FSMA Preventive Controls and Mutual Reliance Implementation Expansion Supplement to RFA-FD-18-001

Notice Number: NOT-FD-20-001

Key Dates
Release Date: October 30, 2019

Related Announcements

Issued by


The Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food Regulation 21 CFR Part 117 ('Preventive Control Rule') is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the United States.

The purpose of this program expansion to RFA-FD-18-001 “Flexible Funding Model Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs” is to support activities necessary to advance implementation of the Preventive Control Rule. The activities funded under this expansion supplement may include legislative research and legal analysis, infrastructure development, establishment of a training program for regulatory staff, development of a Preventive Control Rule inspection and compliance program, establishment of data information sharing capabilities with FDA, and/or expansion and enhancement of joint work planning activities with FDA.

Anticipated Eligible Organizations:

The applicant is:

1. An entity currently receiving funding under RFA-18-001 “Flexible Funding Model Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs” OR an eligible entity which has submitted an application for funding under RFA-18-001 (award under this program is contingent on the applicant receiving funding under RFA-18-001 and the award will be denied if an application to RFA-18-001 is not submitted and awarded to the applicant under this announcement)

2. Currently conducting human food inspections under contract with the FDA

3. Committed to performing full-scope PC inspections under contract with the FDA before the end of the second budget period

Key Dates

Release Date:

First Estimated Application Due Date: February, 2020

Earliest Estimated Award Date: June, 2020

Earliest Estimated Start Date: June, 2020


Please direct all inquiries to:

Graham N. Giesen
Public Health Advisor
Food and Drug Administration
Office of Partnerships