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OMB Burden Statement FDA Form 3540

OMB Burden Statement FDA Form 3540

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Instructions and help about OMB Burden Statement FDA Form 3540

- Hello. My name is Commander David Skanchy with the Division of Lifecycle API. On behalf of myself and Vathsala Salvam, welcome to our poster on the new DMF form 3938. This poster links you to a full webinar that describes in detail the new form's uses and functionality and provides answers to frequently asked questions. The purpose of the new DMF form 3938 is to provide a standardized fill-able electronic form for Drug Master File submissions. This is analogous to the function of the long-used 356H form for application submissions, but applied specifically to DMFs. The form will allow for automated polling of DMF information into FDA databases and capture the relevant DMF submission information submitted using the electronic common technical document format. This will help increase the accuracy and efficiency of the processing of DMF submissions by FDA. We expect the form to be available for use with DMF submissions sometime in 2021. To view the full webinar on DMF form 3938, please

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