[Federal Register Volume 86, Number 68 (Monday, April 12, 2021)]
[Notices]
[Pages 18986-18987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07375]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following virtual public meeting entitled ``Animal 
Generic Drug User Fee Act.'' The purpose of the public meeting is to 
invite public comment on the Animal Generic Drug User Fee Act (AGDUFA) 
program and suggestions regarding the features FDA should consider for 
the next reauthorization of the AGDUFA program. The meeting will be 
open to the public.

DATES: The public meeting will be hosted via a live virtual webcast on 
Thursday, May 20, 2021, from 11 a.m. to 1 p.m. Eastern Time. See the 
SUPPLEMENTARY INFORMATION section for registration dates and 
information. To permit the widest possible opportunity to obtain 
comments on all aspects of the public meeting, the docket will remain 
open for comment throughout the reauthorization process of AGDUFA, 
until December 1, 2022. In addition to being publicly viewable at 
http://www.regulations.gov, comments received by June 21, 2021, 
suggesting changes to the program, will also be published on https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings.

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 December 1, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 1, 2022. 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 comments will be 
made public, you are solely responsible for ensuring that your comments 
do 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-2011-N-0655 for ``Animal Generic Drug User Fee Act.'' Received 
comments, those filed in a timely manner, 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

[[Page 18987]]

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.
    A transcript of the public meeting will be made available in the 
docket, as well as on the FDA website at: https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings.

FOR FURTHER INFORMATION CONTACT: Lisa Kable, Center for Veterinary 
Medicine, Food and Drug Administration, 240-402-6888, 
lisa.kable@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Introduction

    The authority for AGDUFA expires September 30, 2023. Without new 
legislation, FDA will no longer have the authority to collect user fees 
to fund the new animal generic drug review process for future fiscal 
years. Prior to beginning negotiations with the regulated industry on 
AGDUFA reauthorization, section 742(d)(2) of the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j-22(d)(2)) requires FDA 
to: (1) Publish a notice in the Federal Register requesting public 
input on the reauthorization; (2) hold a public meeting at which the 
public may present its views on the reauthorization including specific 
suggestions for changes to the goals referred in section 742(a) of FD&C 
Act; (3) provide a period of 30 days after the public meeting to obtain 
written comments from the public suggesting changes; and (4) publish 
the comments on FDA's website. FDA is holding a public meeting to 
gather information on what FDA should consider including in the 
reauthorization of AGDUFA. FDA is interested in responses from the 
public on the following two general questions and welcomes other 
pertinent information that stakeholders would like to share:
    1. What is your assessment of the overall performance of the AGDUFA 
program thus far?
    2. What aspects of AGDUFA should be retained, changed, or 
discontinued to further strengthen and improve the program?

II. Background

    FDA considers the timely review of generic new animal drug 
submissions to be central to the Agency's mission to protect and 
promote human and animal health. The AGDUFA program began in FY 2009 
and is currently in the third authorization (AGDUFA III). FDA has 
published a number of reports that provide useful background on AGDUFA 
I, AGDUFA II, and AGDUFA III. AGDUFA-related Federal Register notices, 
guidances, legislation, performance reports, and financial reports can 
be found at: https://www.fda.gov/industry/fda-user-fee-programs/animal-generic-drug-user-fee-act-agdufa.

III. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting 
must register no later than midnight Eastern Time on May 18, 2021, by 
emailing complete contact information for each attendee, including 
name, title, affiliation, address, email, telephone number, and if you 
need reasonable accommodations due to a disability (e.g., Closed 
Captioning) to cvmagdufa@fda.hhs.gov. Early registration is 
recommended. Registrants will receive confirmation when their 
registration has been received and will be provided the webcast link.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to make an oral presentation during the public 
meeting. To facilitate agenda development, registrants requesting to 
present will be contacted to provide information regarding which topics 
they intend to address and the title of their presentation. We will do 
our best to accommodate requests to make an oral presentation. 
Individuals and organizations with common interests are urged to 
consolidate or coordinate their presentations, and request time for a 
joint presentation, or submit requests for designated representatives 
to participate. All requests to make oral presentations must be 
received by May 7, 2021.
    We will determine the amount of time allotted to each presenter and 
the approximate time each oral presentation is to begin, and we will 
notify participants by May 11, 2021. Selected presenters planning to 
use an electronic slide deck must submit an electronic copy of their 
presentation to Lisa Kable (see FOR FURTHER INFORMATION CONTACT) with 
the subject line ``AGDUFA Public Meeting Presentation'' on or before 
May 17, 2021. If presenters choose not to use a slide deck, they are 
requested to submit a single slide with their name, affiliation, title 
of their presentation, and contact information. No commercial or 
promotional material will be permitted to be presented at the public 
meeting.

    Dated: April 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07375 Filed 4-9-21; 8:45 am]
BILLING CODE 4164-01-P


