Notice2021-16187
Electronic Study Data Submission; Data Standards; Technical Rejection Criteria for Study Data Effective Date
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
July 29, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 86 Issue 143 (Thursday, July 29, 2021)</title>
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[Federal Register Volume 86, Number 143 (Thursday, July 29, 2021)]
[Notices]
[Pages 40855-40856]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#f3b99c9d92879b929ddda196809d9a9098b3959792dd9b9b80dd949c85"><span class="__cf_email__" data-cfemail="f1bb9e9f908599909fdfa394829f98929ab1979590df999982df969e87">[email protected]</span></a>, 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, <a href="/cdn-cgi/l/email-protection#91c2e5f4e1f9f4ffbfc3f8e1fdf4e8d1f7f5f0bff9f9e2bff6fee7"><span class="__cf_email__" data-cfemail="55062130253d303b7b073c2539302c153331347b3d3d267b323a23">[email protected]</span></a>.
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 (<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>).
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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
(<a href="https://www.fda.gov/industry/study-data-standards-resources/study-data-submission-cder-and-cber">https://www.fda.gov/industry/study-data-standards-resources/study-data-submission-cder-and-cber</a>).
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
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