[Federal Register Volume 89, Number 120 (Friday, June 21, 2024)]
[Notices]
[Pages 52058-52060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13690]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-1275]


Demonstrating Bioequivalence for Type A Medicated Articles 
Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly 
Soluble in Aqueous Media, That Exhibit Little to No Systemic 
Bioavailability, and Are Locally Acting; 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 final guidance for industry (GFI) #279 entitled 
``Demonstrating Bioequivalence

[[Page 52059]]

for Type A Medicated Articles Containing Active Pharmaceutical 
Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That 
Exhibit Little to No Systemic Bioavailability, and Are Locally 
Acting.'' This final guidance describes an approach to satisfy the 
requirements for the completion of the Bioequivalence technical section 
for generic Type A medicated articles (TAMAs) containing poorly 
soluble, locally acting, active pharmaceutical ingredients (APIs) that 
have little to no systemic absorption, and for which blood level 
studies are not considered appropriate to demonstrate product 
bioequivalence. The suggested approach described in this guidance uses 
a combination of in vitro and in vivo data to support a determination 
of bioequivalence to address the unique challenges associated with 
demonstrating bioequivalence of TAMAs containing poorly soluble, 
locally acting APIs that have little to no systemic absorption.

DATES: The announcement of the guidance is published in the Federal 
Register on June 21, 2024.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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-2023-D-1275 for ``Demonstrating Bioequivalence for Type A Medicated 
Articles Containing Active Pharmaceutical Ingredient(s) Considered to 
be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic 
Bioavailability, and Are Locally Acting.'' 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 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 guidance to the 
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. 
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: Ian Hendricks, Center for Veterinary 
Medicine (HFV-172), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0853, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 8, 2023 (88 FR 37551), FDA 
published the notice of availability for a draft guidance entitled 
``Demonstrating Bioequivalence for Type A Medicated Articles Containing 
Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in 
Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and 
Are Locally Acting,'' giving interested persons until August 7, 2023, 
to comment on the draft guidance. In response to a request for an 
extension, we extended the comment period for the draft guidance to 
October 16, 2023 (August 16, 2023, 88 FR 55702).
    FDA received two comment submissions on the draft guidance and 
those comments were considered as the guidance was finalized. For 
example, we revised the final guidance to clearly state that it does 
not cover APIs that are systemically absorbed because they are already 
addressed in other guidances. In addition, several editorial changes 
were made to improve clarity. The guidance announced in this notice 
finalizes the draft guidance dated June 8, 2023.
    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on ``Demonstrating Bioequivalence for Type 
A Medicated

[[Page 52060]]

Articles Containing Active Pharmaceutical Ingredient(s) Considered to 
be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic 
Bioavailability, and Are Locally Acting.'' 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. The 
previously approved 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. 3501-3521). The collections of information 
in section 512(n)(1) of the Federal Food Drug and Cosmetic Act (21 
U.S.C. 360b(n)(1)) have been approved under OMB control number 0910-
0669.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13690 Filed 6-20-24; 8:45 am]
BILLING CODE 4164-01-P