FY 2019 BRAG RFA-Mod # 1.pdf

Biotechnology Risk Assessment Research Grants Program

MODIFIED: Cover Page and Pages 2, 5, 18, 19 and 27 (11/23/18)

Fiscal Year (FY) 2019 Request for Applications (RFA)

LETTER OF INTENT RECEIPT DATE: December 12, 2018

APPLICATION DEADLINE: February 20, 2019

ELIGIBILITY: See Part III, A of RFA

APPROXIMATE AWARD AMOUNT: $3.5 MILLION

NATIONAL INSTITUTE OF FOOD AND AGRICULTURE; U.S. DEPARTMENT OF

AGRICULTURE

BIOTECHNOLOGY RISK ASSESSMENT RESEARCH GRANTS PROGRAM

INITIAL ANNOUNCEMENT

CATALOG OF FEDERAL DOMESTIC ASSISTANCE: This program is listed in the Assistance Listings under the Catalog of Federal Domestic Assistance number 10.219.

DATES: A Letter of Intent (LOI) should be received by 5:00 p.m. Eastern Time on December 12, 2018. Applications must be received by 5:00 p.m. Eastern Time on February 20, 2019. Applications received after this deadline will normally not be considered for funding (see Part IV, C of this RFA). Comments regarding this request for applications (RFA) are requested within six (6) months from the issuance of this notice. Comments received after that date will be considered to the extent practicable.

STAKEHOLDER INPUT: We at the National Institute of Food and Agriculture (NIFA) seek your comments about this RFA. We will consider your comments when we develop the next RFA for the program, if applicable, and we’ll use them to 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)). Submit your written stakeholder comments by the deadline set forth in the DATES portion of this notice via email to Policy@nifa.usda.gov. (This email address is only for receiving comments regarding this RFA and not for requesting information or forms.) In your comments, please state that you are responding to the Biotechnology Risk Assessment Research Grants Program RFA.

Visit the NIFA website to access a factsheet on the Center of Excellence (COE) designation process, including COE criteria, and a list of programs offering COE opportunities. You may also review a recording of COE outreach and COE implementation webinars on the site. We will update COE webpages as appropriate.

EXECUTIVE SUMMARY: NIFA requests applications for the Biotechnology Risk Assessment Research Grants (BRAG) Program for fiscal year (FY) 2019 to support environmental assessment research concerning the introduction of genetically engineered (GE) organisms into the environment. The anticipated amount available for grants in FY 2019 is approximately $3.5 million. This RFA is being released prior to the passage of an appropriations act for FY 2019. Enactment of additional continuing resolutions or an appropriations act may affect the availability or level of funding for this program.

This notice identifies the objectives for BRAG projects, deadline dates, funding information, eligibility criteria for projects and applicants, and application forms and associated instructions needed to apply for a BRAG grant.

mailto:Policy@nifa.usda.gov http://nifa.usda.gov/centers-excellence

Table of Contents

PART I—FUNDING OPPORTUNITY DESCRIPTION

A. Legislative Authority B. Purpose and Priorities C. Program Area Description

PART II – AWARD INFORMATION

A. Available Funding B. Types of Applications C. Project and Grant Types D. Responsible and Ethical Conduct of Research

PART III—ELIGIBILITY INFORMATION

A. Eligible Applicants B. Cost Sharing or Matching C. Centers of Excellence

PART IV—APPLICATION AND SUBMISSION INFORMATION

A. Letter of Intent Instructions

B. Electronic Application Package and Content and Form of Application Submission C. Submission Dates and Times D. Funding Restrictions E. Other Submission Requirements

PART V—APPLICATION REVIEW REQUIREMENTS

A. General B. Evaluation Criteria C. Conflicts of Interest and Confidentiality D. Organizational Management Information E. Application Disposition

PART VI—AWARD ADMINISTRATION

A. General B. Award Notice C. Administrative and National Policy Requirements D. Expected Program Outputs and Reporting Requirements

PART VII—AGENCY CONTACTS

PART VIII—OTHER INFORMATION

A. Use of Funds; Changes B. Confidential Aspects of Applications and Awards C. Regulatory Information D. Definitions E. Materials Available on the Internet

PART I—FUNDING OPPORTUNITY DESCRIPTION

A. Legislative Authority

Authority for the BRAG Program is contained in section 1668 of the Food, Agriculture, Conservation, and Trade Act of 1990 (7 U.S.C. 5921) and amended in section 7210 of the Farm Security and Rural Investment Act of 2002 (7 U.S.C. 7901) (Pub. L. 107-171). In accordance with the legislative authority in the Farm Security and Rural Investment Act of 2002 (7 U.S.C.

7901), 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 jointly administer the BRAG program, while USDA-NIFA, USDA-Agricultural Research Service (ARS) and Forest Service (FS) provide annual funding for the BRAG program.

The administrative regulations for this program are found at 7 CFR 3415 and 7 CFR 3430.

B. Purpose and Priorities

The Biotechnology Risk Assessment Research Grants (BRAG) Program is aligned with the USDA Strategic Plan (https://www.usda.gov/sites/default/files/documents/usda-strategic-plan- 2018-2022.pdf) and specifically addresses Strategic Goal 1: Promote American Agriculture Products and Exports Sustainable Agricultural, Objective 3.1, Expand International Marketing and Opportunities; Objective 3.2: Prevent or Resolve Barriers to Trade That Hinder U.S. Food and Agricultural Exports, Strategic Goal 7: Provide All Americans Access to Safe, Nutritious, and Secure Food Supply, Objective 7.1, Prevent Foodborne Illness and Protection Public Health.

The purpose of the BRAG Program is to support the generation of new information that will assist Federal regulatory agencies in making science-based decisions about the environmental effects of introducing genetically engineered (GE) organisms by recombinant nucleic acid techniques. Such organisms can include plants, microorganisms (including fungi, bacteria, and viruses), arthropods, fish, birds, mammals, and other animals excluding humans. Investigations of effects on both managed and natural environments are relevant. The BRAG program accomplishes its purpose by providing Federal regulatory agencies with relevant scientific information.

The BRAG Program receives input regarding its program priorities through multiple regulatory agencies that have an interest in the environmental risk related to the introduction of GE organisms. These regulatory agencies include, but are not limited to, 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).

https://www.usda.gov/sites/default/files/documents/usda-strategic-plan-2018-2022.pdf https://www.usda.gov/sites/default/files/documents/usda-strategic-plan-2018-2022.pdf https://www.usda.gov/sites/default/files/documents/usda-strategic-plan-2018-2022.pdf

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 (4) 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 above and 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 to include 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 Director(s) (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 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 areas:

1. Standard Research Proposals

2. Conference Proposals

C. Program Area Description

Program Area Code – HX Letters of Intent Receipt Date – Wednesday, December 12, 2018 (5:00 p.m., ET) Application Deadline – Wednesday, February 20, 2019 (5:00 p.m., ET) Proposed Budget Requests –

Standard Research Proposals must not exceed $500,000 total (including indirect costs) for project periods up to four (4) years.

Conference Proposals must not exceed $25,000 total (indirect costs are not allowed on conference grants).

Program Federal Agency Collaboration –

NIFA will competitively award research grants to support biotechnology regulation, thereby helping to addressing concerns about the effects genetically engineered (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 (1) 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 of their application which SINGLE standard research program area aligns best with their proposed project.

STANDARD RESEARCH PROPOSALS

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 (1) of the following five (5) 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, and mitigation methodologies for assuring confinement of GE organisms during field trials, particularly insects and microbes;

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 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, particularly across different environmental conditions (e.g., drought, presence of interspecific competitors);

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;

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 spread, such as birds, rodents, aquatic species, arthropods and other invertebrates. This area may include:

• Basic biological information about the non-modified species that is important for risk assessment and population models, particularly information about dispersal and behavior,

• Studies on genotype and phenotype stability over multiple generations,

• Comparative mating competence or reproductive studies,

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

e) Information on dormancy in the seed (e.g. wheat, barley, rice, and canola or other propagules affecting persistence of such propagules), particularly variety x environment interactive effects, to assure confinement of field trials. This would include dormancy of crop, sexually compatible weedy species, and hybrids of the crop and weedy relatives; or

f) Development and/or evaluation of tools for assessing 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 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 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 micro-organisms to 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 expression of and phenotypes conferred by genetic modification, to inform understanding of the characteristics and potential outcomes of gene transfer;

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

e) Data acquisition and modeling of GE organisms or engineered gene escape into the environment, including modeling to identify parameters that influence gene dispersal and its consequences.

4. Environmental Impacts of GE relative to Non-GE Organisms in the Context of

Production Systems

Environmental assessment research on production systems which compare the relative impacts of animals, plants, and micro-organisms modified through 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 as compared to non-GE organisms on agricultural, aquatic, or forest ecosystems (e.g. on community structures of agro- or forest ecosystems) or unmanaged ecosystems.

Important focus areas are:

• The population dynamics and ecological impacts of various types of beneficial organisms;

• Defining the magnitude and types of changes in communities or indicator species that could trigger concerns regarding ecosystem impacts;

• How the biology and ecology of indicator taxa are influenced by geography, seasonal fluctuations, species, etc.);

c) Assessment of how the introduction of GE organisms alters the impact of agriculture on the rural environment, such as altered land use practices, species displacement, soil erosion, effects on water quality, or other geographically dispersed events.

Comparative management techniques and resources for 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 are to include, but are not limited to:

• Soil health, fertilizer, pesticide, and soil amendment inputs;

• Changes in toxicant and pesticide residue levels;

• Prevalence and distribution of weeds, including those with single or multiple herbicide resistance;

• Prevalence, distribution, and damage from pests and pathogens, including emergence of resistance;

• Land use related to yield and productivity; and/or

e) Identification and experimental assessment of potential adverse environmental impacts of large-scale growth of GE crops, with emphasis on plants used for bioenergy and/or bio-based products (e.g., sorghum, Camelina, sugarcane, eukaryotic algae, or perennial species such as trees and some grasses), 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:

• 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;

• Strategies for conducting large scale GE field studies with minimal environmental risk;

• Landscape level studies to assess environmental impacts of land use changes and/or ecosystem function and services;

• 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;

• 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

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

5. Other Research Topics Designed to Further the Purposes of this Program

Other areas of research designed to improve the knowledge of emerging technologies in genomics, genome editing, and/or biotechnology as it relates to the BRAG program.

Potential areas of research include, but are not limited to:

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

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

c) Research evaluating the potential hazards 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 resigned to contain genetically engineered animals or microbes;

e) Modeling approaches to understand the impact of genetic engineering for population suppression or alteration (gene drive, release of insect carry dominant lethal, etc.) on target populations or non-target species that interact with the targeted species, especially when incorporating biologically realistic parameters (e.g. of resistance evolution, numbers of individuals released, etc.);

f) Comparison of the types and frequencies of nucleic acid changes introduced into important crop genomes, via genetic engineering techniques versus other plant breeding techniques. These studies should support the assessment of potential unintended effects that may occur from genetic engineering compared to other breeding techniques. Proposed projects must be comparative studies designed to analyze and compare statistically relevant data concerning the types and frequencies of genomic sequence changes and associated unintended phenotypic variation resulting from:

• Insertion of DNA with one (1) or more widely used genetic engineering techniques (e.g., particle bombardment, Agrobacterium-mediated transformation), or off target effects of genome editing technologies (e.g., Zinc finger nucleases, TALENS, and CRISPR-Cas9) compared to one (1) or more other mutation-generating plant breeding techniques (e.g., irradiation or chemical mutagenesis, somatic cell culture and clonal propagation, ploidy alterations, wide interspecies or inter-generic crosses, induced structural changes in chromosomes);

g) Research focused on the environmental effects of introducing RNA interference transgenes or other gene silencing mechanisms using RNAi, siRNA, or miRNA as replicating in animals, plants, microbes, and/or insects. Important areas include, but not limited to:

• Assessment of environmental fate and/or persistence of these small RNA molecules; and/or

• 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);

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

i) Research to understand how pests or diseases overcome plant pest or disease resistance traits conferred by engineered genes (Proposals on pest resistance management are not excluded from the program, but any such proposals submitted should describe clear and significant connection with biotechnology and environmental risk assessment/management).

Standard Research Proposals must not exceed $500,000 total (including indirect costs) for project periods up to four (4) 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), 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, provide a clear plan to disseminate the outcome of the conference to the public; and

6. Describe the means by which 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 $25,000 total and the conference must occur after July 12, 2019. Indirect costs are not allowed on conference grants.

PART II – AWARD INFORMATION

A. Available Funding

The anticipated amount available for BRAG grants in FY 2019 is approximately $3.5 million.

This RFA is being released prior to the passage of an appropriations act for FY 2019. Enactment of additional continuing resolutions or an appropriations act may affect the availability or level of funding for this program.

There is no commitment by USDA to fund any particular application or to make a specific number of awards.

The Automated Standard Applications for Payment System (ASAP), operated by the Department of Treasury’s Bureau of the Fiscal Service, is the designated payment system for awards resulting from this RFA. For more information see https://www.fiscal.treasury.gov/fsservices/gov/pmt/asap/asap_home.htm.

B. Types of Applications

In FY 2019, you may only submit an application to the BRAG program as one (1) of the following grant types of requests:

New application. This is a project application that has not been previously submitted to the BRAG program. We will review all new applications competitively using the screening for administrative requirements, review panel evaluation of proposals using evaluation criteria and selection process described in Part V—Application Review Requirements.

Resubmitted application. This is an application that had previously been submitted to the NIFA but not funded. Project Directors (PDs) must respond to the previous review panel summary (see Response to Previous Review, Part IV). We must receive resubmitted applications by the relevant due dates. We will evaluate resubmitted applications in competition with other pending applications in the appropriate area to which they are assigned and review them according to the same evaluation criteria (Part V, B) as new applications. If you are submitting a resubmitted application, you must enter the NIFA-assigned proposal number of the previously-submitted application in the Federal field (Field 4 on the form).

C. Project and Grant Types

NIFA is soliciting applications for the BRAG program under the following project types:

1. Standard Research Proposals

a) Standard research proposals should not exceed $500,000 (including indirect cost) for project periods up to four (4) years of support.

b) Proposal requests exceeding these limits will be excluded from review.

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

2. Conference Proposals

a) Conference proposals should not exceed $25,000. Indirect costs are not allowed on conference grants.

b) 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 or 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.

Grant Types

The following is a list of available grant types under this RFA.

a) Standard. This is an award instrument by which NIFA agrees to support a specified level of effort for a predetermined project period without the announced intention of providing additional support at a future date.

b) Resubmission. 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. For competitive programs, this type of application is evaluated in competition with other pending applications in the area to which it is assigned.

Resubmissions are reviewed according to the same evaluation as new applications. In addition, applicants must respond to the previous panel review summaries, unless waived by NIFA.

D. Responsible and Ethical Conduct of Research

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 shall, upon request, make available to NIFA the policies, procedures, and documentation to support the conduct of the training.

For information about the Responsible and Ethical Conduct of Research, see https://nifa.usda.gov/responsible-and-ethical-conduct-research.

https://nifa.usda.gov/responsible-and-ethical-conduct-research

PART III—ELIGIBILITY INFORMATION

A. Eligible Applicants

Applications may only be submitted by United States public or private research or educational institutions or organizations, including federal research laboratories. Failure to meet an eligibility criterion by the application deadline may result in the application being excluded from consideration or, even though an application may be reviewed, will preclude NIFA from making an award.

B. Cost Sharing or Matching

In accordance with Section 1492 of the National Agricultural Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C. 3371), as added by section 7128 of the Agricultural Act of 2014 (Pub. L. 113-79), for grants awarded after Oct. 1, 2014, the recipient of an award from the BRAG program must provide funds, in-kind contributions, or a combination of both, from sources other than funds provided through such grant in an amount that is at least equal to the amount awarded by NIFA unless one (1) of the exemptions described herein is applicable. Note that NIFA included information at https://nifa.usda.gov/matching-requirement to further assist you in determining if you must meet the new matching requirement.

The matching funds requirement does not apply to grants awarded:

1. To a research agency of the U.S. Department of Agriculture (USDA); or

2. To an entity eligible to receive funds under a capacity and infrastructure program (as defined in section 251(f)(1)(C) of the Department of Agriculture Reorganization Act of 1994, 7 U.S.C. 6971(f)(1)(C)), including a partner (see Part VIII, D., Definitions, for definition of partnership) of such an entity.

Entities eligible to receive funds under a capacity and infrastructure program and exempt from the matching funds requirement include:

1. 1862 land-grant institutions, including State Agricultural Experiment Stations receiving funding under the Hatch Act of 1887;

2. 1890 land-grant institutions;

3. 1994 land-grant institutions;

4. Entities eligible to receive funds under the of Continuing Animal Health and Disease, Food Security, and Stewardship Research, Education, and Extension Program Funds — Capacity and Infrastructure Program (CIP);

5. Hispanic-Serving Agricultural Colleges and Universities (HSACU);

6. Insular area schools eligible to receive funds from the Distance Education/Resident

Instruction Grant Programs;

7. Entities eligible to receive funds under the of McIntire-Stennis Cooperative Forestry

Program Funds;

https://nifa.usda.gov/matching-requirement

8. Non-Land Grant Colleges of Agriculture (NLGCA) – (for exemption from the new matching requirement, these applications must include NLGCA certification, see instructions for requesting certifications at https://nifa.usda.gov/webform/request-non-land-grant-college-agriculture-designation and for attaching the certification, in Part IV, B of this RFA);

9. Entities eligible to receive funds under a program established under Section 1417(b) of the National Agricultural Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C. 3152(b)), including: (1) 1890 Institution Teaching, Research, and Extension Capacity Building Grants Program; (2) Higher Education Challenge Grants Program; (3) Higher Education Multicultural Scholars Program; and (4) Food and Agricultural Sciences National Needs Graduate and Postgraduate Fellowship Grants Program; and

10. Individual public or private, nonprofit Alaska Native-Serving and Native Hawaiian- Serving Institutions of higher education (see 20 U.S.C. 1059d).

Proposal submissions to this RFA may indicate that multiple entities will complete work as a collaborative partnership. All partners must have a substantial involvement in the project throughout the life of the project. Proposals for partnerships among multiple entities must clearly identify the following:

1. A narrative that clearly establishes each entity’s role in the project;

2. How each project partner will contribute to execution of project objectives; determine experimental design; develop the project work plan and time table; and submit collaborative, timely reports; and

3. A comprehensive project budget that reflects each entity’s financial or third party in-kind contribution (see section 2 of 7 CFR 3430 or section 96 of 2 CFR part 200) to the total project budget costs.

If a proposal indicates that multiple entities, as partners, complete work on the project, and at least one (1) entity is exempt from the matching requirement under #2 above, the entire project will be exempt from the matching requirement. Any partner entity may serve as the lead entity on the project. All partners must be significantly involved in the project.

NIFA will examine proposals recommended for award to determine if the proposed division of work reflects substantial involvement of all entities involved. If a proposal is recommended for award to a lead entity that is not otherwise exempt from the matching requirement, and the proposal does not reflect substantial involvement of at least one (1) partner that is exempt under #2 above, then the matching requirement will apply. Exemption from the matching requirement for an entity not otherwise exempt is limited to the project for which it is a partner.

Waiver of Match: NIFA may waive the matching funds requirement for a recipient for one (1) year for a competitive grant that involves research or extension activities that are consistent with the priorities established by the National Agricultural Research, Education, Extension and Economics Advisory Board (NAREEEAB) for the year involved. Refer to the REE Action Plan to determine whether proposed activities are consistent with the priorities of the NAREEEAB.

See R&R Budget under Part IV, B, of this RFA.

https://nifa.usda.gov/webform/request-non-land-grant-college-agriculture-designation https://nifa.usda.gov/webform/request-non-land-grant-college-agriculture-designation https://nifa.usda.gov/webform/request-non-land-grant-college-agriculture-designation https://nifa.usda.gov/resource/ree-action-plan

C. Centers of Excellence

Pursuant to Section 7214 of the Agricultural Act of 2014 (Pub. L. 113-79), beginning in Fiscal Year 2015, for applicable competitive research and extension programs, NIFA will recognize and provide priority in the receipt of funding to applications from “centers of excellence” that carry out research, extension, and education activities that relate to the food and agricultural sciences.

NIFA held listening sessions in July 2014 and accepted written comments from stakeholders to inform NIFA’s implementation of the COE provision. Information from the webinars and a summary of the input are available on NIFA’s website at https://nifa.usda.gov/centers-excellence.

A COE is composed of one (1) 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; or

9. Any group consisting of two (2) or more of the entities described in (1) through (9).

COE designation is available only to standard grant applicants. Part IV, B., 3. of this RFA contains additional requirements for COE consideration.

PART IV—APPLICATION AND SUBMISSION INFORMATION

A. Letter of Intent Instructions

Applicants are highly 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) On Page 1, provide only the following information:

• 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

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

b) On Page 2, include:

• a descriptive title

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

• overall hypothesis or goal

• specific objectives

• approach

• 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 Dr. Shing Kwok (skwok@nifa.usda.gov). In the e-mail subject line, write: Letter of Intent HX _ [PDs Last Name].

4. We discourage the submission of more than one (1) LOI per applicant 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. You must 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.

mailto:skwok@nifa.usda.gov

The Letter of Intent is highly encouraged and the receipt date is December 12, 2018 at 5:00 pm ET.

B. Electronic Application Package and Content and Form of Application Submission

Only electronic applications may be submitted via Grants.gov to NIFA in response to this RFA.

We urge you to submit early to the Grants.gov system. For information about the pre-award phase of the grant lifecycle see https://www.grants.gov/web/grants/learn-grants/grants-101/pre-award-phase.html.

New Users of Grants.gov

Prior to preparing an application, we recommend that the Project Director/Principal Investigator (PD/PI) first contact an Authorized Representative (AR, also referred to as Authorized Organizational Representative, or AOR) to determine if the organization is prepared to submit electronic applications through Grants.gov. If not (e.g., the institution/organization is new to the electronic grant application process through Grants.gov), then the one-time registration process must be completed PRIOR to submitting an application. It can take as long as two (2) weeks to complete the registration process so it is critical to begin as soon as possible. In such situations, the AR should go to “Register,” in the top right corner of the Grants.gov web page (or go to https://www.grants.gov/web/grants/register.html), for information on registering the institution/organization with Grants.gov. Part II, 1 of the NIFA Grants.gov Application Guide contains detailed information regarding the registration process. Refer to item 2, below, to locate the “NIFA Grants.gov Application Guide.”

Steps to Obtain Application Package Materials

To receive application materials:

1. You must download and install a version of Adobe Reader compatible with Grants.gov to access, complete, and submit applications. For basic system requirements and download instructions, see https://www.grants.gov/web/grants/applicants/adobe-software-compatibility.html. Grants.gov has a test package that will help you determine whether your current version of Adobe Reader is compatible.

2. To obtain the application package from Grants.gov, go to https://www.grants.gov/web/grants/applicants/download-application-package.html and enter the funding opportunity number where appropriate:

Funding Opportunity Number: USDA-NIFA-BRAP-006674.

Click “Search.” On the displayed page, click the corresponding link to continue. A Grant Application Package is tied to a particular funding opportunity. You may move forms amongst different Grant Application Packages but you many ONLY submit an application to the particular funding opportunity to which the Grant Application Package is associated.

https://www.grants.gov/web/grants/learn-grants/grants-101/pre-award-phase.html https://www.grants.gov/web/grants/learn-grants/grants-101/pre-award-phase.html https://www.grants.gov/web/grants/learn-grants/grants-101/pre-award-phase.html 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/adobe-software-compatibility.html https://www.grants.gov/web/grants/applicants/adobe-software-compatibility.html https://www.grants.gov/web/grants/applicants/download-application-package.html

Contained within the application package is the “NIFA Grants.gov Application Guide.”

This guide contains an introduction and general Grants.gov instructions, information about how to use a Grant Application Package in Grants.gov, and instructions on how to complete the application forms.

If you require assistance to access the application package (e.g., downloading or navigating Adobe forms) or submitting the application, refer to resources available on the Grants.gov website (https://www.grants.gov/web/grants/support.html). Grants.gov assistance is also available at:

Grants.gov customer support 800-518-4726 Toll-Free or 606-545-5035 Business Hours: 24 hours a day, 7 days a week. Closed on federal holidays.

Email: support@grants.gov

Grants.gov iPortal (see https://grants-portal.psc.gov/Welcome.aspx?pt=Grants): Top 10 requested help topics (FAQs), Searchable knowledge base, self-service ticketing and ticket status, and live web chat (available 7 a.m. - 9 p.m. ET).

Have the following information available when contacting Grants.gov:

a) Funding Opportunity Number (FON)

b) Name of agency you are applying to

c) Specific area of concern

Electronic applications are to be prepared following Parts V and VI of the NIFA Grants.gov Application Guide. This guide is part of the corresponding application package (see Section A of this part). The following is additional information you need to prepare an application in response to this RFA. If there is discrepancy between the two (2) documents, the information contained in this RFA is overriding.

Note the attachment requirements (e.g., PDF) in Part III, Section 3 of the guide. ANY PROPOSALS THAT ARE NON-COMPLIANT WITH THE REQUIREMENTS (e.g., content format, PDF file format, file name restrictions, and no password protected files) WILL BE AT RISK OF BEING EXCLUDED FROM NIFA REVIEW. Grants.gov does not check for NIFA required attachments or whether attachments are in PDF format; see Part III, Section 6.1 of the guide for how to check the manifest of submitted files. Partial applications will be excluded from NIFA review. We will accept subsequent submissions of an application until close of business on the closing date in the RFA (see Part V, 2.1 of the NIFA Grants.gov Application Guide for further information).

For any questions related to the preparation of an application, review the NIFA Grants.gov Application Guide and the applicable RFA. If assistance is still needed for preparing application forms content, contact:

Email: electronic@nifa.usda.gov Phone: 202-401-5048 Business hours: Monday through Friday, 7 a.m. – 5 p.m. ET, excluding federal holidays.

https://www.grants.gov/web/grants/support.html http://www.opm.gov/policy-data-oversight/snow-dismissal-procedures/federal-holidays/ mailto:support@grants.gov https://grants-portal.psc.gov/Welcome.aspx?pt=Grants mailto:electronic@nifa.usda.gov https://www.opm.gov/policy-data-oversight/snow-dismissal-procedures/federal-holidays/

1. SF 424 R&R Cover Sheet

Information related to the questions on this form is dealt with in detail in Part V, 2 of the NIFA Grants.gov Application Guide. See Part V, Section 2.18 of the NIFA Grants.gov Application Guide for the required certifications and assurances (e.g., Prohibition Against Entities Requiring Certain Internal Confidentiality Agreements).

2. SF 424 R&R Project/Performance Site Location(s)

Detailed information related to the questions on this form is available in Part V, 3 of the NIFA Grants.gov Application Guide.

3. R&R Other Project Information Form

Detailed information related to the questions on this form is available in Part V, 4 of the

a) Field 7. Project Summary/Abstract.

The summary should also include the relevance of the project to the goals of BRAG.

See Part V. 4.7 of NIFA Grants.gov Application Guide for further instructions and a link to a suggested template. The use of this template is highly encouraged.

b) Field 8. Project Narrative.

NOTE: The Project Narrative shall not exceed 18 pages of written text regardless of whether it is single- or double-spaced. We have established this maximum (18 pages) to ensure fair and equitable competition. 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 narratives. The Project Narrative must include all of the following:

• 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 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.

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

• 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,…