Standard Development Organizations Whose Susceptibility Test Interpretive Criteria Standards May Be Recognized by the Food and Drug Administration; Request for Information, 50139-50141 [2017-23519]
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Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices
50139
addressed adhesive label to assist that
office in processing your request.
received prior to finalizing this
guidance.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
II. Significance of Guidance
Food and Drug Administration
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Product Labeling
for Certain Ultrasonic Surgical Aspirator
Devices.’’ It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
[Docket No. FDA–2017–N–5925]
Trisha Eustaquio, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1529, Silver Spring,
MD 20993–0002, 301–796–5214.
SUPPLEMENTARY INFORMATION:
sradovich on DSK3GMQ082PROD with NOTICES
I. Background
FDA is issuing this guidance to
recommend the addition of a specific
safety statement to the product labeling
of certain ultrasonic surgical aspirator
devices. This guidance applies to
ultrasonic surgical aspirator devices
with indications for use in laparoscopic
surgery, open surgery, or gynecologic
surgery, as such surgeries can include
gynecologic procedures. Ultrasonic
surgical aspirator devices are surgical
tools intended to fragment, emulsify,
and aspirate hard and soft tissue.
However, the mechanism of action of
ultrasonic surgical aspirator devices
creates the potential for tissue
dissemination. In light of this risk, FDA
is providing a specific labeling
recommendation in this guidance
regarding use of these devices in the
removal of uterine fibroids.
FDA is aware that ultrasonic surgical
aspirator devices are sometimes used to
treat advanced malignancy through
cytoreduction (also known as
debulking). When used in advanced
cancers, the risk of adverse clinical
effects from tissue dissemination may be
small compared to the device’s potential
benefits. In certain clinical
circumstances, however, the unintended
dissemination of cancerous cells may
have a significant adverse effect that
outweighs any demonstrated benefits.
Specifically, use of an ultrasonic
surgical aspirator device during
treatment for symptomatic uterine
fibroids on a woman with an occult
uterine sarcoma could result in
dissemination of this cancer. Therefore,
FDA recommends that manufacturers of
ultrasonic surgical aspirator devices
with indications for use in laparoscopic
surgery, open surgery, or gynecologic
surgery prominently include a specific
contraindication in their product
labeling that the device is not indicated
for and should not be used for the
fragmentation, emulsification, and
aspiration of uterine fibroids.
In the Federal Register on November
10, 2016 (81 FR 79028), FDA announced
the availability of the draft guidance and
interested parties were invited to
comment by January 9, 2017. FDA has
considered all of the public comments
VerDate Sep<11>2014
17:59 Oct 27, 2017
Jkt 244001
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Product Labeling for Certain
Ultrasonic Surgical Aspirator Devices;
Guidance for Industry and Food and
Drug Administration Staff’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 1500072 to identify
the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807, subpart E have been
approved under OMB control number
0910–0120 and the collections of
information in 21 CFR part 801 have
been approved under OMB control
number 0910–0485.
Dated: October 25, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017–23520 Filed 10–27–17; 8:45 am]
BILLING CODE 4164–01–P
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Standard Development Organizations
Whose Susceptibility Test Interpretive
Criteria Standards May Be Recognized
by the Food and Drug Administration;
Request for Information
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Request for information.
The Food and Drug
Administration (FDA, the Agency, or
we) is requesting information to assist in
identifying standard development
organizations (SDOs) that meet the
requirements in the Federal Food, Drug,
and Cosmetic Act (FD&C Act), of the
21st Century Cures Act (Cures Act),
which was signed into law on December
13, 2016.
DATES: Submit either electronic or
written comments on the notice by
November 29, 2017.
ADDRESSES: You may submit comments
and information as follows. Please note
that late, untimely filed comments will
not be considered. Electronic comments
must be submitted on or before
November 29, 2017. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
November 29, 2017. 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.
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
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
E:\FR\FM\30OCN1.SGM
30OCN1
50140
Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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 ‘‘Standard
Development Organizations Whose
Susceptibility Test Interpretive Criteria
Standards May Be Recognized by FDA;
Request for Information.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), 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
VerDate Sep<11>2014
17:59 Oct 27, 2017
Jkt 244001
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 or Katherine.Schumann@
fda.hhs.gov.
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 at the concentrations
of the drug that are attainable at the site
of infection. Historically, susceptibility
test interpretive criteria has 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 for
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 SDOs can be
useful sources of information to identify
and update susceptibility test
interpretive criteria.
Section 511A of the FD&C Act (21
U.S.C. 360a) was added by section 3044
of the Cures Act (Pub. L. 114–255),
which 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 antimicrobial
susceptibility testing devices may rely
upon listed susceptibility test
interpretive criteria to support
premarket authorization of their
PO 00000
Frm 00025
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Sfmt 4703
devices, provided they meet certain
conditions, which provides for a more
streamlined process for incorporating
up-to-date information into such
devices.
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 Web site
containing a list of FDA-recognized
susceptibility test interpretive criteria
standards, as well as other susceptibility
test interpretive criteria identified by
FDA. The list of standards consists of
new or updated susceptibility test
interpretive criteria standards with
respect to legally marketed
antimicrobial drugs that have been: (1)
Established by nationally or
internationally recognized SDOs that
meet the requirements under section
511A(b)(2)(A)(i) of the FD&C Act and (2)
recognized, in whole or in part, by FDA,
pursuant to section 511A(c) of the FD&C
Act.
Section 511A(b)(2)(A)(i) of the FD&C
Act requires that in order for FDA to
recognize, in whole or in part, new or
updated susceptibility test interpretive
criteria standards established by an
SDO, the SDO must: (1) Be a nationally
or internationally recognized SDO that
establishes and maintains procedures to
address potential conflicts of interest
and ensure transparent decision making;
(2) hold meetings to ensure that there is
an opportunity for public input by
interested parties, and establishes and
maintains processes to ensure that such
input is considered in decision making;
and (3) permit its standards to be made
publicly available, through the National
Library of Medicine or a similar source
acceptable to the Secretary of Health
and Human Services.
II. Issues for Consideration and Request
for Information
FDA is currently identifying SDOs
that meet the requirements under
section 511A(b)(2)(A)(i) of the FD&C Act
and invites submission of information
relevant to this task. FDA is particularly
interested in publicly available
information illustrating how an SDO has
national or international recognition,
information illustrating an SDO’s
established and maintained procedures
on how the SDO addresses potential
conflicts of interest and ensures
transparent decision-making,
information illustrating that an SDO
holds open meetings and has
established and maintained processes to
ensure that public input by interested
parties is considered in decisionmaking, and information illustrating
that an SDO’s standards are made
publicly available through the National
E:\FR\FM\30OCN1.SGM
30OCN1
Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices
Institutes of Health/National Library of
Medicine or a similar source. When
providing this information, please
provide weblinks to where this
information is publicly available. This
information may assist in FDA’s
determination of which SDOs may
fulfill the statutory requirements.
Dated: October 25, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017–23519 Filed 10–27–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0334]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Postmarketing
Safety Reports for Human Drug and
Biological Products: Electronic
Submission Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the requirements
for electronic submission of
postmarketing safety reports for human
drug and biological products.
DATES: Submit either electronic or
written comments on the collection of
information by December 29, 2017.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before December 29,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of December 29, 2017.
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.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:59 Oct 27, 2017
Jkt 244001
Electronic Submissions
50141
comments only as a written/paper
submission. You should submit two
Submit electronic comments in the
copies total. One copy will include the
following way:
• Federal eRulemaking Portal: https:// information you claim to be confidential
with a heading or cover note that states
www.regulations.gov. Follow the
‘‘THIS DOCUMENT CONTAINS
instructions for submitting comments.
CONFIDENTIAL INFORMATION.’’ The
Comments submitted electronically,
Agency will review this copy, including
including attachments, to https://
the claimed confidential information, in
www.regulations.gov will be posted to
its consideration of comments. The
the docket unchanged. Because your
second copy, which will have the
comment will be made public, you are
claimed confidential information
solely responsible for ensuring that your
redacted/blacked out, will be available
comment does not include any
for public viewing and posted on
confidential information that you or a
https://www.regulations.gov. Submit
third party may not wish to be posted,
both copies to the Dockets Management
such as medical information, your or
Staff. If you do not wish your name and
anyone else’s Social Security number, or
contact information to be made publicly
confidential business information, such
available, you can provide this
as a manufacturing process. Please note
information on the cover sheet and not
that if you include your name, contact
in the body of your comments and you
information, or other information that
must identify this information as
identifies you in the body of your
‘‘confidential.’’ Any information marked
comments, that information will be
as ‘‘confidential’’ will not be disclosed
posted on https://www.regulations.gov.
except in accordance with 21 CFR 10.20
• If you want to submit a comment
and other applicable disclosure law. For
with confidential information that you
more information about FDA’s posting
do not wish to be made available to the
of comments to public dockets, see 80
public, submit the comment as a
FR 56469, September 18, 2015, or access
written/paper submission and in the
the information at: https://www.gpo.gov/
manner detailed (see ‘‘Written/Paper
fdsys/pkg/FR-2015-09-18/pdf/2015Submissions’’ and ‘‘Instructions’’).
23389.pdf.
Docket: For access to the docket to
Written/Paper Submissions
read background documents or the
Submit written/paper submissions as
electronic and written/paper comments
follows:
received, go to https://
• Mail/Hand delivery/Courier (for
www.regulations.gov and insert the
written/paper submissions): Dockets
docket number, found in brackets in the
Management Staff (HFA–305), Food and
heading of this document, into the
Drug Administration, 5630 Fishers
‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852.
and/or go to the Dockets Management
• For written/paper comments
Staff, 5630 Fishers Lane, Rm. 1061,
submitted to the Dockets Management
Rockville, MD 20852.
Staff, FDA will post your comment, as
FOR FURTHER INFORMATION CONTACT:
well as any attachments, except for
Domini Bean, Office of Operations,
information submitted, marked and
Food and Drug Administration, Three
identified, as confidential, if submitted
White Flint North, 10A–12M, 11601
as detailed in ‘‘Instructions.’’
Instructions: All submissions received Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
must include the Docket No. FDA–
fda.hhs.gov.
2008–N–0334 for ‘‘Agency Information
SUPPLEMENTARY INFORMATION: Under the
Collection Activities; Proposed
PRA (44 U.S.C. 3501–3520), Federal
Collection; Comment Request;
Postmarketing Safety Reports for Human Agencies must obtain approval from the
Drug and Biological Products: Electronic Office of Management and Budget
(OMB) for each collection of
Submission Requirements.’’ Received
information they conduct or sponsor.
comments, those filed in a timely
manner (see ADDRESSES), will be placed ‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
in the docket and, except for those
1320.3(c) and includes Agency requests
submitted as ‘‘Confidential
or requirements that members of the
Submissions,’’ publicly viewable at
public submit reports, keep records, or
https://www.regulations.gov or at the
provide information to a third party.
Dockets Management Staff between 9
Section 3506(c)(2)(A) of the PRA (44
a.m. and 4 p.m., Monday through
U.S.C. 3506(c)(2)(A)) requires Federal
Friday.
Agencies to provide a 60-day notice in
• Confidential Submissions—To
the Federal Register concerning each
submit a comment with confidential
proposed collection of information,
information that you do not wish to be
including each proposed extension of an
made publicly available, submit your
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Frm 00026
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]]>Agencies
[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50139-50141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23519]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-5925]
Standard Development Organizations Whose Susceptibility Test
Interpretive Criteria Standards May Be Recognized by the Food and Drug
Administration; Request for Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Request for information.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
requesting information to assist in identifying standard development
organizations (SDOs) that meet the requirements in the Federal Food,
Drug, and Cosmetic Act (FD&C Act), of the 21st Century Cures Act (Cures
Act), which was signed into law on December 13, 2016.
DATES: Submit either electronic or written comments on the notice by
November 29, 2017.
ADDRESSES: You may submit comments and information as follows. Please
note that late, untimely filed comments will not be considered.
Electronic comments must be submitted on or before November 29, 2017.
The https://www.regulations.gov electronic filing system will accept
comments until midnight Eastern Time at the end of November 29, 2017.
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.
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
[[Page 50140]]
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 ``Standard Development Organizations Whose
Susceptibility Test Interpretive Criteria Standards May Be Recognized
by FDA; Request for Information.'' Received comments, those filed in a
timely manner (see ADDRESSES), 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 or [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 at the concentrations of the drug that are
attainable at the site of infection. Historically, susceptibility test
interpretive criteria has 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
for 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 SDOs can be useful sources of information to identify and
update susceptibility test interpretive criteria.
Section 511A of the FD&C Act (21 U.S.C. 360a) was added by section
3044 of the Cures Act (Pub. L. 114-255), which 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 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 provides for a more streamlined
process for incorporating up-to-date information into such devices.
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 Web site containing a list of FDA-recognized susceptibility
test interpretive criteria standards, as well as other susceptibility
test interpretive criteria identified by FDA. The list of standards
consists of new or updated susceptibility test interpretive criteria
standards with respect to legally marketed antimicrobial drugs that
have been: (1) Established by nationally or internationally recognized
SDOs that meet the requirements under section 511A(b)(2)(A)(i) of the
FD&C Act and (2) recognized, in whole or in part, by FDA, pursuant to
section 511A(c) of the FD&C Act.
Section 511A(b)(2)(A)(i) of the FD&C Act requires that in order for
FDA to recognize, in whole or in part, new or updated susceptibility
test interpretive criteria standards established by an SDO, the SDO
must: (1) Be a nationally or internationally recognized SDO that
establishes and maintains procedures to address potential conflicts of
interest and ensure transparent decision making; (2) hold meetings to
ensure that there is an opportunity for public input by interested
parties, and establishes and maintains processes to ensure that such
input is considered in decision making; and (3) permit its standards to
be made publicly available, through the National Library of Medicine or
a similar source acceptable to the Secretary of Health and Human
Services.
II. Issues for Consideration and Request for Information
FDA is currently identifying SDOs that meet the requirements under
section 511A(b)(2)(A)(i) of the FD&C Act and invites submission of
information relevant to this task. FDA is particularly interested in
publicly available information illustrating how an SDO has national or
international recognition, information illustrating an SDO's
established and maintained procedures on how the SDO addresses
potential conflicts of interest and ensures transparent decision-
making, information illustrating that an SDO holds open meetings and
has established and maintained processes to ensure that public input by
interested parties is considered in decision-making, and information
illustrating that an SDO's standards are made publicly available
through the National
[[Page 50141]]
Institutes of Health/National Library of Medicine or a similar source.
When providing this information, please provide weblinks to where this
information is publicly available. This information may assist in FDA's
determination of which SDOs may fulfill the statutory requirements.
Dated: October 25, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-23519 Filed 10-27-17; 8:45 am]
BILLING CODE 4164-01-P
