[Federal Register Volume 89, Number 211 (Thursday, October 31, 2024)]
[Notices]
[Pages 86809-86811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-25355]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


M13A Bioequivalence for Immediate-Release Solid Oral Dosage 
Forms; International Council for Harmonisation; Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 86810]]


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 entitled ``M13A 
Bioequivalence for Immediate-Release Solid Oral Dosage Forms'' and the 
supplemental document entitled ``M13A Bioequivalence for Immediate-
Release Solid Oral Dosage Forms: Questions and Answers.'' The guidance 
and supplemental questions and answers document were prepared under the 
auspices of the International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use (ICH). The guidance 
describes the scientific and technical aspects of study design and data 
analysis to support bioequivalence (BE) assessment of orally 
administered immediate-release solid oral dosage forms of 
pharmaceutical drugs, such as tablets, capsules, and granules/powders 
for oral suspension. The supplemental questions and answers document 
provides clarity to concepts covered in the guidance and rationales 
behind to facilitate implementation. The guidance is intended to 
provide globally harmonized scientific recommendations for conducting 
BE studies during both the development and postapproval phases of 
immediate-release solid oral dosage forms. The guidance replaces the 
draft guidance ``M13A Bioequivalence for Immediate-Release Solid Oral 
Dosage Forms'' issued on February 1, 2023.

DATES: The announcement of the guidance is published in the Federal 
Register on October 31, 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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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 ``M13A Bioequivalence for Immediate-Release Solid 
Oral Dosage Forms'' and ``M13A Bioequivalence for Immediate-Release 
Solid Oral Dosage Forms Questions and Answers.'' 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.
    <bullet> 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 this 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 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, <a href="/cdn-cgi/l/email-protection#ffb39a9694d1a5979e9198bf999b9ed197978cd1989089"><span class="__cf_email__" data-cfemail="216d44484a0f7b49404f46614745400f4949520f464e57">[email protected]</span></a>.
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6364, Silver Spring, MD 20993-0002, 301-796-5259, 
<a href="/cdn-cgi/l/email-protection#703a191c1c5e31141c1512150217301614115e1818035e171f06"><span class="__cf_email__" data-cfemail="0f45666363214e6b636a6d6a7d684f696b6e2167677c21686079">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``M13A Bioequivalence for Immediate-Release Solid Oral Dosage 
Forms'' and the supplemental document entitled ``M13A Bioequivalence 
for Immediate-Release Solid Oral Dosage Forms: Questions and Answers.'' 
The guidance and supplemental questions and answers document were 
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

[[Page 86811]]

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 the Federal Register of February 1, 2023 (88 FR 6750), FDA 
published a notice announcing the availability of a draft guidance 
entitled ``M13A Bioequivalence for Immediate-Release Solid Oral Dosage 
Forms; International Council for Harmonisation.'' The notice gave 
interested persons an opportunity to submit comments by April 3, 2023.
    After consideration of the comments received and revisions to the 
guideline, a final draft of the guideline was submitted to the ICH 
Assembly and endorsed by the regulatory agencies in July 2024.
    This guidance finalizes the draft guidance issued on February 1, 
2023. The final guidance includes clarification on the scientific and 
technical aspects of study design and data analysis to support BE 
assessment for orally administered immediate-release solid oral dosage 
forms. The supplemental questions and answers document provides further 
clarification and examples of the technical aspects of the main 
guidance in order to effectively implement the guidance. The 
internationally harmonized guidance and questions and answers document 
aim to increase the efficiency of drug development and accelerate the 
availability of safe and effective orally administered immediate-
release solid oral dosage forms.
    This 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 ``M13A Bioequivalence for Immediate-Release 
Solid Oral Dosage Forms''. The guidance and supplemental questions and 
answers document do not establish any rights for any person and are 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 21 CFR 314.94 for content and format for BE studies submitted under 
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 good clinical practice have been approved under OMB 
control number 0910-0014.

III. Electronic Access

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

    Dated: October 23, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-25355 Filed 10-30-24; 8:45 am]
BILLING CODE 4164-01-P


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