National Institute of Dental & Craniofacial Research; Notice of Closed Meeting, 51289 [E9-23997]
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51289
Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices
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 January 1, 2009, through
March 31, 2009. 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 JANUARY 1,
2009, THROUGH MARCH 31, 2009
PMA No.
Docket No.
Applicant
Trade Name
Approval Date
P060030
FDA–2009–M–0033
Roche Molecular Systems, Inc.
Cobas ampliprep/cobas taqman HFC
test
October 30, 2008
P950009 (S8)
FDA–2009–M–0016
BD Diagnostics
BD focal point gs imaging system
December 3, 2008
P080010
FDA–2009–M–0034
Advanced Medical Optics, Inc.
Tecnis multifocal foldable posterior
chamber intraocular lens
January 16, 2009
P080021
FDA–2009–M–0049
Advanced Vision Science, Inc.
xact foldable hydrophobic acrylic UV
light absorbing posterior chamber IOL
February 2, 2009
P030031 (S11)
FDA–2009–M–0071
Biosense Webster, Inc.
Navistar & Celsius thermo cool catheters
February 6, 2009
P070014
FDA–2009–M–0127
Bard Peripheral Vascular, Inc.
lifestent flexstar & flexstar XL vascular
stent system
February 13, 2009
P940015 (S12)
FDA–2009–M–0128
Genzyme Corp.
Synvisc-One
February 26, 2009
P070005
FDA–2009–M–0135
Synthemed Corp.
Repel-cv bioresorbable adhesion barrier
March 6, 2009
P080002
FDA–2009–M–0159
The Female Health Co.
FC2 female condom
March 10, 2009
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Dated: September 24, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and
Radiological Health.
[FR Doc. E9–23962 Filed 10–5–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jlentini on DSKJ8SOYB1PROD with NOTICES
National Institute of Dental &
Craniofacial Research; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
VerDate Nov<24>2008
16:15 Oct 05, 2009
Jkt 220001
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel; Review of P01 applications
on Interdisciplinary Research on Oral
Manifestations of HIV/AIDS in Vulnerable
Populations.
Date: November 12, 2009.
Time: 9 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: Victor Henriquez, PhD,
Scientific Review Officer, DEA/SRB/NIDCR,
6701 Democracy Blvd., Room 668, Bethesda,
MD 20892–4878, 301–451–2405,
henriquv@nidcr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
PO 00000
Frm 00037
Fmt 4703
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Dated: September 29, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–23997 Filed 10–5–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Pediatric 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: Pediatric
Advisory Committee.
E:\FR\FM\06OCN1.SGM
06OCN1
Agencies
[Federal Register Volume 74, Number 192 (Tuesday, October 6, 2009)]
[Notices]
[Page 51289]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23997]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of
Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of the following
meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Dental and Craniofacial
Research Special Emphasis Panel; Review of P01 applications on
Interdisciplinary Research on Oral Manifestations of HIV/AIDS in
Vulnerable Populations.
Date: November 12, 2009.
Time: 9 a.m. to 3 p.m.
Agenda: To review and evaluate grant applications.
Place: Bethesda Marriott Suites, 6711 Democracy Boulevard,
Bethesda, MD 20817.
Contact Person: Victor Henriquez, PhD, Scientific Review
Officer, DEA/SRB/NIDCR, 6701 Democracy Blvd., Room 668, Bethesda, MD
20892-4878, 301-451-2405, henriquv@nidcr.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral
Diseases and Disorders Research, National Institutes of Health, HHS)
Dated: September 29, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-23997 Filed 10-5-09; 8:45 am]
BILLING CODE 4140-01-P