Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting, 36100 [2010-15311]
Download as PDF
<![CDATA[
36100
Federal Register / Vol. 75, No. 121 / Thursday, June 24, 2010 / Notices
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, 2009, through
September 30, 2009, and from October
1, 2009, through December 31, 2009.
There were no denial actions during
either 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,
2009, THROUGH DECEMBER 31, 2009.
PMA No.
Docket No.
Applicant
Trade Name
Approval Date
P070022
FDA–2009–M–0317
Hologic, Inc.
ADIANA PERMANENT CONTRACEPTION SYSTEM
July 6, 2009
P060008/S11
FDA–2009–M–0369
Boston Scientific Corp.
TAXUS LIBERTE LONG PACLITAXEL ELUING
STENT SYSTEM
July 13, 2009
P030050/S2
FDA–2009–M–0370
Sanofi Aventis, LLC
SCULPTRA AESTHETIC
July 28, 2009
P080013
FDA–2009–M–0485
Confluent Surgical, Inc.
DURASEAL XACT SEALANT SYSTEM
September 4, 2009
P080008
FDA–2009–M–0536
bioMerieux, Inc.
VIDAS FREE PSA RT (fPSA) ASSAY
October 8, 2009
P030042
FDA–2009–M–0540
Wright Medical Technology,
Inc.
CONSERVE PLUS TOTAL RESURFACING HIP
SYSTEM
November 3, 2009
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Dated: June 17, 2010.
Nancy Stade,
Acting Associate Director for Regulations and
Policy, Center for Devices and Radiological
Health.
[FR Doc. 2010–15259 Filed 6–23–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
emcdonald on DSK2BSOYB1PROD with NOTICES
Eunice Kennedy Shriver National
Institute of Child Health & 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 contract proposals and
VerDate Mar<15>2010
16:47 Jun 23, 2010
Jkt 220001
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Dated: June 18, 2010.
Anna P. Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel National Childrens
Study.
Date: July 12, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Sathasiva B. Kandasamy,
PhD, Scientific Review Administrator,
Division of Scientific Review, National
Institute of Child Health and Human
Development, 6100 Executive Boulevard,
Room 5B01, Bethesda, MD 20892–9304, (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)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
[FR Doc. 2010–15311 Filed 6–23–10; 8:45 am]
BILLING CODE 4140–01–P
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
E:\FR\FM\24JNN1.SGM
24JNN1
]]>Agencies
[Federal Register Volume 75, Number 121 (Thursday, June 24, 2010)]
[Notices]
[Page 36100]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15311]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & 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 contract proposals and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the contract proposals, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Child Health and Human
Development Special Emphasis Panel National Childrens Study.
Date: July 12, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate contract proposals.
Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda,
MD 20814.
Contact Person: Sathasiva B. Kandasamy, PhD, Scientific Review
Administrator, Division of Scientific Review, National Institute of
Child Health and Human Development, 6100 Executive Boulevard, Room
5B01, Bethesda, MD 20892-9304, (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: June 18, 2010.
Anna P. Snouffer,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-15311 Filed 6-23-10; 8:45 am]
BILLING CODE 4140-01-P
