Notice2021-18303
Electronic Common Technical Document; Data Standards; Specifications for the Electronic Common Technical Document Validation Criteria
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 25, 2021
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 (CDER) and Center for Biologics Evaluation and Research (CBER) are announcing the date that FDA will begin rejecting submissions which fail Electronic Common Technical Document (eCTD) validations 1306 or 1323 that have been raised to high validation errors as described in the "Specifications for eCTD Validation Criteria."
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 162 (Wednesday, August 25, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 162 (Wednesday, August 25, 2021)]
[Notices]
[Pages 47504-47505]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18303]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-1216]
Electronic Common Technical Document; Data Standards;
Specifications for the Electronic Common Technical Document Validation
Criteria
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Drug Evaluation and Research (CDER) and Center for Biologics Evaluation
and Research (CBER) are announcing the date that FDA will begin
rejecting submissions which fail Electronic Common Technical Document
(eCTD) validations 1306 or 1323 that have been raised to high
validation errors as described in the ``Specifications for eCTD
Validation Criteria.''
[[Page 47505]]
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#4f0520212e3b272e21611d2a3c21262c240f292b2e6127273c61282039"><span class="__cf_email__" data-cfemail="c18baeafa0b5a9a0afef93a4b2afa8a2aa81a7a5a0efa9a9b2efa6aeb7">[email protected]</span></a>: 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
to announce that eCTD validations 1306 and 1323, described in
``Specifications for eCTD Validation Criteria,'' have been raised to
high validation errors. Beginning March 1, 2022, FDA will reject
submissions that fail either of these validations.
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,'' submissions subject to section 745A(a) of the
Federal Food, Drug, and Cosmetic Act 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 Data Standards Catalog. eCTD submissions must
follow FDA eCTD technical specification entitled ``The Comprehensive
Table of Contents Headings and Hierarchy.'' Documents which are not
properly referenced in the eCTD backbone as described in the ``M2 eCTD:
Electronic Common Technical Document Specification'' and ``The eCTD
Backbone Files Specification for Module 1,'' result in content that is
not accessible within FDA eCTD technical specification ``The
Comprehensive Table of Contents Headings and Hierarchy.'' eCTD
validations 1306 (``No leaf element for file'') and 1323 (``No file for
leaf element''), within the ``Specifications for eCTD Validation
Criteria,'' describe parts of the eCTD specifications which were not
followed correctly. Rejection for failing to pass either eCTD
validations 1306 or 1323 will begin on March 1, 2022.
Dated: August 18, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18303 Filed 8-24-21; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on August 25, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.