General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 30928-30929 [2013-12230]
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30928
Federal Register / Vol. 78, No. 100 / Thursday, May 23, 2013 / Notices
Dated: May 15, 2013.
Michele Meyer,
Assistant Director, Legislative and Regulatory
Activities Division, Office of the Comptroller
of the Currency.
Board of Governors of the Federal Reserve
System, May 16, 2013.
Robert deV. Frierson,
Secretary of the Board.
Dated at Washington, DC, this 15th day of
May, 2013.
Federal Deposit Insurance Corporation.
Valerie J. Best,
Assistant Executive Secretary.
[FR Doc. 2013–12220 Filed 5–22–13; 8:45 am]
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
Dated: May 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–12274 Filed 5–22–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
BILLING CODE 6210–01–P; 4810–33–P; 6714–01–P
General and Plastic Surgery Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration
[Docket No. FDA–2012–D–0429]
ACTION:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance on Meetings With Industry
and Investigators on the Research and
Development of Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
sroberts on DSK5SPTVN1PROD with NOTICES
Food and Drug Administration,
HHS.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance on Meetings With Industry
and Investigators on the Research and
Development of Tobacco Products’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
December 13, 2012, the Agency
submitted a proposed collection of
information entitled ‘‘Guidance on
Meetings With Industry and
Investigators on the Research and
Development of Tobacco Products’’ to
OMB for review and clearance under 44
U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0731. The
approval expires on February 29, 2016.
A copy of the supporting statement for
VerDate Mar<15>2010
18:14 May 22, 2013
Jkt 229001
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: General and
Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on June 26, 2013, from 8 a.m. to 5
p.m.
Location: Holiday Inn, Ballroom 2,
Montgomery Village Ave., Gaithersburg,
MD 20879. The hotel phone number is
301–948–8900.
Contact Person: Avena Russell, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm.
1535, Silver Spring, MD 20993–0002,
Avena.Russell@fda.hhs.gov, 301–796–
3805, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). A notice in the Federal Register
about last minute modifications that
impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the Agency’s Web
site at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
Agenda: On June 26, 2013, the
committee will discuss and make
PO 00000
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Fmt 4703
Sfmt 4703
recommendations regarding the possible
reclassification of blood lancet devices.
The committee will discuss whether
new scientific data are sufficient to
support the reasonable assurance of
safety and effectiveness to develop
special controls that support regulation
of blood lancets from class I to class II
and class III. The four subsets of blood
lancets have been identified with the
following indications for use:
• Blood lancet with an integral sharps
injury prevention feature is for single
use only, disposable blood lancet with
a blade attached to a solid base which
includes an integral sharps injury
prevention feature that allows the
device to be used once and then renders
it inoperable and incapable of further
use and which is used to puncture the
skin to obtain a drop of blood for
diagnostic purposes;
• Blood lancet without an integral
sharps injury prevention feature is for
single use only, disposable blood lancet
with a blade attached to a solid base
which is used to puncture the skin to
obtain a drop of blood for diagnostic
purposes;
• Blood lancet for single patient use
only is a multiple use capable blood
lancet with a single use blade inserted
into a solid, reusable base which is used
only for a single patient to puncture the
skin to obtain a drop of blood for
diagnostic purposes; and
• Multiple use blood lancet for
multiple patient use is a multiple use
capable blood lancet with a single use
blade inserted into a solid, reusable base
which is used for multiple patients to
puncture the skin to obtain a drop of
blood for diagnostic purposes.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before June 7, 2013. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
E:\FR\FM\23MYN1.SGM
23MYN1
Federal Register / Vol. 78, No. 100 / Thursday, May 23, 2013 / Notices
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before June 6,
2013. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by June 10, 2013.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact AnnMarie
Williams, Committee Management Staff,
at 301–796–5966 or
AnnMarie.Williams@fda.hhs.gov at least
7 days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: May 17, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–12230 Filed 5–22–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sroberts on DSK5SPTVN1PROD with NOTICES
[Docket No. FDA–2013–N–0001]
Drug Safety and Risk Management
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
VerDate Mar<15>2010
18:14 May 22, 2013
Jkt 229001
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Drug Safety and
Risk Management Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on July 10, 2013, from 8 a.m. to 5
p.m.
Location: FDA White Oak Campus,
Building 31, the Great Room, White Oak
Conference Center (Rm. 1503), 10903
New Hampshire Ave., Silver Spring, MD
20993–0002. Information regarding
special accommodations due to a
disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Nicole Vesely, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., WO31–2417, Silver
Spring, MD 20993–0002, 301–796–9001,
FAX: 301–847–8533, email:
DSaRM@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The Food and Drug
Administration Amendments Act of
2007 requires FDA to bring, at least
annually, one or more drugs with Risk
Evaluation and Mitigation Strategies
(REMS) with elements to assure safe use
(ETASU) before its Drug Safety and Risk
Management Advisory Committee
(DSaRM). On July 10, 2013, the Agency
plans to discuss the risk management of
LOTRONEX (alosetron hydrochloride)
tablets, by Prometheus Laboratories Inc.,
which is approved for the treatment of
women with severe diarrhea
predominant irritable bowel syndrome
(IBS-d). The Agency will seek the
committee’s comments as to whether
the REMS with ETASU for this drug
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Fmt 4703
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30929
assures safe use, is not unduly
burdensome to patient access to the
drug, and to the extent practicable,
minimizes the burden to the health care
delivery system.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before June 25, 2013. Oral
presentations from the public will be
scheduled between approximately 1
p.m. to 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before June 17,
2013. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by June 18, 2013.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Nicole
Vesely at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
E:\FR\FM\23MYN1.SGM
23MYN1
]]>Agencies
[Federal Register Volume 78, Number 100 (Thursday, May 23, 2013)]
[Notices]
[Pages 30928-30929]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12230]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: General and Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on June 26, 2013, from 8
a.m. to 5 p.m.
Location: Holiday Inn, Ballroom 2, Montgomery Village Ave.,
Gaithersburg, MD 20879. The hotel phone number is 301-948-8900.
Contact Person: Avena Russell, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 1535, Silver Spring, MD 20993-0002, Avena.Russell@fda.hhs.gov,
301-796-3805, or FDA Advisory Committee Information Line, 1-800-741-
8138 (301-443-0572 in the Washington, DC area). A notice in the Federal
Register about last minute modifications that impact a previously
announced advisory committee meeting cannot always be published quickly
enough to provide timely notice. Therefore, you should always check the
Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm
and scroll down to the appropriate advisory committee meeting link, or
call the advisory committee information line to learn about possible
modifications before coming to the meeting.
Agenda: On June 26, 2013, the committee will discuss and make
recommendations regarding the possible reclassification of blood lancet
devices. The committee will discuss whether new scientific data are
sufficient to support the reasonable assurance of safety and
effectiveness to develop special controls that support regulation of
blood lancets from class I to class II and class III. The four subsets
of blood lancets have been identified with the following indications
for use:
Blood lancet with an integral sharps injury prevention
feature is for single use only, disposable blood lancet with a blade
attached to a solid base which includes an integral sharps injury
prevention feature that allows the device to be used once and then
renders it inoperable and incapable of further use and which is used to
puncture the skin to obtain a drop of blood for diagnostic purposes;
Blood lancet without an integral sharps injury prevention
feature is for single use only, disposable blood lancet with a blade
attached to a solid base which is used to puncture the skin to obtain a
drop of blood for diagnostic purposes;
Blood lancet for single patient use only is a multiple use
capable blood lancet with a single use blade inserted into a solid,
reusable base which is used only for a single patient to puncture the
skin to obtain a drop of blood for diagnostic purposes; and
Multiple use blood lancet for multiple patient use is a
multiple use capable blood lancet with a single use blade inserted into
a solid, reusable base which is used for multiple patients to puncture
the skin to obtain a drop of blood for diagnostic purposes.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before June
7, 2013. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those individuals interested in making
formal oral
[[Page 30929]]
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before June 6, 2013. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by June 10,
2013.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Committee Management Staff, at 301-796-5966 or
AnnMarie.Williams@fda.hhs.gov at least 7 days in advance of the
meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: May 17, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-12230 Filed 5-22-13; 8:45 am]
BILLING CODE 4160-01-P
