21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria Web Page; Request for Comments, 19081-19084 [2019-09007]
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Federal Register / Vol. 84, No. 86 / Friday, May 3, 2019 / Notices
on respondents, including through the
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to comments and suggestions submitted
within 60 days of this publication.
Authority: Act, 42 U.S.C. 9858(c)(6).
Mary B. Jones,
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[FR Doc. 2019–09045 Filed 5–2–19; 8:45 am]
BILLING CODE 4184–81–P
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.
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:
amozie on DSK9F9SC42PROD with NOTICES
SUMMARY:
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,
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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
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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/201523389.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, Katherine.Schumann@
fda.hhs.gov.
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
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Federal Register / Vol. 84, No. 86 / Friday, May 3, 2019 / Notices
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-criteriarecognized-and-listed-on-thesusceptibility-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
ApprovalProcess/Development
Resources/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.
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TABLE 1—NOTICES OF UPDATES TO RECOGNIZED OR UPDATED SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA BY DRUG
Drug
Route of
administration
Action taken
Therapeutic
category
Fluconazole .......................................
Injection, Oral ........
Antifungal ..............
10/3/18
Flucytosine ........................................
Injection .................
FDA identifies 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.
FDA withdraws recognition of Susceptibility Test
Interpretive Criteria for Flucytosine as there
are not sufficient clinical or other data to support these criteria.
Antifungal ..............
10/3/18
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Federal Register / Vol. 84, No. 86 / Friday, May 3, 2019 / Notices
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TABLE 1—NOTICES OF UPDATES TO RECOGNIZED OR UPDATED SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA BY
DRUG—Continued
Drug
Route of
administration
Action taken
Therapeutic
category
Itraconazole .......................................
Injection, Oral ........
Antifungal ..............
10/3/18
Omadacycline ....................................
Injection, Oral ........
Antifungal ..............
10/3/18
Bismuth subcitrate potassium,
Metronidazole, and Tetracycline
hydrochloride.
Oral .......................
Antibacterial ..........
2/09/18
Ceftazidime Avibactam ......................
Injection .................
Antibacterial ..........
6/26/18
Ceftolozane Tazobactam ..................
Injection .................
Antibacterial ..........
6/26/18
Clarithromycin ....................................
Oral .......................
Antibacterial ..........
2/09/18
Dalbavancin .......................................
Injection .................
Antibacterial ..........
6/26/18
Eravacycline ......................................
Injection .................
Antibacterial ..........
8/28/18
Isoniazid, Pyrazinamide, and
Rifampin.
Oral .......................
Antibacterial ..........
2/09/18
Lansoprazole, Amoxicillin, and
Clarithromycin.
Oral .......................
Antibacterial ..........
2/09/18
Piperacillin Tazobactam ....................
Injection .................
Antibacterial ..........
6/26/18
Plazomicin .........................................
Injection .................
Antibacterial ..........
6/26/18
Rifabutin ............................................
Oral .......................
Antibacterial ..........
4/26/18
Rifapentine ........................................
Oral .......................
Antibacterial ..........
2/09/18
Rifaximin ............................................
Oral .......................
Antibacterial ..........
2/09/18
Tedizolid ............................................
Oral, Injection ........
FDA identifies 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.
Added drug to antibacterial susceptibility test interpretive criteria web page. FDA identified
susceptibility test interpretive criteria for
omadacycline injection.
Added drug to antibacterial susceptibility test interpretive criteria web page. No susceptibility
test interpretive criteria recognized or added
by FDA.
FDA recognizes M100 standard for
Enterobacteriaceae and Pseudomonas
aeruginosa.
FDA recognizes M100 standard for disk diffusion
for Enterobacteriaceae.
FDA recognizes CLSI M45 standard for
clarithromycin for Helicobacter pylori.
FDA recognizes M100 standard for Staphylococcus aureus, Enterococcus spp.
(vancomycin-susceptible isolates only), Streptococcus spp b-Hemolytic Group, Streptococcus spp Viridans Group.
Added drug to antibacterial susceptibility test interpretive criteria web page. FDA identified
susceptibility test interpretive criteria for
eravacycline injection.
Added drug to antibacterial susceptibility test interpretive criteria web page. No susceptibility
test interpretive criteria recognized or added
by FDA.
Added drug to antibacterial susceptibility test interpretive criteria web page. No susceptibility
test interpretive criteria recognized or added
by FDA.
FDA recognizes revised M100 standard for
anaerobes.
Added drug to antibacterial susceptibility test interpretive criteria web page. FDA identified
susceptibility test interpretive criteria for
plazomicin injection.
Added drug to antibacterial susceptibility test interpretive criteria web page. No susceptibility
test interpretive criteria recognized or added
by FDA.
Added drug to antibacterial susceptibility test interpretive criteria web page. No susceptibility
test interpretive criteria recognized or added
by FDA.
Added drug to antibacterial susceptibility test interpretive criteria web page. No susceptibility
test interpretive criteria recognized or added
by FDA.
Due to test performance concerns, FDA withdraws recognition of all disk diffusion interpretive criteria.
Antibacterial ..........
6/26/18
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19084
Federal Register / Vol. 84, No. 86 / Friday, May 3, 2019 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–1619]
List of Patient Preference-Sensitive
Priorities; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of the list of
patient preference-sensitive priorities on
FDA’s website entitled, ‘‘Patient
Preference-Sensitive Areas: Using
Patient Preference Information (PPI) in
Medical Device Evaluation.’’ As part of
FDA’s commitments for the
reauthorization of the Medical Device
User Fee Amendments of 2017 (MDUFA
IV), the Center for Devices and
Radiological Health (CDRH) committed
to publish a list of priority areas where
preference-sensitive data can inform
regulatory decision making. FDA is also
establishing a docket to solicit public
input on this list of preference-sensitive
areas that may impact the design and
conduct of premarket medical device
clinical studies, benefit-risk
assessments, and postmarket evaluation.
DATES: Submit either electronic or
written comments on the notice by July
2, 2019 to ensure that the Agency
considers your comment on the list of
patient preference-sensitive priorities.
ADDRESSES: You may submit comments
on this notice as follows:
amozie on DSK9F9SC42PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
16:41 May 02, 2019
Jkt 247001
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 Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
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–
2019–N–1619 for ‘‘List of Patient
Preference-Sensitive Priorities;
Establishment of a Public Docket;
Requests 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
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‘‘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/201523389.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:
Anindita Saha, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5414, Silver Spring,
MD 20993–0002, 301–796–2537.
SUPPLEMENTARY INFORMATION:
I. Background
In 2016, the FDA issued guidance
entitled, ‘‘Patient Preference
Information—Voluntary Submission,
Review in Premarket Approval
Applications, Humanitarian Device
Exemption Applications, and De Novo
Requests, and Inclusion in Decision
Summaries and Device Labeling—
Guidance for Industry, Food and Drug
Administration Staff, and Other
Stakeholders’’ (Ref. 1), outlining how
stakeholders, including industry and
patient advocacy organizations, can
voluntarily collect and submit PPI that
may be used by FDA staff in regulatory
decision making.
As part of FDA’s commitment for the
reauthorization of MDUFA IV), FDA
committed to advancing patient input
and involvement and to identify patient
preference-sensitive priority areas that
may inform regulatory decision making
(Ref. 2). FDA seeks to successfully build
on our strong commitment to patients
by engaging them to understand and
considering their experience and
perspectives, as it relates to medical
device clinical studies, benefit-risk
assessments, and postmarket
surveillance.
As such, on December 7–8, 2017, FDA
cohosted a collaborative workshop with
the Centers of Excellence in Regulatory
Science and Innovation entitled,
‘‘Advancing Use of Patient Preference
Information as Scientific Evidence in
Medical Product Evaluation’’ (Ref. 3).
This workshop discussed the current
progress on incorporating PPI into
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
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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.
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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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
[[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
