This cooperative agreement is intended to enhance the capacity and capabilities of state human and animal food testing laboratories in support of an integrated food safety system (IFSS). This is achieved through prioritized sample testing and food defense preparedness in the areas of microbiology, chemistry, and radiochemistry, as well as method development and capacity/capability development projects that support and expand food safety and food defense testing.

RFA-FD-25-007: Laboratory Flexible Funding Model (LFFM)

Posted Date: January 17, 2025 Open Date (Earliest Submission Date): January 17, 2025 Letter of Intent Due Date(s):

• February 17, 2025
• December 15, 2025
• December 14, 2026
• December 13, 2027

Application Due Date(s):

• March 31, 2025 by 11:59 PM Eastern Time
• January 12, 2026 by 11:59 PM Eastern Time
• January 11, 2027 by 11:59 PM Eastern Time
• January 10, 2028 by 11:59 PM Eastern Time

Expiration Date: January 11, 2028

Updated: March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.

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: FOOD AND DRUG ADMINISTRATION (FDA)

Funding Opportunity Title: Laboratory Flexible Funding Model (LFFM)

Activity Code: U19 Research Program Cooperative Agreements

Announcement Type: New

Related Notices:

• March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.

Funding Opportunity Number (FON): RFA-FD-25-007

Companion Notice of Funding Opportunity: None

Number of Applications: See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s): 93.103

Notice of Funding Opportunity Purpose: This cooperative agreement is intended to enhance the capacity and capabilities of state human and animal food testing laboratories in support of an integrated food safety system (IFSS). This is achieved through prioritized sample testing and food defense preparedness in the areas of microbiology, chemistry, and radiochemistry, as well as method development and capacity/capability development projects that support and expand food safety and food defense testing.

Funding Opportunity Goals: This project will strengthen and improve FDA’s efforts to prevent foodborne illnesses and minimize foodborne exposures through building a nationally integrated laboratory science system and equip our partner laboratories with additional resources that can be employed to build and increase sample throughput capacity within their state.

Key Dates:

• Posted Date: January 17, 2025
• Open Date (Earliest Submission Date): January 17, 2025
• Letter of Intent Due Date(s):
  • February 17, 2025
  • December 15, 2025
  • December 14, 2026
  • December 13, 2027
• Application Due Date(s):
  • March 31, 2025 by 11:59 PM Eastern Time
  • January 12, 2026 by 11:59 PM Eastern Time
  • January 11, 2027 by 11:59 PM Eastern Time
  • January 10, 2028 by 11:59 PM Eastern Time
• Scientific Merit Review:
  • April 2025
  • March 2026
  • March 2027
  • March 2028
• Advisory Council Review: Not Applicable
• Earliest Start Date:
  • July 2025
  • July 2026
  • July 2027
  • July 2028

Expiration Date: January 11, 2028

Due Dates for E.O. 12372: Not Applicable

Required Application Instructions: It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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

Table of Contents

• Part 1. Overview Information
  • Key Dates
• Part 2. Full Text of Announcement
  • Section I. Notice of Funding Opportunity Description
  • Section II. Award Information
  • Section III. Eligibility Information
  • Section IV. Application and Submission Information
  • Section V. Application Review Information
  • Section VI. Award Administration Information
  • Section VII. Agency Contacts
  • Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

The Food Safety Modernization Act (FSMA) outlines a new approach to food safety that is risk-informed and preventive in focus. In order to develop prevention-based systems, sample data and other information are needed to help identify and address hazards. There are different types of sample analyses that will be the focus of this project: routine human and animal food product testing, whole genome sequencing, and emergency response/emerging issues testing.

The LFFM mission is to enhance the capacity and capabilities of state human and animal food testing laboratories in support of an integrated food safety system (IFSS). This is achieved through prioritized sample testing and food defense preparedness in the areas of microbiology, chemistry, and radiochemistry, as well as method development and capacity/capability development projects that support and expand food safety and food defense testing.

The LFFM vision is that our nation’s state human and animal food (HAF) testing laboratories are prepared, equipped, and continuously exercised for response to microbiological, chemical, and radiochemical food safety hazards requiring multi-state response and national coordination/support.

Human and animal food finished products as well as in-process and raw ingredient samples are analyzed to ensure they do not reach consumers with harmful contaminants, or to verify they contain ingredients at levels as declared on product labeling. Analysis of environmental swabs from food production facilities may also be analyzed as part of for-cause facility investigations in response to positive product samples.

Emergency response and emerging issue testing can take the form of either environmental (e.g., water, sediment, soil amendments, other complex environmental samples) or product testing and could include both. Emergency response testing is routinely conducted in response to outbreaks of foodborne illness to help identify the source of the disease-causing pathogen. Emerging issues testing allows the agency to gather information about potential food safety issues based on trends or intelligence the Agency or grantee might have.

This project will produce a large quantity of sample outputs that will drive a risk-based and prevention focused food safety system that both the FDA and our State partners can utilize for tracking and trending, early identification of emerging issues, and evaluation for future sampling initiatives and areas of focus. Participating laboratories will be equipped with additional resources that can be employed to build and increase sample throughput capacity and capability within their state.

The LFFM is a cooperative agreement program, and therefore the work accomplished within the Tracks is public health oriented and of mutual benefit to FDA and state partners. Specifically, within the Product Testing Tracks, FDA sets priorities for commodity-hazard pairs and LFFM labs select what work aligns with their goals, capabilities, and interests, in collaboration with State Regulatory Program (SRP) partners. Samples collected and analyzed under the LFFM HAF Product Testing Tracks may be for a variety of purposes: regulatory, surveillance, blinded studies, Total Diet Study (TDS), signals evaluation surveillance, baseline prevalence data, etc.

Samples collected and analyzed under this cooperative agreement may derive from a variety of sources including but not limited to: an approved sample plan, emergency response and outbreak situations, national special security exercises, or an FDA assignment. Grantees may be invited to participate in FDA-issued assignments, which may have more stringent requirements regarding sampling, methodology, etc., as outlined in detailed planning and instruction documents. Outside of these FDA-issued assignments, states will have flexibility to utilize equivalent methodology, procedures, etc. Apart from FDA assignments and other FDA-directed samples (such as those collected by FDA or a 3rd party and submitted to a participating laboratory for analysis), the samples collected and analyzed under the LFFM Product Testing Tracks are state samples (collected by state regulatory program inspectors or laboratory analysts; and analyzed by state laboratories). These samples cannot be collected under FDA authority, and neither FDA credentials nor commissions can be used for collection activities.

Program Goals:

• The LFFM mission is to enhance the capacity and capabilities of state human and animal food testing laboratories in support of an integrated food safety system (IFSS). This is achieved through prioritized sample testing and food defense preparedness in the areas of microbiology, chemistry, and radiochemistry, as well as method development and capacity/capability development projects that support and expand food safety and food defense testing.
• The LFFM vision is that our nation’s state human and animal food (HAF) testing laboratories are prepared, equipped, and continuously exercised for response to microbiological, chemical, and radiochemical food safety hazards requiring multi-state response and national coordination/support.

Table 1: Overarching Program Structure

Table 2: Required Aims per Track:

Note: The Sample Guide will be provided to prospective applicants after submitting a Letter of Intent and eligibility is confirmed.

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