Notice2024-07495
21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria Web Page; Request for Comments
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Published
April 9, 2024
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 89 Issue 69 (Tuesday, April 9, 2024)</title>
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[Federal Register Volume 89, Number 69 (Tuesday, April 9, 2024)]
[Notices]
[Pages 24844-24846]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-07495]
[[Page 24844]]
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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; Request
for Comments
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 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:
<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.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.
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, <a href="/cdn-cgi/l/email-protection#c084a5a2afb2a1a8ee97a1aea780a6a4a1eea8a8b3eea7afb6"><span class="__cf_email__" data-cfemail="165273747964777e384177787156707277387e7e6538717960">[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 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>.
[[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 (<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, 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\
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Route of Therapeutic
Drug administration Action taken category Date
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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 <a href="https://www.fda.gov/drugs/development-resources/fda-rationale-polymyxin-breakpoints-enterobacterales-pseudomonas-aeruginosa-and-acinetobacter-spp">https://www.fda.gov/drugs/development-resources/fda-rationale-polymyxin-breakpoints-enterobacterales-pseudomonas-aeruginosa-and-acinetobacter-spp</a> 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 <a href="https://www.fda.gov/drugs/development-resources/fda-rationale-piperacillin-tazobactam-breakpoints-enterobacterales">https://www.fda.gov/drugs/development-resources/fda-rationale-piperacillin-tazobactam-breakpoints-enterobacterales</a> 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 <a href="https://www.fda.gov/drugs/development-resources/fda-rationale-polymyxin-breakpoints-enterobacterales-pseudomonas-aeruginosa-and-acinetobacter-spp">https://www.fda.gov/drugs/development-resources/fda-rationale-polymyxin-breakpoints-enterobacterales-pseudomonas-aeruginosa-and-acinetobacter-spp</a> 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.
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\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
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