Document ID: FDA-2018-N-2582-0001
Agency: fda
Document Type: Notice
Title: Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation; Public Workshop; Request for Comments
Posted Date: 2018-08-10T04:00Z

[Federal Register Volume 83, Number 155 (Friday, August 10, 2018)]
[Notices]
[Pages 39761-39763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17130]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2582]

Human Dermal (Skin) Safety Testing for Topical Drug Products: 
Regulatory Utility and Evaluation; 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, Agency, or we) is 
announcing the following 1-day public workshop entitled ``Human Dermal 
(Skin) Safety Testing for Topical Drug Products: Regulatory Utility and 
Evaluation.'' The purpose of the public workshop is to provide a forum 
to discuss the current state and future directions of the collection of 
human data on the potential skin toxicity with the use of medications 
applied topically. The workshop will review current approaches to the 
collection of human data during the clinical development of topical 
drug products. The workshop will also address the impact of human skin 
toxicity studies on drug labeling and consider alternative approaches 
to providing information about skin toxicity.

DATES: The public workshop will be held on September 10, 2018, from 
8:30 a.m. to 4 p.m. Eastern Time. Submit either electronic or written 
comments on this public workshop by October 10, 2018. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the 
Great Room (Rm. 1503, Section A), 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 October 10, 2018. The

[[Page 39762]]

https://www.regulations.gov electronic filing system will accept 
comments until midnight Eastern Time at the end of October 10, 2018. 
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-2018-N-2582 for ``Human Dermal (Skin) Safety Testing for Topical 
Drug Products: Regulatory Utility and Evaluation; Public Workshop; 
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.
     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, 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: Tisha Washington, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1019, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing a public workshop entitled ``Human Dermal (Skin) 
Safety Testing for Topical Drug Products: Regulatory Utility and 
Evaluation'' to discuss the current state and future directions of the 
collection of human data on the potential skin risks from use of 
topical drug products, including irritancy, sensitization, 
phototoxicity, and photoallergenicity.

II. Topics for Discussion at the Public Workshop

    The morning session of the workshop will focus on review and 
discussion of current approaches for the collection of human skin 
toxicity data, limitations of these approaches, and their impact on 
labeling of topical drug products. The afternoon session of the 
workshop will be a panel discussion by individuals with different 
perspectives about alternative approaches to provide information about 
skin toxicity. Thirty minutes of the afternoon session will be 
allocated to an open public hearing. The Agency encourages health care 
providers, industry representatives, and other interested persons to 
attend this public workshop.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following website by September 4, 2018: https://www.eventbrite.com/e/fda-public-workshop-human-dermal-safety-testing-for-topical-drug-products-tickets-47483161414. Please provide complete contact 
information for each attendee, including name, title, affiliation, 
address, email, and telephone, and intended attendance method--in 
person or by webcast. You may also indicate if you wish to present at 
the public comment session (see Requests for Oral Presentations). For 
those unable to attend in person, FDA will provide a live webcast of 
the workshop.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by 5 p.m. Eastern Time, September 4, 2018. 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. 
Seating will be available on a first-come, first-served basis. If time 
and space permit, onsite registration on the day of the workshop will 
be provided beginning at 8:15 a.m. Eastern Time; FDA will let the 
public know whether onsite registration is available before the day of 
the public workshop.
    An agenda for the workshop and any other background materials will 
be made available 5 days before the workshop at https://www.fda.gov/Drugs/NewsEvents/ucm611203.htm.
    If you need special accommodations due to a disability, please 
contact Tisha

[[Page 39763]]

Washington, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
301-796-1019, [email protected] no later than September 4, 
2018.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to present at the 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 request time for a joint presentation. 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 September 5, 2018. 
All requests to make oral presentations must be received by the close 
of registration on September 4, 2018. If selected for presentation, any 
presentation materials must be emailed to Tisha Washington (see FOR 
FURTHER INFORMATION CONTACT) no later than close of business, September 
6, 2018. 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. The webcast link will be available on the following 
web page 5 days before the workshop at: https://www.fda.gov/Drugs/NewsEvents/ucm611203.htm.
    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 website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites 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 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. A link to the transcript will also be available on 
the internet at https://www.fda.gov/Drugs/NewsEvents/ucm611203.htm.

    Dated: August 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17130 Filed 8-9-18; 8:45 am]
 BILLING CODE 4164-01-P