Notice2023-07769
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability
Primary source
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Published
April 13, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs." This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitization (I/S) potential of a proposed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 The recommendations in this revised draft guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The revised draft guidance is intended to clarify FDA's recommendations and expectations related to in vivo skin I/S studies. This guidance revises the October 2018 draft guidance entitled "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs."
Full Text
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<title>Federal Register, Volume 88 Issue 71 (Thursday, April 13, 2023)</title>
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[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Notices]
[Pages 22457-22459]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-07769]
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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Transdermal and Topical Delivery Systems for ANDAs; Revised Draft
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
[[Page 22458]]
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised draft guidance for industry entitled
``Assessing the Irritation and Sensitization Potential of Transdermal
and Topical Delivery Systems for ANDAs.'' This revised draft guidance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 revised draft guidance
relate to studies submitted in support of an abbreviated new drug
application (ANDA). The revised draft guidance is intended to clarify
FDA's recommendations and expectations related to in vivo skin I/S
studies. This guidance revises the October 2018 draft guidance entitled
``Assessing the Irritation and Sensitization Potential of Transdermal
and Topical Delivery Systems for ANDAs.''
DATES: Submit either electronic or written comments on the draft
guidance by June 12, 2023 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
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 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: Melissa Mannion, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1611, Silver Spring, MD 20993-0002, 301-
796-2747.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance for
industry entitled ``Assessing the Irritation and Sensitization
Potential of Transdermal and Topical Delivery Systems for ANDAs.'' This
guidance revises the draft guidance entitled ``Assessing the Irritation
and Sensitization Potential of Transdermal and Topical Delivery Systems
for ANDAs'' that was published in the Federal Register on October 10,
2018 (83 FR 50945). FDA received eight comments on the draft guidance,
which were considered before publication of this revised draft
guidance.
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,
when appropriate, applicants should perform a comparative assessment of
the test (T) and reference
[[Page 22459]]
(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 revised draft guidance provides the following updates to the
original draft guidance:
(1) Clarifies recommendations for the design and conduct of studies
to evaluate the in vivo skin I/S potential of a proposed TDS.
(2) Clarifies when an in vivo study to assess the sensitization
potential of a TDS product may not be needed.
(3) Provides guidance to applicants intending to utilize
alternative scoring scales or alternative approaches to compare
irritation and sensitization between the T and R TDS.
The recommendations in this revised draft guidance relate to
studies submitted in support of an ANDA. The Agency is seeking comments
on the recommendations reflected in the revised draft guidance
announced in this notice. In addition, FDA invites comments on the
scoring scales and any alternative approaches, including those
recommended by international regulatory agencies, that may have been
used 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 conducted in addition to a comparative irritation
assessment.
This revised 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.
II. Paperwork Reduction Act of 1995
While this revised draft guidance contains no collection of
information, it does refer to previously approved FDA collections of
information. Therefore, clearance by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3501-3521) is not required for this guidance. The previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information in 21 CFR part 314 relating to the
submission of abbreviated new drug applications have been approved
under OMB control number 0910-0001. The collections of information
relating to good clinical practice have been approved under OMB control
number 0910-0843.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: April 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07769 Filed 4-12-23; 8:45 am]
BILLING CODE 4164-01-P
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