Document ID: FDA-2017-N-5925-0011
Agency: fda
Document Type: Notice
Title: 21st Century Cures Act: Announcing the Establishment of the Susceptibility Test Interpretive Criteria Website
Posted Date: 2017-12-13T05:00Z

[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Notices]
[Pages 58617-58618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26790]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5925]

21st Century Cures Act: Announcing the Establishment of the 
Susceptibility Test Interpretive Criteria Website

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the establishment of the Susceptibility Test Interpretive 
Criteria Website. The Susceptibility Test Interpretive Criteria Website 
will help to efficiently update susceptibility test interpretive 
criteria for antimicrobial drugs when necessary for public health and 
may allow for more efficient development and evaluation of 
antimicrobial susceptibility test (AST) devices. These changes may lead 
to better patient care and reduce antimicrobial resistance through 
improved antibiotic stewardship. FDA is publishing this notice in 
accordance with procedures established by the 21st Century Cures Act 
(Cures Act).

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

    Antimicrobial susceptibility testing is used to determine if 
certain microorganisms that are isolated from a patient with an 
infection are likely to be killed or inhibited by a particular 
antimicrobial drug. It is important that the in vitro susceptibility 
test methods and susceptibility test interpretive criteria for systemic 
antibacterial or antifungal drugs be reviewed on a regular basis and 
updated to reflect the most current information. The development of new 
mechanisms of resistance in bacteria or fungi may result in decreased 
susceptibility to a particular drug. Decreased susceptibility may raise 
efficacy or safety concerns when out-of-date susceptibility test 
interpretive criteria are used in guiding the treatment of patients.
    Historically, susceptibility test interpretive criteria have been 
contained in the Microbiology subsection of antimicrobial drug 
labeling, and there have been significant challenges associated with 
ensuring that this information is up-to-date in individual 
antimicrobial drug labels. For some time, FDA and other stakeholders 
have recognized that susceptibility test interpretive criteria 
standards established by nationally or internationally recognized 
standard development organizations (SDOs) can be useful sources of 
information to identify and update susceptibility test interpretive 
criteria.
    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 SDOs. It also clarifies 
that sponsors of AST devices may rely upon listed susceptibility 
interpretive criteria to support premarket authorization of their 
devices, provided they meet certain conditions, which provides for a 
more streamlined process for incorporating up-to-date information into 
such devices.

II. Susceptibility Test Interpretive Criteria Website

    Section 511A of the FD&C Act requires FDA to establish within 1 
year after the date of enactment of the Cures Act an Interpretive 
Criteria Website that contains a list of FDA-recognized susceptibility 
test interpretive criteria standards, as well as other susceptibility 
test interpretive criteria identified by FDA. FDA is announcing the 
establishment of this Interpretive Criteria Website, which can be found 
here: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm410971.htm.
    This website 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 Interpretive Criteria 
Website are deemed to be recognized as a standard under section 
514(c)(1) of the FD&C Act (21 U.S.C. 360d(c)(1)).
    At least every 6 months after the establishment of the Interpretive 
Criteria Website, FDA will publish on the Interpretive Criteria Website 
a notice recognizing new or updated susceptibility test interpretive 
criteria standards, or parts of standards; withdrawing recognition of 
susceptibility test interpretive criteria standards, or parts of 
standards; and making any other necessary updates to the lists 
published on the Interpretive Criteria Website. Once a year FDA will 
compile the notices from that year and publish them in the Federal 
Register and provide for public comment. If comments are received, FDA 
will review those comments and make any updates to the recognized 
standards or susceptibility test interpretive criteria as

[[Page 58618]]

needed. In addition to this statutorily required annual notice, FDA 
intends to publish a Federal Register notice within the next few months 
to allow for public comment on the initial recognition of 
susceptibility test interpretive criteria.

    Dated: December 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26790 Filed 12-12-17; 8:45 am]
 BILLING CODE 4164-01-P