Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications; Draft Guidance for Industry; Availability, 50945-50946 [2018-21958]
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Federal Register / Vol. 83, No. 196 / Wednesday, October 10, 2018 / Notices
TABLE 2—REVISED DRAFT PRODUCT- ‘‘Assessing the Irritation and
SPECIFIC GUIDANCES FOR DRUG Sensitization Potential of Transdermal
and Topical Delivery Systems for
PRODUCTS—Continued
Nitroglycerin (multiple Reference Listed
Drugs)
Oxybutynin (multiple Reference Listed Drugs)
Rivastigmine
Rotigotine
Scopolamine
Selegiline
Testosterone
For a complete history of previously
published Federal Register notices
related to product-specific guidances, go
to https://www.regulations.gov and
enter Docket No. FDA–2007–D–0369.
These draft guidances are being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). These draft guidances, when
finalized, will represent the current
thinking of FDA on, among other things,
the product-specific design of BE
studies to support ANDAs. They do not
establish any rights for any person and
are 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.
IV. Electronic Access
Persons with access to the internet
may obtain the draft guidances at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: October 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21957 Filed 10–9–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–3546]
amozie on DSK3GDR082PROD with NOTICES1
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Draft Guidance for Industry;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.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
SUMMARY:
VerDate Sep<11>2014
21:20 Oct 09, 2018
Jkt 247001
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 This draft guidance provides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
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
50945
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/201523389.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
E:\FR\FM\10OCN1.SGM
10OCN1
50946
Federal Register / Vol. 83, No. 196 / Wednesday, October 10, 2018 / Notices
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:
amozie on DSK3GDR082PROD with NOTICES1
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
VerDate Sep<11>2014
21:20 Oct 09, 2018
Jkt 247001
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/Guidance
ComplianceRegulatoryInformation/
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Neurobiology of Learning and Memory.
Date: October 24, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Fairmont Washington, DC, 2401
M Street NW, Washington, DC 20037.
Contact Person: Alexei Kondratyev, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5200,
MSC 7846, Bethesda, MD 20892, 301–435–
1785, kondratyevad@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Health Disparities in and Caregiving for
Alzheimer’s Disease.
Date: November 2, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Gabriel B. Fosu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3108,
MSC 7808, Bethesda, MD 20892, (301) 435–
3562, fosug@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Fellowship:
Infectious Diseases and Microbiology.
Date: November 5–6, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Palomar, 2121 P Street NW,
Washington, DC 20037.
Contact Person: Tamara Lyn McNealy,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3188,
Bethesda, MD 20892, 301–827–2372,
tamara.mcnealy@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Risk, Prevention and Health
Behavior.
Date: November 5–6, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Contact Person: Martha M. Faraday, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3110,
MSC 7808, Bethesda, MD 20892, (301) 435–
3575, faradaym@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Bioengineering Sciences and
Technologies.
E:\FR\FM\10OCN1.SGM
10OCN1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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