Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice, 32125 [2012-13157]
Download as PDF
<![CDATA[
Federal Register / Vol. 77, No. 105 / Thursday, May 31, 2012 / Notices
• The use of a daily responder
analysis for IBS–D as a primary analysis
was included.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on the clinical
evaluation of drugs for the treatment of
IBS. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: May 23, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–13143 Filed 5–30–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Orthopaedic and Rehabilitation
Devices Panel of the Medical Devices
Advisory Committee; Amendment of
Notice
AGENCY:
Food and Drug Administration,
HHS.
srobinson on DSK4SPTVN1PROD with NOTICES
ACTION:
Notice.
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of meeting of the Orthopaedic
and Rehabilitation Devices Panel of the
Medical Devices Advisory Committee.
This meeting was announced in the
Federal Register of March 30, 2012 (77
FR 19293). The amendment is being
made to reflect a change in the DATES
and ADDRESSES portion of the
VerDate Mar<15>2010
17:53 May 30, 2012
Jkt 226001
document. The amendment also
provides a Web address where the
meeting webcast can be accessed. There
are no other changes.
FOR FURTHER INFORMATION CONTACT:
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, 301–796–3805, Avena.
Russell@fda.hhs.gov, or please use the
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), and follow
the prompts to the desired center or
product area. Please call the Information
Line for up-to-date information on this
meeting. 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.
SUPPLEMENTARY INFORMATION: In the
Federal Register of March 30, 2012,
FDA announced that a meeting of the
Orthopaedic and Rehabilitation Devices
Panel would be held on June 27 and 28,
2012. On page 19293, in the first
column the DATES portion of the
document is changed to read as follows:
The meeting will be held on June 27
and 28, 2012, from 7:30 a.m. to 7 p.m.
On page 19293, in the first column, the
ADDRESSES portion of the document is
changed to read as follows:
Hilton Washington DC North/
Gaithersburg, Salons A, B, C, and D, 620
Perry Pkwy., Gaithersburg, MD 20877.
The hotel’s telephone number is 301–
977–8900.
The meeting will be webcast live and
free of charge on both days and can be
accessed at the following Web address:
On June 27, Day 1
https://fda.yorkcast.com/webcast/
Viewer/?peid=12f84ea095b445d78e9b
115f495392731d
On June 28, Day 2
https://fda.yorkcast.com/webcast/
Viewer/?peid=901726ab91944b158ac7
05e48664921c1d
The webcast will be broadcast using
Windows Media Player.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
32125
Dated: May 24, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–13157 Filed 5–30–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Oncologic Drugs 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: Oncologic Drugs
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 24, 2012, from 8 a.m. to 5
p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), 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: Caleb Briggs, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
ODAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), to find out
further information regarding FDA
advisory committee information. 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/Advisory
E:\FR\FM\31MYN1.SGM
31MYN1
]]>Agencies
[Federal Register Volume 77, Number 105 (Thursday, May 31, 2012)]
[Notices]
[Page 32125]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13157]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Orthopaedic and Rehabilitation Devices Panel of the Medical
Devices Advisory Committee; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing an amendment
to the notice of meeting of the Orthopaedic and Rehabilitation Devices
Panel of the Medical Devices Advisory Committee. This meeting was
announced in the Federal Register of March 30, 2012 (77 FR 19293). The
amendment is being made to reflect a change in the DATES and ADDRESSES
portion of the document. The amendment also provides a Web address
where the meeting webcast can be accessed. There are no other changes.
FOR FURTHER INFORMATION CONTACT: 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, 301-796-3805,
Avena.Russell@fda.hhs.gov, or please use the FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), and follow the prompts to the desired center or product area.
Please call the Information Line for up-to-date information on this
meeting. 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.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 30, 2012,
FDA announced that a meeting of the Orthopaedic and Rehabilitation
Devices Panel would be held on June 27 and 28, 2012. On page 19293, in
the first column the DATES portion of the document is changed to read
as follows:
The meeting will be held on June 27 and 28, 2012, from 7:30 a.m. to
7 p.m. On page 19293, in the first column, the ADDRESSES portion of the
document is changed to read as follows:
Hilton Washington DC North/Gaithersburg, Salons A, B, C, and D, 620
Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone number is
301-977-8900.
The meeting will be webcast live and free of charge on both days
and can be accessed at the following Web address:
On June 27, Day 1
https://fda.yorkcast.com/webcast/Viewer/?peid=12f84ea095b445d78e9b115f495392731d
On June 28, Day 2
https://fda.yorkcast.com/webcast/Viewer/?peid=901726ab91944b158ac705e48664921c1d
The webcast will be broadcast using Windows Media Player.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: May 24, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-13157 Filed 5-30-12; 8:45 am]
BILLING CODE 4160-01-P
