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FDA
Posted

RFA-FD-25-007

Laboratory Flexible Funding Model (LFFM)

Summary

AI-generated

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

Research Focus & Contribution

The Laboratory Flexible Funding Model is a cooperative agreement designed to strengthen state human and animal food testing laboratories' capacity to support an integrated food safety system (IFSS) aligned with the Food Safety Modernization Act (FSMA). The program prioritizes sample testing and food defense preparedness across three analytical disciplines: microbiology, chemistry, and radiochemistry. Participating laboratories will conduct routine human and animal food product testing, whole genome sequencing (WGS), emergency response testing, and method development work to identify and address food safety hazards. The initiative generates large-scale sample data and trending information to enable risk-based, prevention-focused food safety surveillance at state and national levels, supporting early identification of emerging issues, outbreak investigation, and evaluation of future sampling priorities.

At-a-Glance

  • Who can apply: State human and animal food testing laboratories (eligibility confirmed after Letter of Intent submission).
  • Funding & project length: Not stated; cooperative agreement mechanism (U19).
  • Award/mechanism: Research Program Cooperative Agreement (U19).
  • Key dates: LOI due February 17, 2025 (and recurring annually); Application due March 31, 2025 by 11:59 PM ET; Scientific merit review April 2025; earliest start July 2025.
  • Best fit for: State regulatory laboratories conducting microbiology, chemistry, or radiochemistry testing; applicants must commit to ISO 17025 accreditation (or equivalent quality system), proficiency testing, FERN membership, and participation in FDA-coordinated sample plans and emergency response activities.

Key Facts

Deadline

Tue, January 11, 2028

Posted

Thu, February 6, 2025

Award Range

$1,500,000

Expected Awards

75

93.103
Cooperative
Grants.gov
Agency

Keywords

foodborne illness prevention
microbiology
chemistry
radiochemistry
whole genome sequencing
food defense
method development and validation
laboratory capacity building
integrated food safety system
pathogen detection
ISO 17025 accreditation
proficiency testing
food safety testing

Research Areas

MeSH
DiseasesC
InfectionsC01Digestive System DiseasesC06Urogenital DiseasesC12Nutritional & Metabolic DiseasesC18Immune System DiseasesC20Environmental DisordersC21Pathological Conditions & SymptomsC23
Chemicals & DrugsD
Organic ChemicalsD02Complex MixturesD20Chemical Actions & UsesD27
Analytical/Diagnostic/Therapeutic TechniquesE
DiagnosisE01Investigative TechniquesE05Equipment & SuppliesE07
Disciplines & OccupationsH
Health OccupationsH02
Technology/Food/BeveragesJ
Health CareN
Health Care ServicesN02Health Care EconomicsN03Health Services AdministrationN04Health Care Quality & EvaluationN05Environment & Public HealthN06
ANZSRC FoR
Agricultural & Food Sciences30
Agricultural Biotechnology3001Agriculture & Farm Management3002Animal Production3003Crop & Pasture Production3004Food Sciences3006
Biological Sciences31
Biochemistry & Cell Biology3101Bioinformatics & Computational Biology3102Microbiology3107
Biomedical & Clinical Sciences32
Clinical Sciences3202Immunology3204Medical Microbiology3207
Chemical Sciences34
Analytical Chemistry3401Inorganic Chemistry3402Macromolecular & Materials Chemistry3403Medicinal & Biomolecular Chemistry3404Physical Chemistry3406
Engineering40
Chemical Engineering4004Environmental Engineering4011
Environmental Sciences41
Ecological Applications4102Environmental Management4104Pollution & Contamination4105
Health Sciences42
Epidemiology4202Health Services & Systems4203Public Health4206
Human Society44
Policy & Administration4407

Gotchas (10)

Soft Block
submissiontimeline deadlines

Multiple application due dates across four cycles (March 2025, January 2026-2028) with strict no-late-submission policy and requirement for error-free submission by 11:59 PM ET

AI

98%

Source Text

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. Late applications will not be accepted for this FOA. 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.

Soft Block
writingsubmission format page limits

FDA does not follow NIH Page Limitation Guidelines or NIH Review Criteria; applicants must consult with FDA Agency Contacts for page limits and review process details

AI

95%

Source Text

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.

Soft Block
planningprogram scope topic

Samples collected under Product Testing Tracks must be state samples collected by state regulatory program inspectors/analysts; cannot be collected under FDA authority and FDA credentials/commissions

AI

93%

Source Text

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 activiti

Soft Block
planningprogram required components

Laboratories must maintain ISO 17025 accreditation for product testing tracks, or alternative quality system for other tracks; this is a strict requirement that could disqualify applicants

AI

95%

Source Text

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.

Soft Block
writingsubmission content requirements

Applicants must follow Multi-Project (M) Instructions from How to Apply - Application Guide, but NOFO-specific instructions override general guidance where they differ

AI

92%

Source Text

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. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Warning
planningprogram required components

Each regulatory program participating in LFFM must collect at least 15% of planned samples annually for which they have jurisdiction

AI

90%

Source Text

Each regulatory program participating in LFFM must collect at least 15% of planned samples for which they have jurisdiction, annually.

Warning
planningaward post award

Attendance of at least two key personnel (or one per discipline, whichever is greater) at annual LFFM Face-to-Face Meeting is required, with mandatory poster or oral presentation

AI

91%

Source Text

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.

Warning
writingcompliance other policy

Applicants must maintain active FERN membership with annual verification and maintain valid 20.88 agreement with FDA as ongoing requirements

AI

88%

Source Text

Maintain active FERN membership, including annual membership verification. Maintain a valid 20.88 agreement with FDA.

Warning
writingcompliance regulatory approvals

Laboratories must participate in and pass annual proficiency testing; if suitable test unavailable, must perform laboratory-developed competency exercises

AI

89%

Source Text

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.

Warning
planningprogram required components

Grantees must support pivot, overflow, emergency, surge capacity, and FDA-issued assignment requests as aligned with laboratory's analytical capabilities

AI

82%

Source Text

Support pivot, overflow, emergency, surge capacity, and FDA-issued assignment requests, as aligned with the laboratory's analytical capabilities.

AI-generated content — verify with the issuing agency’s official FOA/NOFO. Not endorsed by HHS.

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