[Federal Register Volume 83, Number 196 (Wednesday, October 10, 2018)]
[Notices]
[Pages 50945-50946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21958]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3546]


Assessing the Irritation and Sensitization Potential of 
Transdermal and Topical Delivery Systems for Abbreviated New Drug 
Applications; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Assessing 
the Irritation and Sensitization Potential of Transdermal and Topical 
Delivery Systems for ANDAs.'' This draft guidance provides 
recommendations for the design and conduct of studies to evaluate the 
in vivo skin irritation and sensitization (I/S) potential of a proposed 
transdermal or topical delivery system (collectively referred to as 
TDS). The recommendations in this draft guidance relate exclusively to 
studies submitted in support of an abbreviated new drug application 
(ANDA).

DATES: Submit either electronic or written comments on the draft 
guidance by December 10, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

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-D-3546 for ``Assessing the Irritation and Sensitization 
Potential of Transdermal and Topical Delivery Systems for ANDAs.'' 
Received comments 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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food

[[Page 50946]]

and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 
4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Diana Solana-Sodeinde, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 2724, Silver Spring, MD 20993-0002, 240-
402-3908.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Assessing the Irritation and Sensitization Potential of 
Transdermal and Topical Delivery Systems for ANDAs.''
    The components and composition of a TDS formulation, including the 
nature of the drug substance and/or the occlusivity of the TDS 
materials, in conjunction with other factors such as the environmental 
humidity or the condition of the skin, may have the potential to 
irritate the skin or lead to a sensitization reaction. Such reactions 
can be unpleasant to the patient and may affect patient compliance, 
skin permeability, and/or adhesion of the TDS to the skin. The 
collective consequence of these potential effects could create 
uncertainty about the resulting drug delivery profile and uncertainty 
about the rate and extent of drug absorption from the TDS. Therefore, 
applicants should perform a comparative assessment of the test (T) and 
reference (R) TDS products using an appropriately designed skin I/S 
study with human subjects to demonstrate that the potential for a skin 
irritation or sensitization reaction with the T TDS is no worse than 
the reaction observed with the R TDS.
    This draft guidance provides recommendations for the design and 
conduct of studies to evaluate the in vivo skin I/S potential of a 
proposed TDS. The recommendations in this draft guidance relate 
exclusively to studies submitted in support of an ANDA.
    The Agency is seeking comments on the recommendations reflected in 
the draft guidance announced in this notice. In addition, FDA invites 
comments on the scales and any alternative approaches, including those 
recommended by international regulatory agencies, that may have been 
used with success for the comparative assessment of the I/S potential 
for proposed generic TDS products. FDA also specifically invites 
comments regarding the comparative assessment of sensitization itself, 
i.e., whether there are clinical scenarios where a comparative 
sensitization assessment may be uninformative when done in addition to 
a comparative irritation assessment.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Assessing 
the Irritation and Sensitization Potential of Transdermal and Topical 
Delivery Systems for ANDAs.'' It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations. This guidance is not subject to Executive 
Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 314.94 have been approved under 
OMB control number 0910-0001.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: October 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21958 Filed 10-9-18; 8:45 am]
 BILLING CODE 4164-01-P