It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) 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. Notice of 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 Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) is announcing the availability of a cooperative agreement to be awarded under Limited Competition to a national association or organization whose membership includes State, local, territorial, and/or tribal (SLTT) retail food safety regulators or SLTT government agencies that are responsible for retail food safety.

The intended purpose of this NOFO is to advance conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS). Funds will be awarded to a national association/organization to assist state, local, territorial, and tribal (SLTT) jurisdictions to conform with the VNRFRPS by achieving the objectives described below.

Defined Objectives

1. Develop and implement a system to administer financial assistance to state, local, territorial, and tribal retail regulatory food programs based on the FDA's VNRFRPS flexible funding model.

2. Maintain the Self-Assessment Verification Audit course online.

3. Create educational outreach to prospective mentors to understand the requirements of being a mentor, the importance of sharing their knowledge, the benefit to those mentoring, and the long-term public health impacts that being a mentor provides.

4. Develop and host a VNRFRPS symposium to educate VNRFRPS enrolled jurisdiction and prospective enrollees on the Standards.

Financial assistance to SLTTs, defined under objective one, should utilize a Flexible Funding Model established in collaboration with the grantee and the FDA. A suggested basic model is listed below:

Base Funding	Optional Add-Ons
Development	Mentorship
Maintenance and Confidence	Training/Staff Development and Program Standards Engagement
	Capacity Building
	Special Projects

Base funding is a list of required activities to receive funding from the FDA. The optional add-on categories can be offered to those receiving funding in the base of the model.

Once the cooperative agreement has been awarded, the FDA will work with the grantee on the expected eligibility requirements, financial assistance rates, and other aspects of any financial assistance offered to SLTTs.

Any funding system developed by the grantee to provide financial assistance to SLTTs should meet the following criteria:

Establishes a process for applicants to apply for funding based on the VNRFRPS flexible funding model.

Establishes a system for collection of performance outcomes to document return on investment of the sub-awarded funds.

Establishes a system for monitoring the progress of sub-awardees to include the periodic verification of project milestones, performance outcomes, and reporting of the project results to the FDA.

Establishes a system for the management, distribution, and verification of the use of funds sub-awarded to retail food regulatory programs.

Establishes a system for development of corrective action plans when sub-awardees are not completing the projects proposed or using the funds appropriately and notify the FDA Project Manager of the related issue(s).

Contains a communications strategy that includes advertising the availability of funds, projects funded, and project results.

Describes unbiased methods for solicitation of applications, review of submissions, and selection of sub-awardees to ensure distribution of funds over a wide range of state, local, tribal, and territorial retail food regulatory jurisdictions in keeping with the FDA program priorities.

Involves a joint advisory group including the grantee, FDA, and other stakeholders to establish priorities and to ensure the goals of the cooperative agreement are achieved.

Will ensure that the projects proposed by sub-awardees have not been reimbursed under other cooperative agreements, grants, contracts, and other funding mechanisms.

Projects proposed by the sub-awardees should target the requirements of the approved VNRFRPS flexible funding model. Programs applying for sub-awards should submit a proposal detailing the use and outcomes of the funds requested and a progress report at the conclusion of any funded project.

For Objective #1, the data collected should track the following performance outcomes based on the type of funding the SLTT has been approved to use:

1. Completion of a self-assessment of the enrolled jurisdiction's regulatory retail program against all nine VNRFRPS Standards.

2. Development and implementation of a comprehensive strategic implementation plan to address gaps identified in the SLTT's current self-assessment.

3. Increased conformance with meeting the Standards criteria during the current self-assessment period.

4. Completion of a retail food risk factor study or an equivalent public health metric.

5. Implementation of an intervention strategy or strategies designed to reduce the occurrence of foodborne illness risk factors.

6. Completion of verification audit(s) of Standards reported as being met during their current self-assessment period.

7. Conformance with all nine standards, confirmed by a verification audit, during the current self-assessment period.

Data collected under objective #1 to document performance outcomes should be reported no later than 6 months from the closing date of each sub-award grant cycle year.

For Objective #2, the project should track the following performance outcomes:

Develop a plan for maintaining the Self-Assessment and Verification Audit class online. Projects proposed by the applicant should include at a minimum the timeframes for review of the course each year, the method for the FDA approval of any content changes that may be needed, and method for documentation of the planned work.

Create a report that summarizes any work done to maintain the online course each year of the grant.

For Objective #3, the project should track the following performance outcome:

Develop and document a plan for educational outreach to prospective mentors. Projects proposed by the applicant should include at a minimum the action steps planned for the outreach, the timeframes for the action steps, and the method for analyzing the impact of the outreach.

Implement the outreach plan and document the impact of the outreach in developing new mentors.

Create a report that summarizes any work done on this project with detailed information on the findings of the analysis of the impact of the outreach.

For Objective #4, the project should track the following performance outcome:

Develop, with the FDA, a plan for holding an educational symposium about the VNRFRPS. The symposium will be available to those enrolled in the VNRFRPS and those interested in enrolling. The symposium will be a standalone retail regulatory education program and not mixed as part of other conferences covering unrelated topics. The symposium may be virtual or in person. Grantee will work with the CFP Program Standards Committee Chairs to engage with stakeholders beyond the planning committee to discuss challenges and opportunities of the VNRFRPS.

Develop and implement a plan for the logistics associated with holding the symposium.

Create a method to collect and analyze attendees' opinions about the various topics of the symposium.

Create a report that summarizes any work done on this project with detailed information on the findings of the analysis from the symposium.

The FDA is committed to promoting Diversity, Equity, Inclusion, and Accessibility (DEIA) to achieve the FDA’s mission to protect public health. The grantee is expected to promote diversity among the vendor(s) for goods and services by developing a diversity procurement strategy. The grantee should use their diversity procurement strategy to take all necessary affirmative steps to assure that disadvantaged and women-owned small business concerns, as defined by the U.S. Small Business Administration and outlined in 13 CFR 124-103(b) and 13 CFR 127.200, are solicited for all procurement opportunities whenever there are possible sources. This provision is in support of Federal Acquisition Regulations (FAR) Part 52.219.8 Utilization of Small Business Concerns. The HHS Small Business Office can be solicited for recommendations. The grantee should also consider the diversity efforts of vendors as selection criteria for purchasing goods and services especially when disadvantaged and women-owned small businesses cannot be directly utilized. The grantee may be asked to participate in outreach efforts such as conferences and/or trade shows for the purpose of this provision.

Background

The VNRFRPS apply to the operation and management of a retail food regulatory program by providing a framework designed to accommodate both traditional and emerging approaches to food safety with a focus on reducing the occurrence of foodborne illness risk factors. The VNRFRPS include nine individual Program Standards. Each Program Standard has one or more corresponding worksheet(s), forms and explanatory documents. While the VNRFRPS represent a model of an effective, focused retail food protection program, they begin by providing foundational criteria upon which all regulatory programs can assess and build effective infrastructures through a continuous improvement process.

This funding opportunity furthers the FDA's efforts to enhance state, local, territorial, and tribal (SLTT) retail food protection programs. Legislative and strategic initiatives have addressed FDA's relationship with SLTT authorities in retail food protection activities.

a) Food and Drug Administration Amendments Act of 2007 (FDAAA)

Under FDAAA, FDA is required to work with the states to improve food safety. Section 1004 of FDAAA states:

SEC. 1004. STATE AND FEDERAL COOPERATION

(a) IN GENERAL. The Secretary shall work with the states in undertaking activities and programs that assist in improving the safety of food, including fresh and processed produce, so that state food safety programs and activities conducted by the Secretary function in a coordinated and cost-effective manner. With the assistance provided under subsection (b), the Secretary shall encourage states to

(1) Establish, continue, or strengthen state food safety programs, especially with respect to the regulation of retail commercial food establishments; and (2) Establish procedures and requirements for ensuring that processed produce under the jurisdiction of state

food safety programs are not unsafe for human consumption.

(b) ASSISTANCE. The Secretary may provide to a state, for planning, developing, and implementing such a food safety program

(1) Advisory assistance.

(2) Technical assistance, training, and laboratory assistance (including necessary materials and equipment); and

(3) Financial and other assistance.

(c) SERVICE AGREEMENTS. The Secretary may, under an agreement entered into with a federal, state, or local agency, use, on a reimbursable basis or otherwise, the personnel, services, and facilities of the agency to carry out the responsibilities of the agency under this section. An agreement entered into with a state agency under this subsection may provide for training of state employees.

b) FDA Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, provides the FDA with tools to better protect public health by strengthening the food safety system. It enables FDA to focus on preventing food safety problems rather than reacting to problems after they occur. It also provides the FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. These include authorities such as mandatory recall, expanded administrative detention, suspension of facility registration, enhanced product tracing abilities, and additional recordkeeping requirements for high-risk foods. FSMA also gives the FDA important new tools to hold imported foods to the same standards as domestic foods. FSMA directs the FDA to build an integrated national food safety system in partnership with state and local authorities, explicitly recognizing that all food safety agencies need to work together in an integrated way to achieve national public health goals. FSMA identifies some key priorities in working with partners in areas such as: reliance on federal, state, and local agencies for inspections; improving foodborne illness surveillance; and leveraging and enhancing State and Local food safety and defense capacities

c) Retail Food Safety Initiative

Announced in October 2010, the Retail Food Safety Initiative is part of the Food and Drug Administration’s overall prevention-based, farm-to-table food safety strategy to reduce foodborne illness. The FDA actions in this initiative are prompted by a 10-year study of more than 800 retail food establishments to determine compliance with five key risk factors in nine types of retail operations.

FDA's partnerships with the retail and foodservice industries; state, local, territorial, and tribal regulatory authorities; and other government agencies are a foundational building block of the initiative and key to its success in four action areas:

-Make the presence of certified food protection managers a common practice.

-Strengthen active managerial controls at the retail level and ensure better compliance.

-Encourage widespread, uniform, and complete adoption of the FDA Food Code.

-Create an enhanced local regulatory environment for retail food operations by:

(1) Promoting wider implementation by state, local and tribal regulatory programs of the FDA Voluntary National Retail Food Regulatory Programs Standards.

(2) Ensuring universal participation by local regulators in consistent, high-quality training through increased access and increased portability and transferability of the FDA courses.

(3) Seeking increased multi-year funding for the state, local and tribal programs as part of an integrated food safety system.

d) New Era for Smarter Food Safety

On April 30, 2019, the FDA announced a new approach to food safety, one that recognizes and builds on the progress made in the past but looks towards what processes and tools will be needed for the future. This work will build on the advances that have been and are being made in FDA’s implementation of FSMA while advancing the use of technologies that are currently used in society and business sectors all around us. The VNRFRPS provides a foundational framework for an integrated food safety system for regulatory retail food protection programs.

For more information: https://www.fda.gov/food/food-industry/new-era-smarter-food-safety

e) Healthy People 2030

Healthy People is a national effort that sets goals and objectives to improve the health and well-being of people in the United Sates.

Healthy People established foundational principles, overarching goals, and a plan of action to promote, strengthen and evaluate the Nation's efforts to improve the health and well-being of all people.

Healthy People 2030 is the fifth edition of Healthy People. It aims at new challenges and builds on lessons learned from its first 4 decades. The initiative began in 1979, when Surgeon General Julius Richmond issued a landmark report entitled, Healthy People: The Surgeon General’s Report on Health Promotion and Disease Prevention. This report focused on reducing preventable death and injury. It included ambitious, quantifiable objectives to achieve national health promotion and disease prevention goals for the United States within a 10-year period (by 1990). The report was followed in later decades by the release of updated, 10-year Healthy People goals and objectives (Healthy People 2000, Healthy People 2010, and Healthy People 2020).

For more information: https://www.healthypeople.gov/

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 NOFO.

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)

This opportunity is only available to the following nonprofit food safety training entities that collaborate with 1 or more institutions of higher education:

National organization/associations that perform food safety training and whose membership includes, but is not necessarily limited to, state, local, territorial, and/or tribal regulatory retail food safety professionals or government agencies and who collaborate with one or more institutions of higher education.

Competition is limited to these national organizations/associations for the following reasons:

1. National organizations/associations with membership that includes, but is not necessarily limited to, SLTT regulatory retail food professionals or government agencies will have the relationships and communication systems to effectively promote the objectives established under this cooperative agreement.

2. These national organizations/associations have a vested interest and share the FDA’s visions to advance the VNRFRPS and improve public health outcomes. They are also knowledgeable of the VNRFRPS and the requirements to achieve conformance. These national organizations/associations can best collaborate with the FDA.

3. These national organizations/associations can provide a platform for sharing information and national implementation of the projects pursued by the sub awardees through national and regional meetings, web sites, listservs, and other communications. Most national associations/organizations also have committees that may further advance the projects pursued by the sub awardees.

4. Applicant associations must hold an information sharing agreement with the FDA under 21 CFR 20.88(e) or be able to obtain an agreement prior to the start date of the award. Information sharing is limited to pre-decisional information and only for the purpose outlined in this award.

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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, please reference NIH Grants Policy Statement 2.3.9.2 Electronically Submitted Applications for additional information.

• 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.
  • o   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.
  • o   Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; 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 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women 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 NOFO 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 per 2.3.7.4 Submission of Resubmission Application.  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.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

 

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most FDA opportunities. 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), 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:

Terrin Brown
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: Terrin.Brown@fda.hhs.gov

A technical session will be held for prospective applicants in February 2024. The conference call information will be provided to prospective applicants that submit a letter of intent. The technical session will provide an overview of the submission requirements and allow prospective applicants an opportunity to ask questions regarding the application process. Participation in the technical session is optional, but strongly encouraged.

All page limitations described in the How to Apply Application Guide and the Table of Page Limits must be followed.

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

The following section supplements the instructions found in the How to Apply Application Guide , and should be used for preparing a multi-component application.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

When preparing your application, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

 

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

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.
• Indirect/F&A costs under grants to foreign and international organizations will be funded at a fixed rate of 8 percent of modified total direct costs (MTDC), exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000. (With the exception of the American University of Beirut and the World Health Organization, which are eligible for full F&A cost reimbursement). Awards to domestic organizations with a foreign or international consortium participant may include 8 percent of MTDC, exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000.

 

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

Research Strategy: In the Research Strategy, the applicant shall specifically address the ability to perform the following activities to achieve the objectives in the cooperative agreement:

1. Demonstrate the ability to develop and implement a comprehensive strategic plan that includes goals and project milestones that will result in meeting the objectives of the funding announcement including the development, implementation, and management of a program to financially assist regulatory retail food protection programs. The plan should include information related to the data systems that will be developed and used to meet the objectives.

2. Demonstrate the ability to engage and collaborate with regulatory retail food protection programs, the FDA, and other stakeholders to meet the goals and objectives of this cooperative agreement and proposed project.

3. Demonstrate ability to establish an on-line portal/data management system to manage all aspects of providing financial assistance.

4. Demonstrate the availability of adequately trained staff and, if needed, the ability to hire and/or train personnel to meet the deliverables of the cooperative agreement. Provide justification for hiring new staff, including qualifications, training needs, and new equipment needs.

5. Demonstrate the ability to satisfy the reporting requirements outlined in this announcement.

6. Outline a detailed methodology for program assessment, improvement, and collaboration to accomplish the work, as described in this announcement. Program assessment will include predefined performance outcomes required by the FDA.

7. Demonstrate the ability to provide administrative oversight for funds awarded to regulatory retail food protection programs (sub-awardees) and/or similar associations through this cooperative agreement, including distribution of funds, monitoring project deliverables and expenditures, and implementing corrective actions when necessary.

8. As a part of your application, applicants should explain how they intend to measure performance if their application is funded. This should include Acceptable Quality Levels as well as Public Health Measures that are SMART:

Specific (specific, sensible, significant)

Measurable (meaningful, motivating)

Achievable (agreed, attainable)

Relevant (reasonable, realistic and resourced, results-based)

Time-Bound (time-based, time limited, time/cost limited, timely, time sensitive)

9. Demonstrate the ability to perform work on online platforms used for training.

10. Demonstrate the ability to develop plans for engaging potential mentors and outreach activities.

11. Demonstrate the ability to develop and host educational events.

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:

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide, with the following additional requirements:

(A) an assurance that the eligible entity has developed plans to engage in the types of activities described in this NOFO. This assurance must be uploaded as Appendix #1.

(B) an agreement by the eligible entity to report information required by the Secretary to conduct evaluations under this section. This agreement must be uploaded as Appendix 2.

 

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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH 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. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply - 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 and 45 CFR 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement and 45 CFR 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Awards issued under this FOA will be incrementally funded awards for each budget period. NIH and FDA will not issue any awards under this FOA for a single budget period for multiple years.

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

A majority of the cooperative agreement funds should be spent to build relationships and assist SLTT regulatory agencies with primary responsibility for retail food establishments in their jurisdictions or to agencies with substantial control and responsibility over such agencies, which may include financial support.  

If another national association or organization is utilized by the grantee to administer portions of the objectives, any associated fees must be allocated from the grantee's budget.

In addition, work proposed and conducted under this cooperative agreement, including subawards issued, may not be duplicated or funded by other cooperative agreements, contracts, or other funding mechanisms. Projects proposed and conducted under this cooperative agreement and the funding provided shall remain distinct and separate from other projects and funding sources. The grantee shall be able to account separately for fund expenditures, including employee salaries, wages, and benefits, received through contracts, cooperative agreements, grants, and other funding received by the grantee and these cooperative agreements.

Non-allowable costs:

1. Facilities, work, training, and other expenses reimbursed under other cooperative agreements, grants, contracts, and other funding mechanisms shall remain distinct and separate from this cooperative agreement.

2. Vehicle purchases are not permitted.

3. Cooperative agreement may not be utilized for new building construction or remodeling of existing facilities.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 form. 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 the FDA. See Section III of this NOFO for information on registration requirements

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier 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 the policy. Any instructions provided here are in addition to the instructions in the policy. Post submission materials are not intended to correct oversights or errors discovered after submission of the application. The 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 provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the applicant address each of the objectives of the funding announcement?

Does the applicant demonstrate the organizational capacity to manage the project and provide an infrastructure capable of monitoring progress toward achievement of project milestones?

Does the application demonstrate the capacity and capability to implement a VNRFRPS flexible funding model and distribute, track and monitor sub-awarded funding to SLTT s?

Does organization plan to leverage their work with other organizations? If so, is there adequate demonstration of effectiveness in working with other agencies and appropriate organizations to implement the goals of the cooperative agreement?

Are the proposed system, strategies, and approach to meet the intended outcome of the cooperative agreement well-reasoned, appropriate, and complete?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Does the applicant demonstrate the number and strength of relationships with retail food safety regulatory agencies and public health stakeholders necessary to ensure success of the project?

Does the applicant provide demonstration of effectiveness in working with federal, state, local, territorial, and/or tribal regulatory jurisdictions on food safety issues that positions the applicant to successfully implement the intended outcome of the cooperative agreement?

Did the applicant address the expected challenges and minimize barriers to completing the overall project?

Did the applicant provide a strategy to engage State, Local, Tribal and Territorial retail food protection programs ensuring wide distribution of information developed to meet the objectives of the NOFO?

Are the PD(s)/PI(s), collaborators, and other key personnel well suited to the project, including having appropriate experience and training? Has the applicant demonstrated adequate program resources including staff and technology infrastructure, or the ability to obtain the resources necessary, to sustain and complete the activities described in the NOFO (including the ability to process and administer subawards)?

Does the proposal outline a sufficiently robust information technology solution to manage data generated by the program and demonstrate public health impact?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items

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 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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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 impact score.

Generally not applicable.  Reviewers should bring any concerns to the attention of assigned Grants Management Specialist.

Generally not applicable.  Reviewers should bring any concerns to the attention of assigned Grants Management Specialist.

Generally not applicable.  Reviewers should bring any concerns to the attention of assigned Grants Management Specialist.

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 convened by the FDA, 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 NOFO.

Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. 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 for 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 recipient’s business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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.

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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. For additional guidance regarding how the provisions apply to FDA grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see  https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what FDA's expectations are for institutions and the individuals supported on FDA-funded awards, please see FDA's Anti-Harassment and Inappropriate Conduct Policy.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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. 

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 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all FDA grants and cooperative agreements except fellowships.

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.

Termination provisions in 2 CFR 200.340 (a) (1-4) are applicable to awards issued under this Notice of Funding Opportunity.

Cooperative Agreement Terms and Conditions of Award

Standard Terms and Conditions of Award

Reporting Requirements:

All FDA grants require both Financial and Performance reporting.

Financial Reporting:

A. Financial Expenditure Reports

A required Federal Financial Report (FFR) must be submitted annually. All annual FFRs must be submitted electronically using the Payment Management System (PMS). This includes all initial FFRs being prepared for submission and any revised FFRs being submitted or re-submitted to the FDA. Paper expenditure/FFR reports will not accepted.

Annual FFRs must be submitted for each budget period no later than 90 days after the end of the calendar quarter in which the budget period ended. The reporting period for an annual FFR will be that of the budget period for the particular grant; however, the actual submission date is based on the calendar quarter. If a grant is under expanded authorities, the grantee must indicate the carryover amount in Section 12. Remarks of the annual FFR.

Performance Progress Reporting:

When multiple years (more than one budget period) are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually as required in the Notice of Award. Annual RPPRs must be submitted using the RPPR module in eRA Commons. The annual RPPR must include a detailed budget. Annual RPPRs are due no later than 60 days prior to the start of the next budget period.

Failure to submit timely reports may affect future funding. Additional Financial and Performance Progress reports may be required for this award. Any additional reporting requirements will be listed under Section IV Special Terms and Condition of the Notice of Award.

Salary Caps:

None of the funds in this award shall be used to pay the salary of an individual at a rate in excess

of the current Executive Level II of the Federal Executive Pay Scale.

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 the 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 the 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).

Acknowledgment of Federal Support:

When issuing statements, press releases, publications, requests for proposal, bid solicitations and other documents --such as toolkits, resource guides, websites, and presentations (hereafter statements )--describing the projects or programs funded in whole or in part with FDA federal funds, the recipient must clearly state:

1. The percentage and dollar amount of the total costs of the program or project funded with federal money; and,

2. The percentage and dollar amount of the total costs of the project or program funded by non-governmental sources.

When issuing statements resulting from activities supported by FDA financial assistance, the recipient entity must include an acknowledgement of federal assistance using one of the following statements.

If the FDA Grant or Cooperative Agreement is NOT funded with other non-governmental sources:

This [project/publication/program/website, etc.] [is/was] supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $XX with 100 percent funded by FDA]/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

If the FDA Grant or Cooperative Agreement IS partially funded with other nongovernmental sources:

This [project/publication/program/website, etc.] [is/was] supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $XX with XX percentage funded by FDA/HHS and $XX amount and XX percentage funded by non-government source(s). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

The federal award total must reflect total costs (direct and indirect) for all authorized funds (including supplements and carryover) for the total competitive segment up to the time of the public statement. Any amendments by the recipient to the acknowledgement statement must be coordinated with the FDA. If the recipient plans to issue a press release concerning the outcome of activities supported by FDA financial assistance, it should notify the FDA in advance to allow for coordination.

Additional prior approval requirements pertaining to Acknowledgement of Federal Support, publications, press statements, etc. may be required, and if applicable, will be listed under Section IV Special Terms and Condition of the Notice of Award.

Prior Approval:

All prior approval requests must be submitted using the Prior Approval module in eRA Commons. Any requests involving budgetary issues must include a new proposed budget and a narrative justification of the requested changes. If there are any questions regarding the need or requirement for prior approval for any activity or cost, the grantee is to contact the assigned Grants Management Specialist prior to expenditure of funds.

For grant awards not covered under Expanded Authorities, Carryover and No Cost Extension (NCE) requests will require prior approval. All Carryover and NCE requests should be submitted using the Prior Approval module in eRA Commons. ****Please review the section on Expanded Authorities to determine if this award is covered/not covered under Expanded Authorities and whether prior approval is needed for carryover and no cost extension requests.****

The following activities require prior approval from the FDA on all awards:

1. Change in Grantee Organization

2. Significant Rebudgeting

3. Change in Scope or Objectives

4. Deviation from Terms and Conditions of Award

5. Change in Key Personnel which includes replacement of the PD/PI or other key personnel as specified on the NoA.

6. Disengagement from the project for more than three months, or a 25 percent reduction in time devoted to the project, by the approved PD/PI. No individual may be committed to more than 100% professional time and effort. In the event that an individual's commitment exceeds 100%, the grantee must make adjustments to reduce effort. For FDA-sponsored projects, significant reductions in effort (i.e., in excess of 25% of the originally proposed level of effort) for the PD/PI and key personnel named on named on this Notice of Award must receive written prior approval from FDA.

Additional prior approval requirements may be required for this award, and if applicable, will be listed under Section IV Special Terms and Condition of the Notice of Award.

Audits and Monitoring:

Audit Requirements:

1. Recipients of Federal funds are subject to annual audit requirements as specified in 45 CFR 75.501

(https://www.ecfr.gov/cgibin/retrieveECFR?gp=1&SID=8040c4036b962cc9d75c3638dedce240&ty=HTML&h=L&r=PART&n=pt45.1.75#se45.1.75_1501). Grantees should refer to this regulation for the current annual Federal fund expenditure threshold level which requires audit.

2. Foreign recipients are subject to the same audit requirements as for-profit organizations (specified in 45 CFR 75.501(h) through 75.501(k).

3. For-profit and foreign entities can email their audit reports to AuditResolution@hhs.gov or mail them to the following address:

U.S. Department of Health and Human Services
Audit Resolution Division, Room 549D
Attention: Robin Aldridge, Director
200 Independence Avenue, SW
Washington, DC 20201

Monitoring:

Recipients are responsible for managing the day-to-day operations of grant-supported activities using their established controls and policies, as long as they are consistent with Federal, DHHS and FDA requirements. However, to fulfill their role in regard to the stewardship of Federal funds, FDA monitors our grants to identify potential problems and areas where technical assistance might be necessary. This active monitoring is accomplished through review of reports and correspondence from the recipient, audit reports, site visits, and other information available to FDA.

1. Desk review: FDA grants monitoring specialists will periodically reach out to recipients to request information for the completion of desk reviews. Requested information may include:

• Policies and procedures
• List of grant expenditures
• Accounting records
• Supporting documents (e.g., invoices, receipts, paystubs, timesheets, contracts, etc.)
• Financial statements
• Audit reports
• Other related documentation

2. Site visits: FDA will conduct site visits when necessary and will notify the recipient with reasonable advance notice of any such visit(s).

3. Foreign entities: All Foreign entities are subject to the same monitoring requirements as domestic entities. Foreign entities covered under immunity Executive Orders will provide supporting documents for monitoring requirements unless such an action is a violation of the Executive Orders. Recipients may discuss with the FDA to come up with an alternate approach to satisfy the award monitoring requirements.

All recipients will make reasonable efforts to resolve issues found, including audit findings. Successful resolutions to issues are important as they are part of the grant performance review. All recipients are responsible for submitting all requested information in an expeditious manner. Failure to submit timely reports and/or respond to inquiries from FDA may affect future funding or enforcement actions, including withholding, or conversion to a reimbursement payment method.

Financial Conflict of Interest (FCOI):

This award is subject to the Financial Conflict of Interest (FCOI) regulation at 42 CFR Part 50 Subpart F.

Closeout Requirements (when applicable):

A Final Research Performance Progress Report (FRPPR), Final Invention Statement HHS-568 (if applicable), Tangible Personal Property Report SF-428 (if applicable), and Statement of Disposition of Equipment (if applicable) must be submitted within 120 days after the expiration date of the project period. All closeout documents must be submitted electronically in eRA Commons.

The Final Federal Financial Report (FFR SF-425) must be submitted in PMS and indicate the exact balance of unobligated funds and may not reflect unliquidated obligations. There must be no discrepancies between the Final FFR expenditure data and FFR cash transaction data in the Payment Management System (PMS). The expended funds reported on the Final FFR must exactly match the disbursements and the charge advances in PMS. It is the recipient's responsibility to reconcile reports submitted to PMS and to the FDA.

Program Income:

The grantee is required to report any Program Income generated during the Project Period of this grant. Except for royalty income generated from patents and inventions, the amount and disposition of Program Income must be identified on lines 10 (l), (m), (n), and (o) of the grantee’s Federal Financial Report (FFR) SF-425.

Examples of Program Income include (but are not limited to): fees for services performed during the grant or sub-grant period, proceeds from sale of tangible personal or real property, usage or rental fees, patent or copyright royalties, and proceeds from the sale of products and technology developed under the grant.

Any Program Income generated during the Project Period of this grant by the grantee or sub-grantee will be treated as identified below.

Treatment of Program Income:

Prohibition on certain telecommunications and video surveillance services or equipment:

(a) As described in CFR 200.216, recipients and subrecipients are prohibited to obligate or spend grant funds (to include direct and indirect expenditures as well as cost share and program) to:

(1) Procure or obtain,

(2) Extend or renew a contract to procure or obtain; or

(3) Enter into contract (or extend or renew contract) to procure or obtain equipment, services, or systems that use covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. As described in Pub. L. 115-232, section 889, covered telecommunications equipment is telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities).

i. For the purpose of public safety, security of government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities).

ii. Telecommunications or video surveillance services provided by such entities or using such equipment.

iii. Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of the National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise, connected to the government of a covered foreign country.

Other:

This award is subject to the requirements of 2 CFR Part 25 for institutions to maintain an active registration in the System of Award Management (SAM). Should a consortium/subaward be issued under this award, a requirement for active registration in SAM must be included.

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 with cumulative total value greater than $10,000,000 must report and maintain information 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 the Federal Awardee Performance and Integrity Information System (FAPIIS)). Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75.

You must administer your project in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes taking reasonable steps to provide meaningful access to persons with limited English proficiency and providing programs that are accessible to and usable by persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/providerobligations/index.html and https://www.hhs.gov/civil-rights/forindividuals/nondiscrimination/index.html.

You must take reasonable steps to ensure that your project provides meaningful access to persons with limited English proficiency. For guidance on meeting your legal obligation to take reasonable steps to ensure meaningful access to your programs or activities by limited English proficient individuals, see https://www.hhs.gov/civilrights/for-individuals/special-topics/limited-english-proficiency/fact-sheetguidance/index.html and https://www.lep.gov.

For information on your specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and taking appropriate steps to provide effective communication, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sexdiscrimination/index.html.

For guidance on administering your project in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws, see https://www.hhs.gov/conscience/conscienceprotections/index.html and https://www.hhs.gov/conscience/religiousfreedom/index.html.

Other: A majority of the cooperative agreement funds should be spent to build relationships and assist SLTT regulatory agencies with primary responsibility for retail food establishments in their jurisdictions or to agencies with substantial control and responsibility over such agencies, which may include financial support.  

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and FDA grant administration policies.

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.

1. Substantive involvement includes, but is not limited to, the following:

• FDA review and approval of task-oriented guidelines and other documents developed under the award.
• FDA assistance and coordination in the sharing of information to Federal, State, and local agencies and other stakeholders.
• FDA review and approval of publications/web applications or any revisions to existing systems.
• FDA review and approval of financial assistance made using cooperative agreement funds. FDA will coordinate with the grantee on final subaward decisions, and recommend changes to funding amount, priority, and other aspects to ensure the subaward meets the FDA’s intended goals.
• Other assistance or collaboration as requested by associations and State/local agencies.
• FDA will have a minimum of four (4) meetings per year to review grantee progress and discuss cooperative agreement goals and objectives.

Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for and dominant role in planning, directing, and executing the proposed project, with the FDA staff being substantially involved as a partner with the PI.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and FDA policies.

FDA Responsibilities

a. FDA will have prior approval of the appointment of all key administrative and scientific personnel proposed by the grantee.

b. FDA scientists and subject matter experts will participate with the grantee, in determining and carrying out scientific and technical activities. Collaboration will also include data analysis, interpretation of findings and, where appropriate, co-authorship of publications.

In addition, work proposed and conducted under this cooperative agreement, including subawards issued, may not be duplicated or funded by other cooperative agreements, contracts, or other funding mechanisms. Projects proposed and conducted under this cooperative agreement and the funding provided shall remain distinct and separate from other projects and funding sources. The grantee shall be able to account separately for fund expenditures, including employee salaries, wages, and benefits, received through contracts, cooperative agreements, grants, and other funding received by the grantee and these cooperative agreements.

An FDA Program Official (PO) will be assigned and named in the Notice of Award. The PO is accountable for the programmatic oversight of the grant to include coordination, with the Project Manager, on the technical aspects of the grant. S/he ensures the budget of grantees are reasonable and costs are allowable and allocable. The PO reviews the progress reports to verify the budget proposed includes only allowable expenses that support the project goals and objectives. The PO also assists with post-award monitoring and establishing a corrective action plan, if necessary.

An FDA Project Manager (PM) will be assigned to the program. The FDA PM is the responsible official for the programmatic, scientific, and/or technical aspects of assigned applications and cooperative agreements. The FDA PM will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below.

The PM will have substantial involvement in the design, implementation, and evaluation of program activities, and dissemination of program results and outcomes, above and beyond routine grant monitoring. Substantial involvement by FDA/ORA includes, but is not limited to, the following:

Provides guidance, direction, and technical assistance in project planning, implementation, and evaluation.

Provides subject matter expertise, programmatic assistance, and evaluation services to support program activities.

Actively monitors the supported program via telephone conversations, webinars, e-mails, written correspondence, or periodic site visits.

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

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

Participates in data analysis, interpretation of findings, and where appropriate, co-authorship of publications.

Convenes an FDA joint advisory group (JAG) of FDA representatives to monitor the program and provide guidance as needed.

Provides programmatic technical assistance.

Performs 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.

Consistent with the HHS Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the HHS Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the HHS Grants Policy Statement.

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 HHS Grants Policy Statement. FDA NOFOs outline intended research goals and objectives. Post award, FDA will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

In addition, the program specific progress report template is attached to this NOFO and will be provided with the Notice of Award (NOA). Initial, Mid-Year and Annual Program reports are required. The RFFM Program Report will be used by the grantee to report information and data for this cooperative agreement program. The progress report template allows for the recording of SMART goals and performance metrics mentioned in Section IV Application and Submission Information Research Strategy. All progress reports shall contain certain elements as applicable to their approved cooperative agreement and award. The template reporting elements include:

Detailed progress reporting on the grantee meeting the project milestones, objectives, and defined performance outcomes requested by FDA. If other associations or organizations are utilized to achieve project milestones or objectives, the progress report should include their activities.

If additional reporting requirements need to be added, please insert a comment indicating what reporting requirements are desired. Note that additions likely will require approval by OER.

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. FDA FOAs outline intended goals and objectives. Post award, FDA will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. See the HHS Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 Award Term and Condition 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: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Maribeth G. Niesen
Office of Regulatory Affairs (ORA)
Telephone: 513-348-1747
Email: maribeth.niesen@fda.hhs.gov

Suzanne Webb
Office of Regulatory Management Operations (ORMO)
Food and Drug Administration
Telephone: 240-402-3069
Email: suzanne.webb@fda.hhs.gov

Terrin Brown
Office of Acquisitions & Grants Services (OAGS)\
Food and Drug Administration
Email: Terrin.Brown@fda.hhs.gov

Terrin Brown
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: Terrin.Brown@fda.hhs.gov

Recently issued policy notices may affect your application submission. A full list of policy notices published in the Guide for Grants and Contracts. 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 1009 of the Federal Food, Drug, and Cosmetic Act (21 USC 399) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.