Full Announcement_RFA-FD-26-009.pdf

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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

Education and Outreach to Tribal Producers through the Tribal Food Safety Alliance

Activity Code

U01 Research Project Cooperative Agreements

Announcement Type

New

Related Notices

None

Number (FON)

RFA-FD-26-009

Companion Funding Opportunity

None http://www.fda.gov/ https://www.fda.gov/about-fda/fda-organization/human-foods-program http://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=u01&Search.x=0&Search.y=0&Search_Type=Activity

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Number of Applications

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

Assistance Listing Number(s)

93.103

Purpose

The primary purpose of this program is to develop and provide education and/or training, and outreach regarding FDA's Produce Safety Rule to produce farmers who are members of federally recognized Tribes. The program is expected to help Tribal farmers access appropriate technical assistance and may include Tribal farmers who are not currently required to comply with the rule but are interested in complying or see economic benefits in doing so. All activities should consider Tribal history, culture, and regional agricultural practices.

Goals

Develop, maintain, and deliver a produce safety education program for Tribal communities that aligns with the FDA Produce Safety Rule and meets Tribal needs. Strengthen partnerships and regularly evaluate the program to ensure it produces clear, measurable public health results.

Key Dates Posted Date

July 20, 2026

Open Date (Earliest Submission Date)

July 20, 2026

Letter of Intent Due Date(s)

Not applicable.

Application Due Date(s) August 20, 2026

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).

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AIDS Application Due Date(s) Not Applicable

Expiration Date

August 21, 2026

Advisory Council Review

Due Dates for E.O.

12372

Required Application Instructions Conformance to all requirements, both in the the Research (R) Instructions How to Apply - Application Guide and in 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 of this NOFO or an applicable related Notice posted to the Guide for Grants and Contracts.

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.

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 Background https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 http://grants.nih.gov/grants/guide/url_redirect.htm?id=11164 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400

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The Food Safety Modernization Act (FSMA), signed into law in 2011, provided FDA with a legislative mandate to require comprehensive, prevention-based controls across the food supply, including standards for produce safety. FSMA also calls for enhanced partnerships with Federal, State, local, Tribal, and territorial partners to achieve public health goals and build an integrated national food safety system.

Federally recognized Tribes lack adequate access to culturally appropriate and affordable food safety education and/or training, outreach, and technical assistance needed to comply with FSMA Produce Safety requirements, creating disparities in implementation of the integrated national food safety system and potentially compromising public health outcomes in Tribal communities. Existing training materials, such as the Produce Safety Alliance's standardized curriculum, will continue to serve as a foundation for customization to meet Tribal needs, including regional and culturally specific practices.

This cooperative agreement benefits public health by driving compliance with FSMA's Produce Safety Rule (PSR), ensuring consistent implementation throughout the United States, leveraging existing Tribal expertise and authorities, and ultimately reducing food-borne illness.

Purpose and Priorities

The Food and Drug Administration's (FDA) Human Foods Program (HFP) is announcing its intent to renew a Cooperative Agreement with an estimated amount of $500,000.00 (direct and indirect costs) for fiscal year 2027. Future years of support are anticipated, depending on annual appropriations and successful performance.

This cooperative agreement will fund an entity with active working relationships with Native American tribes and/or organizations with demonstrated experience developing and providing science-based, culturally specific produce safety education and/or training, outreach, and technical assistance for Tribes, Tribal businesses, and/or tribal members, with an emphasis on agricultural production. Subcontracts to qualifying organizations are encouraged. Applicants must collaborate with national and regional Tribal stakeholder leaders, Tribal organizations, recipients of the FDA – state produce safety implementation cooperative agreement program, established FDA Food Safety Modernization Act (FSMA) Alliances, FDA HFP and other FDA program offices, the National Coordination and Regional Food Safety Centers, and FDA's FSMA partners at USDA and other federal organizations with food safety interests among Tribal stakeholders.

The primary purpose of this program is to develop and provide education and/or training, outreach and technical assistance regarding the PSR to produce farmers who are members of federally recognized Tribes. The program will help Tribal farmers access appropriate technical assistance and may include Tribal farmers who are not currently required to comply with the rule but are interested in complying or see economic benefits in doing so.

The following definitions are helpful in determining activities to comply with the objectives:

• Education and/or Training: A targeted instructional activity that facilitates two-way learning through formal or informal approaches utilizing real-time, self-paced, or a combination of formats to transfer experiences, skills, and information among participants. Examples include Produce Safety Alliance (PSA) grower training and Tribal supplemental material delivery.

• Outreach: An interactive dissemination of produce safety information and regulatory requirements that may include discussions for understanding and interactive feedback. Examples include On-Farm Readiness Reviews (OFRR) and workshops.

• Technical Assistance: A collaborative, problem-solving process to provide two-way dialogue for customized support through to address specific produce safety issues. Examples include phone calls and emails on specific issues as well as in-person discussion on specific targeted issues.

Phased Implementation Requirement The recipient must implement the program in sequentially numbered phase. FDA will review progress at the end of each phase before recipient can begin the next phase

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Limited overlap of activities may occur only with prior FDA approval and must be justified in the annual work plan.

Phase 1: Foundation and Planning of Program (Objectives 1, 2, and 3)

Objective 1: Develop an annual work plan

The recipient must develop and maintain an FDA-approved annual work plan that describes program goals, planned activities, partnerships, performance measures, timelines, expected outcomes and evaluation approaches.

Content and expectations of the annual plan will be discussed in greater detail with FDA post award

Objective 2: Develop and maintain guiding documents

The recipient will create foundational documents to guide the development and implementation of the Tribal produce safety program.

I. Conduct a Tribal covered produce landscape analysis

a. Develop and document an inventory identifying Tribal nations with production of covered produce, including the characterization of the production scale, infrastructure, location, market types, and covered produce under the PSR

II. Conduct an annual Tribal needs assessment that captures challenges, needs, barriers, and associated hazards with the framework of prioritization for the implementation of the PSR on Tribal lands, and share findings with FDA

Content and expectations of landscape analysis and needs assessment will be discussed in greater detail with FDA post award.

Objective 3: Develop a logic model

The recipient must develop a program logic model informed by the landscape analysis and needs assessment that illustrates the relationship between program inputs, activities, outputs, and intended outcomes and impacts.

Specific components and format will be finalized in collaboration with FDA post-award.

Phase 2 National Trainer Network Development (Objective 4)

Objective 4: Establish and maintain a qualified national network of Tribal produce safety trainers

A successful application will demonstrate how the program will:

a. Identify and increase the number of Produce Safety Alliance (PSA) Lead Trainers and Tribal supplemental Lead Trainers.

b. Standardize trainer qualification criteria, including required education, experience, certification, and continuing education.

c. Establish and maintain a national database of qualified Tribal produce safety trainers.

d. Provide ongoing professional development and technical assistance to current trainers, in coordination with FDA, through continuing education, mentorship, and communities of practice.

e. Deliver Train-the-Trainer (TTT) sessions for Tribal supplemental materials, offered virtually and/or in person.

f. Document all training provided to trainers and the delivery of training to Tribal nations.

Phase 3 Implementation, Integration and Continuous Improvement (Objectives 5 and 6)

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Objective 5: Promote understanding and integration of produce safety and environmental considerations and co-management practices.

A successful application will demonstrate how the program will:

a. Co-develop with FDA and partnering agencies materials and resources on produce safety and environmental considerations and co-management practices tailored to farms and packinghouses within Tribal nations.

b.Establish partnerships and mechanisms with Tribal entities and relevant federal and state partners to support understanding of environmental considerations and co-management practices.

c. Capture considerations for Tribal stakeholders to implement with a focus on produce safety.

d. Create new materials and document considerations specific to Tribal produce systems.

e. Provide case examples demonstrating successful integration of produce safety and environmental co-management practices in Tribal produce systems.

Objective 6: Improve the effectiveness and reach of produce safety training and outreach

A successful application will demonstrate how the program will:

a. Apply prioritization to produce safety content education and/or training, outreach, and technical assistance for Tribal nations to ensure resources are responsive, updated, strategic, integrated, and appropriately targeted.

b. Strengthen collaboration and coordination with FDA and other produce safety partners (including Federally recognized Tribes Extension Program extension educators, 1994 Tribal land-grant colleges and universities, the Produce Safety Alliance, the FDA National Coordination Center, FSMA USDA partners, and FDA/USDA Regional Centers established under the National Food Safety Training, Education, Extension, Outreach and Technical Assistance Program) to ensure activities align with current FDA produce safety priorities and support national produce safety efforts.

c. Develop new and maintain existing trainings, workshops, field-based learning opportunities, and/or one-on-one technical assistance provided to Tribal produce growers and packers.

d. Increase the visibility of training opportunities by leveraging FDA and external partner resources to foster awareness of upcoming trainings serving Tribal populations.

e. Foster coordination of outreach activities with FDA and FDA-State Produce Safety Implementation Cooperative Agreement recipients to ensure cohesive, non-duplicative engagement with farms having Tribal affiliation.

f. Coordinate and communicate with FDA regarding Tribal engagement activities, including discussing available outreach options when Federally recognized Tribes or farms on Tribal lands initiate contact, and consulting with FDA upon receipt of requests for an On-Farm Readiness Review (OFRR) from farms with Tribal affiliation to determine the appropriate entity to conduct the OFRR.

g. Update produce safety education and/or training, outreach and technical assistance materials, tailored to Tribal contexts and producer needs, to advance understanding and capture new information from outbreaks, prevention strategies, and FDA prioritized identified areas and content for educational engagement.

h. Provide FDA materials to review for alignment to the PSR prior to utilization.

i. Develop evaluation tools and provide an annual summary of data-driven information from pre/post assessments, participant feedback surveys, and other evaluation findings, lessons learned, and data-informed improvements made to training and outreach activities to better understand training effectiveness and relevance to Tribal context.

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Other Requirements

Provide a properly detailed budget (one for each of the 5 years) tied into an annual work plan intended to advance the education, training and outreach program, including identification of technical assistance resources, and estimated costs for education and outreach activities, to advance understanding of the PSR.

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.

Application Types Allowed

Renewal The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

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.

The award will provide one (1) year of support and include future recommended support for up to four (4) additional years contingent upon annual appropriations, availability of funding and satisfactory recipient performance.

HFP intends to commit up to $500,000.00 in FY 2026 to fund one (1) award.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

YR 01: $500,000.00

YR 02: $500,000.00

YR 03: $500,000.00

YR 04: $500,000.00

YR 05: $500,000.00

http://grants.nih.gov/grants/guide/url_redirect.htm?id=11116

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Award Project Period

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

The maximum project period is five (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 Only the following applicant is eligible to apply for this single source funding: The University of Arkansas

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.

o NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

o Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process.

The same UEI must be used for all registrations, as well as on the grant application.

• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov 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) https://www.hhs.gov/sites/default/files/hhs-grants-policy-statement-oct-2025.pdf 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

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

3. Additional Information on Eligibility Number of Applications Applicant organizations may not submit more than one application.

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. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. 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 Research (R) Instructions in the How to Apply - Application 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.

Letter of Intent Not applicable.

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

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

SF424(R&R) Cover All instructions in the How to Apply - Application Guide must be followed.

Descriptive Title of Applicant's Project: Applicants must include Organization Name/Abbreviation, the Project title in the applicant’s title.

SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information https://grants.nih.gov/grants/guide/url_redirect.php?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=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=61134 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400

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

The Project Summary/Abstract must include the problem statement, objectives, and intended stakeholders targeted.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - Application Guide must be followed.

R&R or Modular Budget All instructions in the How to Apply - Application Guide must be followed.

• Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested. The budget and justification for the first budget year should be detailed and reflect costs that accurately and realistically portray the work that will be completed within the first budget year. A reasonable approximation of what you intend to spend in the following years must be provided making sure to include enough details to convince the reviewers that you have a good sense of the overall costs. A detailed budget justification must be submitted for each proposed subaward (see R&R Subaward Budget section).

• 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.

R&R Subaward Budget All instructions in the How to Apply - Application Guide must be followed.

A detailed budget and justification must be submitted for each proposed subaward.

PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims: The Specific Aims document should list succinctly the goals for each applicable objective and summarize the expected outcome(s).

Research Strategy: As part of the research strategy, the applicant must address the following areas under each program objective for the applicable budget period.

Coversheet:

Project title

Program problem statement, objectives, and the intended tribal stakeholders for engagement during the entire funded period.

Phase 1 Foundation and Planning of Program (Objectives 1, 2, and 3)

Objective 1: Develop an annual work plan

Planned activities related toall objectives

Staffing Matrix

Subawards, including subaward name(s) and planned activities https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400

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Contract entity/entities and planned services

Objective 2: Develop and maintain guiding documents

Planned activities related to Objective 2

Objective 3: Develop a logic model

Planned activities related to Objective 3

Phase 2 National Trainer Network Development (Objective 4)

Objective 4: Promote understanding and integration of produce safety and environmental considerations and co-management practices.

Planned activities related to Objective 4

Phase 3 Implementation, Integration and Continuous Improvement (Objectives 5 and 6)

Objective 5: Establish and maintain a qualified national network of Tribal produce safety trainers

Planned activities related to Objective 5

Objective 6: Improve the effectiveness and reach of produce safety training and outreach

Planned activities related to Objective 6

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.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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 Appendix materials are allowed as outlined below.

Applicants must attach as Appendix #1, an organizational structure to accomplish the implementation, oversight, monitoring, and reporting of program phases and corresponding objectives. Roles and responsibilities must be outlined and must directly relate to accomplishing the applicable program phases and objectives.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or FDA-defined clinical trials (and when applicable, clinical trials research experience) 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, you must include at least one human subjects study record using the Study Record:

PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400

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

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). 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.

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

Information on the submission process and a definition of on-time submission are provided in the How to Apply - Application Guide.

5. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review.

6. Funding Restrictions All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations, and applicable judicial holdings.

Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate:

racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety. If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

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.

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

https://grants.nih.gov/grants/glossary.htm#DelayedOnsetStudy https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.html?id=82380 http://grants.nih.gov/grants/guide/url_redirect.htm?id=11128 http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/policy/nihgps/html5/section_10/10.10.1_executive_orders.htm

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For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the 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.

Not applicable.

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 programmatic review.

Overall Impact Programmatic 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).

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

Significance

Maximum Points: 10 https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/dealing-with-system-issues.htm https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/dealing-with-system-issues.htm https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 http://grants.nih.gov/grants/guide/url_redirect.htm?id=11146 http://grants.nih.gov/grants/guide/url_redirect.htm?id=82299 http://grants.nih.gov/grants/guide/url_redirect.htm?id=82299

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Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Does the applicant demonstrate the ability to sustain the progress made beyond the duration of the cooperative agreement?

Investigator(s)

Maximum Points: 10

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

Does the applicant demonstrate the ability to maintain program staff and partnerships necessary to implement, oversee, monitor, and report on program phases and objectives?

Does the applicant demonstrate the availability of adequately trained personnel to provide education and/or training, outreach, and technical assistance to Tribal stakeholders?

Does the applicant describe the criteria and capacity to hire and/or train personnel needed to meet the deliverables of the cooperative agreement?

Innovation

Maximum Points: 30

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?

Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Maximum Points: 25

FDA OCT _ 2026 Page 15 of 22

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?

Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves human subjects and/or FDA-defined clinical research, are the plans to address the protection of human subjects from research risks justified in terms of the scientific goals and research strategy proposed?

Does the applicant demonstrate the ability to develop and provide a range of educational tools for Tribal stakeholders related to FSMA regulations, specifically the Produce Safety Rule for federally recognized Tribes?

Does the applicant demonstrate the ability to develop and implement a training plan aligned with project goals that advances Tribal stakeholders' understanding of on-farm produce safety, incorporates existing materials and relevant cultural practices, and supports understanding of Produce Safety Rule requirements and other federal preventive controls standards to facilitate compliance?

Does the applicant demonstrate the ability to identify culturally appropriate methods for delivering training, outreach, and educational materials, and mechanisms to connect federally recognized Tribes with relevant technical assistance resources?

Does the applicant demonstrate the ability to meet the reporting requirements outlined in Section VI.4 of this announcement?

Environment

Maximum Points: 25

Will the scientific environment in which the work will be done contribute to the probability of success?

Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Does the applicant demonstrate the ability to engage and collaborate with national and regional Native American organization leaders, national organizations, land-grant university extension programs, the Produce Safety Alliance, the National Coordination and Regional Centers, FDA, and other federal agencies to advance understanding of the FSMA Produce Safety Rule among the target audience?

Does the applicant demonstrate the ability to cooperate and coordinate extensively with FDA's Human Foods Program (HFP), other FDA program offices, and FDA's FSMA partners at USDA to strengthen and support an integrated produce food safety system?

Does the applicant demonstrate the ability to effectively reach the target audience and collaborate with relevant partners–including Tribal academic institutions, Tribal governments, land-grant cooperative extension programs, federally recognized Tribal extension agents, Tribal NGOs and community-based organizations, and federal agencies such as USDA, CDC, and the Indian Health Service–to support work with the target audience on relevant food safety issues?

Additional Review Criteria 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.

FDA OCT _ 2026 Page 16 of 22

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

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

Vertebrate Animals The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research.

Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

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

Resubmissions Not applicable.

Renewals For Renewals, the committee will consider the progress made in the last funding period.

Revisions Not applicable.

Additional Review Considerations 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.

Applications from Foreign Organizations Not Applicable.

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

http://grants.nih.gov/grants/guide/url_redirect.htm?id=11175 http://grants.nih.gov/grants/guide/url_redirect.htm?id=11175 http://grants.nih.gov/grants/guide/url_redirect.htm?id=11150

FDA OCT _ 2026 Page 17 of 22

Resource Sharing Plans Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate FDA staff, using the stated review criteria.

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

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.

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.

2. Administrative and National Policy Requirements As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part

300. These regulations replace those in 45 CFR Part 75.

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.

https://sharing.nih.gov/other-sharing-policies/model-organism-sharing-policy#policy-overview https://grants.nih.gov/grants/policy/nihgps/html5/section_2/2.4.2_appeals_of_initial_scientific_review.htm https://www.hhs.gov/sites/default/files/hhs-grants-policy-statement-oct-2025.pdf https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-25-003.html#FundingRestrictionsanchor https://www.hhs.gov/sites/default/files/hhs-grants-policy-statement-oct-2025.pdf https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200

FDA OCT _ 2026 Page 18 of 22

• 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…