Notice2022-21304
Animal Generic Drug User Fee Act; Public Meeting; Request for Comments
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Published
September 30, 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 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.
Full Text
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<title>Federal Register, Volume 87 Issue 189 (Friday, September 30, 2022)</title>
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[Federal Register Volume 87, Number 189 (Friday, September 30, 2022)]
[Notices]
[Pages 59441-59443]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 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:
<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-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
<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
``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.
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#ee82879d8fc0858f8c828bae888a8fc086869dc0898198"><span class="__cf_email__" data-cfemail="1e72776d7f30757f7c727b5e787a7f3076766d30797168">[email protected]</span></a>.
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: <a href="https://www.fda.gov/industry/fda-user-fee-programs/animal-generic-drug-user-fee-act-agdufa">https://www.fda.gov/industry/fda-user-fee-programs/animal-generic-drug-user-fee-act-agdufa</a>.
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 <a href="https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings">https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings</a>.
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 <a href="https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings">https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings</a>, no later than one 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-generic-drug-user-fee-act-agdufa/agdufa-meetings">https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings</a>.
III. Participating in the Public Meeting
Registration: Persons interested in attending this public meeting
must register online at <a href="https://fda.zoomgov.com/meeting/register/vJItcuCtqD4pGPe2DNgbbQZYaRswsTm9iRM">https://fda.zoomgov.com/meeting/register/vJItcuCtqD4pGPe2DNgbbQZYaRswsTm9iRM</a> 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 <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-generic-drug-user-fee-act-agdufa/agdufa-meetings">https://www.fda.gov/industry/animal-generic-drug-user-fee-act-agdufa/agdufa-meetings</a>.
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
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