Science Board to the Food and Drug Administration; Notice of Meeting, 6643-6644 [E9-2797]
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Federal Register / Vol. 74, No. 26 / Tuesday, February 10, 2009 / Notices
the agency now posts this information
on the Internet on FDA’s home page at
https://www.fda.gov. FDA believes that
this procedure expedites public
notification of these actions because
announcements can be placed on the
Internet more quickly than they can be
published in the Federal Register, and
FDA believes that the Internet is
accessible to more people than the
Federal Register.
In accordance with section 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the act.
The 30-day period for requesting
reconsideration of an FDA action under
§ 10.33(b) (21 CFR 10.33(b)) for notices
announcing approval of a PMA begins
on the day the notice is placed on the
Internet. Section 10.33(b) provides that
FDA may, for good cause, extend this
30-day period. Reconsideration of a
denial or withdrawal of approval of a
PMA may be sought only by the
applicant; in these cases, the 30-day
period will begin when the applicant is
notified by FDA in writing of its
decision.
The regulations provide that FDA
publish a quarterly list of available
safety and effectiveness summaries of
PMA approvals and denials that were
announced during that quarter. The
following is a list of approved PMAs for
which summaries of safety and
effectiveness were placed on the
Internet from July 1, 2008, through
September 30, 2008. There were no
denial actions during this period. The
list provides the manufacturer’s name,
the product’s generic name or the trade
name, and the approval date.
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1,
2008, THROUGH SEPTEMBER 30, 2008.
PMA No.
Docket No.
Applicant
TRADE NAME
Approval Date
P060037
FDA–2008–M–0522
Zimmer, Inc.
NEXGEN LPS–FLEX MOBILE & LPS MOBILE BEARING KNEE SYSTEM
December 10, 2007
P850048 (S021)
FDA–2008–M–0425
Beckman Coulter, Inc.
ACCESS HYBRITECH PSA REAGENTS
May 9, 2008
P060027
FDA–2008–M–0426
ELA Medical, Inc.
OVATIO CRT–D SYSTEM
May 15, 2008
P060039
FDA–2008–M–0478
Medtronic Cardiac Rhythm Disease Management
ATTAIN STARFIX MODEL 4195 LEAD
June 13, 2008
P070013
FDA–2008–M–0402
Colbar Lifescience Ltd.
EVOLENCE COLLAGEN FILLER
June 27, 2008
P050040
FDA–2008–M–0437
Invitrogen Corporation
SPOT–LIGHT HER2 CISH KIT
July 1, 2008
P070006
FDA–2008–M–0477
Oxford Immunotec, Ltd.
T SPOT–TB TEST
July 30, 2008
P040037 (S007)
FDA–2008–M–0467
W.L. Gore & Associates, Inc.
VIABAHN ENDOPROSTHESIS
August 14, 2008
P050028
FDA–2008–M–0501
Roche Molecular Systems, Inc.
COBAS TAQMAN HBV TEST
September 4, 2008
P060022
FDA–2008–M–0515
Bausch & Lomb, Inc.
AKREOS POSTERIOR CHAMBER INTRAOCULAR
LENS
September 5, 2008
II. Electronic Access
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Food and Drug Administration
Dated: January 15, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological
Health.
[FR Doc. E9–2685 Filed 2–9–09; 8:45 am]
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BILLING CODE 4160–01–S
[Docket No. FDA–2009–N–0664]
Science Board to the Food and Drug
Administration; 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.
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14:17 Feb 09, 2009
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Name of Committee: Science Board to
the Food and Drug Administration
(Science Board).
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 Tuesday, February 24, 2009,
from 8 a.m. to 3 p.m.
Addresses: Hilton Washington DC
North/Gaithersburg, 620 Perry Pkwy.,
Gaithersburg, MD 20877.
˜
Contact Person: Carlos Pena, Office of
the Commissioner, Food and Drug
Administration (HF–33), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–6687, or
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10FEN1
erowe on PROD1PC63 with NOTICES
6644
Federal Register / Vol. 74, No. 26 / Tuesday, February 10, 2009 / Notices
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512603. 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 and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: The Science Board will hear
about and discuss updates from the
agency on the continued assessment of
Bisphenol A (BPA) in FDA-regulated
products. The Science Board will hear
about the plans for the following: (1)
The review of FDA Center’s science
programs, (2) the review of each
Center’s projects within scientific
priority areas, and (3) the handling of
biospecimens used for genomic and
proteomic analyses. The Science Board
will also hear updates from two working
groups on economically motivated
adulteration of FDA-regulated products
and rapid detection of Salmonella in
foods.
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/ohrms/
dockets/ac/acmenu.htm, click on the
year and scroll down to the appropriate
advisory committee 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 February 17, 2009.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those desiring to make
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 February 11, 2009. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
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14:17 Feb 09, 2009
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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
February 12, 2009.
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 Dr. Carlos
˜
Pena 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/oc/advisory/
default.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: January 30, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–2797 Filed 2–9–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Vaccines and Related Biological
Products 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: Vaccines and
Related Biological Products 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 18, 2009, from 8:30
a.m. to approximately 5:30 p.m. and on
February 19, 2009, from 8:30 a.m. to
approximately 4 p.m.
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Location: Hilton Washington DC/
Silver Spring, 8727 Colesville Rd.,
Silver Spring, MD 20910.
Contact Person: Christine Walsh or
Denise Royster, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, 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
3014512391. 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 and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On February 18, 2009, in the
morning, the committee will discuss
and make recommendations on the
selection of strains to be included in the
influenza virus vaccine for the 2009—
2010 influenza season and in the
afternoon will discuss the utility of
adding a second B strain to current
seasonal influenza vaccines. On
February 19, 2009, the committee will
discuss the conducting of clinical
studies of pandemic influenza vaccine
in the pediatric population in the
absence of an influenza pandemic.
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/ohrms/
dockets/ac/acmenu.htm, click on the
year 2009 and scroll down to the
appropriate advisory committee 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 February 12, 2009.
Oral presentations from the public will
be scheduled between approximately
1:15 p.m. and 1:45 p.m. on February 18,
2009, and between approximately 1:30
p.m. and 2 p.m. on February 19, 2009.
Those desiring to make formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
E:\FR\FM\10FEN1.SGM
10FEN1
]]>Agencies
[Federal Register Volume 74, Number 26 (Tuesday, February 10, 2009)]
[Notices]
[Pages 6643-6644]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-2797]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Science Board to the Food and Drug Administration; 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: Science Board to the Food and Drug
Administration (Science Board).
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 Tuesday, February 24,
2009, from 8 a.m. to 3 p.m.
Addresses: Hilton Washington DC North/Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20877.
Contact Person: Carlos Pe[ntilde]a, Office of the Commissioner,
Food and Drug Administration (HF-33), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301-827-6687, or
[[Page 6644]]
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in the Washington, DC area), code 3014512603. 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 and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: The Science Board will hear about and discuss updates from
the agency on the continued assessment of Bisphenol A (BPA) in FDA-
regulated products. The Science Board will hear about the plans for the
following: (1) The review of FDA Center's science programs, (2) the
review of each Center's projects within scientific priority areas, and
(3) the handling of biospecimens used for genomic and proteomic
analyses. The Science Board will also hear updates from two working
groups on economically motivated adulteration of FDA-regulated products
and rapid detection of Salmonella in foods.
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/ohrms/dockets/ac/acmenu.htm, click on
the year and scroll down to the appropriate advisory committee 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
February 17, 2009. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those desiring to make 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 February 11, 2009. 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 February
12, 2009.
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 Dr. Carlos
Pe[ntilde]a 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/oc/advisory/
default.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: January 30, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-2797 Filed 2-9-09; 8:45 am]
BILLING CODE 4160-01-S
