Document ID: FDA-2017-N-5437-0001
Agency: fda
Document Type: Notice
Title: Topical Dermatological Generic Drug Products: Overcoming Barriers to
Development and Improving Patient Access; Public Workshop; Request for Comments
Posted Date: 2017-10-03T04:00Z

[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46065-46066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21186]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5437]

Topical Dermatological Generic Drug Products: Overcoming Barriers 
to Development and Improving Patient Access; Public Workshop; Request 
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public workshop entitled ``Topical 
Dermatological Generic Drug Products: Overcoming Barriers to 
Development and Improving Patient Access.'' The purpose of the public 
workshop is to provide an overview of current regulatory science 
initiatives related to generic topical dermatological drug products, 
solicit public input on scientific barriers that may limit patient 
access to such drug products, and discuss approaches to overcome/
address any such barriers. FDA is seeking public input from a variety 
of stakeholders, including industry, academia, patient advocates, and 
professional associations.

DATES: The public workshop will be held on October 20, 2017, from 8:30 
a.m. to 4:30 p.m., Eastern Standard Time. Submit either electronic or 
written comments on this public workshop by November 20, 2017. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public workshop will be held at FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public 
workshop 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/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before November 20, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 20, 2017. 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-2017-N-5437 for ``Topical Dermatological Generic Drug Products: 
Overcoming Barriers to Development and Improving Patient Access.'' 
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

[[Page 46066]]

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, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/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: Sam Raney, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 75, Rm. 4706, Silver Spring, MD 20993, 240-402-7967, email: 
Sameersingh.Raney@fda.hhs.gov; or Markham Luke, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 4712, Silver Spring, MD 20993, 301-796-
5556, email: Markham.Luke@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    The conventional approach to establish bioequivalence (BE) for most 
topical dermatological generic drug products relies upon clinical 
endpoint BE studies. The risk of failing to demonstrate BE due to the 
relative insensitivity of these clinical endpoint studies, combined 
with their burden and length, may represent a barrier to generic drug 
development and may adversely impact patient access to some topical 
dermatological generic drug products. FDA is evaluating alternative BE 
approaches for topical dermatological generic drug products, using 
methods that are more efficient, and also more sensitive and 
reproducible. FDA believes that these BE approaches would benefit from 
public discussion.

II. Topics for Discussion at the Public Workshop

    This public workshop will focus on a discussion of current 
regulatory science initiatives intended to foster the development of 
topical dermatological generic drug products, examining alternative BE 
approaches that may be more efficient and less risky than traditional 
approaches. FDA is also interested in receiving public input about any 
barriers that may limit the use of such alternative BE approaches in 
the development of topical dermatological generic drug products. Public 
input is also sought about strategies to overcome these barriers.

III. Participating in the Public Workshop

    Registration: Persons interested in attending this public workshop 
must register online at https://survey.co1.qualtrics.com/jfe/form/SV_9YQDLZJRjXtYiXz. Please 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. Persons interested in attending this public 
workshop must register by October 13, 2017, midnight, Eastern Time. 
Early registration is recommended because seating is limited; 
therefore, FDA may limit the number of participants from each 
organization.
    If you need special accommodations due to a disability, please 
contact Sam Raney (see FOR FURTHER INFORMATION CONTACT) no later than 
October 13, 2017.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to present during a public comment session, and 
which topic(s) you wish to address. 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 
presentations, and to request time for a joint presentation, or to 
submit requests for designated representatives to participate in the 
focused sessions. Following the close of registration, we will 
determine the amount of time allotted to each presenter and the 
approximate time each oral presentation is to begin, and will select 
and notify participants by October 16, 2017. All requests to make oral 
presentations must be received by the close of registration on October 
9, 2017. If selected for presentation, any presentation materials must 
be emailed to GDUFARegulatoryScience@fda.hhs.gov no later than October 
13, 2017. No commercial or promotional material will be permitted to be 
presented or distributed at the public workshop.
    Streaming webcast of the public workshop: This public workshop will 
also be webcast. A live webcast of this workshop will be viewable at 
https://collaboration.fda.gov/ogddermaldrug/ on the day of the 
workshop.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the Web site addresses in this document, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop 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/NewsEvents/ucm557252.htm.

    Dated: September 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21186 Filed 10-2-17; 8:45 am]
BILLING CODE 4164-01-P