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ONADE: Updated New Animal Drug and Manufacturing (ADMS) capabilities within eSubmitter to better allow the Division of Manufacturing Technology (DMT) to manage the latest information on establishment supply chain data across applications:
Updated submission types ANADA/NADA Minor Changes and Stability Reports (A/N-B-CA, A/N-F-CA, A-B-AR, A-F-AR).
Added support to simplify the inclusion of additional supply chain roles when adding or editing supply chain items for an establishment of an application/file.
ALL: Added support for simultaneous packaging within a shared temporary folder.
Fixes
ONADE: Updated the Route of Administration dictionary to include OTIC (C38192) and to fix a misspelling of INTRASYNOVIAL.
ALL: Fixed the FDA ESG webpage link within the final step of the eSubmitter packaging process.
1. ONADE: Updated New Animal Drug and Manufacturing (ADMS) capabilities within eSubmitter to better allow the Division of Manufacturing Technology (DMT) to manage the latest information on establishment supply chain data across applications:
Updated submission types N/A-C/R-AI/AP/AS/CI/CP/CS and I/J-P-MC.
Added support for copying/moving supply chain items from one file/application or establishment to another within the ADMS Supply Chain book.
Added support for editing establishment/supply chain information directly within the ADMS Establishment List section of a submission.
2. ONADE: Added a new question within ANADA/NADA Original/Reactivation (A/N-A/E-OT), CMC Supplement/Reactivation of Supplement (A/N-C/R-CI/CS/CP/AI/AS/AP), and JINAD/INAD Major Technical section (J/I-P-MC) submissions to identify whether a toxicology assessment is provided.
Fixes
ONADE: Fixed a textual issue where messages containing section numbers within Request for Meeting (I/N-Z-OM) submission types were no longer correct after a reordering of sections occurred in a previous update.
ONADE: Fixed a textual issue in Request for Meeting (I/J/N/A/V/G-Z-OM) and Environmental Technical Section submission types to reflect that there are now two Environmental Safety Teams within HFV-160.
ONADE: Updated submission type V-A-OT for VMF Type VIII Import Tolerance submissions to reflect that a U.S. Agent is now required (21 CFR 510.205(d)), effective 1/19/2022, as published in the FEDERAL REGISTER (86 FR 52401) on September 21, 2021.