Pediatric Advisory Committee; Notice of Meeting, 51289-51290 [E9-24013]
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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]
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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
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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
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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]
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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
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jlentini on DSKJ8SOYB1PROD with NOTICES
51290
Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices
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, December 8, 2009,
from 8 a.m. to 6 p.m.
Location: Hilton, Washington, DC/
Rockville Executive Meeting Center,
Plaza Ballroom, 1750 Rockville Pike,
Rockville, MD 20852.
Contact Person: Doreen Kezer, Office
of Medical and Scientific Programs (HF33), Office of the Commissioner, Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1249, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 8732310001. 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 December 8, 2009, the
Pediatric Advisory Committee will meet
to discuss pediatric-focused safety
reviews, as mandated by the Best
Pharmaceuticals for Children Act and
the Pediatric Research Equity Act, for
Abilify (aripiprazole), Argatroban
(argatroban), Orencia (abatacept),
Humira (adalimumab), Zemuron
(rocuronium bromide), Cancidas
(caspofungin acetate), Cardiolite
(technetium Tc99 sestamibi), Evicel—
fibrin sealant (human), Artiss—fibrin
sealant (human), Voluven—6%
hydroxyethyl starch 130/0.4 in 0.9%
sodium chloride injection, Reyataz
(atazanavir sulfate), Kaletra (lopinavir/
ritonavir), Aptivus (tipranavir), Zetia
(ezetimibe), Vytorin (ezetimibe/
simvastatin), Ventolin HFA (albuterol
sulfate). The committee will also receive
a brief update on atypical antipsychotic
drugs as requested by the Pediatric
Advisory Committee Meeting on
November 18, 2008.
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
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16:15 Oct 05, 2009
Jkt 220001
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. 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 Tuesday, November
24, 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 Monday,
November 16, 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 Tuesday, November
17, 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 Doreen Kezer
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/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.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: October 1, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–24013 Filed 10–5–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of The Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
Director’s Council of Public
Representatives.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Director’s Council of
Public Representatives.
Date: October 30, 2009.
Time: 9 a.m. to 5 p.m.
Agenda: Key topics for this meeting will
focus on emerging issues of public
importance in biomedical and behavioral
research. Further information will be
available on the COPR Web site.
Place: National Institutes of Health,
Building 31, Conference Room 6, 9000
Rockville Pike, Bethesda, MD 20852.
Contact Person: Kelli L. Carrington
Executive Secretary/Public Liaison Officer,
Office of Communications and Public
Liaison, Office of the Director, National
Institutes of Health, 9000 Rockville Pike,
Building 1, Room 344, Bethesda, MD 20892,
301–594–4575, carringkmaiI.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: https://
www.copr.nih.gov, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
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]]>Agencies
[Federal Register Volume 74, Number 192 (Tuesday, October 6, 2009)]
[Notices]
[Pages 51289-51290]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24013]
-----------------------------------------------------------------------
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.
[[Page 51290]]
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, December 8,
2009, from 8 a.m. to 6 p.m.
Location: Hilton, Washington, DC/Rockville Executive Meeting
Center, Plaza Ballroom, 1750 Rockville Pike, Rockville, MD 20852.
Contact Person: Doreen Kezer, Office of Medical and Scientific
Programs (HF-33), Office of the Commissioner, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1249,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 8732310001. 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 December 8, 2009, the Pediatric Advisory Committee will
meet to discuss pediatric-focused safety reviews, as mandated by the
Best Pharmaceuticals for Children Act and the Pediatric Research Equity
Act, for Abilify (aripiprazole), Argatroban (argatroban), Orencia
(abatacept), Humira (adalimumab), Zemuron (rocuronium bromide),
Cancidas (caspofungin acetate), Cardiolite (technetium Tc99 sestamibi),
Evicel--fibrin sealant (human), Artiss--fibrin sealant (human),
Voluven--6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride
injection, Reyataz (atazanavir sulfate), Kaletra (lopinavir/ritonavir),
Aptivus (tipranavir), Zetia (ezetimibe), Vytorin (ezetimibe/
simvastatin), Ventolin HFA (albuterol sulfate). The committee will also
receive a brief update on atypical antipsychotic drugs as requested by
the Pediatric Advisory Committee Meeting on November 18, 2008.
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/AdvisoryCommittees/Calendar/default.htm. 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
Tuesday, November 24, 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 Monday, November 16, 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 Tuesday, November 17, 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 Doreen Kezer 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/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.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: October 1, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24013 Filed 10-5-09; 8:45 am]
BILLING CODE 4160-01-S
