[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Notices]
[Pages 70833-70835]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25274]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0656]


Animal 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 Drug User Fee 
Act.'' The purpose of the public meeting is to discuss the proposed 
recommendations for the reauthorization of the Animal Drug User Fee Act 
(ADUFA V) for fiscal years 2024 through 2028.

DATES: The public meeting will be held virtually on December 7, 2022, 
from 1 p.m. to 3 p.m. Eastern Time. Either electronic or written 
comments on this public meeting must be submitted by December 19, 2022. 
See the SUPPLEMENTARY INFORMATION section for registration date 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 December 19, 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-0656 for ``Animal 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

[[Page 70834]]

``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.
    Transcripts of the meeting will be available on FDA's website at 
https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings approximately 30 days after the meeting.

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 ADUFA, which authorizes FDA 
to collect user fees and use them for the process of reviewing new 
animal drug applications and associated submissions. The authority for 
ADUFA expires September 30, 2023. Without new legislation, FDA will no 
longer have the authority to collect user fees to fund the new animal 
drug review process for future fiscal years. Section 740A(d)(4) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-13(d)(4)) requires 
that, after holding negotiations with regulated industry and periodic 
consultations with stakeholder, and before transmitting the Agency's 
final recommendation to Congress for the reauthorized program (ADUFA 
V), 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 the safety and effectiveness of 
new animal drug applications (NADAs) to be central to the Agency's 
mission to protect and promote human and animal health. Prior to 2004, 
the timeliness and predictability of the new animal drug review program 
was a concern. The Animal Drug User Fee Act of 2003 (Pub. L. 108-130; 
hereinafter referred to as ``ADUFA I'') authorized FDA to collect user 
fees dedicated to the timely review of new animal drug applications in 
accordance with certain performance goals and to expand and modernize 
the new animal drug review program from fiscal year (FY) 2004 to 2008. 
The Agency agreed, under ADUFA I, to meet a comprehensive set of 
performance goals established to show significant improvement in the 
timeliness and predictability of the new animal drug review process. 
The implementation of ADUFA I provided a significant funding increase 
that enabled FDA to increase the number of staff dedicated to the new 
animal drug application review process by 30 percent in ADUFA I.
    With the reauthorization of ADUFA for an additional 5 years under 
ADUFA II (FY 2009 to FY 2013), FDA agreed to further enhance and 
improve the review process. ADUFA II performance goals were established 
based on ADUFA I FY 2008 review timeframes. In addition, FDA provided 
program enhancements to reduce review cycles and improve communications 
during reviews. The ADUFA programs have enabled FDA to meet performance 
timeframes for application review for new animal drugs without 
compromising the quality of the Agency's review.
    The ADUFA III reauthorization (FY 2014 to FY 2018) maintained the 
FY 2013 review timeframes for key submissions in addition to 
enhancements to the program. Enhancements included: replacing the End 
Review Amendment with a short, second-round review; reducing time for 
microbial food safety hazard characterization submissions to 100 days; 
and changes to the financial structure. There were also chemistry, 
manufacturing, and controls (CMC) enhancements, including developing 
guidance for a two-phased CMC technical section submission and review 
process under the investigational new animal drug file.
    Most recently, ADUFA was reauthorized for an additional 5 years 
under ADUFA IV (FY 2019 to FY 2023). The ADUFA IV authorization 
enhancements included adding new performance goals for presubmission 
conferences and tissue residue method trial demonstrations, requiring 
100 percent electronic submissions, and requiring an ``approved by 
FDA'' statement along with a NADA number on approved animal drugs by 
September 30, 2023. Additionally, a new provision was added that any 
excess collections would be used to offset workload adjuster or 
shortfall fee increases, if invoked.
    FDA has published a number of reports that provide useful 
background on ADUFA I, II, III, and IV. ADUFA-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-drug-user-fee-act-adufa.

II. Topics for Discussion at the Public Meeting

    In preparing the proposed recommendation to Congress for ADUFA 
reauthorization, we conducted discussions with the regulated industry, 
and consulted with stakeholders as required by the law. We began the 
ADUFA reauthorization process with a public meeting held on May 20, 
2021 (86 FR 18989, April 12, 2021). Following the May 2021 public 
meeting, FDA conducted negotiations with regulated industry and 
continued regular consultations with public stakeholders from October 
2021 through August 2022. As directed by Congress, FDA posted minutes 
of these discussions on its website at https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings.
    The proposed enhancements in ADUFA V will address priorities 
identified by stakeholders, regulated industry, and FDA. The full 
description of these proposed recommendations can be found in the 
proposed ADUFA V Performance Goals and Procedures Letter. FDA intends 
to post the full text of the proposed ADUFA V Performance Goals and 
Procedures Letter at https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings, no later than 1 week prior to the public 
meeting. FDA will post the agenda approximately 5 days before the 
meeting at https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings.

[[Page 70835]]

III. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting 
must register online at https://fda.zoomgov.com/webinar/register/WN_DBPaDGi5QXaaCoxkJkx7g no later than December 5, 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 
December 1, 2022.
    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 December 5, 2022. All requests to make oral 
presentations must be received by December 1, 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 December 5, 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-drug-user-fee-act-adufa/adufa-meetings.

    Dated: November 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-25274 Filed 11-18-22; 8:45 am]
BILLING CODE 4164-01-P