[Federal Register Volume 83, Number 117 (Monday, June 18, 2018)]
[Notices]
[Pages 28237-28238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12969]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1216]


Technical Specifications for Electronic Submissions; 
Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
establishing a public docket to receive information, recommendations, 
and comments on matters related to the Agency's publication of 
technical specifications, which explain, clarify, and define the 
specific use of data standards in new drug applications (NDAs), 
abbreviated new drug applications (ANDAs), biologics license 
applications (BLAs), and certain investigational new drug applications 
(INDs) to the Center for Biologics Evaluation and Research (CBER) and 
the Center for Drug Evaluation and Research (CDER). This docket is 
intended for general comments related to technical specifications that 
are not specific to documents or issues that are the subject of other 
dockets, or for comments specific to electronic submission guidances.

DATES: The announcement of this establishment of a public docket is 
published in the Federal Register on June 18, 2018.

ADDRESSES: You may submit either electronic or written comments to this 
docket 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-2018-D-1216 for ``Technical Specifications for Electronic 
Submissions; Establishment of a Public Docket.'' 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 and other 
applicable disclosure laws. 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.

FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1115, Silver Spring, MD 20993-0002, 301-
796-5333, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 745A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 379k-1) requires that submissions under section 505(b), (i), 
or (j) of the FD&C Act (21 U.S.C. 355(b), (i), or (j)) and submissions 
under section 351(a) or (k) of the Public Health Service Act (42 U.S.C. 
262(a) or (k)) be submitted in the electronic format specified by FDA, 
beginning no earlier than 24 months after FDA issues a final guidance 
specifying an electronic submission format.
    The Agency has concluded it is not feasible to describe and 
implement the electronic format or formats that would apply to all the 
submissions covered by section 745A(a) in one guidance document. 
Therefore, FDA issued the guidance for industry ``Providing Regulatory 
Submissions in Electronic Format--Submissions under Section 745A(a) of 
the Federal Food, Drug, and Cosmetic Act,'' which describes how FDA 
interprets the electronic submission requirements of section 745A(a) of 
the FD&C Act (see https://www.fda.gov/downloads/drugs/guidances/ucm384686.pdf).
    To assist sponsors in the submission of data in standardized 
electronic format in NDAs, ANDAs, BLAs, and certain INDs, CBER and CDER 
have developed technical specifications guidances which provide useful 
technical specifications, recommendations, and general considerations 
for submitting standardized data and related information in electronic 
format. Technical specifications guidances are guidances that explain, 
clarify, and define the specific use of data standards

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in regulatory submissions. Technical specifications guidances are 
available at: https://www.fda.gov/ForIndustry/DataStandards/default.htm.

II. Establishment of a Docket

    FDA is establishing a public docket so that anyone can share 
information, comments, and ideas on any matters related to the use of 
technical specifications that are not specific to the documents or 
issues addressed in other dockets. This information will give the 
Agency insight into stakeholders' experiences and views regarding the 
use of technical specifications guidances and the data standards they 
contain. The docket also permits anyone to share information, comments, 
or ideas that are specific to one or more technical specifications 
guidances. Instructions regarding how to submit comments to specific 
technical specifications documents have been posted within the docket.
    This docket will be open for comment simultaneously with several 
other dockets that are specific to particular electronic common 
technical document (eCTD) submissions and FDA data standards documents. 
(For more information on eCTD submissions and FDA data standards, see 
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm153574.htm and 
https://www.fda.gov/ForIndustry/DataStandards/default.htm, 
respectively). Do not submit comments to this general docket that have 
already been submitted to other dockets. As FDA finalizes specific 
documents or requests comments on specific issues for which another 
docket exists, the Agency will generally consider only those comments 
that have been submitted to that specific docket. Do not submit 
comments related to another specific docket to this general technical 
specifications docket, as the Agency may not consider them. FDA will 
not respond directly to questions or requests submitted to this docket 
but will consider any submitted information in its work to develop and 
issue technical specifications guidances.

    Dated: June 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12969 Filed 6-15-18; 8:45 am]
 BILLING CODE 4164-01-P