Electronic Common Technical Document (eCTD); Data Standards; Supporting Forward Compatibility for eCTD 4.0

Issuing agencies

Abstract

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

Full Text

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<title>Federal Register, Volume 91 Issue 199 (Friday, October 16, 2026)</title>
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[Federal Register Volume 91, Number 199 (Friday, October 16, 2026)]
[Notices]
[Pages 65752-65753]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21197]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Electronic Common Technical Document (eCTD); Data Standards; 
Supporting Forward Compatibility for eCTD 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 Forward Compatibility for 
Electronic Common Technical Document (eCTD) Version 4.0 (v4.0)-based 
electronic submissions.

DATES: FDA support for Forward Compatibility for eCTD v4.0 electronic 
submissions begins October 16, 2026. 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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
    <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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#da90b5b4bbaeb2bbb4f488bfa9b4b3b9b19abcbebbf4b2b2a9f4bdb5ac"><span class="__cf_email__" data-cfemail="713b1e1f100519101f5f2314021f18121a311715105f1919025f161e07">[email&#160;protected]</span></a>; or Chris McCormick, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7266, Silver Spring, MD 20993-0002, 
301-651-7158, <a href="/cdn-cgi/l/email-protection#e8ab809a819bc6a58bab879a85818b83a88e8c89c680809bc68f879e"><span class="__cf_email__" data-cfemail="d794bfa5bea4f99ab494b8a5babeb4bc97b1b3b6f9bfbfa4f9b0b8a1">[email&#160;protected]</span></a>.

[[Page 65753]]


SUPPLEMENTARY INFORMATION: FDA is issuing this Federal Register notice 
to announce that FDA is ready to receive eCTD v4.0 Forward 
Compatibility electronic submissions. According to the guidance for 
industry titled ``Providing Regulatory Submissions in Electronic 
Format--Certain Human Pharmaceutical Product Applications and Related 
Submissions Using the eCTD Specifications'' (available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-certain-human-pharmaceutical-product-applications">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-certain-human-pharmaceutical-product-applications</a>), 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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-catalog">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-catalog</a>).
    Forward Compatibility enables FDA to process eCTD v4.0 submissions 
to applications originally submitted and established using eCTD v3.2.2. 
This will allow industry to fully transition to eCTD v4.0 while 
retaining the capability to continue open regulatory activities and 
life-cycle content previously submitted under eCTD v3.2.2. 
Specifications for eCTD v4.0 are available on FDA's eCTD web page 
(available at <a href="https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd">https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd</a>).

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-21197 Filed 10-15-26; 8:45 am]
BILLING CODE 4164-01-P


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