[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Pages 64239-64240]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23017]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-1859]


In Vitro Release Test Studies for Topical Products Submitted in 
Abbreviated New Drug Applications; Draft Guidance for Industry; 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the availability of a draft guidance for industry entitled ``In Vitro 
Release Test Studies for Topical Products Submitted in ANDAs.'' This 
draft guidance provides recommendations for in vitro release test 
(IVRT) studies for locally acting liquid-based and/or other semisolid 
topical products. This draft guidance is intended to assist applicants 
who are submitting abbreviated new drug applications (ANDAs) for such 
products, by providing recommendations for IVRT studies, which can be 
used to support a demonstration that two topical products are 
bioequivalent.

DATES: Submit either electronic or written comments on the draft 
guidance by December 23, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-1859 for ``In Vitro Release Test Studies for Topical 
Products Submitted in 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.
     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

[[Page 64240]]

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 Office of Communication, Outreach and Development, 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 the office 
in processing your requests. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Susan Levine, 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.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``In Vitro Release Test Studies for Topical Products Submitted 
in ANDAs.'' This draft guidance provides recommendations on IVRT 
studies for locally acting liquid-based and/or other semisolid topical 
products. This draft guidance is intended to assist applicants who are 
submitting ANDAs for such products, by providing recommendations for 
IVRT studies, which can be used to support a demonstration that two 
topical products are bioequivalent.
    Once validated, an IVRT study may also be useful in controlling 
product quality and/or establishing acceptability of post-approval 
manufacturing changes. This draft guidance focuses on general 
considerations and recommendations for the method development, method 
validation, and conduct of IVRT studies that are submitted in ANDAs and 
intended to support a demonstration of bioequivalence.
    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 ``In Vitro 
Release Test Studies for Topical Products Submitted in 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 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 for the submission of ANDAs have been approved under OMB 
control number 0910-0001. Applicant submission of controlled 
correspondence related to generic drug development and FDA approval is 
approved under OMB control number 0910-0797. The collections of 
information that support ``Good Laboratory Practice (GLP) for Non-
Clinical Laboratory Studies'' have been approved under OMB control 
number 0910-0119. The collections of information in 21 CFR part 320 for 
``Investigational New Drug Safety Reporting Requirements for Human Drug 
and Biological Products and Safety Reporting Requirements for 
Bioavailability and Bioequivalence Studies in Humans'' have been 
approved under OMB control number 0910-0014. The recordkeeping 
requirement for CGMP sample retention in 21 CFR 211.170 has been 
approved under OMB control number 0910-0139.

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. 2022-23017 Filed 10-21-22; 8:45 am]
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