Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting, 1432 [E6-71]
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Federal Register / Vol. 71, No. 5 / Monday, January 9, 2006 / Notices
TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1,
2005, THROUGH SEPTEMBER 30, 2005—Continued
PMA No./Docket No.
Applicant
Trade name
Approval date
P040044/2005M–0359
Access Closure, Inc.
MATRIX VSG SYSTEM MODEL
MX–100
August 17, 2005
P930016(S21)/2005M–0382
Visx, Inc.
STAR S4 IR EXCIMER LASER
SYSTEM WITH VARIABLE SPOT
SCANNING (VSS)
August 30, 2005
P040038/2005M–0381
Abbott Vascular Devices
XACT CAROTID STENT SYSTEM
September 6, 2005
P930014(S15)/2005M–0378
Alcon Laboratories
ACRYSOF TORIC POSTERIOR
CHAMBER INTRAOCULAR LENS
September 14, 2005
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Dated: December 20, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E6–59 Filed 1–6–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Cellular, Tissue and Gene Therapies
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
cprice-sewell on PROD1PC66 with NOTICES
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: Cellular, Tissue
and Gene Therapies 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 February 9, 2006, from 8 a.m.
to approximately 5:30 p.m. and on
February 10, 2006, from 8 a.m. to
approximately 1 p.m.
Location: Gaithersburg Hilton, 620
Perry Pkwy., Gaithersburg, MD.
Contact Person: Gail Dapolito or
Rosanna L. Harvey, Food and Drug
Administration, 1401 Rockville Pike
(HFM–71), Rockville, MD 20852, 301–
827–0314 or FDA Advisory Committee
Information Line, 1–800–741–8138
(301)–443–0572 in the Washington, DC
area), code 301–451–2389. Please call
VerDate Aug<31>2005
15:31 Jan 06, 2006
Jkt 208001
the Information Line for up-to-date
information on this meeting.
Agenda: On February 9, 2006, in open
session, the committee will conduct a
scientific discussion of potency
measurements for cellular and gene
transfer products. On February 10, in
open session, the committee will (1)
Discuss the National Toxicology
Program on Retroviral Mutagenesis and
(2) receive a brief update on the recent
review of the research program of the
Office of Cellular, Tissue and Gene
Therapies, FDA.
Procedure: On February 9, 2006, from
8 a.m. to approximately 5:30 p.m., and
on February 10, 2006, from 8 a.m. to
approximately 11:30 a.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 February 2, 2006. Oral
presentations from the public will be
scheduled between approximately 1:30
p.m. and 2 p.m. on February 9, 2006,
and between approximately 9:40 a.m.
and 10:10 a.m. on February 10, 2006.
Time allotted for each presentation may
be limited. Those desiring to make
formal oral presentations should notify
the contact person before February 2,
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
February 10, 2006, from approximately
11:30 a.m. to 1 p.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)); and
where disclosure would constitute a
clearly unwarranted invasion of
personal privacy (5 U.S.C. 552b(c)(6)).
The committee will discuss the report of
the Research Subcommittee of the
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
Cellular, Tissue and Gene Therapies
Advisory Committee related to a review
of the research program in the Office of
Cellular, Tissue and Gene Therapies.
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 Gail Dapolito
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: January 3, 2006.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. E6–71 Filed 1–6–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0468]
Draft Guidance for Industry and Food
and Drug Administration Staff; Class II
Special Controls Guidance Document:
Herpes Simplex Virus Types 1 and 2
Serological Assays; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Class II Special Controls
Guidance Document: Herpes Simplex
Virus Types 1 and 2 Serological
Assays.’’ This draft guidance document
E:\FR\FM\09JAN1.SGM
09JAN1
]]>Agencies
[Federal Register Volume 71, Number 5 (Monday, January 9, 2006)]
[Notices]
[Page 1432]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-71]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Cellular, Tissue and Gene Therapies 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: Cellular, Tissue and Gene Therapies 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 February 9, 2006, from 8
a.m. to approximately 5:30 p.m. and on February 10, 2006, from 8 a.m.
to approximately 1 p.m.
Location: Gaithersburg Hilton, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Gail Dapolito or Rosanna L. Harvey, Food and Drug
Administration, 1401 Rockville Pike (HFM-71), Rockville, MD 20852, 301-
827-0314 or FDA Advisory Committee Information Line, 1-800-741-8138
(301)-443-0572 in the Washington, DC area), code 301-451-2389. Please
call the Information Line for up-to-date information on this meeting.
Agenda: On February 9, 2006, in open session, the committee will
conduct a scientific discussion of potency measurements for cellular
and gene transfer products. On February 10, in open session, the
committee will (1) Discuss the National Toxicology Program on
Retroviral Mutagenesis and (2) receive a brief update on the recent
review of the research program of the Office of Cellular, Tissue and
Gene Therapies, FDA.
Procedure: On February 9, 2006, from 8 a.m. to approximately 5:30
p.m., and on February 10, 2006, from 8 a.m. to approximately 11:30
a.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 February 2, 2006. Oral presentations from the public will be
scheduled between approximately 1:30 p.m. and 2 p.m. on February 9,
2006, and between approximately 9:40 a.m. and 10:10 a.m. on February
10, 2006. Time allotted for each presentation may be limited. Those
desiring to make formal oral presentations should notify the contact
person before February 2, 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 February 10, 2006, from
approximately 11:30 a.m. to 1 p.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)); and where disclosure would
constitute a clearly unwarranted invasion of personal privacy (5 U.S.C.
552b(c)(6)). The committee will discuss the report of the Research
Subcommittee of the Cellular, Tissue and Gene Therapies Advisory
Committee related to a review of the research program in the Office of
Cellular, Tissue and Gene Therapies.
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 Gail Dapolito 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: January 3, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-71 Filed 1-6-06; 8:45 am]
BILLING CODE 4160-01-S
