Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 26637 [E7-9054]

Download as PDF Federal Register / Vol. 72, No. 90 / Thursday, May 10, 2007 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. pwalker on PROD1PC71 with NOTICES 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 June 27, 2007, from 8 a.m. to 5 p.m. Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: James Swink, Center for Devices and Radiological Health (HFZ–450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–4179, 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. Agenda: The committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by CryoCor Inc., for the CryoCor Cryoablation System, which is intended for the treatment of isthmusdependent atrial flutter in patients 18 years or older. FDA intends to make background material available to the public no later than 1 business day 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/ohrms/ dockets/ac/acmenu.htm, click on the year 2007 and 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 VerDate Aug<31>2005 15:04 May 09, 2007 Jkt 211001 submissions may be made to the contact person on or before June 13, 2007. Oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of committee deliberations and for approximately 30 minutes near the end of committee deliberations. 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 June 5, 2007. 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 June 6, 2007. 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 240–276–8932, 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: May 3, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7–9054 Filed 5–9–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Vaccines and Related Biological Products PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 26637 Advisory Committee. This meeting was originally announced in the Federal Register of April 16, 2007 (72 FR 19003). The amendment is being made to reflect a change in the Date and Time, Agenda, and Procedure portions of the meeting. FOR FURTHER INFORMATION CONTACT: Christine Walsh or Denise Royster, Center for Biologics Evaluation and Research (HFM–71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–0314, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512391. SUPPLEMENTARY INFORMATION: In the Federal Register of April 16, 2007, FDA announced that a meeting of the Vaccines and Related Biological Products Advisory Committee would be held on May 16, 2007, from 9 a.m. to 4:30 p.m. and May 17, 2007, from 8 a.m. to 1 p.m. Changes to the meeting times, agenda, and procedure are as follows: • The meeting will be held on May 16, 2007, from 8:30 a.m. to 4:45 p.m. and on May 17, 2007, from 9 a.m. to 3:30 p.m. • In addition to the agenda items listed in the April 16, 2007, meeting notice, on May 16, 2007, in the afternoon session, the committee will hear an update on the influenza strain selection for the 2007 to 2008 influenza season. As stated in the April 16, 2007, meeting notice, FDA intends to make background material available to the public no later than 1 business day 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/ohrms/dockets/ac/ acmenu.htm, click on the year 2007 and scroll down to the appropriate advisory committee link. • On May 16, 2007, from 8:30 a.m. to 4:05 p.m. and on May 17, 2007, from 9 a.m. to 3:30 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. Oral presentations from the public will be scheduled between approximately 11:25 a.m. and 11:55 a.m. and between 3:35 p.m. and 4:05 p.m. on May 16, 2007, and between approximately 12:45 p.m. and 1:15 a.m. on May 17, 2007. • On May 16, 2007, from 4:05 p.m. to 4:45 p.m., the meeting will be closed to E:\FR\FM\10MYN1.SGM 10MYN1

Agencies

[Federal Register Volume 72, Number 90 (Thursday, May 10, 2007)]
[Notices]
[Page 26637]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9054]



[[Page 26637]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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 June 27, 2007, from 8 
a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and 
C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: James Swink, Center for Devices and Radiological 
Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 240-276-4179, 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.
    Agenda: The committee will discuss, make recommendations, and vote 
on a premarket approval application, sponsored by CryoCor Inc., for the 
CryoCor Cryoablation System, which is intended for the treatment of 
isthmus-dependent atrial flutter in patients 18 years or older.
    FDA intends to make background material available to the public no 
later than 1 business day 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/ohrms/dockets/ac/acmenu.htm, click on 
the year 2007 and 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 June 
13, 2007. Oral presentations from the public will be scheduled for 
approximately 30 minutes at the beginning of committee deliberations 
and for approximately 30 minutes near the end of committee 
deliberations. 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 June 
5, 2007. 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 June 6, 2007.
    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 240-276-8932, 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: May 3, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-9054 Filed 5-9-07; 8:45 am]
BILLING CODE 4160-01-S

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