Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 7282-7283 [2010-3032]
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7282
Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices
(nevirapine), Valtrex (valacyclovir),
Zmax (azithromycin), Rotarix (rotavirus
vaccine, live, oral), Kinrix (Diphtheria
and Tetanus Toxoids and Acellular
Pertussis Adsorbed and Inactivated
Poliovirus Vaccine), Pentacel
[Diphtheria and Tetanus Toxoids and
Acellular Pertussis Adsorbed,
Inactivated Poliovirus and Haemophilus
b Conjugate (Tetanus Toxoid Conjugate)
Vaccine], and Daptacel (Diphtheria and
Tetanus Toxoids and Acellular Pertussis
Vaccine Adsorbed vaccine). The
committee will also receive an update
on Topical Calcineurin Inhibitors: Elidel
(pimecrolimus) and Protopic
(tacrolimus). Also, the committee will
receive a brief followup on the FDA
Early Communication about reports of
liver-related adverse events in patients
taking orlistat (marketed as Alli and
Xenical).
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 March 8, 2010. 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 28, 2010. 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
March 1, 2010.
Persons attending FDA’s advisory
committee meetings are advised that the
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14:39 Feb 17, 2010
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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: February 4, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–3024 Filed 2–17–10; 8:45 am]
BILLING CODE 4160–01–S
breast and cervical cancer screening; Impact
of the revised clinical screening
recommendations for both breast and cervical
cancer on the National Breast and Cervical
Cancer Early Detection Program; Discussion
of what, if any, modifications should be
made to the NBCCEDP’s current screening
policies based on revised recommendations.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information: Dr.
Chastity Walker, Designated Federal Officer,
BCCEDCAC, Division of Cancer Prevention
and Control, National Center for Chronic
Disease Prevention and Health Promotion,
CDC, 4770 Buford Highway, Mailstop K–57,
Chamblee, Georgia 30316, Telephone: 770–
488–3013.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: February 3, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–3143 Filed 2–17–10; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
Centers for Disease Control and
Prevention
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Breast and Cervical Cancer Early
Detection and Control Advisory
Committee (BCCEDCAC)
Food and Drug Administration
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following committee
meeting:
Times and Dates: 12 p.m.–5 p.m., March
15, 2010. 8:30 a.m.–5 p.m., March 16, 2010.
8:30 a.m.–3 p.m., March 17, 2010.
Place: Crowne Plaza Atlanta Perimeter at
Ravinia, 4355 Ashford Dunwoody Road,
Atlanta, GA 30346, Telephone: 770–395–
7700.
Status: Open to the public, limited only by
the number of seats available.
Purpose: The committee is charged with
advising the Secretary, Department of Health
and Human Services, and the Director, CDC,
regarding the early detection and control of
breast and cervical cancer. The committee
makes recommendations regarding national
program goals and objectives;
implementation strategies; and program
priorities including surveillance,
epidemiologic investigations, education and
training, information dissemination,
professional interactions and collaborations,
and policy.
Matters To Be Discussed: The agenda will
include discussion and review of U.S.
Preventive Services Task Force guidelines for
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[Docket No. FDA–2010–N–0001]
Circulatory System Devices Panel of
the Medical Devices 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: Circulatory
System Devices Panel of the Medical
Devices 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 March 18 and 19, 2010, from 8
a.m. to 6 p.m.
Location: College Park Holiday Inn,
Grand Ballroom, 10000 Baltimore Ave.,
College Park, MD.
Contact Person: James Swink, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
E:\FR\FM\18FEN1.SGM
18FEN1
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices
20993, 301–796–6313, e-mail:
James.Swink@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512625. 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 March 18, 2010, the
committee will discuss, make
recommendations, and vote on the
premarket approval application (PMA)
for the Cardiac Resynchronization
Therapy Defibrillators (CRT–Ds)
sponsored by Boston Scientific. The
sponsor is seeking expanded indications
for the their CRT–Ds to include patients
with low left ventricular ejection
fraction (≤30%) and wide QRS (≥130
ms) who are NYHA Class II (ischemic or
non-ischemic etiology) or NYHA Class I
(ischemic etiology).
On March 19, 2010, the committee
will discuss, make recommendations
and vote on a PMA for the REVO MRI
Pacemaker System sponsored by
Medtronic. The REVO MRI Pacing
System is a pacemaker (with a standard
pacing indication) that has been
specifically designed to be safe for the
MRI environment under certain MR
scanning conditions.
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 March 11, 2010.
Oral presentations from the public will
be scheduled immediately following
lunch. Those desiring to make formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
VerDate Nov<24>2008
14:39 Feb 17, 2010
Jkt 220001
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 March 3, 2010. 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 March 4, 2010.
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 AnnMarie
Williams at 301–796–5966 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: February 4, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–3032 Filed 2–17–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Strengthening
Global Human-Animal Interface
Activities for Avian Influenza and Other
Zoonotic Diseases, Funding
Opportunity Announcement (FOA)
CK10–001, Initial Review
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
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7283
Time and Date: 12 p.m.–2 p.m., April 7,
2010 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘Strengthening Global HumanAnimal Interface Activities for Avian
Influenza and other Zoonotic Diseases, FOA
CK10–001.’’
Contact Person for More Information:
Gregory Anderson, M.S., M.P.H., Scientific
Review Officer, CDC, 1600 Clifton Road, NE.,
Mailstop E60, Atlanta, GA 30333, Telephone:
(404) 498–2293.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: February 11, 2010.
Andre Tyler,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2010–3141 Filed 2–17–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Board of Scientific Counselors,
Coordinating Center for Infectious
Diseases, (BSC, CCID)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting of the
aforementioned committee:
Time and Date: 10 a.m.–11 a.m., March 2,
2010.
Place: Teleconference.
Status: Open to the public, the toll free dial
in number is 1–866–880–0098 with a pass
code of 9887280.
Purpose: The BSC, CCID shall advise the
Secretary, HHS, and the Director, CDC
concerning strategies and goals for the
programs and research within the national
centers; will administer and oversee peer
review of scientific programs; and monitor
the overall strategic direction and focus of
the national centers.
Matters To Be Discussed: Agenda items
will include:
1. Update from Dr. Khabbaz.
2. Update on H1N1 response.
3. Update from National Center for HIV/
AIDS, Viral Hepatitis, STD, and TB
Prevention.
E:\FR\FM\18FEN1.SGM
18FEN1
Agencies
[Federal Register Volume 75, Number 32 (Thursday, February 18, 2010)]
[Notices]
[Pages 7282-7283]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3032]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Circulatory System Devices Panel of the Medical Devices 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: Circulatory System Devices Panel of the Medical
Devices 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 March 18 and 19, 2010,
from 8 a.m. to 6 p.m.
Location: College Park Holiday Inn, Grand Ballroom, 10000 Baltimore
Ave., College Park, MD.
Contact Person: James Swink, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD
[[Page 7283]]
20993, 301-796-6313, e-mail: James.Swink@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 3014512625. 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 March 18, 2010, the committee will discuss, make
recommendations, and vote on the premarket approval application (PMA)
for the Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)
sponsored by Boston Scientific. The sponsor is seeking expanded
indications for the their CRT-Ds to include patients with low left
ventricular ejection fraction (<=30%) and wide QRS (>=130 ms) who are
NYHA Class II (ischemic or non-ischemic etiology) or NYHA Class I
(ischemic etiology).
On March 19, 2010, the committee will discuss, make recommendations
and vote on a PMA for the REVO MRI Pacemaker System sponsored by
Medtronic. The REVO MRI Pacing System is a pacemaker (with a standard
pacing indication) that has been specifically designed to be safe for
the MRI environment under certain MR scanning conditions.
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
March 11, 2010. Oral presentations from the public will be scheduled
immediately following lunch. 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 March 3, 2010. 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 March 4,
2010.
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 AnnMarie Williams at
301-796-5966 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: February 4, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-3032 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S