Document ID: FDA-2011-N-0655-0032
Agency: fda
Document Type: Notice
Title: Animal Generic Drug User Fee Act; Public Meeting; Request for Comments; Extension of Comment Period
Posted Date: 2022-10-20T04:00Z

[Federal Register Volume 87, Number 202 (Thursday, October 20, 2022)]
[Notices]
[Pages 63782-63783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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-

[[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 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: Lisa Kable, Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, 
MD 20855, 240-402-6888, [email protected].

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 https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings, 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