Notice2024-20897
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
Primary source
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Published
September 16, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
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 Electronic Common Technical Document (eCTD) Version 4.0 (v4.0)-based electronic submissions.
Full Text
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<title>Federal Register, Volume 89 Issue 179 (Monday, September 16, 2024)</title>
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[Federal Register Volume 89, Number 179 (Monday, September 16, 2024)]
[Notices]
[Pages 75545-75546]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <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
[[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 <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,
<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 <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 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: <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>).
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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