Federal Register / Vol. 72, No. 90 / Thursday, May 10, 2007 / Notices 26637 

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 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 http://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 

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 

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 http:// 

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 


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