Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 18765 [E6-5411]
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Federal Register / Vol. 71, No. 70 / Wednesday, April 12, 2006 / Notices
the Agency for Toxic Substances and
Disease Registry.
Dated: April 6, 2006.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E6–5359 Filed 4–11–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Radiological Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
wwhite on PROD1PC61 with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed 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 May 23, 2006, from 9:30 a.m. to
4:30 p.m.
Location: Holiday Inn, Walker/
Whetstone Rooms, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact Person: Nancy Wersto, Center
for Devices and Radiological Health
(HFZ–470), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301–594–1212,
ext. 144, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512526. Please call the
Information Line for up-to-date
information on this meeting.
Agenda: The committee will hear a
presentation explaining FDA’s Critical
Path Initiative and a presentation by the
Office of Surveillance and Biometrics in
the Center for Devices and Radiological
Health outlining their responsibility for
the review of postmarket study design.
Subsequently, FDA will present key
points for the committee to consider for
the reclassification of full field digital
mammography (FFDM) systems from
Class III to Class II devices. The
committee will discuss and make
recommendations on the reclassification
of FFDMs. Background information for
this meeting, including the agenda and
VerDate Aug<31>2005
17:42 Apr 11, 2006
Jkt 208001
questions for the committee, will be
available to the public 1 business day
before the meeting on the Internet at
https://www.fda.gov/cdrh/panel.
Procedure: On May 23, 2006, from 10
a.m. to 4:30 p.m., the meeting is open
to the public. 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 by May 9, 2006. Oral
presentations from the public will be
scheduled between approximately 11:45
a.m. and 12:45 p.m. Time allotted for
each presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before May 9, 2006, 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.
Closed Committee Deliberations: On
May 23, 2006, from 9:30 a.m. to 10 a.m.,
the meeting will be closed to permit
discussion and review of trade secret
and/or confidential information (5
U.S.C. 552b(c)(4)) on current and
pending issues regarding radiological
devices.
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, Conference Management
Staff, at 240–276–0450, ext. 113, at least
7 days in advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: April 5, 2006.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. E6–5411 Filed 4–11–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00063
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18765
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 June 2, 2006, from 10 a.m. to 2
p.m.
Location: Omni Hotel at CNN Center,
International Ballroom, 100 CNN
Center, Atlanta, Georgia. The hotel
phone number is 404–659–0000.
Contact Person: Johanna M. Clifford,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
7001, FAX: 301–827–6776, e-mail:
cliffordj@cder.fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512542. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: The committee will discuss
new drug application (NDA) 21–986,
proposed trade name SPRYCEL
(dasatinib) tablets, Bristol-Myers Squibb
Co., with proposed indications for the:
(1) Treatment of adults with chronic,
accelerated, or blast phase chronic
myeloid leukemia with resistance or
intolerance to prior therapy including
imatinib and (2) treatment of adults
with Philadelphia chromosome–positive
acute lymphoblastic leukemia, and
lymphoid blast chronic myeloid
leukemia with resistance or intolerance
to prior therapy.
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 by May 18, 2006. Oral
presentations from the public will be
scheduled between approximately 12
noon and 1 p.m. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before May 18, 2006, 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.
Persons attending FDA’s advisory
committee meetings are advised that the
E:\FR\FM\12APN1.SGM
12APN1
]]>Agencies
[Federal Register Volume 71, Number 70 (Wednesday, April 12, 2006)]
[Notices]
[Page 18765]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-5411]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Radiological 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). At least one
portion of the meeting will be closed 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 May 23, 2006, from 9:30
a.m. to 4:30 p.m.
Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact Person: Nancy Wersto, Center for Devices and Radiological
Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-594-1212, ext. 144, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 3014512526. Please call the Information Line for up-to-date
information on this meeting.
Agenda: The committee will hear a presentation explaining FDA's
Critical Path Initiative and a presentation by the Office of
Surveillance and Biometrics in the Center for Devices and Radiological
Health outlining their responsibility for the review of postmarket
study design. Subsequently, FDA will present key points for the
committee to consider for the reclassification of full field digital
mammography (FFDM) systems from Class III to Class II devices. The
committee will discuss and make recommendations on the reclassification
of FFDMs. Background information for this meeting, including the agenda
and questions for the committee, will be available to the public 1
business day before the meeting on the Internet at https://www.fda.gov/
cdrh/panel.
Procedure: On May 23, 2006, from 10 a.m. to 4:30 p.m., the meeting
is open to the public. 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 by
May 9, 2006. Oral presentations from the public will be scheduled
between approximately 11:45 a.m. and 12:45 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before May 9, 2006, 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.
Closed Committee Deliberations: On May 23, 2006, from 9:30 a.m. to
10 a.m., the meeting will be closed to permit discussion and review of
trade secret and/or confidential information (5 U.S.C. 552b(c)(4)) on
current and pending issues regarding radiological devices.
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,
Conference Management Staff, at 240-276-0450, ext. 113, at least 7 days
in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: April 5, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-5411 Filed 4-11-06; 8:45 am]
BILLING CODE 4160-01-S
