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 3.2.2 and Version 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 the date FDA will begin rejecting electronic submissions that fail new Electronic Common Technical Document (eCTD) Version 3.22 (v3.22) and Version 4.0 (v4.0) based validations. The new eCTD v3.2.2 validations are 2024 and 2025, which are high-severity validation errors as described in the Specifications for eCTD Validation Criteria. The new eCTD v4.0 validations are eCTD4-084, eCTD4-085, US-eCTD4-561, US-eCTD4-562, US-eCTD4-563, and US-eCTD4-564, which are high-severity validation errors as described in the Specifications for eCTD v4.0 Validation Criteria.

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 65749-65750]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21195]


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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 3.2.2 
and 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 the date FDA will begin rejecting electronic 
submissions that fail new Electronic Common Technical Document (eCTD) 
Version 3.22 (v3.22) and Version 4.0 (v4.0) based validations. The new 
eCTD v3.2.2 validations are 2024 and 2025, which are high-severity 
validation errors as described in the Specifications for eCTD 
Validation Criteria. The new eCTD v4.0 validations are eCTD4-084, 
eCTD4-085, US-eCTD4-561, US-eCTD4-562, US-eCTD4-563, and US-eCTD4-564, 
which are high-severity validation errors as described in the 
Specifications for eCTD v4.0 Validation Criteria.

DATES: Rejection for failing to pass the new high-severity eCTD v3.22 
and v4.0 validations will begin January 16, 2027. 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 3.2.2 and 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

[[Page 65750]]

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#eca683828d98848d82c2be899f82858f87ac8a888dc284849fc28b839a"><span class="__cf_email__" data-cfemail="87cde8e9e6f3efe6e9a9d5e2f4e9eee4ecc7e1e3e6a9efeff4a9e0e8f1">[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#fbb893899288d5b698b8948996929890bb9d9f9ad5939388d59c948d"><span class="__cf_email__" data-cfemail="80c3e8f2e9f3aecde3c3eff2ede9e3ebc0e6e4e1aee8e8f3aee7eff6">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: FDA is issuing this Federal Register notice 
to announce that eCTD v3.2.2 validations 2024 and 2025 and the eCTD 
v4.0 validations eCTD4-084, eCTD4-085, US-eCTD4-561, US-eCTD4-562, US-
eCTD4-563, and US-eCTD4-564 (described in Specifications for eCTD 
Validation Criteria and Specifications for eCTD v4.0 Validation 
Criteria, respectively) will become effective. Beginning January 16, 
2027, FDA will reject electronic submissions that fail these 
validations.
    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>). FDA plans to update the 
Specifications for eCTD Validation Criteria and the Specifications for 
eCTD v4.0 Validation Criteria to add the effective dates for the above-
referenced high-severity validations after publication of this notice. 
Specifications and validation criteria for eCTD 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. 2026-21195 Filed 10-15-26; 8:45 am]
BILLING CODE 4164-01-P


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