Cardiovascular and Renal Drugs Advisory Committee; Cancellation, 50702 [2012-20607]
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50702
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Federal Register / Vol. 77, No. 163 / Wednesday, August 22, 2012 / Notices
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: Radiological
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 October 24, 2012, from 8 a.m.
to 6 p.m.
Location: 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.
Contact Person: Shanika Craig, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm.
1613, Silver Spring, MD 20993,
Shanika.Craig@fda.hhs.gov, 301–796–
6639, 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/
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 October 24, 2012, the
committee will discuss, make
recommendations, and vote on a
premarket approval application
supplement to expand the indications
for use of the Selenia Dimensions 3D
System with C-View Software Module,
sponsored by Hologic, Inc.
The Selenia Dimensions 3D System is
currently approved for breast cancer
screening and diagnosis. The screening
exam can consist of field digital
mammography (FFDM) alone or the
combination of FFDM with digital
breast tomosynthesis (DBT).
The new C-View Software Module
can generate synthetic 2D images from
the DBT data. Hologic requests to
expand the indications for use to allow
the combination of DBT with synthetic
2D images to be used as another exam
option for breast cancer screening.
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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 October 15, 2012.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 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 October
5, 2012. 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 October 9, 2012.
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 James Clark,
Conference Management Staff, at
James.Clark@fda.hhs.gov or 301–796–
5293, 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.
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 17, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–20608 Filed 8–21–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Cardiovascular and Renal Drugs
Advisory Committee; Cancellation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The meeting of the
Cardiovascular and Renal Drugs
Advisory Committee scheduled for
September 14, 2012, is cancelled. The
meeting is no longer needed. This
meeting was announced in the Federal
Register of July 23, 2012 (77 FR 43093).
FOR FURTHER INFORMATION CONTACT:
Kalyani Bhatt, 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:
CRDAC@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 or visit
our Web site at https://www.fda.gov/
AdvisoryCommittees/default.htm.
SUMMARY:
Dated: August 17, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–20607 Filed 8–21–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0839]
Ranbaxy Laboratories Limited;
Withdrawal of Approval of 27
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\22AUN1.SGM
Notice.
22AUN1
]]>Agencies
[Federal Register Volume 77, Number 163 (Wednesday, August 22, 2012)]
[Notices]
[Page 50702]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20607]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Cardiovascular and Renal Drugs Advisory Committee; Cancellation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The meeting of the Cardiovascular and Renal Drugs Advisory
Committee scheduled for September 14, 2012, is cancelled. The meeting
is no longer needed. This meeting was announced in the Federal Register
of July 23, 2012 (77 FR 43093).
FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, 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: CRDAC@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 or visit our Web site at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: August 17, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-20607 Filed 8-21-12; 8:45 am]
BILLING CODE 4160-01-P
