Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting, 54155-54156 [2010-22087]
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54155
Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Notices
I. Background
In the Federal Register of January 30,
1998 (63 FR 4571), FDA published a
final rule that revised 21 CFR 814.44(d)
and 814.45(d) to discontinue individual
publication of PMA approvals and
denials in the Federal Register. Instead,
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 April 1, 2010, through
June 30, 2010. 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 APRIL 1,
2010, THROUGH JUNE 30, 2010
PMA No. Docket No.
Applicant
TRADE NAME
Approval Date
P090018
FDA–2010–M–0244
Envoy Medical Corp.
ESTEEM TOTALLY IMPLANTABLE HEARING
SYSTEM
March 17, 2010
P080029
FDA–2010–M–0220
Interventional Therapies,
LLC
QUICK CLOSE VASCULAR SUTURING SYSTEM
April 8, 2010
P090022
FDA–2010–M–0219
Lenstec, Inc.
SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)
April 12, 2010
P080032
FDA–2010–0242
Asthmatix, Inc.
ALAIR BRONCHIAL THERMOPLASTY
April 27, 2010
P090007
FDA–2010–M–0261
Roche Diagnostics Corp.
ELECSYS ANTI-HCV IMMUNOASSAY AND
ELECSYS PRECICONTROL ANTI-HCV FOR
USE ON THE COBAS E411 IMMUNOASSAY
ANALYZER
April 29, 2010
P090008
FDA–2010–M–0262
Roche Diagnostics Corp.
ELECSYS ANTI-HCV IMMUNOASSAY AND
ELECSYS PRECICONTROL ANTI-HCV FOR
USE ON THE COBAS E601 IMMUNOASSAY
ANALYZER
April 29, 2010
P090009
FDA–2010–M–0264
Roche Diagnostics Corp.
ELECSYS ANTI-HCV IMMUNOASSAY AND
ELECSYS PRECICONTROL ANTI-HCV FOR
USE ON THE MODULAR ANALYTICS E170
ANALYZER
April 29, 2010
P050027
FDA–2010–M–0294
Karl Storz endoscopy—
America, Inc.
PHOTODYNAMIC DIAGNOSTIC D-LIGHT C
May 28, 2010
P060029
FDA–2010–M–0285
Ethicon, Inc.
OMNEX SURGICAL SEALANT
June 3, 2010
II. Electronic Access
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
srobinson on DSKHWCL6B1PROD with NOTICES
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
National Institutes of Health
Dated: August 31, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2010–22085 Filed 9–2–10; 8:45 am]
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Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; 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.
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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.
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54156
Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Notices
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Review of T32
Applications on Clinical and Developmental
Pharmacology.
Date: September 29, 2010.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Sathasiva B. Kandasamy,
PhD, Scientific Review Officer, Division of
Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, NIH, 6100 Executive
Blvd., Room 5B01, Bethesda, MD 20892,
301–435–6680, skandasa@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos.93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: August 30, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–22087 Filed 9–2–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meetings
srobinson on DSKHWCL6B1PROD with NOTICES
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 meetings.
The meetings 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 on
Aging Initial Review Group, Neuroscience of
Aging Review Committee.
Date: October 4–5, 2010.
Time: 4 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda, 8120
Wisconsin Avenue, Bethesda, MD 20892.
Contact Person: William Cruce, PhD,
Scientific Review Administrator, National
Institute On Aging, Scientific Review Office,
Gateway Building 2C–212, 7201 Wisconsin
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Ave., Bethesda, MD 20814, 301–402–7704,
crucew@nia.nih.gov.
Name of Committee: National Institute on
Aging Initial Review Group, Clinical Aging
Review Committee.
Date: October 7–8, 2010.
Time: 7 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda, 8120
Wisconsin Avenue, Bethesda, MD 20892.
Contact Person: Alicja L. Markowska, PhD,
DSC, National Institute On Aging, National
Institutes of Health, Gateway Building 2C212,
7201 Wisconsin Avenue, Bethesda, MD
20892, 301–496–9666,
markowsa@nia.nih.gov.
Name of Committee: National Institute on
Aging Initial Review Group, Biological Aging
Review Committee.
Date: October 7, 2010.
Time: 12 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Suite 2C212, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Bita Nakhai, PhD.,
Scientific Review Officer, Scientific Review
Branch, National Institute On Aging,
Gateway Bldg., 2C212, 7201 Wisconsin
Avenue, Bethesda, MD 20814, 301–402–
7701, nakhaib@nia.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: August 27, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–22089 Filed 9–2–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Language and
Communication Study Section, October
4, 2010, 8 a.m. to October 5, 2010, 5
p.m., Ritz Carlton Hotel, 1150 22nd
Street, NW., Washington, DC 20037
which was published in the Federal
Register on August 25, 2010, 75 FR
52357.
The meeting will be one day only
October 4, 2010. The meeting time and
location remain the same. The meeting
is closed to the public.
Dated: August 26, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–22090 Filed 9–2–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
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 meetings.
The meetings 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: Oncology 2—
Translational Clinical Integrated Review
Group, Basic Mechanisms of Cancer
Therapeutics Study Section.
Date: October 4–5, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Marina del Rey Hotel, 13534 Bali
Way, Marina del Rey, CA 90292.
Contact Person: Lambratu Rahman, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214,
MSC 7804, Bethesda, MD 20892, 301–451–
3493, rahmanl@csr.nih.gov.
Name of Committee: Infectious Diseases
and Microbiology Integrated Review Group,
Clinical Research and Field Studies of
Infectious Diseases Study Section.
Date: October 7–8, 2010.
Time: 8:30 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Churchill Hotel, 1914
Connecticut Avenue, NW., Washington, DC
20009.
Contact Person: Soheyla Saadi, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3211,
MSC 7808, Bethesda, MD 20892, 301–435–
0903, saadisoh@csr.nih.gov.
Name of Committee: Oncology 2—
Translational Clinical Integrated Review
Group, Clinical Oncology Study Section.
Date: October 11–12, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Long Beach and Executive
Meeting Center, 701 West Ocean Boulevard,
Long Beach, CA 90831.
Contact Person: Malaya Chatterjee, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6192,
MSC 7804, Bethesda, MD 20892, 301–451–
0131, chatterm@csr.nih.gov.
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Agencies
[Federal Register Volume 75, Number 171 (Friday, September 3, 2010)]
[Notices]
[Pages 54155-54156]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22087]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and
Human Development; 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.
[[Page 54156]]
Name of Committee: National Institute of Child Health and Human
Development Special Emphasis Panel; Review of T32 Applications on
Clinical and Developmental Pharmacology.
Date: September 29, 2010.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6100 Executive Boulevard,
Rockville, MD 20852 (Telephone Conference Call).
Contact Person: Sathasiva B. Kandasamy, PhD, Scientific Review
Officer, Division of Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health and Human Development, NIH, 6100
Executive Blvd., Room 5B01, Bethesda, MD 20892, 301-435-6680,
skandasa@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos.93.864,
Population Research; 93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation Research; 93.209,
Contraception and Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: August 30, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-22087 Filed 9-2-10; 8:45 am]
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