Request for Nominations on the Tobacco Products Scientific Advisory Committee, 54101-54102 [2016-19312]
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sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Notices
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applicable disclosure law. For more
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regulatoryinformation/dockets/
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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 ‘‘Premarket
Notification (510(k)) Submissions for
Electrosurgical Devices for General
Surgery’’ 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 selfaddressed adhesive label to assist that
office in processing your request.
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19:23 Aug 12, 2016
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FOR FURTHER INFORMATION CONTACT:
Jismi Johnson, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1524, Silver Spring,
MD 20993–0002, 301–796–6424.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has developed this guidance
document to assist industry in preparing
premarket notification (510(k))
submissions for electrosurgical devices
intended for use in general surgery.
These devices are designed to cut and/
or remove tissue and control bleeding
through the use of high-frequency
electrical current. For the purpose of
this guidance, electrosurgical devices
may also be called radiofrequency
devices or high-frequency devices. The
scope of this document is limited to the
class II electrosurgical devices and
accessories classified under 21 CFR
878.4400, Electrosurgical cutting and
coagulation device and accessories.
In the Federal Register of March 24,
2014 (79 FR 16008), FDA announced the
availability of the draft guidance.
Interested persons were invited to
comment by June 23, 2014. A total of six
sets of comments were received. FDA
reviewed and considered all the public
comments received and revised sections
of the guidance, where applicable.
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 premarket
notification (510(k)) submissions for
electrosurgical devices for general
surgery. 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.
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 ‘‘Premarket Notification (510(k))
Submissions for Electrosurgical Devices
for General Surgery’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
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54101
document. Please use the document
number 1835 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information.
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; the
collections of information in 21 CFR
part 820 have been approved under
OMB control number 0910–0073; the
collections of information in 21 CFR
part 801 have been approved under
OMB control number 0910–0485; and
the collections of information in the
guidance document ‘‘Requests for
Feedback on Medical Device
Submissions: The Pre-Submission
Program and Meetings with Food and
Drug Administration Staff’’ have been
approved under OMB control number
0910–0756.
Dated: August 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–19404 Filed 8–12–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Request for Nominations on the
Tobacco Products Scientific Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of a
nonvoting member to represent the
interests of tobacco growers to serve on
the Tobacco Products Scientific
Advisory Committee for the Center for
Tobacco Products (CTP), notify FDA in
writing. FDA is also requesting
nominations for a nonvoting member to
represent the interests of tobacco
growers to serve on the Tobacco
Products Scientific Advisory
Committee, and an alternate to this
representative. A nominee may either be
self-nominated or nominated by an
organization to serve as a nonvoting
industry representative. Nominations
SUMMARY:
E:\FR\FM\15AUN1.SGM
15AUN1
54102
Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
will be accepted for current vacancies
effective with this notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent the interests of
tobacco growers must send a letter
stating that interest to FDA by
September 14, 2016 (see sections I and
II of this document for further details).
Concurrently, nomination materials for
prospective candidates should be sent to
FDA by September 14, 2016.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
should be sent to Caryn Cohen (see FOR
FURTHER INFORMATION CONTACT). All
nominations for nonvoting industry
representatives should be submitted
electronically by accessing the FDA
Advisory Committee Membership
Nomination Portal at: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member of an FDA advisory
committee can also be obtained by
visiting FDA’s Web site at: https://
www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Caryn Cohen, Office of Science, Center
for Tobacco Products, Food and Drug
Administration, Center for Tobacco
Products, Document Control Center,
Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 1–877–287–1373 (choose
Option 5), email: TPSAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add nonvoting
industry representatives to the following
advisory committee:
I. Tobacco Products Scientific Advisory
Committee
The Tobacco Products Scientific
Advisory Committee (the Committee)
advises the Commissioner of Food and
Drugs (the Commissioner) or designee in
discharging responsibilities related to
the regulation of tobacco products. The
Committee reviews and evaluates safety,
dependence, and health issues relating
to tobacco products and provides
appropriate advice, information, and
recommendations to the Commissioner.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent the interests of tobacco
VerDate Sep<11>2014
19:23 Aug 12, 2016
Jkt 238001
growers should send a letter stating that
interest to the FDA contact (see FOR
FURTHER INFORMATION CONTACT) within
30 days of publication of this document
(see DATES). Within the subsequent 30
days, FDA will send a letter to each
organization that has expressed an
interest, attaching a complete list of all
such organizations, and a list of all
nominees along with their current
´
´
resumes. The letter will also state that
it is the responsibility of the interested
organizations to confer with one another
and to select a candidate, within 60
days after the receipt of the FDA letter,
to serve as the nonvoting member to
represent the interests of tobacco
growers for the committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within 60 days, the
Commissioner will select the nonvoting
member to represent the interests of
tobacco growers.
III. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
member to represent the interests of
tobacco growers. Contact information,
current curriculum vitae, and the name
of the committee of interest should be
sent to the FDA Advisory Committee
Membership Nomination Portal (see
ADDRESSES) within 30 days of
publication of this document (see
DATES). FDA will forward all
nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process.)
FDA seeks to include the views of
women, and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore encourages
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: August 9, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special
Medical Programs.
[FR Doc. 2016–19312 Filed 8–12–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0218]
Premarket Notification Submissions
for Bipolar Electrosurgical Vessel
Sealers for General Surgery; 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 ‘‘Premarket
Notification (510(k)) Submissions for
Bipolar Electrosurgical Vessel Sealers
for General Surgery.’’ FDA has
developed this guidance document to
assist industry in preparing premarket
notification (510(k)) submissions for
bipolar electrosurgical vessel sealers
intended for use in general surgery.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: You may submit comments
as follows:
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
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’’).
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Agencies
[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)]
[Notices]
[Pages 54101-54102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19312]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Request for Nominations on the Tobacco Products Scientific
Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organizations interested in participating in the selection of
a nonvoting member to represent the interests of tobacco growers to
serve on the Tobacco Products Scientific Advisory Committee for the
Center for Tobacco Products (CTP), notify FDA in writing. FDA is also
requesting nominations for a nonvoting member to represent the
interests of tobacco growers to serve on the Tobacco Products
Scientific Advisory Committee, and an alternate to this representative.
A nominee may either be self-nominated or nominated by an organization
to serve as a nonvoting industry representative. Nominations
[[Page 54102]]
will be accepted for current vacancies effective with this notice.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent the interests
of tobacco growers must send a letter stating that interest to FDA by
September 14, 2016 (see sections I and II of this document for further
details). Concurrently, nomination materials for prospective candidates
should be sent to FDA by September 14, 2016.
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process should be sent to
Caryn Cohen (see FOR FURTHER INFORMATION CONTACT). All nominations for
nonvoting industry representatives should be submitted electronically
by accessing the FDA Advisory Committee Membership Nomination Portal
at: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management
Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 5103, Silver Spring, MD 20993-0002. Information about becoming
a member of an FDA advisory committee can also be obtained by visiting
FDA's Web site at: https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Caryn Cohen, Office of Science, Center
for Tobacco Products, Food and Drug Administration, Center for Tobacco
Products, Document Control Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373 (choose
Option 5), email: TPSAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The Agency intends to add nonvoting industry
representatives to the following advisory committee:
I. Tobacco Products Scientific Advisory Committee
The Tobacco Products Scientific Advisory Committee (the Committee)
advises the Commissioner of Food and Drugs (the Commissioner) or
designee in discharging responsibilities related to the regulation of
tobacco products. The Committee reviews and evaluates safety,
dependence, and health issues relating to tobacco products and provides
appropriate advice, information, and recommendations to the
Commissioner.
II. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent the interests
of tobacco growers should send a letter stating that interest to the
FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of
publication of this document (see DATES). Within the subsequent 30
days, FDA will send a letter to each organization that has expressed an
interest, attaching a complete list of all such organizations, and a
list of all nominees along with their current r[eacute]sum[eacute]s.
The letter will also state that it is the responsibility of the
interested organizations to confer with one another and to select a
candidate, within 60 days after the receipt of the FDA letter, to serve
as the nonvoting member to represent the interests of tobacco growers
for the committee. The interested organizations are not bound by the
list of nominees in selecting a candidate. However, if no individual is
selected within 60 days, the Commissioner will select the nonvoting
member to represent the interests of tobacco growers.
III. Application Procedure
Individuals may self-nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting member to represent the
interests of tobacco growers. Contact information, current curriculum
vitae, and the name of the committee of interest should be sent to the
FDA Advisory Committee Membership Nomination Portal (see ADDRESSES)
within 30 days of publication of this document (see DATES). FDA will
forward all nominations to the organizations expressing interest in
participating in the selection process for the committee. (Persons who
nominate themselves as nonvoting industry representatives will not
participate in the selection process.)
FDA seeks to include the views of women, and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore encourages nominations of
appropriately qualified candidates from these groups.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: August 9, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-19312 Filed 8-12-16; 8:45 am]
BILLING CODE 4164-01-P