Document ID: FDA-2019-D-3989-0001
Agency: fda
Document Type: Notice
Title: Drug Master Files; Draft Guidance for Industry; Availability
Posted Date: 2019-10-21T04:00Z

[Federal Register Volume 84, Number 203 (Monday, October 21, 2019)]
[Notices]
[Pages 56194-56195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22821]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3989]

Drug Master Files; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Drug 
Master Files.'' Once finalized, this guidance will provide FDA's 
current thinking on drug master files (DMFs), which are submissions to 
FDA that may be used to provide confidential, detailed information 
about facilities, processes, or articles used in the manufacturing, 
processing, packaging, and storing of human drug products. DMFs are 
submitted solely at the discretion of their holders and are not 
required by statute or regulation. This draft guidance, when finalized, 
will revise the guidance for industry ``Drug Master Files: Guidelines'' 
that published in September 1989.

DATES: Submit either electronic or written comments on the draft 
guidance by December 20, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-D-3989 for ``Drug Master Files.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20

[[Page 56195]]

and other applicable disclosure law. For more information about FDA's 
posting of comments to public dockets, see 80 FR 56469, September 18, 
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Rick Ensor, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 75, Rm. 6652, Silver Spring, MD 20993-0002, 240-402-2733, or 
Stephen Ripley, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Drug Master Files.'' Once finalized, this guidance will 
provide FDA's current thinking on DMFs, which are submissions to FDA 
that may be used to provide confidential, detailed information about 
facilities, processes, or articles used in the manufacturing, 
processing, packaging, and storing of human drug products. DMFs are 
submitted solely at the discretion of their holders and are not 
required by statute or regulation. After submission, information in 
DMFs can be incorporated by reference into applications \1\ or other 
DMFs submitted to FDA.
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    \1\ This guidance focuses on DMFs under 21 CFR 314.420 that are 
used to support new drug applications, abbreviated new drug 
applications, and investigational new drug applications under the 
FD&C Act and DMFs and other master files under 21 CFR 601.51(a) that 
are used to support biologics license applications under the Public 
Health Service Act. Additionally, information contained in DMFs can 
generally be referenced in premarket submissions for devices (e.g., 
premarket approvals) and animal drugs (e.g., new animal drug 
applications).
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    This draft guidance, when finalized, will revise the guidance for 
industry ``Drug Master Files: Guidelines'' that published in September 
1989. This update includes a change in FDA's contact person for the 
guidance, new procedures for DMFs referenced in abbreviated new drug 
applications that reflect commitments under the Generic Drug User Fee 
Amendments of 2012 (Pub. L. No. 112-144, Title III; reauthorized in 
2017, Pub. L. 115-52), more detailed instructions regarding the 
submission of original DMFs versus amendments, reference to the 
electronic submission requirements under section 745A of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1) that apply 
to certain DMFs, removal of Type I as a DMF category, and clarification 
and reorganization of material associated with Type III and Type IV 
DMFs.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Drug Master 
Files.'' It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collection of information in 21 CFR part 314 has been 
approved under OMB control number 0910-0001.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: October 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22821 Filed 10-18-19; 8:45 am]
 BILLING CODE 4164-01-P