Notice2025-11928
Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases-Questions and Answers; Guidance for Industry; Availability
Primary source
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Published
June 27, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--Questions and Answers." This guidance assists in the clinical development of new antibacterial drugs to treat serious bacterial diseases in patients with unmet medical needs, including patients with a serious bacterial disease for which effective antibacterial drugs are limited or lacking. This guidance finalizes the draft guidance entitled "Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--Questions and Answers (Revision 1)" issued on May 24, 2022.
Full Text
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<title>Federal Register, Volume 90 Issue 122 (Friday, June 27, 2025)</title>
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[Federal Register Volume 90, Number 122 (Friday, June 27, 2025)]
[Notices]
[Pages 27621-27623]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11928]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0744]
Antibacterial Therapies for Patients With an Unmet Medical Need
for the Treatment of Serious Bacterial Diseases--Questions and Answers;
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 entitled
``Antibacterial Therapies for Patients With an Unmet Medical Need for
the Treatment of Serious Bacterial Diseases--Questions and Answers.''
This guidance assists in the clinical development of new antibacterial
drugs to treat serious bacterial diseases in patients with unmet
medical needs, including patients with a serious bacterial disease for
which effective antibacterial drugs are limited or lacking. This
guidance finalizes the draft guidance entitled ``Antibacterial
Therapies for Patients With an Unmet Medical Need for the Treatment of
Serious Bacterial Diseases--Questions and Answers (Revision 1)'' issued
on May 24, 2022.
DATES: The announcement of the guidance is published in the Federal
Register on June 27, 2025.
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: <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
[[Page 27622]]
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-2013-D-0744 for ``Antibacterial Therapies for Patients With an
Unmet Medical Need for the Treatment of Serious Bacterial Diseases--
Questions and Answers.'' 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)).
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: Ramya Gopinath, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Avenue, Bldg. 22, Rm. 6150, Silver Spring, MD 20993, 240-402-
5328.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Antibacterial Therapies for Patients With an Unmet Medical
Need for the Treatment of Serious Bacterial Diseases--Questions and
Answers.'' The Federal Food, Drug, and Cosmetic Act (FD&C Act) provides
several regulatory programs that are intended to expedite development
and review of drugs for serious conditions. For example, section 3042
of the 21st Century Cures Act (Pub. L. 114-255) established the limited
population pathway for antibacterial and antifungal drugs (LPAD), to
facilitate the development of certain drugs that are intended to treat
a serious or life-threatening infection in a limited population of
patients with unmet medical needs. The purpose of this guidance is to
assist sponsors in the clinical development of new antibacterial drugs
to treat serious bacterial diseases in patients with unmet medical
needs. FDA considered the applicability of Executive Order 14192, per
OMB guidance in M-25-20, and finds this action to be deregulatory in
nature.
This guidance finalizes the draft guidance entitled ``Antibacterial
Therapies for Patients With an Unmet Medical Need for the Treatment of
Serious Bacterial Diseases--Questions and Answers (Revision 1)'' issued
on May 24, 2022 (87 FR 31568). FDA provided clarifying edits to the
final guidance and included additional information after considering
comments received on the draft guidance. Edits included deleting the
nested noninferiority trials/superiority clinical trials section
because of difficulty in interpreting such trials, updating the add-on
superiority trial design section, and updating to include subjects with
infections across body sites in trials.
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 ``Antibacterial Therapies for Patients With
an Unmet Medical Need for the Treatment of Serious Bacterial Diseases--
Questions and Answers.'' 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 (44 U.S.C. 3501-3521). The collections of information in 21
CFR part 312 for the submissions of investigational new drug
applications, including clinical trial design, have been approved under
OMB control number 0910-0014. The collections of information in 21 CFR
part 314 pertaining to the submissions of new drug applications have
been approved under OMB control number 0910-0001. The collections of
information in the guidance for industry entitled ``Expedited Programs
for Serious Conditions--Drugs and Biologics'' have been approved under
OMB control number 0910-0765. The collections of information in 21 CFR
201.56 and 201.57 for the content and format requirements for labeling
of drugs and
[[Page 27623]]
biologics have been approved under OMB control number 0910-0572.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: June 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11928 Filed 6-26-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on June 27, 2025.
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