Document ID: FDA-2016-N-1092-0014
Agency: fda
Document Type: Notice
Title: Over-the-Counter Monograph User Fees: Reopening of Comment Period; Stakeholder Meeting
Posted Date: 2016-08-08T04:00Z

[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52444-52445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18717]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1092]

Over-the-Counter Monograph User Fees: Reopening of Comment 
Period; Stakeholder Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; reopening of comment period; 
stakeholder meeting.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the document that announced a public meeting in the 
Federal Register of May 11, 2016. In the document, FDA invited public 
comment as the Agency considers a user-fee program for nonprescription 
(over-the-counter or OTC) monograph drugs. FDA will hold a Webinar for 
stakeholders on September 6, 2016. This Webinar is intended to be a 
followup to the June 10, 2016, public meeting on this topic and to 
provide stakeholders with a status update on the process of FDA and 
industry discussions that began in July 2016.

DATES: Submit either electronic or written comments by October 6, 2016. 
FDA will hold a Webinar for stakeholders on Tuesday, September 6, 2016, 
from 10:30 a.m. to 12 p.m. EDT.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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

[[Page 52445]]

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2016-N-1092 for ``Over-the-Counter Monograph User Fees: Reopening 
of Comment Period; Stakeholder Meeting.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amy Bertha, Office of Executive 
Programs, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
301-796-1647, email: OTCMonographUserFeeProgram@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is reopening until October 6, 2016, the comment period for the 
document that announced a public meeting in the Federal Register of May 
11, 2016 (81 FR 29275). In the document, FDA invited public comment as 
the Agency considers a user-fee program for nonprescription (over-the-
counter or 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. A public meeting on this topic was held on June 10, 2016, 
and interested persons were given until July 11, 2016, to submit 
comments. To ensure that all interested persons have sufficient 
opportunity to share their views on a potential OTC monograph user-fee 
program, FDA is reopening the comment period until October 6, 2016.
    FDA will hold a Webinar for stakeholders on September 6, 2016. This 
Webinar is intended to be a followup to the June 10, 2016, public 
meeting and provide stakeholders with a status update on the process of 
FDA and industry discussions that began in July 2016. Meeting minutes 
from these discussions can be found at: http://www.fda.gov/omuf. 
Additional background information on OTC monograph drugs (such as how 
OTC drugs can be marketed, 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 
FDA asked the public to consider and provide input, can be found in the 
Federal Register document from the June 10, 2106, 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: http://www.fda.gov/Drugs/NewsEvents/ucm499390.htm.

II. 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 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 Tuesday, August 30, 2016 (https://www.eventbrite.com/e/over-the-counter-monograph-user-fees-stakeholder-meeting-tickets-26751882601). FDA will email the registered attendees a URL to join the 
Webinar at least 1 day before the meeting.

    Dated August 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18717 Filed 8-5-16; 8:45 am]
BILLING CODE 4164-01-P