Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 35435 [E6-9601]

Download as PDF Federal Register / Vol. 71, No. 118 / Tuesday, June 20, 2006 / Notices Organization for Animal Health (OlE) have confirmed additional cases of highly pathogenic avian influenza (H5N1), USDA/APHIS has added additional countries to its ban. Because of the documentation of highly pathogenic avian influenza H5N1 in poultry, HHS/CDC added the following countries to its embargo: Kazakhstan, 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; Jordan on March 29, 2006; Burkina Faso on April 10, 2006; Pakistan on April 10, 2006; Gaza, the West Bank, and the ˆ Ivory Coast (Cote d’Ivoire) on April 28, 2006; and Sudan on May 16, 2006. On May 27, 2006, OlE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Djibouti. At this time, HHS/CDC is adding Djibouti to its current embargo. USDA has also taken a similar action with respect to this region. This action is effective on June 2, 2006, and will remain in effect until further notice. SUPPLEMENTARY INFORMATION: Background On May 27, 2006, OlE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Djibouti city region, Djibouti. 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. rwilkins on PROD1PC63 with NOTICES Immediate Action Therefore, pursuant to 42 CFR 71.32(b), HHS/CDC is amending the February 4, 2004, order to add Djibouti 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; March 29, 2006; April 10, 2006; April 10, 2006; VerDate Aug<31>2005 18:14 Jun 19, 2006 Jkt 208001 April 28, 2006; and May 16, 2006 shall remain in effect until further notice. Julie Louise Gerberding, Director, Centers for Disease Control and Prevention. [FR Doc. E6–9646 Filed 6–19–06; 8:45 am] BILLING CODE 4150–05–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Ophthalmic 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). At least one portion of the meeting will be closed to the public. Name of Committee: Ophthalmic 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 July 14, 2006, from 8 a.m. to 6 p.m. Location: Hilton Washington DC North/Gaithersburg, Montgomery Ballroom, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Sara M. Thornton, Center for Devices and Radiological Health (HFZ–460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–594–2053 x 127, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512396. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will hear a presentation on FDA’s Critical Path Initiative and a presentation by the Office of Surveillance and Biometrics, Center for Devices and Radiological Health, outlining their responsibility for the review of postmarket study design. Subsequently, the committee will discuss, make recommendations, and vote on a premarket approval application for an implantable miniature telescope (IMT). The IMTTM is a visual prosthetic device which, when combined with the optics of the cornea, constitutes a telephoto lens and is indicated for use in patients with bilateral, stable macular degeneration PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 35435 and other bilateral, stable untreatable central vision disorders. Background information, 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 Committee/ Panel Meetings’’). Procedure: On July 14, 2006, from 8:45 a.m. to 6 p.m., the meeting is open to the public. 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 July 5, 2006. Oral presentations from the public will be scheduled between approximately 9:45 a.m. and 10:15 a.m., and between approximately 3:30 p.m. and 4 p.m. Time allotted for each presentation may be limited. 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 July 5, 2006. Closed Committee Deliberations: On July 14, 2006, from 8 a.m. to 8:45 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). This information is relevant to pending and future device submissions for vitreoretinal, surgical and diagnostic devices, intraocular and corneal implants, and contact lenses. 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, Conference Management Staff, at 301–827–7291 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: June 12, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6–9601 Filed 6–19–06; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\20JNN1.SGM 20JNN1

Agencies

[Federal Register Volume 71, Number 118 (Tuesday, June 20, 2006)]
[Notices]
[Page 35435]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9601]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Ophthalmic 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). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Ophthalmic 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 July 14, 2006, from 8 
a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Montgomery 
Ballroom, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Sara M. Thornton, Center for Devices and 
Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2053 x 127, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), code 3014512396. Please call the Information 
Line for up-to-date information on this meeting.
    Agenda: The committee will hear a presentation on FDA's Critical 
Path Initiative and a presentation by the Office of Surveillance and 
Biometrics, Center for Devices and Radiological Health, outlining their 
responsibility for the review of postmarket study design. Subsequently, 
the committee will discuss, make recommendations, and vote on a 
premarket approval application for an implantable miniature telescope 
(IMT). The IMT\TM\ is a visual prosthetic device which, when combined 
with the optics of the cornea, constitutes a telephoto lens and is 
indicated for use in patients with bilateral, stable macular 
degeneration and other bilateral, stable untreatable central vision 
disorders. Background information, 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 Committee/Panel Meetings'').
    Procedure: On July 14, 2006, from 8:45 a.m. to 6 p.m., the meeting 
is open to the public. 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 July 5, 2006. Oral presentations from the public will be 
scheduled between approximately 9:45 a.m. and 10:15 a.m., and between 
approximately 3:30 p.m. and 4 p.m. Time allotted for each presentation 
may be limited. 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 July 
5, 2006.
    Closed Committee Deliberations: On July 14, 2006, from 8 a.m. to 
8:45 a.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential commercial information (5 U.S.C. 
552b(c)(4)). This information is relevant to pending and future device 
submissions for vitreoretinal, surgical and diagnostic devices, 
intraocular and corneal implants, and contact lenses.
    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, 
Conference Management Staff, at 301-827-7291 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: June 12, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-9601 Filed 6-19-06; 8:45 am]
BILLING CODE 4160-01-S

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