Notice2021-18395
Evaluation of Study Data Exchange Standards for Submission of Study Data to the Center for Veterinary Medicine; Request for Comments; Extension of Comment Period
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 26, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is extending the comment period for the request for comments that appeared in the Federal Register of June 15, 2021. In that notice, FDA requested comments on the use of study data exchange standards from persons involved in study conduct, data collection, data management, and submission of animal study data intended to support the approval of new animal drug applications (NDAs), abbreviated new animal drug applications (ANDAs), or applications for conditional approval. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Full Text
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<title>Federal Register, Volume 86 Issue 163 (Thursday, August 26, 2021)</title>
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[Federal Register Volume 86, Number 163 (Thursday, August 26, 2021)]
[Notices]
[Pages 47647-47648]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18395]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2319]
Evaluation of Study Data Exchange Standards for Submission of
Study Data to the Center for Veterinary Medicine; Request for Comments;
Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is extending
the comment period for the request for comments that appeared in the
Federal Register of June 15, 2021. In that notice, FDA requested
comments on the use of study data exchange standards from persons
involved in study conduct, data collection, data management, and
submission of animal study data intended to support the approval of new
animal drug applications (NDAs), abbreviated new animal drug
applications (ANDAs), or applications for conditional approval. The
Agency is taking this action in response to requests for an extension
to allow interested persons additional time to submit comments.
DATES: FDA is extending the comment period on the request for comments
published on June 15, 2021 (86 FR 31720). Submit either electronic or
written comments by November 12, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 12, 2021. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 12, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
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'').
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-2020-N-2319 for ``Evaluation of Study Data Exchange Standards for
Submission of Study Data to the Center for Veterinary Medicine.''
Received comments, those filed in a timely manner (see ADDRESSES), 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
[[Page 47648]]
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: Charles Andres, Center for Veterinary
Medicine (HFV-180), Food and Drug Administration, 7500 Standish Pl,
Rockville, MD 20855, 240-402-0653, <a href="/cdn-cgi/l/email-protection#c2a1aaa3b0aea7b1eca3aca6b0a7b182a4a6a3ecaaaab1eca5adb4"><span class="__cf_email__" data-cfemail="32515a53405e57411c535c56405741725456531c5a5a411c555d44">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 15, 2021,
FDA published a request for comments with a 90-day comment period to
request comments on the use of study data exchange standards from
persons involved in study conduct, data collection, data management,
and submission of animal study data intended to support the approval of
NDAs, ANDAs, or applications for conditional approval. Comments on the
use of study data exchange standards will help us evaluate the
potential use of study data exchange standards for animal studies
submitted as part of the new animal drug approval process
Interested persons were originally given until September 13, 2021,
to comment on document. The Agency has received a request for a 60-day
extension of the comment period. The request conveyed concern that the
current 90-day comment period does not allow sufficient time to develop
a meaningful or thoughtful response to the request for comments. FDA
has considered the request and is extending the comment period for the
request for comments for 60 days, until November 12, 2021. The Agency
believes that a 60-day extension allows adequate time for interested
persons to submit comments.
Dated: August 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18395 Filed 8-25-21; 8:45 am]
BILLING CODE 4164-01-P
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