[Federal Register Volume 86, Number 165 (Monday, August 30, 2021)]
[Notices]
[Pages 48431-48432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18587]


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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 Electronic Common Technical Document Validation 
Criteria

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for 
Drug Evaluation and Research (CDER) is announcing the date that FDA 
will begin rejecting submissions that fail either Electronic Common 
Technical Document (eCTD) validation 1551 or 1553, which are high 
severity validation errors as described in the Specifications for eCTD 
Validation Criteria. Validation errors 1551 and 1553 have been added to 
the Specifications for eCTD Validation Criteria.

DATES: Rejection for failing to pass either eCTD validation 1551 or 
1553 under a submission to CDER will begin on October 18, 2021.

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.

SUPPLEMENTARY INFORMATION: FDA's CDER is issuing this Federal Register 
notice to announce that eCTD validations 1551 and 1553 have been added 
to the Specifications for eCTD Validation Criteria (available at 
https://www.fda.gov/media/87056/download) as high validation errors. 
Beginning October 18, 2021, FDA will reject submissions that fail 
either of these validations.
    Under section 745A(a) (21 U.S.C. 379k-1(a)) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act), at least 24 months after the 
issuance of a final guidance document in which FDA has

[[Page 48432]]

specified the electronic format for submitting certain submission types 
to the Agency, such content must be submitted electronically and in the 
format specified by FDA. According to the guidance for industry 
``Providing Regulatory Submissions in Electronic Format--Certain Human 
Pharmaceutical Product Applications and Related Submissions Using the 
eCTD Specifications'' (available at https://www.fda.gov/media/135373/download), submissions subject to section 745A(a) of the FD&C 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 (available at https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources).
    As described in the guidance for industry ``Providing Regulatory 
Submissions in Electronic and Non-Electronic Format--Promotional 
Labeling and Advertising Materials for Human Prescription Drugs'' (The 
Promotional Labeling Guidance) (available at https://www.fda.gov/media/128163/download), certain types of promotional-material-related 
submissions, including postmarketing submissions of promotional 
materials using Form FDA 2253 (required by Sec.  314.81(b)(3)(i) (21 
CFR 314.81(b)(3)(i)) and 21 CFR 601.12(f)(4)) (called 2253 
submissions), fall within the scope of section 745A(a) of the FD&C Act 
and are, therefore, subject to the mandatory electronic submission 
requirements (unless such submission is exempt from the electronic 
submission requirements or if FDA has granted a waiver). The 
Promotional Labeling Guidance provides that 2253 submissions are 
required to be accompanied by a completed fillable Form FDA 2253. When 
submitting Form FDA 2253, firms must submit the most current product 
labeling, as required in Sec.  314.81(b)(3)(i), under eCTD section 
1.14.6, as described in the Promotional Labeling Guidance. Electronic 
Common Technical Document validations 1551 (``2253 submission does not 
include Product Labeling'') and 1553 (``The only valid FDA Form to 
include in a 2253 submission is FDA Form 2253'') describe parts of the 
eCTD specifications that were not followed correctly (see the 
Specifications for eCTD Validation Criteria, pp. 29 and 30, 
respectively). Submissions to CDER that are subject to section 745A(a) 
of the FD&C Act and fail to pass either eCTD validation 1551 or 1553 
will begin being rejected on October 18, 2021.

    Dated: August 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18587 Filed 8-27-21; 8:45 am]
BILLING CODE 4164-01-P


