The U.S. Food and Drug Administration (FDA) launched modular training on information sharing for state and local regulatory and public health officials. This new training will be conducted using the Office of Regulatory Affairs’ (ORA) existing training platform, Pathlore Learning Management System (LMS).

The intent of the training is to improve the understanding of state and local officials regarding their roles and responsibilities for safeguarding non-public information (NPI) and the authorized mechanisms for information sharing. All state and local regulatory and public health officials who are authorized to receive NPI or those considering signing information sharing agreements are strongly encouraged to take this new training. Information on the new training course is available at ORA’s Pathlore LMS website http://app.info.fda.gov/e/er?utm_campaign=National%20Broadcast%20Message%20-%20FDA%20Launches%20New%20InfoShare%20Training&utm_medium=email&utm_source=Eloqua&s=2027422842&lid=6890&elqTrackId=395F8FA1A8D3495EAFCC490C5FD6FF3C&elq=3defa950c3d24f3799850162c115cec9&elqaid=7150&elqat=1

To access the new training course in ORA’s Pathlore LMS:

· Click on the Pathlore LMS website link above and sign on at the top of the screen. Log in with your existing credentials, or contact your FDA State Liaison to create a new account;

· Search for Course CC8010W; and

· Follow on-screen instructions to begin the course. It should take between 30-60 minutes to complete.

During emergencies, the FDA shares critically important non-public information or NPI regarding food-borne illness outbreaks, illnesses and deaths caused by FDA-regulated products, and pre-decisional information with state and local regulatory and public health officials who we are authorized to receive it. The agency may also disclose certain NPI to authorized state and local officials when they need the information because it concerns the safety, effectiveness, or quality of a product or information concerning an investigation; or the state agency is able to exercise its regulatory authority more expeditiously than the FDA.

FDA currently shares NPI with state and local regulatory and public health officials using two separate programs and processes: 20.88 information sharing agreements authorized under 21 CFR 20.88(d) and the FDA Commissioning Program authorized under 21 U.S.C. Section 372.

FDA is responsible for ensuring that the sharing of NPI with state and local officials meet legal requirements and is protected against unauthorized disclosure. The agency will only share NPI with state and local officials who have certified that they have the ability to maintain and protect the confidentiality of NPI from any public disclosure and will not further disclose it without the written confirmation from FDA that such information can be released to the public.

Unauthorized disclosure of certain NPI may be a criminal violation under federal law. State and local regulatory and public health officials who are not authorized to receive NPI may be excluded from participating in important conference calls and meetings with FDA where critical NPI will be discussed.

For more information on FDA Commissioning and information sharing agreements, please visit the Agency’s internet website at:

https://www.fda.gov/ForFederalStateandLocalOfficials/CommunicationsOutreach/default.htm<https://www.fda.gov/ForFederalStateandLocalOfficials/CommunicationsOutreach/default.htm?utm_campaign=National%20Broadcast%20Message%20-%20FDA%20Launches%20New%20InfoShare%20Training&utm_medium=email&utm_source=Eloqua&elqTrackId=22350839e21d4152ab762e58bd34b2d1&elq=3defa950c3d24f3799850162c115cec9&elqaid=7150&elqat=1&elqCampaignId=5856>

This message is being broadcast by the Division of Communications in FDA’s ORA.

Thank you,

FDA/ORA

Office of Communications and Project Management

Division of Communications

Mailbox: DivComm-ORA@fda.hhs.gov<mailto:DivComm-ORA@fda.hhs.gov>

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