2013 brag rfa-modification 12 21 2012.pdf

Biotechnology Risk Assessment Research Grants Program

MODIFICATION: PAGE 17

2013 Request for Applications

LETTER OF INTENT RECEIPT DATE: January 22, 2013 APPLICATION DEADLINE: March 21, 2013

U.S. Department of Agriculture

National Institute of Food and Agriculture

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 Catalog of Federal Domestic Assistance under 10.219, Biotechnology Risk Assessment Research.

DATES: Letters of Intent Receipt date and time is the close of business (COB) on Tuesday, January 22, 2013 (5:00 p.m. Eastern Time). Applications must be received by close of business (COB) on Thursday, March 21, 2013 (5:00 p.m. Eastern Time). Applications received after this deadline will normally not be considered for funding. The agency strongly encourages applicants to submit applications well before the deadline to allow time for correction of technical errors identified by Grants.gov.

Comments regarding this request for applications (RFA) are requested within six months from the issuance of this notice. Comments received after that date will be considered to the extent practicable.

STAKEHOLDER INPUT: The National Institute of Food and Agriculture (NIFA) is requesting comments regarding this RFA from any interested party. These comments will be considered in the development of the next RFA for the program, if applicable, and will be used 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)). This section requires the Secretary to solicit and consider input on a current RFA from persons who conduct or use agricultural research, education and extension for use in formulating future RFAs for competitive programs. Written stakeholder comments on this RFA should be submitted in accordance with the deadline set forth in the DATES portion of this Notice.

Written stakeholder comments should be submitted by mail to: Policy and Oversight Division;

Office of Grants and Financial Management; National Institute of Food and Agriculture; USDA;

STOP 2299; 1400 Independence Avenue, SW; Washington, DC 20250-2299; or via e-mail to:

Policy@nifa.usda.gov. (This e-mail address is intended only for receiving comments regarding this RFA and not requesting information or forms.) In your comments, please state that you are responding to the Biotechnology Risk Assessment Research Grants Program RFA.

EXECUTIVE SUMMARY: NIFA announces the availability of grant funds and requests applications for the Biotechnology Risk Assessment Research Grants Program (BRAG) for fiscal year (FY) 2013 to support environmental assessment research concerning the introduction of genetically engineered organisms (GE) into the environment. NIFA anticipates that the amount available for support of this program in FY 2013 will be approximately $4 million. This RFA is being released prior to the passage of an Appropriations Act for FY 2013. Enactment of mailto:RFA-OGFM@nifa.usda.gov additional Continuing Resolutions or Appropriations Act may affect the availability or level of funding for this program.

This notice identifies the objectives for BRAG projects, the eligibility criteria for projects and applicants, and the application forms and associated instructions needed to apply for a BRAG grant. NIFA additionally requests stakeholder input from any interested party for use in the development of the next RFA for this program.

Changes in the FY 2013 RFA. In FY 2013, a submission of a full proposal application with a corresponding LOI is strongly encouraged (with exception of conference grant applications), but not required. The time and date of receipt of a LOI is 5:00 p.m. ET on Thursday, January 22, 2013. For instructions on how to prepare a LOI, please see Part IV, A. The deadline for submission of a full proposal application is 5:00 p.m. ET on Thursday, March 21, 2013. In FY 2014, a full proposal submitted without a corresponding LOI will not be considered for review.

Table of Contents

PART I—FUNDING OPPORTUNITY DESCRIPTION

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

PART II—AWARD INFORMATION

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

PART III—ELIGIBILITY INFORMATION

A. Eligible Applicants B. Cost Sharing or Matching

PART IV—APPLICATION AND SUBMISSION INFORMATION

A. Letter of Intent Instructions B. Electronic Application Package C. Content and Form of Application Submission D. Submission Dates and Times E. Funding Restrictions F. Other Submission Requirements

PART V—APPLICATION REVIEW REQUIREMENTS

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

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. Access to Review Information B. Use of Funds; Changes C. Confidential Aspects of Applications and Awards D. Regulatory Information E. Definitions

PART I—FUNDING OPPORTUNITY DESCRIPTION

A. Legislative Authority and Background

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 ARS of the U.S. Department of Agriculture (USDA) jointly administer the BRAG program. The administrative regulations for this program are found at 7 CFR 3415 and 7 CFR 3430.

B. Purpose and Priorities

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 effects of introducing into the environment organisms genetically engineered (GE) by recombinant and/or synthetic 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 scientific information relevant to regulatory issues.

The BRAG program supports applied and/or fundamental risk assessment research, which is defined as the science-based evaluation and interpretation of factual information in which a given hazard, if any, is identified, and the consequences associated with the hazard are explored.

Research funded through this program will be 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 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 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 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 information useful to regulators for making science-based decisions in their assessments of genetically engineered (GE) organisms. Accordingly, applicants are encouraged to address the following questions in their applications:

• What is the relevance of this research to the evaluation of GE organisms?

• What information will be provided by this research to help regulators adequately assess GE organisms?

• How does this research provide information or methods or model exposures useful in identifying and/or characterizing hazards associated with introducing GE organisms into the environment?

Applications to the BRAG program must address one of the following program areas or seek partial funding for a conference that addresses science-based risk assessment or risk management of GE organisms released into the environment (See Part I, C. for more detailed descriptions.):

1. Research designed to identify and develop appropriate management practices to minimize physical and biological risks to the environment associated with GE animals, plants, and microorganisms;

2. Research designed to develop methods to monitor the dispersal of GE animals, plants, and microorganisms;

3. Research designed to further existing knowledge with respect to the characteristics, rates, and methods of gene transfer that may occur between GE animals, plants, and microorganisms, and related wild and agricultural organisms;

4. Environmental assessment research designed to provide analysis which compares the relative impacts of animals, plants, and microorganisms modified through genetic engineering to other types of production systems; or

5. Other areas of research designed to further the purposes of the BRAG program.

Awards will not be made for food safety risk assessment or risk management, health risk assessment or risk management of humans or domestic food animals exposed to GE organisms, social or economic research, methods for seed storage, clinical trials, commercial product development, product marketing strategies, or other research deemed inappropriate to risk assessment or risk management relative to the environment.

C. Program Area Description

Program Area Code – HX

Letters of Intent Receipt - Tuesday, January 22, 2013 (5:00 p.m., ET) Application Deadline – Thursday, March 21, 2013 (5:00 p.m., ET) Proposed Budget Requests –

Priority Research Proposals must not exceed $1,000,000 total (including indirect costs) for project periods of up to 4 years.

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

Conference Proposals must not exceed $25,000 total (no indirect costs are allowed on conference grants).

Requested Project Type – Research Projects

Program Area Contacts:

Dr. Shing Kwok (202-401-6060, skwok@nifa.usda.gov), National Program Leader; Plant Systems-Production; Institute of Food Production and Sustainability; National Institute of Food and Agriculture.

Dr. Mark Mirando (202-401-4336, mmirando@nifa.usda.gov), National Program Leader;

Animal Systems; Institute of Food Production and Sustainability; National Institute of Food and Agriculture.

Dr. Jack Okamuro (301-504-5912, mobile: 202-285-9520; jack.okamuro@ars.usda.gov), National Program Leader; Crop Production and Protection; Agricultural Research Service.

NIFA and ARS will competitively award research grants to support science-based biotechnology regulation, thereby helping to address concerns about the effects of introducing genetically engineered (GE) organisms into the environment and helping regulators to develop policies regarding such introduction. The BRAG program also encourages proposals seeking partnership with or involvement of international entities where appropriate and domestically beneficial. In addition, the BRAG program is accepting proposals seeking partial funding for a conference that addresses science-based risk assessment or risk management of GE organisms released into the environment.

PRIORITY RESEARCH PROPOSALS

A priority research project would apply trans-disciplinary and, where appropriate, multi-state and multi-institutional approaches to provide viable solutions to the highest priority issues in biotechnology risk assessment research. A priority award under the BRAG program should encourage maximum flexibility in biotechnology risk assessment and risk management. The research team for a priority grant should be comprised of members working in discovery and mailto:skwok@nifa.usda.gov mailto:mmirando@nifa.usda.gov mailto:jack.okamuro@ars.usda.gov learning and should conduct trans-disciplinary research in an emerging or priority area in biotechnology risk assessment research. Priority research proposals may be focused on applied and/or fundamental research projects.

Areas of interest to the BRAG program for a priority grant are the following:

1. Comparison between Transformation-associated Genomic Variation and Genomic

Variation Introduced by Non-genetic Engineering Approaches in Plants

Comparison of the types and frequencies of nucleic acid changes introduced into plant genomes via genetic insertion techniques versus other plant breeding techniques.

Proposed projects must be comparative studies designed to obtain, analyze, and compare data concerning the types and frequencies of unintended phenotypic variation and the types and frequencies of the associated genomic sequence changes by:

(a) Insertion of DNA with one or more widely used genetic engineering techniques (e.g., particle bombardment, Agrobacterium-mediated transformation), AND

(b) One 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 intergeneric crosses, induced structural changes in chromosomes).

Proposed projects must be conducted in a commercially significant crop species which can include specialty crops and clonally propagated crops. Experimental designs must generate statistically relevant data. These studies should support the assessment of potential unintended effects of the construct that may occur from genetic engineering compared to other breeding techniques.

The use of the word “phenotype” above is not to be confused with the intended new phenotype introduced into the plant by genetic engineering but rather, refers to the introduction of unintended changes to the existing phenotype. The focus of the project is on the unintended consequences of DNA insertion and not on the consequences of the specific DNA inserted.

2. Development of a Risk Assessment Framework for the Environmental Impacts of GE crops at the Landscape Level

Identification and experimental assessment of potential environmental impacts of large-scale growth of GE crops, with emphasis on plants used for biofuels (e.g., perennial species such as trees or grasses, camelina, sorghum, sugarcane, etc.), to support the development of a risk assessment framework. Project must address multiple BRAG topic areas, preferentially chosen from (but not limited to) the following:

(a) Strategies for conducting large scale GE field studies with minimal environmental risk;

(b) Impacts on ecosystem function and services;

(c) Landscape level studies of environmental impacts of land use changes;

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

(e) Assessment of the likelihood and impact of gene flow to related organisms under various management strategies;

(f) Basic biology and ecology of the species; and/or

(g) Weediness or invasiveness of the GE organism.

Priority Research Proposals must not exceed $1,000,000 total (including indirect costs) for project periods of up to four years.

STANDARD RESEARCH PROPOSALS

Proposals that address issues related to newly developed GE organisms (e.g., trees and other perennials, including biofuel crops are especially sought). 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

Research designed to identify and develop appropriate management practices to minimize physical and biological risks to the environment associated with GE animals, plants, and microorganisms. Potential areas of research include, but are not limited to:

(a) Evaluation of management, monitoring, and mitigation methodologies for confinement of field trials of GE organisms;

(b) Development of management methodologies for reducing the spread and persistence of GE organisms into natural and managed environments, and assessments of the stability and efficacy of such methodologies in field environments;

(c) Assessing environmental impact and molecular effects of multi-transgenic stacked traits in transgenic organisms;

(d) Defining and assessing pathways of and parameters for environmental exposure from GE imports for food, feed or processing;

(e) Development of effective bioconfinement strategies, and evaluation of the efficacy of genetic techniques, to prevent gene transfer or outcrossing;

(f) Assessing the effects and effectiveness of reproductive or breeding containment strategies such as sterilization or mono-sexing transgenic animals;

(g) Mitigation measures to limit gene introgression when: transgenic animals are released or escape into the environment, physical containment fails, or biological containment is unavailable; and/or

(h) Development of mechanisms, strategies, and/or tools that foster stewardship and mitigate environmental risks of GE organisms.

2. Methods to Monitor Dispersal of GE Organisms

Research designed to develop methods to monitor the dispersal of GE animals, plants, and microorganisms. Potential areas of research include, but are not limited to:

(a) Assessing the effects of transgene(s) in engineered animal species that may easily spread such as birds, aquatic species, arthropods and other invertebrates. This area may include:

• Studies of transgene stability over multiple generations,

• Comparative mating competence or reproductive studies,

• Juvenile and adult viability studies, and/or

• Comparative behavior and biological studies, including studies addressing whether transgenes can alter host range or ecological interactions;

(b) Survivability profiles and/or fitness of transgenic organisms in the wild; and/or

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

3. Gene Transfer to Domesticated and Wild Relatives

Research designed to further existing knowledge with respect to the characteristics, rates, and methods of gene transfer that may occur between GE animals, plants, and microorganisms, and related wild and agricultural organisms. Potential areas of research include, but are not limited to:

(a) Impacts of gene flow from transgenic plants, insects, animals, or microorganisms to related organisms, communities, or ecosystems. Gene flow research should be directed to organisms with a high potential for outcrossing to sexually compatible plant species, gene flow to feral or wild relatives, or for gene introgression (e.g., those species with high rates of outcrossing) and to genes that have a high potential for altering the fitness of the recipient organism for its environment. With regard to plants, preference will be given to studies with species that have sexually compatible wild relatives in the United States;

(b) Development of new tools to limit unwanted gene flow to sexually compatible organisms.

(c) Fate and stability (persistence) of transgenes that have been introgressed by outcrossing into populations of non-transgenic organisms, and the degree to which they confer a selective advantage or disadvantage upon the carriers, especially with regard to transgenes that confer enhanced growth or abiotic stress tolerance;

(d) Measuring impact of transgene placement (nuclear or cytoplasmic) on the transfer and introgression of transgenes into wild and feral plants, animals, or fungi especially as a means of confinement;

(e) Assessing the influence of genetic background on the expression of and phenotypes conferred by regulatory genes; and/or

(f) Data acquisition and modeling of transgene or transgenic organism escape into the environment, including modeling to identify parameters that influence gene dispersal and its consequences, with a particular interest in insect-mediated gene movement between plants.

Model development should include testing of the model‘s robustness and outcomes over large temporal-spatial scales and different environment.

4. Environmental Impacts of GE relative to non-GE Production Systems

Environmental assessment research designed to provide analysis which compares the relative impacts of animals, plants, and microorganisms modified through genetic engineering to other types of production systems. Potential areas of research include, but are not limited to:

(a) Elucidation of the influence of genetically-engineered crops on ecosystem function including bioenergy crops and other crops engineered for pharmaceutical/industrial production, agronomic trait enhancement, pest resistance, herbicide resistance, etc.;

(b) Landscape level studies of the environmental impacts of land use changes caused by genetic engineering of biofuel crops;

(c) Assessment of the use of transgenic as compared to non-transgenic organisms on the impacts of agricultural or forest management systems (e.g., on community structures of agro- or forest ecosystems). Important focus areas are:

• The presence and function of various types of beneficial organisms,

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

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

(d) Assessment of how the introduction of transgenic organisms alters the impact of agriculture on the rural environment. Documentation of significant off-site community or ecosystem effects that are not revealed by studies on small plots (including both beneficial and detrimental effects), such as altered land use practices or other aspects of human ecology, species displacement, soil erosion, effects on water quality, or other geographically dispersed events. There is a need to identify appropriate sample size, plot size, study duration, and positive and negative controls, including consideration of specific pesticides in conventional agronomic practices, untreated control plots, or organic production systems;

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

(f) 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:

• Community structure,

• Fertilizer, pesticide, and soil amendment inputs,

• Non-target impacts,

• 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,

• Soil health, and/or

• Land use related to yield and productivity;

(g) Assessment of the impacts of genetic engineering on plant-pest interactions, including impacts on the plants themselves and on plant-pest populations;

(h) Development and/or evaluation of tools for assessing weediness or invasiveness of GE plants relative to unmodified parent organisms;

(i) Assessment of the efficacy of existing unintended presence mitigation techniques on a crop by crop basis and/or in seed production/multiplication systems on a crop by crop basis; and/or

(j) Development of novel strategies to mitigate unintended presence of GE organisms in non-GE production systems.

5. Other Research Topics

Other areas of research designed to further the purposes of the BRAG Program. Potential areas of research include, but are not limited to:

(a) Comparative assessment of the effects of GE plants with either a single transgenic resistance gene vs. multiple transgenic resistance genes or single transgenic resistance gene

vs. multiple transgenic genes that confer resistance to insects, diseases, and/or herbicides in order to understand how pest, disease and weedy organisms overcome the resistance conferred. Research focus areas may include:

• The impact of multiple transgenic genes on non-target species,

• The effects of multiple transgenic genes on pest populations, and/or

• Ecological significance and practices needed to manage weeds which are sexually compatible with crops that have multiple transgenic resistance genes to insects and/or diseases.

• Ecological significance and practices needed to manage the GE crop and/or weeds to prevent the selection of single or multiple herbicide resistant crop/weed biotypes either through transgene flow, herbicide selection, or both.

Proposals on pest resistance management are not excluded from the program, but any such proposals submitted should describe a clear and significant connection with biotechnology risk assessment/management.

(b) Biological and ecological studies associated with GE perennial species. Studies may focus on:

• Gene flow,

• Environmental risk persistence,

• Dormancy, and other fitness characteristics,

• Ecosystem interactions and potential ecosystem changes when grown in new settings, and/or

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

(c) Development of environmental risk assessment methodologies for GE organisms when there is little baseline data on the unmodified parent organism (e.g., Panicum virgatum, Miscanthus, Populus spp., Eucalyptus spp., eukaryotic algae); and/or

(d) Assessment of environmental fate, persistence, and potential for off-target, non-target, or unintended effects of RNA interference transgenes or other gene silencing mechanisms using RNAi, siRNA, or miRNA.

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

CONFERENCE PROPOSALS

Applicants to the BRAG program may request partial funding to organize a conference that brings together scientists, regulators, and other stakeholders to review the science-based data relevant to science-based 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 scientific disciplines, such as ecology, population biology, pathology, production and resource management science, as well as educators, extension specialists and others, as appropriate.

BRAG conference applications should: 1) describe the relevance of the proposed conference to agricultural biotechnology risk assessment and/or risk management in the United States,

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, 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 will be required.

Conference Proposals must not exceed $25,000 total. No indirect costs are allowed on conference grants.

PART II—AWARD INFORMATION

A. Available Funding

There is no commitment by USDA to fund any particular application or to make a specific number of awards. Subject to the availability of funds, NIFA anticipates that approximately $4.0 million will be available to fund applications in FY 2013. This RFA is being released prior to the passage of an Appropriations Act for FY 2013. Enactment of additional Continuing Resolutions or Appropriations Act may affect the availability or level of funding for this program.

Awards issued as a result of this RFA will have designated the Automated Standard Applications for Payment System (ASAP), operated by the Department of Treasury’s Financial Management Service, as the payment system for funds. For more information see http://www.nifa.usda.gov/business/method_of_payment.html.

B. Types of Applications

In FY 2013, applications may be submitted to the BRAG Program as one of the following four types of requests:

(1) New application. This is a project application that has not been previously submitted to the BRAG Program. All new applications will be reviewed competitively using the selection process and evaluation criteria described in Part V—Application Review Requirements.

(2) Renewal application. This is a project application that requests additional funding for a project beyond the period that was approved in an original or amended award. Applications for renewed funding must contain the same information as required for new applications, and additionally must contain a Progress Report (see Project Narrative, Part IV). Renewal applications must be received by the relevant due dates, will be evaluated in competition with other pending applications in appropriate area to which they are assigned, and will be reviewed according to the same evaluation criteria as new applications.

(3) Resubmitted application. This is an application that had previously been submitted to the BRAG Program but not funded. Project Directors (PDs) must respond to the previous review panel summary (see Response to Previous Review, Part IV). Resubmitted applications must be received by the relevant due dates, will be evaluated in competition with other pending applications in appropriate area to which they are assigned, and will be reviewed according to the same evaluation criteria as new applications.

(4) Resubmitted renewal application. This is a project application that requests additional funding for a project beyond the period that was approved in the original award. In addition, this is an application that had previously been submitted for renewal to the BRAG Program but not funded. Therefore, PDs must provide a Progress Report as required under the Project Narrative, Part IV, and must respond to the previous review panel summary as required under Response to Previous Review, Part IV. Resubmitted renewal applications must be received by the relevant http://www.nifa.usda.gov/business/method_of_payment.html due dates, will be evaluated in competition with other pending applications in appropriate areas to which they are assigned, and will be reviewed according to the same evaluation criteria as new applications.

C. Project Types

Priority research proposals submitted to the BRAG program should not exceed $1 million (including indirect costs) for project periods of up to 4 years of support. Standard research proposals should not exceed $500,000 (including indirect costs) for project periods of up to 4 years of support. Conference proposals should not exceed $25,000. No indirect costs are allowed on conference grants. Proposal requests exceeding these limits will be excluded from review.

Project periods for Research grants cannot exceed five years, the statutory time limit.

The BRAG program will not support applications for postdoctoral fellowships.

D. Responsible and Ethical Conduct of Research

The responsible and ethical conduct of research (RCR) is critical for excellence, as well as public trust, in science and engineering. Consequently, education in RCR is considered essential in the preparation of future scientists. In accordance with sections 2, 3, and 8 of 7 CFR Part 3022, institutions that conduct extramural research funded by USDA must foster an atmosphere conducive to research integrity, bear primary responsibility for prevention and detection of research misconduct and are to maintain and effectively communicate and train their staff regarding policies and procedures. In the event an application to NIFA results in an award, the AOR assures, through acceptance of the award that the institution will comply with the above requirements. Per award terms and conditions, grant recipients shall, upon request, make available to NIFA the policies and procedures as well as documentation to support the conduct of the training.

Note that the training referred to herein shall be either on-campus or the Collaborative Institutional Training Initiative (CITI) program for RCR (https://www.citiprogram.org/rcrpage.asp). The general content of the ethics training, at a minimum, will emphasize three key areas of research ethics: authorship and plagiarism, data and research integration and reporting misconduct. Each institution will be responsible for developing its own training system, as schools will need flexibility to develop training tailored to their specific student needs. Typically RCR education addresses the topics of: Data Acquisition and Management - collection, accuracy, security, access; Authorship and Publication; Peer Review; Mentor/Trainee Responsibilities; Collaboration; Conflict of Interest; Research Misconduct; Human Subject Research; and Use of Animals in Research.

https://www.citiprogram.org/rcrpage.asp

PART III—ELIGIBILITY INFORMATION

A. Eligible Applicants

Applications may be submitted by any United States public or private research or educational institution or organization. Award recipients may subcontract to organizations not eligible to apply provided such organizations are necessary for the conduct of the project. An applicant’s failure to meet an eligibility criterion by the time of an 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

NIFA does not require matching support for this program. Applications shall be peer reviewed and selected for funding without regard to matching resources.

PART IV—APPLICATION AND SUBMISSION INFORMATION

A. Letter of Intent Instructions

In FY 2013, a submission of a full proposal application with a corresponding LOI is strongly encouraged (with exception of conference grant applications), but not required.

Please follow the guidelines below for LOI submission requirements

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 inch in all directions

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

2. The Letter of Intent is limited to two pages for all project and grant types.

a. On Page 1 provide only the following information:

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 Program Area or the Priority Area that is most closely addressed in the application

b. On Page 2 include:

i. a descriptive title

ii. rationale

iii. overall hypothesis or goal

iv. specific objectives

v. approach

vi. potential impact and expected outcomes

3. NIFA will only accept Letters of Intent in the portable document format (PDF). Attach the

PDF Letter of Intent to an e-mail addressed to Dr. Shing Kwok (skwok@nifa.usda.gov) for Submission of Letter of Intent. In the e-mail subject line, write: Letter of Intent [ProgramArea Code] _ [PDs Last Name].

4. A Letter of Intent is strongly encouraged, but not required, for all grant types except

Conference Grant applications.

5. Submission of more than one Letter of Intent to a program is discouraged.

6. An acknowledgement receipt will be sent by replying to the sender within 5 business days.

7. Letters of Intent will be reviewed by scientific program staff in order to plan for appropriate expertise for the peer review panel and ensure that the proposed project fits appropriately within the Program Area Priorities.

8. Applicants must notify the appropriate Program Area Contact of any changes to project key personnel, title, or objectives from the Letter of Intent to the submission of a full application.

mailto:skwok@nifa.usda.gov

9. The Letter of Intent due date is January 22, 2013 at 5:00 pm ET.

B. Electronic Application Package

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

Applicants are advised to submit early to the Grants.gov system.

New Users of Grants.gov

Prior to preparing an application, it is suggested that the 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 the organization is not prepared (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 much as two weeks to complete the registration process so it is critical to begin as soon as possible. In such situations the AR should go to “Get Registered” on the Grants.gov left navigation bar (or go to http://www.grants.gov/applicants/get_registered.jsp) for information on registering the institution/organization with Grants.gov. A quick reference guide listing the steps is available as a 4-page PDF document at the following website:

http://grants.gov/assets/Grants.govRegistrationBrochure.pdf.

Steps to Obtain Application Package Materials

The steps to access application materials are as follows:

1. In order to access, complete and submit applications, applicants must download and install a version of Adobe Reader compatible with Grants.gov. This software is essential to apply for NIFA Federal assistance awards. For basic system requirements and download instructions, please see http://www.grants.gov/help/download_software.jsp. To verify that you have a compatible version of Adobe Reader, Grants.gov established a test package that will assist you in making that determination. Grants.gov Adobe Versioning Test Package:

http://www.grants.gov/applicants/AdobeVersioningTestOnly.jsp.

2. The application package must be obtained via Grants.gov, go to www.grants.gov, click on “Apply for Grants” in the left-hand column, click on “Step 1: Download a Grant Application Package and Instructions,” enter the funding opportunity number USDA- NIFA-BRAP-004069 in the appropriate box and click “Download Package.” From the search results, click “Download” to access the application package.

Contained within the application package is the “NIFA Grants.gov Application Guide: A Guide for Preparation and Submission of NIFA Applications via Grants.gov.” 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.

http://www.grants.gov/applicants/get_registered.jsp http://grants.gov/assets/Grants.govRegistrationBrochure.pdf http://www.grants.gov/help/download_software.jsp http://www.grants.gov/applicants/AdobeVersioningTestOnly.jsp http://www.grants.gov/

If assistance is needed to access the application package (e.g., downloading or navigating Adobe forms), or to submit the application then refer to resources available on the Grants.gov web site first (www.grants.gov). Grants.gov assistance is also available as follows:

Grants.gov customer support 1-800-518-4726 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: Top 10 requested help topics (FAQs), Searchable knowledge base, self service ticketing and ticket status, and live web chat (available 7:00 A.M. - 9:00 P.M. ET). Get help now!

Please have the following information available when contacting Grants.gov, to help expedite your inquiry:

• Funding Opportunity Number (FON)

• Name of Agency You Are Applying To

• Specific Area of Concern

See http://grants.gov/applicants/app_help_reso.jsp or http://www.nifa.usda.gov/funding/electronic.html for additional resources for applying electronically.

C. Content and Form of Application Submission

Electronic applications should be prepared following Part V and VI of the document entitled “A Guide for Preparation and Submission of NIFA Applications via Grants.gov.” This guide is part of the corresponding application package (see Section A. of this Part). The following is additional information needed in order to prepare an application in response to this RFA. If there is discrepancy between the two documents, the information contained in this RFA is overriding.

Note the attachment requirements (e.g., portable document format) in Part III section 3. of the Guide. ANY PROPOSALS CONTAINING NON-PDF DOCUMENTS WILL BE AT RISK OF BEING EXCLUDED FROM NIFA REVIEW. Partial applications will be excluded from NIFA review. With documented prior approval, resubmitted applications will be accepted until close of business on the closing date in the RFA.

If you do not own PDF-generating software, Grants.gov provides online tools to assist applicants. Users will find a link to “Convert Documents to PDF” on http://grants.gov/help/download_software.jsp#pdf_conversion_programs.

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

http://www.grants.gov/ http://www.grants.gov/aboutgrants/Federal_Holidays_2011.jsp mailto:support@grants.gov https://grants-portal.psc.gov/Welcome.aspx?pt=Grants http://grants.gov/applicants/app_help_reso.jsp http://www.nifa.usda.gov/funding/electronic.html http://grants.gov/help/download_software.jsp#pdf_conversion_programs http://www.csrees.usda.gov/fo/funding.cfm

• Email: electronic@nifa.usda.gov

• Phone: 202-401-5048

• Business hours: Monday through Friday, 7:00 am – 5:00 pm Eastern Time, excluding

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.

2. SF 424 R&R Project/Performance Site Location(s) Information related to the questions on this form is dealt with in detail in Part V, 3. of the NIFA Grants.gov Application Guide.

3. R&R Other Project Information Form Information related to the questions on this form is dealt with in detail in Part V, 4. of the NIFA Grants.gov Application Guide.

a. Field 7. Project Summary/Abstract. The summary should also include the relevance of the project to the goals of the BRAG program. Please find the suggested Project Summary/Abstract Template at: http://www.nifa.usda.gov/home/faq_apply.html#abstract.

b. Field 8. Project Narrative.

PLEASE NOTE: The Project Narrative shall not exceed eighteen (18) pages of written text including figures and tables regardless of whether it is single or double spaced. Use an easily readable font face (e.g., Geneva, Helvetica, Times New Roman). This maximum page limit has been established to ensure fair and equitable competition. The Project Narrative must include all of the following:

(1) Introduction. A clear statement of the long-term goals and supporting objectives of the proposed project should preface the project description. The most significant published work in the field under consideration, including the work of key project personnel on the current application, should be reviewed. The current status of research in the particular scientific field also should be described.

(2) Progress report. Renewal applications and resubmitted renewal applications (as described in Part II, B.) should include a clearly marked performance report describing results to date from the previous award. This section should contain the following information: (1) a comparison of actual accomplishments with the goals established for the previous award; (2) the reasons established goals were not met, if applicable; and (3) a listing of any publications resulting from the previous award. Copies of reprints or preprints may be included in the Appendices to Project Narrative portion of the submission.

(3) Rationale and significance. Present concisely the rationale for the proposed project. The project’s specific relationship and relevance to the program area in which an application is submitted (see Part I, C.) and its specific relationship and relevance to potential regulatory issues mailto:electronic@nifa.usda.gov http://www.nifa.usda.gov/home/faq_apply.html#abstract of United States biotechnology research should be shown clearly. Any novel ideas or contributions that the proposed project offers should also be discussed in this section.

(4) 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: (1) a description of the investigations and/or experiments proposed and the sequence in which the investigations or experiments are to be performed; (2) techniques to be used in carrying out the proposed project, including the feasibility of the techniques; (3) results expected;

(4) means by which experimental data will be analyzed or interpreted; (5) pitfalls that may be encountered; (6) limitations to proposed procedures; and (7) a tentative schedule for conducting major steps involved in these investigations and/or experiments.

In the experimental plan, the applicant must explain fully any materials, procedures, situations, or activities that may be hazardous to personnel (whether or not they are directly related to a particular phase of the proposed project), along with an outline of precautions to be exercised to avoid or mitigate the effects of such hazards.

a. Field 9. Bibliography & References Cited. All work cited, including that of key personnel, should be referenced in this section of the application.

b. Field 12. Other Attachments:

1. Response to Previous Review. This requirement only applies to “Resubmitted Applications” and “Resubmitted Renewal Applications” as described in Part II, B. PDs must respond to the previous review panel summary on no more than one (1) page, titled “RESPONSE TO

PREVIOUS REVIEW.”

2. Cooperation and Institutional Units Involved. Cooperative, multi-institutional and multidisciplinary applications are encouraged. Where applicable, identify each institutional unit contributing to the project and designate the lead institution or institutional unit. Clearly define the programmatic roles, responsibilities and budget for each institutional partner.

3. Appendices to Project Narrative. Appendices to the Project Narrative are allowed if they are directly germane to the proposed project. The addition of appendices should not be used to circumvent the text and/or figures and tables page limitations.

4. Collaborative Arrangements. If it will be necessary to enter into formal consulting or collaborative arrangements with others, such arrangements should be fully explained and justified. If the consultants or collaborators are known at the time of application, a vitae or resume and Statement of Work (SOW) should be provided. In addition, evidence (e.g., letter of support) should be provided that the collaborators involved have agreed to render these services.

The applicant also will be required to provide additional information on consultants and collaborators in the budget portion of the application.

4. R&R Senior/Key Person Profile (Expanded)

Information related to the questions on this form is dealt with in detail in Part V, 5. of the NIFA Grants.gov Application Guide. The number of Co-PDs is limited to eight (8). Please do not list more than this number.

Also, you must attach ‘Current and Pending Support’ information (see NIFA Grants.gov Application Guide p. 33, item 5.3, for guidelines and a suggested format) for each senior/key person identified above. Please find suggested Current and Pending Support Template at:

http://www.nifa.usda.gov/home/faq_apply.html#current. Note: Even if no other funding is currently reported under the ‘Active’ section of this attachment, you must still list information for this grant application under the ‘Pending’ section of this attachment for each senior/key person identified above. Also note: The salary amounts requested for Senior/Key personnel should be below or commensurate with the stated time commitment listed on the Current and Pending Form. A person cannot draw a salary amount for time on the project which exceeds the time committed on the Current and Pending Form.

5. R&R Personal Data – As noted in Part V, 6. of the NIFA Grants.gov Application Guide, the submission of this information is voluntary and is not a precondition of award. If completing the information, do not enter any data in the field requesting the social security number.

6. R&R Budget Information related to the questions on this…