Part 1. Overview Information

Key Dates

July 25, 2025

March 1, 2026

March 1, 2027

All applications are due by 11:59 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.  No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Not Applicable

August 2025 for application due date July 25, 2025

April 2026 for application due date March 1, 2026

April 2027 for application due date March 1, 2027

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.




There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of 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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

The Food and Drug Administration (FDA), Human Food Program (HFP) and Center for Veterinary Medicine (CVM), is anticipating the availability of up to $10,600,000 in FY 2025 to be awarded under limited competition to state animal food regulatory programs.  The Animal Feed Regulatory Program Standards (AFRPS) allows for the development and maintenance of risk-based animal feed safety programs by establishing a uniform basis for measuring and improving the performance of state animal food regulatory programs in the United States. For more information on the AFRPS Program, please visit: https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/regulatory-program-standards/animal-food-regulatory-program-standards-afrps-and-preventive-controls-cooperative-agreement-program

The FDA anticipates the availability for one year of funding with the possibility of up to two additional years of additional non-competitive support, contingent on performance and continued availability of federal funds. For AFRPS, it is anticipated that full implementation of the AFRPS will be achieved within 5 total funding years under an AFRPS Cooperative Agreement, based on assessment of your program by FDA Audit Staff to ensure the elements have been implemented.

As state regulatory program achieve full implementation with the AFRPS, the FDA would like to further advance mutual reliance with our state regulatory partners through the comprehensive sharing and reliance upon each other's regulatory information to maximize our public health impact and regulatory oversight.  The end result is the coordination of inspections, investigations and enforcement activities to effectively and efficiently protect public health to further the Integrated Food Safety System (IFSS).

The application should detail how the programs objectives will be achieved.

Applicants must refer to the eligibility section of this NOFO to determine which funding track they should apply for (AFRPS Development or AFRPS Maintenance).  Applicants must select either the AFRPS Development (states that are new to the AFRPS cooperative agreement program, or have received less than 5 years of cooperative agreement funding) or AFRPS Maintenance tracks.  Within the AFRPS Maintenance Track (only), eligible applicants applying for the Mutual Reliance funding track should detail how the objectives of that track will be achieved, and specify activities planned to accomplish each objective.  Further information on eligibility for the funding option(s), award levels, and other administrative considerations can be found in this document below.

A schematic outlining the two funding tracks and the funding option(s) available for each track is below:

The AFRPS allows for the development of risk-based animal food safety programs by establishing a uniform basis for measuring, evaluating, and improving the performance of State animal food regulatory programs in the United States. By achieving and maintaining implementation of these program Standards, Federal and State food regulatory programs can better direct their regulatory activities toward preventing animal food safety hazards, which can cause illness or injury to animals or humans, in facilities that manufacture, process, pack, or hold animal food and ingredients. Consequently, the safety and security of the United States animal food supply and protection of human public health will improve.

The AFRPS are comprised of eleven Standards (See link above in Notice of Funding Opportunity Description) which establish foundations for the critical elements that serve as an objective framework to evaluate and improve components of a State animal food program. These elements cover the State animal food program's regulatory foundation, training, inspection program, auditing, animal food-related illness or death and emergency response, enforcement program, outreach activities, planning and resources, laboratory services, sampling program, and assessment and improvement of Standard implementation.

Achieving and maintaining implementation of the program Standards will require comprehensive self-assessment on the part of a State program and will encourage continuous improvement and innovation. FDA recognizes that the time required for achieving full implementation of the AFRPS will vary between States. However, all State animal food regulatory programs will be expected to implement strategic improvement plans to ensure continuous improvement and demonstrate that they are moving towards full implementation. State animal food regulatory programs receiving funds under this cooperative agreement will be expected to achieve and maintain full implementation by the conclusion of the cooperative agreement.

Awardees will achieve and maintain implementation with the AFRPS (most recent published version).

For the purpose of this funding opportunity, "full implementation" is defined as the State animal food regulatory program having all elements, systems, and programs, as required in the Program Elements and Documentation sections of the AFRPS; and can demonstrate the use of those elements, systems, or programs. If implementation is not achieved by the conclusion of the cooperative agreement or at the end of funding year 5 (whichever comes first), the State program will provide a detailed strategic improvement plan on how the remaining AFRPS elements and documentation requirements will be fully implemented and demonstrated. The strategic improvement plan will include: A detailed timeline including what needs to be accomplished to implement the element and/or documentation requirement, and when the work will be completed.

Program Objectives - AFRPS Development Track:

1. Develop a strategic improvement plan that will result in full implementation of the AFRPS.

A maximum of 5 years is expected to reach full implementation of the AFRPS (by the interval 3 assessment). Once a state animal food regulatory program has received 5 years of development funding, the program will transition to the maintenance funding levels and maintain full implementation with the current AFRPS.

A. Awardees will participate in regularly scheduled visits consisting of key personnel from the State animal food regulatory program and FDA to discuss grant performance. Participation includes providing meeting space, accessibility of key State animal food regulatory program management and staff, and access to records, databases, and other materials supporting AFRPS implementation.

B. Participate in collaborative regulatory activities with FDA and state animal food regulatory programs.

Year 1 (If it is the initial Year of AFRPS funding):

C. Conduct a comprehensive baseline self-assessment/baseline evaluation, as required in Standard 9 of the AFRPS.

D. Following the baseline evaluation, develop strategic improvement plan(s) that will result in implementation of the AFRPS by the completion of Year 5 (Interval 3 assessment) of the cooperative agreement. Review and update strategic improvement plan(s) on an annual basis. Documentation related to the evaluation and strategic improvement plan(s) must be maintained.

Subsequent years:

E. Implementation of the strategic improvement plan. The strategic improvement plan should be updated to accurately reflect when specific objectives and tasks have been met, and when new objectives and tasks are identified to achieve full implementation of the AFRPS. Progress achieved should indicate that full implementation of the AFRPS can be expected by completion of Year 5 (Interval 3 assessment).

F. Review and update strategic improvement plan(s) on an annual basis. Documentation related to the evaluation and strategic improvement plan(s) must be maintained.

G. Awardees will participate in scheduled assessments by the FDA Audit Staff of the state animal food program to verify implementation status of the AFRPS. Participation includes providing meeting space, accessibility of state key animal food program staff, and access to records, databases, and other materials supporting the state program's implementation of the AFRPS. Findings identified in the assessment should be addressed in the strategic improvement plan.

2. Contribute to the continuous improvement of the AFRPS through attendance at an annual face-to-face meeting, active participation in presenting and sharing resources with other awardees, and additional initiatives that contribute to the improvement in regulatory activities in the IFSS.

3. Awardees with a laboratory participating in the Laboratory Flexible Funding Model (LFFM) cooperative agreement will apply their AFRPS response, enforcement and regulatory framework to conduct follow-up inspections, investigations (including traceback/forward), and enforcement actions (including embargos, recalls, warning letters, and closures) to positive and violative samples identified as part of the LFFM cooperative agreement. Coordination with the Rapid Response Team (RRT) and activation, if applicable, is required for recipients that also participate in that cooperative agreement program. Potentially violative LFFM samples may come to the AFRPS program from any laboratory participating in the LFFM Animal Food Product Testing track for microbiology or chemistry. This includes samples collected by LFFM laboratories within the same state as the AFRPS program (may or may not be the primary servicing laboratory for AFRPS) and samples collected by other states and analyzed by other LFFM laboratories where the potentially violative product is traced back to the AFRPS program’s state.

A. Recipients will coordinate response and compliance follow-up on LFFM samples with the FDA in real-time, to include sharing findings and compliance actions or other follow-up activities discussing regulatory/compliance strategy with the FDA.

B. If a potentially violative LFFM sample comes to a AFRPS program but is outside of the AFRPS program’s regulatory authority/jurisdiction, the AFRPS program agrees to identify and notify the appropriate state/federal agencies with jurisdiction, and to notify the FDA.

C. Recipients will collect samples at the manufacturer and other locations, in accordance with the collection instructions for each hazard-commodity pair on the approved LFFM sample plan, as needed.

D. Recipients will use the necessary regulatory and compliance response infrastructure to investigate and respond to violative samples, including qualified personnel, IT resources, and regulatory authorities.

E. Perform an annual estimate of capacities and capabilities for animal food sample collection and analysis for chemical and microbiological hazards for emergency response, surveillance, and compliance efforts.  This may be accomplished by participating in the annual FERN laboratory membership verification process.

Program Objectives - AFRPS Maintenance Track:

1. Maintain full implementation with the current AFRPS which is recognized as a critical element to creating a national, fully integrated food safety system.

A. Awardees will participate in regularly scheduled visits consisting of key personnel from the State animal food regulatory program and FDA to discuss grant performance. Participation includes providing meeting space, accessibility of key State animal food regulatory program management and staff, and access to records, databases, and other materials supporting AFRPS implementation.

B. Participate in collaborative regulatory activities with FDA and state animal food regulatory programs.

C. Awardees will maintain implementation with the current AFRPS.  If implementation is not maintained upon award and throughout the cooperative agreement, the state will develop and use a strategic improvement plan to reach implementation.  Strategic improvements are expected to be completed as expeditiously as possible.

D. Awardees will participate in scheduled assessments by the FDA Audit Staff of the state animal food program to verify implementation status of the AFRPS. Participation includes providing meeting space, accessibility of state key animal food program staff, and access to records, databases, and other materials supporting the state program's implementation of the AFRPS. Findings identified in the assessment should be addressed in the strategic improvement plan.

2. Contribute to the continuous improvement of the AFRPS through attendance at an annual face-to-face meeting, active participation in committees, presenting and sharing resources with other awardees, and additional initiatives that contribute to the improvement in regulatory activities in the IFSS.

3. Awardees with a laboratory participating in the Laboratory Flexible Funding Model (LFFM) cooperative agreement will apply their AFRPS response, enforcement and regulatory framework to conduct follow-up inspections, investigations (including traceback/forward), and enforcement actions (including embargos, recalls, warning letters, and closures) to positive and violative samples identified as part of the LFFM cooperative agreement. Coordination with the Rapid Response Team (RRT) and activation, if applicable, is required for recipients that also participate in that cooperative agreement program. Potentially violative LFFM samples may come to the AFRPS program from any laboratory participating in the LFFM Animal Food Product Testing track for microbiology or chemistry. This includes samples collected by LFFM laboratories within the same state as the AFRPS program (may or may not be the primary servicing laboratory for AFRPS) and samples collected by other states and analyzed by other LFFM laboratories where the potentially violative product is traced back to the AFRPS program’s state.

A. Recipients will coordinate response and compliance follow-up on LFFM samples with the FDA in real-time, to include sharing findings and compliance actions or other follow-up activities discussing regulatory/compliance strategy with the FDA.

B. If a potentially violative LFFM sample comes to a AFRPS program but is outside of the AFRPS program’s regulatory authority/jurisdiction, the AFRPS program agrees to identify and notify the appropriate state/federal agencies with jurisdiction, and to notify the FDA.

C. Recipients will collect samples at the manufacturer and other locations, in accordance with the collection instructions for each hazard-commodity pair on the approved LFFM sample plan, as needed.

D. Recipients will use the necessary regulatory and compliance response infrastructure to investigate and respond to violative samples, including qualified personnel, IT resources, and regulatory authorities.

E. Perform an annual estimate of capacities and capabilities for animal food sample collection and analysis for chemical and microbiological hazards for emergency response, surveillance, and compliance efforts.  This may be accomplished by participating in the annual FERN laboratory membership verification process.

4. For animal food regulatory programs with 3 or more inspectors, develop and implement an auditing program that moves the program into Phase 2 of the SMG-8076 audit program. By the conclusion of Year 2, be in Phase 2 of the audit program as outlined in SMG-8076 on the current contract, and in Year 3 perform a minimum of 50% the annual inspection audits required to meet the SMG-8076 audit requirements.

Program Objectives - Mutual Reliance Track:

1. Maintain and continuously improve inspection and enforcement programs that utilize a mutual reliance approach that results in data exchange and acceptability by the FDA and other state regulatory partners, including but not limited to FDA utilizing this data for risk prioritization, to move inspection cover-by dates, and to take regulatory action.

2. Facilitate the IFSS through risk-based workplanning, work sharing, and data exchange with the FDA. The workplan will prioritize performing risk-based inspections at the frequency identified by the state program's risk framework or FDA's FSMA inspection frequency mandate (whichever is shorter).  The workplan will be representative of their firm inventory. Minimum data elements will be defined by the awardee and the FDA with continuous assessment and improved based upon awardee and FDA needs.  Programs will provide plans for each year of the project to:

A. Actively participate in risk-based workplanning with FDA for firms and inspections in state inventory and workplan, including non-contract inspections.  Ongoing collaboration and monitoring of the workplan should be prioritized between the program and FDA.

B. Utilize work sharing and data exchange practices and methods resulting in more efficient inspections and sampling between FDA and the states, including but not limited to elimination of duplicate work and updating of firm operational status.

C. Annually provide FDA with a current and complete inventory of state firms and collaborate to identify firms subject to FDA regulation.

3. The awardee and the FDA will meet quarterly to:

A. Provide updates on the State (contract and non-contract) and FDA workplans, regulatory accomplishments (e.g. inspections, investigations, and enforcement), audit schedule, special assignments, and emerging issues such as outbreaks and recalls.

B. Review FDA and State regulatory and policy updates.

C. Review State and FDA enforcement actions taken and identify collaborative approaches to obtaining compliance.

D. Conduct program performance evaluation and improvement that results in mutual reliance and data acceptability.

E. Identify training needs - classroom and field - and resources available to conduct/receive training..

F. Review and confirm data submission requirements and frequencies and resolve any challenges.

Program should solicit feedback from FDA and other stakeholders and assess meetings, coordination, and data elements regularly for continuous improvement.

4. Share animal food facility information (including firm risk categorization data), inspections, investigations, enforcement actions, complaints, sample analyses, and other regulatory data with FDA through automated or electronic data exchange systems. The awardee will provide the data using agreed upon data elements, submission frequencies, and systems.

5. Perform comprehensive non-contract animal food inspections according to Compliance Program Guidance Manual (CPGM) 7371.000.  A comprehensive inspection is defined as covering all applicable program areas, animal food regulations, and PAC codes as defined in CPGM 7371.000.  The number of comprehensive non-contract inspections performed will be based upon the program's firm inventory. For purposes of this track, comprehensive non-contract inspections of a firm that FDA can utilize and rely on the data.  The combination of contract, non-contract, and FDA inspections should result in comprehensive regulatory coverage of the state's animal food industry.  State Programs will provide plans for each year of the project which:

A. Perform and provide annual plans to perform comprehensive non-contract inspections to be performed under the state program authority, procedures and policies, OR

B. Perform and provide annual plans to perform comprehensive non-contract inspections under FDA authority, procedures and policies.

AND

C. Perform comprehensive non-contract inspections at facilities that are subject to food facility registration under section 415 of the Federal Food, Drug, and Cosmetic Act  (unless an exemption applies to registration or exempt to 21 CFR Part 507) or required to be licensed under 21 CFR Part  515. Comprehensive non-contract inspections should prioritize FSMA inspection dates to accomplish FDA work obligations for at least 10% of these facilities annually for the state, during the three-year project period.

6. Actively perform inspections, surveillance sampling, follow-up to complaints, and monitor recalls, advisories, and information from other regulatory and public health programs for the early detection of animal food safety issues.

7. Provide the evidence and support to enable other animal food regulatory programs to take advisory and regulatory actions.

8. Promptly investigate any animal food related event likely to cause Serious Adverse Health Consequences or Death to Humans or Animals (SAHCODHA) based on data such as recalls, complaints, violative laboratory results, Reportable Food Registry (RFR) reports, outbreaks, and other information from other Federal (FDA, CDC, and USDA), state, and local regulatory and public health partners.

9. Progressively move towards performing all audits required by the AFRPS and animal food contract program by moving from Phase 2 to Phase 3 of the audit program as outlined in SMG-8076:

Applicants that have received AFRPS + PC Funding:

A. Initial application and Year 1: Be in Phase 2 of audit program at the grant application due date. The awardee should focus on training and qualifying auditors so responsibility for the audit program is increased in Year 2.

B. Year 2: Perform a minimum of 50% the annual inspection audits required to meet the SMG-8076 audit requirements obligated to the contract and be in Phase 2 of the audit program as outlined in SMG-8076 on the current contract.

C. Year 3: Be recognized as being in Phase 3 of the audit program and demonstrate the ability to perform the inspection, training, and verification audits and other audits required in the AFRPS Standard 4 and SMG-8076.

Applicants that did not previously receive PC Funding:

A. Year 1: Enter Phase 2 of the audit program as defined by SMG-8076. The awardee should focus on training and qualifying auditors so the responsibility for the audit program is increased in Year 2.

B. Year 2: Progress into Phase 2 of the audit program as defined by SMG-8076

C. Year 3: Perform a minimum of 50% the annual inspection audits required to meet the SMG-8076 audit requirements obligated to the contract and be in Phase 2 of the audit program as outlined in SMG-8076 on the current contract.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

State Governments

Additional Eligibility Requirements

The eligibility for this opportunity is limited to State animal food safety programs meeting the following criteria:

Applicants must maintain an FDA inspectional contract in good standing by completing all agreed upon inspectional work, audits, and associated compliance and regulatory activities.  The contract must include performing comprehensive animal food inspections under 21 CFR Part 507 that is representative of the state's firm inventory and supports the FDA and state regulatory program in meeting a risk-based inspection frequency. The contract should result in a minimum of 10% of the firm inventory regulated by the FDA being inspected for all applicable regulations.

Applicant organizations must have a valid 20.88 agreement with FDA prior to the time of application.

Applicants will be categorized under one of two funding tracks: AFRPS Development or AFRPS Maintenance (see eligibility criteria above. Within the AFRPS Maintenance funding track only, an applicant may apply to the Mutual Reliance funding option, provided they meet the funding option eligibility criteria (below).

Applicants are encouraged to apply for cooperative agreement assistance that reflects their jurisdiction's needs in terms of amounts of funding and number of project years.

To ascertain an applicant's tier funding level, please consult Section II. Award Information.

Funding Track 1: AFRPS Development Phase

Applicants must have received less than five (5) years of funding under a past AFRPS cooperative agreement, or have never received an AFRPS cooperative agreement. Applicants may request up to $300,000 per year for this funding track. State programs will move to AFRPS Maintenance funding levels in the sixth year of funding under AFRPS cooperative agreements. Applicants with less than five (5) years of funding under a past AFRPS cooperative agreement may elect to count years of AFRPS enrollment under the FDA Animal Food Safety Inspection Contract toward the five (5) years AFRPS funding eligibility requirement when determining the entry date for Funding Track 2 (AFRPS Maintenance Phase), and may elect to move to Funding Track 2 (AFRPS Maintenance Phase) for the award year after full implementation of the AFRPS has been achieved (as determined by an assessment by FDA Audit Staff).

See below for AFRPS Funding Track 2 (AFRPS Maintenance Phase) variable funding levels.

Funding Track 2: AFRPS Maintenance Phase

Applicants must have received five (5) years of funding under a past AFRPS cooperative agreement. Applicants with less than five (5) years funding under a past AFRPS cooperative agreement may elect to count years of AFRPS enrollment toward the five (5 years AFRPS funding eligibility requirement when determining the entry date for Funding Track 2 (AFRPS Maintenance Phase), and may elect to move to Funding Track 2 (AFRPS Maintenance Phase for the award year after full implementation of the AFRPS has been achieved (as determined by an assessment by FDA Audit Staff). If the state program is not currently deemed to be in full implementation and their corrective actions are still pending (in response to the most recent assessment by FDA Audit Staff), then the program must address the corrective actions in their strategic improvement plan submitted as part of the application.

Applicants have been classified into three (3) levels of funding levels based on a variety of factors unique to that jurisdiction (See data sources below). This approach establishes funding levels proportional to the applicant's jurisdictional work volume and costs for this program area. To determine which funding level is applicable to your program, please consult the table below. Applicants are encouraged to apply for cooperative agreement assistance that reflects their jurisdiction's needs both in terms of amounts of funding and number of project years.

Eligible AFRPS Maintenance Phase Track applicants are also eligible to apply for the Optional Mutual Reliance Track.

Data Sources used to determine eligibility (see table below for further details):

• FY23 FDA Animal Food Safety Inspection Contract Data and Inspection Time Projections.
• FY24 FDA firm inventory data (as of 8/12/2024).
• OP will maintain a copy of the funding algorithm and supporting data used to place State programs into funding levels.  If you would like to obtain the data set specific to your State program, please email [email protected].

*Includes workload obligation yes and Bioterrorism registration information from FDA.

**Ranges established using FY23 FDA Animal Food Safety Contract data from FDA.

Eligible AFRPS Funding Track 2 (AFRPS Maintenance Phase) applicants are also eligible to apply for the Mutual Reliance Funding Track.

Funding Track 3 (Optional): Mutual Reliance

Applicants must be recognized as being in full implementation by the FDA audit staff prior to the time of application.

Non-domestic (non-U.S.) Entities (Foreign Organization) 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 NIH Grants Policy Statement, are not allowed. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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 the HHS Grants Policy Statement 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.
  • 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.
  • 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 registrations; 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 their organization to develop an application for 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 How to Apply - Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

2. Cost Sharing

The funds provided under this NOFO shall be available to an eligible entity that receives a grant under this NOFO only to the extent such entity funds the food safety programs of such entity independently of any grant under this NOFO in each year of the grant at a level equal to the level of such funding in the previous year, increased by the Consumer Price Index. Such non-Federal matching funds may be provided directly or through donations from public or private entities and may be in cash or in-kind, fairly evaluated, including plant, equipment, or services.

Grant funds received under this NOFO shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this NOFO.

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique entity identifier UEI) is allowed per application period.

Section IV. Application and Submission Information

1. Requesting an Application Package

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 the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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 How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most FDA opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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 emailed to:

Danielle Head

Office of Acquisitions and Grants 
Grants Management Specialist
Office of Acquisitions and Grants Services

email:  [email protected] 

Technical sessions will be tentatively held for prospective applicants in July 2025 and February of 2026-2027.  The technical session for the first application period is tentatively scheduled for July 1, 2025 , from 3-4 PM Eastern Time, and attendees can register for the session here.   The technical session information will be provided to prospective applicants that submit a letter of intent.  The technical sessions 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. 

Page Limitations

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 total, for all components listed above.

Instructions for the Submission of Multi-Component Applications

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

The application should consist of the following components:

• Overall: required
• Projects: required

Overall Component

When preparing the application, use Component Type “Overall.”

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Specific names provided for Other Attachments must be no more than 50 characters including spaces.

Project/Performance Site Locations (Overall)

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.

Research and Related Senior/Key Person Profile (Overall)

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.

Budget (Overall)

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

The following additional instructions must also be followed:

• Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each funding track/option selected by the applicant, for each year of financial support requested.
• Applicants must project their eligibility and interest in the funding option over the three (3) year cooperative agreement, as options to expand participation in the funding option after the award is made will be limited.
• 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'.
• Applicants may also apply funding for personnel, training, and it will be available for these projects.
• Where personnel costs are requested, documentation must be provided to associate these costs with the specific objectives.
• Funds should be requested in the budget for key project personnel to travel to meetings, on-site visits, assessments and audits with FDA program staff to discuss the State self-assessment and implementation of the AFRPS, and for training and coordination for regulatory and project work for Mutual Reliance Funding Track (only applicable if applying for the funding option) with appropriate State and FDA staff. All anticipated meetings for attendance should be listed and referenced by name in the application.
• A portion of budgeted travel funds should also be set aside for key personnel (a minimum of 2) to attend required annual face-to-face meeting and any required training (as determined by FDA/OP) and committee meetings supporting the AFRPS, and the Mutual Reliance Funding Track (only applicable if applying for the funding option).
• All other anticipated meetings and trainings, to include required annual meeting(s) and required training, for attendance, should be listed and referenced by name in the application.
• Funding Plan:  Awardees whose State human or animal food regulatory program receives funding from an FDA Rapid Response Team (RRT) cooperative agreement are required to participate in the RRT and should ensure that their efforts to meet the program elements of the AFRPS Standard 5 are aligned/integrated with the existing RRT and their participation therein.  Funds from the AFRPS Cooperative Agreement are to be used for the program elements indicated under each Standard.  RRT-specific activities support the program elements under Standard 5, but it is not a requirement of Standard 5.
• 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.

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.

PHS 398 Research Plan (Overall)

Research Plan sections are: Introduction to Application, Specific Aims, Research Strategy, Progress Report Publication List, Vertebrate Animals, Select Agent Research, Multiple PD/PI Leadership Plan, Consortium/Contractual Arrangements, Other Plan(s) Authentication of Key Biological and/or Chemical Resources, and Appendix.

Specific Aims:

Research Strategy:

Page one of the Research Strategy must be a cover sheet with the following table indicating funding track(s) and funding option (if applicable) selected for each of the three (3) years of the cooperative agreement. For each year, list the amount requested under each option, and the total award amount for each year.

Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

The PHS Human Subjects and Clinical Trials Information form is used for NOFOs that allow clinical trials and NOFOs that do not allow clinical trials. See https://grants.nih.gov/grants/how-to-apply-application-guide.html for instructions for more information.

Other Plan(s): 

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by the FDA) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - 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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall)

All instructions in the How to Apply- Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

Project 1: AFRPS Development

When preparing your application, use Component Type “Insert Name.”

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted. 

SF424 (R&R) Cover (Project 1: AFRPS Development)

Complete only the following fields:

• Applicant Information.
• Type of Applicant (optional).
• Descriptive Title of Applicant's Project.
• Proposed Project Start/Ending Dates.

PHS 398 Cover Page Supplement (Project 1: AFRPS Development)

Research & Related Other Project Information (Project 1: AFRPS Development)

Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project 1: AFRPS Development)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project 1: AFRPS Development)

• In the Project Director/Principal Investigator section of the form, use Project Role of “Other” with Category of “Project Lead” and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project 1: AFRPS Development)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Include a budget for each year of the project that lists the itemized costs for the amount of regulatory work planned under this track, including but not limited to compliance and enforcement work (can be based on previous violation data, if known), reporting, and data sharing.

PHS 398 Research Plan (Project 1: AFRPS Development)

Research Strategy:

• Provide plans, documentation and evidence describing and supporting how the program will accomplish the objectives listed in this NOFO.
• Identify specific personnel responsible for objectives of each funding track/option selected in the application (e.g. AFRPS Development). These personnel may be different from the Principal Investigator (PI) on the overall cooperative agreement.
• For the AFRPS Development Funding Tracks, there must be at least one dedicated full-time employee/equivalent (FTE) to lead day-to-day oversight, such as an AFRPS Coordinator.  This employee/equivalent FTE needs to be a full time employee(s), but not all of their duties or work time need to necessarily be applied or dedicated to the AFRPS program.
• Indicate the level of adequately trained staff and the ability to hire and/or train personnel to meet the objectives of this cooperative agreement. This should include a description of training needs to support AFRPS implementation and Regulatory work for Animal food CGMP, PC and comprehensive inspections, as well as requirements of the FDA animal food safety inspection contract (allowable expenses under this cooperative agreement).
• Provide justification for hiring new staff, including qualifications, training needs, and new equipment needs.
• Describe plans to satisfy the reporting requirements outlined in section VI.3 of this announcement.
• Describe any identified or potential obstacles in achieving and maintaining implementation with the AFRPS and approaches to overcome these obstacles.
• There must be a separate and distinct methodology section for each funding option included in the application. See page limitations (Section IV of the NOFO).
• Submit your most recent assessment audit report provided by FDA Audit Staff (if applicable) as an appendix following the directions in the SF-424 Guide.

Project 2: AFRPS Maintenance

When preparing your application, use Component Type “Insert Name.”

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project 2: AFRPS Maintenance)

Complete only the following fields:

• Applicant Information.
• Type of Applicant (optional).
• Descriptive Title of Applicant's Project.
• Proposed Project Start/Ending Dates.

PHS 398 Cover Page Supplement (Project 2: AFRPS Maintenance)

Research & Related Other Project Information (Project 2: AFRPS Maintenance)

Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project 2: AFRPS Maintenance)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project 2: AFRPS Maintenance)

• In the Project Director/Principal Investigator section of the form, use Project Role of “Other” with Category of “Project Lead” and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project 2: AFRPS Maintenance)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Include a budget for each year of the project that lists the itemized costs for the amount of regulatory work planned under this track, including but not limited to compliance and enforcement work (can be based on previous violation data, if known), reporting, and data sharing.

PHS 398 Research Plan (Project 2: AFRPS Maintenance)

Research Strategy:

• Provide plans, documentation and evidence describing and supporting how the program will accomplish the objectives listed in this NOFO.
• Identify specific personnel responsible for objectives of each funding track/option selected in the application (e.g. AFRPS Maintenance, and Mutual Reliance Optional Track if applicable). These personnel may be different from the Principal Investigator (PI) on the overall cooperative agreement.
• For the AFRPS Maintenance Funding Track, there must be at least one dedicated full-time employee/equivalent (FTE) to lead day-to-day oversight, such as an AFRPS Coordinator.  This employee/equivalent FTE needs to be a full time employee(s), but not all of their duties or work time need to necessarily be applied or dedicated to the AFRPS program.
• Indicate the level of adequately trained staff and the ability to hire and/or train personnel to meet the objectives of this cooperative agreement. This should include a description of training needs to support AFRPS implementation and Regulatory work for Animal food CGMP, PC and comprehensive inspections, as well as requirements of the FDA animal food safety inspection contract (allowable expenses under this cooperative agreement).
• Provide justification for hiring new staff, including qualifications, training needs, and new equipment needs.
• Describe plans to satisfy the reporting requirements outlined in section VI.3 of this announcement.
• Describe any identified or potential obstacles in maintaining implementation with the AFRPS and approaches to overcome these obstacles.
• There must be a separate and distinct methodology section for each funding option included in the application. See page limitations (Section IV of the NOFO).
• Submit your most recent assessment audit report provided by FDA Audit Staff as an appendix following the directions in the SF-424 Guide.

Project 3: Mutual Reliance

When preparing your application, use Component Type “Insert Name.”

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project 3: Mutual Reliance)

Complete only the following fields:

• Applicant Information.
• Type of Applicant (optional).
• Descriptive Title of Applicant's Project.
• Proposed Project Start/Ending Dates.

PHS 398 Cover Page Supplement (Project 3: Mutual Reliance)

Research & Related Other Project Information (Project 3: Mutual Reliance)

Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project 3: Mutual Reliance)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project 3: Mutual Reliance)

• In the Project Director/Principal Investigator section of the form, use Project Role of “Other” with Category of “Project Lead” and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project 3: Mutual Reliance)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Include a budget for each year of the project that lists the itemized costs for the amount of non-contract regulatory work planned, including but not limited to inspections, compliance and enforcement work (can be based on previous violation data, if known), inspection audits, reporting, and data sharing.  Justification is required with the budget(s) if the costs for non-contract inspections exceed the costs for similar contract work.

PHS 398 Research Plan (Project 3: Mutual Reliance)

Research Strategy:

• Provide plans, documentation and evidence describing and supporting how the program will accomplish the objectives listed in this NOFO.  Documentation may include, but is not limited to examples of and plans to:
  • Provide data and inspections which FDA used to perform an enforcement or other activity.
  • Inspection reports that include evidence of necessary elements for Jurisdiction, Interstate Commerce, Violation, and Responsibility (JIVR) to support FDA actions.
• Program should include plans and methods to identify and implement improvements to state inspection and enforcement programs when FDA is not able to utilize state regulatory work for necessary actions.
• Program provides an overview of systems used (e.g. eSAF, ORAPPS, IDP, etc.) and data elements provided for data sharing for inspections, samples, and other regulatory data (firm risk categorization data, inspections, investigations, enforcement actions, complaints, sample analyses, etc.).
• Program provides plans for each year of the project and documentation from recent meetings and coordination with FDA related to workplanning, firm inventory data sharing, and assessment and improvement of workplanning practices indicating:
  • Integration and improvement of FDA firm inventory from data shared by state program.
  • Assessment and improvement of workplanning processes and efficient performance of work (inspections and samples) according to workplan.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. 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.

4. Submission Dates and Times

Part I. 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, FDA's electronic system for grants administration. FDA 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. No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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 How to Apply- Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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. 

1. Facilities and work reimbursed under the FDA human or animal food safety inspection contracts or other funding mechanisms such as the Laboratory Flexible Funding Model, Manufactured Food Regulatory Program Standards, Produce Safety, or Rapid Response Teams cooperative agreements must remain distinct and separate from this cooperative agreement.

2. Vehicle purchases are not permitted.

3. Cooperative agreement funds may not be utilized for new building construction; however, remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 10% of the grant award amount.

4. Cooperative agreement funds may not be utilized for clothing and uniforms with the exception of personal protective equipment (PPE).  PPE is defined as protective clothing or other outerwear required to mitigate a defined workplace hazard.

5. Detailed budget justification narrative is required and must be approved before funds can be used for cell phones and cell service plans, data management software development costs.

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

Non-allowable costs:

1) Facilities, work, and training reimbursed under the FDA animal food safety inspection contract and other funding mechanisms must remain distinct and separate from the cooperative agreement. The State must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, as well as sub-contractor and/or primary servicing laboratory expenditures, under the animal food safety inspection contracts and other funding mechanisms and these cooperative agreements.

2) Vehicle purchases are not permitted.

3) Food may not be purchased.

4) Clothing/uniforms may not be purchased.

5) Cooperative agreement funds may not be utilized for new building construction; however, remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 10% of the grant award amount.

Only primary servicing laboratories are eligible to receive funds through the awardee, in order to help the State animal food regulatory program to implement the AFRPS.  Primary servicing laboratories are defined as State funded regulatory laboratories, funded by the same State as the State animal food regulatory program, which perform 51% or more of the analyses on all samples collected by the State animal food regulatory program.  Awardees may provide no more that 25% of annual award funds from the AFRPS track funding to primary servicing laboratories for the purpose of achieving or expanding accreditation for animal food analyses under the current version of ISO/IEC 17025.

Grant funds received under this NOFO shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this NOFO.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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 How to Apply - 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 FDA Grants Management Specialist and responsiveness by components of participating organizations. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Post-submission materials are those submitted after submission of the grant application but prior to objective 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. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the FDA in support of the FDA mission are evaluated for scientific and technical merit through the FDA objective review system.

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).  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the objectives of the project?

Reviewers will consider each of the review criteria for each track applicants are eligible for 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.

Scored Review Criteria - AFRPS Development

Rationale and Design (60 Points)

Demonstrates plans to achieve the objectives of the cooperative agreement and project proposed.

Cooperation & Integration (20 Points)

Demonstration of effectiveness in working with federal, State, and local partners and other appropriate organizations to implement the objectives of the cooperative agreement, including the program's current AFRPS implementation status according to their most recent assessment by the FDA Audit Staff (if applicable).

Demonstration of plans to facilitate the incorporation of project developed capabilities into the entity’s animal food safety system. Expected challenges are documented and addressed.

Resources (20 Points)

Demonstration of adequate program resources (including staff) and infrastructure, or the ability to obtain the resources necessary, to complete the project objectives.  Demonstrate and justify anticipated hiring and training needs to accomplish the project objectives, including anticipated equipment needs.

Scored Review Criteria - AFRPS Maintenance

Rationale and Design (60 Points)

Demonstrates plans to achieve the objectives of the cooperative agreement and project proposed.

Cooperation & Integration (20 Points)

Demonstration of effectiveness in working with federal, State, and local partners and other appropriate organizations to implement the objectives of the cooperative agreement, including the program's current AFRPS implementation status according to their most recent assessment by the FDA Audit Staff (if applicable).

Demonstration of plans to facilitate the incorporation of project developed capabilities into the entity’s animal food safety system. Expected challenges are documented and addressed.

Resources (20 Points)

Demonstration of adequate program resources (including staff) and infrastructure, or the ability to obtain the resources necessary, to complete the project objectives. Demonstrate and justify anticipated hiring and training needs to accomplish the project objectives, including anticipated equipment needs.

Scored Review Criteria - Mutual Reliance

Rationale and Design (60 Points)

Demonstration of strategies and plans that are specific, measurable, achievable, relevant and timely which are likely to achieve each objective of the cooperative agreement and project proposed.

Demonstration of strategies and plans for non-contract inspections likely to be utilized to move facility cover-by dates for FDA or support FDA's ability to take action.

Cooperation and Integration (20 Points)

Demonstration of effectiveness in working with federal, State, and local partners and other appropriate organizations to implement each objective of the cooperative agreement.

Demonstration of plans to facilitate the incorporation of project developed capabilities into the entity’s animal food safety system. Expected challenges are documented and addressed, including plans to identify and implement improvements to inspection and enforcement programs when state non-contract inspections do not support FDA's ability to move cover-by dates or to take action.

Demonstration of plans or examples of current work planning and data sharing practices that provide for assessment and improvement of joint workplans and firm inventories, as well as other regulatory products and processes applicable to the objectives of this project.

Resources (20 Points)

Demonstration of adequate program resources (including staff) and infrastructure, or the ability to obtain the resources necessary, to complete each project objective.

Do they have the trained staff, available IT resources, and does the program have the authority or commissioning to perform comprehensive non-contract inspections and enforcement.

Additional Review Criteria - Overall

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.

Resubmissions

Not applicable.

Renewals

Not Applicable.

Revisions

Not applicable.

Additional Review Considerations - Overall

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.

Not Applicable.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Committee convened by the FDA, using the stated review criteria. Assignment to an Objective Review Committee will be shown in eRA Commons.

As part of the objective review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial 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.

3. Anticipated Announcement and Award Dates

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.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement. 

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the HHS Grants Policy Statement.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in FDA-funded studies, the recipient must provide FDA copies of documents related to all major changes in the status of ongoing protocols.

The following Federal wide and HHS-specific policy requirements apply to awards funded through FDA:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in the HHS Grants Policy Statement.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  FDA may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and HHS Grants Policy Statement.

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to HHS Grants Policy Statement for additional information. 

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 (HHS) grant administration regulations at 2 CFR Part 200, 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 recipients is anticipated during the performance of the activities. Under the cooperative agreement, the FDA purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the FDA as defined below.

The Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with FDA 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.

FDA/HFP Program Staff will have substantial programmatic involvement that is above and beyond the normal programmatic oversight, monitoring, and stewardship of awards, as described below:

• Provide subject matter expertise, programmatic assistance, and evaluation services to support program studies and activities.
• Evaluate the supported program, including development of program-level performance measures, consistent data collection, and reporting procedures and protocols.
• Participate in data analysis, interpretation of findings, and where appropriate, co-authorship of publications.
• Monitor sharing of workplan and facility information and updating of FDA inventory with data provided by the awardee(s).
• FDA/HFP SMEs will collaborate with recipients to support development of their quality systems designed and implemented to protect the public health

3. Data Management and Sharing

Consistent with the FDA 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.  In addition to completing the RPPR in eRA Commons, awardees must also upload a completed copy of the most recent version of the AFRPS Reporting Documents.

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, the FDA will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), 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 2 CFR Part 200.113 and Appendix XII to 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 (Responsibility/Qualification in SAM.gov, formerly 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 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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)

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

Isaiah Isakson 
FDA - Office of Partnerships
Telephone: 406-465-9363
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Danielle Head
Grants Management Specialist
Office of Acquisitions and Grants Services
Email: [email protected] 

Section VIII. Other Information

Recently issued policy notices may affect your application submission. A full list of policy notices is provided 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), 21 USC 2104, and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.