[Federal Register Volume 85, Number 201 (Friday, October 16, 2020)]
[Notices]
[Pages 65827-65828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22971]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Electronic Common Technical Document; Data Standards; Support 
Ends for Electronic Common Technical Document Module 1 U.S. Regional 
Document Type Definition Version 2.01 and Requirement Begins for 
Electronic Common Technical Document Module 1 U.S. Regional Document 
Type Definition Version 3.3

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for 
Drug Evaluation and Research and Center for Biologics Evaluation and 
Research are announcing the date that FDA will no longer support 
electronic submissions using the Electronic Common Technical Document 
(eCTD) Backbone Files Specification for Module 1 Version 1.3, 
Comprehensive Table of Contents Headings and Hierarchy Version 1.2.2, 
U.S. Regional Document Type Definition (DTD) Version 2.01, and U.S. 
Regional Stylesheet Version 1.1, and will require electronic 
submissions to be submitted using eCTD Module 1 U.S. Regional DTD 
Version 3.3. The Agency will update the eCTD Submission Standards 
document to reflect these changes.

DATES: The requirement for electronic submissions to be submitted using 
eCTD Module 1 U.S. Regional DTD Version 3.3 will begin on March 1, 
2022.

ADDRESSES: You may submit either electronic or written comments 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 ``Electronic Common Technical Document; Data 
Standards; Support Ends for Electronic Common Technical Document Module 
1 U.S. Regional Document Type Definition Version 2.01 and Requirement 
Begins for Electronic Common Technical Document Module 1 U.S. Regional 
Document Type Definition Version 3.3.'' 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, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your

[[Page 65828]]

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 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.govinfo.gov/content/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Jonathan Resnick, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 3160, Silver Spring, MD 20993-0002, 301-
796-7997, [email protected], or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: FDA is issuing this Federal Register notice 
pursuant to the guidelines described in the FDA guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Submissions Under Section 745A(a) of the Federal Food, Drug, and 
Cosmetic Act'' (December 2014, available at https://www.fda.gov/media/88120/download), section III.F ``When will revisions or updates to 
existing formats take effect?'' to announce the end of support for 
electronic submissions using eCTD Module 1 U.S. Regional DTD Version 
2.01 and the date the requirement begins to submit using eCTD Module 1 
U.S. Regional DTD Version 3.3 as described in this notice.
    On June 15, 2015, FDA began accepting electronic submissions using 
eCTD Module 1 U.S. Regional DTD Version 3.3 as described in ``The eCTD 
Backbone Files Specification for Module 1'' Version 2.3. This upgrade 
of eCTD Module 1 includes functionality for promotional material and 
risk evaluation and mitigation strategies submissions, the ability to 
dynamically update certain heading elements (e.g., FDA forms), and the 
ability to submit grouped submissions. FDA has continued to accept 
electronic submissions using the previous version of the eCTD Module 1, 
using U.S. Regional DTD Version 2.01 as described in ``The eCTD 
Backbone Files Specification for Module 1'' Version 1.3.
    Due to the limitations of eCTD Module 1 U.S. Regional DTD Version 
2.01, FDA support for electronic submissions using eCTD Backbone Files 
Specification for Module 1 Version 1.3, Comprehensive Table of Contents 
Headings and Hierarchy Version 1.2.2, U.S. Regional DTD Version 2.01, 
and U.S. Regional Stylesheet Version 1.1 will end on March 1, 2022. The 
requirement for electronic submissions to be submitted using eCTD 
Module 1 U.S. Regional DTD Version 3.3 will begin on March 1, 2022. The 
Agency will update the eCTD Submission Standards document to reflect 
these changes.

    Dated: October 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22971 Filed 10-15-20; 8:45 am]
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