21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria Web Page; Request for Comments, 67353-67355 [2020-23439]
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67353
Federal Register / Vol. 85, No. 205 / Thursday, October 22, 2020 / Notices
request that a drug product be included
in the OTC drug monograph system and
describes the process for submitting that
information.
In the Federal Register of July 30,
2020 (85 FR 45892), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Time and extent application and submission of information
(§ 330.14(c) and (d)) .........................................................
Safety and effectiveness data (§ 330.14(f) and (i)) .............
Sponsor
request
for
an
informal
conference
(§ 330.14(j)(3)) ..................................................................
Sponsor signed statement that submission is complete
(§ 330.14(j)(4)) ..................................................................
Sponsor request for FDA to withdraw TEA consideration
(§ 330.14(k)(1)) .................................................................
Sponsor request for FDA not to deem the submission
withdrawn (§ 330.14(k)(2)) ................................................
Total ..............................................................................
1 There
Dated: October 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–23357 Filed 10–21–20; 8:45 am]
BILLING CODE 4164–01–P
Total hours
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4,700
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7,756
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
Food and Drug Administration,
HHS.
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
SUMMARY:
VerDate Sep<11>2014
17:35 Oct 21, 2020
accordance with procedures established
by the 21st Century Cures Act (Cures
Act).
This notice is published in the
Federal Register on October 22, 2020.
DATES:
You may submit either
electronic or written comments and
information as follows:
ADDRESSES:
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Average
burden per
response
Total annual
responses
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
AGENCY:
No. of
responses per
respondent
Number of
respondents
21 CFR part and activity
Jkt 253001
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’’).
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
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
E:\FR\FM\22OCN1.SGM
22OCN1
67354
Federal Register / Vol. 85, No. 205 / Thursday, October 22, 2020 / Notices
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-201509-18/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, 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
VerDate Sep<11>2014
17:35 Oct 21, 2020
Jkt 253001
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-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
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
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, 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.
E:\FR\FM\22OCN1.SGM
22OCN1
Federal Register / Vol. 85, No. 205 / Thursday, October 22, 2020 / Notices
67355
TABLE 1—NOTICES OF UPDATES TO RECOGNIZED OR UPDATED SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA (STIC) BY
DRUG
Drug
Route of
administration
Action taken
Therapeutic
category
Azithromycin ........................
Oral, Injection .......
Antibacterial .........
6/10/19
Cefiderocol ..........................
Injection ................
Antibacterial .........
11/18/19
Ceftaroline fosamil ...............
Ceftolozane Tazobactam ....
Injection ................
Injection ................
Antibacterial .........
Antibacterial .........
8/29/19
6/10/19
Cefuroxime ..........................
Injection ................
Antibacterial .........
6/10/19
Ciprofloxacin ........................
Oral, Injection .......
Antibacterial .........
6/10/19
Colistimethate ......................
Injection ................
Antibacterial .........
6/10/19
Daptomycin ..........................
Injection ................
Antibacterial .........
6/10/19
Delafloxacin .........................
Imipenem-CilastatinRelebactam.
Lefamulin .............................
Levofloxacin .........................
Injection, Tablets ..
Injection ................
For Neisseria gonorrhoeae, STIC are not recognized at
this time. FDA review of these STIC is ongoing.
Added drug to antibacterial Susceptibility Test Interpretive Criteria web page. FDA identified STIC.
Typographical error corrected ..........................................
For Enterobacteriaceae, 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.
For Neisseria gonorrhoeae, FDA agrees with the recognized standard that it is no longer appropriate to list
STIC.
For Enterobacteriaceae and Pseudomonas aeruginosa,
the updated standard is recognized.
For Pseudomonas aeruginosa and Acinetobacter spp.,
FDA has reviewed these STIC and concludes that
STIC cannot be recognized at this time.
For Enterococcus spp. (vancomycin-susceptible isolates
only), an exception to the recognized standard is provided. FDA review of these STIC is ongoing.
FDA identified STIC ..........................................................
FDA identified STIC ..........................................................
Antibacterial .........
Antibacterial .........
10/25/19
7/18/19
Antibacterial .........
Antibacterial .........
8/29/19
6/10/19
Meropenem .........................
Injection ................
Antibacterial .........
12/23/19
Meropenem- Vaborbactam ..
Injection ................
Antibacterial .........
6/10/19
Ofloxacin ..............................
Oral ......................
Antibacterial .........
6/10/19
Omeprazole magnesium,
Amoxicillin, and Rifabutin.
Pretomanid ..........................
Oral ......................
FDA identified STIC ..........................................................
For Enterobacteriaceae and Pseudomonas aeruginosa,
the updated standard is recognized.
For Acinetobacter spp., the updated standard is recognized.
For Enterobacteriaceae, the updated standard is recognized.
For Neisseria gonorrhoeae, FDA identified STIC are
provided. FDA review of these STIC is ongoing.
Added drug to antibacterial Susceptibility Test Interpretive Criteria web page. No STIC identified at this time.
Added drug to antibacterial Susceptibility Test Interpretive Criteria web page. No STIC identified at this time.
Antibacterial .........
11/18/19
Antibacterial .........
8/29/19
Oral, Injection .......
Oral, Injection .......
Oral ......................
Dated: October 19, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–23439 Filed 10–21–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1806]
Fit for Use Pilot Program Invitation for
the Clinical Data Interchange
Standards Consortium for Standard for
Exchange of Nonclinical Data
Implementation Guide Developmental
and Reproductive Toxicology: Version
1.1
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
17:35 Oct 21, 2020
Jkt 253001
The Food and Drug
Administration (FDA or Agency) is
announcing that it intends to conduct a
Fit for Use (FFU) pilot program to test
the processing and analysis of
nonclinical study data provided
electronically for the Clinical Data
Interchange Standards Consortium
(CDISC) for Standard for Exchange of
Nonclinical Data (SEND)
Implementation Guide (IG):
Developmental and Reproductive
Toxicology v1.1 (SEND–DART). The
Agency’s Center for Drug Evaluation
and Research (CDER) will test the
processing and analysis of nonclinical
study data provided electronically in
SEND–DART format. FDA is inviting
individual firms that wish to participate
in this pilot program to submit
participation requests via email or in
writing.
SUMMARY:
To be considered for
participation in the pilot program,
submit electronic or written requests by
DATES:
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
Date
February 26, 2021. See the ADDRESSES
section for participation request
instructions.
Submit electronic requests
to participate in the pilot and comments
regarding this pilot project to Docket
No. FDA–2020–N–1806 at https://
www.regulations.gov. Submit written
requests to participate in the pilot and
comments regarding the pilot to Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
by February 26, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
ADDRESSES:
E:\FR\FM\22OCN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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 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
----------------------------------------------------------------------------------------------------------------
Drug Route of administration Action taken Therapeutic category Date
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
Dated: October 19, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23439 Filed 10-21-20; 8:45 am]
BILLING CODE 4164-01-P
