Reauthorization of the Over-the-Counter Monograph Drug User Fee Program; Public Meeting; Request for Comments, 60688-60690 [2023-19059]
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Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices
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3521). The collections of information in
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III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: August 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–19081 Filed 9–1–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–3575]
Reauthorization of the Over-theCounter Monograph Drug User Fee
Program; 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, Agency, or we) is
announcing a public meeting to discuss
proposed recommendations for the
reauthorization of the Over-the-Counter
(OTC) Monograph Drug User Fee
Program (OMUFA) for fiscal years (FYs)
2026 through 2030. OMUFA authorizes
FDA to assess and collect user fees to
support OTC monograph drug activities.
The current legislative authority for
OMUFA expires September 30, 2025. At
that time, new legislation will be
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:02 Sep 01, 2023
Jkt 259001
required to reauthorize the OMUFA
program for future fiscal years. The
Federal Food, Drug, and Cosmetic Act
(FD&C Act) directs that FDA consult
with the public as part of the OMUFA
reauthorization process. FDA invites
public comment as the Agency begins
the process to reauthorize the program
for FYs 2026 through 2030.
DATES: The public meeting will be held
on September 28, 2023, from 9 a.m. to
5 p.m. Registration to attend the meeting
should be received by September 27,
2023. Either electronic or written
comments on this public meeting must
be submitted by October 27, 2023. See
the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: The public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, Rm. 1503, Silver
Spring, MD 20993. Entrance for the
public meeting participants (non-FDA
employees) is through Building 1 where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/about-fda/visitorinformation. Any changes to the public
meeting location and remote
information, as appropriate, will be
posted to https://www.fda.gov/industry/
fda-user-fee-programs/over-countermonograph-drug-user-fee-programomufa in advance of the meeting.
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 October 27, 2023.
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.
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
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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–
2023–N–3575 for ‘‘Reauthorization of
the Over-the-Counter Monograph Drug
User Fee Program; 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
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Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices
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.
Transcripts of the meeting will be
available on the FDA website at: https://
www.fda.gov/industry/fda-user-feeprograms/over-counter-monographdrug-user-fee-program-omufa after the
meeting.
FOR FURTHER INFORMATION CONTACT:
Grace Carmouze-Cunningham, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6170,
Silver Spring, MD 20993–0002, 301–
796–4223, Grace.Carmouze@
fda.hhs.gov.
ddrumheller on DSK120RN23PROD with NOTICES1
I. Background
FDA is announcing a public meeting
to begin the process for developing
reauthorization recommendations for
the OMUFA program under section
744M of the FD&C Act (21 U.S.C. 379j–
72). This legislation authorizes FDA to
assess and collect OMUFA user fees to
support OTC monograph drug activities,
including in various components in
FDA including the Center for Drug
Evaluation and Research, the Office of
the Commissioner, and the Office of
Regulatory Affairs. The current
authorization of the program (OMUFA I)
expires in September 2025. New
legislation is required to reauthorize the
OMUFA program for future fiscal years,
to help fund OTC monograph drug
activities. Section 744N(d) of the FD&C
Act requires that FDA consult with the
public on the development of proposed
reauthorization recommendations. This
notice, the public meeting, the 30-day
comment period after the meeting, and
the posting of the comments on the FDA
website will help satisfy these
requirements. The purpose of the
meeting is to hear stakeholder views on
OMUFA as we develop
recommendations for elements to
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propose, update, or possibly
discontinue in the program. FDA is
interested in responses to the following
questions and welcomes any other
pertinent information stakeholders
would like to share:
• What current elements of OMUFA
should be modified to ensure the
continued efficiency and effectiveness
of FDA’s OTC monograph drug
activities?
• What new elements should FDA
consider recommending be added to the
program to enhance the efficiency and
effectiveness of the Agency’s OTC
monograph drug activities?
II. What is OMUFA? What does it do?
The following information is provided
to help potential meeting participants
better understand the history of OMUFA
and its status. On March 27, 2020, the
Coronavirus Aid, Relief, and Economic
Security Act (CARES Act) available at
https://www.congress.gov/116/bills/
hr748/BILLS-116hr748enr.pdf was
signed into law. Division A of the
CARES Act included an important
legislative initiative, detailed in subtitle
F of title III, that reformed and
modernized the way certain
nonprescription, OTC drugs are
regulated in the United States. These
drugs, known as OTC monograph drugs,
may be marketed without an approved
drug application under section 505 of
the FD&C Act (21 U.S.C. 355) if they
meet the requirements of section 505G
of the FD&C Act, as well as other
applicable requirements. Accompanying
this OTC monograph reform legislation
were provisions added by the CARES
Act to the FD&C Act authorizing FDA to
assess and collect user fees dedicated to
OTC monograph drug activities.
This user fee program with respect to
OTC monograph drugs, which we refer
to as OMUFA, is modeled after the
successful Prescription Drug User Fee
Act (PDUFA). For OMUFA purposes,
industry-paid fees help support FDA’s
OTC monograph drug activities, and in
the OMUFA I commitment letter
negotiated with industry, FDA agreed to
adhere to certain performance goals,
including to review certain submissions
within specific time frames. As with
PDUFA, FDA anticipates that
continuing this user fee program will
provide additional resources to help the
Agency conduct these important
regulatory activities in a timely manner
and ultimately help provide the public
with access to innovative OTC
monograph drugs.
OMUFA is authorized under sections
744L and 744M of the FD&C Act, as
added by the CARES Act, under which
FDA will assess and collect fees from
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60689
submitters of OTC Monograph Order
Requests (OMORs), other than OMORs
for certain safety changes, as well as
from qualifying manufacturers of OTC
monograph drugs, to help fund the
Agency’s OTC monograph drug
activities.
OMUFA is intended to provide for
additional funding so that FDA can hire
staff, improve systems, and establish
and better manage the Agency’s OTC
monograph drug activities, including to
make important safety-related
monograph changes and to facilitate
timely availability of safe, effective,
high-quality, and innovative OTC
monograph drugs to the public. As part
of FDA’s negotiated agreement with
industry during each reauthorization, as
reflected in the accompanying OMUFA
commitment letter, the Agency agrees to
certain performance and procedural
goals and other commitments that apply
to aspects of the Agency’s OTC
monograph drug activities. These goals
apply, for example, to the review of
OMORs, including safety-related
OMORs.
A list of the deliverables developed to
meet OMUFA I commitments is
available on the FDA web page at:
https://www.fda.gov/media/146283/
download.
III. Public Meeting Information
A. Purpose and Scope of the Meeting
In general, the meeting format will
include presentations by FDA and a
series of panels representing different
stakeholder groups. FDA policy issues
unrelated to the OMUFA user fee
program are beyond the scope of these
reauthorization recommendation
discussions. Accordingly, the
presentations should focus on elements
of the OMUFA user fee program,
including possible process
enhancements, and not address other
FDA matters. Please consider the
following questions for this meeting:
• What new elements should FDA
consider recommending be added to the
program to enhance the efficiency and
effectiveness of the Agency’s OTC
monograph drug activities?
• What current elements of OMUFA
should be modified to ensure the
continued efficiency and effectiveness
of the Agency’s OTC monograph drug
activities?
B. Participating in the Public Meeting
Registration: Persons interested in
attending this public meeting should
register online by 11:59 p.m. Eastern
Time on September 27, 2023, at https://
OMUFA_
Reauthorization.eventbrite.com. Please
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Federal Register / Vol. 88, No. 170 / Tuesday, September 5, 2023 / Notices
provide complete contact information
for each attendee, including name, title,
affiliation, address, email, and
telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
accepted. If time and space permit,
onsite registration on the day of the
public meeting will be provided
beginning at 8 a.m. We will let
registrants know if registration closes
before the day of the public meeting.
If you need special accommodations
due to a disability, please contact Grace
Carmouze-Cunningham (see FOR
FURTHER INFORMATION CONTACT) at least 7
days before the meeting.
Streaming Webcast of the Public
Meeting: This public meeting will also
be webcast. You will be asked to
indicate in your registration if you plan
to attend in person or via the webcast.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
Dated: August 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–19059 Filed 9–1–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–3549]
Merck Sharp & Dohme LLC, et al.;
Withdrawal of Approval of 35 New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 35 new drug
SUMMARY:
applications (NDAs) 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.
Approval is withdrawn as of
October 5, 2023.
DATES:
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
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 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:
Application No.
Drug
Applicant
NDA 001546 ......
Guanidine (guanidine hydrochloride (HCl)) Tablets, 125 milligrams (mg).
Peganone (ethotoin) Tablets, 250 mg and 500 mg .................
Merck Sharp & Dohme LLC, 126 East Lincoln Ave., P.O. Box
2000, Rahway, NJ 07065.
Recordati Rare Diseases Inc., 100 Corporate Dr., Lebanon,
NJ 08833.
Fresenius Kabi USA, LLC, 3 Corporate Dr., Lake Zurich, IL
60047.
B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA
18109.
NDA 010841 ......
NDA 016801 ......
NDA 016822 ......
NDA 017407 ......
NDA 017425 ......
NDA 017534 ......
ddrumheller on DSK120RN23PROD with NOTICES1
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/fda-user-fee-programs/
prescription-drug-user-fee-amendments.
NDA 018582 ......
NDA 018676 ......
NDA 018878 ......
VerDate Sep<11>2014
Xylocaine Preservative Free (lidocaine HCl) Injection, 1%,
2%, 4%, 10%, and 20%.
FreAmine 8.5% (amino acids) Injection, 8.5 grams (g)/100
milliliters (mL).
FreAmine HBC 6.9% (amino acids) Injection, 6.9 g/100 mL.
FreAmine II 8.5% (amino acids) Injection, 8.5 g/100 mL.
FreAmine III 10% (amino acids) Injection, 10 g/100 mL.
FreAmine III 8.5% (amino acids) Injection, 8.5 g/100 mL.
FreAmine III 8.5% with electrolytes (amino acids, magnesium
acetate, phosphoric acid, potassium acetate, potassium
chloride, sodium acetate) Injection, 8.5%; 110mg/100mL;
230mg/100mL; 10mg/100mL; 440mg/100mL; 690mg/
100mL.
FreAmine III 3% with electrolytes (amino acids, magnesium
acetate, phosphoric acid, potassium chloride, sodium acetate, sodium chloride) Injection, 3%; 54mg/100mL; 40mg/
100mL; 150mg/100mL; 200mg/100mL; 120mg/100mL.
Catapres (clonidine HCl) Tablets, 0.1 mg, 0.2 mg, and 0.3
mg.
Proglycem (diazoxide) Capsules, 50 mg and 100 mg ............
Fiorinal (aspirin, butalbital, caffeine) Capsules, 325 mg/50
mg/40 mg.
Fiorinal (aspirin, butalbital, caffeine) Tablets, 325 mg/50 mg/
40 mg.
Procalamine (amino acids, calcium acetate, glycerin, magnesium acetate, phosphoric acid, potassium chloride, sodium
acetate, sodium chloride) Injection, 3%; 26mg/100mL; 3g/
100mL; 54mg/100mL; 41mg/100mL; 150mg/100mL;
200mg/100mL; 120mg/100mL.
HepatAmine 8% (amino acids) Injection, 8g/100mL ...............
Indocin (indomethacin sodium) Injection, equivalent to (EQ) 1
mg base/vial.
18:02 Sep 01, 2023
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Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury
Rd., P.O. Box 368, Ridgefield, CT 06877.
Teva Branded Pharmaceutical Products R&D, Inc., 145 Brandywine Pkwy., West Chester, PA 19380.
AbbVie Inc., 1 North Waukegan Rd., North Chicago, IL
60064.
B. Braun Medical Inc.
Do.
Recordati Rare Diseases Inc.
E:\FR\FM\05SEN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 170 (Tuesday, September 5, 2023)]
[Notices]
[Pages 60688-60690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19059]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3575]
Reauthorization of the Over-the-Counter Monograph Drug User Fee
Program; 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, Agency, or we) is
announcing a public meeting to discuss proposed recommendations for the
reauthorization of the Over-the-Counter (OTC) Monograph Drug User Fee
Program (OMUFA) for fiscal years (FYs) 2026 through 2030. OMUFA
authorizes FDA to assess and collect user fees to support OTC monograph
drug activities. The current legislative authority for OMUFA expires
September 30, 2025. At that time, new legislation will be required to
reauthorize the OMUFA program for future fiscal years. The Federal
Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA consult with
the public as part of the OMUFA reauthorization process. FDA invites
public comment as the Agency begins the process to reauthorize the
program for FYs 2026 through 2030.
DATES: The public meeting will be held on September 28, 2023, from 9
a.m. to 5 p.m. Registration to attend the meeting should be received by
September 27, 2023. Either electronic or written comments on this
public meeting must be submitted by October 27, 2023. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503, Silver
Spring, MD 20993. Entrance for the public meeting participants (non-FDA
employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to https://www.fda.gov/about-fda/visitor-information. Any
changes to the public meeting location and remote information, as
appropriate, will be posted to https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-drug-user-fee-program-omufa in
advance of the meeting.
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 October 27, 2023. 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.
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-2023-N-3575 for ``Reauthorization of the Over-the-Counter Monograph
Drug User Fee Program; 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
[[Page 60689]]
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-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 the FDA website at: https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-drug-user-fee-program-omufa after the meeting.
FOR FURTHER INFORMATION CONTACT: Grace Carmouze-Cunningham, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6170, Silver Spring, MD 20993-0002, 301-
796-4223, [email protected].
I. Background
FDA is announcing a public meeting to begin the process for
developing reauthorization recommendations for the OMUFA program under
section 744M of the FD&C Act (21 U.S.C. 379j-72). This legislation
authorizes FDA to assess and collect OMUFA user fees to support OTC
monograph drug activities, including in various components in FDA
including the Center for Drug Evaluation and Research, the Office of
the Commissioner, and the Office of Regulatory Affairs. The current
authorization of the program (OMUFA I) expires in September 2025. New
legislation is required to reauthorize the OMUFA program for future
fiscal years, to help fund OTC monograph drug activities. Section
744N(d) of the FD&C Act requires that FDA consult with the public on
the development of proposed reauthorization recommendations. This
notice, the public meeting, the 30-day comment period after the
meeting, and the posting of the comments on the FDA website will help
satisfy these requirements. The purpose of the meeting is to hear
stakeholder views on OMUFA as we develop recommendations for elements
to propose, update, or possibly discontinue in the program. FDA is
interested in responses to the following questions and welcomes any
other pertinent information stakeholders would like to share:
What current elements of OMUFA should be modified to
ensure the continued efficiency and effectiveness of FDA's OTC
monograph drug activities?
What new elements should FDA consider recommending be
added to the program to enhance the efficiency and effectiveness of the
Agency's OTC monograph drug activities?
II. What is OMUFA? What does it do?
The following information is provided to help potential meeting
participants better understand the history of OMUFA and its status. On
March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act
(CARES Act) available at https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf was signed into law. Division A of the CARES Act
included an important legislative initiative, detailed in subtitle F of
title III, that reformed and modernized the way certain
nonprescription, OTC drugs are regulated in the United States. These
drugs, known as OTC monograph drugs, may be marketed without an
approved drug application under section 505 of the FD&C Act (21 U.S.C.
355) if they meet the requirements of section 505G of the FD&C Act, as
well as other applicable requirements. Accompanying this OTC monograph
reform legislation were provisions added by the CARES Act to the FD&C
Act authorizing FDA to assess and collect user fees dedicated to OTC
monograph drug activities.
This user fee program with respect to OTC monograph drugs, which we
refer to as OMUFA, is modeled after the successful Prescription Drug
User Fee Act (PDUFA). For OMUFA purposes, industry-paid fees help
support FDA's OTC monograph drug activities, and in the OMUFA I
commitment letter negotiated with industry, FDA agreed to adhere to
certain performance goals, including to review certain submissions
within specific time frames. As with PDUFA, FDA anticipates that
continuing this user fee program will provide additional resources to
help the Agency conduct these important regulatory activities in a
timely manner and ultimately help provide the public with access to
innovative OTC monograph drugs.
OMUFA is authorized under sections 744L and 744M of the FD&C Act,
as added by the CARES Act, under which FDA will assess and collect fees
from submitters of OTC Monograph Order Requests (OMORs), other than
OMORs for certain safety changes, as well as from qualifying
manufacturers of OTC monograph drugs, to help fund the Agency's OTC
monograph drug activities.
OMUFA is intended to provide for additional funding so that FDA can
hire staff, improve systems, and establish and better manage the
Agency's OTC monograph drug activities, including to make important
safety-related monograph changes and to facilitate timely availability
of safe, effective, high-quality, and innovative OTC monograph drugs to
the public. As part of FDA's negotiated agreement with industry during
each reauthorization, as reflected in the accompanying OMUFA commitment
letter, the Agency agrees to certain performance and procedural goals
and other commitments that apply to aspects of the Agency's OTC
monograph drug activities. These goals apply, for example, to the
review of OMORs, including safety-related OMORs.
A list of the deliverables developed to meet OMUFA I commitments is
available on the FDA web page at: https://www.fda.gov/media/146283/download.
III. Public Meeting Information
A. Purpose and Scope of the Meeting
In general, the meeting format will include presentations by FDA
and a series of panels representing different stakeholder groups. FDA
policy issues unrelated to the OMUFA user fee program are beyond the
scope of these reauthorization recommendation discussions. Accordingly,
the presentations should focus on elements of the OMUFA user fee
program, including possible process enhancements, and not address other
FDA matters. Please consider the following questions for this meeting:
What new elements should FDA consider recommending be
added to the program to enhance the efficiency and effectiveness of the
Agency's OTC monograph drug activities?
What current elements of OMUFA should be modified to
ensure the continued efficiency and effectiveness of the Agency's OTC
monograph drug activities?
B. Participating in the Public Meeting
Registration: Persons interested in attending this public meeting
should register online by 11:59 p.m. Eastern Time on September 27,
2023, at https://OMUFA_Reauthorization.eventbrite.com. Please
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provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone.
Registration is free and based on space availability, with priority
given to early registrants. Early registration is recommended because
seating is limited; therefore, FDA may limit the number of participants
from each organization. Registrants will receive confirmation when they
have been accepted. If time and space permit, onsite registration on
the day of the public meeting will be provided beginning at 8 a.m. We
will let registrants know if registration closes before the day of the
public meeting.
If you need special accommodations due to a disability, please
contact Grace Carmouze-Cunningham (see FOR FURTHER INFORMATION CONTACT)
at least 7 days before the meeting.
Streaming Webcast of the Public Meeting: This public meeting will
also be webcast. You will be asked to indicate in your registration if
you plan to attend in person or via the webcast.
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/fda-user-fee-programs/prescription-drug-user-fee-amendments.
Dated: August 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19059 Filed 9-1-23; 8:45 am]
BILLING CODE 4164-01-P
