[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for Abbreviated New Drug Applications; Revised Draft Guidance for 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the availability of a revised draft guidance for industry entitled 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 This revised draft guidance supersedes the draft guidance 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 This revised draft guidance provides 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draft guidance relate exclusively to studies submitted in support of an 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draft guidance by December 10, 2018 to ensure that the Agency considers 
your comment on this revised draft guidance before it begins work on 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]
 BILLING CODE 4164-01-P


