[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Proposed Rules]
[Pages 44944-44945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11229]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201, 500, 501, 510, 514, and 516
[Docket No. FDA-2023-N-5160]
RIN 0910-AI43
Labeling Requirements for Approved or Conditionally Approved New
Animal Drugs; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the proposed rule entitled ``Labeling
Requirements for Approved or Conditionally Approved New Animal Drugs''
published in the Federal Register of March 12, 2024, by 60 days. The
Agency is taking this action in response to a request for an extension
to allow interested persons additional time to submit comments.
DATES: FDA is extending the comment period on the proposed rule
published March 12, 2024 (89 FR 18262), by 60 days. Either electronic
or written comments must be submitted by August 9, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 9, 2024. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received 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-2023-N-5160 for ``Labeling Requirements for Approved or
Conditionally Approved New Animal Drugs.'' 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 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: With regard to the proposed rule:
Suzanne Sechen, Center for Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0814,
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of March 12, 2024
(89 FR 18262), FDA published a proposed rule entitled ``Labeling
Requirements for Approved or Conditionally Approved New Animal Drugs''
with a 90-day
[[Page 44945]]
period for submission of public comments.
The Agency has received a request for an extension of the comment
period for the proposed rule. The request conveyed concern that the
current comment period does not allow sufficient time to develop a
meaningful or thoughtful response to the proposed rule.
FDA has considered the request and is extending the comment period
for the proposed rule for 60 days, until August 9, 2024. The Agency
believes that a 60-day extension allows adequate time for interested
persons to submit comments without significantly delaying rulemaking on
these important issues.
Dated: May 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11229 Filed 5-21-24; 8:45 am]
BILLING CODE 4164-01-P