Notice2026-09438
21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria web page
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Published
May 12, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of the Agency's annual compilation of notices of updates to the Agency's Susceptibility Test Interpretive Criteria web page. The Agency established the Susceptibility Test Interpretive Criteria web page on December 13, 2017, and since establishment has provided updates to both the format of the web pages and the susceptibility test interpretive criteria identified and recognized by FDA on the web pages. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).
Full Text
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<title>Federal Register, Volume 91 Issue 91 (Tuesday, May 12, 2026)</title>
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[Federal Register Volume 91, Number 91 (Tuesday, May 12, 2026)]
[Notices]
[Pages 25894-25896]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-09438]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-5925]
21st Century Cures Act: Annual Compilation of Notices of Updates
From the Susceptibility Test Interpretive Criteria web page
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of the Agency's annual compilation of
notices of updates to the Agency's Susceptibility Test Interpretive
Criteria web page. The Agency established the Susceptibility Test
Interpretive Criteria web page on December 13, 2017, and since
establishment has provided updates to both the format of the web pages
and the susceptibility test interpretive criteria identified and
recognized by FDA on the web pages. FDA is publishing this notice in
accordance with procedures established by the 21st Century Cures Act
(Cures Act).
DATES: This notice is published in the Federal Register on May 12,
2026.
ADDRESSES: You may submit either electronic or written comments and
information 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 below (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-2017-N-5925 for ``Susceptibility Test Interpretive Criteria
Recognized and Listed on the Susceptibility Test Interpretive web page;
Request for Comments.'' 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.gpo.gov/fdsys/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.
FOR FURTHER INFORMATION CONTACT: Deborah Kim, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6349, Silver Spring, MD 20993-0002, 301-
796-9053, <a href="/cdn-cgi/l/email-protection#91d5f4f3fee3f0f9bfc6f0fff6d1f7f5f0bff9f9e2bff6fee7"><span class="__cf_email__" data-cfemail="155170777a67747d3b42747b72557371743b7d7d663b727a63">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 511A of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360a-2), as added by section 3044 of the Cures Act (Pub. L.
114-255), was signed into law on December 13, 2016. This provision
clarified FDA's authority to identify and efficiently update
susceptibility test interpretive criteria, including through the
recognition by FDA of standards established by standards development
organizations (SDOs). It also clarified that sponsors of antimicrobial
susceptibility testing devices may rely upon listed susceptibility test
interpretive criteria to support premarket authorization of their
devices, provided they meet certain conditions, which allows for a more
streamlined process for incorporating up-to-date information into such
devices.
In the Federal Register notice of December 13, 2017 (82 FR 58617),
FDA announced the establishment of the Susceptibility Test Interpretive
Criteria web page. This web page recognizes susceptibility test
interpretive criteria established by an SDO that fulfills the
requirements under section 511A(b)(2)(A) of the FD&C Act; identifies
when FDA does not recognize, in whole or in part, susceptibility test
interpretive criteria established by an SDO; and lists susceptibility
test interpretive criteria identified by FDA outside the SDO process.
The susceptibility test interpretive criteria listed by FDA on the
Susceptibility Test
[[Page 25895]]
Interpretive Criteria web page is deemed to be recognized as a standard
under section 514(c)(1) of the FD&C Act (21 U.S.C. 360d(c)(1)). The
Susceptibility Test Interpretive Criteria web page can be found at
<a href="https://www.fda.gov/STIC">https://www.fda.gov/STIC</a>.
On March 1, 2018, FDA published a notice in the Federal Register
(83 FR 8883) requesting comments on FDA's initial susceptibility test
interpretive criteria recognition and listing determinations on the
Susceptibility Test Interpretive Criteria web page (<a href="https://www.federalregister.gov/documents/2018/03/01/2018-04175/susceptibility-test-interpretive-criteria-recognized-and-listed-on-the-susceptibility-test">https://www.federalregister.gov/documents/2018/03/01/2018-04175/susceptibility-test-interpretive-criteria-recognized-and-listed-on-the-susceptibility-test</a>). FDA may consider information provided by interested third
parties as a basis for evaluating new or updated interpretive criteria
standards (section 511A(c)(2)(B) of the FD&C Act); third parties should
submit any information they wish to convey to the Agency to Docket No.
FDA-2017-N-5925. If comments are received, FDA will review those
comments and will make, as appropriate, updates to the recognized
standards or susceptibility test interpretive criteria.
At least every 6 months after the establishment of the
Susceptibility Test Interpretive Criteria web page, FDA is required, as
appropriate to: (1) publish on that web page a notice recognizing new
or updated susceptibility test interpretive criteria standards, or
recognizing or declining to recognize parts of standards; (2) withdraw
recognition of susceptibility test interpretive criteria standards, or
parts of standards; and (3) make any other necessary updates to the
lists published on the Susceptibility Test Interpretive Criteria web
page (section 511A(c)(1)(A) of the FD&C Act). FDA has provided notices
of updates on the Susceptibility Test Interpretive Criteria web page,
which can be found here: <a href="https://www.fda.gov/drugs/development-resources/notice-updates">https://www.fda.gov/drugs/development-resources/notice-updates</a>. Interested parties may also sign up to
receive emails informing them of these updates as they occur by using
the link provided either on the main Susceptibility Test Interpretive
Criteria web page (<a href="https://www.fda.gov/STIC">https://www.fda.gov/STIC</a>) or on the updates page.
Once a year, FDA is required to compile the new notices published
on the Susceptibility Test Interpretive Criteria web page, publish them
in the Federal Register, and provide for public comment (see section
511A(c)(3) of the FD&C Act). This Federal Register notice satisfies
that requirement. If comments are received, FDA will review them and
make updates to the recognized standards or susceptibility test
interpretive criteria as needed.
II. Annual Compilation of Notices, 2025: Susceptibility Test
Interpretive Criteria web page
A. Updates to Standards Recognition
As of February 12, 2025, the following standard is no longer
recognized:
<bullet> Clinical and Laboratory Standards Institute (CLSI).
Performance Standards for Antimicrobial Susceptibility Testing. 34th
ed. CLSI supplement M100; 2024.
As of February 12, 2025, unless specific exceptions and additions
are identified, FDA fully recognizes the standards published in:
<bullet> Clinical and Laboratory Standards Institute (CLSI).
Performance Standards for Antimicrobial Susceptibility Testing. 35th
ed. CLSI supplement M100; 2025.
As of January 16, 2025, unless specific exceptions and additions
are identified, FDA fully recognizes the standards published in:
<bullet> Clinical and Laboratory Standards Institute (CLSI).
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of
Infrequently Isolated or Fastidious Bacteria. 3rd ed. CLSI document
M45; 2015.
<bullet> Clinical and Laboratory Standards Institute (CLSI).
Performance Standards for Susceptibility Testing of Mycobacteria,
Nocardia spp., and Other Aerobic Actinomycetes. 2nd Ed. CLSI document
M24S; 2023.
<bullet> Clinical and Laboratory Standards Institute (CLSI).
Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas;
Approved Guideline. 1st ed. CLSI document M43-A; 2011.
<bullet> Clinical and Laboratory Standards Institute (CLSI).
Performance Standards for Antifungal Susceptibility Testing of
Filamentous Fungi. 3rd Ed. CLSI document M38M51S; 2022.
B. Updates by Drug
Table 1--Notices of Updates to Recognized or Updated Susceptibility Test Interpretive Criteria (STIC) by Drug
\1\
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Route of Therapeutic
Drug administration Action taken category Date
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Amikacin.................... Injection...... FDA recognizes M100 standard Antibacterial....... 10/22/2025
(MIC and disk diffusion) for
Enterobacterales
andPseudomonas aeruginosa.
(Rationale available at
<a href="https://www.fda.gov/drugs/development-resources/fda-rationale-recognition-decision-gentamicin-tobramycin-and-amikacin-enterobacterales-and-p">https://www.fda.gov/drugs/development-resources/fda-rationale-recognition-decision-gentamicin-tobramycin-and-amikacin-enterobacterales-and-p</a>).
Amoxicillin and clavulanate. Oral........... FDA recognizes M100 standard Antibacterial....... 5/15/2025
(MIC) for Haemophilus
influenzae. (Rationale
available at <a href="https://www.fda.gov/drugs/development-resources/fda-rationale-recognition-decision-amoxicillin-and-clavulanate-against-haemophilus-influenzae">https://www.fda.gov/drugs/development-resources/fda-rationale-recognition-decision-amoxicillin-and-clavulanate-against-haemophilus-influenzae</a> influenzae).
Azithromycin................ Oral, Injection FDA identified STIC (MIC) for Antibacterial....... 1/16/2025
Neisseria gonorrhoeae.
(Rationale available at
<a href="https://www.fda.gov/drugs/development-resources/fda-rationale-breakpoints-recognition-decision-azithromycin-and-neisseria-gonorrhoeae">https://www.fda.gov/drugs/development-resources/fda-rationale-breakpoints-recognition-decision-azithromycin-and-neisseria-gonorrhoeae</a> gonorrhoeae).
Aztreonam and avibactam..... Injection...... FDA identified STIC (MIC and Antibacterial....... 2/07/2025
disk diffusion) for
Enterobacterales.
Cefepime.................... Injection...... FDA recognizes M100 standard Antibacterial....... 1/16/2025
(MIC and disk diffusion) for
P. aeruginosa.
Ceftazidime................. Injection...... FDA recognizes M100 standard Antibacterial....... 1/16/2025
(MIC and disk diffusion) for
P. aeruginosa.
Chloramphenicol............. Injection...... FDA does not recognize M45 Antibacterial....... 1/16/2025
standard for Abiotrophia
spp., Granulicatella spp.,
and Aeromonas spp.
[[Page 25896]]
Clindamycin................. Injection, Oral FDA does not recognize M45 Antibacterial....... 1/16/2025
standard for Moraxella
catarrhalis.
Colistimethate.............. Injection...... FDA recognizes STIC (MIC) for Antibacterial....... 2/12/2025
Enterobacterales, P.
aeruginosa, and Acinetobacter
spp. (Rationale available at
<a href="https://www.fda.gov/drugs/development-resources/fda-rationale-breakpoints-recognition-decision-polymyxins-and-enterobacterales-pseudomonas">https://www.fda.gov/drugs/development-resources/fda-rationale-breakpoints-recognition-decision-polymyxins-and-enterobacterales-pseudomonas</a>).
Fosfomycin.................. Injection...... FDA identified STIC (MIC and Antibacterial....... 10/22/2025
disk diffusion) for E. coli
and K. pneumoniae.
Gentamicin.................. Injection...... FDA recognizes M100 standard Antibacterial....... 10/22/2025
(MIC and disk diffusion) for
Enterobacterales. FDA removed
STIC for Pseudomonas
aeruginosa (Rationale
available at <a href="https://www.fda.gov/drugs/development-resources/fda-rationale-recognition-decision-gentamicin-tobramycin-and-amikacin-enterobacterales-and-p">https://www.fda.gov/drugs/development-resources/fda-rationale-recognition-decision-gentamicin-tobramycin-and-amikacin-enterobacterales-and-p</a> p).
Gepotidacin................. Oral........... FDA identified STIC (MIC and Antibacterial....... 12/11/2025
disk diffusion) for Neisseria
gonorrhoeae.
Gepotidacin................. Oral........... FDA identified STIC (MIC and Antibacterial....... 3/25/2025
disk diffusion) for
Enterobacterales,
Staphylococcus saprophyticus,
and Enterococcus faecalis.
Isavuconazonium sulfate *... Oral, Injection FDA recognizes M38M51S Antifungal.......... 8/22/2025
standard for Aspergillus
fumigatus. (Rational
available at <a href="https://www.fda.gov/drugs/development-resources/fda-rationale-recognition-decision-isavuconazonium-sulfate">https://www.fda.gov/drugs/development-resources/fda-rationale-recognition-decision-isavuconazonium-sulfate</a>).
Piperacillin................ Injection...... FDA recognizes M100 standard Antibacterial....... 9/23/2025
(MIC and disk diffusion) for
Enterobacterales, P.
aeruginosa and Acinetobacter
spp.
Piperacillin and Tazobactam. Injection...... FDA recognizes M100 standard Antibacterial....... 1/16/2025
(MIC and disk diffusion) for
P. aeruginosa. (Rationale
available at <a href="https://www.fda.gov/drugs/development-resources/fda-rationale-breakpoints-recognition-decision-piperacillin-tazobactam-and-pseudomonas-aeruginosa">https://www.fda.gov/drugs/development-resources/fda-rationale-breakpoints-recognition-decision-piperacillin-tazobactam-and-pseudomonas-aeruginosa</a> aeruginosa).
Polymyxin B Sulfate......... Injection...... FDA recognizes STIC (MIC) for Antibacterial....... 2/12/2025
Enterobacterales, P.
aeruginosa, and Acinetobacter
spp (Rational available at
<a href="https://www.fda.gov/drugs/development-resources/fda-rationale-breakpoints-recognition-decision-polymyxins-and-enterobacterales-pseudomonas">https://www.fda.gov/drugs/development-resources/fda-rationale-breakpoints-recognition-decision-polymyxins-and-enterobacterales-pseudomonas</a>).
Rifampin.................... Oral, Injection FDA does not recognize M45 Antibacterial....... 1/16/2025
standard for HACEK group:
Haemophilus spp.,
Aggregatibacter spp.,
Cardiobacterium hominis,
Eikenella corrodens and
Kingella spp., and for
Moraxella catarrhalis.
Tobramycin.................. Injection...... FDA recognizes M100 standard Antibacterial....... 10/22/2025
(MIC and disk diffusion) for
Enterobacterales and
Pseudomonas aeruginosa
(Rationale available at
<a href="https://www.fda.gov/drugs/development-resources/fda-rationale-recognition-decision-gentamicin-tobramycin-and-amikacin-enterobacterales-and-p">https://www.fda.gov/drugs/development-resources/fda-rationale-recognition-decision-gentamicin-tobramycin-and-amikacin-enterobacterales-and-p</a>).
Voriconazole................ Tablets, Powder FDA recognizes M38M51S Antifungal.......... 1/16/2025
for Oral standard for Aspergillus
Suspension, fumigatus. (Rationale
Injection. available at <a href="https://www.fda.gov/drugs/development-resources/fda-rationale-recognition-decision-voriconazole">https://www.fda.gov/drugs/development-resources/fda-rationale-recognition-decision-voriconazole</a> voriconazole).
Zoliflodacin................ Oral........... FDA identified STIC (MIC) for Antibacterial....... 12/15/2025
Neisseria gonorrhoeae.
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\1\ M100 standard in the table refers to CLSI Performance Standards for Antimicrobial Susceptibility Testing.
35th ed. CLSI supplement M100; 2025.
M45 standard refers to CLSI Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently
Isolated or Fastidious Bacteria. 3rd ed. CLSI document M45; 2015. M38M51S standard in the table refers to CLSI
Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi. 3rd Ed. CLSI document
M38M51S; 2022.
* Isavuconazonium sulfate is the prodrug of isavuconazole.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-09438 Filed 5-11-26; 8:45 am]
BILLING CODE 4164-01-P
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