20.88 Single-Signature Agreements

This database contains the list of State agencies who have entered into a long-term 20.88 Agreement CFR 20.88⁶ . The agencies must have a counterpart function to the FDA (regulatory law enforcement, health oversight or public health function). These agreements cover the entire agency/division/office when signed by the highest head of the agency/division/office. The single signature covers the person signing and every state employee under his/her chain of command. The agreement provides the FDA the discretion to share non-public information with these agencies. The reference to "non-public information" covered by this agreement includes any information protected from public disclosure under federal law and regulations, including the Freedom of Information Act and 21 CFR Part 20. For FDA documents shared under this agreement, this may include: confidential commercial information, personal privacy information, pre-decisional information, deliberative information, and law enforcement records. Most importantly, this agreement includes a nondisclosure agreement (NDA) that prohibits the further sharing of FDA records shared under a 20.88 agreement without express permission by the FDA because the records and information remain FDA property. Please note that any reference to State is intended to be inclusive of state, local, territories, and/or state universities employing state employees.

Please contact ORAInfoShare@fda.hhs.gov if your agency is interested in pursuing a long term 20.88 Information Sharing Agreement.

An agreement signed by State agencies responsible for public health programs and laboratories that concern food, feed and/or cosmetic-related product information, inspections, enforcement actions, and foodborne illness investigation (including data and trace back information) in which they agree to protect FDA non-public information. This agreement is valid from the date of signature and lasts through June 30, 2024.

An agreement signed by State agencies responsible for public health programs and laboratories that concern food, feed and/or cosmetic-related product information, inspections, enforcement actions, and foodborne illness investigation (including data and trace back information) in which they agree to protect FDA non-public information. This agreement provides the authority for the primary state agency to share non-public information that it has received from the FDA with those local public health agencies that have signed into the Limited Scope Food, Feed and Cosmetics 20.88 with FDA. This agreement is valid from the date of signature and lasts through June 30, 2029.

An agreement signed by Local Public Health agencies responsible for public health programs and laboratories that concern food, feed and/or cosmetic-related product information, inspections, enforcement actions, and foodborne illness investigation (including data and trace back information) in which they agree to protect FDA non-public information. This agreement does not allow the Local Public Health agencies to request information directly from the FDA. However, this agreement allows for the Local Public Health agency to receive non-public information from FDA and the primary State agency that signed into the Extension 20.88. This agreement is valid from the date of signature and lasts through June 30, 2029.

An agreement signed by state agencies that have a counterpart regulatory function in this product area in which they agree to protect FDA non-public information. Cannabinoid hemp products information for purposes of this agreement means that the information is related to an FDA regulated product that either is a cannabinoid hemp product or that is a product in which cannabinoid hemp products are a component. This agreement is valid from the date of signature and last through October 31, 2026.

An agreement signed by State agencies and officials responsible for regulating human or animal drugs or biologics related information. Information that can be shared under this agreement includes information pertaining to inspections and regulatory actions, including reports, warning letters, and enforcement actions. This agreement is valid from the date of signature and lasts through October 31, 2028.

An agreement signed by State agencies and officials responsible for compounded drug products (human and veterinary drugs), human drug supply chain security information and related public health, and safety information. Information that can be shared under this agreement includes compounding of human and animal drugs, and human drug supply chain security matters including new product tracing, product identifier and authorized trading partner requirements, provisions related to product verification, as well as national standards for licensing and regulation of certain trading partners. This agreement is valid from the date of signature and lasts through June 30, 2025.

An agreement signed by State agencies and officials responsible for the exchange of Import-related Cross-commodity pertaining to human and animal food, pet food animal feed, cosmetics, human and animal drugs, biologics, devices, and tobacco information. The Import-related information means information that was obtained by FDA under Section 801 (Imports and Exports) of the Food Drug and Cosmetics Act (FCDA). Information obtained by FDA under any other authority is not authorized for sharing under this agreement. This agreement is valid from the date of signature and lasts through October 31, 2028.