Nonsub Change to add Form FDA 3938

UNITED STATES FOOD & DRUG ADMINISTRATION
Applications for FDA Approval to Market a New Drug
OMB Control No. 0910-0001
Request for change: New Form FDA 3938: DRUG MASTER FILE FORM
This change request supports implementation of a new form. As provided for in 21 Code of
Federal Regulations (CFR) Part 314.420(a), a drug master file (DMF) is a submission of
information to the Food and Drug Administration by a person (the DMF holder) who intends it
to be used for one of the following purposes: to permit the holder to incorporate the information
by reference when the holder submits an investigational new drug application under part 312 or
submits an application or an abbreviated application or an amendment or supplement to them
under part 314 or a biologics license application under section 351(a) of the Public Health
Service Act; or, to permit the holder of the DMF to authorize third parties to reference the
information to support a submission to FDA without the DMF holder having to disclose the
information to the third party.
Form FDA 3938 has been designed for submission with new DMFs, all DMF amendments, and
any correspondence requesting changes of information within the DMF. Its purpose is to clearly
identify DMF Holder and Agent information, and to facilitate submission and archive of DMF
correspondence in electronic format. The information collected includes the name of the
organization, DMF holder, DMF agent, contact information, type of DMF, submission type
(original or amendment), establishment information, and certifications. These data elements are
provided for by our new drug application regulations, approved under OMB Control No. 09100001. We believe use of the form will improve efficiency in collecting and using the data and
helps identify, verify, and archive documents in each DMF submission. The form is to be made
available for electronic submission. We believe the form allows for a more streamlined
approach for accepting data.
We anticipate using Form FDA 3938 will require less than 1 hour for respondents to complete,
however we believe this burden is offset by the current practice of submitting a cover letter.
Consistent with our Good Guidance Practice (GGP) regulation in 21 CFR 10.115, we developed
the draft guidance document, “Drug Master Files: Guidance for Industry,” (inviting public
comment October 21, 2019 (84 FR 56194)) and communicate to respondents that we intend to
develop a form to replace the need for the DMF holder to create a cover letter for submitting the
information data elements.

Submitted: January 2020