Document ID: FDA-2018-D-1216-0019
Agency: fda
Document Type: Notice
Title: Electronic Common Technical Document; Data Standards; Specifications for the Electronic Common Technical Document
Validation Criteria
Posted Date: 2021-08-25T04:00Z

[Federal Register Volume 86, Number 162 (Wednesday, August 25, 2021)]
[Notices]
[Pages 47504-47505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18303]

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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; 
Specifications for the Electronic Common Technical Document Validation 
Criteria

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 (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, Jonathan.Resnick@fda.hhs.gov: 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]
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