Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate, 18987-18988 [2021-07374]
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Federal Register / Vol. 86, No. 68 / Monday, April 12, 2021 / Notices
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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-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.
A transcript of the public meeting will
be made available in the docket, as well
as on the FDA website at: https://
www.fda.gov/industry/animal-genericdrug-user-fee-act-agdufa/agdufameetings.
FOR FURTHER INFORMATION CONTACT: Lisa
Kable, Center for Veterinary Medicine,
Food and Drug Administration, 240–
402–6888, lisa.kable@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
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. Prior to beginning
negotiations with the regulated industry
on AGDUFA reauthorization, section
742(d)(2) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
379j-22(d)(2)) requires FDA to: (1)
Publish a notice in the Federal Register
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21:37 Apr 09, 2021
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requesting public input on the
reauthorization; (2) hold a public
meeting at which the public may
present its views on the reauthorization
including specific suggestions for
changes to the goals referred in section
742(a) of FD&C Act; (3) provide a period
of 30 days after the public meeting to
obtain written comments from the
public suggesting changes; and (4)
publish the comments on FDA’s
website. FDA is holding a public
meeting to gather information on what
FDA should consider including in the
reauthorization of AGDUFA. FDA is
interested in responses from the public
on the following two general questions
and welcomes other pertinent
information that stakeholders would
like to share:
1. What is your assessment of the
overall performance of the AGDUFA
program thus far?
2. What aspects of AGDUFA should
be retained, changed, or discontinued to
further strengthen and improve the
program?
II. Background
FDA considers the timely review of
generic new animal drug submissions to
be central to the Agency’s mission to
protect and promote human and animal
health. The AGDUFA program began in
FY 2009 and is currently in the third
authorization (AGDUFA III). 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-feeprograms/animal-generic-drug-user-feeact-agdufa.
III. Participating in the Public Meeting
Registration: Persons interested in
attending this public meeting must
register no later than midnight Eastern
Time on May 18, 2021, by emailing
complete contact information for each
attendee, including name, title,
affiliation, address, email, telephone
number, and if you need reasonable
accommodations due to a disability
(e.g., Closed Captioning) to cvmagdufa@
fda.hhs.gov. Early registration is
recommended. Registrants will receive
confirmation when their registration has
been received and will be provided the
webcast link.
Requests for Oral Presentations:
During online registration you may
indicate if you wish to make an oral
presentation during the public meeting.
To facilitate agenda development,
registrants requesting to present will be
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18987
contacted to provide information
regarding which topics they intend to
address and the title of their
presentation. We will do our best to
accommodate requests to make an oral
presentation. 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. All requests to make oral
presentations must be received by May
7, 2021.
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 May 11, 2021. Selected
presenters planning to use an electronic
slide deck must submit an electronic
copy of their presentation to Lisa Kable
(see FOR FURTHER INFORMATION CONTACT)
with the subject line ‘‘AGDUFA Public
Meeting Presentation’’ on or before May
17, 2021. If presenters choose not to use
a slide deck, they are requested to
submit a single slide with their name,
affiliation, title of their presentation,
and contact information. No commercial
or promotional material will be
permitted to be presented at the public
meeting.
Dated: April 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–07375 Filed 4–9–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0655]
Animal Generic Drug User Fee Act;
Stakeholder Consultation Meetings on
the Animal Generic Drug User Fee Act
Reauthorization; Request for
Notification of Stakeholder Intention
To Participate
AGENCY:
Food and Drug Administration,
HHS.
Notice: Request for notification
of participation.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is issuing this notice to request that
public stakeholders notify FDA of their
intent to participate in periodic
consultation meetings on
reauthorization of the Animal Generic
Drug User Fee Act (AGDUFA). The
statutory authority for AGDUFA expires
September 30, 2023. The Federal Food,
SUMMARY:
E:\FR\FM\12APN1.SGM
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18988
Federal Register / Vol. 86, No. 68 / Monday, April 12, 2021 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
Drug, and Cosmetic Act (FD&C Act)
requires that FDA consult with a range
of stakeholders—including patient and
consumer advocacy groups, veterinary
professionals, and scientific and
academic experts—in developing
recommendations for the next AGDUFA
program and hold discussions with
these stakeholders at least once every 4
months during FDA’s negotiations with
the regulated industry. The purpose of
this request for notification is to ensure
consistent stakeholder representation at
the consultation meetings.
DATES: Submit notification of intention
to participate in continued periodic
stakeholder consultation meetings
regarding AGDUFA reauthorization by
May 20, 2021. These stakeholder
meetings are expected to commence on
July 2021 and will continue at least
once every 4 months during
reauthorization negotiations with the
regulated industry. See the
SUPPLEMENTARY INFORMATION section for
further information regarding
notification of intention to participate.
ADDRESSES: The stakeholder meetings
will be held virtually.
FOR FURTHER INFORMATION CONTACT: Lisa
Kable, Center for Veterinary Medicine,
Food and Drug Administration, 240–
402–6888, Lisa.Kable@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
In 2018 Congress passed the Animal
Generic Drug User Fee Amendments of
2018 (Pub. L. 115–234; AGDUFA III).
The authority for AGDUFA III expires
September 30, 2023. Without new
legislation to reauthorize the program,
FDA will no longer be able to collect
user fees for future fiscal years to fund
the generic new animal drug review
process. Section 742(d)(1) of the FD&C
Act (21 U.S.C. 379j–22(d)(1)) requires
that FDA consult with a range of
stakeholders in developing
recommendations for consideration for
the next AGDUFA program, including
representatives from patient and
consumer advocacy groups, veterinary
professionals, and scientific and
academic experts. To initiate this
process of consultation, elsewhere in
this issue of the Federal Register, we are
announcing a public meeting to be held
on May 20, 2021, where stakeholders
and other members of the public will be
given an opportunity to present their
views on the reauthorization. The
meeting and written comments
submitted to the docket will provide
critical input as the Agency prepares for
reauthorization discussions. Section
742(d)(3) of the FD&C Act further
requires that FDA continue meeting
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21:37 Apr 09, 2021
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with these stakeholders at least once
every 4 months during negotiations with
the regulated industry to continue
discussions of their views on the
reauthorization, including suggested
changes to the AGDUFA program.
FDA is issuing this Federal Register
notice to request that stakeholders—
including veterinary, patient and
consumer groups, as well as scientific
and academic experts—notify FDA of
their intent to participate in the periodic
consultation meetings on AGDUFA
reauthorization. FDA believes that
consistent stakeholder representation at
these meetings is essential in the
reauthorization process. If you wish to
participate in this part of the
reauthorization process, please
designate one or more representatives
from your organization who will
commit to attending these meetings and
preparing for the discussions.
Stakeholders who identify themselves
through this notice will be included in
all future stakeholder discussion while
FDA negotiates with the regulated
industry. If a stakeholder decides to
participate in these meetings at a later
time, they may still participate in
remaining meetings by notifying FDA
(see FOR FURTHER INFORMATION CONTACT).
These stakeholder discussions will
satisfy the requirement in section
742(d)(3) of the FD&C Act.
II. Notification of Intent To Participate
in Periodic Stakeholder Consultation
Meetings
If you intend to participate in
continued periodic stakeholder
consultation meetings regarding
AGDUFA reauthorization, please submit
notification by email to: cvmagdufa@
fda.hhs.gov by May 18, 2021. Your
email should contain complete contact
information for each attendee, including
name, title, affiliation, address, email
address, telephone number, and notice
of any special accommodations required
due to a disability (e.g., Closed
Captioning). Stakeholders will receive
confirmation and additional information
about the first meeting, and subsequent
meeting when scheduled, after FDA
receives this notification of intent to
participate.
Dated: April 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–07374 Filed 4–9–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1736]
Potential Approach for Ranking of
Antimicrobial Drugs According to
Their Importance in Human Medicine:
A Risk Management Tool for
Antimicrobial New Animal Drugs;
Reopening of the Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting and
request for comments; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
reopening the comment period for the
notice announcing a public meeting and
requesting comments that appeared in
the Federal Register of October 13,
2020. In that notice, FDA announced a
public meeting, which was held on
November 16, 2020, and requested
public input on a potential revised
approach for considering the human
medical importance of antimicrobial
new animal drugs when assessing and
managing the antimicrobial resistance
risks associated with the use of
antimicrobial drugs in animals.
Specifically, the Agency requested
comments on the potential revised
process for ranking antimicrobials
according to their relative importance in
human medicine, on the potential
criteria for their ranking, and on the
resulting ranked list of antimicrobial
drugs. We are taking this action in
response to technical difficulties
submitting comments to the Federal
eRulemaking portal.
DATES: Submit either electronic or
written comments by April 22, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 22,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 22, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
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]]>Agencies
[Federal Register Volume 86, Number 68 (Monday, April 12, 2021)]
[Notices]
[Pages 18987-18988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07374]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0655]
Animal Generic Drug User Fee Act; Stakeholder Consultation
Meetings on the Animal Generic Drug User Fee Act Reauthorization;
Request for Notification of Stakeholder Intention To Participate
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice: Request for notification of participation.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing this notice to request that public stakeholders notify FDA of
their intent to participate in periodic consultation meetings on
reauthorization of the Animal Generic Drug User Fee Act (AGDUFA). The
statutory authority for AGDUFA expires September 30, 2023. The Federal
Food,
[[Page 18988]]
Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a
range of stakeholders--including patient and consumer advocacy groups,
veterinary professionals, and scientific and academic experts--in
developing recommendations for the next AGDUFA program and hold
discussions with these stakeholders at least once every 4 months during
FDA's negotiations with the regulated industry. The purpose of this
request for notification is to ensure consistent stakeholder
representation at the consultation meetings.
DATES: Submit notification of intention to participate in continued
periodic stakeholder consultation meetings regarding AGDUFA
reauthorization by May 20, 2021. These stakeholder meetings are
expected to commence on July 2021 and will continue at least once every
4 months during reauthorization negotiations with the regulated
industry. See the SUPPLEMENTARY INFORMATION section for further
information regarding notification of intention to participate.
ADDRESSES: The stakeholder meetings will be held virtually.
FOR FURTHER INFORMATION CONTACT: Lisa Kable, Center for Veterinary
Medicine, Food and Drug Administration, 240-402-6888,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Introduction
In 2018 Congress passed the Animal Generic Drug User Fee Amendments
of 2018 (Pub. L. 115-234; AGDUFA III). The authority for AGDUFA III
expires September 30, 2023. Without new legislation to reauthorize the
program, FDA will no longer be able to collect user fees for future
fiscal years to fund the generic new animal drug review process.
Section 742(d)(1) of the FD&C Act (21 U.S.C. 379j-22(d)(1)) requires
that FDA consult with a range of stakeholders in developing
recommendations for consideration for the next AGDUFA program,
including representatives from patient and consumer advocacy groups,
veterinary professionals, and scientific and academic experts. To
initiate this process of consultation, elsewhere in this issue of the
Federal Register, we are announcing a public meeting to be held on May
20, 2021, where stakeholders and other members of the public will be
given an opportunity to present their views on the reauthorization. The
meeting and written comments submitted to the docket will provide
critical input as the Agency prepares for reauthorization discussions.
Section 742(d)(3) of the FD&C Act further requires that FDA continue
meeting with these stakeholders at least once every 4 months during
negotiations with the regulated industry to continue discussions of
their views on the reauthorization, including suggested changes to the
AGDUFA program.
FDA is issuing this Federal Register notice to request that
stakeholders--including veterinary, patient and consumer groups, as
well as scientific and academic experts--notify FDA of their intent to
participate in the periodic consultation meetings on AGDUFA
reauthorization. FDA believes that consistent stakeholder
representation at these meetings is essential in the reauthorization
process. If you wish to participate in this part of the reauthorization
process, please designate one or more representatives from your
organization who will commit to attending these meetings and preparing
for the discussions. Stakeholders who identify themselves through this
notice will be included in all future stakeholder discussion while FDA
negotiates with the regulated industry. If a stakeholder decides to
participate in these meetings at a later time, they may still
participate in remaining meetings by notifying FDA (see FOR FURTHER
INFORMATION CONTACT). These stakeholder discussions will satisfy the
requirement in section 742(d)(3) of the FD&C Act.
II. Notification of Intent To Participate in Periodic Stakeholder
Consultation Meetings
If you intend to participate in continued periodic stakeholder
consultation meetings regarding AGDUFA reauthorization, please submit
notification by email to: [email protected] by May 18, 2021. Your
email should contain complete contact information for each attendee,
including name, title, affiliation, address, email address, telephone
number, and notice of any special accommodations required due to a
disability (e.g., Closed Captioning). Stakeholders will receive
confirmation and additional information about the first meeting, and
subsequent meeting when scheduled, after FDA receives this notification
of intent to participate.
Dated: April 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07374 Filed 4-9-21; 8:45 am]
BILLING CODE 4164-01-P
