FY24-BRAG-RFA-P.pdf

REQUEST FOR APPLICATIONS

Biotechnology Risk Assessment Research Grants Program

FUNDING YEAR: Fiscal Year (FY) 2024

APPLICATION DEADLINE: February 29, 2024

ANTICIPATED FUNDING: $5,500,000

AVERAGE AWARD RANGE: $50,000-$650,000

FUNDING OPPORTUNITY NUMBER: USDA-NIFA-BRAP-010309

ASSISTANCE LISTING NUMBER: 10.219

LETTER OF INTENT DEADLINE: January 11, 2024 Note: Letter of Intent Encouraged but Not Required

INITIAL ANNOUNCEMENT

National Institute of Food and Agriculture United States Department of Agriculture

Assistance Listing Number (ALN): The Biotechnology Risk Assessment Research Grants Program (BRAG) is listed under number 10.219.

Table 1: Key Dates and Deadlines

Task Description Deadline

Application: 5:00 P.M. Eastern Time, February 29, 2024

Letter of Intent (LOI): 5:00 P.M. Eastern Time, January 11, 2024 (LOI encouraged but not required)

Applicants Comments: Within six months from the issuance of this notice (NIFA may not consider comments received after the sixth month)

Advancing Diversity, Equity, Inclusion, and Accessibility (DEIA). The National Institute of Food and Agriculture (NIFA) recognizes research, education, and extension efforts will have the greatest impacts when programs are grounded in DEIA. NIFA is committed to enhancing diversity, equity, inclusion, and accessibility of programs and encourages individuals, institutions, and organizations from underserved communities to apply to funding opportunities as lead, co-lead, or subaward recipient(s), and to engage as leaders in the peer panel review process to support the development of strong networks and collaborations. NIFA encourages applications that engage diverse communities and have broad impacts through research, education, extension, and integrated activities to address current and future challenges.

Stakeholder Input. NIFA seeks comments on all Request for Applications (RFA) so it can deliver programs efficiently, effectively, with integrity, and with a focus on customer service.

NIFA considers comments to the extent possible when developing RFAs, and uses comments to help meet 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)). Applicants may submit written comments to Policy@usda.gov. Please use the following subject line: Response to the BRAG RFA.

Centers of Excellence. Applicants are encouraged to visit the NIFA’s Center of Excellence (COE) for information on COE designation process, including COE criteria, and a list of programs offering COE opportunities. A recording of COE outreach and COE implementation webinars are also available.

https://uscode.house.gov/view.xhtml?req=(title:7%20section:7613%20edition:prelim)%20OR%20(granuleid:USC-prelim-title7-section7613)&f=treesort&edition=prelim&num=0&jumpTo=true mailto:Policy@usda.gov https://nifa.usda.gov/centers-excellence https://nifa.usda.gov/centers-excellence

EXECUTIVE SUMMARY

This notice identifies the objectives for the BRAG projects, deadlines, funding information, eligibility criteria for projects and applicants, and application forms and associated instructions.

NIFA requests applications for the BRAG program for fiscal year (FY) 2024 to support environmental assessment research concerning the introduction of genetically engineered (GE) organisms into the environment.

This RFA is being released prior to the passage of a full appropriations act for FY 2024.

Enactment of a continuing resolution, appropriations act, or other authorizing legislation may affect the availability or level of funding for this program. The amount available for grants in FY 2024 is approximately $5,500,000.

TABLE OF CONTENTS

INITIAL ANNOUNCEMENT

EXECUTIVE SUMMARY

PART I. FUNDING OPPORTUNITY DESCRIPTION

A. Legislative Authority B. Purpose and Priorities

PART II. AWARD INFORMATION

A. Available Funding B. Application Restrictions C. Project and Grant Types D. Ethical Conduct of Funded Projects

PART III. ELIGIBILITY INFORMATION

A. Eligibility Requirements B. Cost Sharing or Matching C. Centers of Excellence

PART IV. APPLICATION AND SUBMISSION

A. Letter of Intent Instructions B. Method of Application C. Content and Form of the Application D. Funding Restrictions

PART V. APPLICATION REVIEW REQUIREMENTS

E. NIFA’s Evaluation Process F. Evaluation Criteria G. Centers of Excellence H. Organizational Management Information I. Application Disposition

PART VI. AWARD ADMINISTRATION

A. General B. Administrative and National Policy Requirements

PART VII OTHER INFORMATION

A. Use of Funds and Changes in Budget B. Confidential Aspects of Applications and Awards C. Regulatory Information D. Limited English Proficiency

APPENDIX I: AGENCY CONTACT

APPENDIX II: GLOSSARY OF TERMS

APPENDIX III: DEFINITIONS

TABLE OF TABLES

Table 1: Key Dates and Deadlines Table 2: Program Key Information Table 3. Steps to Obtain Application Materials Table 4: Help and Resources Table 5: Key Application Instructions

PART I. FUNDING OPPORTUNITY DESCRIPTION

A. Legislative Authority Section 1664 of the Food, Agriculture, Conservation, and Trade Act of 1990 (7 U.S.C. 5921) provides authority for the Biotechnology Risk Assessment Research (BRAG) Program. The BRAG program supports research designed to identify and develop appropriate management practices to minimize physical and biological risks associated with genetically engineered animals, plants, and microorganisms. NIFA and the Agricultural Research Service (ARS) of the U.S. Department of Agriculture (USDA) jointly administer the BRAG program, while USDA- NIFA, USDA-ARS and USDA-Forest Service (FS) provide annual funding for the BRAG program.

B. Purpose and Priorities The purpose of the BRAG program, Assistance Listing 10.219, is to support the generation of new information that will assist Federal regulatory agencies [USDA’s – 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?

The BRAG program will also support risk management research, which is defined as either:

1. Research aimed primarily at reducing negative effects of specific biotechnology derived agents; or

2. A policy and decision-making process that uses risk assessment data in deciding how to avoid or mitigate the negative consequences identified in a risk assessment.

Although project directors (PDs) are not required to perform actual risk assessments as part of the research they propose, they should design studies that will provide useful science-based information for Federal regulators assessing GE organisms or that have been derived via https://uscode.house.gov/view.xhtml?req=(title:7%20section:5921%20edition:prelim)%20OR%20(granuleid:USC-prelim-title7-section5921)&f=treesort&edition=prelim&num=0&jumpTo=true https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/home/ https://www.aphis.usda.gov/aphis/ourfocus/biotechnology https://www.aphis.usda.gov/aphis/ourfocus/biotechnology https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/introduction-biotechnology-regulation-pesticides https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/introduction-biotechnology-regulation-pesticides https://www.fda.gov/animal-veterinary/biotechnology-products-cvm-animals-and-animal-food/animals-intentional-genomic-alterations https://www.fda.gov/animal-veterinary/biotechnology-products-cvm-animals-and-animal-food/animals-intentional-genomic-alterations synthetic biology defined as: the ability to generate novel traits or organisms using synthetic genes (synthesized de novo outside the organism of origin).

NIFA is soliciting applications for the BRAG program under the following program areas:

1. Standard Research Proposals

2. Conference Proposals

Handling of baseline data and data collection must be addressed in the Data Management Plan (DMP) in accordance with the Part IV, C of this RFA.

Additional requirements on expected performance goals, indicators and targets may be required as a condition of award.

The BRAG program is aligned with the following USDA Strategic Plan FY 2022-2026 goals:

Strategic Goal 2: Ensure America’s Agricultural System is Equitable, Resilient, and Prosperous.

Strategic Goal 3: Foster an Equitable and Competitive Marketplace for All Agricultural Producers Strategic Goal 4: Provide all Americans Safe, Nutritious Food

The BRAG program is aligned with the following USDA Science and Research Strategy, 2023– 2026 priorities:

1. Priority 1: Accelerating Innovative Technologies & Practices

2. Priority 4: Cultivating Resilient Ecosystems

3. Priority 5: Translating Research Into Action

Table 2: Program Key Information

Title Description

Program Code: HX

Program Code Name: Biotechnology Risk Assessment

ALN: 10.219

Project Type: Research projects only

Grant Type: Standard and Conference grants only

Letter of Intent Deadline 2024: Thursday January 11, 2024 LOIs are encouraged (not required) only for Standard grants and not for Conference grants.

LOIs should follow instructions in Part IV, A of this RFA

Application Deadline February 29, 2024

Grant Duration: 24-48 Months

Maximum Award Amount: Standard Research - $650,000 Conference - $50,000

Minimum Award Amount: $10,000 https://www.usda.gov/sites/default/files/documents/usda-fy-2022-2026-strategic-plan.pdf https://www.usda.gov/sites/default/files/documents/usda-science-research-strategy.pdf https://www.usda.gov/sites/default/files/documents/usda-science-research-strategy.pdf

Program Federal Agency Collaboration. NIFA will competitively award research grants to support biotechnology regulation, thereby helping address concerns about the effects of GE organisms introduced into the environment and helping regulators develop policies regarding such introduction. The BRAG program also encourages proposals seeking partnership with or involvement of international entities where appropriate and domestically beneficial. Research proposals must be of high quality and have merit based upon their relevance to the purpose of the BRAG program. The BRAG program is especially interested in research that is not already in well-developed areas of study. Exploratory research that relates specifically to federal regulatory needs is preferred.

Applications to the BRAG program MUST address one of the following standard research program areas (see below) or seek funding for a conference/workshop. In addition, applicants must state in the first sentence of their Project Summary which SINGLE standard research program area aligns best with their proposed project.

Standard Research Proposals. Address issues related to newly developed GE organisms that are animals, plants, insects, and/or microorganisms. Research proposals can be applied and/or fundamental and must address one of the following five program areas:

1. Management Practices to Minimize Environmental Risk of GE Organisms. Research designed to develop appropriate management practices to minimize physical and biological risks to the environment associated with GE organisms. Potential areas of research include, but are not limited to:

a. Evaluation of management, monitoring (e.g., detection), and mitigation methodologies (e.g., devitalization), for assuring confinement and managing the persistence of GE organisms both during and after field trials, particularly insects, microbes, perennial plant species, aquatic species, and weeds;

b. Evaluation of safeguards for controlling the spread of gene drives during research to understand the effect of the desired genetic change on organisms and populations;

c. Development of practical management methodologies for reducing the spread and persistence of GE organisms in natural and managed environments after intentional release or escape from containment;

d. Development or evaluation of effective strategies, including molecular and/or genetic, to limit gene transfer (gene flow) or outcrossing to sexually compatible organisms or transfer of genetic material between viruses, insects, or microorganisms;

e. Mitigation measures to limit gene flow when GE organisms are released or escape into the environment, physical containment fails, or biological containment is unavailable;

f. Ecological effects of technologies for reducing the undesired spread of GE organisms;

and/or

g. Exploration of risk mitigation strategies to ameliorate undesirable environmental impacts associated with GE organisms.

2. Methods to Monitor and Understand the Dispersal of GE Organisms. Research designed to develop methods to monitor and understand the dispersal and/or population dynamics of GE organisms. Potential areas of research include, but are not limited to:

a. Ability to survive and/or fitness of GE organisms in the wild as compared to appropriate non-GE or previous GE counterparts that are not subjected to regulation, particularly across different environmental conditions (e.g., drought, presence of interspecific competitors), different media (e.g., soil, water, or air) and different hosts (e.g., plants, animals, insects, nematodes, or bacteria);

b. Understanding and predicting the dynamics of gene drives in organisms when released into the environment; especially the identification of the key factors impacting persistence, spread, and frequencies in populations of the organism and its relatives with field or laboratory studies and/or simulation modeling;

c. Strategies for large-scale deployment or field studies of GE organisms, with special reference to those considerations that may not be revealed through contained or small-scale evaluation and tests;

d. Assessing the effects of engineered traits in animal species that may easily disperse, such as birds, rodents, aquatic species, microbes, arthropods, and other invertebrates.

This area may include:

i. Basic biological information about the non-modified species that is important for risk assessment and population models, particularly information about life-history traits like mating structure, dispersal, and behavior

ii. Studies on genotype and phenotype stability over multiple generations

iii. Comparative mating competence or reproductive studies

iv. Comparative behavior and biological studies, including studies addressing whether traits introduced by genetic engineering can alter the range or ecological interactions of organisms such as birds, rodents, aquatic species, arthropods, and other invertebrates;

e. To prevent persistence of plants used in field trials, information on dormancy in the seed (e.g., wheat, barley, rice, canola, trees, or other propagules affecting persistence of such propagules), particularly variety x environment interactive effects. This would include the dormancy of crop, sexually compatible weedy species, and hybrids of the crop and weedy relatives and sexually compatible crops cultivated in sympatry; or

f. Development and/or evaluation of tools for assessing the weediness or invasiveness of GE plants relative to unmodified parent organisms.

3. Gene Transfer between Genetically Engineered Animals, Plants, and Microorganisms and Related Wild and Agricultural Organisms. Research designed to further existing knowledge about the characteristics, rates, and mechanisms of gene transfer that may occur between GE organisms, and related wild and agricultural organisms. Gene flow research should be directed to organisms with a high potential for the transfer of genetic material (e.g., outcrossing to sexually compatible species or transfer of genetic material between microorganisms or viruses) and to genes that have a high potential for altering the fitness of the recipient organism in its environment. For plants, preference will be given to studies with species that have sexually compatible wild or weedy relatives in the United States. For microorganisms, preference will be given to species co-occurring in the same host organism or microenvironment. Potential areas of research include, but are not limited to:

a. Impacts of gene flow from GE plants, particularly perennials (e.g., trees, grasses such as switchgrass), insects, animals, or microorganisms on related organisms, communities, or ecosystems;

b. Fate and stability (persistence) of engineered genes that have been moved by outcrossing or other means into populations of non-GE organisms, and the degree to which they confer a selective advantage or disadvantage upon the recipients/carriers or are inherited in a non-Mendelian manner (e.g., gene drives), especially with regard to engineered genes that may confer increased fitness (e.g., enhanced growth or abiotic stress tolerance) in wild populations, and the environmental contexts in which those advantages or disadvantages manifest;

c. Assessing the influence of genetic background on the phenotypic expression conferred by genetic modification, to inform understanding of the characteristics and potential outcomes of gene transfer in a new genetic background;

d. Basic research on the genes related to weediness and their location in the genome of weedy relatives of crop plants; and/or

e. Modeling engineered gene escape into the environment, including modeling to identify parameters that influence gene dispersal and its consequences.

4. Environmental Effects of GE Organisms relative to Non-GE Organisms in the Context of Production Systems. Environmental assessment research on production systems that compares the relative impacts of animals, plants, and microorganisms modified through the incorporation of traits introduced by genetic engineering to other types of production systems. Potential areas of research include, but are not limited to:

a. Assessment of how traits introduced by genetic engineering may change aspects of the ecology or behavior of engineered organisms (e.g., mating systems, host range).

b. Assessment of the influence of GE organisms as compared to non-GE organisms on managed (agricultural, aquatic, or forest ecosystems such as on community structures of agro or forest ecosystems) or unmanaged ecosystems. Important focus areas are the impacts of GE organisms on:

i. The population dynamics and ecology of various types of beneficial organisms

ii. The magnitude and types of changes in communities or indicator species that could trigger concerns regarding ecosystem impacts

iii. The biology and ecology of indicator taxa with respect to geography, seasonal fluctuations, species, pests, diseases, etc.;

c. Assessment of how the cultivation of GE organisms alters agricultural impacts on the rural environment, such as altered land use practices, species displacement, soil erosion, water usage and water quality, or other geographically dispersed events.

Comparative assessment of management techniques and resources for the maintenance of non-GE animals versus GE animals (e.g., changes in land use or manure management practices required for GE animals engineered to utilize feed more efficiently);

d. Comparative assessment of environmental impacts of agricultural production systems using organic and/or conventional methods with those involving plant, animal, or microbial biotechnology. Appropriate parameters or metrics include, but are not limited to:

i. Soil health, fertilizer, pesticide, and soil amendment inputs,

ii. Changes in toxicant and pesticide residue levels,

iii. Prevalence, shifts, and distribution of and damage from weeds, including those with single or multiple herbicide resistance,

iv. Prevalence, distribution, and damage from pests and pathogens, including emergence of resistance,

v. Land use related to yield and productivity and/or

vi. Water quality and hydrology impacting beneficial non-target organisms;

e. Identification and experimental assessment, modeling, or meta-analysis of potential adverse environmental impacts of large-scale cultivation of GE plants, with emphasis on plants used for bioenergy, bio-based construction products (e.g., sorghum, Camelina, sugarcane, eukaryotic algae, or perennial species such as trees and some grasses), and plant-made pharmaceuticals and industrials to support the development of a risk assessment framework. For the purposes of this standard area, large-scale refers to cultivation on 100 or more acres. Projects must address multiple BRAG topic areas, preferentially chosen from the following:

i. Biological and ecological baseline studies, including fitness characteristics, associated with unmodified perennial species that are being genetically engineered and that will aid in the development of comparative risk assessment methodologies and include measurements of variation among cultivars and environments,

ii. Strategies for conducting large-scale GE field studies with minimal environmental risk and incorporating adaptive management,

iii. Landscape level studies to assess environmental impacts of land use changes and/or ecosystem function and services,

iv. Assessment and documentation of significant community or ecosystem effects that are not revealed by studies on small plots: such as effects on plant, microbial or animal communities; species displacement; soil health; fertilizer, soil amendment, and pesticide inputs; hydrology; water quality; fire frequency or intensity; toxicant and pesticide residue levels, and/or new plant pests,

v. Assessment of the likelihood and impact of gene flow to sexually compatible plants and stable inheritance in related organisms under various management strategies, and/or

vi. Weediness or invasiveness of the GE organism relative to the non-GE parent organism.

5. Other Research Topics Designed to Support the Purposes of this Program. Other areas of research designed to help identify and analyze the environmental effects of biotechnology and help regulators develop long-term policies concerning the introduction of such technologies. Potential areas of research include, but are not limited to:

a. Research addressing phenotypic effects associated with unintended and off-target modifications in GE organisms developed using genome editing technology or other genetic engineering techniques and potential hazards or adverse effects (e.g., resistance) associated with these phenotypic effects to the environment;

b. Research evaluating the potential hazards or adverse effects of GE livestock intended to be reared under commercial conditions on the environment, including the potential need for containment;

c. Research evaluating the efficacy or adverse effects associated with GE animals intended for release into the environment (e.g., for pest population suppression);

d. Research evaluating the performance of various technologies to track the effectiveness of limited field release conditions designed to contain genetically engineered animals or microbes;

e. Modeling approaches to understand the impact of genetic engineering for population suppression or alteration (gene drives including for weed control, release of an insect carrying a dominant lethal, etc.) on target populations or non-target species that interact with the targeted species, especially when incorporating biologically realistic parameters (e.g., numbers of individuals released, dispersal, mating behavior, and other life-history traits, etc.);

f. Research on the efficacy of GE microorganisms used in animal agriculture and/or the downstream impacts on the environment (e.g., the effect of GE microorganisms on biological diversity of soil microorganisms, the effect of GE microorganisms on hydrology and aquatic organisms important for agriculture or the persistence of GE microorganisms in the environment);

g. Research focused on the environmental effects of introducing RNA interference transgenes or other gene silencing mechanisms using RNAi. Important areas include, but are not limited to:

i. Assessment of environmental fate and/or persistence of small RNA molecules, especially those modified to enhance stability; and/or

ii. Potential off-target (within the organism), non-target (effects on other organisms), or other unintended effects of these small RNA molecules in animals and plants (including GE and non-GE plants), and ways to design RNAi, siRNAs, or miRNA to minimize or avoid such effects;

h. Assessment of the effects of multiple engineered insects and/or nematode resistance genes (e.g., Bacillus thuringiensis and RNAi) in a plant on non-target arthropod species and communities;

i. Research to understand the frequency and mechanisms by which pests or diseases overcome plant pest or disease resistance traits conferred by engineered genes (including where relevant how this compares to resistance to traditional approaches);

j. Research evaluating the relative efficacy of various biotechnology and non-biotechnology approaches used alone or in combination for mitigation of pests; and/or

k. Development and/or evaluation of high-throughput methodologies to assess pathogenicity, biocontrol properties, or any other plant pest risk properties of novel strains of GE microorganisms such as but not limited to comparison of bioinformatic

vs. empirical assessment to determine these properties.

Standard Research Proposals must not exceed $650,000 total (including indirect costs) for project periods up to four years.

CONFERENCE PROPOSALS. Applicants to the BRAG program may request partial funding to organize a conference or workshop that brings together scientists, regulators, and other stakeholders to review science-based data relevant to gene flow and co-existence, emerging technologies related to biotechnology (such as genome editing and gene drives), risk assessment, or risk management of GE organisms released into the environment. To be eligible for funding, the steering committee for the proposed conference should include representatives from a variety of relevant and appropriate scientific disciplines. BRAG conference applications must include the following:

1. Describe the relevance of the proposed conference to biotechnology risk assessment in U.S.

agriculture;

2. Explain the uniqueness and timeliness of the conference;

3. Outline the qualifications of the organizing committee and the appropriateness of the invited speakers to the topic areas to be covered;

4. State clearly the goals of the conference and the likely outcomes;

5. Explain the need for the various elements of the budget;

6. Provide a clear plan to disseminate the outcome of the conference to the public; and

7. Describe how the organizers will make up the total costs of the conference from other sources.

The goals for the conference should include sharing of scientific information and identification of gaps in knowledge, and/or public education and outreach, among others. Publication of the proceedings is highly encouraged, and a copy of any publications should be provided to NIFA.

Conference Proposals must not exceed $50,000 total and the conference must occur after August 1, 2024. Indirect costs are not allowed on conference grants.

PART II. AWARD INFORMATION

A. Available Funding This RFA is being released prior to the passage of a full appropriations act for FY 2024.

Enactment of a continuing resolution, appropriations act, or other authorizing legislation may affect the availability or level of funding for this program. The amount available for BRAG in FY 2024 is approximately $5,500,000. USDA is not committed to fund any particular application or to make a specific number of awards.

The Automated Standard Application for Payments, operated by the Department of Treasury, Bureau of Fiscal Service, is the designated payment system for awards resulting from this RFA.

B. Application Restrictions NIFA will evaluate applications using the criteria described in Part V of this RFA. Application for FY2024 is limited to the following types:

1. New application: New applications will be evaluated using the criteria described in Part V of this RFA and are subject to the due dates herein (see Appendix III for definition).

2. Resubmitted application: This is a project application that has been submitted for consideration under the same program previously but has not been approved for an award under the program. Resubmitted applications must include the response to the previous review panel summary and are subjected to the same criteria and due dates herein.

Resubmitted applications must contain the NIFA-assigned proposal number of the previously submitted application in the Federal Field (Field 4) on the application form (see Appendix III for definition).

C. Project and Grant Types The following describes the types of projects and grants that are eligible for funding:

1. Project Types. Applicants must propose a Research project as described in Purpose and Priorities in Part I, B of this RFA. Only Research projects described in Part I, B of this RFA will be considered for review.

2. Grant Types. Applicants must select the appropriate grant type specified within the program area description in Part I, B of this RFA.

a. Standard Proposals. Standard research proposals should not exceed $650,000 (including indirect costs) for project periods up to four (4) years of support.

Proposal requests exceeding these limits will be excluded from review.

b. Conference Proposals. Conference proposals should not exceed $50,000.

Indirect costs are not allowed on conference grants. Proposal requests exceeding these limits will be excluded from review.

The BRAG program will not support applications for postdoctoral fellowships. In addition, the BRAG program will not support applications in any of the following areas:

food safety risk assessment; health risk assessment or risk assessment of humans or domestic food animals exposed to GE organisms, including clinical trials; methods for seed storage; commercial product development; product marketing strategies; or other research unrelated to environmental risk assessment or risk management.

https://www.fiscal.treasury.gov/fsservices/gov/pmt/asap/asap_home.htm

D. Ethical Conduct of Funded Projects In accordance with sections 2, 3, and 8 of 2 CFR Part 422, institutions that conduct USDA-funded extramural research must foster an atmosphere conducive to research integrity, bear primary responsibility for prevention and detection of research misconduct, and maintain and effectively communicate and train their staff regarding policies and procedures. In the event an application to NIFA results in an award, the Authorized Representative (AR) assures, through acceptance of the award that the institution will comply with the above requirements. Award recipients must, upon request, make available to NIFA the policies, procedures, and documentation to support the conduct of the training. See Responsible and Ethical Conduct of Research for further information.

https://www.ecfr.gov/cgi-bin/text-idx?SID=272377e0bfb609ea128bb36aeb425903&mc=true&node=pt2.1.422&rgn=div5 https://nifa.usda.gov/responsible-and-ethical-conduct-research https://nifa.usda.gov/responsible-and-ethical-conduct-research

PART III. ELIGIBILITY INFORMATION

A. Eligibility Requirements Applicants for the BRAG program are limited to public or private research or educational institutions or organizations and must meet all the requirements discussed in this RFA. Failure to meet the eligibility criteria by the application deadline may result in exclusion from consideration or preclude NIFA from making an award. For those new to Federal financial assistance, NIFA’s Grants Overview provides highly recommended information about grants and other resources to help understand the Federal awards process.

Duplicate or Multiple Submissions – In accordance with Part III of the NIFA Grants Application Guide, submission of duplicate or predominantly overlapping applications is not allowed. NIFA will disqualify both applications if an applicant submits multiple applications that are duplicative or substantially overlapping to NIFA programs within the same fiscal year.

B. Cost Sharing or Matching No Match Required - The BRAG program has no matching requirement. NIFA will not factor matching resources into the review process as an evaluation criterion.

C. Centers of Excellence Pursuant to Section 7214 of the Agricultural Act of 2014 (Pub. L. 113-79), 7 U.S.C. 5926, NIFA will recognize and prioritize COE applicants that carry out research, extension, and education activities that relate to the food and agricultural sciences. A COE is composed of one or more of the following entities that provide financial or in-kind support to the COE.

1. State agricultural experiment stations

2. Colleges and universities

3. University research foundations

4. Other research institutions and organizations

5. Federal agencies

6. National laboratories

7. Private organizations, foundations, or corporations

8. Individuals

9. Any group consisting of two or more of the entities described in (1) through (8).

https://nifa.usda.gov/resource/grants-overview https://www.nifa.usda.gov/nifa-22-001-nifa-grants-application-guide https://www.nifa.usda.gov/nifa-22-001-nifa-grants-application-guide https://uscode.house.gov/view.xhtml?req=(title:7%20section:5926%20edition:prelim)%20OR%20(granuleid:USC-prelim-title7-section5926)&f=treesort&edition=prelim&num=0&jumpTo=true https://www.nifa.usda.gov/nifa-15-019-centers-excellence-provision

PART IV. APPLICATION AND SUBMISSION

A. Letter of Intent Instructions Applicants are strongly encouraged to submit a “Letter of Intent to Submit an Application” by the Letter of Intent (LOI) request date specified in this RFA. This does not obligate the applicant in any way but provides useful information to the BRAG program regarding the project’s fit with the program and assists in preparing for application review. Applicants who do not submit a letter of intent by the specified request date are still allowed to submit an application by the application due date specified in the RFA. We request a LOI for all grant types, except Conference Grant type.

Please follow the guidelines below for LOI submission

1. The Letter of Intent must adhere to the following formatting guidelines:

a. Font size must be at least 12 point.

b. Margins must be at least one (1) inch in all directions.

c. Line spacing must not exceed six (6) lines of text per vertical inch.

d. Page size must be letter (i.e., 8.5 inches × 11 inches).

2. The Letter of Intent is limited to two (2) pages.

a. Provide the following on Page 1:

i. the name, professional title, department, institution, and e-mail address of the lead project director (PD) and name, professional title, department, and institution of all collaborating investigators

ii. the one (1) Program Area that is most closely addressed in the application

b. Provide the following on Page 2:

i. a descriptive title

ii. rationale and one (1) specific program area the project best aligns with

iii. overall hypothesis or goal

iv. specific objectives

v. approach

vi. potential impact and expected outcomes for federal regulatory agencies related to biotechnology.

3. NIFA will only accept LOI in the portable document format (PDF). Attach the PDF LOI to an e-mail addressed to Pushpa Kathir (pushpa.kathir@usda.gov). In the e-mail subject line, write: Letter of Intent HX _ [PDs Last Name].

4. NIFA discourages the submission of more than one (1) LOI per lead PD to a program.

5. Scientific program staff will review LOIs to plan for appropriate expertise for the peer review panel and to ensure that proposed projects fit appropriately within the Program Areas.

6. Please notify the main Program Area Contact of any changes to key project personnel, title, or objectives between the submission of the LOI and the full application.

B. Method of Application Applicants must apply to this RFA electronically; no other method or response is accepted. The electronic application for this RFA and additional resources are available on Grants.gov and Grants 101. Table 3 provides instructions on how to obtain an electronic application. Part III of the NIFA Grants Application Guide contains detailed information regarding the Grants.gov registration process.

https://www.grants.gov/ https://www.grants.gov/web/grants/learn-grants/grants-101/pre-award-phase.html/ https://www.nifa.usda.gov/nifa-22-001-nifa-grants-application-guide

Table 3. Steps to Obtain Application Materials

Steps Action

Step One:

Register

New Users to Grants.gov must register early with Grants.gov prior to submitting an application (Register Here).

Step Two:

Download Adobe

Download and Install Adobe Reader (see Adobe Software Compatibility for basic system requirements).

Step Three: Find Application

Using this funding opportunity number: USDA-NIFA-BRAP-010309, search for application here: Opportunity Package.

Step Four: Assess Readiness

Contact an AR prior to starting an application to assess the organization’s readiness to submit an electronic application.

Table 4: Help and Resources

Grants.gov Support NIFA Support Grants.gov Online Support Telephone support: 800-518-4726 Toll-Free or 606-545-5035 Email support: support@grants.gov Self-service customer-based support:

Grants.gov iPortal grantapplicationquestions@usda.gov Key Information: Customer service business hours 24/7, except federal holidays.

Email:grantapplicationquestions@usda.gov

Key Information: Business hours: Monday thru Friday, 7a.m. – 5p.m. ET, except federal holidays

C. Content and Form of the Application The NIFA Grants Application Guide is part of the corresponding application package for this RFA. The RFA overrides the NIFA Grants Application Guide if there is a discrepancy between the two documents. NIFA will accept subsequent submissions to an application until the application deadline. However, applicants that do not meet the application requirements, to include partial applications, risk being excluded from NIFA’s review. NIFA will assign a proposal number to all applications that meet the requirements of this RFA. Applicants must refer to the proposal number when corresponding with NIFA. Table 5 outlines other key instructions for applicants.

https://www.grants.gov/web/grants/register.html https://get.adobe.com/reader/ https://www.grants.gov/web/grants/applicants/adobe-software-compatibility.html https://www.grants.gov/web/grants/applicants/search-opportunity-package.html https://www.grants.gov/web/grants/support.html mailto:support@grants.gov https://grants-portal.psc.gov/Welcome.aspx?pt=Grants mailto:grantapplicationquestions@usda.gov https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/ mailto:grantapplicationquestions@usda.gov https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/ https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/

Table 5: Key Application Instructions Instruction References

(All references are to the NIFA Grants Application Guide)

Attachments must be in a portable document format (PDF) format.

Part IV

Check the manifest of submitted files to verify attachments are in the correct format.

Part IV

Conduct an administrative review of the application before submission.

Part IV

Follow the submission instructions. Part IV

Provide an accurate email address, where designated, on the SF-424 R&R.

Part V

Contact the Grants.gov helpdesk for technical support and keep a record of the correspondence.

N/A

Contact NIFA if applicant does not receive correspondence from NIFA regarding an application within 30 days of the application deadline.

N/A

SF 424 R&R Cover Sheet. See Part V of the NIFA Grants Application Guide for the required certifications and assurances.

SF 424 R&R Project/Performance Site Location(s). See Part V of the NIFA Grants Application Guide.

R&R Other Project Information Form. See Part V of the NIFA Grants Application Guide.

1. Field 7. Project Summary (PS)/Abstract. The PS must show how the project goals align with the project goals of the BRAG program. See Part V of the NIFA Grants Application Guide for instructions and suggested templates.

2. Field 8. Project Narrative (PN). The PN shall not exceed 18 pages of written text, including figures and tables, regardless of line spacing. This established maximum is to ensure fair and equitable competition. Applicants requesting consideration of COE status must include their justification at the end of their PN and within the page limits provided for the PN. The PN must include all the following:

a. Introduction: Include a clear statement of the long-term goal(s) and supporting objectives of the proposed activities. Summarize the body of knowledge or other past activities that substantiate the need for the proposed project. Describe ongoing or recently completed significant activities that relate to the proposed project including the work of the key project personnel. Include preliminary data/information pertinent https://www.nifa.usda.gov/nifa-22-001-nifa-grants-application-guide https://www.nifa.usda.gov/nifa-22-001-nifa-grants-application-guide https://www.grants.gov/web/grants/support.html https://www.nifa.usda.gov/nifa-22-001-nifa-grants-application-guide https://www.nifa.usda.gov/nifa-22-001-nifa-grants-application-guide https://www.nifa.usda.gov/nifa-22-001-nifa-grants-application-guide https://www.nifa.usda.gov/nifa-22-001-nifa-grants-application-guide to the proposed project. In addition, this section should include in-depth information on the following, when applicable:

i. Estimates of the magnitude of the issues and their relevance to stakeholders and to federal regulatory agencies.

ii. Reasons for performing the work at the proposed institution;

b. Rationale and significance: The rationale for the proposed project should be concisely presented. The project’s specific relationship and relevance to the program area in which an application is submitted (see Part I, B of this RFA) and its specific relationship and relevance to potential regulatory issues of United States biotechnology research should be shown clearly;

c. Objectives: All applications must include a statement(s) of specific aims of the proposed effort in clear, concise, complete, and logically arranged terms;

d. Experimental Plan: The hypotheses or questions being asked and the methodology to be applied to the proposed project should be stated explicitly. Specifically, this section must include:

i. a description of the investigations and/or experiments proposed and the sequence in which the investigations or experiments are to be performed,

ii. techniques/methods to be used in carrying out the proposed project, including the feasibility of the techniques,

iii. experimental unit, replication, and sample sizes for each experimental group,

iv. results expected,

v. means by which experimental data will be analyzed or interpreted, using power analyses, when appropriate,

vi. pitfalls that may be encountered; limitations to proposed procedures, and

vii. a project timetable that outlines all the important phases of the project as a function of time, year by year, for the entire project, including periods beyond the grant funding period;

e. Centers of Excellence Justification: Applicants requesting consideration of COE status must include their justification at the end of their Project Narratives and within the page limits provided for the project narrative; and

f. For Resubmissions: The response to previous review must not exceed one-page and must be included at the beginning of project narrative document. (This does not count towards the 18-page limit for the project narrative).

3. Field 12, Add Other Attachments. See Part V of the NIFA Grants Application Guide.

R&R Senior/Key Person Profile (Expanded). See Part V of the NIFA Grants Application Guide for profile requirements, details about the biographical sketch, and suggested support templates.

R&R Personal Data. This information is voluntary and is not a precondition of award (see Part V of the NIFA Grants Application Guide).

R&R Budget. See Part V of the NIFA Grants Application Guide.

Indirect costs (IDC) – See Part IV, D of this RFA for funding restrictions regarding indirect cost, and Part V of the NIFA Grants Application Guide for additional information.

https://www.nifa.usda.gov/nifa-22-001-nifa-grants-application-guide https://www.nifa.usda.gov/nifa-22-001-nifa-grants-application-guide https://www.nifa.usda.gov/nifa-22-001-nifa-grants-application-guide

Data Management Plan. Two (2) page limit. Title the attachment as ‘Data Management Plan’ and save file as ‘DataManagementPlan’. A DMP is required for this program; if a DMP is not included, your application may still be accepted for review, but a missing DMP may negatively impact the ranking of the application. Applicants should clearly articulate how the project director (PD) and co-PDs plan to manage and disseminate the data generated by the project. The DMP will be considered during the merit review process (see Part V, B of this RFA, NIFA’s Data Management Plan). NIFA is aware of the need to provide flexibility in assessing DMPs.

The DMP should contain the following components:

1. Expected Data Type. Describe the type of data (e.g., digital, non-digital), how will they be generated, and whether the data are primary or metadata. Research examples include lab work, field work and surveys.

2. Data Format. For data to be readily accessible and usable, it is critical to use the existing appropriate community-recognized standard, and machine-readable format. If the data will be managed in domain-specific workspaces or submitted to public databases (see section c and d) indicate that their required formats will be followed. Regardless of the format used, the data set must contain enough information to allow independent use of the data.

3. Data Storage and Preservation. Data must be stored in a safe environment with adequate measures taken for its long-term preservation. Applicants must describe the plans for storing and preserving the data during and after the project and specify the data workspaces and repositories if they exist. Databases or data repositories for long-term preservation may be the same that are used to provide Data Sharing and Public Access (see section d). Estimate how much data will be preserved and state the planned retention period. Include an outline of strategies, tools, and contingency plans that will be used to avoid data loss, degradation, or damage.

4. Data Sharing and Public Access. Describe your data access and sharing procedures during and after the grant (e.g., publication or public release). Name specific repositories and catalogs as appropriate. Outline any restrictions such as copyright, confidentiality, patent, appropriate credit, disclaimers, or conditions for use of the data by other parties.

5. Roles and Responsibilities. Who will ensure DMP implementation? This is particularly important for multi-investigator and multi-institutional projects. Provide a contingency plan in case key personnel leave the project. Also, what resources will be needed for the DMP? If funds are needed, have they been added to the budget request and budget narrative? Projects must budget sufficient resources to develop and implement the proposed DMP.

Supplemental Information Form. See Part V of the NIFA Grants Application Guide.

1. Field 2. Program to which the applicant is applying. Enter the program name

(Biotechnology Risk Assessment) and the program code (HX). Accurate entry is critical.

2. Field 8. Conflict of Interest List. See Part V of the NIFA Grants Application Guide.

D. Funding Restrictions Indirect Cost (IDC) not to exceed 30 percent of Total Federal Funds Awarded (TFFA).

Section 1462(a) and (c) of the National Agricultural Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C. 3310(a) and (c)) limits IDC for the overall award to 30 percent of TFFA https://nifa.usda.gov/resource/data-management-plan-nifa-funded-research-projects https://nifa.usda.gov/resource/data-management-plan-nifa-funded-research-projects https://www.nifa.usda.gov/nifa-22-001-nifa-grants-application-guide https://uscode.house.gov/view.xhtml?req=(title:7%20section:3310%20edition:prelim)%20OR%20(granuleid:USC-prelim-title7-section3310)&f=treesort&edition=prelim&num=0&jumpTo=true under a research, education, or extension grant. The maximum IDC rate allowed under the award is determined by calculating the amount of IDC using:

1. the sum of an institution’s negotiated IDC rate and the IDC rate charged by sub-awardees, if any; or

2. 30 percent of TFFA.

The maximum allowable IDC rate under the award, including the IDC charged by the sub-awardee(s), if any, is the lesser of the two rates.

If the result of number one above is the lesser of the two rates, the grant recipient is allowed to charge the negotiated IDC rate on the prime award and the sub-award(s), if any. Any sub-awards would be subject to the sub-awardee’s negotiated IDC rate.