[Federal Register Volume 86, Number 163 (Thursday, August 26, 2021)]
[Notices]
[Pages 47647-47648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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'').

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-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 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

[[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 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: Charles Andres, Center for Veterinary 
Medicine (HFV-180), Food and Drug Administration, 7500 Standish Pl, 
Rockville, MD 20855, 240-402-0653, [email protected].

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]
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