[Federal Register Volume 89, Number 179 (Monday, September 16, 2024)]
[Notices]
[Pages 75545-75546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20897]


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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; Center for 
Drug Evaluation and Research and Center for Biologics Evaluation and 
Research Supporting Electronic Common Technical Document Version 4.0

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 support for Electronic Common Technical 
Document (eCTD) Version 4.0 (v4.0)-based electronic submissions.

DATES: Support for eCTDv4.0 electronic submissions begins September 16, 
2024. FDA will also continue to support eCTDv3.2.2 electronic 
submissions. Submit either electronic or written comments at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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 ``Instruction.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-1216 for ``Electronic Common Technical Document; Data 
Standards; Center for Drug Evaluation and Research and Center for 
Biologics Evaluation and Research Supporting Electronic Common 
Technical Document Version 4.0.'' 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.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be

[[Page 75546]]

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 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, 
<a href="/cdn-cgi/l/email-protection#3e7451505f4a565f50106c5b4d50575d557e585a5f1056564d10595148"><span class="__cf_email__" data-cfemail="22684d4c43564a434c0c7047514c4b4149624446430c4a4a510c454d54">[email protected]</span></a>; or James Myers, Center for Biologics 
Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 
7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: According to the guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Certain Human Pharmaceutical Product Applications and Related 
Submissions Using the eCTD Specifications'' (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-certain-human-pharmaceutical-product-applications), submissions subject to section 
745A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379k-
1(a)) must be submitted in eCTD format using the version of eCTD 
currently supported by FDA unless such submission is exempt from the 
electronic submission requirements or if FDA has granted a waiver. The 
version of eCTD currently supported by FDA is specified in the FDA Data 
Standards Catalog (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-catalog). FDA 
plans to update the FDA Data Standards Catalog to add eCTDv4.0 upon 
publication of this notice. FDA will support both eCTDv3.2.2 and 
eCTDv4.0 submissions before eventually only supporting eCTDv4.0 
submissions. FDA will provide advance notice of when the Agency will 
begin supporting electronic submission only in eCTDv4.0. Specifications 
for eCTDv3.2.2 and v4.0 are available on FDA's eCTD web page (available 
at: https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd).

    Dated: September 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20897 Filed 9-13-24; 8:45 am]
BILLING CODE 4164-01-P


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