Full_Announcement_PAR-27-014.pdf

Department of Health and Human Services Part 1. Overview Information

Participating Organization(s)

U.S. Food and Drug Administration (FDA)

NOTE: The policies, guidelines, terms, and conditions stated in this Notice of Funding Opportunity (NOFO) may differ from those used by the NIH. Where this NOFO provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this NOFO.

The FDA does not follow the NIH Page Limitation Guidelines or the NIH Review Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Objective Review Process.

Components of Participating Organizations

Human Foods Program (HFP)

Funding Opportunity Title

Development and Maintenance of Human and Animal Food Rapid Response Teams

Activity Code

UF4

Announcement Type

New

Related Notices

None

Number (FON)

PAR-27-014

Companion Funding Opportunity

None http://www.fda.gov/ https://www.fda.gov/about-fda/fda-organization/human-foods-program

Number of Applications

See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.103

Purpose

The purpose of this Notice of Funding Opportunity (NOFO) is to develop and maintain Rapid Response Teams (RRTs) to facilitate long-term improvements and innovation within the national integrated food safety system by unifying and coordinating federal, state, and local human and animal food (HAF) emergency response efforts including:

1) Strengthening the link among epidemiology, lab, and environmental health/regulatory components and supporting foodborne illness detection, investigation, control, and prevention efforts;

2) Improving States' regulatory and surveillance HAF protection and prevention programs through the development and continued use of Incident Command System (ICS)/National Incident Management System (NIMS) principles and a Unified Command structure to conduct integrated responses to all-hazards HAF emergencies, rapidly identifying and removing tainted food from commerce, and conducting root cause investigations to inform future prevention efforts;

3) Addressing supporting components, such as training, data sharing, data analysis, communications, continuous process improvement, and development of best practices and other resources to support national response capacity/capability development; and

4) Identifying and implementing innovative approaches in alignment with presidential initiatives to Make America Healthy Again (MAHA) and Make Our Children Healthy Again (MOCHA) with the aim of reducing long term implications of foodborne illness through prevention, detection, and response efforts.

Goals

The goals of this project are to:

• Strengthen and enhance collaboration in an integrated food safety system.

• Minimize the time between agency notification of a human or animal food incident and implementation of effective control measures to protect public health.

• Facilitate long-term improvements in response efforts.

• Strengthen the link among epidemiology, lab, and environmental health/regulatory components and supporting foodborne illness detection, investigation, control, and prevention efforts.

• Improve States' regulatory and surveillance HAF prevention programs through the development and continued use of Incident Command System (ICS)/National Incident Management System (NIMS) principles and a Unified Command structure to conduct integrated responses to all-hazards HAF emergencies, rapidly identifying and removing tainted food from commerce, and conducting root cause investigations to inform future prevention efforts.

• Address supporting components, such as training, data sharing, data analysis, communications, continuous process improvement, and development of best practices and other resources to support national response capacity/capability development.

Key Dates Posted Date

November 4, 2026

Open Date (Earliest Submission Date)

November 4, 2026

Letter of Intent Due Date(s)

December 4, 2026

October 6, 2028

October 5, 2029

October 4, 2030

October 3, 2031

Application Due Date(s)

January 4, 2027

November 6, 2028

November 5, 2029

November 4, 2030

November 3, 2031

All applications are due by 11:59 PM local time of applicant organization. No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Earliest Award Date April 1, 2027

Late Applications

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).

Expiration Date

November 4, 2031

Due Dates for E.O.

12372

Not Applicable

Required Application Instructions Conformance to all requirements, both in the Application Instruction Guide and in the NOFO, is required and strictly enforced. When the program-specific instructions deviate from those in the Application Instruction Guide, follow the program-specific instructions.

Applications that do not comply with these instructions will not accepted for review.

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 Rapid Response Teams Background

Rapid Response Teams (RRTs) are multi-agency, multi-disciplinary teams that operate using Incident Command System (ICS)/National Incident Management System (NIMS) principles and a Unified Command structure to respond to human and animal food emergencies, to include preparation and detection through investigation, control, and follow-up. The desired outcome of RRT development is to maximize collaboration, through clearly defined organizational roles of state, local, and federal partners, in an integrated food safety system in order to minimize the time between agency notification of a human or animal food incident and implementation of effective control measures, thus reducing long-term health implications that stem from foodborne illness. Human and animal food incidents include: all hazards, farm-to-fork, outbreaks, natural disasters, potential tampering and/or intentional adulteration, positive samples, recalls, and radiological preparedness. RRTs take three years to fully develop, which is termed "RRT Development" focus area. RRTs may apply for up to $300k for each grant year in development. After three years in development, RRTs transition to "RRT Maintenance" focus area (except in unique circumstances described below) where criteria-based data is used to put RRTs into one of three funding tiers (Level 1-$150k, Level 2-$225k, Level 3-$300k). See additional information under Section III Eligibility Information.

Applicants must refer to Section III Eligibility Information to determine which funding focus area they should apply for: RRT Development or RRT Maintenance.

Applicants should take sustainability into account when designing projects proposed under this notice of funding opportunity to maximize the longevity of resulting outcomes, resources, and program infrastructure beyond the end of the project period.

The RRT Program supports development and maintenance/continued operations of multi-jurisdictional, multi-disciplinary RRTs for program improvement and requires extensive cooperation and coordination among state, local, and federal programs (human and animal food regulatory programs, laboratory, epidemiology, emergency management), and corresponding to the FDA Division Office and the Office of Domestic Partnerships (ODP). Incident response and surveillance work conducted by the RRT, including investigations, tracebacks, root cause analysis, sample collection, laboratory analyses, and recalls are considered within scope for this NOFO.

The RRT objectives below must be achieved each budget period. These RRT objectives are aligned with the RRT Program 6-Year Plan (2023-2029) and the RRT Capacity Building Process and Mentorship Framework found on the RRT website noted above.

Annual objectives for RRT Development Focus Area:

1. Complete the RRT Capacity Building Process and Mentorship Framework phases 1 and 2, including:

developing the RRT structure (inclusive of human and animal food regulatory, epidemiology, and laboratory partners), holding quarterly meetings, training of team members, and development of standard operating procedures.

2. Submit a Sustainability Assessment, which describes the following: 1) Resources critical to RRT operations and program maintenance; 2) Current funding source for each resource (State, Federal, etc.);

3) Approximate dollar value of each resource; 4) Contingency plans and impact on each resource should Federal RRT funds cease. Provide updates with progress reports.

3. Conduct at least one joint training addressing a common need among RRT member agencies/partners (e.g. Epi-Ready, Environmental Sampling, Tracebacks, etc.).

4. Complete and submit the Capability Assessment Tool (CAT), annually, to include identification of improvement items. Participate in workgroup to revise CAT, when available.

https://www.fda.gov/food/integrated-food-safety-system-ifss/rapid-response-teams-rrts-human-and-animal-foods

5. If the recipient is part of the Laboratory Flexible Funding Model (LFFM) by signing on to an approved LFFM sampling plan, they will follow their Rapid Response Team procedures to conduct follow-up inspections, investigations (including traceback/forward) and enforcement actions (e.g., embargos, holds, recalls, warning letters, closures, etc.) for positive samples identified as part of the LFFM cooperative agreement.

· Recipients will commit to coordinating 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.

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

· Potentially violative LFFM samples may come to the RRT from any laboratory participating in the LFFM Human Food Product Testing track for microbiology or chemistry. This includes samples collected by LFFM laboratories within the same state as the RRT Program (may or may not be the primary servicing laboratory for RRT Program); samples collected by other states/analyzed by other LFFM laboratories where the potentially violative product is traced back to the RRT Program’s state.

· Recipients will collect additional samples in accordance with the collection instructions for each hazard-commodity pair on the approved LFFM sample plan, as needed.

6. Conduct at least one planned joint exercise with all RRT partners to focus on improving response capabilities identified as needing improvement (e.g. tracebacks, sampling, root cause analysis, recalls etc.). The exercise must include ICS elements and standing up an Incident Management Team to manage the incident.

7. Conduct at least one presentation (oral or poster) about the development of the RRT or documenting a specific investigation (in years 2 and 3).

8. Complete timely after-action reviews and summary reports for exercises and responses to significant real incidents. At least one after-action report shall be shared with the FDA each grant year through After Action eXchange (AAX) or FoodSHIELD.

9. Develop an improvement plan based on the results of the capability assessment AND investigative findings detected through after-action review (AARs), to include task descriptions (what needs to be accomplished), a detailed timeline (when the work will start, who will be doing the work and when the work will be completed), and status updates.

10. A minimum of two (2) key RRT personnel must attend an annual face-to-face RRT or virtual meeting (as determined by FDA ODP) and at least one person representing the RRT must attend the biennial Integrated Foodborne Outbreak Response Management (InFORM) Conference and the Regional InForm meetings (held in non-InFORM annual meeting years) as a condition of the award.

Yearly objectives for RRT Maintenance Focus Area:

Because the RRT maintenance funding is tiered, some goals are optional based on the state program funding tier as described below.

1. Maintenance and Continuous Program Improvement (All Sub-Parts Required)

1-1. Maintain the RRT:

a1. SOPs must be current and fit for use.

a2. Maintain the team.

a3. Equip the team.

https://www.aax.directory/ https://www.foodshield.org/ a4. Complete at least one exercise using ICS (or actual incident response that includes ICS activation) each grant year.

a5. Ensure that state/local agencies who receive RRT funding from the primary awardee agency (pass through funding/subawards) will provide details of what was accomplished with the funding to the state RRT Coordinator or PI/PD to be shared with FDA via mid-year and end-of-year RRT Cooperative Agreement progress reports.

b. RRTs must be responding and/or activating to outbreaks and other food incidents that impact industry and meet criteria for activation/response.

c. Execute the training plan.

d. If the recipient is part of the Laboratory Flexible Funding Model by signing on to an approved LFFM sampling plan, they will follow their Rapid Response Team procedures to conduct follow-up inspections, investigations (including traceback/forward) and enforcement actions (e.g., embargos, holds, recalls, warning letters, closures, etc.) for positive samples identified as part of the LFFM cooperative agreement.

· Recipients will commit to coordinating 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.

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

· Potentially violative LFFM samples may come to the RRT from any laboratory participating in the LFFM Human Food Product Testing track for microbiology or chemistry. This includes samples collected by LFFM laboratories within the same state as the RRT Program (may or may not be the primary servicing laboratory for RRT Program); samples collected by other states/analyzed by other LFFM laboratories where the potentially violative product is traced back to the RRT Program’s state.

· Recipients will collect additional samples in accordance with the collection instructions for each hazard-commodity pair on the approved LFFM sample plan, as needed.

1-2. Complete After Action Reviews (AARs) for RRT responses, activations, and exercises according to RRT SOPs.

1-3. Complete and submit Capability Assessment Tool (CAT), annually, to include identification of improvement items. Participate in workgroup to revise CAT, when available.

1-4. Develop an improvement plan based on the results of the capability assessment AND investigative findings detected through AARs, to include task descriptions (what needs to be accomplished), a detailed timeline (when the work will start, who will be doing the work and when the work will be completed), and status updates.

1-5. Submit a Sustainability Assessment, which describes the following: 1) Resources critical to RRT operations and program maintenance; 2) Current funding source for each resource (State, Federal, etc.);

3) Approximate dollar value of each resource; 4) Contingency plans and impact on each resource should Federal RRT funds cease. Provide updates with progress reports. Diversify support for RRT operations/maintenance (ideally split across state and federal grant funds); in particular, ensuring key RRT personnel salaries are on partial state funds and O&M costs for IT systems and other technologies are on state, not federal, funds. Provide an update on diversification of funding (successful or unsuccessful) in progress reports.

2. RRT Innovation, Integration, and National Capacity/Capability Development (Level 3 RRTs: Must Have 2 Distinct Projects Per Year; Level 2 RRTs: Must Have 1 Project Per Year; Level 1 RRTs: No Requirement)

2-1. Mentor a voluntary RRT or a newly established RRT, OR a newly hired/reassigned RRT Coordinator in an established RRT.

2-2. Develop and execute an inter-RRT project/collaboration, aimed at any RRT-related topic of mutual interest. Examples include, Regional RRT meetings, Division-wide RRT collaboration, multi-RRT After Action Reports (AAR)/improvement plans, identifying and proposing solutions to regional/national needs/gaps (surveillance, response or prevention; training; exercise; data sharing), and working with relevant partners to propose outreach, education, legislative and other activities to prevent incident/contamination recurrence.

2-3. Pilot, implement, and evaluate newly established best practices. This may include developing the capacity to: stand up an incident management team (IMT) using the concepts of ICS compressed, assemble and utilize “Go-Kits”, use the RRT Coordinator chapter to train a new RRT Coordinator, use the Root Cause Analysis (RCA) chapter to conduct an RCA/Root Cause Investigation (RCI). This includes a written evaluation of the effectiveness of implementing the best practice and any recommendations for improvement.

2-4. Assist non-RRT agencies in developing advanced response capabilities. This includes training on the RRT Best Practices Manual, the Capacity Building and Mentorship Framework, and sharing how they developed and maintain their RRT by sharing procedures used for RRT responses and activations.

2-5. Develop and execute a specific project aimed at enhancing/improving collaboration with local health departments during RRT responses and activations, or with another RRT partner that has historically not been involved in the RRT (e.g., USDA FSIS, a new human food/animal food commodity area, law enforcement, emergency management). Which partners meet this criterion will largely depend on how the RRT is structured.

2-6. Develop and execute a training-related project.

2-7. Participate in individual, multi-state or national initiatives to undertake innovative approaches to response and/or create and provide tools and resources to help others enhance their ability to effectively respond to human food/animal food contamination incidents.

2-8. Additional projects the RRT is working on related to Program Objective 2 may be submitted to FDA/ODP for review and approval to be added as optional goals.

3. Gathering and Sharing Data to Support Prevention (Number 3-3 is Required for all RRTs; Level 3 RRTs:

Must Have 2 Project Per Year Selected from Other Sub-Parts; Level 1 & 2 RRTs: No Requirement, however:

optional and strongly encouraged).

3-1. Develop and execute a project aimed at combatting critical health challenges facing American citizens in alignment with goals in the February 13, 2025, White House memo (and related documents) to Make America Healthy Again (MAHA), Establishing the President's Make America Healthy Again Commission – The White House and in the MAHA report through:

a. Engaging with local health departments and/or other state agencies to collaborate on educational programs targeting children's nutrition and hygienic practices around food and/or encouraging prevention of childhood health issues.

b. Engaging with industry or local health departments to encourage food safety practices that aim to reduce the occurrence of long-term implications of foodborne illness.

c. Engage with industry and/or academic partners to implement MAHA Initiatives.

d. Amplifying outreach and/or public messaging to specific impacted industry, uniquely impacted populations, and/or especially vulnerable consumers on public health concerns, including those pertaining to risks for chronic illness and those related to prolonged exposure (e.g. heavy metals in foods intended for children, contaminants in water used as a food ingredient, or toxins detected in tableware).

https://www.whitehouse.gov/presidential-actions/2025/02/establishing-the-presidents-make-america-healthy-again-commission/ https://www.whitehouse.gov/presidential-actions/2025/02/establishing-the-presidents-make-america-healthy-again-commission/ https://www.whitehouse.gov/maha/

e. Engaging with local health departments, universities, and/or other state programs to review data sources (AAR reports, foodborne outbreak response summaries, foodborne outbreak attribution data, etc.), identifying vulnerable populations affected by foodborne illness outbreaks that lead to chronic health conditions, paying particular attention to the availability of nutritious and wholesome foods.

f. Strengthening capacity for children's health protection through the development of specialized protocols for addressing food safety issues in schools and childcare facilities, implementing targeted surveillance programs for foods commonly consumed by children or creating educational materials on food safety tailored for children, caregivers, and/or school food handlers.

g. Other efforts that align with these public health and safety goals, as approved by ODP staff.

3-2. Address gaps in procedures or training necessary to support conducting root cause analysis (assessments geared at identifying contributing factors and environmental antecedents that led to a human food or animal food contamination event).

3-3. Use the Root Cause Analysis chapter of the RRT Best Practices Manual process to document RCA findings. Share results of RCAs via the capability assessment tool, NEARS, and NORS. Root cause or innovative findings are shared in a written report, during RRT monthly teleconference updates, or at the annual meeting.

3-4. Share investigation findings with industry, or work with relevant partners to propose recommendations for industry or other preventive measures based on findings from root cause analysis.

Examples include organizing/hosting workshops or trainings for industry, developing and providing written guidelines/best practices or other resources to industry, publishing articles in trade journals, leveraging State Food Protection Task Force events, and speaking at industry events.

3-5. Use Reportable Food Registry (RFR), Root Cause Analysis (RCA) findings, recalls, import alerts, and/or consumer complaint data to develop a project to target chronic health conditions and implement preventive measures (education, outreach, public messaging campaigns, surveillance sampling of foods consumed by vulnerable populations).

3-6. Collaborate with regulatory partners to suggest and implement prevention-focused improvements in routine inspection and sampling activities based on lessons learned and findings from past root cause analysis and investigations. Examples include, revision of inspection/investigation questionnaires or protocols, implementation of or changes to surveillance sampling schedules, revision of sampling protocols, and changes in risk classification of firm inventory.

3-7. Work with RRT member agencies/partners to capture and report root cause analysis data to national reporting systems, such as: the FDA’s Farm Investigation Questionnaire for on-farm/produce related microbiological contamination events, and CDC’s National Outbreak Reporting System for any human foodborne illness outbreak. Use of the most updated version of the FDA Root Cause Analysis Process Overview in conducting root cause analysis is encouraged. Completing a root cause analysis for outbreaks impacting vulnerable populations is also strongly encouraged.

3-8. Work with RRT member agencies/partners to capture and report root cause analysis data to CDC’s National Environmental Assessment Reporting System (NEARS) for outbreaks linked to food service establishments.

3-9. Using an emerging issue or recent response outcomes, develop and execute a project in line with the new HHS priority of ending America's epidemic of chronic illness by focusing on safe, wholesome food, clean water, and the elimination of environmental toxins.

4. Communicating RRT Impact (All Sub-Parts Required)

4-1. Conduct at least two presentations per year (oral or poster) documenting a specific RRT investigation or other activity and share a copy of the presentation within the RRT Program Workgroup in FoodSHIELD.

At least one of these two presentations must be at a regional or national meeting (a RRT Face to Face (F2F) Meeting presentation cannot count as the regional/national meeting presentation).

4-2. Present at least once per year on the national RRT monthly teleconference and present a poster at the national RRT F2F meeting to share investigation or project outcomes, as well as emerging or nascent stage lessons learned and best practices with other RRTs.

4-3. Prepare and post at least one report per year of a significant investigation, successful prevention effort, or other RRT action taken to protect public health on a Food Protection Task Force webpage, a state agency webpage or other public webpage and notify RRT Program Coordinators to allow cross-linking from the FDA RRT webpage. RRT authorship on a peer reviewed journal article is acceptable for this goal.

4-4. For each revision cycle of the RRT Manual, participate in at least one aspect of RRT Manual revision.

Options include review chapters to verify content or identify content requiring revision (at least 3 chapters), participate in the national review (review at least 3 chapters), and participate in a chapter committee (at least 1 committee). This goal may not be applicable during each year of the cooperative agreement.

4-5. A minimum of two (2) key RRT personnel must attend an annual face-to-face or virtual RRT meeting (as determined by FDA ODP) and at least one person representing the RRT must attend the biennial Integrated Foodborne Outbreak Response Management (InFORM) Conference and the Regional InFORM meetings (held in non-InFORM annual meeting years) as a condition of the award.

Applicants must review and address these yearly RRT objectives within their application and provide mid-year and Performance Progress Report (PPR)/end-of-year progress report updates for each grant year.

Legislation/other references of authority

National Integrated Food Safety System:

Integrated Food Safety System (IFSS) | FDA

Food Safety Modernization Act:

http://www.fda.gov/Food/GuidanceRegulation/FSMA/

Full text of the law: http://www.fda.gov/food/guidanceregulation/fsma/ucm247548.htm

PERFORMANCE MEASURES:

Consistent with the Uniform Guidance, codified at 2 CFR Part 200, an emphasis will be placed on the applicant’s ability to measure progress and track performance using objective, proven, and measurable data.

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

Section II. Award Information Funding Instrument

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. See Section VI.2 for additional information about the substantial involvement for this NOFO.

https://www.fda.gov/food/integrated-food-safety-system-ifss/food-protection-task-forces-fptfs https://www.fda.gov/food/federal-state-local-tribal-and-territorial-cooperative-human-food-programs/integrated-food-safety-system-ifss http://www.fda.gov/Food/GuidanceRegulation/FSMA/ http://www.fda.gov/food/guidanceregulation/fsma/ucm247548.htm

Application Types Allowed

New

Only those application types listed here are allowed for this NOFO.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications.

Award(s) will provide one (1) year of support and include future recommended support for four (4) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory awardee performance and workload.

FDA /HFP intends to fund up to $6.5 million for fiscal year (FY) 2027 in support of this grant program. Funding for FY2028, FY2029, FY2030 and FY2031 will be contingent upon annual appropriations and availability of funding.

It is anticipated that up to twenty-eight (28) awards will be made, not to exceed $360,000 in total costs (direct plus indirect), per award.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

YR 01: $360,000

YR 02: $360,000

YR 03: $360,000

YR 04: $360,000

YR 05: $360,000

Applicants must refer to Section III Eligibility Information to determine which focal area they should apply for: RRT Development or RRT Maintenance and the funding limits.

Award Project Period

The scope of the proposed project should determine the project period.

The maximum project period is 5 years.

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 Eligible Organizations Eligibility for this funding opportunity is limited to state human and animal food regulatory programs listed here: manufactured food regulatory programs, retail food regulatory programs, produce regulatory programs, and animal food regulatory programs that meet the eligibility criteria below may apply for funding under this cooperative agreement. Competition is limited to these programs. Only one application is allowed per state. Jurisdictions interested in involving multiple state entities (within their jurisdiction) should internally coordinate and choose one (1) entity to apply.

https://www.hhs.gov/sites/default/files/hhs-grants-policy-statement-oct-2025.pdf

Eligible state human and animal food regulatory programs should discuss who is best suited to lead development of new RRTs. States that have existing RRTs should continue to maintain their RRTs using the existing program lead team and infrastructure developed through prior RRT cooperative agreement investments.

Applicants will be categorized under one of two (2) focus areas: RRT Development or RRT Maintenance (see eligibility criteria and funding ceilings (maximum amount that may be requested)). Applicants must indicate the focus area applicable in the application. Passing up to 20% of these total base awards to partners is allowable. Additionally, funding will be offered to Maintenance RRT states, ONLY, as subawards for prevention projects related to MAHA objectives that exceed the minimum required for a grantee's funding level, up to a maximum of three (3) subawards of $20,000 per state. RRT partner recipients of subawards must agree to document how the subawards and passthrough funds are used to assist the RRT in meeting program objectives. This includes information related to the overall RRT budget and Capability Assessment Tool submissions. Progress updates on subaward funded activities must be included in mid-year and end-of-year progress reports.

Applicants are encouraged to tailor their cooperative agreement requests to their jurisdiction's needs in terms of funding amount and number of project years.

Focus Area: RRT Development A state agency is generally only eligible for the RRT Development focus area if they have received less than three (3) years funding under a past RRT/FFM cooperative agreement or have never received a RRT cooperative agreement.

Applicants may request up to $300,000/year for this funding option.

RRT Development Focus Area:

Eligible RRTs receive up to $300,000 per year Max of 3 years of funding*

* An applicant may be eligible, upon ODP review and approval, for one additional year of development funding under certain circumstances to include, for example: a large turnover in RRT staff, a significant pause in RRT participation, a significant reduction in one or multiple years of development funds, turnover of key personnel, or any other circumstance as approved by ODP staff. ODP should be notified of the state's intent to request development funding beyond 3 years in the letter of intent.

To apply for RRT Development, the state human or animal food regulatory program must meet the following eligibility criteria:

Manufactured Food Program eligibility requirements:

Must be in conformance with the Manufactured Food Regulatory Program Standards (MFRPS) https://www.fda.gov/food/regulatory-program-standards-food/manufactured-food-regulatory-program-standards-mfrps

· Must have a 20.88 agreement with the FDA or agree to complete a 20.88 agreement with the FDA by the end of grant year one (March 31, 2028)

Retail Food Program eligibility requirements:

· Retail food code adoptions (must have adopted one of the latest 4 versions);

https://www.fda.gov/food/fda-food-code/adoption-fda-food-code-state-and-territorial-agencies-responsible-oversight-restaurants-and-retail https://www.fda.gov/food/regulatory-program-standards-food/manufactured-food-regulatory-program-standards-mfrps https://www.fda.gov/food/regulatory-program-standards-food/manufactured-food-regulatory-program-standards-mfrps https://www.fda.gov/food/fda-food-code/adoption-fda-food-code-state-and-territorial-agencies-responsible-oversight-restaurants-and-retail https://www.fda.gov/food/fda-food-code/adoption-fda-food-code-state-and-territorial-agencies-responsible-oversight-restaurants-and-retail

· Must be actively implementing the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS): https://www.fda.gov/food/voluntary-national-retail-food-regulatory-program-standards/listing-jurisdictions-enrolled-voluntary-national-retail-food-regulatory-program-standards

· Must have a 20.88 agreement with the FDA or agree to complete a 20.88 agreement with the FDA by the end of grant year one (March 31, 2028)

Produce Program eligibility requirements:

· PATH B and PATH C grantee agencies may apply

· Must enroll in the Produce Regulatory Program Standards when available

· Must have a 20.88 agreement with the FDA or agree to complete a 20.88 agreement with the FDA by the end of grant year one (March 31, 2028)

Animal Food Program eligibility requirements:

· Must be in implementation with the Animal Food Regulatory Program Standards (AFRPS) per last audit; https://www.fda.gov/food/regulatory-program-standards-food/animal-food-regulatory-program-standards-afrps-preventive-controls-cooperative-agreement-program

· Must have a 20.88 agreement with the FDA or agree to complete a 20.88 agreement with the FDA by the end of grant year one (March 31, 2028)

Focus Area: RRT Maintenance A state agency is eligible for the RRT Maintenance focus area if they have previously received three (3) or more years funding under past RRT and/or FFM cooperative agreements.

RRT Maintenance Funding Criteria:

Manufactured Food

Criteria-based data was used to tier manufactured food programs into three funding levels (Level 1- $150k, Level 2-$225k, or Level 3-$300k). Criteria-based data used: state population, FSMA High Risk Firm Count + Non-High-Risk Firms= state total, and count of multi-state outbreaks the state is involved in (average over past 10 years per CDC's National Outbreak Reporting System (NORS)). Note: for state regulatory programs based outside of manufactured food programs, manufactured food firm counts were also used to calculate funding levels.

RRT Maintenance Focus Area:

Level I $150,000 Level II $225,000 Level III $300,000 $20,000 (up to 3 subawards)* $20,000 (up to 3 subawards)* $20,000 (up to 3 subawards)*

* Subawards will be considered for prevention projects related to MAHA objectives that exceed the minimum required for a grantee's funding level, up to a maximum of three (3) subawards of $20,000 per state. In addition, passing up to 20% of awarded baseline funds to partners is allowable. RRT partner recipients of subawards (both those from baseline funds or extra subawards) must agree to document how the subawards and pass-through funds are used to assist the RRT in meeting program objectives.

This includes information related to the overall RRT budget and Capability Assessment Tool submissions.

Progress updates on subaward funded activities must be included in mid-year and PPR/end-of-year progress reports. APPLICANTS MUST INCLUDE A STATEMENT IN THE BUDGET JUSTIFICATION

NARRATIVE SPECIFYING WHETHER THE SUBAWARD FUNDING IS FROM THE APPLICANT'S BASE

AWARD OR IF IT IS ADDITIONAL SUBAWARD FUNDING.

Program eligibility requirement:

https://www.fda.gov/food/voluntary-national-retail-food-regulatory-program-standards/listing-jurisdictions-enrolled-voluntary-national-retail-food-regulatory-program-standards https://www.fda.gov/food/voluntary-national-retail-food-regulatory-program-standards/listing-jurisdictions-enrolled-voluntary-national-retail-food-regulatory-program-standards https://www.fda.gov/food/regulatory-program-standards-food/animal-food-regulatory-program-standards-afrps-preventive-controls-cooperative-agreement-program https://www.fda.gov/food/regulatory-program-standards-food/animal-food-regulatory-program-standards-afrps-preventive-controls-cooperative-agreement-program

· Must be in conformance with Manufactured Food Regulatory Program Standards (MFRPS) per the last audit or return to full conformance within one grant budget period.

· Must have a 20.88 agreement with the FDA or agree to complete a 20.88 agreement with the FDA by the end of grant year one (March 31, 2028).

Manufactured Food Program- RRT Maintenance Funding Ceiling Table:

RRT Level 1

Eligible for up to $150,000

RRT Level 2

Eligible for up to $225,000

RRT Level 3

Eligible for up to $300,000

Mississippi Arkansas California Rhode Island Arizona Florida West Virginia Connecticut Michigan Georgia Minnesota Indiana New York Iowa Pennsylvania Kansas Texas Kentucky Wisconsin Maryland Massachusetts Missouri North Carolina South Carolina Tennessee Utah Virginia Washington

Retail Food Program maintenance requirements:

· Retail food code adoptions (must have adopted one of the latest 4 versions)

· Must be actively implementing the Voluntary National Retail Food Regulatory Program Standards

(VNRFRPS)

· Must have a 20.88 agreement with the FDA or agree to complete a 20.88 agreement with the FDA by the end of grant year one (March 31, 2028).

Produce Program maintenance requirements:

· PATH B and PATH C grantee agencies may apply

· Must enroll in the Produce Regulatory Program Standards when available

· Must have a 20.88 agreement with the FDA or agree to complete a 20.88 agreement with the FDA by the end of grant year one (March 31, 2028).

Animal Food Program eligibility requirements:

· Must be in implementation with the Animal Food Regulatory Program Standards (AFRPS) per last audit.

· Must have a 20.88 agreement with the FDA or agree to complete a 20.88 agreement with the FDA by the end of grant year one (March 31, 2028).

Foreign Organizations 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 NIH Grants Policy Statement, are not allowed.

Required Registrations 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.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed project 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.

http://grants.nih.gov/grants/guide/url_redirect.htm?id=11118 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://www.hhs.gov/sites/default/files/hhs-grants-policy-statement-oct-2025.pdf https://grants.nih.gov/grants/guide/url_redirect.htm?id=82390 http://grants.nih.gov/grants/guide/url_redirect.htm?id=11176 https://grants.nih.gov/grants/guide/url_redirect.htm?id=11123 http://grants.nih.gov/grants/guide/url_redirect.htm?id=82300 https://grants.nih.gov/grants/guide/url_redirect.php?id=82400

2. Cost Sharing This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement.

3. Additional Information on Eligibility Number of Applications

Jurisdictions interested in involving multiple state entities (within their jurisdiction) should internally coordinate and choose one (1) entity to apply. Eligible state human and animal food regulatory programs should discuss who is best suited to lead development of new RRTs.

Section IV. Application and Submission Information

1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Application Instruction Guide except where instructed in this notice of funding opportunity to do otherwise. 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.

Technical Sessions A technical session will be held for prospective applicants around November 2026. The conference call information will be provided to all prospective applicants. 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.

Technical session(s) will be held for prospective applicants in approximately two weeks after the NOFO posts. Subsequent technical sessions for future application due dates will be held as necessary. The technical session(s) 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.

To register for the technical session, please contact:

Thanh Andrews Office of Domestic Partnerships (ODP) Email: Thanh.Andrews@fda.hhs.gov

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 https://www.hhs.gov/sites/default/files/hhs-grants-policy-statement-oct-2025.pdf https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 mailto:Thanh.Andrews@fda.hhs.gov

Send letter of intent to:

Danielle Head Office of Acquisitions and Grants Services (OAGS) Email: Danielle.Head@fda.hhs.gov

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

Component Form to use Page limit Project abstract Project Abstract Summary form 1 page Project narrative Project Narrative Attachment form 30 pages Budget narrative Budget Narrative Attachment form No

Instructions for Application Submission The following section supplements the instructions found in the Application Guide and should be used for preparing an application to this NOFO.

Application for Federal Financial Assistance (SF-424) All instructions in the Application Guide must be followed. In the "Descriptive Title of Applicant's Project:"

field applicants must include the applicable focus area (Development or Maintenance) and State Organization Name/Abbreviation in the Project Title.

SF-424 A Budget Information - Non-Construction Programs Form All instructions in the Application Guide must be followed.

Project/Performance Site Location(s) All instructions in the Application Guide must be followed.

Project Abstract Summary All instructions in the Application Guide must be followed.

Project Narrative Attachment All instructions in the Application Guide must be followed. Applicants must address RRT objectives appropriate to the applicable focus area (Development or Maintenance).

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

For RRT Maintenance Applicants:

• Applicants must include a statement in the budget justification narrative specifying whether the subaward funding is from the applicant's base award or if it is additional subaward funding.

• Submit most recent RRT Capability Assessment Tool and Activity Table as appendix 1.

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

Submission Dates and Times mailto:Danielle.Head@fda.hhs.gov https://grants.nih.gov/grants/guide/url_redirect.htm?id=61134

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). 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. Applications that miss the due date and time are subjected to the FDA Policy on Late Application Submission.

App…