Document ID: FDA-2022-D-2170-0001
Agency: fda
Document Type: Notice
Title: Topical Dermatologic Corticosteroids: In Vivo Bioequivalence; Draft Guidance
for Industry; Availability
Posted Date: 2022-10-24T04:00Z

[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Pages 64229-64230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23032]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2170]

Topical Dermatologic Corticosteroids: In Vivo Bioequivalence; 
Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Topical 
Dermatologic Corticosteroids: In Vivo Bioequivalence.'' This draft 
guidance is intended to assist applicants who submit abbreviated new 
drug applications (ANDAs) for topical dermatologic corticosteroid 
products of all potency groups (referred to in this notice as topical 
corticosteroids). The draft guidance describes recommendations for an 
in vivo pharmacodynamic approach to demonstrate the bioequivalence of 
topical corticosteroids. When finalized, this guidance will replace 
FDA's 1995 guidance for industry of the same name. Revising this 
guidance will provide clarity for potential ANDA applicants on the 
appropriate pilot and pivotal studies and other recommendations for 
pharmacodynamic approach to assess the bioequivalence of topical 
dermatologic corticosteroids. These recommendations have evolved since 
the original guidance was issued in 1995.

DATES: Submit either electronic or written comments on the draft 
guidance by December 23, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2022-D-2170 for ``Topical Dermatologic Corticosteroids: In Vivo 
Bioequivalence.'' 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.
     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

[[Page 64230]]

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 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: Susan Levine, Office of Generic Drugs, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 75, Rm. 1674, Silver Spring, MD 20993-
0002, 240-402-7936, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Topical Dermatologic Corticosteroids: In Vivo 
Bioequivalence.'' This draft guidance is intended to assist applicants 
who submit ANDAs for topical corticosteroids. This draft guidance 
describes recommendations for an in vivo pharmacodynamic approach to 
demonstrate the bioequivalence of topical corticosteroids. When 
finalized, this guidance will replace FDA's 1995 guidance for industry 
of the same name.
    This draft guidance provides recommendations for the study design, 
method qualification, data analysis, and data reporting for the pilot 
dose-duration vasoconstrictor response study and pivotal 
vasoconstrictor bioequivalence study used for topical corticosteroids. 
The draft guidance also discusses considerations and approaches for 
estimating key study parameters and sample size for the pivotal 
vasoconstrictor bioequivalence study.
    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 ``Topical 
Dermatologic Corticosteroids: In Vivo Bioequivalence.'' 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 guidance 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 314 have been approved under OMB control 
number 0910-0001. The collections of information related to current 
good manufacturing practices have been approved under OMB control 
number 0910-0139. The collections of information pertaining to 
controlled correspondence related to generic drug development have been 
approved under OMB control number 0910-0797.

III. Electronic Access

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

    Dated: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23032 Filed 10-21-22; 8:45 am]
BILLING CODE 4164-01-P