[Federal Register Volume 84, Number 225 (Thursday, November 21, 2019)]
[Notices]
[Pages 64319-64321]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25246]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4447]


Transdermal and Topical Delivery Systems--Product Development and 
Quality Considerations; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled 
``Transdermal and Topical Delivery Systems--Product Development and 
Quality Considerations.'' This guidance provides recommendations to 
applicants and manufacturers of transdermal and topical delivery 
systems (TDS) regarding the pharmaceutical development and quality 
information to include in new drug applications (NDAs) and abbreviated 
new drug applications (ANDAs). Specifically, the guidance discusses 
FDA's current thinking on product design and pharmaceutical 
development, manufacturing process and control, and finished product 
control. It also addresses special considerations for areas where 
quality is closely tied to product performance and potential safety 
issues, such as adhesion failure and the impact of applied heat on drug 
delivery.

DATES: Submit either electronic or written comments on the draft 
guidance by February 19, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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

[[Page 64320]]

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-2019-D-4447 for ``Transdermal and Topical Delivery Systems--Product 
Development and Quality Considerations.'' 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 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 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: Mohamed Ghorab, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3141, Silver Spring, MD 20993, 240-402-
8940.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Transdermal and Topical Delivery Systems--Product 
Development and Quality Considerations.'' Transdermal delivery systems 
and topical delivery systems, collectively identified as TDS, are used 
in a variety of therapeutic areas and treatment populations. 
Transdermal delivery systems are designed to deliver an active 
ingredient (drug substance) across the skin and into systemic 
circulation, while topical delivery systems are designed to deliver the 
active ingredient to local tissue. Both transdermal delivery systems 
and topical delivery systems present similar manufacturing and quality 
control concerns and similar risks to patients.
    The draft guidance in its entirety may not be applicable to all 
TDS, and some TDS (for example, microneedles, active transport TDS, 
reservoir TDS, and TDS applied to broken skin) have other 
considerations that are not addressed in this guidance. Because of the 
inherent failure modes and safety risks associated with the reservoir 
TDS, FDA recommends TDS manufacturers and applicants focus development 
efforts on matrix type TDS.
    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 transdermal 
and topical delivery systems product development and quality 
considerations. 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

    This 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 (PRA) (44 U.S.C. 3501-3520). 
The collections of information in 21 CFR parts 210 and 211 have been 
approved under OMB control number 0910-0139. The collections of 
information in 21 CFR part 314 for the submission of NDAs and ANDAs, 
including the submission of labeling under 21 CFR 314.50(e)(2)(ii) and 
314.50(l)(1)(i) and advertisements and promotional labeling under 21 
CFR 314.81(b)(3)(i), have been approved under OMB control number 0910-
0001. The submission of prescription drug labeling under 21 CFR 201.56 
and 201.57 has been approved under OMB control number 0910-0572.
    In accordance with the PRA, prior to publication of any final 
guidance document, FDA intends to solicit public comment and obtain OMB 
approval for any information collections recommended in this guidance 
that are new or that would represent material modifications to those 
previously approved collections of information found in FDA regulations 
or guidances.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/

[[Page 64321]]

GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: November 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25246 Filed 11-20-19; 8:45 am]
BILLING CODE 4164-01-P