Animal Drug User Fee Act; Public Meeting; Request for Comments, 70833-70835 [2022-25274]
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Federal Register / Vol. 87, No. 223 / Monday, November 21, 2022 / Notices
information submitted will be used by
the agency to ensure compliance with
the statute; to monitor, evaluate, and
measure grantee achievements in
addressing the investigation and
70833
prosecution of child abuse and neglect;
and to report to Congress.
Respondents: State governments.
ANNUAL BURDEN ESTIMATES
Instrument
Total number
of respondents
Annual
number of
responses per
respondent
Average burden hours per
response
Annual burden
hours
Application and Annual Report ........................................................................
52
1
60
3,120
Estimated Total Annual Burden Hours: 3,120.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 42 U.S.C. 5106c Sec. 107
(b)4; and 42 U.S.C. 5106 Sec. 107 (B)5.
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.
Mary B. Jones,
ACF/OPRE Certifying Officer.
Electronic Submissions
[FR Doc. 2022–25223 Filed 11–18–22; 8:45 am]
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’’).
BILLING CODE 4184–25–P
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.
Notice of public meeting;
request for comments.
ACTION:
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
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SUMMARY:
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21:25 Nov 18, 2022
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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.
ADDRESSES:
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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
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70834
Federal Register / Vol. 87, No. 223 / Monday, November 21, 2022 / Notices
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‘‘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-201509-18/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-druguser-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, lisa.kable@fda.hhs.gov.
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
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21:25 Nov 18, 2022
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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
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Sfmt 4703
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. ADUFArelated Federal Register notices,
guidances, legislation, performance
reports, and financial reports can be
found at: https://www.fda.gov/industry/
fda-user-fee-programs/animal-druguser-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-druguser-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-druguser-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/animaldrug-user-fee-act-adufa/adufa-meetings.
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Federal Register / Vol. 87, No. 223 / Monday, November 21, 2022 / Notices
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
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2826]
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 10 abbreviated
new drug applications (ANDAs) from
multiple applicants. The applicants
notified the Agency in writing that the
drug products were no longer marketed
and requested that the approval of the
applications be withdrawn.
SUMMARY:
Approval is withdrawn as of
December 21, 2022.
DATES:
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
Allergan Sales, LLC, et al.; Withdrawal
of Approval of 10 Abbreviated New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
Application No.
Drug
Applicant
ANDA 040099 ....
Norco (hydrocodone bitartrate and acetaminophen) Tablets,
5 milligrams (mg)/325 mg.
ANDA 040148 ....
Norco (hydrocodone bitartrate and acetaminophen) Tablets,
2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg, 10 mg/325
mg, and 10 mg/500 mg.
Chlorhexidine Gluconate Solution, 0.12% ...............................
Allergan Sales, LLC, U.S. Agent for Allergan Pharmaceuticals International Limited, 5 Giralda Farms, Madison,
NJ 07940.
Do.
ANDA 076434 ....
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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-actadufa/adufa-meetings.
70835
ANDA 079076 ....
Ranitidine Hydrochloride (HCl) Injection, Equivalent to (EQ)
25 mg base/milliliters (mL).
ANDA 090054 ....
ANDA 201804 ....
Ranitidine HCl Syrup, EQ 15 mg base/mL ..............................
Letrozole Tablets, 2.5 mg ........................................................
ANDA 201832 ....
Nimodipine Capsules, 30 mg ...................................................
ANDA 203419 ....
ANDA 203519 ....
Donepezil HCl Tablets, 23 mg .................................................
Morphine Sulfate Solution, 20 mg/5 mL ..................................
ANDA 206151 ....
Abacavir Sulfate and Lamivudine Tablets, EQ 600 mg base;
300 mg.
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21:25 Nov 18, 2022
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Sunstar Americas, Inc., 301 East Central Rd., Schaumburg,
IL 60195.
Mylan Pharmaceuticals Inc., a Viatris Company, U.S. Agent
for Mylan Laboratories Limited, 3711 Collins Ferry Rd.,
Morgantown, WV 26505.
Tolmar Inc., 701 Centre Ave., Fort Collins, CO 80526.
Indicus Pharma, LLC, 2530 Meridian Parkway, Durham, NC
27713.
Sofgen Pharmaceuticals, LLC, 21500 Biscayne Blvd., Suite
600, Aventura, FL 33180.
Indicus Pharma, LLC.
Tris Pharma, Inc., 2033 Route 130, Suite D, Monmouth
Junction, NJ 08852.
Aurobindo Pharma USA, Inc., U.S. Agent for Aurobindo
Pharma Limited, 279 Princeton-Hightstown Rd., East
Windsor, NJ 08520.
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]]>Agencies
[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]
-----------------------------------------------------------------------
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 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
