[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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