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The U.S. Food and Drug Administration (FDA) will begin utilizing the following electronic ACE messaging when a final admissibility decision is rescinded:
Reason Code
37 PGA Decision Rescinded-Do Not Distribute Product
Subreason Code
198 May Proceed Rescinded-Hold for Further Information From PGA
199 Release Rescinded-Hold for Further Information From PGA
200 Refusal Rescinded-Hold for Further Information From PGA
This enhancement will be deployed in the lower environment for testing on December 17, 2021 at approximately 10:00 PM. This enhancement will be deployed in production on January 15, 2022 at approximately 10:00 PM.
For FDA ACE technical inquiries, contact FDA ACE Support, ACE_Support@fda.hhs.gov. ACE Support Hours: Monday - Friday, 8:00 AM - 8:00 PM.
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