[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efficacy or safety concerns when out-of-date susceptibility test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