Document ID: FDA-2017-N-0001-0029
Agency: fda
Document Type: Notice
Title: Over-the-Counter Monograph User Fees: Stakeholder Meeting
Posted Date: 2017-08-02T04:00Z

[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)]
[Notices]
[Pages 35965-35966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16229]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Over-the-Counter Monograph User Fees: Stakeholder Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) will hold a webinar for 
stakeholders on August 23, 2017, to provide stakeholders with a status 
update on the process of FDA and industry discussions on an Over-the-
Counter (OTC) Monograph user fee program that began in July 2016. FDA 
will also provide an overview of proposed performance goals and 
procedures related to a potential new OTC monograph user fee program. 
This webinar is intended to be a followup to the June 10, 2016, public 
meeting and the September 6, 2016, stakeholder webinar on a potential 
new OTC monograph user fee program.

DATES: FDA will hold a webinar for stakeholders on Wednesday, August 
23, 2017, from 12:30 p.m. to 2 p.m. EDT.

FOR FURTHER INFORMATION CONTACT: Mary Vienna, Office of Executive 
Programs, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903-0002, 
301-796-4150, email: OTCMonographUserFeeProgram@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Introduction

    On June 10, 2016, FDA held a public meeting on a potential new user 
fee program for nonprescription (over-the-counter or OTC) monograph 
drugs. In the announcement of the public meeting in the Federal 
Register (May 11, 2016, 81 FR 29275), FDA invited public comment as the 
Agency considers a user-fee program for OTC monograph drugs. A user-fee 
program would provide funding to supplement congressional non-user-fee 
appropriations, and would support timely and efficient FDA review of 
the efficacy and safety of ingredients included in or proposed for 
inclusion in a monograph. Interested persons were given until July 11, 
2016, to submit comments. A stakeholder webinar was held on September 
6, 2016, which provided stakeholders with a status update on the 
process of FDA and industry discussions that began in July 2016. In the 
notice of public meeting (August 8, 2016, 81 FR 52444), FDA invited 
public comments and interested parties were given until October 6, 
2016, to submit comments.
    FDA will hold a webinar for stakeholders on August 23, 2017, to 
provide stakeholders with a status update on the process of FDA and 
industry discussions on an OTC Monograph user fee program that began in 
July 2016. FDA will also provide an overview of proposed performance 
goals and procedures related to a potential new OTC monograph user fee 
program. This webinar is intended to be a followup to the June 10, 
2016, public meeting and the September 6, 2016, stakeholder webinar on 
a potential new OTC monograph user fee program.

II. Background

    Meeting minutes from FDA and industry discussions on a new OTC 
monograph user fee program can be found at: https://www.fda.gov/ForIndustry/UserFees/OTCMonographUserFee/default.htm. The proposed OTC 
Monograph User Fee Program Performance Goals and Procedures--Fiscal 
Years 2018-2022 document can also be found at that same Web site.
    Additional background information on OTC monograph drugs (such as 
how OTC drugs can be marketed, and the differences between marketing 
through approved applications and marketing under the monographs), 
factors FDA considers important in developing a user-fee program, and 
the questions for which FDA asked the public to consider and provide 
input, can be found in the Federal Register notice from the June 10, 
2016, public meeting (https://www.federalregister.gov/articles/2016/05/11/2016-11098/over-the-counter-monograph-user-fees-public-meeting-request-for-comments). The meeting transcript, meeting recording, and 
presentations from the June 10, 2016, public meeting, which can serve 
as further background information, can be found at: https://www.fda.gov/ForIndustry/UserFees/OTCMonographUserFee/default.htm. A 
summary of the September 6, 2016, stakeholders' webinar, can also be 
found at: https://www.fda.gov/ForIndustry/UserFees/OTCMonographUserFee/default.htm.

III. Stakeholder Meeting Participation

    FDA is seeking participation at the webinar by stakeholders, 
including scientific and academic experts, health care professionals, 
representatives of patient and consumer advocacy groups, and 
representatives of the OTC monograph industry. Participating in the 
webinar is free. The webinar format

[[Page 35966]]

will include presentations by FDA staff and an opportunity for 
stakeholders to ask questions. If you wish to attend the webinar, FDA 
asks that you please register through Eventbrite by 12 a.m. EDT, 
Saturday, August 19, 2017: https://www.eventbrite.com/e/over-the-counter-monograph-user-fees-stakeholder-meeting-registration-33593404778. FDA will email the registered attendees a URL to join the 
webinar at least 1 day before the meeting.

    Dated July 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16229 Filed 8-1-17; 8:45 am]
 BILLING CODE 4164-01-P