Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture’s National Institute of Food and Agriculture (NIFA) have joined in a collaborative partnership to administer and manage the National Training, Education, Extension, Outreach, and Technical Assistance Competitive Grants Program: Regional Center Grants to Enhance Food Safety. This program is designed to develop and implement a comprehensive food safety training, education and technical assistance program for those affected by the FDA Food Safety Modernization Act (FSMA). The intention is to begin building an infrastructure that will support a national food safety training, education, extension, outreach, and technical assistance system and provide significant opportunities for funding through subcontracts and for partnerships with eligible stakeholder groups, including community-based and non-governmental organizations. Specifically, this program will address the needs of owners and operators of small and medium-sized produce farms, beginning farmers, socially disadvantaged farmers, small processors, or small fresh fruit and vegetable merchant wholesalers. The joint program will award competitive grant funds that enable awardees to establish one National Coordination Center and four Regional Centers for Food Safety Training, Education, Extension, Outreach, and Technical Assistance. The National Coordination Center will coordinate the overall program, while the Regional Centers will reach out into local communities to work with FSMA audiences across the country. Regional Centers will also coordinate with one another through the National Coordination Center.

FDA is issuing this RFA to request applications for the establishment of two Regional Centers, one in the North Central Region and one in the Northeast Region as defined by Cooperative Extension System Regions (http://www.aplu.org/members/commissions/food-environment-and-renewable-resources/board-on-agriculture-assembly/cooperative-extension-section/ecop-members/regions.html) for the Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program. USDA NIFA will issue a separate Funding Opportunity Announcement to request applications for the establishment of two Regional Centers, one in the Western Region and one in the Southern Region for the Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program. Although applications for the four Regional Centers will be submitted to separate agencies, FDA and NIFA will work jointly to manage and administer the overall program for the duration of the awards. The Regional Centers will lead, manage, and coordinate the regional development and implementation of food safety training, education, outreach and technical assistance programs for the intended audiences. Project Teams for the Regional Centers will be required to assemble training teams that include representatives from non-governmental organizations and community-based organizations. Training teams are also highly encouraged to include representatives from Extension, food hubs, local farm cooperatives, and others who can address specific needs of the communities they serve.

FDA has previously issued a separate Funding Opportunity Announcement for the National Coordination Center for Food Safety Training, Education, Extension, Outreach, and Technical Assistance (http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-15-003.html). Under the umbrella of the National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Competitive Grant Program, jointly managed by FDA and NIFA, the National Coordination Center and the Regional Centers will work together to begin building an effective, seamless and sustainable program that will meet the needs of intended audiences affected by new FSMA guidelines.

The National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Grant Program: Regional Centers Grants to Enhance Food Safety will award grants that increase the understanding and adoption of established food safety standards, guidance, and protocols. This program is designed to develop and implement a comprehensive food safety training, education and technical assistance program for those affected by the Food Safety Modernization Act (FSMA). Specifically, this program will address the needs of owners and operators of small and medium-sized produce farms, beginning farmers, socially disadvantaged farmers, small processors, or small fresh fruit and vegetable merchant wholesalers. Grants awarded through this program, to the extent possible, will be carried out in a manner that facilitates the integration of food safety standards and guidance with a variety of agricultural production and processing systems, including conventional, sustainable, organic, and conservation and environmental practices carried out by the eligible entities. The assistance provided by these programs shall be coordinated with and delivered in cooperation with similar services or assistance by other federal agencies or programs serving those eligible entities.

The FDA Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. The law enabled the Food and Drug Administration (FDA), and its Federal food safety partners, to better protect public health, while strengthening the food safety system, by focusing increasingly on preventive food safety measures. FSMA requires the Secretary of Health and Human Services to establish preventive standards for produce safety and for the manufacturing/processing, packing and holding of human food. Successful implementation of new standards will require food safety training, education and technical assistance for small and mid-sized entities.

The Food Safety Modernization Act (FSMA) empowered the Food and Drug Administration (FDA), and its Federal food safety partners, to better protect public health, while strengthening the food safety system, by focusing increasingly on preventive food safety measures. FSMA provided FDA with new enforcement authorities not only to focus on prevention but to help contain problems as they occurred. The law also directed FDA to build an integrated national food safety system in partnership with state and local authorities.

To build an integrated national food safety system, new training related to FSMA will need to be available to all produce growers and vendors, to processors, and to merchant wholesalers. Owners and operators of small and medium-sized produce farms, beginning farmers, socially-disadvantaged farmers, small food processors, and small fruit and vegetable merchant wholesalers frequently have limited access to adequate and affordable food safety training, education, and outreach. Further, they have limited access to the technical assistance that will enable them to implement new food safety guidelines in their respective environments. NIFA, in close collaboration with FDA, will competitively award grants to organizations that develop and implement food safety training, education, extension, outreach and technical assistance to key target audiences, including owners and operators of small and medium-sized farms, small food processors, and small fruit and vegetable vendors affected by FSMA. The program will focus on helping those audiences understand and interpret new Federal food safety guidelines enacted under FSMA, thus enabling them to implement those guidelines in their respective environments and in each of their various agricultural production and processing systems. The intention of this program is to begin building an infrastructure that will support a national food safety training, education, extension, outreach, and technical assistance system and provide significant opportunities for funding through subcontracts and for partnerships with eligible stakeholder groups, including community-based and non-governmental organizations.

Program Area Priorities:

For FY2016, the National Training, Education, Extension, Outreach, and Technical Assistance Competitive Grants Program: Regional Center Grants to Enhance Food Safety are expected to describe Regional Centers that have a leading role in coordinating the development and implementation of FSMA-related training, education, and outreach programs and resources for small and medium-sized farms, beginning farmers, socially disadvantaged farmers, small processors, and/or small fresh fruit and vegetable merchant wholesalers. An outreach plan for conducting education and training to a cadre of regional FSMA trainers must be developed, along with an implementation plan for extending both training and technical assistance to the targeted audiences of farmers, processors and vendors in the respective regions. The implementation plan must include details about how the project teams will assemble and prepare training teams that are required to include representatives from non-governmental organizations and community-based organizations. The National Training, Education, Extension, Outreach, and Technical Assistance Competitive Grants Program: Regional Center Grants to Enhance Food Safety program will fund projects that provide significant funding opportunities through subcontracts to or partnerships with eligible stakeholders, including community-based and non-governmental organizations and others who work directly with the target audiences, for the purpose of providing training and outreach to small and medium-sized farms, beginning farmers, socially-disadvantaged farmers, small food processors, and small fruit and vegetable vendors, and for the various production and processing systems. Project teams are also highly encouraged to include representatives from Extension, food hubs, local farm cooperatives, and others who can address specific needs of the communities they serve.

Applications for the Regional Centers must address all of the following:

• Demonstrate a capacity to lead, manage, and coordinate the development and implementation of food safety training, education, extension, and outreach programs related to the new FSMA guidelines that can be implemented across a variety of agricultural production and food processing systems. Training programs should include development and/or adaptation of already-existing curricula, educational materials, teaching tools, background resources, etc. Curricula, materials, and resources must be consistent with FSMA produce safety standards and preventive control requirements for manufacturing, processing, packing, and holding human food. The materials should be individualized (or readily modified) for the various target audiences, processing, and production systems;
• Identify, recruit, and train a network of key individuals within the respective regions who can reach the target audiences at the regional or local levels. This network must include representatives from non-governmental organizations and community-based organizations to ensure participatory capacity building in the local communities and is highly encouraged to include representatives from Extension, food hubs, local farm cooperatives, and others who can address specific needs of the communities they serve. The Regional Centers will coordinate the network in developing and implementing training, education, extension, outreach, and providing technical assistance throughout communities in their respective localities using curricula, materials, and resources that they develop or adapt from other sources. Curricula, materials, and resources must be consistent with FSMA guidelines. Regional Centers are strongly encouraged to support these training, education, extension, outreach and technical assistance activities through subcontracts or other resource-sharing partnerships with regional or local entities.
• All applicants must clearly demonstrate a significant partnership with community-based organizations, non-governmental organizations and/or other local entities currently working with the target audiences, which may be accomplished through subcontracts to these groups. Significant partners would actively be involved in the development of educational materials and the implementation of training programs to include the identification, recruitment, and training of local trainers.
• Ensure that training and other activities reach all key target audiences, including small and medium-sized farms, beginning farmers, socially-disadvantaged farmers, small food processors, small fruit and vegetable vendors, and various production and processing systems;
• Develop and implement a process for reporting progress to FDA and NIFA through the National Coordination Center. Progress must be reported on an annual basis, but can be reported more frequently if desired; and
• Work collaboratively with the National Coordination Center and other Regional Centers for Food Safety Training, Education, Extension, Outreach, and Technical Assistance (http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-15-003.html) to ensure that training curricula and resources cover core competencies across all funded regional centers, and to provide annual updates to NIFA/FDA on overall program accomplishments.

Other Requirements

• All applicants must clearly demonstrate a capacity to lead, manage, and coordinate a Regional Center focused on developing and implementing training, education, extension, outreach, and technical assistance related to FSMA produce safety standards and preventive control guidelines for manufacturing, processing, packing, and holding food for the range of target audiences, production, and processing systems;
• Applicants should describe multi-state and multi-institutional projects that involve organizations with knowledge and expertise in working with the various regions and audiences, and with the various production and processing systems;
• Successful applicants will demonstrate significant partnerships and collaborations with eligible stakeholders, including community-based organizations, non-governmental
• organizations, food hubs, farm cooperatives, Extension, and/or others skilled at working with key target audiences and will document in the application how resources will be shared with these entities to facilitate direct work with the target audiences;
• Applicants should demonstrate that project teams have a strong track record of serving key target audiences, including owners and operators of small and medium-sized farms, beginning farms, socially-disadvantaged farmers, small food processors, and small fruit and vegetable vendors;
• Applicants should demonstrate that projects will work with target audiences to enhance the co-management of food safety, conservation systems, and ecological health;
• Applicants should demonstrate that projects address a variety of agricultural production and processing systems, encompassing conventional, sustainable, organic, and conservation systems; and
• Projects that address/evaluate costs associated with maintaining FSMA-related education, training, and technical assistance beyond the life of the grants are highly encouraged.

This program encourages projects that, where possible, support activities being implemented by the Cooperative Extension System s eXtension Initiative. This may ensure that project results are widely distributed to a variety of audiences. For detailed guidance on how to partner with eXtension, go to http://create.extension.org/node/2057 .

The focus of this grant opportunity is specifically to award competitive grant funds that enable awardees to develop and implement training, education, extension, outreach, and technical assistance related to new FSMA guidelines. Proposals with a focus on research, formal classroom education, or clinical interventions will not be considered for funding.

Post Award Program Management

In addition, this grant opportunity has common programmatic conditions in order to execute a seamlessly collaborative program between FDA and NIFA as one national unit. For fulfilling the purpose, the following common programmatic terms and conditions will be followed:

• Each Regional Center will develop a communication plan to ensure transparent open communication channels among the Regional Centers, the National Coordination Center, and staff at NIFA and FDA;
• The communication plan must include sharing of all the data pertinent to the activities conducted by the Regional Center, including plans for the development of a sustainable national network for food safety training, education, extension, outreach and technical assistance;
• Active communication among the Regional Centers, the National Coordination Center, and staff at NIFA and FDA should involve joint meetings through teleconferences, webinars, and/or other mechanisms;
• The Regional Centers will work collaboratively with, and seek advice from, the National Coordination Center, FDA and NIFA staff to ensure that training curricula developed and/or adapted will help key target audiences understand and implement food safety practices consistent with new FSMA guidelines.
• The Project Director will be responsible for managing all technical and programmatic aspects of the grant and will be responsible for appropriately acknowledging FDA support in publications, announcements, news programs, and other media; and
• The Project Director and members of the project team will be responsible for attending an annual meeting with staff from NIFA, FDA, Regional Centers, and the National Coordination Center, beginning in the second year of the award, where they will provide updates on project progress, completed training materials or curricula, and any other significant programmatic outputs.

HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Award recipients may subcontract to organizations not eligible to apply directly for grant funds provided such organizations are necessary for the conduct of the project.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission. Late applications will not be accepted for this FOA.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The FDA will not accept duplicate or highly overlapping applications under review at the same time. This means that the FDA will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows FDA/CFSAN staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
Descriptive title of proposed activity
Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
Names of other key personnel
Participating institution(s)
Number and title of this funding opportunity

The letter of intent should be emailed to:

Martin Bernard
Grants Management Specialist
Food and Drug Administration
Office of Acquisition & Grants Services (OAGS)
Telephone: 240-402-7564
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• For this specific FOA, the Research Strategy section is limited to 30 pages.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

• Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
• If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission. This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
• If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed. MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract. MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA’s electronic system for grants administration. eRA Commons and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Late applications will not be accepted for this FOA.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

Additional funding restrictions may be part of the Notice of Award.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the assigned Grants Management Specialist and responsiveness by components of participating organizations, FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process.

Reviewers will consider each of the review criteria below in the determination of scientific merit.

This criterion is used to assess the likelihood that this project will develop and implement a food safety training, education, extension, outreach, and technical assistance program with core competencies to address FSMA guidelines and protocols; mobilize a team of regional FSMA trainers and training teams that must include representatives from non-governmental organizations and community-based organizations. Teams are also highly encouraged to include representatives from Extension, food hubs, farm cooperatives and others skilled at working with key target audiences; and develop technical assistance plans for key target audiences, including owners and operators of small and medium-sized produce farms, beginning farmers, socially disadvantaged farmers, small processors, and small fresh fruit and vegetable merchant wholesalers. Elements considered include: a clear statement of the long-term goal(s) and supporting objectives of the proposed activities, identification of a problem or opportunity to be addressed; body of knowledge, preliminary data and other past activities used to substantiate the need for the proposed project; justification and criteria used to select the population groups to be served; innovation; and the degree to which the proposed project will be sustainable and will advance awareness, understanding, and implementation of new FSMA guidelines.

This criterion is used to assess the soundness of the proposed approach. Elements considered include: soundness/evidence-base of educational curricula to be used in the project; proposed activities and sequence of activities; participant and/or trainer recruitment; methodology and limitations of the proposed approach; project timeline; and expected new products and results (e.g., educational approaches including training curricula, workshops, meetings, conferences, exhibits, publications, electronic communication, fact sheets, newsletters, social media, and mass media)

This criterion is used to assess the adequacy of the proposed recruitment, training, and outreach plan and how the extension and outreach methodology will be evaluated. Elements considered include: stakeholder identification methods, data collection, analysis, and communication plans; and the strengths and limitations of the proposed evaluation approach.

Explicitly state the procedures or methodology you will apply to the proposed effort. This section should include but not necessarily be limited to, descriptions of:

(1) stakeholder involvement in problem identification, planning, implementation and evaluation;
(2) proposed project activities, listed sequentially;
(3) techniques to be employed in this project, including their feasibility and rationale;
(4) expected results;
(5) how extension and education activities will be evaluated;
(6) how data will be analyzed or interpreted;
(7) plans to communicate results to stakeholders and the public;
(8) pitfalls that might be encountered; and
(9) limitations to proposed procedures.

This criterion is used to assess adequacy of proposed project management, including key staff and their functions (to include their ability to serve key target audiences including owners and operators of small and medium-sized produce farms, beginning farmers, socially-disadvantaged farmers, small food processors, and small fruit and vegetable vendors), reporting, accounting procedures (for funds used by the parent organizations and local sites), and coordination of collaborative efforts with local and/or community partners involved in the project.

Project Timetable: The proposal should outline all important phases as a function of time, year by year, for the entire project, including periods beyond the grant funding period.

This criterion is used to assess the extent to which the total budget adequately supports the objectives, is appropriate to the project objectives being proposed, and is cost effective. Elements considered include: the necessity and reasonableness of costs to carry out project activities and achieve project objectives; the appropriateness of budget allocations between the applicant and any collaborating organization(s); and appropriateness of the budget relative to time committed to the project by key project personnel.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall score.

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or FDA-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not Applicable

Not Applicable

Not Applicable

Not Applicable

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by an Objective Review Committee, using the stated review criteria.

As part of the objective review, all applications:

• Will receive a written critique.

Appeals of objective review will not be accepted for applications submitted in response to this FOA.

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by objective review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

Successful applicants will be notified of additional information that may be required or other actions leading to an award. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found in the HHS Grants Policy Statement.

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.

Additional terms and conditions regarding FDA regulatory and CENTER FOR FOOD SAFETY AND APPLIED NUTRITION programmatic requirements may be part of the Notice of Award.

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

Mary Tijerina
Consumer Safety Officer
Center for Food Safety and Applied Nutrition (CFSAN)
Telephone: 240-402-0405
Email: [email protected]

Scarlett Salem
Consumer Safety Officer
Center for Food Safety and Applied Nutrition (CFSAN)
Telephone: 240-402-2080
Email: [email protected]

Martin Bernard
Grants Management Specialist
Grants Management Branch
Food and Drug Administration
Office of Acquisition & Grants Services (OAGS)
Telephone: 240-402-7564
Email: [email protected]

Martin Bernard
Office of Acquisition & Grants Services (OAGS)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20857
Telephone: 240-402-7564
Email: [email protected]

All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.