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Information Sharing

What are information sharing/20.88 agreements?

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 (referred to collectively as state officials below). 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).

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What are the rules governing the sharing of non-public information?

In order for FDA to share any non-public information under a 20.88 agreement, there must be:

  1. A written statement establishing that the state government agency entering into the agreement with FDA has the authority to protect certain non-public information, and
  2. A written commitment that the state agency will not further disclose any such information provided to it.

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What is Confidential Commercial Information?

CCI is valuable data or information which is used in a business and is of such type that it 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.  Examples of CCI include raw material supplier lists, finished product customer lists, trace back information, etc.  CCI is exempt from Freedom of Information Act requests, but can be shared through a 20.88 agreement.

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What is Trade Secret Information?

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.  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.

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Who do I contact to ask questions about Information Sharing Agreements?

Questions regarding Information Sharing Agreements should be directed to ORAinfoshare@fda.hhs.gov.

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