Product Labeling for Certain Ultrasonic Surgical Aspirator Devices; Guidance for Industry and Food and Drug Administration Staff; Availability, 50138-50139 [2017-23520]
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50138
Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
........................
........................
........................
........................
Activity
Total .........................................
1
2
7,434
Total
operating and
maintenance
costs 2
$6,313
There are no capital costs associated with this collection of information.
No change from approved information collection. This information is retained for the convenience of the reader.
Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–23500 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–2016–D–3275]
Product Labeling for Certain Ultrasonic
Surgical Aspirator Devices; Guidance
for Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the
guidance entitled ‘‘Product Labeling for
Certain Ultrasonic Surgical Aspirator
Devices.’’ FDA is providing a specific
labeling recommendation in this
guidance to promote the safe and
effective use of ultrasonic surgical
aspirator devices. The labeling
recommendation is being made in light
of the risk of tissue dissemination and
relates to use of these devices in the
removal of uterine fibroids.
DATES: The announcement of the
guidance is published in the Federal
Register on October 30, 2017.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
Electronic Submissions
sradovich on DSK3GMQ082PROD with NOTICES
Total hours
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
VerDate Sep<11>2014
17:59 Oct 27, 2017
Jkt 244001
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 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–
2016–D–3275 for ‘‘Product Labeling for
Certain Ultrasonic Surgical Aspirator
Devices; Guidance for Industry and
Food and Drug Administration Staff.’’
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
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
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
‘‘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 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/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 Dockets Management Staff,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Product Labeling for
Certain Ultrasonic Surgical Aspirator
Devices’’ to the Office of the Center
Director, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one self-
E:\FR\FM\30OCN1.SGM
30OCN1
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
]]>Agencies
[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50138-50139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23520]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-3275]
Product Labeling for Certain Ultrasonic Surgical Aspirator
Devices; Guidance for Industry and Food and Drug Administration Staff;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``Product Labeling for
Certain Ultrasonic Surgical Aspirator Devices.'' FDA is providing a
specific labeling recommendation in this guidance to promote the safe
and effective use of ultrasonic surgical aspirator devices. The
labeling recommendation is being made in light of the risk of tissue
dissemination and relates to use of these devices in the removal of
uterine fibroids.
DATES: The announcement of the guidance is published in the Federal
Register on October 30, 2017.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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 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-2016-D-3275 for ``Product Labeling for Certain Ultrasonic Surgical
Aspirator Devices; Guidance for Industry and Food and Drug
Administration Staff.'' 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 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 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 Dockets Management Staff, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Product Labeling for Certain Ultrasonic Surgical Aspirator Devices''
to the Office of the Center Director, Guidance and Policy Development,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-
[[Page 50139]]
addressed adhesive label to assist that office in processing your
request.
FOR FURTHER INFORMATION CONTACT: 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:
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 received prior to finalizing this guidance.
II. Significance of Guidance
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.
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 [email protected] 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
