Assessing Adhesion With Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications; Revised Draft Guidance for Industry; Availability, 50942-50943 [2018-21959]
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Federal Register / Vol. 83, No. 196 / Wednesday, October 10, 2018 / Notices
interested persons to submit comments
regarding the 16 drug substances. Any
comments received will be considered
by HHS when it prepares a scientific
and medical evaluation for drug
substances that is responsive to the
WHO Questionnaire for these drug
substances. HHS will forward such
evaluation of these drug substances to
WHO, for WHO’s consideration in
deciding whether to recommend
international control/decontrol of any of
these drug substances. Such control
could limit, among other things, the
manufacture and distribution (import/
export) of these drug substances and
could impose certain recordkeeping
requirements on them.
Although FDA is, through this notice,
requesting comments from interested
persons, which will be considered by
HHS when it prepares an evaluation of
these drug substances, HHS will not
now make any recommendations to
WHO regarding whether any of these
drugs should be subjected to
international controls. Instead, HHS will
defer such consideration until WHO has
made official recommendations to the
Commission on Narcotic Drugs, which
are expected to be made in mid-2018.
Any HHS position regarding
international control of these drug
substances will be preceded by another
Federal Register notice soliciting public
comments, as required by paragraph
(d)(2)(B) of the CSA.
Dated: October 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21954 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 2016–D–1254]
Assessing Adhesion With Transdermal
and Topical Delivery Systems for
Abbreviated New Drug Applications;
Revised Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
amozie on DSK3GDR082PROD with NOTICES1
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a revised
draft guidance for industry entitled
‘‘Assessing Adhesion With Transdermal
and Topical Delivery Systems for
ANDAs.’’ This revised draft guidance
supersedes the draft guidance entitled
SUMMARY:
VerDate Sep<11>2014
21:20 Oct 09, 2018
Jkt 247001
‘‘Assessing Adhesion with Transdermal
Delivery Systems and Topical Patches
for ANDAs,’’ which was announced in
the Federal Register on June 1, 2016.
This revised draft guidance provides
recommendations for the design and
conduct of studies evaluating the
adhesive performance of a transdermal
or a topical delivery system (collectively
referred to as TDS). Depending on the
objectives of a TDS product
development program, applicants may
choose to evaluate TDS adhesion in
clinical studies performed to evaluate
TDS adhesion only or in clinical studies
performed with a combined purpose
(e.g., for the simultaneous evaluation of
adhesion and bioequivalence (BE) with
pharmacokinetic (PK) endpoints). The
recommendations in this revised 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 revised draft
guidance by December 10, 2018 to
ensure that the Agency considers your
comment on this revised 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:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
• 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 2016–
D–1254 for ‘‘Assessing Adhesion With
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
E:\FR\FM\10OCN1.SGM
10OCN1
Federal Register / Vol. 83, No. 196 / Wednesday, October 10, 2018 / Notices
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 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: Kris
Andre, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 4728, Silver Spring,
MD 20993–0002, 240–402–7959.
SUPPLEMENTARY INFORMATION:
amozie on DSK3GDR082PROD with NOTICES1
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.’’ This revised draft
guidance supersedes the draft guidance
entitled ‘‘Assessing Adhesion with
Transdermal Delivery Systems and
Topical Patches for ANDAs,’’ which was
announced in the Federal Register on
June 1, 2016 (81 FR 35025). FDA
received six comments on the draft
guidance, which were considered before
publication of this revised draft
guidance.
This revised draft guidance provides
recommendations for the design and
conduct of studies evaluating the
adhesive 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 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.
During the product’s labeled wear
period, a TDS is reasonably expected to
encounter torsional strains arising from
VerDate Sep<11>2014
21:20 Oct 09, 2018
Jkt 247001
body movements, changes in
environmental temperature or humidity
such as the daily exposure to water (e.g.,
during routine showering), and contact
with clothing, bedding, or other
surfaces. TDS products that do not
maintain consistent and uniform
adhesion with the skin during the
labeled wear period can experience
varying degrees of TDS detachment,
including complete detachment, at
different times during the product wear.
When the adhesion characteristics of
a TDS are not sufficiently robust, as
evaluated against its labeled conditions
of use, the TDS may exhibit variability
in the surface area that is in contact
with the skin. For example, when a TDS
is partially detached, there may be
uncertainty about the resulting drug
delivery profile and, hence, uncertainty
about the rate and extent of drug
absorption from the TDS. When the
potential for complete detachment of
the TDS increases, the risk of
unintentional exposure of the drug
product to an unintended recipient (e.g.,
a household member who may be a
child) also increases.
This revised draft guidance 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. This guidance is not subject
to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This revised 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 have been
approved under OMB control number
0910–0001.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
50943
Dated: October 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21959 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–2007–D–0369]
Product-Specific Guidances; Draft and
Revised Draft Guidances 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
additional draft and revised draft
product-specific guidances. The
guidances provide product-specific
recommendations on, among other
things, the design of bioequivalence
(BE) studies to support abbreviated new
drug applications (ANDAs). In the
Federal Register of June 11, 2010, FDA
announced the availability of a guidance
for industry entitled ‘‘Bioequivalence
Recommendations for Specific
Products’’ that explained the process
that would be used to make productspecific guidances available to the
public on FDA’s website. The guidances
identified in this notice were developed
using the process described in that
guidance.
SUMMARY:
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:
DATES:
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
E:\FR\FM\10OCN1.SGM
10OCN1
Agencies
[Federal Register Volume 83, Number 196 (Wednesday, October 10, 2018)]
[Notices]
[Pages 50942-50943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21959]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 2016-D-1254]
Assessing Adhesion With Transdermal and Topical Delivery Systems
for Abbreviated New Drug Applications; Revised 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 revised draft guidance for industry entitled
``Assessing Adhesion With Transdermal and Topical Delivery Systems for
ANDAs.'' This revised draft guidance supersedes the draft guidance
entitled ``Assessing Adhesion with Transdermal Delivery Systems and
Topical Patches for ANDAs,'' which was announced in the Federal
Register on June 1, 2016. This revised draft guidance provides
recommendations for the design and conduct of studies evaluating the
adhesive performance of a transdermal or a topical delivery system
(collectively referred to as TDS). Depending on the objectives of a TDS
product development program, applicants may choose to evaluate TDS
adhesion in clinical studies performed to evaluate TDS adhesion only or
in clinical studies performed with a combined purpose (e.g., for the
simultaneous evaluation of adhesion and bioequivalence (BE) with
pharmacokinetic (PK) endpoints). The recommendations in this revised
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 revised
draft guidance by December 10, 2018 to ensure that the Agency considers
your comment on this revised 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 2016-D-1254 for ``Assessing Adhesion With 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
[[Page 50943]]
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 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: Kris Andre, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 4728, Silver Spring, MD 20993-0002, 240-402-7959.
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.'' This revised draft guidance supersedes
the draft guidance entitled ``Assessing Adhesion with Transdermal
Delivery Systems and Topical Patches for ANDAs,'' which was announced
in the Federal Register on June 1, 2016 (81 FR 35025). FDA received six
comments on the draft guidance, which were considered before
publication of this revised draft guidance.
This revised draft guidance provides recommendations for the design
and conduct of studies evaluating the adhesive 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 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.
During the product's labeled wear period, a TDS is reasonably
expected to encounter torsional strains arising from body movements,
changes in environmental temperature or humidity such as the daily
exposure to water (e.g., during routine showering), and contact with
clothing, bedding, or other surfaces. TDS products that do not maintain
consistent and uniform adhesion with the skin during the labeled wear
period can experience varying degrees of TDS detachment, including
complete detachment, at different times during the product wear.
When the adhesion characteristics of a TDS are not sufficiently
robust, as evaluated against its labeled conditions of use, the TDS may
exhibit variability in the surface area that is in contact with the
skin. For example, when a TDS is partially detached, there may be
uncertainty about the resulting drug delivery profile and, hence,
uncertainty about the rate and extent of drug absorption from the TDS.
When the potential for complete detachment of the TDS increases, the
risk of unintentional exposure of the drug product to an unintended
recipient (e.g., a household member who may be a child) also increases.
This revised draft guidance 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.
This guidance is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This revised 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 have been approved
under OMB control number 0910-0001.
III. Electronic Access
Persons with access to the internet may obtain the 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. 2018-21959 Filed 10-9-18; 8:45 am]
BILLING CODE 4164-01-P