[Federal Register Volume 86, Number 143 (Thursday, July 29, 2021)]
[Notices]
[Pages 40855-40856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16187]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1216]


Electronic Study Data Submission; Data Standards; Technical 
Rejection Criteria for Study Data Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for 
Biologics Evaluation and Research (CBER) and Center for Drug Evaluation 
and Research (CDER) are announcing the effective date for Electronic 
Common Technical Document (eCTD) validations referenced in FDA's 
``Technical Rejection Criteria for Study Data'' (TRC).

DATES: The eCTD validations will become applicable on September 15, 
2021.

ADDRESSES: You may submit either electronic or written comments at any 
time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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'').

[[Page 40856]]

Written/Paper Submissions

    Submit written/paper submissions as follows:
     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.
     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 ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-1216 for ``Electronic Study Data Submission; Data Standards; 
Technical Rejection Criteria for Study Data Effective Date.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be 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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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 (CDER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 3160, Silver Spring, MD 20993-0002, 301-
796-7997, [email protected], or Stephen Ripley, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-
0002, 240-402-7911, [email protected].

SUPPLEMENTARY INFORMATION: In accordance with the guidance \1\ for 
industry ``Providing Regulatory Submissions in Electronic Format--
Standardized Study Data,'' submissions that are not submitted 
electronically and electronic submissions that are not in a format that 
FDA can process, review, and archive will not be filed or received, 
unless they have an exemption or waiver from the electronic submission 
requirements. The Agency can process, review, and archive electronic 
submissions of study data that use the standards specified in the Data 
Standards Catalog posted to FDA's Study Data Standards Resources web 
page (https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources).
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    \1\ Under section 745A(a) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1(a)), at least 24 months 
after the issuance of a final guidance document in which FDA has 
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.
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    The technical rejection criteria are automated validations by the 
CDER or CBER inbound processing system using the specifications set 
forth in FDA's ``Specifications for eCTD Validation Criteria'' to 
determine compliance with the requirement to submit electronic 
standardized study data. The eCTD validations referenced in FDA's TRC 
will become effective on September 15, 2021. Starting September 15, 
2021, FDA will reject submissions that contain any high validation 
errors included in the TRC. The latest version of the TRC is available 
on FDA's web page on Study Data for Submission to CDER and CBER 
(https://www.fda.gov/industry/study-data-standards-resources/study-data-submission-cder-and-cber).

    Dated: July 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16187 Filed 7-28-21; 8:45 am]
BILLING CODE 4164-01-P