Notice2022-22744
Animal Generic Drug User Fee Act; Public Meeting; 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
October 20, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is extending the comment period for the notice announcing a public meeting and requesting comments that appeared in the Federal Register of September 30, 2022. In that notice, FDA announced a public meeting to discuss the proposed recommendations for the reauthorization of the Animal Generic Drug User Fee Act (AGDUFA IV) for fiscal years 2024 through 2028 and that the comment period would be open until November 9, 2022. FDA is taking this action due to a delay in the posting of the AGDUFA IV Performance Goals and Procedures Letter. This extension will provide the public 30 days to comment as required.
Full Text
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<title>Federal Register, Volume 87 Issue 202 (Thursday, October 20, 2022)</title>
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[Federal Register Volume 87, Number 202 (Thursday, October 20, 2022)]
[Notices]
[Pages 63782-63783]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-22744]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0655]
Animal Generic Drug User Fee Act; Public Meeting; Request for
Comments; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments; extension of
comment period.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
extending the comment period for the notice announcing a public meeting
and requesting comments that appeared in the Federal Register of
September 30, 2022. In that notice, FDA announced a public meeting to
discuss the proposed recommendations for the reauthorization of the
Animal Generic Drug User Fee Act (AGDUFA IV) for fiscal years 2024
through 2028 and that the comment period would be open until November
9, 2022. FDA is taking this action due to a delay in the posting of the
AGDUFA IV Performance Goals and Procedures Letter. This extension will
provide the public 30 days to comment as required.
DATES: FDA is extending the comment period announced in the notice of
public meeting and request for comments published September 30, 2022
(87 FR 59441). Either electronic or written comments on the notice must
be submitted by November 14, 2022, to ensure that the Agency considers
your comments regarding this public meeting and request for comments.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. 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 14, 2022. 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:
<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-
[[Page 63783]]
2011-N-0655 for ``Animal Generic Drug User Fee Act.'' 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 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: Lisa Kable, Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855, 240-402-6888, <a href="/cdn-cgi/l/email-protection#014d6872602f4a60636d64416765602f6969722f666e77"><span class="__cf_email__" data-cfemail="4a0623392b64012b28262f0a2c2e2b64222239642d253c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of September 30,
2022, FDA published a notice announcing a public meeting and requesting
comments on the proposed recommendations for the reauthorization of the
AGDUFA IV for fiscal years 2024 through 2028.
Interested persons were originally given until November 9, 2022, to
comment on the public meeting and request for comments. Due to a delay
in the posting of the AGDUFA IV Performance Goals and Procedures Letter
to our website at <a href="https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings">https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings</a>, we are extending the comment
period until November 14, 2022, to allow for a 30-day comment period.
Dated: October 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22744 Filed 10-19-22; 8:45 am]
BILLING CODE 4164-01-P
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