[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]
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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.
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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.
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\1\ See https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/fda-crowdsourcing.
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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.
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\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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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.
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\3\ See https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/fda-crowdsourcing.
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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]
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