It is critical that applicants follow the Research (R) 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

To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA) has established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. The FDA established these standards in its rule, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (commonly referred to as the "Produce Safety Rule"), as part of the implementation of the FDA Food Safety Modernization Act. To achieve the requirements of the Produce Safety Rule, a wide-ranging level of cooperation between federal, state, and territory produce regulatory entities is required. Many state and territorial regulatory and food safety agencies plan to align, are in the process of aligning, or have already aligned their produce safety regulatory authority and practices to reflect the modernized aspects of the Produce Safety Rule. Such alignment requires significant investment to successfully develop and implement multifaceted programs in support of the Produce Safety Rule that are nationally uniform and consistent.

This cooperative agreement program is intended to establish, improve, and implement, in partnership with the FDA, a comprehensive and nationally consistent system of support and accompanying resources for state and territorial produce safety regulatory agencies with actual or potential regulatory oversight and responsibility over their respective jurisdiction s commodities regulated in FDA's Produce Safety Rule, and in particular those programs enrolled in the cooperative agreement program "PAR 16-137: State and Territory Cooperative Agreement to Enhance Produce Safety in Preparation of Implementation of FDA's Rule: Standards for the Growing, Harvesting, Packing, & Holding of Produce for Human Consumption (U18)" and any future state and territorial produce safety implementation cooperative agreement programs.

The purpose of this support system will be to assist these agencies, in conjunction with the FDA, in advancing efforts for a nationally integrated food safety system through research, planning, establishment, and/or enhancement of state and territorial produce safety regulatory programs that encourage the safe production of fresh fruits and vegetables, promote understanding of the Produce Safety Rule, and enforce compliance with the Produce Safety Rule's requirements.

Consistent with an increased focus on performance accountability as required by the Uniform Guidance 2 CFR 200, an emphasis will be placed on the applicant’s ability to measure progress and track its performance using objective, proven, and measurable data. As such, applicants should carefully consider the Scored Review Criteria listed in Section V of this announcement when submitting their application. Each applicant is encouraged to identify performance measures, baseline data, and targets for activities listed in the Program Priorities section of this announcement as appropriate and feasible.

The grantee of this cooperative agreement program shall work in close partnership with the FDA to provide leadership and administrative support for a nationally consistent system designed to promote uniform and harmonized adoption and enforcement of the Produce Safety Rule, and to assure consistency in FSMA Produce Safety Rule implementation in state and territorial produce safety regulatory programs.

The grantee shall jointly develop the following items with the FDA through the use of agreed upon documents and best practices and using unified communication and messaging. Any information gathering done under the auspices of the cooperative agreement program should be shared with the FDA and completed in coordination with the FDA.

Goals and Objectives include the following:

Objectives for the Entire Project Period (2019-2024)

A. Overall Cooperative Agreement Program Coordination

In collaboration with the FDA, support consistent implementation of and communication about this cooperative agreement program through the following:

1. Develop with the FDA a written oversight and decision-making process for this cooperative agreement program with the goal of establishing long term infrastructure and program development for the state grantees in this program.

2. Establish a joint FDA and Association communication team, which shall create agreed upon methods for communicating about the outcomes, action items, and any deliverables from this cooperative agreement program, as well as from meetings conducted under the requirements and funding of this cooperative agreement program, including the National Consortium, regional meetings, and meetings of the Produce Integration Group. The communication team shall:

i. Implement a vehicle for sharing consolidated questions and answers from PAR 16-137 and any future state and territorial produce safety implementation cooperative agreement program grantees on produce safety program implementation questions, gathered from the National Consortium and from regional meetings.

ii. Draft and finalize, with full FDA participation and collaboration, joint communication documents to promote the activities of the National Consortium, regional meetings, the Produce Integration Group, work groups, and other collaborative efforts, groups, and meetings conducted under this cooperative agreement program.

B. Support State and Territorial Produce Safety Regulatory Program Consistency

Support consistency of state and territorial produce safety regulatory programs, produce inspections, and produce compliance and enforcement actions through the following:

1. Continue execution and updating of the Model Produce Safety Implementation Framework and advance the goal of consistency across all state produce safety regulatory agencies through supporting new and existing work groups that consist of representative members from the FDA and state and territorial produce safety regulatory programs. The Association shall achieve this through recommending new work groups, facilitating the work groups' formation, and conducting project management for the work groups.

2. With the full collaboration of the FDA, develop a communications plan for clarifying FDA and state authorities as they relate to on-farm inspections and enforcement actions under the Produce Safety Rule. Target audiences shall include state and territorial produce safety regulatory program staff, FDA produce safety staff, and the Association’s constituents.

C. State and Territorial Produce Safety Regulatory Program Assistance

In collaboration with the FDA, provide program assistance to state and territorial produce safety regulatory programs for developing, implementing, and improving produce safety regulatory programs which support compliance with and enforcement of the Produce Safety Rule through the following:

1. Develop a procedure in coordination with the FDA to address questions regarding the deliverables and assistance provided to state and territorial produce safety regulatory programs under this cooperative agreement program.

2. Provide examples of produce safety regulations and legislation, and best practices for adopting legislation related to the Produce Safety Rule, upon request from state and territorial produce safety regulatory programs.

3. Develop, post, and distribute best practices for program development and resource allocation for states and territories within their produce safety regulatory programs, either upon request from state and territorial produce safety regulatory programs or if the Association identifies a need within a program.

4. Develop, post, and distribute items related to human resources for produce safety regulatory programs, such as position descriptions, options for hiring, and capacity building, either upon request from state and territorial produce safety regulatory programs or if the Association identifies a need within a program.

5. Establish and execute mentoring programs between state and territorial produce safety regulatory agencies. The association shall, in coordination with FDA, identify potential mentor and mentee relationships based on program needs, and facilitate the programs in coming to a mutually agreed upon scope in their relationship. The role of the Association shall be to facilitate the relationships and permit the participating programs to direct the content of the relationship to suit their identified needs. Needs and scope of the mentoring partnerships could include challenges to application of the Produce Safety Rule, components of the regulation that need additional education and training, strategies to understand and apply the requirements, or regional or commodity specific needs.

D. Meetings and Work Groups

Facilitate and take a leadership role in meetings related to Produce Safety Rule implementation through the following:

1. Lead, with full FDA participation and collaboration, the planning and delivery of an annual National Consortium meeting of all regulatory parties involved in produce implementation, for the purposes of providing program updates, sharing best practices and providing FDA with feedback on opportunities for enhancements and future developmental ideas. The Association’s duties shall include:

i. Administrative work and planning, including but not limited to arranging and reserving hotels, meeting spaces, and audio-visual needs; ensuring adequate facilitation and administrative support before and during the meeting; providing needed handouts; and other administrative support actions and items. FDA reserves the right to request prior approval of costs related to any of these meetings.

ii. Leading and project managing a planning committee with representative members to determine the agenda for the National Consortium and ensuring adequate review and approval of the agenda.

iii. Capturing high level discussion and action items; working with the FDA to establish next steps, communication methods, and timelines for action items; and providing the next steps, communication methods, and timelines for action items to the FDA within fifteen (15) business days of the conclusion of the National Consortium for posting in an agreed upon platform accessible to all attendees.

2. Assist as needed in the collaborative organization of at least one face-to-face quarterly meeting with each of the four (4) FDA Produce Safety Network regions, with full FDA and state and territory program participation and collaboration, for the purposes of promoting best practices, addressing specific administrative and operational questions, and generating ideas for enhancements and future developmental areas. The Association’s duties shall include:

i. Assisting the regions as needed with administrative work and planning, including but not limited to arranging and reserving hotels, meeting spaces, and A/V needs; organizing and coordinating planning committees; ensuring adequate facilitation and administrative support before and during the meeting; providing needed handouts; and other administrative support actions and items. FDA reserves the right to request prior approval of costs related to any of these meetings.

ii. Assisting the regions as needed with capturing high level discussion and action items.

3. Organize quarterly face-to-face meetings of the Produce Integration Group, consisting of members of the FDA, the Association, representative grantees of PAR 16-137 and any future state and territorial produce safety implementation cooperative agreement program, and other produce safety stakeholders.

The duties shall include:

i. Administrative work and planning, including but not limited to arranging and reserving hotels, meeting spaces, and audio-visual needs; ensuring adequate facilitation and administrative support before and during the meeting; providing needed handouts; and other administrative support actions and items. FDA reserves the right to request prior approval of costs related to any of these meetings.

ii. Development of a draft agenda and organizing and convening a pre-call with all attendees no later than three (3) weeks prior to the quarterly meeting to review the agenda and making adjustments to the agenda as needed.

iii. Ensuring delivery of the following no later than two (2) weeks prior to the quarterly meeting: one-page summaries of all workgroup activities, accomplishments, documents, plans, and timelines; copies of all documents to be presented and discussed at the quarterly meeting; any other items to be reviewed and discussed as part of the meeting's goals and agenda.

iv. Capturing high level discussion and action items from the meeting; working with the FDA to establish next steps, communication methods, and timelines for action items; and providing the next steps, communication methods, and timelines for action items to the FDA within fifteen (15) business days of the conclusion of the meeting for posting in an agreed upon platform accessible to all attendees.

4. Organize meetings of produce work groups and sub-work groups, as needed, to produce agreed-upon procedural and best practices documents and materials. The Association’s duties shall include:

i. Administrative work and planning, including but not limited to arranging and reserving hotels, meeting spaces, and audio-visual needs; ensuring adequate facilitation and administrative support before and during the meeting; providing needed handouts; and other administrative support actions and items. FDA reserves the right to request prior approval of costs related to any of these meetings.

iii. Capturing high level discussion and action items; developing project plans for the deliverables, to include timelines for the overall deliverables and specific action items; and providing the next steps, communication methods, and timelines for action items to all attendees within fifteen (15) business days of the conclusion of the meeting for posting in an agreed upon platform accessible to all attendees.

E. Training

Assist the FDA in researching and identifying additional produce safety training needs and gaps through the following:

1. Research and identify additional training needs and gaps for state and territorial implementation of programs related to the Produce Safety Rule, provide collected data to the FDA and training partners for consideration, and work with the FDA and training partners to determine how the gaps can be addressed.

Limited Term Objectives within the Project Period

Objective for Award Years 1-2 (September 1, 2019 - August 31, 2021)

The grantee should coordinate with the FDA to ensure adequate pre-planning and goal setting for this specific objective to ensure it is completed by award year 2 of the Cooperative Agreement, which is anticipated to conclude on August 31, 2021. Costs for this objective will not be allowed in award years 3-5 (anticipated September 1, 2021 August 31, 2024).

F. On Farm Readiness Reviews (OFRRS)

Continue the OFRR program to promote conformance with the Produce Safety Rule by produce growers, and research and analyze the outcomes of the OFRR program through the following:

1. Assume a leadership role in promoting and coordinating domestic OFRRs, and organize and provide domestic OFRR training in states and territories. Update and improve OFRR training manuals and other related documents and activities in conjunction with the FDA and PAR-16-137 recipients and any future state and territorial produce safety implementation cooperative agreement program grantees.

2. Develop a mechanism for those who perform domestic OFRRs to conduct standardized data collection of outcomes from completed domestic OFRRs in order to analyze OFRR outcomes and make evidence-based improvements to the domestic OFRR system.

i. Summarize the data nationally, regionally, and state-by-state, and compile and report the data to the FDA on at least a quarterly basis.

ii. Assist the FDA in assessing the data.

iii. Propose data-based updates and modifications to the domestic OFRR system and to other domestic OFRR related procedures, training, and education based upon the outcomes of the collection and analysis of the domestic OFRR outcome data. .

3. Create an online resource containing complete and comprehensive information related to conducting domestic OFRRs, such as training information and manuals, updates to the program, and translations of any materials. The resources shall be fully accessible to the FDA and to state and territorial produce safety programs funded under the PAR-16-137 Cooperative Agreement Program and any future state and territorial produce safety implementation cooperative agreement program.

4. Develop a long-term plan in coordination with the FDA to set up a self-sustainable OFRR training and delivery program.

Objective for Award Years 3-5 (September 1, 2021 August 31, 2024)

The grantee should coordinate with the FDA to ensure adequate pre-planning and goal setting for this specific objective. Costs for this objective will not be allowed until award years 3-5 (anticipated September 1, 2021 August 31, 2024).

G. Produce Regulatory Program Standards Development

Assist in the development of national produce safety regulatory program standards that will establish and promote a uniform foundation of produce safety, including research on existing program standards and how they can be leveraged to develop national produce safety regulatory program standards. Through implementation of national regulatory produce safety standards, the FDA can recognize state and territorial programs foundations and achievements in order to maintain programmatic support, implement improvements, and ensure the protection of the nation’s produce supply. Development of produce safety regulatory standards should include mechanisms for implementing uniform and equitable statutes, regulations, inspections, compliance and enforcement, outreach and education, and resource capacities.

1. Establish and implement a committee structure consisting of members from the FDA and the grantee Association and a minimum of six (6) members representing states and/or territorial produce safety regulatory programs to develop a produce safety national program standard within years 3-5 of the award (anticipated September 1, 2021 - August 31, 2024). FDA representatives will serve as technical advisors and facilitators for the development of the standards. The minimum 6 state and/or territorial members shall represent grantees from all regions and funding tiers currently implementing the FDA State Produce Safety Implementation Cooperative Agreement Program and any future state and territorial produce safety implementation cooperative agreement programs.

2. Conduct research and data gathering on existing program standards and how they can be leveraged and applied to the development of national produce safety regulatory program standards, and share the data in full with FDA. Based upon this data, make recommendations for the development and content of a national produce safety regulatory program standard for state and territorial produce safety regulatory programs, including identification of program standard’s purpose, requirement summary, elements, outcomes and documentation. The framework for regulatory program standards development may be derived from existing national regulatory program standards based upon the outcomes of the background research e.g., Manufactured Food Regulatory Program Standards (MFRPS) and/or Animal Feed Regulatory Program Standards (AFRPS). The expectation is to have a draft national produce safety regulatory program standard completed by the end of award year 5 of the performance period for acceptance by FDA, anticipated August 31, 2024.

3. The grantee will be responsible for hosting a minimum of three (3) program standards planning meetings (minimum two (2) days each) per year (award years 3-5). The grantee will furnish necessary personnel, material, services, facilities, and incidentals to support the meetings; provide funding travel funding for state and association committee member; and solicit support and participation by states, territories, the FDA, and committee members.

4. In collaboration with the FDA, develop draft agendas, and organize and convene pre- and post-meeting calls with program standards committee members.

5. Utilize existing web platforms for the program and maintain folders and files to assist in the dissemination and storage of information and materials associated with the development of the program standards.

6. Provide to the FDA, by end of award year 5 performance period (anticipated August 31, 2024), recommendations for the development and maintenance of a joint (FDA plus non-federal members) committee structure that would be responsible for future updates and maintenance of the standards, coordination with state and territorial regulatory agencies, and long-term plans for sustaining a national produce safety regulatory program standard.

See Section VIII. Other Information for award authorities and regulations.

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

The entities eligible to apply for funding under this funding opportunity announcement must represent State departments of agriculture and/or State departments of health as a primary purpose. The competition is limited because these entities have a unique role in working with States and fostering federal-State collaboration in the areas covered by this Cooperative Agreement.

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.

• 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) 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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 not submit more than one application.

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.

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, 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.

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 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), email 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 sent to:

Daniel Lukash
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7596
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.

The budget justification should also include how resources will be allocated between high and low priority projects.

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:

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:

• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving FDA-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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 and time. 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.

This award may only be used for activities associated with achieving the goals and objectives of the cooperative agreement and work proposed by the grantee. Work proposed under this cooperative agreement may not be duplicated or funded by other cooperative agreements, contracts, or other funding mechanisms. Projects proposed under this cooperative agreement must remain distinct and separate from other projects and funding sources. The grantee must be able to account separately for fund expenditures.

Non-allowable costs:

1. Facilities and work covered under current contracts, cooperative agreements/grants, partnership funds, and other sources cannot be counted towards the fulfillment of the cooperative agreement and must remain distinct and separate from the cooperative agreement. The grantee must be able to account separately for fund expenditures other sources of FDA funding and these cooperative agreements.

2. Vehicle purchases are not permitted.

3. Cooperative agreement funds may not be utilized for new building construction.

4. Food may not be purchased.

5. 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 How to Apply Application Guide. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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.

Post-submission materials are those submitted after submission of the grant application but prior to initial peer review. They are not intended to correct oversights or errors discovered after submission of the application. FDA accepts limited information between the time of initial submission of the application and the time of objective review. Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist.

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.

1. The extent to which the applicant provides clear goals, objectives, performance measures, and intended outcomes that align with an operational plan for identifying, supporting, developing, conducting, and coordinating the overall purpose of this grant and each of the Program priorities. These operations should:

a. support effective, integrated, and uniform produce safety regulations;

b. coordinate efficiently, effectively, and transparently with the FDA and with state and territorial produce safety partners; and

c. have resources and funds appropriately directed into priorities

2. The extent to which the applicant describes collaborative processes with the FDA and state and territorial produce safety regulatory partners.

3. The extent to which the applicant describes how each of the proposed sub-activities will address the overall purpose of this grant and adhere to the Program priorities.

4. The extent to which methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes.

1. The extent to which the applicant proposes clear plans and relevant metrics to monitor progress and outcomes of proposed activities and implementation.

2. The extent to which the evaluation plan aligns with project goals, objectives, activities, and performance measures.

1. The extent to which the management plan demonstrates how applicant will achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks.

2. The extent and relevancy of background, expertise, and administrative experience of key project staff who will direct, manage, and administer the program and/or identify key hires that will be necessary to carry out the program.

3. The extent to which the applicant describes expected organizational, fiscal, administrative, and programmatic risks, challenges and/or limitations associated with their proposed activities and strategies to mitigate and/or overcome these challenges or limitations.

4. The extent to which the applicant incorporates the use of creative, new approaches to information sharing partners

1. The extent to which the applicant demonstrates success in leading and coordinating program evaluation activities, projects, and collaborative efforts among produce safety regulators.

2. The extent to which the applicant documents strong partnerships and collaborations with produce safety regulators and farming communities, including any involvement it has with existing produce safety networks.

3. The extent to which the applicant describes its experience in program development, coordination and evaluation, systems evaluation, and the development of performance metrics and standards.

As applicable for the project proposed, reviewers will evaluate the following additional items but will not give separate 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 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 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 individuals of all ages (including children and older adults) 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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 Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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) appropriate 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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), FDA awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all FDA grants and cooperative agreements.

FDA considers the sharing of research resources developed through FDA-sponsored research an important means to enhance the value and further the advancement of research. When research resources have been developed with FDA funds and the associated research findings published, those findings must be made readily available to the scientific community.

Upon acceptance for publication, scientific researchers must submit the author’s final manuscript of the peer-reviewed scientific publication resulting from research supported in whole or in part with FDA funds to the NIH National Library of Medicine's (NLM) PubMed Central (PMC). FDA defines the author's final manuscript as the final version accepted for journal publication, which includes all modifications from the publishing peer review process. The PMC archive is the designated repository for these manuscripts for use by the public, health care providers, educators, scientists, and FDA. Please see the FDA Public Access Policy.

Certificates of Confidentiality 42 U.S.C. 241(d)

Awardees are responsible for complying with all requirements to protect the confidentiality of identifiable, sensitive information that is collected or used in biomedical, behavioral, clinical, or other research (including research on mental health and research on the use and effect of alcohol and other psychoactive drugs) funded wholly or in part by the Federal Government. See 42 U.S.C. 241(d). All research funded by FDA, in whole or in part, that is within the scope of these requirements is deemed to be issued a Certificate of Confidentiality through these Terms and Conditions. Certificates issued in this manner will not be issued as a separate document.

Awardees are expected to ensure that any investigator or institution not funded by FDA who receives a copy of identifiable, sensitive information protected by these requirements, understand they are also subject to the requirements of 42 U.S.C. 241(d). Awardees are also responsible for ensuring that any subrecipient that receives funds to carry out part of the FDA award involving a copy of identifiable, sensitive information protected by these requirements understand they are also subject to subsection 42 U.S.C. 241(d).

Additional terms and conditions regarding FDA regulatory and ORA/CFSAN programmatic requirements may be part of the Notice of Award.

Cooperative Agreement Terms and Conditions of Award

The administrative and funding instrument used for this program will be the cooperative agreement, an assistance mechanism (rather than an acquisition mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, FDA’s objective is to support and stimulate the recipient’s activities by involvement in and otherwise working jointly with the award recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role of activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardee for the project as a whole, although specific tasks and activities may be shared between the awardee and the FDA as defined below.

A. Cooperative Agreement--Project Director/Principal Investigator Rights and Responsibilities:

The Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with FDA/ORA staff being substantially involved as a partner with the PD/PI, as described below.

The PD/PI will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff have sufficient clearance and/or background checks to work on this project. This individual will work closely with designated officials within the recipient organization and with partner organizations to create and maintain necessary documentation, including both technical and administrative reports; prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal, regulatory, and organizational requirements.

B. Cooperative Agreement--FDA Responsibilities:

An FDA Program Official (PO) and an FDA Project Manager/Technical Advisor will be assigned and named in the Notice of Award. The FDA Program Official and Project Manager/Technical Advisor will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below:

1. Provide guidance, direction, and technical assistance in project planning, implementation, and evaluation;

2. Provide subject matter expertise, programmatic assistance, and evaluation services to support program studies and activities;

3. Actively monitor the supported program via telephone conversations, e-mails, written correspondence, or periodic site visits;

4. Evaluate the supported program, including development of program-level performance measures, consistent data collection, and reporting procedures and protocols;

5. Convene trainings, meetings, conference calls, and site visits with grantee to facilitate collaboration and information sharing;

6. Participate in data analysis, interpretation of findings, and where appropriate, co-authorship of publications;

7. Development of programs to meet the FDA mission;

8. Provision of programmatic technical assistance;

9. Post-award monitoring of project/program performance, including review of progress reports and making site visits; and other activities complementary to those of the FDA.

C. Monitoring Activities:

Periodic program monitoring will be conducted by FDA on an ongoing basis which may include telephone conversations and site visits between the Principal Investigator and FDA Staff assigned to the program. Monitoring also includes the review of written reports. The results of these monitoring activities will be recorded in the official cooperative agreement file and will be available to the grant recipient, upon request, consistent with applicable disclosure statutes and FDA disclosure regulations. Also, the grantee organization shall comply with all special terms and conditions of the cooperative agreement, including those which state that future funding of the project will depend on recommendations from the FDA Staff assigned to the program.

The scope of the recommendation shall confirm that:

a. there has been acceptable progress on the project as measured by mutually agreed upon performance measures;

b. there is continued compliance with all FDA regulatory requirements;

c. if necessary, there is an indication that corrective action has taken place.

The grantee of this cooperative agreement program will include FDA in the dissemination of all information, documents, processes, and procedures created under this agreement, to ensure mutual transparency on messaging, both between the grantee and FDA, and to states and territories and to state and territory extension personnel, particularly those funded under the current or future State Cooperative Agreement to Enhance Produce Safety. FDA will be invited, either as participant or as an observer, to all meetings (in person or electronic) involving grantees of the current or future State Cooperative Agreement to Enhance Produce Safety that discuss any aspects of either cooperative agreement.

The grantee shall ensure that technical assistance provided to state and territorial produce safety programs is not counter to the FDA's laws, regulations, policies, procedures, and program guidance, and that is does not inhibit or counter FDA's ability to perform its required grant and program management requirements and responsibilities, including management of the current or future State Cooperative Agreement to Enhance Produce Safety.

Any information gathering activities conducted under this cooperative agreement program should be conducted in coordination with FDA, and the results of information gathering should be shared with the FDA.

Additional requirements may be listed in the Notice of Award.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the Notice of Award.

Mid-year and annual progress reports must report against the progress made for each of the objectives and activities outlined in the application and agreed upon by the grantee and FDA. The grantee and FDA will determine the specific progress reporting requirements within 90 days of the award.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the terms and conditions of award and 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Alicia Schroder
Office of Regulatory Affairs (ORA)
Office of Partnerships
Telephone: 425-582-3148
Email: [email protected]

Alicia Schroder
Office of Regulatory Affairs (ORA)
Office of Partnerships
Telephone: 425-582-3148
Email: [email protected]

Daniel Lukash
Office of Acquisitions & Grants Services (OAGS)Food and Drug Administration
Telephone: 240-402-7596
Email: [email protected]

Daniel Lukash
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7596
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 Section 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.