[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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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, <a href="/cdn-cgi/l/email-protection#c48fada9a6a1b6a8bdea90a5bda8abb684a2a0a5eaacacb7eaa3abb2"><span class="__cf_email__" data-cfemail="e0ab898d8285928c99ceb481998c8f92a0868481ce888893ce878f96">[email protected]</span></a>.

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:
    <bullet> $2,373,000 for FY 2026.
    <bullet> $1,233,000 for FY 2027.
    <bullet> $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:
    <bullet> $135,000 for FY 2026.
    <bullet> $300,000 for FY 2027.
    <bullet> $55,000 for FY 2028.
    <bullet> $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


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