Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 20111 [E6-5783]
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Federal Register / Vol. 71, No. 75 / Wednesday, April 19, 2006 / Notices
Romania, Russia, Turkey, and Ukraine
on December 29, 2005; Nigeria on
February 8, 2006; India on February 22,
2006; Egypt on February 27, 2006; Niger
on March 2, 2006; Albania, Azerbaijan,
Cameroon, and Burma (Myanmar) on
March 15, 2006; Israel on March 20,
2006; Afghanistan on March 21, 2006;
and Jordan on March 29, 2006.
On April 3, 2006, OIE reported
confirmation of highly pathogenic avian
influenza H5N1 in guinea fowl in
Burkina Faso. USDA added Burkina
Faso to their ban on April 5, 2006. At
this time, HHS/CDC is adding Burkina
Faso to its current embargo. This action
is effective on April 10, 2006, and will
remain in effect until further notice.
SUPPLEMENTARY INFORMATION:
Background
An outbreak of avian influenza
subtype H5N1 in guinea fowl has been
´
reported at Gampela, Kadiogo province,
Burkina Faso.
Introduction of birds infected with
highly pathogenic avian influenza H5N1
into the United States could lead to
outbreaks of disease among birds and
among the human population, a
significant public health threat. Banning
the importation of all avian species from
affected countries is an effective means
of limiting this threat. HHS/CDC is
therefore taking this action to reduce the
likelihood of introduction or spread of
influenza A H5N1 into the United
States.
Immediate Action
cchase on PROD1PC60 with NOTICES
Therefore, pursuant to 42 CFR
71.32(b), HHS/CDC is amending the
February 4, 2004, order to add Burkina
Faso to the list of countries subject to
the order’s embargo of birds and
products derived from birds. All other
portions of the February 4, 2004, order,
as further amended on March 10, 2004;
September 28, 2004; December 29, 2005;
February 8, 2006; February 22, 2006;
February 27, 2006; March 2, 2006;
March 15, 2006; March 20, 2006; March
21, 2006; and March 29, 2006, shall
remain in effect until further notice.
Dated: April 13, 2006.
Julie Louise Gerberding,
Director, Centers for Disease Control and
Prevention, U.S. Department of Health and
Human Services.
[FR Doc. E6–5841 Filed 4–18–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Orthopaedic and Rehabilitation
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: Orthopaedic and
Rehabilitation 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 June 2, 2006, from 8:30 a.m. to
3:30 p.m.
Location: Holiday Inn, Walker/
Whetstone Rooms, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact Person: Janet L. Scudiero,
Center for Devices and Radiological
Health (HFZ–410), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301–594–1184,
ext. 176, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512521. Please call the
Information Line for up-to-date
information on this meeting.
Agenda: The committee will discuss
and make a recommendation on the
reclassification of the noninvasive bone
growth stimulator indicated for the
treatment of established nonunion
fractures acquired secondary to trauma
and as an adjunct to the treatment of
lumbar spinal fusion surgery for one or
two levels.
Background information for the
topics, including the agenda and
questions for the committee, will be
available to the public 1 business day
before the meeting on the Internet at
https://www.fda.gov/cdrh/panel (click on
‘‘Upcoming CDRH Advisory Panel/
Committee Meetings’’).
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 by May 19, 2006. Oral
presentations from the public will be
scheduled between approximately 8:45
a.m. and 9:45 a.m. Time allotted for
each presentation may be limited. Those
PO 00000
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20111
desiring to make formal oral
presentations should notify the contact
person before May 19, 2006, 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.
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 Shirley
Meeks at 240–276–0450, ext. 105, at
least 7 days in advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: April 12, 2006.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. E6–5783 Filed 4–18–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Docket No. 2005D–0195
Guidance for Industry and FDA Staff;
The Mammography Quality Standards
Act Final Regulations: Modifications
and Additions to Policy Guidance Help
System #9; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘The Mammography Quality Standards
Act Final Regulations: Modifications
and Additions to Policy Guidance Help
System #9.’’ This guidance document is
intended to assist facilities and their
personnel in meeting the Mammography
Quality Standards Act (MQSA) final
regulations.
Submit written or electronic
comments on this guidance at any time.
General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘The Mammography Quality
Standards Act Final Regulations:
DATES:
E:\FR\FM\19APN1.SGM
19APN1
]]>Agencies
[Federal Register Volume 71, Number 75 (Wednesday, April 19, 2006)]
[Notices]
[Page 20111]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-5783]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Orthopaedic and Rehabilitation 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: Orthopaedic and Rehabilitation 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 June 2, 2006, from 8:30
a.m. to 3:30 p.m.
Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact Person: Janet L. Scudiero, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1184, ext. 176, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 3014512521. Please call the Information
Line for up-to-date information on this meeting.
Agenda: The committee will discuss and make a recommendation on the
reclassification of the noninvasive bone growth stimulator indicated
for the treatment of established nonunion fractures acquired secondary
to trauma and as an adjunct to the treatment of lumbar spinal fusion
surgery for one or two levels.
Background information for the topics, including the agenda and
questions for the committee, will be available to the public 1 business
day before the meeting on the Internet at https://www.fda.gov/cdrh/panel
(click on ``Upcoming CDRH Advisory Panel/Committee Meetings'').
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 by May 19, 2006.
Oral presentations from the public will be scheduled between
approximately 8:45 a.m. and 9:45 a.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before May 19, 2006, 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.
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 Shirley Meeks at
240-276-0450, ext. 105, at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: April 12, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-5783 Filed 4-18-06; 8:45 am]
BILLING CODE 4160-01-S
