Notice2022-25274
Animal Drug User Fee Act; Public Meeting; Request for Comments
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
November 21, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 223 (Monday, November 21, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Notices]
[Pages 70833-70835]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-25274]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <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 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:
<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-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 <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
[[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: <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.
Transcripts of the meeting will be available on FDA's website at
<a href="https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings">https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings</a> 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, <a href="/cdn-cgi/l/email-protection#c9a5a0baa8e7a2a8aba5ac89afada8e7a1a1bae7aea6bf"><span class="__cf_email__" data-cfemail="24484d57450a4f45464841644240450a4c4c570a434b52">[email protected]</span></a>.
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: <a href="https://www.fda.gov/industry/fda-user-fee-programs/animal-drug-user-fee-act-adufa">https://www.fda.gov/industry/fda-user-fee-programs/animal-drug-user-fee-act-adufa</a>.
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 <a href="https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings">https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings</a>.
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 <a href="https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings">https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings</a>, no later than 1 week prior to the public
meeting. FDA will post the agenda approximately 5 days before the
meeting at <a href="https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings">https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings</a>.
[[Page 70835]]
III. Participating in the Public Meeting
Registration: Persons interested in attending this public meeting
must register online at <a href="https://fda.zoomgov.com/webinar/register/WN_DBPaDGi5QXaaCoxkJkx7g">https://fda.zoomgov.com/webinar/register/WN_DBPaDGi5QXaaCoxkJkx7g</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at <a href="https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings">https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings</a>.
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on November 21, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.