[Federal Register Volume 87, Number 189 (Friday, September 30, 2022)]
[Notices]
[Pages 59441-59443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21304]


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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 public meeting entitled ``Animal Generic Drug 
User Fee Act.'' The purpose of the meeting is to discuss the proposed 
recommendations for the reauthorization of the Animal Generic Drug User 
Fee Act (AGDUFA IV) for fiscal years 2024 through 2028.

DATES: The public meeting will be held virtually on October 26, 2022, 
from 2 p.m. to 4 p.m. eastern time. Either electronic or written 
comments on this meeting must be submitted by November 9, 2022. See the 
SUPPLEMENTARY INFORMATION section for registration dates and further 
information.

ADDRESSES: The public meeting will be hosted via a live virtual 
webcast.
    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 Wednesday, November 9, 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-2011-N-0655 for ``Animal Generic Drug User Fee Act; Public Meeting; 
Request for Comments.'' 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:

I. Background

    FDA is announcing a virtual public meeting to discuss proposed 
recommendations for the reauthorization of AGDUFA, which authorizes FDA 
to collect user fees and use them for the process of reviewing new 
animal generic drug applications

[[Page 59442]]

and associated submissions. 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. Section 742(d)(4) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379j-
13(d)(4)) requires that, after holding negotiations with regulated 
industry and periodic consultations with stakeholders, and before 
transmitting the Agency's final recommendation to Congress for the 
reauthorized program (AGDUFA IV), we do the following: (1) present the 
recommendation to the relevant congressional committees, (2) publish 
such recommendations in the Federal Register, (3) provide for a period 
of 30 days for the public to provide written comments on such 
recommendations, (4) hold a meeting at which the public may present its 
views on such recommendations, and (5) consider such public views and 
comments and revise such recommendations as necessary. This notice, the 
30-day comment period, and the public meeting will satisfy certain of 
these requirements. After the public meeting, we will revise the draft 
recommendations as necessary. In addition, the Agency will present the 
draft recommendations to the congressional committees.
    FDA considers the timely review of abbreviated new animal drug 
applications (ANADAs) to be central to the Agency's mission to protect 
and promote human and animal health. Prior to 2009, the timeliness and 
predictability of the generic new animal drug review program was a 
concern. The Animal Generic Drug User Fee Act enacted in 2008 (Pub. L. 
110-316; hereinafter referred to as ``AGDUFA I'') amended the FD&C Act 
to authorize FDA's first-ever generic animal drug user fee program. 
AGDUFA I provided FDA with additional funds to enhance the performance 
and predictability of the generic new animal drug review process. 
Furthermore, the authorization of AGDUFA I enabled FDA's continued 
assurance that generic new animal drug products are safe and effective.
    Under AGDUFA I, FDA agreed to meet review performance goals for 
certain submissions over 5 years from FY 2009 through FY 2013. The 
purpose of establishing these review performance goals was to ensure 
the timely review of ANADAs and reactivations, supplemental ANADAs, and 
generic investigational new animal drug (JINAD) submissions and have 
enabled FDA to reduce the time for the application review process for 
generic new animal drugs without compromising the quality of the 
Agency's review.
    With the reauthorization of AGDUFA for an additional 5 years under 
AGDUFA II (FY 2014 to FY 2018), FDA agreed to further enhance and 
improve the review process. The AGDUFA II authorization enhancements 
included developing Question Based Review Process for Bioequivalence 
Submissions and shortening review time for key submission types. 
Additionally, there were Chemistry, Manufacturing, and Controls (CMC) 
enhancements, including permitting manufacturing supplements to be 
resubmitted as ``Supplement-Changes Being Effected in 30 Days'' if 
deficiencies are not substantial for manufacturing supplements 
requiring prior approval according to Sec.  514.8(b) (21 CFR 514.8(b)); 
permitting comparability protocols as described in Sec.  514.8(b)(2)(v) 
to be submitted as protocols without substantial data in a JINAD file; 
and developing guidance for a two-phased CMC technical section 
submission and review process under the JINAD file. Finally, the 
proportion of revenue collected from user fees was redistributed as 
follows: application fees from 30 percent to 25 percent; product fees 
from 35 percent to 37.5 percent; and sponsor fees from 35 percent to 
37.5 percent.
    Most recently, AGDUFA was reauthorized for an additional 5 years 
under AGDUFA III (FY 2019 to FY 2023). The AGDUFA III authorization 
enhancements included reducing performance goal review times for nearly 
all submission types, requiring 100 percent electronic submission and 
requiring an ``approved by FDA'' statement along with an ANADA number 
on approved animal drugs by September 30, 2023. Additionally, the 
inflation adjuster was changed from a fixed rate to a variable rate and 
the final year offset provision was eliminated. Finally, a new 
provision was added that any excess collections would be used to offset 
workload adjuster fee increases, if invoked.
    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.

II. Topics for Discussion at the Public Meeting

    In preparing the proposed recommendation to Congress for AGDUFA 
reauthorization, we conducted discussions with the regulated industry, 
and consulted with stakeholders as required by the law. We began the 
AGDUFA reauthorization process with a public meeting held on May 20, 
2021 (86 FR 18986, April 12, 2021). Following the May 2021 public 
meeting, FDA conducted negotiations with regulated industry and 
continued regular consultations with public stakeholders from July 
through October 2021. As directed by Congress, FDA posted minutes of 
these discussions on its website at https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings.
    The proposed enhancements in AGDUFA IV will address priorities 
identified by stakeholders, regulated industry, and FDA. The full 
description of these proposed recommendations can be found in the 
proposed AGDUFA IV Performance Goals and Procedures Letter. FDA intends 
to post the full text of the proposed AGDUFA IV Performance Goals and 
Procedures Letter at https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings, no later than one week prior to 
the public meeting. FDA will post the agenda approximately 5 days 
before the meeting at https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings.

III. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting 
must register online at https://fda.zoomgov.com/meeting/register/vJItcuCtqD4pGPe2DNgbbQZYaRswsTm9iRM no later than October 24, 2022. 
Please provide complete contact information for each attendee, 
including name, title, affiliation, address, email, and telephone. 
Also, please self-identify as a member of one of the following 
stakeholder categories: scientific or academic experts, veterinary 
professionals, patients and consumer advocacy groups, or the regulated 
industry, and whether you are requesting a scheduled presentation. 
Early registration is recommended. Registrants will receive 
confirmation when their registration has been received and will be 
provided the webcast link.
    If you need special accommodations due to a disability, please 
contact Lisa Kable (see FOR FURTHER INFORMATION CONTACT) no later than 
October 20, 2022.

[[Page 59443]]

    Requests for Oral Presentations: During online registration you may 
indicate if you wish to present during the public comment session, and 
which topic(s) you wish to address. We will do our best to accommodate 
requests to make public comments. 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. 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 October 24, 2022. All requests to make oral 
presentations must be received by October 20, 2022, 11:59 p.m. eastern 
time. If selected for presentation, any presentation materials must be 
emailed to Lisa Kable (see FOR FURTHER INFORMATION CONTACT) no later 
than October 24, 2022. No commercial or promotional material will be 
permitted to be presented at the public meeting.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
internet at https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings.

    Dated: September 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21304 Filed 9-29-22; 8:45 am]
BILLING CODE 4164-01-P