Document ID: FDA-2023-N-3575-0001
Agency: fda
Document Type: Notice
Title: Reauthorization of the Over-the-Counter Monograph Drug User Fee Program; Public Meeting; Request for Comments
Posted Date: 2023-09-05T04:00Z

[Federal Register Volume 88, Number 170 (Tuesday, September 5, 2023)]
[Notices]
[Pages 60688-60690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19059]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3575]

Reauthorization of the Over-the-Counter Monograph Drug User Fee 
Program; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing a public meeting to discuss proposed recommendations for the 
reauthorization of the Over-the-Counter (OTC) Monograph Drug User Fee 
Program (OMUFA) for fiscal years (FYs) 2026 through 2030. OMUFA 
authorizes FDA to assess and collect user fees to support OTC monograph 
drug activities. The current legislative authority for OMUFA expires 
September 30, 2025. At that time, new legislation will be required to 
reauthorize the OMUFA program for future fiscal years. The Federal 
Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA consult with 
the public as part of the OMUFA reauthorization process. FDA invites 
public comment as the Agency begins the process to reauthorize the 
program for FYs 2026 through 2030.

DATES: The public meeting will be held on September 28, 2023, from 9 
a.m. to 5 p.m. Registration to attend the meeting should be received by 
September 27, 2023. Either electronic or written comments on this 
public meeting must be submitted by October 27, 2023. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503, Silver 
Spring, MD 20993. Entrance for the public meeting participants (non-FDA 
employees) is through Building 1 where routine security check 
procedures will be performed. For parking and security information, 
please refer to https://www.fda.gov/about-fda/visitor-information. Any 
changes to the public meeting location and remote information, as 
appropriate, will be posted to https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-drug-user-fee-program-omufa in 
advance of the meeting.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of October 27, 2023. Comments received by mail/hand 
delivery/courier (for written/paper submissions) will be considered 
timely if they are postmarked or the delivery service acceptance 
receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-N-3575 for ``Reauthorization of the Over-the-Counter Monograph 
Drug User Fee Program; Public Meeting; Request for Comments.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you

[[Page 60689]]

must identify this information as ``confidential.'' Any information 
marked as ``confidential'' will not be disclosed except in accordance 
with 21 CFR 10.20 and other applicable disclosure law. For more 
information about FDA's posting of comments to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500. Transcripts of the meeting 
will be available on the FDA website at: https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-drug-user-fee-program-omufa after the meeting.

FOR FURTHER INFORMATION CONTACT: Grace Carmouze-Cunningham, Center for 
Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6170, Silver Spring, MD 20993-0002, 301-
796-4223, [email protected].

I. Background

    FDA is announcing a public meeting to begin the process for 
developing reauthorization recommendations for the OMUFA program under 
section 744M of the FD&C Act (21 U.S.C. 379j-72). This legislation 
authorizes FDA to assess and collect OMUFA user fees to support OTC 
monograph drug activities, including in various components in FDA 
including the Center for Drug Evaluation and Research, the Office of 
the Commissioner, and the Office of Regulatory Affairs. The current 
authorization of the program (OMUFA I) expires in September 2025. New 
legislation is required to reauthorize the OMUFA program for future 
fiscal years, to help fund OTC monograph drug activities. Section 
744N(d) of the FD&C Act requires that FDA consult with the public on 
the development of proposed reauthorization recommendations. This 
notice, the public meeting, the 30-day comment period after the 
meeting, and the posting of the comments on the FDA website will help 
satisfy these requirements. The purpose of the meeting is to hear 
stakeholder views on OMUFA as we develop recommendations for elements 
to propose, update, or possibly discontinue in the program. FDA is 
interested in responses to the following questions and welcomes any 
other pertinent information stakeholders would like to share:
     What current elements of OMUFA should be modified to 
ensure the continued efficiency and effectiveness of FDA's OTC 
monograph drug activities?
     What new elements should FDA consider recommending be 
added to the program to enhance the efficiency and effectiveness of the 
Agency's OTC monograph drug activities?

II. What is OMUFA? What does it do?

    The following information is provided to help potential meeting 
participants better understand the history of OMUFA and its status. On 
March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act 
(CARES Act) available at https://www.congress.gov/116/bills/hr748/BILLS-116hr748enr.pdf was signed into law. Division A of the CARES Act 
included an important legislative initiative, detailed in subtitle F of 
title III, that reformed and modernized the way certain 
nonprescription, OTC drugs are regulated in the United States. These 
drugs, known as OTC monograph drugs, may be marketed without an 
approved drug application under section 505 of the FD&C Act (21 U.S.C. 
355) if they meet the requirements of section 505G of the FD&C Act, as 
well as other applicable requirements. Accompanying this OTC monograph 
reform legislation were provisions added by the CARES Act to the FD&C 
Act authorizing FDA to assess and collect user fees dedicated to OTC 
monograph drug activities.
    This user fee program with respect to OTC monograph drugs, which we 
refer to as OMUFA, is modeled after the successful Prescription Drug 
User Fee Act (PDUFA). For OMUFA purposes, industry-paid fees help 
support FDA's OTC monograph drug activities, and in the OMUFA I 
commitment letter negotiated with industry, FDA agreed to adhere to 
certain performance goals, including to review certain submissions 
within specific time frames. As with PDUFA, FDA anticipates that 
continuing this user fee program will provide additional resources to 
help the Agency conduct these important regulatory activities in a 
timely manner and ultimately help provide the public with access to 
innovative OTC monograph drugs.
    OMUFA is authorized under sections 744L and 744M of the FD&C Act, 
as added by the CARES Act, under which FDA will assess and collect fees 
from submitters of OTC Monograph Order Requests (OMORs), other than 
OMORs for certain safety changes, as well as from qualifying 
manufacturers of OTC monograph drugs, to help fund the Agency's OTC 
monograph drug activities.
    OMUFA is intended to provide for additional funding so that FDA can 
hire staff, improve systems, and establish and better manage the 
Agency's OTC monograph drug activities, including to make important 
safety-related monograph changes and to facilitate timely availability 
of safe, effective, high-quality, and innovative OTC monograph drugs to 
the public. As part of FDA's negotiated agreement with industry during 
each reauthorization, as reflected in the accompanying OMUFA commitment 
letter, the Agency agrees to certain performance and procedural goals 
and other commitments that apply to aspects of the Agency's OTC 
monograph drug activities. These goals apply, for example, to the 
review of OMORs, including safety-related OMORs.
    A list of the deliverables developed to meet OMUFA I commitments is 
available on the FDA web page at: https://www.fda.gov/media/146283/download.

III. Public Meeting Information

A. Purpose and Scope of the Meeting

    In general, the meeting format will include presentations by FDA 
and a series of panels representing different stakeholder groups. FDA 
policy issues unrelated to the OMUFA user fee program are beyond the 
scope of these reauthorization recommendation discussions. Accordingly, 
the presentations should focus on elements of the OMUFA user fee 
program, including possible process enhancements, and not address other 
FDA matters. Please consider the following questions for this meeting:
     What new elements should FDA consider recommending be 
added to the program to enhance the efficiency and effectiveness of the 
Agency's OTC monograph drug activities?
     What current elements of OMUFA should be modified to 
ensure the continued efficiency and effectiveness of the Agency's OTC 
monograph drug activities?

B. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting 
should register online by 11:59 p.m. Eastern Time on September 27, 
2023, at https://OMUFA_Reauthorization.eventbrite.com. Please

[[Page 60690]]

provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Early registration is recommended because 
seating is limited; therefore, FDA may limit the number of participants 
from each organization. Registrants will receive confirmation when they 
have been accepted. If time and space permit, onsite registration on 
the day of the public meeting will be provided beginning at 8 a.m. We 
will let registrants know if registration closes before the day of the 
public meeting.
    If you need special accommodations due to a disability, please 
contact Grace Carmouze-Cunningham (see FOR FURTHER INFORMATION CONTACT) 
at least 7 days before the meeting.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be webcast. You will be asked to indicate in your registration if 
you plan to attend in person or via the webcast.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
internet at https://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments.

    Dated: August 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19059 Filed 9-1-23; 8:45 am]
BILLING CODE 4164-01-P