Laboratory Flexible Funding Model (LFFM)

Laboratory Flexible Funding Model (LFFM) is sponsored by Food and Drug Administration (FDA). Supports state and local laboratories in enhancing food safety testing capabilities for human and animal food, including method development and food defense.

RFA-FD-25-007: Laboratory Flexible Funding Model (LFFM) 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. 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 FOOD AND DRUG ADMINISTRATION ( FDA ) Funding Opportunity Title Laboratory Flexible Funding Model (LFFM) U19 Research Program Cooperative Agreements 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) Companion Notice of Funding Opportunity See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) 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.

Open Date (Earliest Submission Date) Letter of Intent 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.

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. Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants. gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date.

Late applications will not be accepted for this FOA. AIDS Application Due Date(s) No late applications will be accepted for this Notice of Funding Opportunity (NOFO). 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. AIDS Application Due Date(s) No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information 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. 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 Discipline Analytical Tracks Microbiology A1: Human Food Product Testing A2: NARMS Product Testing A3: Animal Food Product Testing A4: Whole Genome Sequencing - Maintenance A5: Whole Genome Sequencing - Throughput A6: Food Defense A7: Method Development/Validation A8: Capacity/Capability Development Chemistry B1: Human Food Product Testing B2: Animal Food Product Testing B3: Food Defense B4: Method Development/Validation B5: Capacity/Capability Development Radiochemistry C1: Food Defense C2: Method Development/Validation C3: Capacity/Capability Development 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.

Aim WGS Product Testing Tracks Food Defense Attendance of at least two (2) key personnel, or one per discipline, whichever is greater, at an annual LFFM Face-to-Face Meeting. In addition to attendance, each grantee must present either a poster or an oral presentation. Exception for WGS-track only labs.

X X Attendance of at least one (1) key personnel to the annual GenomeTrakr Meeting. X Maintain active FERN membership, including annual membership verification. X X X Maintain a valid 20.

88 agreement with FDA. X X Maintain facilities and personnel necessary to complete the work proposed under this project. X X X Participate in routine Track webinars/meetings X X X Respond to communications and inquiries from FDA/LFFM staff in a timely manner X X X Participate in, and pass, an annual proficiency test offered through a suitable proficiency testing program, for any work performed under this project.

If a suitable proficiency test is unavailable, then laboratory-developed competency exercises must be performed. X X X Participate in small-scale method development, method validation, and matrix extension work, as requested by the FDA. X X X Support pivot, overflow, emergency, surge capacity, and FDA-issued assignment requests, as aligned with the laboratory's analytical capabilities.

X X X Laboratories participating in product testing tracks must maintain ISO 17025 accreditation. Laboratories participating solely in tracks other than product testing must either maintain ISO 17025 accreditation or a quality system that ensures quality assurance and quality control of laboratory testing including but not limited to: validated methods, document control, training programs, and analyst competency requirements.

X X X Provide training and mentorship to other state laboratories, as requested. X X X Ensure methods used for analyzing samples under this project have been validated, with the exception of emergency situations, as identified by FDA, where the rapid development and deployment of a method is needed to immediately address an outbreak event.

X X X Follow LFFM Sample Guide (current version) for proper sampling and laboratory data documentation. X Follow LFFM Sample Guide (current version) for timely notification of presumptive and confirmed positive samples to identified points of contact. X Follow LFFM Sample Guide (current version) for LFFM Sample Follow-up Procedures, to include SRP-led follow-up and coordination with FDA.

X Laboratories must have the commitment and support of the regulatory programs (e.g., Manufactured Food Regulatory Program Standards (MFRPS), Animal Food Regulatory Program Standards (AFRPS), Produce, etc.) with jurisdiction for products being collected and tested. Follow LFFM Sample Guide (current version) for sample plan proposal development, sample collection, and laboratory/SRP coordination.

X Each regulatory program participating in LFFM must collect at least 15% of planned samples for which they have jurisdiction, annually. X Provide a detailed quarterly summary of all samples collected and analyzed using the appropriate discipline's Quarterly Sample Summary form (OMB #0910-0909) through the FERN website, or other FDA approved system.

The Quarterly Sample Summary forms will be provided to prospective applicants after submitting a Letter of Intent and eligibility is confirmed. X Discipline A: Microbiology Table 3: Microbiology Funding Table Use the table below to determine the amount of funding available based on the work selected.

Analytical Track Sample/ Analysis Tier Funding Maintenance Target # of Awards per Track Notes A1 Human Food Product Testing 100 Based on Sample/Analysis Tier Total A1-A3: The amount of additional maintenance funding is based on the total number of sample/analysis when A1, A2, and A3 selections are added together. Maintenance is for labs in M-HF, M-AF, NARMS Tracks only. A2 NARMS Testing 150 $50,000 See Above 5 Labs can select either 1.)

NARMS only or 2.) Animal Food, not both. However, labs may apply to the Animal Food Product Testing Track with intent to split sampling between animal food and NARMS commodities.

A3 Animal Food Product Testing 100 $35,000 See Above 15 Labs can select either 1.) NARMS only or 2.) Animal Food, not both.

However, labs may apply to the Animal Food Product Testing Track with intent to split sampling between animal food and NARMS commodities. A4 Whole Genome Sequencing - Maintenance N/A $25,000 N/A 16 Labs can select either WGS maintenance or throughput, not both. A5 Whole Genome Sequencing - Throughput 400 $110,000 N/A 5 Labs can select either WGS maintenance or throughput, not both.

A6 Food Defense N/A $170,000 N/A 8 N/A A7 Method Development/ Validation N/A Up to: $50,000 N/A N/A Up to two projects per year; funding level for the first project is $35,000 and the second project is $15,000 A8 Capacity/ Capability Development N/A Up to: $200,000 N/A N/A Funding level set per project; projects change every year; projects can be 'stacked' Analytical Track A1: Microbiology Human Food Product Testing The purpose of this analytical track is to support and strengthen state surveillance programs for microbiological contamination of human food products and environmental samples from human food production or handling facilities.

Participation in this track requires support of a state regulatory program with jurisdiction over the commodities being collected and analyzed. Collection and analysis of products produced within the state is encouraged (regardless of whether those products are collected at the manufacturer, distributor, or retail level).

The test results generated from this sampling can be used to remove adulterated food from commerce and aid regulatory inspection programs in conducting investigations. Sample results may be used by state regulatory programs and FDA to support follow-up regulatory and enforcement actions and outbreak response (if applicable).

Additionally, aggregate data from this Track can be used for risk assessment, future policy development, knowledge gap filling, and to inform future surveillance activities.

To be considered for this analytical track, laboratories must have: (1) ISO 17025 accreditation for at least one method applicable to microbiological analysis of human or animal food (2) Letter of support from manufactured food state regulatory program, as well as other state regulatory program (SRP) components, if other commodities will be collected/analyzed (e.g., produce from farms, dairy not covered by manufactured food program, etc.).

Must include affirmative statement that the SRP is willing to follow the LFFM Sample Guide and is willing to collect at least 15% of planned samples for which they have jurisdiction, annually.

(3) Affirmative statement that the laboratory is willing to accept and analyze samples collected by FDA or other states in the event of an emergency requiring surge capacity coordinated by FDA/FERN (if the laboratory has the capability to perform requested analyses) (4) Affirmative statement that the laboratory and SRP are willing to follow the LFFM Sample Guide for planning, collecting, analyzing, reporting, and following up on LFFM samples (5) Implemented use of GFP-tagged control strains for major foodborne pathogens aligned with the laboratory's testing capabilities (specifically: Salmonella spp.

, Listeria monocytogenes, E. coli, Cronobacter sakazakii) The commodity-hazard pairs available for surveillance under this track are pre-determined by FDA on an annual basis, and laboratories may submit a proposal to participate in the commodity-hazard pairs of their choice each year.

States are encouraged to participate in FDA’s annual work planning request and prioritization process to suggest commodity-hazard pairs for inclusion under LFFM. The LFFM Sample Guide and the list of the 2024-2025 projects will be provided to prospective applicants after submitting a Letter of Intent and eligibility is confirmed as an example of the types of projects conducted under this track.

The list of 2025-2026 projects will be available in March 2025 and will be provided to approved applicants at that time. Development of the sample plan for the year is a collaborative process that follows the LFFM Sample Guide and will be done after applications are reviewed and scored but before the project period starts.

Analytical Track A2: National Antimicrobial Monitoring System (NARMS) Testing The purpose of this analytical track is to support and strengthen state surveillance programs for microbiological contamination of retail raw meat samples in support of the NARMS Program. NARMS Track surveillance is non-regulatory in scope and does not require regulatory or enforcement follow-up from state partners.

The NARMS program helps promote and protect public health by providing information about emerging bacterial antimicrobial resistance (AMR), how resistant infections differ from susceptible infections, and the impact of interventions designed to limit the spread of AMR. NARMS data are used by FDA to help inform regulatory decisions designed to preserve the effectiveness of antibiotics for humans and animals.

To be considered for this analytical track, laboratories must have: (1) Affirmative statement that the laboratory (and any other group responsible for sample collections, i.e., if partnering with inspectional staff to collect samples) is willing to collect samples from a wide variety of retail grocery stores and follow a randomized collection schedule set by the NARMS program, which pulls from a list of zip codes that the laboratory (or other collection partners) is willing/able to collect from.

(2) Affirmative statement that the laboratory is willing to follow the LFFM Sample Guide for planning, collecting, analyzing, reporting of NARMS samples.

(3) Laboratory cannot be a recipient of the standalone NARMS cooperative agreement PAR-20-124 "NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens", or any subsequent NARMS cooperative agreement managed and funded by the FDA The commodity-hazard pairs available for surveillance under this track are pre-determined by FDA on an annual basis, and laboratories may submit a proposal to participate in the commodity-hazard pairs of their choice each year.

The LFFM Sample Guide and the list of the 2024-2025 projects will be provided to prospective applicants after submitting a Letter of Intent and eligibility is confirmed as an example of the types of projects conducted under this track. The list of 2025-2026 projects will be available in March 2025 and will be provided to approved applicants at that time.

Development of the sample plan for the year is a collaborative process that follows the LFFM Sample Guide and will be done after applications are reviewed and scored but before the project period starts.

Analytical Track A3: Microbiology Animal Food Product Testing The purpose of this analytical track is to support and strengthen state surveillance programs for microbiological contamination of animal food products or ingredients intended for use in manufacturing animal food. Participation in this track requires support of a state regulatory program with jurisdiction over the commodities being collected and analyzed.

Collection and analysis of products produced within the state is encouraged (regardless of whether those products are collected at the manufacturer, distributor, or retail level). The test results generated from this sampling can be used to remove adulterated food from commerce and aid regulatory inspection programs in conducting investigations.

Sample results may be used by state regulatory programs and FDA to support follow-up regulatory and enforcement actions and human or animal illness outbreak response (if applicable). Additionally, aggregate data from this Track can be used for risk assessment, future policy development, knowledge gap filling, and to inform future surveillance activities.

To be considered for this analytical track, laboratories must have: (1) ISO 17025 accreditation for at least one method applicable to microbiological analysis of human or animal food (2) Letter of support from animal food state regulatory program. Must include affirmative statement that the SRP is willing to follow the LFFM Sample Guide and is willing to collect at least 15% of planned samples for which they have jurisdiction, annually.

Must include affirmative statement that the SRP has the capability and willingness to collect at least a portion of samples from manufacturer and distributor level.

(3) Affirmative statement that the laboratory is willing to accept and analyze samples collected by FDA or other states in the event of an emergency requiring surge capacity coordinated by FDA/FERN (if the laboratory has the capability to perform requested analyses) (4) Affirmative statement that the laboratory and SRP are willing to follow the LFFM Sample Guide for planning, collecting, analyzing, reporting, and following up on LFFM samples (5) Implemented use of GFP-tagged control strains for major foodborne pathogens aligned with the laboratory's testing capabilities (specifically: Salmonella spp.

, Listeria monocytogenes, E. coli) The commodity-hazard pairs available for surveillance under this track are pre-determined by FDA on an annual basis, and laboratories may submit a proposal to participate in the commodity-hazard pairs of their choice each year. States are encouraged to engage with CVM to suggest commodity-hazard pairs for inclusion under LFFM.

The LFFM Sample Guide and the list of the 2024-2025 projects will be provided to prospective applicants after submitting a Letter of Intent and eligibility is confirmed as an example of the types of projects conducted under this track. The list of 2025-2026 projects will be available in March 2025 and will be provided to approved applicants at that time.

Development of the sample plan for the year is a collaborative process that follows the LFFM Sample Guide and will be done after applications are reviewed and scored but before the project period starts.

Analytical Track A4: Microbiology Whole Genome Sequencing – Maintenance The objective of Analytical Track 4 is to allocate funds to GenomeTrakr laboratories for the sequencing of foodborne pathogen genomes sourced from LFFM product testing tracks, specifically from Micro Human or Animal Food Product Testing and/or NARMS Tracks (M-HAF Product Testing Tracks).

Participating laboratories are required to sequence all isolates obtained from their LFFM M-HAF product testing and submit the resulting whole genome sequence (WGS) data, along with associated contextual data, to the National Center for Biotechnology Information (NCBI) in accordance with current protocols issued by the FDA’s GenomeTrakr Program Coordinators.

This track aims not only to cover sequencing for the M-HAF testing but also to facilitate the sequencing of isolates from broader state-conducted human and animal food product surveillance, outbreak investigations, and emergency response testing. Additionally, there may be occasions where laboratories will need to assist with sequencing for other states that do not have WGS capabilities.

To be considered for this analytical track, laboratories must: (1) Participate in either LFFM Micro Human Food, Micro NARMS, or Micro Animal Food Product Testing Track (2) Have WGS capabilities for enteric pathogens, including ability to submit genomic data to NCBI (3) Affirmative statement that the laboratory will follow current protocols issued by the FDA’s GenomeTrakr Program Coordinators, which include completing “sequenced_by” and “project_name” fields in a manner that supports querying NCBI to determine isolate accomplishments.

Analytical Track A5: Microbiology Whole Genome Sequencing – Throughput The objective of Analytical Track 5 is to allocate funds to GenomeTrakr laboratories for sequencing foodborne pathogens isolated from environmental, food, and animal samples (see target list for priority pathogens and sample types).

Participating laboratories are required to submit the resulting whole genome sequence (WGS) data, along with associated contextual data, to the National Center for Biotechnology Information (NCBI) in accordance with current protocols issued by the FDA’s GenomeTrakr Program Coordinators.

This track aims to provide a baseline signal to the GenomeTrakr database, either by sequencing historical isolate collections, or by sequencing pathogens isolated from routinely collected environmental samples. Laboratories may choose between two options: 1. Sequence isolates: Laboratories focused exclusively on sequencing should process and upload data for at least 400 enteric pathogens each funding year.

2. Environmental sample collection and analysis: Alternatively, laboratories can use the funds to cover the full scope of work for environmental pathogen surveillance, including the collection, microbiological analysis, isolation, and sequencing of enteric pathogens from routine samples, like water, in agricultural growing regions.

While there is no annual minimum number of sequences for this option, sampling plans should include weekly sampling, or another routine schedule, throughout the year or during applicable growing seasons, depending on the location. All positive samples should be sequenced. Please note that grantees will be responsible for establishing their own collaborations to obtain the necessary isolates or environmental samples.

If the laboratory is also participating in a Micro Human or Animal Food Product Testing and/or NARMS Tracks, the laboratory is required to sequence all isolates obtained from their LFFM M-HAF product testing and submit the resulting WGS data, along with associated contextual data, to NCBI in accordance with current protocols issued by the FDA’s GenomeTrakr Program Coordinators.

Laboratories may also be asked to support sequencing of LFFM M-HAF product testing track isolates from other states lacking WGS capacity. Priority foodborne bacterial pathogens for Analytical Track 5: E.

coli (specifically Shiga toxin-producing strains, STECs) Other emerging foodborne pathogens as determined by GenomeTrakr coordinators Priority samples sources for Analytical Track 5: Collections from locations involved in the production, packaging, and handling of foods overseen by the FDA, which includes facilities, restaurants, and farms.

Environmental samples from agricultural growing regions, such as compost, manure, water sources like irrigation ditches or ponds, soil amendments (including animal by-products), sediment, dust, air, along with samples from wastewater treatment plants.

FDA-regulated food products, including dietary supplements Animal sources, specifically wildlife associated with agriculture, such as wild birds and other animals that may encroach on agricultural spaces.

Both domestic and international collaborations to source isolates are acceptable To be considered for this analytical track, laboratories must: (1) Have WGS capabilities for enteric pathogens, including ability to submit genomic data to NCBI (2) Have sufficient partnerships and network to support sourcing approximately 400 enteric pathogen isolates per year or to establish routine environmental samples, demonstrated by letters of support.

(3) Affirmative statement that the laboratory will follow current protocols issued by the FDA’s GenomeTrakr Program Coordinators, which include completing “sequenced_by” and “project_name” fields in a manner that supports querying NCBI to determine isolate accomplishments. (4) Affirmative statement that the laboratory will prioritize sequencing of M-HAF product testing track isolates, if the laboratory is also applying to those tracks.

Analytical Track A6: Microbiology Food Defense The purpose of this analytical track is to support and maintain geographically diverse national capacity, capability, and readiness for intentional or unintentional microbiological contamination of human and animal foods using BSL2+ and BSL3 laboratories. Specifically, laboratories in this track will maintain readiness, demonstrate competency, and respond to FDA’s requests for testing.

To be considered for this analytical track, laboratories must have: (1) A BSL2+ facility, with personal protective equipment and safeguards in place. Analytical Track A7: Microbiology Method Development and Method Validation The purpose of this analytical track is to conduct preliminary, short-term or exploratory investigations that focus on the feasibility of a new method and/or technology.

These projects could include proof of concept for new analytical approaches, method development for representative food matrices, single laboratory validations of methods, matrix extensions, alternative instrument platform extensions, or multi-laboratory validations. Generally, projects will be one-year in duration but can be renewed for additional years upon demonstration of appropriate progress with tangible results.

Multiple-year sequential efforts may be proposed but will be approved on a year-by-year basis. Under this track, laboratories can either propose their own method development or method validation project aligned with the FERN mission or choose to participate in one of the FDA pre-determined projects.

During the Objective Review of applications under this announcement, laboratories that are approved for a Microbiology Human Food Product Testing Track, Microbiology Animal Food Product Testing Track, Microbiology Food Defense, or the Whole Genome Sequencing tracks will automatically be eligible to participate in the Microbiology Method Development and Validation Track.

The list of the 2024-2025 projects will be provided to prospective applicants after submitting a Letter of Intent and eligibility is confirmed as an example of the types of projects conducted under this track. The list of 2025-2026 projects will be available in March 2025 and will be provided to approved applicants at that time.

This is also the time that laboratories will have the opportunity to propose additional projects, not included on the FDA pre-determined list. Laboratories have the option to opt-out of this track annually if there are not any projects being offered that are of interest to them.

Analytical Track A8: Microbiology Capability/Capacity Development The purpose of this analytical track is to assist laboratories in implementing new capabilities (i.e., methods, equipment) to support microbiological testing related to human and animal foods. Capabilities developed under this track are expected to be operationalized in subsequent years under a human or animal food product testing, WGS, or food defense track.

An example would be implementing BAM Ch4A qPCR for Shiga-toxin producing E. coli in foods, and then conducting surveillance under the Microbiological Human or Animal Food Product Testing Track the following year. Generally, projects will