evaluate these applications. The peer panel included faculty and administrators from land grant and non-land grant colleges and universities and practitioners from the food and agricultural sciences community. Funds were available to support 9 awards in the following Project Types (conferences, standard, and priority grants) The funding success rate for this program in FY 2016 was 22% for research grants. For the Fiscal Year (FY) 2016 award cycle, the (Payment to States) amount available for awards was $ 2,433,375. A total of 44 applications requesting a total of $ 23,790,339 were received in this year’s competition. In June 2016, a 14-member peer review panel will evaluate these applications. The peer panel included faculty and administrators from land grant and non-land grant colleges and universities and practitioners from the food and agricultural sciences community. Funds were available to support nine (9) awards in the following Project Types (conferences, standard, and priority grants) The funding success rate for this program in FY 2016 was 22% for research grants.
Fiscal Year 2017 For the FY 2017 award cycle, the (Payment to States) amount available for awards was $ 3,926,101. A total of 42 applications requesting a total of $ 19,129,634 were received in this year’s competition. In June 2017, a 13-member peer review panel will evaluate these applications. The peer panel included faculty and administrators from land grant and non-land grant colleges and universities and practitioners from the food and agricultural sciences community. Funds were available to support 13 awards in the following Project Types (2 conferences for a total of $50,000 and 11 standard grants for a total of $5,345,838) The funding success rate for this program in FY 2016 was 28% for research grants.
Fiscal Year 2018 For the FY 2018 award cycle, the (Payment to States) amount available for awards was $ 5,626,545. SPECIAL NOTE: The amount available for awards includes carryovers and prior year’s de-obligations. A total of 37 applications requesting a total of $ 16,979,744 were received in this year’s competition. In June 2018, a 13-member peer review panel will evaluate these applications. The peer panel included faculty and administrators from land grant and non-land grant colleges and universities and practitioners from the food and agricultural sciences community. Funds were available to support 14 awards in the following Project Types (1 conferences for a total of $25,000 and 13 standard grants for a total of $6,104,457) The funding success rate for this program in FY 2018 was 35% for research grants.
Fiscal Year 2019 For the FY 2019 award cycle, the (Payment to States) amount available for awards was $5,490,935. SPECIAL NOTE: The amount available for awards includes carryovers and prior year’s de-obligations. A total of 33 applications requesting a total of $13,697,878 were received in this year’s competition. In June 2019, a 11-member peer review panel will evaluate these applications. The peer panel included faculty and administrators from land grant and non-land grant colleges and universities and practitioners from the food and agricultural sciences community. Funds were available to support 14 awards in the following Project Types (3 conferences for a total of $75,000 and 11 standard grants for a total of $ $5,163,970) The funding success rate for this program in FY 2019 was 39% for research grants.
Fiscal Year 2020 Based upon the President’s Budget, NIFA projects that $3,736,564 will be available for awards. Similar projects will be supported as those funded in FY 2019. Pertinent information will be provided by Program at a future date.
Fiscal Year 2024 Pertinent information will be provided by Program at a future date. Farm Security and Rural Investment Act of 2002, Section 7210, Public Law 101-171 , 7 U.S.C. 5921
Food, Agriculture, Conservation, and Trade Act of 1990, Section 1668, 7 U.S.C. 7901 Any public or private research or educational institution or organization. Any public or private research or educational institution or organization. The System for Award Management (SAM) combines eight federal procurement systems, including CCR, and the Catalog of Federal Domestic Assistance into one new system. CCR activities are conducted through SAM (the CCR website will redirect users to SAM). Unique Entity Identifier (UEI) Number and System for Award Management (SAM): Each applicant (unless excepted under 2 CFR ? 25.110(b) or (c), or has an exception approved by the Federal awarding agency under 2 CFR ? 25.110(d)) is required to: (i) Be registered in SAM before submitting its application; (ii) Provide a valid UEI number in its application; and (iii) Continue to maintain an active SAM registration with current information at all times during which it has an active Federal award or an application or plan under consideration by a Federal awarding agency. It also must state that the Federal awarding agency may not make a Federal award to an applicant until the applicant has complied with all applicable UEI and SAM requirements and, if an applicant has not fully complied with the requirements by the time the Federal awarding agency is ready to make a Federal award, the Federal awarding agency may determine that the applicant is not qualified to receive a Federal award and use that determination as a basis for making a Federal award to another applicant. Applicants must furnish the information required in the Competitive Request for Applications (RFAs). Successful applicants recommended for funding must furnish the information and assurances requested during the award documentation process. These include, but are not limited to the following: Organizational Management Information - Specific management information relating to an applicant shall be submitted on a one time basis, with updates on an as needed basis, as part of the responsibility determination prior to the award of a grant identified under this RFA, if such information has not been provided previously under this or another NIFA program. NIFA will provide copies of forms recommended for use in fulfilling these requirements as part of the pre-award process. Although an applicant may be eligible based on its status as one of these entities, there are factors which may exclude an applicant from receiving Federal financial and nonfinancial assistance and benefits under this program (e.g., debarment or suspension of an individual involved or a determination that an applicant is not responsible based on submitted organizational management information). This information collection is approved under OMB Circular Control No. 0524-0026, "Assurance of Compliance with the Department of Agriculture Regulations Assuring Civil Rights, Compliance and Organization Information." SPECIAL NOTE: Please refer to the Competitive Request for Applications (RFAs) for further specific and pertinent details. The most current RFAs are available as follows: https://nifa.usda.gov/funding-opportunity/biotechnology-risk-assessment-research-grants-program-brag RFAs are generally released annually. Hence, the RFAs provide the most current and accurate information available. Any specific instructions in the Competitive RFAs supersede the general information provided in the CFDA database. 2 CFR 200, Subpart E - Cost Principles applies to this program. Preapplication coordination is required. All RFAs are published on the Agency’s website and Grants.gov. Applicants must complete the Grants.gov registration process. Please see the following Grants.gov link for more information: http://www.grants.gov/applicants/get_registered.jsp 2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program. The National Institute of Food and Agriculture (NIFA) only accepts electronic applications which are submitted via Grants.gov in response to specific Requests for Applications (RFA). Applicants must complete the Grants.gov registration process. For information about the pre-award phase of the grant lifecycle application processes see: http://www.grants.gov/web/grants/learn-grants/grants-101/pre-award-phase.html. Further, applicants must follow the instructions provided in the NIFA Grants.gov Application Guide, which can be assessed as follows: Adobe NIFA Applications. 2 CFR part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards and 2 CFR part 400 USDA's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards apply to this program. SPECIAL NOTE: Please refer to the Competitive Request for Applications (RFAs) for further specific and pertinent details. The most current RFAs are available via: https://nifa.usda.gov/funding-opportunity/biotechnology-risk-assessment-research-grants-program-brag RFAs are generally released annually. Hence, the RFAs provide the most current and accurate information available. Any specific instructions in the Competitive RFAs supersede the general information provided in the CFDA database. Applications are subjected to a system of peer and merit review in accordance with section 103 of the Agricultural Research, Extension and Education Reform Act of 1998 (7 U.S.C. 7613) by a panel of qualified scientists and other appropriate persons who are specialists in the field covered by the proposal. Within the limit of funds available for such purpose, the NIFA Authorized Departmental Officer (ADO) shall make grants to those responsible, eligible applicants whose applications are judged most meritorious under the procedures set forth in the RFA. Reviewers will be selected based upon training and experience in relevant scientific, extension, or education fields, taking into account the following factors: (a) The level of relevant formal scientific, technical education, or extension experience of the individual, as well as the extent to which an individual is engaged in relevant research, education, or extension activities; (b) the need to include as reviewers experts from various areas of specialization within relevant scientific, education, or extension fields; (c) the need to include as reviewers other experts (e.g., producers, range or forest managers/operators, and consumers) who can assess relevance of the applications to targeted audiences and to program needs; (d) the need to include as reviewers experts from a variety of organizational types (e.g., colleges, universities, industry, state and Federal agencies, private profit and non-profit organizations) and geographic locations; (e) the need to maintain a balanced composition of reviewers with regard to minority and female representation and an equitable age distribution; and (f) the need to include reviewers who can judge the effective usefulness to producers and the general public of each application. Evaluation Criteria will be delineated in the Competitive Request for Applications (RFA). 2 CFR 200 - Subpart C and Appendix I and 2 CFR part 400 apply to this Program. SPECIAL NOTE: Please refer to the Competitive Request for Applications (RFAs) for further specific and pertinent details. The most current RFAs are available via: https://nifa.usda.gov/funding-opportunity/biotechnology-risk-assessment-research-grants-program-brag RFAs are generally released annually. Hence, the RFAs provide the most current and accurate information available. Any specific instructions in the Competitive RFAs supersede the general information provided in the CFDA database. Contact the headquarters or regional location, as appropriate for application deadlines From 30 to 60 days. Contact the National Program Leader (NPL), as indicated per CFDA Section # 152 - Headquarters Office regarding dates for specific deadlines, start and end dates, and range of approval/disapproval time. Information is also available via our website and may be obtained via the Grants.gov website. NIFA's respective links regarding general information are provided below: http://nifa.usda.gov/ http://www.grants.gov. SPECIAL NOTE: Please refer to the Competitive Request for Applications (RFAs) for further specific and pertinent details. The most current RFA is available via: https://nifa.usda.gov/funding-opportunity/biotechnology-risk-assessment-research-grants-program-brag RFAs are generally released annually. Hence, the RFAs provide the most current and accurate information available. Any specific instructions in the Competitive RFAs supersede the general information provided in the CFDA database. Not applicable. Specific details are provided in the Request for Applications (RFA), which are generally published annually. The most current RFA is available via: https://nifa.usda.gov/funding-opportunity/biotechnology-risk-assessment-research-grants-program-brag 2 CFR part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards and 2 CFR part 400 USDA's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards apply to this program. Within guidelines established for the program as described in the Competitive Request for Application (RFA). The most current RFAs are available via: https://nifa.usda.gov/funding-opportunity/biotechnology-risk-assessment-research-grants-program-brag Grant funds must be used for allowable costs necessary to conduct approved research objectives. Funds may not be used for purposes other than those approved in the grant award documents. Performance Reports: PERFORMANCE MONITORING: See above for pertinent and specific details. Relation to other audit requirements, but records must be available for review or audit by appropriate officials of the Federal agency, pass-through entity, and Government Accountability Office (GAO). This program is also subject to audit by the cognizant Federal audit agency and the USDA Office of Inspector General. Records must be available for review or audit by appropriate officials of the Federal agency, pass-through entity, and Government Accountability Office (GAO). This program is also subject to audit by the cognizant Federal audit agency and the USDA Office of Inspector General. In accordance with 2 CFR Part 400 - Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, ? 200.334 Retention requirements for records. Grantees shall maintain separate records for each grant to ensure that funds are used for authorized purposes. Grant-related records are subject to inspection during the life of the grant and must be retained at least three (3) years. Records must be retained beyond the three (3) year period if litigation is pending or audit findings have not been resolved. 2 CFR Part 200, Subpart D applies to this program. Statutory formula is not applicable to this assistance listing.

Matching requirements are not applicable to this assistance listing.

MOE requirements are not applicable to this assistance listing. In accordance with statutory time limits, project periods, including no-cost extensions of time, are not to exceed five (5) years. Further details are provided in the Award document Form NIFA-2009 and the NIFA General Terms and Conditions Grants and Cooperative Agreements (dated October 2016) at: https://nifa.usda.gov/resource/nifa-general-terms-and-conditions-grants-and-cooperative-agreements-october-2016. SPECIAL NOTE: Please refer to the Competitive Request for Applications (RFAs) for specific and pertinent details. The most current RFAs are available via: https://nifa.usda.gov/funding-opportunity/biotechnology-risk-assessment-research-grants-program-brag RFAs are generally released annually. Hence, the RFAs provide the most current and accurate information available. Any specific instructions in the Competitive RFAs supersede the general information provided in the CFDA database. NIFA utilizes the Automated Standard Application for Payments (ASAP), a secure, web-based electronic payment and information system that allows federal agencies to administer funds. Currently, ASAP is the only payment source for new NIFA grantees. National Institute of Food and Agriculture U.S. Department of Agriculture P.O. Box 419205, Mail Stop 10000, Kansas City, MO 64141-6205 Courier/Package Delivery Address: 2312 East Bannister Road, Mail Stop 10000, Kansas City, MO 64141-3061 USDA, NIFA, National Program Leader,
Institute of Food Production and Sustainability, Division of Plant Systems-Production, National Institute of Food and Agriculture
U.S. Department of Agriculture
P.O. Box 419205, Mail Stop 10000, Kansas City, MO 64141-6205
Courier/Package Delivery Address:
2312 East Bannister Road, Mail Stop 10000, Kansas City, MO 64141-3061
Kansas City, MO 64141 US
john.erickson@usda.gov
Phone: (816)-283-6422 http://nifa.usda.gov/program/biotechnology-risk-assessment-research-grants-program 12-1502-0-1-352 (Project Grants) FY 22$5,000,000.00; FY 23 est $5,500,000.00; FY 24 est $5,500,000.00; FY 21$4,500,000.00; FY 20$4,500,000.00; FY 19$4,289,919.00; FY 18$4,213,797.00; FY 17$3,926,101.00; FY 16$2,433,375.00; - NOTES: (1) Some of these funds are no year.In terms of availability of appropriations (time), there are no time limits as to when "no-year" funds may be obligated and expended and the funds remain available for their original purposes until expended. (2) BRAG funds are deducted from five (5) treasury symbols. The increase in biotechnology related work is the result of increased funding for the Agriculture & Food Research Initiative (AFRI) program and related set-asides. If minimum or maximum amounts of funding per competitive and/or capacity project grant, or cooperative agreement are established, these amounts will be announced in the annual Competitive Request for Application (RFA). The most current RFA is available via: https://nifa.usda.gov/funding-opportunity/biotechnology-risk-assessment-research-grants-program-brag As an administrator of U.S. government support, NIFA works in partnership with grantees to ensure responsible stewardship of federal funds. Our grantees and partners are required to comply with all relevant rules and regulations. The following resources are provided to NIFA's partners and award recipients to support their adherence to federal regulations governing program performance: NIFA's primary (main) website: https://nifa.usda.gov/regulations-and-guidelines The following represent specific documents and direct links: POLICY GUIDE NIFA's Federal Assistance Policy Guide describes agency policies and procedures. https://nifa.usda.gov/policy-guide CERTIFICATIONS AND REPRESENTATIONS Certifications and representations provided through the NIFA application process. https://nifa.usda.gov/certifications-and-representations ACKNOWLEDGEMENT OF USDA SUPPORT BY NIFA When acknowledging USDA support in accordance with 2 CFR Part 415, grantees must use the following acknowledgement for all projects or initiatives supported by NIFA. https://nifa.usda.gov/acknowledgment-usda-support-nifa FEDERAL REGULATIONS The Code of Federal Regulations (CFR) lists all regulations published in the Federal Register. https://nifa.usda.gov/federal-regulations FOIA The Freedom of Information Act (FOIA) provides that any person has the right to request access to federal documents and information such as research data. https://nifa.usda.gov/foia NEPA POLICY AND GUIDANCE The National Environmental Policy Act (NEPA) Policy and Guidance set the standard for identifying potential environmental impacts. https://nifa.usda.gov/nepa-policy-and-guidance OGFM ISSUED CORRESPONDENCE The Office of Grants and Financial Management occasionally issues correspondence to applicants, grantees, and/or the general public for informational or clarification purposes. https://nifa.usda.gov/ogfm-issued-correspondence RESEARCH MISCONDUCT NIFA requires that all its awardees adhere to the USDA Scientific Integrity Policy and the Federal Policy on Research Misconduct. https://nifa.usda.gov/research-misconduct NIFA'S GENERAL AWARD TERMS AND CONDITIONS Award terms and conditions are determined by statutory, regulatory, and agency requirements, as well as each grant's circumstances. Terms and conditions dictate important items related to your grant, including method of payment, reporting frequency and content, and prior approval requirements. References to the terms and conditions of awards are located on the NIFA 2009 Award Fact Sheet. NIFA's general award terms and conditions (see link below) is applicable to this program, for awards with an award date on December 26, 2014 and thereafter. https://nifa.usda.gov/resource/nifa-general-terms-and-conditions-grants-and-cooperative-agreements-october-2016. Fiscal Year 2016 For FY 2016: Awards have not yet been finalized. FY 2016 awards will be finalized on or before September 30, 2016. Pertinent data to be provided by Program at a future date. (1) Development and evaluation of safeguards for conditional suppressive gene drives for spotted wing Drosophila and the New World screwworm (standard grant) (2) Improving Bt Risk Assessment and Management by Genomic Monitoring (standard grant) (3) A Data-Driven Approach to CRISPR Design for Reduced Off-Target Activity in Plant Genome Editing (standard grant) (4) Designer Algae Biotechnology Risk Assessment (standard grant) (5) Regulatory Protocols for Current and Emerging Genome Editing Technologies in Crop Improvement (conference grant)
Fiscal Year 2017 (1) Neonicotinoid seed treatments in Bt maize: balancing contributions to insect resistance management with impacts on soil health (standard grant) (2) Environmental Fate of RNA Molecules from RNA Interference (RNAi) Agricultural Biotechnology (standard grant) (3) CRISPR/CAS9 mutagenesis for genetic containment of forest trees (standard grant) (4) Development of a Transgene Biocontainment System for Switchgrass (standard grant) (5) Monitoring and inhibiting interspecies gene flow in a OneHealth context (standard grant)
Fiscal Year 2018 1. Extending a model of gene flow by insect pollinators to discontinuous landscapes 2. Genome wide evaluation of off-targets from gene editing reagents in seed vs. vegetatively propagated crop species 3. Risk of Resistance to Cry34/35Ab1 by Western Corn Rootworm 4. Effect of Gene Editing of Reproductive Genes on Fertility, Growth, Disease Resistance and Body Composition of Transgenic Catfish 5. Genome-wide analysis of off-target effects of base editing systems in crops
Fiscal Year 2019 1. Assessing Risks of Transport and Uptake of Antibiotic Resistance and RNA Silencing Transgenes in Soils via Experiments and Modeling 2. Programmable elimination of gene drive transgenes from an agricultural pest insect 3. Transgene containment and removal in important perennial grasses 4. Characterizing off-target CRISPR/Cas9 changes in soybean 5. Potential for genes targeted toward plant pathogen control to interfere with natural and applied pathogens affecting insect pests
Fiscal Year 2020 It is anticipated that similar projects will be funded in Fiscal Year 2020. Pertinent information will be provided by Program at a future date.
Fiscal Year 2024 Pertinent information will be provided by Program at a future date.