Notice2025-17292
M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver; International Council for Harmonisation; Draft Guidance for Industry; Reopening of the Comment Period
Primary source
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Published
September 9, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the draft guidance announced in the notice entitled "M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver; International Council for Harmonisation; Draft Guidance for Industry," published in the Federal Register of June 2, 2025. The Agency is taking this action to allow interested persons additional time to submit comments.
Full Text
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<title>Federal Register, Volume 90 Issue 172 (Tuesday, September 9, 2025)</title>
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[Federal Register Volume 90, Number 172 (Tuesday, September 9, 2025)]
[Notices]
[Page 43453]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-17292]
[[Page 43453]]
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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Harmonisation; Draft Guidance for Industry; Reopening of the Comment
Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; reopening of the comment period.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
reopening the comment period for the draft guidance announced in the
notice entitled ``M13B Bioequivalence for Immediate-Release Solid Oral
Dosage Forms: Additional Strengths Biowaiver; International Council for
Harmonisation; Draft Guidance for Industry,'' published in the Federal
Register of June 2, 2025. The Agency is taking this action to allow
interested persons additional time to submit comments.
DATES: FDA is reopening the comment period for the draft guidance
announced in the notice published on June 2, 2025 (90 FR 23339). Submit
either electronic or written comments on the draft guidance by October
9, 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 ``M13B Bioequivalence for Immediate-Release Solid
Oral Dosage Forms: Additional Strengths Biowaiver; International
Council for Harmonisation; Draft Guidance for Industry.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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)).
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#83cfe6eac8add9ebe2ede4c3e5e7e2adebebf0ade4ecf5"><span class="__cf_email__" data-cfemail="e2ae878ba9ccb88a838c85a2848683cc8a8a91cc858d94">[email protected]</span></a>.
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,
<a href="/cdn-cgi/l/email-protection#2062524f4f4b450e64414c73414e544f604644410e4848530e474f56"><span class="__cf_email__" data-cfemail="1e5c6c7171757b305a7f724d7f706a715e787a7f3076766d30797168">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 2, 2025 (90
FR 23339), FDA published a notice with a 30-day period to provide
comments on the draft guidance for industry entitled, ``M13B
Bioequivalence for Immediate-Release Solid Oral Dosage Forms:
Additional Strengths Biowaiver.'' Interested persons were originally
given until August 1, 2025, to submit comments to the docket. The
Agency is reopening the comment period for the draft guidance until
October 9, 2025. The Agency is planning to host a webinar on September
11, 2025, to present an overview of the draft guidance, explain the
current scientific thinking behind the draft guidance, and highlight
the main areas that differ from FDA's current guidance on selected
topics. The Agency believes that an additional 30 days will allow
adequate time for interested persons to submit comments after the
webinar.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-17292 Filed 9-8-25; 8:45 am]
BILLING CODE 4164-01-P
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