21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria Web Page; Request for Comments, 24844-24846 [2024-07495]
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24844
Federal Register / Vol. 89, No. 69 / Tuesday, April 9, 2024 / Notices
Food and Drug Administration
written/paper submission and in the
manner detailed below (see ‘‘Written/
Paper Submissions’’ and
‘‘Instructions’’).
[Docket No. FDA–2017–N–5925]
Written/Paper Submissions
21st Century Cures Act: Annual
Compilation of Notices of Updates
From the Susceptibility Test
Interpretive Criteria Web Page;
Request for Comments
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–
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
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://
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
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).
SUMMARY:
This notice is published in the
Federal Register on April 9, 2024.
ADDRESSES: You may submit either
electronic or written comments and
information as follows:
DATES:
ddrumheller on DSK120RN23PROD with NOTICES1
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
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www.govinfo.gov/content/pkg/FR-201509-18/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.
FOR FURTHER INFORMATION CONTACT:
Deborah (Wang) 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, Deborah.Wang@fda.hhs.gov.
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
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 https://www.fda.gov/STIC.
E:\FR\FM\09APN1.SGM
09APN1
Federal Register / Vol. 89, No. 69 / Tuesday, April 9, 2024 / Notices
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
(https://www.federalregister.gov/
documents/2018/03/01/2018-04175/
susceptibility-test-interpretive-criteriarecognized-and-listed-on-thesusceptibility-test). 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: https://
www.fda.gov/drugs/developmentresources/notice-updates. 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 (https://
www.fda.gov/STIC) 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
24845
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,
2023: Susceptibility Test Interpretive
Criteria Web Page
A. Updates to Standards Recognition
As of April 21, 2023, the following
standards are no longer recognized:
‘‘Clinical and Laboratory Standards
Institute (CLSI). Performance Standards
for Antimicrobial Susceptibility Testing.
32nd ed. CLSI supplement M100.
Wayne, PA: Clinical and Laboratory
Standards Institute; 2022.’’
As of April 21, 2023, with certain
exceptions, FDA recognizes the
standards published in: ‘‘Clinical and
Laboratory Standards Institute (CLSI).
Performance Standards for
Antimicrobial Susceptibility Testing.
33rd ed. CLSI supplement M100.
Wayne, PA: Clinical and Laboratory
Standards Institute; 2023.’’
B. Updates by Drug
ddrumheller on DSK120RN23PROD with NOTICES1
TABLE 1—NOTICES OF UPDATES TO RECOGNIZED OR UPDATED SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA (STIC) BY
DRUG 1
Drug
Route of administration
Action taken
Therapeutic category
Amikacin ........................
Injection ........................
Antibacterial .................
4/21/2023
Cefepime .......................
Injection ........................
Antibacterial .................
6/21/2023
Cefiderocol ....................
Injection ........................
Antibacterial .................
1/31/2023
Colistimethate ................
Injection ........................
Antibacterial .................
1/17/2023
Fluconazole ...................
Injection, Oral ...............
Antifungal .....................
8/10/2023
Gentamicin ....................
Injection ........................
Antibacterial .................
4/21/2023
Lefamulin .......................
Oral, Injection ...............
Antibacterial .................
2/16/2023
Piperacillin and
Tazobactam.
Injection ........................
FDA does not recognize M100 standard (MIC
and disk diffusion) for Enterobacterales and
Pseudomonas aeruginosa.
FDA recognizes M100 susceptible-dose dependent standard (MIC and disk diffusion) for
Enterobacterales.
FDA recognizes M100 disk diffusion standards
for Enterobacterales.
FDA does not recognize M100 standard (MIC)
for
Enterobacterales,
Pseudomonas
aeruginosa, or Acinetobacter spp. (Rationale
available at https://www.fda.gov/drugs/development-resources/fda-rationale-polymyxinbreakpoints-enterobacterales-pseudomonasaeruginosa-and-acinetobacter-spp.).
FDA recognizes M27M44S susceptible-dose
dependent standard (MIC and disk diffusion)
for Candida species.
FDA does not recognize M100 standard (MIC
and disk diffusion) for Enterobacterales and
Pseudomonas aeruginosa.
FDA recognizes M100 standard (MIC and disk
diffusion)
for
Staphylococcus
aureus
(methicillin-susceptible isolates), Streptococcus pneumoniae, and Haemophilus
influenzae.
FDA does not recognize M100 standard (MIC
and disk diffusion) for Pseudomonas
aeruginosa.
Antibacterial .................
4/21/2013
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Date
24846
Federal Register / Vol. 89, No. 69 / Tuesday, April 9, 2024 / Notices
TABLE 1—NOTICES OF UPDATES TO RECOGNIZED OR UPDATED SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA (STIC) BY
DRUG 1—Continued
Drug
Route of administration
Action taken
Therapeutic category
Date
Piperacillin and
Tazobactam.
Injection ........................
Antibacterial .................
1/17/2023
Plazomicin .....................
Injection ........................
Antibacterial .................
4/21/2023
Polymyxin B ..................
Injection ........................
Antibacterial .................
1/17/2023
Rezafungin ....................
Injection ........................
Antifungal .....................
4/18/2023
Sulbactam and
Durlobactam.
Injection ........................
Antibacterial .................
5/25/2023
Tobramycin ....................
Injection ........................
FDA has updated STIC (MIC and disk diffusion)
for Enterobacterales. FDA has recognized
M100 standard for susceptible and resistant
breakpoints and updated an intermediate
breakpoint. FDA does not recognize M100
standard for a susceptible dose dependent
breakpoint. (Rationale available at https://
www.fda.gov/drugs/development-resources/
fda-rationale-piperacillin-tazobactambreakpoints-enterobacterales.).
FDA recognizes M100 standard (MIC and disk
diffusion) for Enterobacterales.
FDA does not recognize M100 standard (MIC)
for
Enterobacterales,
Pseudomonas
aeruginosa, or Acinetobacter spp. (Rationale
available at https://www.fda.gov/drugs/development-resources/fda-rationale-polymyxinbreakpoints-enterobacterales-pseudomonasaeruginosa-and-acinetobacter-spp.).
FDA identified STIC (MIC and disk diffusion) for
C. albicans, C. glabrata, and C. tropicalis.
FDA has reviewed STIC (MIC) for C.
parapsilosis, and the M27M44S standard is
recognized.
FDA identified STIC (disk diffusion) for C.
parapsilosis.
FDA identified STIC (MIC and disk diffusion) for
Acinetobacter baumannii-calcoaceticus complex.
FDA does not recognize M100 standard (MIC
and disk diffusion) for Enterobacterales and
Pseudomonas aeruginosa.
Antibacterial .................
4/21/2023
1 M100 standard in the table refers to Clinical and Laboratory Standards Institute (CLSI) Performance Standards for Antimicrobial Susceptibility
Testing, 33rd ed. CLSI supplement M100; 2023.
Dated: April 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
would constitute a clearly unwarranted
invasion of personal privacy.
[FR Doc. 2024–07495 Filed 4–8–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
ddrumheller on DSK120RN23PROD with NOTICES1
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
VerDate Sep<11>2014
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Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Hispanic Community Health Study—Study
of Latinos (HCHS–SOL) Coordinating Center.
Date: April 30, 2024.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
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Place: National Institutes of Health,
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MD 20892 (Virtual Meeting).
Contact Person: Susan Wohler Sunnarborg,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA National, Heart,
Lung, and Blood Institute, National Institutes
of Health, 6705 Rockledge Drive, Room 208–
Z, Bethesda, MD 20892, (301) 827–7987,
susan.sunnarborg@nih.gov.
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and Resources Research, National Institutes
of Health, HHS)
PO 00000
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Dated: April 4, 2024.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–07499 Filed 4–8–24; 8:45 am]
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E:\FR\FM\09APN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 69 (Tuesday, April 9, 2024)]
[Notices]
[Pages 24844-24846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07495]
[[Page 24844]]
-----------------------------------------------------------------------
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; Request
for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
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 April 9,
2024.
ADDRESSES: You may submit either electronic or written comments and
information 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 below (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-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 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.
FOR FURTHER INFORMATION CONTACT: Deborah (Wang) 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, [email protected].
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 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 https://www.fda.gov/STIC.
[[Page 24845]]
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 (https://www.federalregister.gov/documents/2018/03/01/2018-04175/susceptibility-test-interpretive-criteria-recognized-and-listed-on-the-susceptibility-test). 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: https://www.fda.gov/drugs/development-resources/notice-updates. 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 (https://www.fda.gov/STIC) 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, 2023: Susceptibility Test
Interpretive Criteria Web Page
A. Updates to Standards Recognition
As of April 21, 2023, the following standards are no longer
recognized: ``Clinical and Laboratory Standards Institute (CLSI).
Performance Standards for Antimicrobial Susceptibility Testing. 32nd
ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards
Institute; 2022.''
As of April 21, 2023, with certain exceptions, FDA recognizes the
standards published in: ``Clinical and Laboratory Standards Institute
(CLSI). Performance Standards for Antimicrobial Susceptibility Testing.
33rd ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory
Standards Institute; 2023.''
B. Updates by Drug
Table 1--Notices of Updates to Recognized or Updated Susceptibility Test Interpretive Criteria (STIC) by Drug
\1\
----------------------------------------------------------------------------------------------------------------
Route of Therapeutic
Drug administration Action taken category Date
----------------------------------------------------------------------------------------------------------------
Amikacin....................... Injection......... FDA does not recognize Antibacterial..... 4/21/2023
M100 standard (MIC and
disk diffusion) for
Enterobacterales and
Pseudomonas aeruginosa.
Cefepime....................... Injection......... FDA recognizes M100 Antibacterial..... 6/21/2023
susceptible-dose
dependent standard
(MIC and disk
diffusion) for
Enterobacterales.
Cefiderocol.................... Injection......... FDA recognizes M100 Antibacterial..... 1/31/2023
disk diffusion
standards for
Enterobacterales.
Colistimethate................. Injection......... FDA does not recognize Antibacterial..... 1/17/2023
M100 standard (MIC)
for Enterobacterales,
Pseudomonas
aeruginosa, or
Acinetobacter spp.
(Rationale available
at https://www.fda.gov/drugs/development-resources/fda-rationale-polymyxin-breakpoints-enterobacterales-pseudomonas-aeruginosa-and-acinetobacter-spp spp.).
Fluconazole.................... Injection, Oral... FDA recognizes M27M44S Antifungal........ 8/10/2023
susceptible-dose
dependent standard
(MIC and disk
diffusion) for Candida
species.
Gentamicin..................... Injection......... FDA does not recognize Antibacterial..... 4/21/2023
M100 standard (MIC and
disk diffusion) for
Enterobacterales and
Pseudomonas aeruginosa.
Lefamulin...................... Oral, Injection... FDA recognizes M100 Antibacterial..... 2/16/2023
standard (MIC and disk
diffusion) for
Staphylococcus aureus
(methicillin-
susceptible isolates),
Streptococcus
pneumoniae, and
Haemophilus influenzae.
Piperacillin and Tazobactam.... Injection......... FDA does not recognize Antibacterial..... 4/21/2013
M100 standard (MIC and
disk diffusion) for
Pseudomonas aeruginosa.
[[Page 24846]]
Piperacillin and Tazobactam.... Injection......... FDA has updated STIC Antibacterial..... 1/17/2023
(MIC and disk
diffusion) for
Enterobacterales. FDA
has recognized M100
standard for
susceptible and
resistant breakpoints
and updated an
intermediate
breakpoint. FDA does
not recognize M100
standard for a
susceptible dose
dependent breakpoint.
(Rationale available
at https://www.fda.gov/drugs/development-resources/fda-rationale-piperacillin-tazobactam-breakpoints-enterobacterales enterobacterales.).
Plazomicin..................... Injection......... FDA recognizes M100 Antibacterial..... 4/21/2023
standard (MIC and disk
diffusion) for
Enterobacterales.
Polymyxin B.................... Injection......... FDA does not recognize Antibacterial..... 1/17/2023
M100 standard (MIC)
for Enterobacterales,
Pseudomonas
aeruginosa, or
Acinetobacter spp.
(Rationale available
at https://www.fda.gov/drugs/development-resources/fda-rationale-polymyxin-breakpoints-enterobacterales-pseudomonas-aeruginosa-and-acinetobacter-spp spp.).
Rezafungin..................... Injection......... FDA identified STIC Antifungal........ 4/18/2023
(MIC and disk
diffusion) for C.
albicans, C. glabrata,
and C. tropicalis.
FDA has reviewed STIC
(MIC) for C.
parapsilosis, and the
M27M44S standard is
recognized..
FDA identified STIC
(disk diffusion) for
C. parapsilosis..
Sulbactam and Durlobactam...... Injection......... FDA identified STIC Antibacterial..... 5/25/2023
(MIC and disk
diffusion) for
Acinetobacter
baumannii-
calcoaceticus complex.
Tobramycin..................... Injection......... FDA does not recognize Antibacterial..... 4/21/2023
M100 standard (MIC and
disk diffusion) for
Enterobacterales and
Pseudomonas aeruginosa.
----------------------------------------------------------------------------------------------------------------
\1\ M100 standard in the table refers to Clinical and Laboratory Standards Institute (CLSI) Performance
Standards for Antimicrobial Susceptibility Testing, 33rd ed. CLSI supplement M100; 2023.
Dated: April 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-07495 Filed 4-8-24; 8:45 am]
BILLING CODE 4164-01-P
