Intent to Publish Notice: FSMA Preventive Controls and Mutual Reliance Implementation Expansion Supplement to RFA-FD-18-001

Notice Number: NOT-FD-20-002

Key Dates
Release Date: November 4, 2019

Related Announcements
RFA-FD-18-001

Issued by
FOOD AND DRUG ADMINISTRATION (FDA)

Purpose

The purpose of this notice is to inform the FDA grantee community, FDA/ORA's intent to publish a program expansion opportunity under consideration for RFA-FD-18-001 “Flexible Funding Model Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs”.

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 expansion and/or 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 and

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

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:

Estimated Publication Date of Funding Opportunity Announcement: December, 2019

First Estimated Application Due Date: February, 2020

Earliest Estimated Award Date: June, 2020

Earliest Estimated Start Date: July, 2020

Inquiries

Please direct all inquiries to:

Dan Lukash
FDA Grants Specialist
240/402-7596
daniel.lukash@fda.hhs.gov