Notice Number: NOT-FD-20-003
Key Dates
Release Date: November 15, 2019
Estimated Publication Date of Announcement: February 2020
First Estimated Application Due Date: May 2020
Earliest Estimated Award Date: August 2020
Earliest Estimated Start Date: September 2020
None
Issued by
U.S. Food and Drug Administration (FDA)
Purpose
The U.S. Food and Drug Administration, Office of Regulatory Affairs (ORA) and Center for Veterinary Medicine (CVM), intends to promote an initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for new cooperative agreement projects designed to advance efforts for a nationally integrated food safety system by assisting State animal food regulatory programs to achieve and maintain full implementation of the Animal Feed Regulatory Program Standards (AFRPS), and to provide optional funding for State animal food regulatory programs to perform regulatory work and promote compliance under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PCAF) regulation, found in 21 CFR Part 507.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
The FOA is expected to be published in early 2020 with an expected application due date sixty days (60) after publication.
Details
The FOA for this program is under development. Over the course of the upcoming months, FDA has arranged to present information on this initiative to various audiences, including potential applicants for this limited competition announcement. This combination of face-to-face and teleconference engagements will inform the audiences of the project concept, in addition to providing an overview of the design and goals of this new model.
Two tracks are anticipated to be available for 5 total years of possible funding under this Funding Opportunity Announcement as follows:
Animal Feed Regulatory Program Standards (Development Phase Track)
- Flat Funding level
Animal Feed Regulatory Program Standards (Maintenance Phase Track)
- Tiered Funding level
In addition to the base funding tracks above, a funding option is anticipated with this FOA to develop regulatory work under the PCAF regulation, which is found in 21 CFR Part 507. Funding awarded for this funding option is intended to supplement the funding for the two tracks above, at a flat funding level.
Anticipated Eligible Organizations
The following eligibility criteria for State animal food regulatory programs (Governments) are anticipated to be eligible to apply for the Animal Feed Regulatory Program Standards funding tracks listed above:
- Programs that have and maintain an FDA animal food safety contract in good standing, either currently or at the earliest possible date.
- For the AFRPS Maintenance Phase Track only, programs that have (or will have) received 5 years of total funding to implement the AFRPS.
The following eligibility criteria for State animal food regulatory programs (Governments) are anticipated to be eligible to apply for the PC funding option listed above:
- Programs enrolled in the Animal Feed Regulatory Program Standards awarded under this new FOA.
In addition, the following terms and conditions are anticipated to apply to programs electing the PC Funding option.
- Programs that are performing CGMP and PC contract work under the scope of 21 CFR Part 507, in their FDA animal food safety inspection contract, by the end of funding year 2.
APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.
Inquiries
Please direct all inquiries to:
Gordana Zuber
Grants Management Specialist
Office of Operations, Office of Finance Budget & Acquisitions
Office of Acquisitions and Grants Services, HFA-500
U.S. Food and Drug Administration
Tel: 301-348-1747
gordana.zuber@fda.hhs.gov
and Human Services (HHS)
