[Federal Register Volume 84, Number 86 (Friday, May 3, 2019)]
[Notices]
[Pages 19081-19084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09007]


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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 May 3, 2019.

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.
     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.gpo.gov/fdsys/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.

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

[[Page 19082]]

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 and 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

A. Formatting Changes to the Susceptibility Test Interpretive Criteria 
Web Page

    On October 4, 2018, FDA updated the format of the Antifungal 
Susceptibility Test Interpretive Criteria web pages for clarity, in 
response to stakeholder feedback.
    On June 26, 2018, FDA updated the format of the Antibacterial 
Susceptibility Test Interpretive Criteria web pages for clarity, in 
response to stakeholder feedback.

B. Updates to Standards Recognition

    As of October 4, 2018, the following susceptibility test 
interpretive criteria standards are no longer recognized (for 
information regarding recognition of methods and quality control 
standards see Recognized Consensus Standards):
     Clinical and Laboratory Standards Institute (CLSI). 
Reference Method for Broth Dilution Antifungal Susceptibility Testing 
of Yeasts; Fourth Informational Supplement. CLSI document M27-S4 
(2012). Clinical and Laboratory Standards Institute, 940 West Valley 
Rd., Suite 2500, Wayne, PA 19087, USA (CLSI M27-S4).
     Clinical and Laboratory Standards Institute (CLSI). Method 
for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; 
Approved Guideline--Second Edition. CLSI document M44-S3 (2009). 
Clinical and Laboratory Standards Institute, 950 West Valley Rd., Suite 
500, Wayne, PA 19087, USA (CLSI M44-S3).
     Clinical and Laboratory Standards Institute (CLSI). 
Reference Method for Broth Dilution Antifungal Susceptibility Testing 
of Yeasts; Fourth Informational Supplement. CLSI document M27-S3 
(2008). Clinical and Laboratory Standards Institute, 940 West Valley 
Rd., Suite 2500, Wayne, PA 19087, USA (CLSI M27-S3).
    As of October 4, 2018, with certain exceptions, FDA recognizes the 
following standard:
     Clinical and Laboratory Standards Institute (CLSI). 
Performance Standards for Antifungal Susceptibility Testing of Yeasts. 
1st ed. CLSI supplement M60 (2017). Clinical and Laboratory Standards 
Institute, 940 West Valley Rd., Suite 2500, Wayne, PA 19087, USA (CLSI 
M60).
    As of June 26, 2018, the following standard is no longer 
recognized:
     Clinical and Laboratory Standards Institute (CLSI). 
Performance Standards for Antimicrobial Susceptibility Testing. 27th 
ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards 
Institute; 2017.
    As of June 26, 2018, with certain exceptions, FDA recognizes the 
following standard:
     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.

     Table 1--Notices of Updates To Recognized or Updated Susceptibility Test Interpretive Criteria by Drug
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                                         Route of                                     Therapeutic
               Drug                   administration          Action taken              category          Date
----------------------------------------------------------------------------------------------------------------
Fluconazole......................  Injection, Oral....  FDA identifies            Antifungal.........    10/3/18
                                                         exceptions to the
                                                         recognized standard for
                                                         Fluconazole. The term
                                                         ``Susceptible-Dose
                                                         Dependent'' is not
                                                         recognized pending
                                                         further clarification
                                                         of the definition of
                                                         the term by standards
                                                         development
                                                         organizations.
Flucytosine......................  Injection..........  FDA withdraws             Antifungal.........    10/3/18
                                                         recognition of
                                                         Susceptibility Test
                                                         Interpretive Criteria
                                                         for Flucytosine as
                                                         there are not
                                                         sufficient clinical or
                                                         other data to support
                                                         these criteria.

[[Page 19083]]

 
Itraconazole.....................  Injection, Oral....  FDA identifies            Antifungal.........    10/3/18
                                                         Susceptibility Test
                                                         Interpretive Criteria
                                                         for itraconazole and
                                                         Candida albicans. The
                                                         current minimum
                                                         inhibitory
                                                         concentration
                                                         distribution data
                                                         demonstrates that the
                                                         sensitivity of C.
                                                         albicans to
                                                         itraconazole has not
                                                         changed over time.
                                                         Therefore, the in-vitro
                                                         activity and clinical
                                                         response data reviewed
                                                         previously by FDA and
                                                         described in product
                                                         labeling continue to
                                                         support these
                                                         interpretive criteria
                                                         for C. albicans.
Omadacycline.....................  Injection, Oral....  Added drug to             Antifungal.........    10/3/18
                                                         antibacterial
                                                         susceptibility test
                                                         interpretive criteria
                                                         web page. FDA
                                                         identified
                                                         susceptibility test
                                                         interpretive criteria
                                                         for omadacycline
                                                         injection.
Bismuth subcitrate potassium,      Oral...............  Added drug to             Antibacterial......    2/09/18
 Metronidazole, and Tetracycline                         antibacterial
 hydrochloride.                                          susceptibility test
                                                         interpretive criteria
                                                         web page. No
                                                         susceptibility test
                                                         interpretive criteria
                                                         recognized or added by
                                                         FDA.
Ceftazidime Avibactam............  Injection..........  FDA recognizes M100       Antibacterial......    6/26/18
                                                         standard for
                                                         Enterobacteriaceae and
                                                         Pseudomonas aeruginosa.
Ceftolozane Tazobactam...........  Injection..........  FDA recognizes M100       Antibacterial......    6/26/18
                                                         standard for disk
                                                         diffusion for
                                                         Enterobacteriaceae.
Clarithromycin...................  Oral...............  FDA recognizes CLSI M45   Antibacterial......    2/09/18
                                                         standard for
                                                         clarithromycin for
                                                         Helicobacter pylori.
Dalbavancin......................  Injection..........  FDA recognizes M100       Antibacterial......    6/26/18
                                                         standard for
                                                         Staphylococcus aureus,
                                                         Enterococcus spp.
                                                         (vancomycin-susceptible
                                                         isolates only),
                                                         Streptococcus spp
                                                         [beta]-Hemolytic Group,
                                                         Streptococcus spp
                                                         Viridans Group.
Eravacycline.....................  Injection..........  Added drug to             Antibacterial......    8/28/18
                                                         antibacterial
                                                         susceptibility test
                                                         interpretive criteria
                                                         web page. FDA
                                                         identified
                                                         susceptibility test
                                                         interpretive criteria
                                                         for eravacycline
                                                         injection.
Isoniazid, Pyrazinamide, and       Oral...............  Added drug to             Antibacterial......    2/09/18
 Rifampin.                                               antibacterial
                                                         susceptibility test
                                                         interpretive criteria
                                                         web page. No
                                                         susceptibility test
                                                         interpretive criteria
                                                         recognized or added by
                                                         FDA.
Lansoprazole, Amoxicillin, and     Oral...............  Added drug to             Antibacterial......    2/09/18
 Clarithromycin.                                         antibacterial
                                                         susceptibility test
                                                         interpretive criteria
                                                         web page. No
                                                         susceptibility test
                                                         interpretive criteria
                                                         recognized or added by
                                                         FDA.
Piperacillin Tazobactam..........  Injection..........  FDA recognizes revised    Antibacterial......    6/26/18
                                                         M100 standard for
                                                         anaerobes.
Plazomicin.......................  Injection..........  Added drug to             Antibacterial......    6/26/18
                                                         antibacterial
                                                         susceptibility test
                                                         interpretive criteria
                                                         web page. FDA
                                                         identified
                                                         susceptibility test
                                                         interpretive criteria
                                                         for plazomicin
                                                         injection.
Rifabutin........................  Oral...............  Added drug to             Antibacterial......    4/26/18
                                                         antibacterial
                                                         susceptibility test
                                                         interpretive criteria
                                                         web page. No
                                                         susceptibility test
                                                         interpretive criteria
                                                         recognized or added by
                                                         FDA.
Rifapentine......................  Oral...............  Added drug to             Antibacterial......    2/09/18
                                                         antibacterial
                                                         susceptibility test
                                                         interpretive criteria
                                                         web page. No
                                                         susceptibility test
                                                         interpretive criteria
                                                         recognized or added by
                                                         FDA.
Rifaximin........................  Oral...............  Added drug to             Antibacterial......    2/09/18
                                                         antibacterial
                                                         susceptibility test
                                                         interpretive criteria
                                                         web page. No
                                                         susceptibility test
                                                         interpretive criteria
                                                         recognized or added by
                                                         FDA.
Tedizolid........................  Oral, Injection....  Due to test performance   Antibacterial......    6/26/18
                                                         concerns, FDA withdraws
                                                         recognition of all disk
                                                         diffusion interpretive
                                                         criteria.
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[[Page 19084]]

    Dated: April 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09007 Filed 5-2-19; 8:45 am]
BILLING CODE 4164-01-P