A: The FDA State Liaison interacts with counterpart State and local officials to help promote cohesive and uniform policies and activities in food and drug-related matters, and who will serve as the liaison for information transfer between FDA and state, territorial, tribal, and local agencies. Serve as primary contact for state cooperative agreements, contracts, information sharing, general inquiries, AFPRS, MFRPS, Produce Safety Grant, and Tissue Residue Grant. State Liaisons monitor the status of commissioning or credentialing.

A: Internal – Internal FDA Inadvertent Disclosure Guidance

A: External – Contact [email protected] and FDA POCs, as soon as possible.

A: Non-Public Information Categories

A: Categories of NPI

Trade Secret Information (TS)?

A trade secret includes the characteristics of CCI and further includes any commercially valuable plan, formula, process, or device that is used for making, preparing, compounding, or processing of commodities, and it can be said to be the end product of either substantial effort or innovation.  In order for CCI to be considered a trade secret, there must be a direct relationship between the trade secret and the manufacturing methods and processes. See 21 CFR 20.61(a).

An example of a trade secret would be the formula for the natural flavorings in a carbonated soft drink.

Trade secret information is exempt from Freedom of Information Act requests, but cannot be shared, even with a 20.88 agreement, unless the owner of the information agrees or puts in writing that the information is no longer confidential.

The FDA is prohibited from disclosing Trade Secret by law. See 18 U.S.C. § 1905; §§ 301(j) and 331(j) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 331 et seq., and 21 C.F.R. § 20.88.

Confidential Commercial Information (CCI)?

CCI is valuable data or information that is used in a business and is customarily held in strict confidence or regarded as privileged and not disclosed to any member of the public by the entity to whom it belongs. See 21 CFR 20.61(b).

Examples of CCI include raw material supplier lists, finished product customer lists, traceback information, etc.

A: ORA Recall Coordinators

A: FDA recall coordinators are aligned in program-based divisions: Division of Medical Devices and Radiological Health Operations, Division of Human and Animal Food Operations (includes cosmetics), Division of Biological Products Operations, Division of Pharmaceutical Quality Operations and Tobacco Operations. Establishments outside of the United States should contact  ORA Office of Policy Compliance & Enforcement Recall Operations Branch (OPCE ROB).

A: Confidential Commercial Information (CCI)-not for Tobacco or Devices, Personal Privacy          Information (PPI) – only if documented ‘need to know’, Law Enforcement, Pre-Decisional or Deliberative Process

A: ORA/DIDP, among other roles, has been tasked as the lead FDA office to coordinate the response to requests for information made by State and local officials and agencies under 20.88          agreements.

A: Information Sharing Disclaimers NPI Coversheet

A: “The enclosed document(s) may contain information prohibited from public disclosure by law. Unauthorized disclosure of non-public information could be a civil or criminal violation and carry consequences for the disclosing official. If you are not the intended recipient or believe that you have received document(s) in error, do not copy, disseminate, or otherwise use the information and contact FDA regarding the handling of these documents(s). Any request to share this information outside of the intended recipient must be approved by advance by FDA. Contact [email protected]”

A: Sharing Under Commissioning: To be used to share information for situational awareness related to an FDA use, not for state action:

Subject line: [For Official FDA Use Only Not for Public Disclosure}

“This information is for official FDA use only and intended for the exclusive use of the commissioned recipient(s) named above for their work with the FDA. It may contain protected, privileged, or confidential non-public information, including trade secrets, and cannot be disseminated, distributed, or copied to persons who do not currently have an FDA commission (e.g., you are not permitted to share this information with someone who covered under a 20.88 information sharing agreement). You may share this material only with members of your staff who are also covered by an FDA commission with the same endorsement, specifying they can receive and review the type of official FDA information being shared. Because this information is being shared under a commission, you must not further disclose this FDA material unless FDA provides you written permission allowing further disclosure. Pursuant to 21 U.S.C. § 372(a), commissioned state and local government officials are “officers” of the U.S. Department of Health and Human Services, making them subject to the same disclosure restrictions and penalties any other employee of the FDA. If you wish to share this information with individuals other than those just described, please contact the FDA’s Division of Information Disclosure Policy (DIDP) at [email protected]. If you are not the intended recipient, any dissemination, distribution, or copying is strictly prohibited. If you think you received this e-mail message in error, please e-mail the sender immediately at [Insert sender’s email].

A: Chapter 21 of the Code of Federal Regulations (CFR) 20.88 allows FDA to share certain non-public information with state and local government officials. FDA commonly refers to these agreements as ’20.88s’ and they are used for sharing confidential commercial information (CCI), personal privacy information (PPI), and pre-decisional information (PDI). However, 20.88s do not allow for the sharing of trade secret information (TSI)

Information Sharing, U.S. Food and Drug Administration

A: 20.88 Single-Signature Agreements

A: A Long Term 20.88 Information Sharing Agreement allows FDA to provide non-public information to states, local public health agencies, and territories. It is considered an umbrella agreement – all officials under the signatory can view and receive information. These agreements can be valid for up to 3-5 years, depending on the commodity, they are commonly used by states when they are able to protect FDA’s non-public information.

A: A Case Specific 20.88 refers to a request for specific records within a specific timeframe. The information can only be shared with those officials who sign the Confidentiality Commitment.           These agreements are commonly used by states when they are unable to protect FDA’s non-public information due to their sunshine laws.

A: The Long Term 20.88 Agreements allows access to NPI to the entire agency/division/office when signed at the highest level of the agency/division/office. This single signature covers the person signing and every state employee under their chain of command.

The Case Specific 20.88 Agreement allows access to NPI to only those who have signed the         Confidentiality Commitment, which should include all state government officials or officials seeking access to the non-public information.

A: Dependent on the record retention schedule, the type of record, and the Administrator established controls.

A: Contact DIDP, at [email protected], within 5 days.