Reauthorization of the Over-The-Counter Monograph Drug User Fee Program; Public Meeting; Request for Comments, 87376-87380 [2024-25458]
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collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
November 15, 2024.
ADDRESSES: When commenting, please
reference the applicable form number
(CMS–10398 #86) and the OMB control
number (0938–1148). To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address:
CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development, Attention:
CMS–10398 #86/OMB control number:
0938–1148, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
medicare/regulations-guidance/
legislation/paperwork-reduction-act1995/pra-listing.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at 410–786–4669.
SUPPLEMENTARY INFORMATION:
Following is a summary of the use
and burden associated with the subject
information collection(s). More detailed
information can be found in the
collection’s supporting statement and
associated materials (see ADDRESSES).
Generic Information Collection
1. Title of Information Collection:
Section 1115 Reentry Demonstration
Initiative; Type of Information
Collection Request: New information
collection request; Use: On April 17,
2023, CMS released a State Medicaid
Directors Letter (SMDL #23–003)
announcing a demonstration
opportunity to support community
reentry and improve care transitions for
individuals who are incarcerated and
who are otherwise eligible for Medicaid
to receive medical assistance under title
XIX. The Section 1115 Reentry
Demonstration Opportunity (hereinafter,
‘‘the Reentry Demonstration Initiative’’)
will allow states to offer coverage for
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certain pre-release services for up to 90
days prior to the individual’s expected
release date that could not otherwise be
covered by Medicaid due to the
Medicaid inmate exclusion policy. The
provision is consistent with section
5032 of the Substance Use Disorder
Prevention that Promotes Opioid
Recovery and Treatment for Patients
and Communities Act (SUPPORT Act)
(Pub. L. 115–271), ‘‘Promoting State
Innovations to Ease Transitions
Integration to the Community for
Certain Individuals.’’
States applying for the Reentry
Demonstration Initiative must provide a
minimum set of pre-release services
called the ‘‘pre-release benefit package.’’
The benefit package aims to improve
transitions for individuals being
released from jails or prisons and
returning to their communities. The
benefit package must include: (1) case
management to assess and address
physical and behavioral health needs
and health-related social needs; and (2)
medication-assisted treatment services
for all types of substance use disorders
as clinically appropriate, with
accompanying counseling. Also
required in the minimum set of services
is a 30-day supply of all prescription
medications that have been prescribed
for the beneficiary.
This collection of information request
includes three templates that are
intended to expedite CMS’s review of
reentry demonstration initiative
applications and to support state
implementation planning and related
transparency by standardizing the
presentation of key information
necessary for approvals, thereby
reducing rounds of clarifying questions
with state applicants. The three
templates include the: (1) reentry
demonstration initiative preprint, (2)
reentry implementation plan template,
and (3) reentry budget neutrality
formulation workbook. The templates
are strongly encouraged but optional
and described in the following section.
Form Number: CMS–10398 #86 (OMB
control number: 0938–1148); Frequency:
Annual and on occasion; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
10; Total Annual Responses: 30; Total
Annual Hours: 300. (For policy
questions regarding this collection
contact: Raven Smith at 410–786–3731.)
William N. Parham III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
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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, the Agency, or
we) is hosting a public meeting to
discuss proposed recommendations for
the reauthorization of the Over-TheCounter [OTC] Monograph Drug User
Fee Program (OMUFA) for fiscal years
(FYs) 2026 through 2030. Under
OMUFA, FDA collects 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 OMUFA for
future fiscal years. Following
negotiations with the regulated industry
and consultation with interested
members of the public, the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) directs FDA to publish
recommendations for the
reauthorization of the OMUFA program
in the Federal Register, provide for a
period of 30 days for the public to
provide written comments on such
recommendations, and hold a meeting
at which the public may present its
views on such recommendations. FDA
will then consider such public views
and comments and revise such
recommendations as necessary.
DATES: The public meeting will be held
on November 20, 2024, from 9 a.m. to
12:30 p.m. Submit either electronic or
written comments on this public
meeting by December 20, 2024. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting is
scheduled to 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/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
SUMMARY:
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ucm241740.htm. 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 December 20, 2024.
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’’).
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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.’’
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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.
• 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
‘‘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, 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.
FOR FURTHER INFORMATION CONTACT:
Kimberly Taylor, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 4150,
Silver Spring, MD 20993–0002, 240–
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705–2316, Kimberly.Taylor@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a public meeting
to discuss proposed recommendations
for the reauthorization of OMUFA
provisions of the FD&C Act, which
authorize FDA to collect user fees to
support OTC monograph drug activities.
The current authorization of the
program (OMUFA I) expires in
September 2025. Without new
legislation, FDA will no longer be able
to collect user fees for future fiscal years
to help fund OTC monograph drug
activities. Section 744N(d) of the FD&C
Act (21 U.S.C. 379j–73(d)) requires that
after FDA holds negotiations with
regulated industry and consults with
interested members of the public, we do
the following: (1) present the
recommendations to the House
Committee on Energy and Commerce
and the Senate Committee on Health,
Education, Labor, and Pensions, (2)
publish the recommendations in the
Federal Register, (3) provide a period of
30 days for the public to provide written
comments on the recommendations, (4)
hold a meeting at which the public may
present its views on the
recommendations, and (5) after
consideration of public views and
comments, revise the recommendations
as necessary.
This Federal Register notice, the 30day comment period, and the public
meeting will satisfy some of these
requirements. After the public meeting,
we will revise the recommendations as
necessary and present our
recommendations to the Congressional
committees.
The purpose of the public meeting
announced in this Federal Register
notice is to obtain the public’s views on
the proposed recommendations for the
reauthorization of the OMUFA program
(OMUFA II). The following information
is provided to help potential meeting
participants better understand the
history and evolution of the OMUFA
program and the current status of the
proposed OMUFA II recommendations.
II. What is OMUFA and what does it
do?
On March 27, 2020, the Coronavirus
Aid, Relief, and Economic Security Act
(or the CARES Act; available at: https://
www.congress.gov/116/bills/hr748/
BILLS-116hr748enr.pdf) was signed into
law. The CARES Act included an
important legislative initiative, detailed
in amendments to the FD&C Act, that
reformed and modernized the way
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certain nonprescription, or OTC drugs
are regulated in the United States. These
drugs, commonly 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 (21 U.S.C. 355g), 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. Similar to
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, safe, and
effective OTC monograph drugs.
OMUFA is authorized under sections
744L and 744M of the FD&C Act (21
U.S.C. 379j–71 and 379j–72, 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 support the
Agency’s OTC monograph drug
activities.
OMUFA is intended to provide for
additional funding so that FDA can hire
additional staff, improve systems, and
establish and better manage the
Agency’s OTC monograph drug
activities, including making important
safety-related changes to OTC
monographs, as needed, and facilitating
more timely availability of safe,
effective, high-quality, and innovative
OTC monograph drugs to the public. As
part of FDA’s negotiated agreement with
industry regarding 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
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OMORs, including safety-related
OMORs.
A list of the deliverables to meet
OMUFA I commitments is available on
the FDA web page at https://
www.fda.gov/media/146283/download.
III. Proposed OMUFA II
Recommendations
To prepare the proposed
recommendations to Congress for
OMUFA reauthorization, FDA
conducted discussions with the
regulated industry and consulted with
interested members of the public, as
required by the law. We began the
OMUFA reauthorization process by
publishing a notice in the Federal
Register requesting public input on
reauthorization and announcing a
public meeting that was held on
September 28, 2023. The meeting
included presentations by FDA and a
series of panels with representatives of
different interested parties. The
materials from the meeting, including a
transcript and webcast recording, can be
found at https://www.fda.gov/drugs/
news-events-human-drugs/publicmeeting-reauthorization-over-countermonograph-drug-user-fee-programomufa-09282023-09282023.
Following the September 28, 2023,
public meeting, FDA conducted
negotiations with the regulated industry
from November 2023 until June 2024.
As directed by Congress, FDA posted
minutes of these meetings on its website
at https://www.fda.gov/industry/fdauser-fee-programs/omufareauthorization-fiscal-years-2026-2030.
The proposed recommendations for
OMUFA II address many of the top
priorities identified by interested
members of the public, the regulated
industry, and FDA. While some of the
proposed recommendations are new,
many either build on or refine elements
from the existing program. Among the
recommendations are specific proposed
enhancements in the following areas: (1)
OMOR review, (2) test methods, (3)
meeting management, (4) education, (5)
information transparency, (6)
monograph product quality
enhancement, and (7) financial
transparency and management. The full
text of the proposed OMUFA II
commitment letter can be found here at
https://www.fda.gov/media/182750/
download. Each significant new or
modified enhancement is described
briefly below:
A. OMOR Review
The statute requires that the public
have the opportunity to comment on
proposed monograph orders, and thus to
align with the statute, FDA is proposing
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in the OMUFA II commitment letter that
no major amendments to an OMOR be
accepted by the Agency after the public
comment period for a proposed order
has closed. This revision helps ensure
that the public will have the
opportunity to comment on any changes
made to the proposed order as a result
of a major amendment. The statute also
gives flexibility for the public comment
period on proposed orders to be
extended. To acknowledge this
flexibility and provide greater
predictability on timing, FDA is
proposing the final order goal date be
extended by the same length of any
public comment period extension, up to
a certain amount. This is described in
section I.A.2 of the proposed OMUFA II
commitment letter.
The statute also specifies that filing
eligibility determinations required for
certain types of OMORs occur after
submission of the OMOR to the Agency.
In recognition that this activity takes
time, FDA is proposing to extend the
filing assessment period for these
OMORs. This is described in section
I.C.2 of the OMUFA II commitment
letter. Additionally, to provide more
clarity on the filing eligibility portion of
the filing assessment process, FDA is
proposing to draft guidance pertaining
to the eligibility determination
requirements and implementation. This
enhancement is described in section I.I
of the OMUFA II commitment letter.
B. Test Methods
Some of the test methods in OTC
monographs were established decades
ago and may not reflect the latest
scientific methodology. To solicit
general feedback from interested
members of the public on issues of
concern with test methods in existing
monographs (final orders), FDA is
proposing to issue a Federal Register
notice followed by a crowdsourcing on
FDA’s crowdsourcing platform 1 to
further refine the public input. This
enhancement is described in section
I.H.2 of the OMUFA II commitment
letter.
Additionally, FDA is proposing that
Congress amend the statute to add a
new type of Tier Two OMOR for
OMORs proposing the addition or
modification of certain testing methods
in OTC monographs. To qualify for this
new type of Tier Two OMOR, these
additional or modified testing methods
would need to be reflected in a
voluntary consensus standard for
pharmaceutical quality established by a
national or international standards
1 See https://www.fda.gov/about-fda/center-drugevaluation-and-research-cder/fda-crowdsourcing.
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development organization and would
also need to be recognized by FDA (via
a process described in guidance 2) prior
to submission of the OMOR, with such
recognition being made available on the
FDA website. See also section I.B.1 of
the OMUFA II commitment letter.
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C. Meeting Management
To enhance overall meeting
management, FDA is proposing a new
mechanism to allow requestors to
submit clarifying questions to the
Agency within a certain time period
following receipt of meeting minutes or
a written response, in lieu of submitting
a new meeting request. FDA is also
proposing to expand the Type Y
meeting to include requests for feedback
on a protocol synopsis and to allow
protocol synopsis feedback as a standalone topic at a Type Z meeting.
Furthermore, FDA is proposing that for
OMUFA performance goals to be
applied to a meeting request, it must be
submitted through the CDER NextGen
portal (or any successor system). These
enhancements are described in section
I.E.1 of the proposed OMUFA II
commitment letter.
Additionally, FDA recognizes that
many OTC-related Advisory Committee
(AdCom) meetings pertain to multiple
OTC drug products and classes, rather
than to products of a single requestor.
The Agency also understands that
impacted parties may need appropriate
time to coordinate and prepare for the
AdCom meeting. FDA is proposing that
for this subset of OTC monographrelated AdCom meetings (where the
existing policy on advance notice in
FDA’s 2008 Advisory Committee
Meetings Guidance does not apply) that
are not related to an emerging safety
issue, FDA intends to announce the
meeting on its website at least 100
business days in advance of the
meeting. This enhancement is described
in section I.E.10 of the OMUFA
commitment letter.
D. Education
External parties often have questions
regarding processes and procedures
related to OTC-monograph related data.
To better understand what questions
industry and other parties have about
the process FDA intends to use for
obtaining data to be used in FDAinitiated generally recognized as safe
(GRASE) finalizations and how industry
might organize and submit data for both
FDA-initiated and industry-initiated
2 See FDA’s guidance on ‘‘CDER’s Program for the
Recognition of Voluntary Consensus Standards
Related to Pharmaceutical Quality Guidance for
Industry,’’ available at https://www.fda.gov/media/
121305/download.
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(GRASE) finalizations, FDA is proposing
to run a crowdsourcing on FDA’s
crowdsourcing platform 3 to solicit
questions about the process from
interested members of the public,
followed by a webinar to answer those
questions for which established policy
exists. This enhancement is described in
section I.H.I of the proposed OMUFA II
commitment letter.
FDA is also proposing hosting a
webinar to detail steps about how to
submit an OMOR using the NextGen
Portal. This enhancement is described
in section II.D of the OMUFA II
commitment letter. Furthermore, FDA is
proposing to issue draft guidance to
provide additional information on
confidentiality of information submitted
to FDA in connection with proceedings
under section 505G of the FD&C Act,
including with respect to an OMOR.
This enhancement is described in
section I.1.2 of the OMUFA II
commitment letter.
Furthermore, FDA is proposing to
work to finalize the proposed order/
draft guidance pair relating to minor
changes in dosage form for solid oral
OTC monograph drug products, which
FDA committed to develop under the
terms of the OMUFA I commitment
letter. This enhancement is described in
section I.J of the OMUFA II commitment
letter.
E. Information Transparency
To ensure that historical information
related to OTC monograph drug
products is accessible to the public,
FDA is proposing to post to a public
docket the pre-OMUFA documents that
were catalogued as part of OMUFA I.
Additionally, FDA is proposing to
maintain the historical status of the OTC
Rulemaking website.
To help increase transparency around
marketing exclusivity in the context of
OTC monograph drugs, FDA is
proposing to publish a web page
detailing information regarding
monograph-related exclusivity afforded
by final orders. These enhancements are
described in section II of the proposed
OMUFA II commitment letter.
F. Monograph Product Quality
Enhancement
To enhance monograph product
quality surveillance, FDA is proposing
several initiatives to help focus its
efforts in this area, including vetting a
certain percentage of new OTC
monograph drug registrants within a
certain number of months of registration
to confirm whether they should be
3 See https://www.fda.gov/about-fda/center-drugevaluation-and-research-cder/fda-crowdsourcing.
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included in CDER’s catalog of OTC
monograph drugs and establishments. It
is also proposing to update the riskbased Site Selection Model it uses to
prioritize drug-related surveillance
inspections and its associated manual of
policy and procedure to include risk
factors associated with OTC monograph
drugs, as appropriate. FDA is also
proposing to hold a workshop to assist
industry in improving quality and
compliance with current good
manufacturing practice requirements.
To increase transparency around its
surveillance efforts in general, FDA is
proposing to report aggregate
information about records requests
issued to OTC monograph drug
manufacturers on its website and
enhance its warning letters web page.
These enhancements are described in
section III of the proposed OMUFA II
commitment letter.
G. Financial Transparency
To promote transparency and help
focus user fee recovery efforts, FDA is
proposing several mechanisms to
highlight and enhance information
about facilities in arrears. Proposed
mechanisms include taking steps to
increase the visibility of the arrears list,
enhancing the list to include whether a
firm is foreign or domestic and
publishing on a quarterly basis a list of
all facilities that have paid the OMUFA
facility fee for the prior fiscal year. FDA
is also proposing to publish summary
registration and arrears information in
the annual OMUFA financial reports
and to use information from records
requests issued to OTC monograph drug
manufacturers to focus outstanding user
fee recovery efforts. This enhancement
is described in section IV of the
proposed OMUFA II commitment letter.
H. Financial Management
The current overall OMUFA fee
structure and the fee setting process
were established by Congress for
OMUFA I. There are two fee types:
facility fees and OMOR fees. The
process and adjustments for establishing
annual target revenue for facility fees
are defined in statute; the OMOR fee
amounts were set in statute for the first
year of OMUFA I and are adjusted for
inflation each year thereafter. FDA is
proposing that Congress amend the
statute to make several targeted
modifications to the process to enhance
administrative efficiency and to ensure
that FDA has adequate and timely user
fee funding. Currently, the annual
OMUFA facility fee due date is in June
of the fiscal year, and thus not aligned
with the October 1 due date for annual
fees under other drug user fee programs.
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Federal Register / Vol. 89, No. 212 / Friday, November 1, 2024 / Notices
This leads to administrative burdens
and financial inefficiencies for the
Agency and can be confusing for
manufacturers that participate in other
user fee programs. To address this issue,
FDA is proposing that Congress shift the
facility fee due date to October and
change the liability period for annual
facility fees to be the 12 months
immediately preceding the start of the
fiscal year for which the fees are due.
The proposal also includes an option for
the facility to be paid in two
installments in the transition year to
ease the burden on fee-paying
companies.
To ensure that FDA is adequately
resourced with OMUFA fees, FDA is
also proposing that Congress authorize a
one-time adjustment in calculating
annual target revenue if the average
number of fee-liable facilities exceeds a
particular number in certain years of
OMUFA II. This would help
accommodate the additional work
required to oversee these facilities. If
this adjustment is made, FDA is
proposing it would be part of the base
revenue going forward. Additionally,
FDA is proposing that Congress reset the
starting base revenue for OMUFA II to
include the additional direct cost
adjustment from the final year of
OMUFA I, which reflects funding to
support information technology
operations and maintenance activities.
khammond on DSKJM1Z7X2PROD with NOTICES
H. Impact of OMUFA II Enhancements
on User Fee Revenue
To implement the proposed
enhancements for OMUFA II, user fee
funding for a cumulative total of 11 fulltime equivalent staff is proposed to be
phased in by Congress over the course
of OMUFA II. The proposed new
funding will be phased in as follows, as
an additional dollar amount in annual
fee setting:
• $2,373,000 for FY 2026.
• $1,233,000 for FY 2027.
• $854,000 for FY 2028.
In addition, to support the other
additional direct costs associated with
the OMUFA II enhancements, the
following amounts are proposed to be
added as an additional direct cost
adjustment:
• $135,000 for FY 2026.
• $300,000 for FY 2027.
• $55,000 for FY 2028.
• $30,000 for FY 2030.
IV. Public Meeting Information
A. Purpose and Scope of the Meeting
The public meeting will include a
presentation by FDA and a series of
invited panels representing different
interested parties. For members of the
VerDate Sep<11>2014
16:47 Oct 31, 2024
Jkt 265001
public who would like to make verbal
comments on the proposed
enhancements and other
recommendations (see instructions
below), there will be a public comment
period at the end of the meeting.
Individuals can also submit written
comments to the docket [LINK] before
and after the meeting until December
20, 2024.
Dated: October 28, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
B. Participating in the Public Meeting
Health Resources and Services
Administration
Registration: Persons interested in
attending this public meeting must
register online by 11:59 p.m. Eastern
Time on November 19, 2024, at https://
fda.zoomgov.com/webinar/register/WN_
aW5YWtFfQiyOSzkABY3G4A#/
registration. Provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone.
Opportunity for Public Comment:
Those who register online by November
13, 2024, will have the opportunity to
participate in the public comment
session of the meeting. If you wish to
speak during the public comment
session, respond ‘‘yes’’ to that question
in the registration form. 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
comments and request time jointly. All
those who wish to make a public
comment during the meeting must be
registered by November 13, 2024, at
11:59 p.m. Eastern Time. We will
determine the amount of time allotted to
each commenter, the approximate time
each comment is to begin, and will
select and notify participants by
November 18, 2024. No commercial or
promotional material will be permitted
to be presented at the public 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.
The webcast for this public meeting is
available at https://fda.zoomgov.com/
webinar/register/WN_
aW5YWtFfQiyOSzkABY3G4A#/
registration.
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/drugs/
news-events-human-drugs/publicmeeting-recommendations-overcounter-monograph-drug-user-feeprogram-omufa-reauthorization.
PO 00000
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[FR Doc. 2024–25458 Filed 10–31–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Data System
for Organ Procurement and
Transplantation Network
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than December 31,
2024.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14NWH04, 5600 Fishers
Lane, Rockville, Maryland, 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Joella Roland, the HRSA
Information Collection Clearance
Officer, at (301) 443–3983.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Data System for Organ Procurement and
Transplantation Network, OMB No.
0915–0157—Revision.
Abstract: Section 372 of the Public
Health Service Act requires that the
Secretary of Health and Human
Services, by awards, provide for the
establishment and operation of the
Organ Procurement and Transplantation
Network (OPTN), which, under HRSA’s
SUMMARY:
E:\FR\FM\01NON1.SGM
01NON1
]]>Agencies
[Federal Register Volume 89, Number 212 (Friday, November 1, 2024)]
[Notices]
[Pages 87376-87380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25458]
-----------------------------------------------------------------------
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, the Agency, or we) is
hosting 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. Under OMUFA,
FDA collects 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 OMUFA for
future fiscal years. Following negotiations with the regulated industry
and consultation with interested members of the public, the Federal
Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish
recommendations for the reauthorization of the OMUFA program in the
Federal Register, provide for a period of 30 days for the public to
provide written comments on such recommendations, and hold a meeting at
which the public may present its views on such recommendations. FDA
will then consider such public views and comments and revise such
recommendations as necessary.
DATES: The public meeting will be held on November 20, 2024, from 9
a.m. to 12:30 p.m. Submit either electronic or written comments on this
public meeting by December 20, 2024. See the SUPPLEMENTARY INFORMATION
section for registration date and information.
ADDRESSES: The public meeting is scheduled to 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/AboutFDA/WorkingatFDA/
BuildingsandFacilities/WhiteOakCampusInformation/
[[Page 87377]]
ucm241740.htm. 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 December 20, 2024. 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.
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
``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, 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.
FOR FURTHER INFORMATION CONTACT: Kimberly Taylor, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 4150, Silver Spring, MD 20993-0002, 240-
705-2316, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a public meeting to discuss proposed
recommendations for the reauthorization of OMUFA provisions of the FD&C
Act, which authorize FDA to collect user fees to support OTC monograph
drug activities. The current authorization of the program (OMUFA I)
expires in September 2025. Without new legislation, FDA will no longer
be able to collect user fees for future fiscal years to help fund OTC
monograph drug activities. Section 744N(d) of the FD&C Act (21 U.S.C.
379j-73(d)) requires that after FDA holds negotiations with regulated
industry and consults with interested members of the public, we do the
following: (1) present the recommendations to the House Committee on
Energy and Commerce and the Senate Committee on Health, Education,
Labor, and Pensions, (2) publish the recommendations in the Federal
Register, (3) provide a period of 30 days for the public to provide
written comments on the recommendations, (4) hold a meeting at which
the public may present its views on the recommendations, and (5) after
consideration of public views and comments, revise the recommendations
as necessary.
This Federal Register notice, the 30-day comment period, and the
public meeting will satisfy some of these requirements. After the
public meeting, we will revise the recommendations as necessary and
present our recommendations to the Congressional committees.
The purpose of the public meeting announced in this Federal
Register notice is to obtain the public's views on the proposed
recommendations for the reauthorization of the OMUFA program (OMUFA
II). The following information is provided to help potential meeting
participants better understand the history and evolution of the OMUFA
program and the current status of the proposed OMUFA II
recommendations.
II. What is OMUFA and what does it do?
On March 27, 2020, the Coronavirus Aid, Relief, and Economic
Security Act (or the CARES Act; available at: https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf) was signed into law. The CARES
Act included an important legislative initiative, detailed in
amendments to the FD&C Act, that reformed and modernized the way
[[Page 87378]]
certain nonprescription, or OTC drugs are regulated in the United
States. These drugs, commonly 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 (21 U.S.C. 355g), 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. Similar to 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, safe, and effective OTC monograph drugs.
OMUFA is authorized under sections 744L and 744M of the FD&C Act
(21 U.S.C. 379j-71 and 379j-72, 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
support the Agency's OTC monograph drug activities.
OMUFA is intended to provide for additional funding so that FDA can
hire additional staff, improve systems, and establish and better manage
the Agency's OTC monograph drug activities, including making important
safety-related changes to OTC monographs, as needed, and facilitating
more timely availability of safe, effective, high-quality, and
innovative OTC monograph drugs to the public. As part of FDA's
negotiated agreement with industry regarding 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 to meet OMUFA I commitments is available
on the FDA web page at https://www.fda.gov/media/146283/download.
III. Proposed OMUFA II Recommendations
To prepare the proposed recommendations to Congress for OMUFA
reauthorization, FDA conducted discussions with the regulated industry
and consulted with interested members of the public, as required by the
law. We began the OMUFA reauthorization process by publishing a notice
in the Federal Register requesting public input on reauthorization and
announcing a public meeting that was held on September 28, 2023. The
meeting included presentations by FDA and a series of panels with
representatives of different interested parties. The materials from the
meeting, including a transcript and webcast recording, can be found at
https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-reauthorization-over-counter-monograph-drug-user-fee-program-omufa-09282023-09282023.
Following the September 28, 2023, public meeting, FDA conducted
negotiations with the regulated industry from November 2023 until June
2024. As directed by Congress, FDA posted minutes of these meetings on
its website at https://www.fda.gov/industry/fda-user-fee-programs/omufa-reauthorization-fiscal-years-2026-2030.
The proposed recommendations for OMUFA II address many of the top
priorities identified by interested members of the public, the
regulated industry, and FDA. While some of the proposed recommendations
are new, many either build on or refine elements from the existing
program. Among the recommendations are specific proposed enhancements
in the following areas: (1) OMOR review, (2) test methods, (3) meeting
management, (4) education, (5) information transparency, (6) monograph
product quality enhancement, and (7) financial transparency and
management. The full text of the proposed OMUFA II commitment letter
can be found here at https://www.fda.gov/media/182750/download. Each
significant new or modified enhancement is described briefly below:
A. OMOR Review
The statute requires that the public have the opportunity to
comment on proposed monograph orders, and thus to align with the
statute, FDA is proposing in the OMUFA II commitment letter that no
major amendments to an OMOR be accepted by the Agency after the public
comment period for a proposed order has closed. This revision helps
ensure that the public will have the opportunity to comment on any
changes made to the proposed order as a result of a major amendment.
The statute also gives flexibility for the public comment period on
proposed orders to be extended. To acknowledge this flexibility and
provide greater predictability on timing, FDA is proposing the final
order goal date be extended by the same length of any public comment
period extension, up to a certain amount. This is described in section
I.A.2 of the proposed OMUFA II commitment letter.
The statute also specifies that filing eligibility determinations
required for certain types of OMORs occur after submission of the OMOR
to the Agency. In recognition that this activity takes time, FDA is
proposing to extend the filing assessment period for these OMORs. This
is described in section I.C.2 of the OMUFA II commitment letter.
Additionally, to provide more clarity on the filing eligibility portion
of the filing assessment process, FDA is proposing to draft guidance
pertaining to the eligibility determination requirements and
implementation. This enhancement is described in section I.I of the
OMUFA II commitment letter.
B. Test Methods
Some of the test methods in OTC monographs were established decades
ago and may not reflect the latest scientific methodology. To solicit
general feedback from interested members of the public on issues of
concern with test methods in existing monographs (final orders), FDA is
proposing to issue a Federal Register notice followed by a
crowdsourcing on FDA's crowdsourcing platform \1\ to further refine the
public input. This enhancement is described in section I.H.2 of the
OMUFA II commitment letter.
---------------------------------------------------------------------------
\1\ See https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/fda-crowdsourcing.
---------------------------------------------------------------------------
Additionally, FDA is proposing that Congress amend the statute to
add a new type of Tier Two OMOR for OMORs proposing the addition or
modification of certain testing methods in OTC monographs. To qualify
for this new type of Tier Two OMOR, these additional or modified
testing methods would need to be reflected in a voluntary consensus
standard for pharmaceutical quality established by a national or
international standards
[[Page 87379]]
development organization and would also need to be recognized by FDA
(via a process described in guidance \2\) prior to submission of the
OMOR, with such recognition being made available on the FDA website.
See also section I.B.1 of the OMUFA II commitment letter.
---------------------------------------------------------------------------
\2\ See FDA's guidance on ``CDER's Program for the Recognition
of Voluntary Consensus Standards Related to Pharmaceutical Quality
Guidance for Industry,'' available at https://www.fda.gov/media/121305/download.
---------------------------------------------------------------------------
C. Meeting Management
To enhance overall meeting management, FDA is proposing a new
mechanism to allow requestors to submit clarifying questions to the
Agency within a certain time period following receipt of meeting
minutes or a written response, in lieu of submitting a new meeting
request. FDA is also proposing to expand the Type Y meeting to include
requests for feedback on a protocol synopsis and to allow protocol
synopsis feedback as a stand-alone topic at a Type Z meeting.
Furthermore, FDA is proposing that for OMUFA performance goals to be
applied to a meeting request, it must be submitted through the CDER
NextGen portal (or any successor system). These enhancements are
described in section I.E.1 of the proposed OMUFA II commitment letter.
Additionally, FDA recognizes that many OTC-related Advisory
Committee (AdCom) meetings pertain to multiple OTC drug products and
classes, rather than to products of a single requestor. The Agency also
understands that impacted parties may need appropriate time to
coordinate and prepare for the AdCom meeting. FDA is proposing that for
this subset of OTC monograph-related AdCom meetings (where the existing
policy on advance notice in FDA's 2008 Advisory Committee Meetings
Guidance does not apply) that are not related to an emerging safety
issue, FDA intends to announce the meeting on its website at least 100
business days in advance of the meeting. This enhancement is described
in section I.E.10 of the OMUFA commitment letter.
D. Education
External parties often have questions regarding processes and
procedures related to OTC-monograph related data. To better understand
what questions industry and other parties have about the process FDA
intends to use for obtaining data to be used in FDA-initiated generally
recognized as safe (GRASE) finalizations and how industry might
organize and submit data for both FDA-initiated and industry-initiated
(GRASE) finalizations, FDA is proposing to run a crowdsourcing on FDA's
crowdsourcing platform \3\ to solicit questions about the process from
interested members of the public, followed by a webinar to answer those
questions for which established policy exists. This enhancement is
described in section I.H.I of the proposed OMUFA II commitment letter.
---------------------------------------------------------------------------
\3\ See https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/fda-crowdsourcing.
---------------------------------------------------------------------------
FDA is also proposing hosting a webinar to detail steps about how
to submit an OMOR using the NextGen Portal. This enhancement is
described in section II.D of the OMUFA II commitment letter.
Furthermore, FDA is proposing to issue draft guidance to provide
additional information on confidentiality of information submitted to
FDA in connection with proceedings under section 505G of the FD&C Act,
including with respect to an OMOR. This enhancement is described in
section I.1.2 of the OMUFA II commitment letter.
Furthermore, FDA is proposing to work to finalize the proposed
order/draft guidance pair relating to minor changes in dosage form for
solid oral OTC monograph drug products, which FDA committed to develop
under the terms of the OMUFA I commitment letter. This enhancement is
described in section I.J of the OMUFA II commitment letter.
E. Information Transparency
To ensure that historical information related to OTC monograph drug
products is accessible to the public, FDA is proposing to post to a
public docket the pre-OMUFA documents that were catalogued as part of
OMUFA I. Additionally, FDA is proposing to maintain the historical
status of the OTC Rulemaking website.
To help increase transparency around marketing exclusivity in the
context of OTC monograph drugs, FDA is proposing to publish a web page
detailing information regarding monograph-related exclusivity afforded
by final orders. These enhancements are described in section II of the
proposed OMUFA II commitment letter.
F. Monograph Product Quality Enhancement
To enhance monograph product quality surveillance, FDA is proposing
several initiatives to help focus its efforts in this area, including
vetting a certain percentage of new OTC monograph drug registrants
within a certain number of months of registration to confirm whether
they should be included in CDER's catalog of OTC monograph drugs and
establishments. It is also proposing to update the risk-based Site
Selection Model it uses to prioritize drug-related surveillance
inspections and its associated manual of policy and procedure to
include risk factors associated with OTC monograph drugs, as
appropriate. FDA is also proposing to hold a workshop to assist
industry in improving quality and compliance with current good
manufacturing practice requirements.
To increase transparency around its surveillance efforts in
general, FDA is proposing to report aggregate information about records
requests issued to OTC monograph drug manufacturers on its website and
enhance its warning letters web page.
These enhancements are described in section III of the proposed
OMUFA II commitment letter.
G. Financial Transparency
To promote transparency and help focus user fee recovery efforts,
FDA is proposing several mechanisms to highlight and enhance
information about facilities in arrears. Proposed mechanisms include
taking steps to increase the visibility of the arrears list, enhancing
the list to include whether a firm is foreign or domestic and
publishing on a quarterly basis a list of all facilities that have paid
the OMUFA facility fee for the prior fiscal year. FDA is also proposing
to publish summary registration and arrears information in the annual
OMUFA financial reports and to use information from records requests
issued to OTC monograph drug manufacturers to focus outstanding user
fee recovery efforts. This enhancement is described in section IV of
the proposed OMUFA II commitment letter.
H. Financial Management
The current overall OMUFA fee structure and the fee setting process
were established by Congress for OMUFA I. There are two fee types:
facility fees and OMOR fees. The process and adjustments for
establishing annual target revenue for facility fees are defined in
statute; the OMOR fee amounts were set in statute for the first year of
OMUFA I and are adjusted for inflation each year thereafter. FDA is
proposing that Congress amend the statute to make several targeted
modifications to the process to enhance administrative efficiency and
to ensure that FDA has adequate and timely user fee funding. Currently,
the annual OMUFA facility fee due date is in June of the fiscal year,
and thus not aligned with the October 1 due date for annual fees under
other drug user fee programs.
[[Page 87380]]
This leads to administrative burdens and financial inefficiencies for
the Agency and can be confusing for manufacturers that participate in
other user fee programs. To address this issue, FDA is proposing that
Congress shift the facility fee due date to October and change the
liability period for annual facility fees to be the 12 months
immediately preceding the start of the fiscal year for which the fees
are due. The proposal also includes an option for the facility to be
paid in two installments in the transition year to ease the burden on
fee-paying companies.
To ensure that FDA is adequately resourced with OMUFA fees, FDA is
also proposing that Congress authorize a one-time adjustment in
calculating annual target revenue if the average number of fee-liable
facilities exceeds a particular number in certain years of OMUFA II.
This would help accommodate the additional work required to oversee
these facilities. If this adjustment is made, FDA is proposing it would
be part of the base revenue going forward. Additionally, FDA is
proposing that Congress reset the starting base revenue for OMUFA II to
include the additional direct cost adjustment from the final year of
OMUFA I, which reflects funding to support information technology
operations and maintenance activities.
H. Impact of OMUFA II Enhancements on User Fee Revenue
To implement the proposed enhancements for OMUFA II, user fee
funding for a cumulative total of 11 full-time equivalent staff is
proposed to be phased in by Congress over the course of OMUFA II. The
proposed new funding will be phased in as follows, as an additional
dollar amount in annual fee setting:
$2,373,000 for FY 2026.
$1,233,000 for FY 2027.
$854,000 for FY 2028.
In addition, to support the other additional direct costs
associated with the OMUFA II enhancements, the following amounts are
proposed to be added as an additional direct cost adjustment:
$135,000 for FY 2026.
$300,000 for FY 2027.
$55,000 for FY 2028.
$30,000 for FY 2030.
IV. Public Meeting Information
A. Purpose and Scope of the Meeting
The public meeting will include a presentation by FDA and a series
of invited panels representing different interested parties. For
members of the public who would like to make verbal comments on the
proposed enhancements and other recommendations (see instructions
below), there will be a public comment period at the end of the
meeting. Individuals can also submit written comments to the docket
[LINK] before and after the meeting until December 20, 2024.
B. Participating in the Public Meeting
Registration: Persons interested in attending this public meeting
must register online by 11:59 p.m. Eastern Time on November 19, 2024,
at https://fda.zoomgov.com/webinar/register/WN_aW5YWtFfQiyOSzkABY3G4A#/registration. Provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone.
Opportunity for Public Comment: Those who register online by
November 13, 2024, will have the opportunity to participate in the
public comment session of the meeting. If you wish to speak during the
public comment session, respond ``yes'' to that question in the
registration form. 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 comments and request time
jointly. All those who wish to make a public comment during the meeting
must be registered by November 13, 2024, at 11:59 p.m. Eastern Time. We
will determine the amount of time allotted to each commenter, the
approximate time each comment is to begin, and will select and notify
participants by November 18, 2024. No commercial or promotional
material will be permitted to be presented at the public 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. The webcast for this
public meeting is available at https://fda.zoomgov.com/webinar/register/WN_aW5YWtFfQiyOSzkABY3G4A#/registration.
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/drugs/news-events-human-drugs/public-meeting-recommendations-over-counter-monograph-drug-user-fee-program-omufa-reauthorization.
Dated: October 28, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-25458 Filed 10-31-24; 8:45 am]
BILLING CODE 4164-01-P
