- What is the Preventive Controls program expansion?
- What are its goals?
- Who can I contact for more information?
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-18-001.
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 regulators
- Developing 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 modernization
- Building capacity to support a Preventive Controls program.
The goals of this funding opportunity are as follows:
- Awardees will incorporate the PCHF rule, 21 CFR Part 117, into their implementation strategy of the MFRPS, including training, inspection, enforcement, auditing, laboratory/testing and outreach programs.
- Manufactured Food regulatory agencies will have training and auditing programs necessary to ensure a sufficient number of staff are qualified to conduct inspections under the PCHF Rule, 21 CFR Part 117 on a risk-based inspection frequency.
- Awardees will build the infrastructure necessary for a manufactured foods regulatory program based upon the PCHF rule. Infrastructure includes qualified personnel, IT resources, and regulatory authorities.
- Awardees will adopt regulatory authorities equivalent to the PCHF rule and associated FSMA rules.
- Awardees will participate in IT-data exchange development/implementation with FDA to enable necessary information exchange between FDA and state/territory.
- Awardees will have the expertise and capacity to perform environmental and product sampling
- Utilize best practices for enhanced coordination between FDA and state/territory for information sharing coordination and leveraging of resources for regulatory work conducted under the authority of the PCHF rule, or equivalent state/territorial regulatory authorities.
Specific questions on this program can be directed to the appropriate Office of Partnerships' contact within the Division of Partnership Investments and Agreements. Please visit the Office of Partnerships Contacts webpage to obtain a downloaded version of the staffing roster.
You can also find contact information and more on the funding opportunity announcement.
General questions can be directed to the Office of Partnerships' general mailbox: email@example.com.