Revision Applications - FSMA Human Foods Preventive Controls Implementation Expansion Supplement to RFA-FD-18-001 (U18 Clinical Trials Not Allowed)

The intended outcome of this program expansion to RFA-FD-18-001 “Flexible Funding Model – Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs” is to advance the efforts for a nationally Integrated Food Safety System (IFSS) by assisting State manufactured


food regulatory programs to promote compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation (PCHF Rule).

PCHF is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the United States.

This program expansion provides funding to incorporate PCHF activities into the existing human food safety framework being implemented by the grantees under RFA-FD-18-00 1. By participating in this program expansion, grantees will develop infrastructure, programs, and trained personnel to support full adoption and implementation of the PCHF Rule, which may include:Establishing a PCHF training coordination/monitoring program for their regulatorsDeveloping an inspection and compliance program to conduct full-scope Preventive Control Rule inspections under 21 CFR Part 117,Establishing data information sharing capabilities with FDA and work planning activities promoting an IFSS,Enhancing state regulatory foundations, including regulatory drafting, legislative research, and support for statute modernizationBuilding capacity to support a Preventive Controls program.For the purposes of this FOA, the term State encompasses all eligible organizations as defined in Section 3
Agency: Department of Health and Human Services

Office: Food and Drug Administration

Estimated Funding: $14,000,000

Who's Eligible

Obtain Full Opportunity Text:
full application

Additional Information of Eligibility:
Eligibility for this funding opportunity requires that the applicant: Currently holds an award under RFA-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; Currently conducts food safety inspection audits in Phase II or III of the food contract audit program OR submits a completed Appendix H audit agreement signed by the applicant's agency leadership and Division demonstrating their commitment to be in Phase II of the audit program and to conduct audits under the food safety inspection contract during the first budget period.

The grantee should progress from Phase II to Phase III of the audit program by the completion of the project and; Applicants must indicate the number of full-scope PC inspections they plan to conduct, and the number should be commensurate with the firm inventory, during the Federal Fiscal Year 2020 - 2021 contract cycle.

All grantees are expected to perform a minimum of the respective percentage (based on the MFRPS funding tier referenced in the next bullet) full-scope PCHF inspections that should be performed based upon the firm inventory and risk-based inspection frequency during the Federal Fiscal Year 2020 - 2021.

For grantees already meeting the minimum of percentage required for the number of full scope PCHF inspections should remain constant or increase.

FDA can provide to each grantee the annualized needs to each state, which outlines an average number of inspections that are required to perform by FDA to meet FSMA inspection frequencies and; Performs the respective percentage of full-scope PC inspection based on their MFRPS Tier: Tier 1 - 25% Tier 2 - 15% Tier 3 - 10% For grantees in a state with more than one agency participating in this program, funding will be contingent upon meeting the overall cumulative percentage for the state among the agencies in the Manufactured Regulatory Program Standards.

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