[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draft guidance ``M13A Bioequivalence for Immediate-Release Solid Oral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:
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 ``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.
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, [email protected].
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,
[email protected].
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
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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]
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