Notice2021-18587
Electronic Common Technical Document; Data Standards; Specifications for 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 30, 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) 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.
Full Text
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<title>Federal Register, Volume 86 Issue 165 (Monday, August 30, 2021)</title>
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[Federal Register Volume 86, Number 165 (Monday, August 30, 2021)]
[Notices]
[Pages 48431-48432]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#763c191817021e171858241305181f151d36101217581e1e0558111900"><span class="__cf_email__" data-cfemail="5e1431303f2a363f30700c3b2d30373d351e383a3f7036362d70393128">[email protected]</span></a>.
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
<a href="https://www.fda.gov/media/87056/download">https://www.fda.gov/media/87056/download</a>) 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 <a href="https://www.fda.gov/media/135373/download">https://www.fda.gov/media/135373/download</a>), 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 <a href="https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources">https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources</a>).
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 <a href="https://www.fda.gov/media/128163/download">https://www.fda.gov/media/128163/download</a>), 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
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