[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Notices]
[Pages 22456-22457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07770]


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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for Abbreviated New Drug Applications; Revised Draft Guidance for 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the availability of a revised draft guidance for industry entitled 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'' (Revision 2). This draft guidance (Revision 2) revises the 
Revision 1 draft guidance of the same name, which was announced in the 
Federal Register on October 10, 2018. This revised draft guidance 
provides recommendations for the design and conduct of studies 
evaluating the adhesion performance of a transdermal or topical 
delivery system (collectively referred to as TDS). Depending on the 
objectives of a generic 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 bioequivalence (BE) 
with pharmacokinetic (PK) endpoints). The recommendations in this 
revised draft guidance relate to studies submitted in support of an 
abbreviated new drug application (ANDA).

DATES: Submit either electronic or written comments on the draft 
guidance by June 12, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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 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, 240-
402-7500.

[[Page 22457]]

     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.govinfo.gov/content/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, 240-402-7500.
    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: Melissa Mannion, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1611, Silver Spring, MD 20993-0002, 301-
796-2747.

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'' (Revision 2). This revised draft guidance 
(Revision 2) revises the Revision 1 draft guidance of the same name, 
which was announced in the Federal Register on October 10, 2018 (83 FR 
50942). FDA received five comments on the revised draft guidance 
(Revision 1), which were considered before publication of this revised 
draft guidance (Revision 2).
    This revised draft guidance (Revision 2) provides recommendations 
for the design and conduct of studies evaluating the adhesion 
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 
(Revision 2) 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.
    Specifically, in response to the comments received from industry, 
FDA is clarifying the following components of the guidance. When 
recording measurements of TDS adhesion, applicants may use appropriate 
methods (e.g., a trained visual assessment and/or dot matrix templates) 
and are encouraged to explore the use of alternative scales (other than 
the five-point adhesion scale) to estimate the percentage of the entire 
TDS surface area that is adhered to the skin. At each adhesion 
assessment time point, applicants should also record photographic 
evidence showing the extent of TDS adhesion to the skin. Because 
percent adhesion can span a range and yet be classified as a single 
score, the photographic evidence can be used to support the visual 
observation of the percent adhesion reported at each time point and is 
not intended to be used for automated or photometric analysis at this 
time. Additional clarity is also provided related to the statistical 
analysis of data. Finally, FDA recommends that an applicant who seeks 
to use an alternative approach to FDA's recommendations for the design 
and conduct of studies evaluating the adhesion performance of a TDS to 
contact the Agency to discuss the proposed alternative approach to 
evaluate adhesion performance for that particular drug product.
    This revised draft guidance (Revision 2) 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.

II. Paperwork Reduction Act of 1995

    While this revised draft guidance (Revision 2) contains no 
collection of information, it does refer to previously approved FDA 
collections of information. Therefore, clearance by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The 
previously approved collections of information are subject to review by 
OMB under the PRA. The collections of information in 21 CFR part 314 
have been approved under OMB control number 0910-0001.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.regulations.gov, or https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.

    Dated: April 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07770 Filed 4-12-23; 8:45 am]
BILLING CODE 4164-01-P