[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]
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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for Abbreviated New Drug Applications; Revised Draft Guidance for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.
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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the availability of a revised draft guidance for industry entitled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 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 This revised draft guidance supersedes the draft guidance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 This revised draft guidance provides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draft guidance relate exclusively to studies submitted in support of an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draft guidance by December 10, 2018 to ensure that the Agency considers
your comment on this revised draft guidance before it begins work on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]
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