[Federal Register Volume 81, Number 105 (Wednesday, June 1, 2016)]
[Notices]
[Pages 35025-35026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12822]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-1254]
Assessing Adhesion With Transdermal Delivery Systems and Topical
Patches for Abbreviated New Drug Applications; Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Assessing
Adhesion with Transdermal Delivery Systems and Topical Patches for
ANDAs.'' This draft guidance is intended to provide recommendations for
the design and conduct of studies evaluating the adhesive performance
of a Transdermal Delivery System or a topical patch (collectively,
TDS). This guidance, once finalized, is intended to provide updated
recommendations for the design and conduct of adhesion studies
submitted in support of an Abbreviated New Drug Application (ANDA) for
a TDS.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 1, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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 Delivery
Systems and Topical Patches for ANDAs.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management 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
[[Page 35026]]
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 http://www.regulations.gov. Submit both copies to the Division of
Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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: Kris Andre, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 4726, Silver Spring, MD 20993-0002, 240-402-7959.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Assessing Adhesion with Transdermal Delivery Systems and
Topical Patches for ANDAs.'' This draft guidance provides
recommendations for the design and conduct of clinical studies
evaluating the adhesive performance of a TDS submitted in support of an
ANDA. The recommendations in this guidance relate exclusively to TDS
adhesion studies submitted in support of an ANDA.
The amount of drug delivered into and through the skin from a TDS
is dependent, in part, on the surface area dosed. It is expected that
the entire surface area of a TDS should remain consistently and
uniformly adhered to the skin throughout the duration of wear under the
conditions of use included in the product label. Under circumstances in
which a TDS loses its adherence during wear, the amount of drug
delivered to the patient may be reduced.
During the course of the product's labeled wear period, a TDS is
reasonably expected to encounter torsional strains arising from
anatomical 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 under the
range of conditions experienced during the labeled wear period for the
TDS can result in varying degrees of TDS detachment, including complete
detachment, at different times during the course of 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 area that is in contact with the skin. In
such situations where 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.
In addition, as the potential for complete detachment of the TDS
increases, so does the risk of unintentional exposure of the drug
product to an unintended recipient (e.g., a household member who may
potentially be a child).
This guidance describes the recommended approach to the adhesion
clinical study design and, therefore, will supersede the
recommendations related to adhesion studies provided in individual
product-specific guidances published prior to the date of publication
of this guidance. This guidance, once finalized, is intended to provide
updated recommendations for the design and conduct of adhesion studies
submitted in support of an ANDA for a TDS. FDA recommends that
applicants consult this guidance in conjunction with any relevant
product-specific guidance documents when considering other studies
(e.g. irritation, sensitization) that may be necessary to support the
bioequivalence (BE) of a proposed generic TDS drug product to its RLD.
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
Adhesion with Transdermal Delivery Systems and Topical Patches 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. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: May 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12822 Filed 5-31-16; 8:45 am]
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