Federal Register, Volume 90 Issue 104 (Monday, June 2, 2025)

[Federal Register Volume 90, Number 104 (Monday, June 2, 2025)]
[Notices]
[Pages 23339-23340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-09900]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-0093]


M13B Bioequivalence for Immediate-Release Solid Oral Dosage 
Forms: Additional Strengths Biowaiver; International Council for 
Harmonisation; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``M13B 
Bioequivalence for Immediate-Release Solid Oral Dosage Forms: 
Additional Strengths Biowaiver.'' The draft guidance was prepared under 
the auspices of the International Council for Harmonisation of 
Technical Requirements for Pharmaceuticals for Human Use (ICH). The 
draft guidance is the second in the ICH M13 series of guidances and 
describes the scientific and technical aspects of study design and data 
analysis to support bioequivalence (BE) assessment for additional 
strengths of orally administered immediate-release (IR) solid oral 
dosage forms (i.e., tablets, capsules, and granules/powders for oral 
suspension), including considerations for biowaivers. The intent of 
this draft guidance is to provide harmonized criteria and data that 
support waivers for drug applications with multiple strengths when in 
vivo BE has been demonstrated for at least one strength using the 
principles outlined in the final guidance ``M13A Bioequivalence for 
Immediate-Release Solid Oral Dosage Forms'' published in October 2024.

DATES: Submit either electronic or written comments on the draft 
guidance by August 1, 2025 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2023-D-0093 for ``M13B Bioequivalence for Immediate-Release Solid 
Oral Dosage Forms: Additional Strengths Biowaiver.'' 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://

[[Page 23340]]

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: 
    Regarding the guidance: Lei Zhang, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
75, Rm. 4724, Silver Spring, MD 20993-0002, 301-796-1635, 
[email protected].
    Regarding the ICH: Brooke Dal Santo, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6304, Silver Spring, MD 20993-0002, 301-348-1967, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``M13B Bioequivalence for Immediate-Release Solid Oral Dosage 
Forms: Additional Strengths Biowaiver.'' The draft guidance was 
prepared under the auspices of ICH. ICH seeks to achieve greater 
regulatory harmonization worldwide to ensure that safe, effective, 
high-quality medicines are developed, registered, and maintained in the 
most resource-efficient manner.
    By harmonizing the regulatory requirements in regions around the 
world, ICH guidelines enhance global drug development, improve 
manufacturing standards, and increase the availability of medications. 
For example, ICH guidelines have substantially reduced duplicative 
clinical studies, prevented unnecessary animal studies, standardized 
the reporting of important safety information, and standardized 
marketing application submissions.
    The six Founding Members of the ICH are the FDA; the Pharmaceutical 
Research and Manufacturers of America; the European Commission; the 
European Federation of Pharmaceutical Industries Associations; the 
Japanese Ministry of Health, Labour, and Welfare; and the Japanese 
Pharmaceutical Manufacturers Association. The Standing Members of the 
ICH Association include Health Canada and Swissmedic. ICH membership 
continues to expand to include other regulatory authorities and 
industry associations from around the world (refer to https://www.ich.org/).
    ICH works by engaging global regulatory and industry experts in a 
detailed, science-based, and consensus-driven process that results in 
the development of ICH guidelines. The regulators around the world are 
committed to consistently adopting these consensus-based guidelines, 
realizing the benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in 
the development of each of the ICH guidelines, which FDA then adopts 
and issues as guidance for industry. FDA's guidance documents do not 
establish legally enforceable responsibilities. Instead, they describe 
the Agency's current thinking on a topic and should be viewed only as 
recommendations, unless specific regulatory or statutory requirements 
are cited.
    In February 2025, the ICH Assembly endorsed the draft guideline 
entitled ``M13B Bioequivalence for Immediate-Release Solid Oral Dosage 
Forms: Additional Strengths Biowaiver'' and agreed that the guideline 
should be made available for public comment. The draft guideline is the 
product of the M13 Multidisciplinary Expert Working Group of the ICH. 
Comments about this draft will be considered by FDA and the M13 
Multidisciplinary Expert Working Group.
    The draft guidance provides guidance on scientific and technical 
aspects of demonstrating BE for additional strengths of IR solid oral 
dosage forms, including internationally harmonized criteria for 
biowaivers. The draft guidance builds upon BE principles discussed in 
the final guidance ``M13A Bioequivalence for Immediate-Release Solid 
Oral Dosage Forms'' published in October 2024.
    As we develop any final guidance on this topic, FDA will consider 
comments on the applicability of Executive Order 14192, per OMB 
guidance M-25-20, and in particular, on any costs or cost savings.
    This draft guidance has been left in the original ICH format. The 
final guidance will be reformatted and edited to conform with FDA's 
good guidance practices regulation (21 CFR 10.115) and style before 
publication. The draft guidance, when finalized, will represent the 
current thinking of FDA on ``M13B Bioequivalence for Immediate-Release 
Solid Oral Dosage Forms: Additional Strengths Biowaiver.'' 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 
for content and format for BE studies submitted under new and 
abbreviated new drug applications have been approved under OMB control 
number 0910-0001. The collections of information for the implementation 
of improved quality and integrity of the study data approaches 
pertaining to bioequivalence of additional strengths of immediate-
release solid oral dosage forms have been approved under OMB control 
number 0910-0014.

III. Electronic Access

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

    Dated: May 27, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-09900 Filed 5-30-25; 8:45 am]
BILLING CODE 4164-01-P