[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96013-96015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31626]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1953]


Providing Regulatory Submissions in Electronic Format--Submission 
of Manufacturing Establishment Information; Draft Guidance for 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the availability of a draft guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--Submission of 
Manufacturing Establishment Information.'' This guidance discusses the 
requirements for a valid electronic submission of manufacturing 
establishment information (MEI) under the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act). This action will streamline the review of 
all manufacturing establishments involved in the preparation of a drug 
or biological product by consolidating information in one location and 
eliminating the inclusion of erroneous and/or outdated information from 
other Agency files.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 27, 2017.

ADDRESSES: You may submit comments as follows:

[[Page 96014]]

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2014-D-1953 for ``Providing Regulatory Submissions in Electronic 
Format--Submission of Manufacturing Establishment Information.'' 
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 Division of Dockets Management 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 Division of Dockets Management. 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 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 to 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. 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: Regarding drug products: Karen 
Takahashi, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4244, Silver 
Spring, MD 20993-0002, 301-796-3191.
    Regarding biological products: Stephen Ripley, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-
7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Submission of Manufacturing Establishment Information.''
    This draft guidance discusses the requirements and implementation 
of section 745A(a) of the FD&C Act (21 U.S.C. 379k-1) regarding valid 
electronic submissions of MEI. Twenty-four months after this draft has 
been finalized, MEI contained in new drug applications (NDAs), 
abbreviated new drug applications (ANDAs), biologics license 
applications (BLAs), and amendments, supplements, or resubmissions of 
these application types must be submitted electronically in the format 
specified in this guidance. This draft guidance also applies to drug 
master files that are submitted for incorporation by reference into an 
NDA, ANDA, or BLA.
    Under current regulations at 21 CFR 314.50(d) and 21 CFR 601.2(a), 
applicants and holders of approved applications are required to submit 
contact information for each manufacturing establishment involved in 
the manufacture of the drug or biological product, as well as other 
information relating to the manufacture of the product. This 
information is part of the existing application form (FDA Form 356h, 
``Application to Market a New Drug, Biologic, or an Antibiotic Drug for 
Human Use''). We have found that the MEI is sometimes incomplete, and 
scattered throughout electronic submissions. This can lead to delays in 
application processing.
    The Agency is requiring that applicants submit a single, 
consolidated list of information about each manufacturing establishment 
mentioned in any application. This information must include the name 
and address of each manufacturing establishment involved in the 
manufacture of the drug or biological product, specific information 
regarding the physical location of the establishment, facility 
identifiers assigned to the establishment by FDA, contact information 
for the person responsible for scheduling inspections at the 
establishment, and

[[Page 96015]]

the specific manufacturing operations conducted at the establishment.
    We believe the required electronic MEI can be consolidated to 
appear in a single location to facilitate the complete, timely, and 
accurate review of all manufacturing establishments involved in the 
preparation of a drug or biological product. This will help to 
eliminate the inclusion and/or maintenance of potentially outdated and 
erroneous information that could be retrieved from other Agency files 
and will enable proper identification and timely evaluation of 
manufacturing establishments for conformance with requirements, 
including current good manufacturing practices.

II. Paperwork Reduction Act of 1995

    The 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 draft guidance discusses the electronic submission of MEI 
contained in an NDA, ANDA, or BLA to the Center for Drug Evaluation and 
Research and the Center for Biologics Evaluation and Research by 
specifying the format for the electronic submission of such 
submissions. The information collection discussed in the guidance is 
contained in our NDA and ANDA regulations (part 314) and approved under 
OMB control number 0910-0001, and our BLA regulations (part 601) and 
approved under OMB control number 0910-0338. Currently, MEI is 
submitted as part of the existing application form, Form FDA 356h, and 
is approved by OMB under control number 0910-0338.

III. Electronic Access

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

    Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31626 Filed 12-28-16; 8:45 am]
 BILLING CODE 4164-01-P