Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs; Revised Draft Guidance for Industry; Availability, 22457-22459 [2023-07769]
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Federal Register / Vol. 88, No. 71 / Thursday, April 13, 2023 / Notices
• 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.govinfo.gov/content/pkg/FR-201509-18/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, 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 this 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 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.
VerDate Sep<11>2014
17:56 Apr 12, 2023
Jkt 259001
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a revised draft guidance for industry
entitled ‘‘Assessing Adhesion With
Transdermal and Topical Delivery
Systems for ANDAs’’ (Revision 2). This
revised draft guidance (Revision 2)
revises the Revision 1 draft guidance of
the same name, which was announced
in the Federal Register on October 10,
2018 (83 FR 50942). FDA received five
comments on the revised draft guidance
(Revision 1), which were considered
before publication of this revised draft
guidance (Revision 2).
This revised draft guidance (Revision
2) provides recommendations for the
design and conduct of studies
evaluating the adhesion performance of
a TDS submitted in support of an
ANDA. Depending on the objectives of
a TDS product development program,
applicants may choose to evaluate TDS
adhesion in studies performed to
evaluate TDS adhesion only or in
studies performed with a combined
purpose (e.g., for the simultaneous
evaluation of adhesion and BE with PK
endpoints). FDA recommends that
applicants consult this revised draft
guidance (Revision 2) in conjunction
with any relevant product-specific
guidances for industry when
considering the design and conduct of
studies that may be appropriate to
support the BE of a proposed generic
TDS product to its reference listed drug
and/or reference standard product.
Specifically, in response to the
comments received from industry, FDA
is clarifying the following components
of the guidance. When recording
measurements of TDS adhesion,
applicants may use appropriate methods
(e.g., a trained visual assessment and/or
dot matrix templates) and are
encouraged to explore the use of
alternative scales (other than the fivepoint adhesion scale) to estimate the
percentage of the entire TDS surface
area that is adhered to the skin. At each
adhesion assessment time point,
applicants should also record
photographic evidence showing the
extent of TDS adhesion to the skin.
Because percent adhesion can span a
range and yet be classified as a single
score, the photographic evidence can be
used to support the visual observation
of the percent adhesion reported at each
time point and is not intended to be
used for automated or photometric
analysis at this time. Additional clarity
is also provided related to the statistical
analysis of data. Finally, FDA
recommends that an applicant who
seeks to use an alternative approach to
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22457
FDA’s recommendations for the design
and conduct of studies evaluating the
adhesion performance of a TDS to
contact the Agency to discuss the
proposed alternative approach to
evaluate adhesion performance for that
particular drug product.
This revised draft guidance (Revision
2) is being issued consistent with FDA’s
good guidance practices regulation (21
CFR 10.115). The revised draft
guidance, when finalized, will represent
the current thinking of FDA on
‘‘Assessing Adhesion With 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
(Revision 2) 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 have
been approved under OMB control
number 0910–0001.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents,
https://www.regulations.gov, or https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs.
Dated: April 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–07770 Filed 4–12–23; 8:45 am]
BILLING CODE 4164–01–P
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.
E:\FR\FM\13APN1.SGM
13APN1
22458
ACTION:
Federal Register / Vol. 88, No. 71 / Thursday, April 13, 2023 / Notices
Written/Paper Submissions
Notice of availability.
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:
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
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’’).
VerDate Sep<11>2014
17:56 Apr 12, 2023
Jkt 259001
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, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/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://
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
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, 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
E:\FR\FM\13APN1.SGM
13APN1
Federal Register / Vol. 88, No. 71 / Thursday, April 13, 2023 / Notices
lotter on DSK11XQN23PROD with NOTICES1
(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
VerDate Sep<11>2014
17:56 Apr 12, 2023
Jkt 259001
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 https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
[OMB No. 0915–0379
Revision]
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title:
Questionnaire and Data Collection
Testing, Evaluation, and Research for
the Health Resources and Services
Administration
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than June 12, 2023.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 20857.
SUMMARY:
PO 00000
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22459
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Samantha Miller, the acting
HRSA Information Collection Clearance
Officer, at (301) 594–4394.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Questionnaire and Data Collection
Testing, Evaluation, and Research for
HRSA—OMB No. 0915–0379—Revision
Abstract: The purpose of information
collections under this generic umbrella
ICR package is to allow HRSA to
continue collecting feedback from
members of the public for HRSA to use
when developing new questions,
questionnaires, and tools; pilot/pre-test
instruments to be deployed by HRSA;
and to identify problems in instruments
currently in use.
This generic clearance is limited to
data collection for the development or
revision of HRSA tools and data
collection instruments, as well as
reports for internal decision-making and
development purposes. Information
collected under this generic clearance
will not be used for data collection,
reports, or policy documents to be
released to the public. It is anticipated
that data collection approved under this
generic clearance will rely heavily on
qualitative techniques and not the
collection of numerical data. In general,
these activities are not designed to yield
results that meet generally accepted
standards of statistical rigor but
designed to obtain information to
develop clearer and more effective and
efficient data collection tools that will
yield more accurate results and decrease
public non-response. The forms
submitted under this generic clearance
will be voluntary, low-burden, and
uncontroversial.
HRSA originally developed this
generic umbrella ICR to support similar
needs across HRSA’s bureaus and
offices as reflected in their specific
activities informed by their specific
authorizing statutes. The purpose is to
collect qualitative data from small
groups of people in response to short
questionnaires, using questions posed
on HRSA’s website, through focus
groups and individual interviews of
HRSA staff and members of the public.
The abbreviated clearance process of the
generic clearance helps ensure timely
data gathering on current issues HRSA
is addressing (e.g., allows program
offices to gather a suitable pool of
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\13APN1.SGM
13APN1
]]>Agencies
[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Notices]
[Pages 22457-22459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07769]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
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, 240-402-7500.
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.govinfo.gov/content/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, 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 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: April 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07769 Filed 4-12-23; 8:45 am]
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