[Federal Register Volume 85, Number 205 (Thursday, October 22, 2020)]
[Notices]
[Pages 67353-67355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23439]


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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 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 October 22, 
2020.

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

[[Page 67354]]

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: Katherine Schumann, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 301-
796-1182, [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 clarifies 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 clarifies 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/DevelopmentApprovalProcess/DevelopmentResources/ucm593952.htm. 
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: Susceptibility Test Interpretive 
Criteria Web Page

Updates to Standards Recognition

    As of June 10, 2019, the following standard is no longer 
recognized: Clinical and Laboratory Standards Institute (CLSI). 
Performance Standards for Antimicrobial Susceptibility Testing. 28th 
ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards 
Institute; 2018.
    As of June 10, 2019, with certain exceptions, FDA recognizes the 
standard published in: Clinical and Laboratory Standards Institute 
(CLSI). Performance Standards for Antimicrobial Susceptibility Testing. 
29th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory 
Standards Institute; 2019.
    For disk diffusion, information regarding disk strength that is not 
included in recognized standards has been added for the following 
drugs: Delafloxacin, eravacycline, omadacycline, plazomicin, 
tigecyline.

[[Page 67355]]



  Table 1--Notices of Updates to Recognized or Updated Susceptibility Test Interpretive Criteria (STIC) by Drug
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             Drug                Route of administration    Action taken     Therapeutic  category       Date
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Azithromycin..................  Oral, Injection.........  For Neisseria     Antibacterial..........      6/10/19
                                                           gonorrhoeae,
                                                           STIC are not
                                                           recognized at
                                                           this time. FDA
                                                           review of these
                                                           STIC is ongoing.
Cefiderocol...................  Injection...............  Added drug to     Antibacterial..........     11/18/19
                                                           antibacterial
                                                           Susceptibility
                                                           Test
                                                           Interpretive
                                                           Criteria web
                                                           page. FDA
                                                           identified STIC.
Ceftaroline fosamil...........  Injection...............  Typographical     Antibacterial..........      8/29/19
                                                           error corrected.
Ceftolozane Tazobactam........  Injection...............  For               Antibacterial..........      6/10/19
                                                           Enterobacteriac
                                                           eae, an
                                                           exception to
                                                           the recognized
                                                           standard is
                                                           provided for
                                                           Disk Diffusion.
                                                           For Haemophilus
                                                           influenzae, the
                                                           FDA-identified
                                                           STIC are
                                                           provided. STIC
                                                           are based on
                                                           dosing regimens
                                                           that differ by
                                                           the serious
                                                           infection being
                                                           treated, and
                                                           this
                                                           information is
                                                           provided.
Cefuroxime....................  Injection...............  For Neisseria     Antibacterial..........      6/10/19
                                                           gonorrhoeae,
                                                           FDA agrees with
                                                           the recognized
                                                           standard that
                                                           it is no longer
                                                           appropriate to
                                                           list STIC.
Ciprofloxacin.................  Oral, Injection.........  For               Antibacterial..........      6/10/19
                                                           Enterobacteriac
                                                           eae and
                                                           Pseudomonas
                                                           aeruginosa, the
                                                           updated
                                                           standard is
                                                           recognized.
Colistimethate................  Injection...............  For Pseudomonas   Antibacterial..........      6/10/19
                                                           aeruginosa and
                                                           Acinetobacter
                                                           spp., FDA has
                                                           reviewed these
                                                           STIC and
                                                           concludes that
                                                           STIC cannot be
                                                           recognized at
                                                           this time.
Daptomycin....................  Injection...............  For Enterococcus  Antibacterial..........      6/10/19
                                                           spp.
                                                           (vancomycin-
                                                           susceptible
                                                           isolates only),
                                                           an exception to
                                                           the recognized
                                                           standard is
                                                           provided. FDA
                                                           review of these
                                                           STIC is ongoing.
Delafloxacin..................  Injection, Tablets......  FDA identified    Antibacterial..........     10/25/19
                                                           STIC.
Imipenem-Cilastatin-Relebactam  Injection...............  FDA identified    Antibacterial..........      7/18/19
                                                           STIC.
Lefamulin.....................  Oral, Injection.........  FDA identified    Antibacterial..........      8/29/19
                                                           STIC.
Levofloxacin..................  Oral, Injection.........  For               Antibacterial..........      6/10/19
                                                           Enterobacteriac
                                                           eae and
                                                           Pseudomonas
                                                           aeruginosa, the
                                                           updated
                                                           standard is
                                                           recognized.
Meropenem.....................  Injection...............  For               Antibacterial..........     12/23/19
                                                           Acinetobacter
                                                           spp., the
                                                           updated
                                                           standard is
                                                           recognized.
Meropenem- Vaborbactam........  Injection...............  For               Antibacterial..........      6/10/19
                                                           Enterobacteriac
                                                           eae, the
                                                           updated
                                                           standard is
                                                           recognized.
Ofloxacin.....................  Oral....................  For Neisseria     Antibacterial..........      6/10/19
                                                           gonorrhoeae,
                                                           FDA identified
                                                           STIC are
                                                           provided. FDA
                                                           review of these
                                                           STIC is ongoing.
Omeprazole magnesium,           Oral....................  Added drug to     Antibacterial..........     11/18/19
 Amoxicillin, and Rifabutin.                               antibacterial
                                                           Susceptibility
                                                           Test
                                                           Interpretive
                                                           Criteria web
                                                           page. No STIC
                                                           identified at
                                                           this time.
Pretomanid....................  Oral....................  Added drug to     Antibacterial..........      8/29/19
                                                           antibacterial
                                                           Susceptibility
                                                           Test
                                                           Interpretive
                                                           Criteria web
                                                           page. No STIC
                                                           identified at
                                                           this time.
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    Dated: October 19, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23439 Filed 10-21-20; 8:45 am]
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