[Federal Register Volume 88, Number 96 (Thursday, May 18, 2023)]
[Notices]
[Pages 31760-31762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10603]


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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, 2021 and 
2022 Updates; 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 with updates made in 2021 and 2022. 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 to 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 18, 
2023.

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 (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://

[[Page 31761]]

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 (the 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.
    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, 2021: Web Page

                       Table 1--Notices of Updates to Recognized or Updated Susceptibility Test Interpretive Criteria by Drug \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                Drug                  Route of administration                    Action taken                      Therapeutic category        Date
--------------------------------------------------------------------------------------------------------------------------------------------------------
Azithromycin........................  Oral, Injection........  For Neisseria gonorrhoeae, FDA has reviewed       Antibacterial..........        10/14/21
                                                                susceptibility test interpretive criteria and
                                                                concludes no changes are needed at this time.
                                                                (Rationale available at https://www.fda.gov/drugs/development-resources/rationale-fdas-position-azithromycin-susceptible-only-breakpoint-neisseria-gonorrhoeae).
Cefazolin...........................  Injection..............  For Enterobacterales, FDA has reviewed            Antibacterial..........        10/14/21
                                                                susceptibility test interpretive criteria and
                                                                the updated standard is recognized. (Rationale
                                                                available at https://www.fda.gov/drugs/development-resources/.
                                                                rationale-fdas-position-cefazolin-breakpoints-
                                                                enterobacterales).
Cefiderocol.........................  Injection..............  FDA recognizes M100 MIC standard for              Antibacterial..........        10/14/21
                                                                Enterobacteriaceae.
Ceftolozane; tazobactam.............  Injection..............  FDA recognizes M100 standard for Haemophilus      Antibacterial..........        10/14/21
                                                                influenzae.
Colistimethate......................  Injection..............  FDA does not recognize M100 standard for          Antibacterial..........        10/14/21
                                                                Enterobacteriaceae.
Imipenem/cilastatin/relebactam......  Injection..............  FDA recognizes M100 standard for                  Antibacterial..........        10/14/21
                                                                Enterobacteriaceae, Pseudomonas aeruginosa, and
                                                                anaerobes.
Lefamulin...........................  Oral, Injection........  FDA recognizes M100 standard for Staphylococcus   Antibacterial..........        10/14/21
                                                                aureus, Streptococcus pneumoniae, and
                                                                Haemophilus influenzae.
Polymyxin B.........................  Injection..............  FDA does not recognize M100 standard for          Antibacterial..........        10/14/21
                                                                Enterobacteriaceae and Pseudomonas aeruginosa.

[[Page 31762]]

 
Telithromycin.......................  Oral...................  FDA has removed telithromycin susceptibility      Antibacterial..........        10/14/21
                                                                test interpretive criteria as the drug is no
                                                                longer approved in any application under
                                                                section 505 of the FD&C Act (21 U.S.C. 355)
                                                                (see 84 FR 47309).
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\1\ M100 standard in the table refers to Clinical and Laboratory Standards Institute (CLSI) Performance Standards for Antimicrobial Susceptibility
  Testing, 31st ed. CLSI supplement M100; 2021.

III. Annual Compilation of Notices, 2022: Susceptibility Test 
Interpretive Criteria Web Page

A. Updates to Standards Recognition

    As of May 18, 2022, the following standards are no longer 
recognized: ``Clinical and Laboratory Standards Institute (CLSI). 
Performance Standards for Antimicrobial Susceptibility Testing. 31st 
ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards 
Institute; 2021.''
    As of May 18, 2022, with certain exceptions, FDA recognizes the 
standards published in: ``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.''

B. Updates by Drug

                       Table 2--Notices of Updates to Recognized or Updated Susceptibility Test Interpretive Criteria by Drug \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                Drug                  Route of administration                    Action taken                      Therapeutic category        Date
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amoxicillin and clavulanate.........  Oral...................  FDA does not recognize M100 standard and          Antibacterial..........         5/17/22
                                                                provides susceptibility test interpretive
                                                                criteria for Haemophilus influenzae.
Cefadroxil..........................  Oral...................  FDA removed the statement ``Susceptibility of     Antibacterial..........         4/27/22
                                                                Enterobacteriaceae to cefadroxil may be deduced
                                                                from testing cefazolin.'' (Rationale available
                                                                at https://www.fda.gov/drugs/development-resources/ resources/.
                                                                rationale-fdas-position-cefadroxil.)...........
Cefazolin...........................  Injection..............  FDA does not recognize M100 standard for          Antibacterial..........        10/20/22
                                                                cefazolin as a surrogate to predict
                                                                susceptibility of oral cephalosporins when used
                                                                for the treatment of uncomplicated urinary
                                                                tract infections caused by Escherichia coli,
                                                                Klebsiella pneumoniae and Proteus mirabilis.
                                                                (Rationale available at https://www.fda.gov/drugs/development-.
                                                                resources/rationale-fdas-position-use-cefazolin-
                                                                breakpoints-surrogate-determining-breakpoints-
                                                                oral.).
Cefoxitin...........................  Injection..............  FDA recognizes M100 standard for Staphylococcus   Antibacterial..........         10/4/22
                                                                aureus complex and Staphylococcus lugdunensis.
                                                                FDA recognizes M100 disk diffusion standard for
                                                                Staphylococcus epidermidis and other
                                                                Staphylococci spp.
Ceftolozane and tazobactam..........  Injection..............  FDA recognizes M100 disk diffusion standard for   Antibacterial..........         5/17/22
                                                                Enterobacterales.
Lefamulin...........................  Oral, Injection........  FDA does not recognize M100 disk diffusion        Antibacterial..........         5/17/22
                                                                standard and provides susceptibility test
                                                                interpretive criteria for Streptococcus
                                                                pneumoniae and Haemophilus influenzae.
Oxacillin...........................  Injection..............  FDA concurs with the revised CLSI susceptibility  Antibacterial..........         10/4/22
                                                                test interpretive criteria for Staphylococcus
                                                                by species level. (Rationale available at
                                                                https://www.fda.gov/drugs/development-resources/rationale-fdas-position-oxacillin-breakpoints-staphylococcus staphylococcus). FDA references Cefoxitin
                                                                susceptibility test interpretive for
                                                                Staphylococcus spp. as a surrogate test.
Piperacillin and tazobactam.........  Injection..............  FDA does not recognize M100 standard for          Antibacterial..........         5/17/22
                                                                Enterobacterales.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ M100 standard in the table refers to CLSI Performance Standards for Antimicrobial Susceptibility Testing, 32nd ed. CLSI supplement M100; 2022.


    Dated: May 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10603 Filed 5-17-23; 8:45 am]
BILLING CODE 4164-01-P