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You are here: Home / Grant Size / $50,000 to $500,000 / FDA: Manufactured Food Flexible Funding Model Compliance and Enforcement Expansion Supplement

FDA: Manufactured Food Flexible Funding Model Compliance and Enforcement Expansion Supplement

Dated: January 27, 2022

The Manufactured Food Flexible Funding Model Compliance and Enforcement Expansion Supplement (U18) seeks proposals to advance public health by building the capacity and capability of grantees to take the appropriate action in response to confirmed and potentially violative samples identified as part of the Laboratory Flexible Funding Model (LFFM) cooperative agreement.

Donor Name: Food and Drug Administration

State: All States

County: All Counties

Type of Grant: Grant

Deadline (mm/dd/yyyy): 04/04/2022

Grant Size: $100,000

Grant Duration: 1 year

Details:

The goals of this funding opportunity are as follows:

  • Awardees will apply their Manufactured Food Regulatory Program Standards (MFRPS) response, enforcement and regulatory framework to conduct follow-up inspections, investigations (including traceback/forward), and enforcement actions (including embargos, recalls, warning letters, and closures) to positive and violative samples identified as part of the LFFM cooperative agreement. Coordination with the RRT and activation, if applicable, is required for grantees also awarded the RRT track.
  • Manufactured food regulatory agencies will have training and auditing programs necessary to ensure a sufficient number of staff are qualified to conduct regulatory and compliance activities in response to violative laboratory samples.
  • Awardees will build the necessary regulatory and compliance response infrastructure to investigate and respond to violative samples, including qualified personnel, IT resources, and regulatory authorities.
  • Awardees will expand upon the LFFM goals to participate in IT-data exchange development/implementation with the FDA to enable necessary information exchange between the FDA and state/territory. This will set best practices for enhanced coordination between the FDA and state/territory for information sharing coordination and leveraging of resources for regulatory work.
  • To increase the use of best practices for enhanced coordination between the FDA and state/territory for information sharing, coordination, and leveraging of resources for regulatory work, awardees will participate in IT-data exchange development/implementation with the FDA to enable information exchange between FDA and state/territory. This includes collaborating with LFFM laboratories to ensure all sample collection information is complete and meets ORA DX requirements, for LFFM samples to be submitted via ORA DX, including FEI and product code fields.

Funding Information

  • The FDA/ORA intends to commit up to $1,500,000 in FY 2022 to fund 15 awards.
  • Applicants may request support for 1 year, not to exceed the remaining number of years on the parent grant.

Eligibility Criteria

  • State governments
  • Native American tribal governments (Federally recognized)
  • This opportunity is only available to State, Tribal or Territorial feed/animal food safety programs which meet the following criteria: – Currently holds an award under RFA-FD-18-001 “Flexible Funding Model – Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs” and is satisfactorily meeting the conditions of the award; and – Currently is conducting human food inspections under contract with the FDA and maintains a food safety inspection contract in good standing for the duration of the award project period; and – Collaborates with one or more human food testing laboratories currently holding an award under PAR-20-105 “Laboratory Flexible Funding Model (LFFM) and participating in the Human Food Product Testing Track(s) – Micro or Chem” with the LFFM lab in the same state as the FFM CAP program.

For more information, visit Grants.gov.

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