[Federal Register: October 18, 2007 (Volume 72, Number 201)]
[Page 59098-59099]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Cardiovascular and Renal Drugs Advisory Committee; Notice of 

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: Cardiovascular and Renal Drugs Advisory 
    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 December 11 and 12, 
2007, from 8 a.m. to 5 p.m.
    Location: Sheraton College Park Hotel, 4095 Powder Mill Rd., 
Beltsville, MD, 301-937-4422.
    Contact Person: Cathy A. Miller, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for 
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 
301-827-7001, FAX: 301-827-6776, e-mail: Cathy.Miller1@fda.hhs.gov, or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area), code 3014512533. 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 December 11, 2007, the committee will discuss new drug 
application (NDA) 22-034, vernakalant hydrochloride injection, 20 
milligrams (mg) per milliliter (ml), Astellas Pharma U.S., Inc., for 
the proposed indication of use for conversion of atrial fibrillation to 
normal sinus rhythm. On December 12, 2007, the committee will discuss 
NDA 22-123, PULZIUM (tedisamil sesquifumarate) IV solution 2 mg per ml, 
Solvay Pharmaceuticals, Inc., for the proposed indication of use for 
conversion of atrial fibrillation or atrial flutter to normal sinus 
    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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 

the year 2007 and scroll down to the appropriate advisory committee 
    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 
November 27, 2007. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. on both days for the 
corresponding agenda. 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 
November 16, 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 November 20, 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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 John Lauttman 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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.htm
 for procedures on public conduct during advisory committee 

    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

[[Page 59099]]

    Dated: October 11, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-20512 Filed 10-17-07; 8:45 am]