Document ID: FDA-2010-N-0001-0068
Agency: fda
Document Type: Notice
Title: Cardiovascular and Renal Drugs Advisory Committee
Posted Date: 2010-06-22T04:00Z

[Federal Register: June 22, 2010 (Volume 75, Number 119)]
[Notices]               
[Page 35496]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jn10-62]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

 
Cardiovascular and Renal Drugs 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: Cardiovascular and Renal Drugs 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 29, 2010, from 8 
a.m. to 5 p.m.
    Location: The Marriott Inn and Conference Center, University of 
Maryland University College, 3501 University Blvd. East, Adelphi, MD. 
The conference center telephone number is 301-985-7300.
    Contact Person: Elaine Ferguson, c/o Christine Shipe, Center for 
Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, rm. 2419, Silver Spring, MD 20993-0002, 301-
796-9001, FAX: 301-847-8532, e-mail: elaine.ferguson@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 July 29, 2010, the committee will discuss Revatio 
(sildenafil) for the treatment of pediatric pulmonary arterial 
hypertension (PAH) and whether to amend the clinical trials section of 
the written request, issued by FDA to Pfizer, to include assessment of 
a hemodynamic endpoint. An area of particular interest will be what the 
appropriate study endpoint should be in patients with PAH unable to 
perform exercise testing. The discussion will help the agency determine 
what studies to request for products intended to treat pediatric PAH.
    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://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. 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 July 
14, 2010. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. 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 6, 2010. 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 July 7, 
2010.
    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 Elaine Ferguson 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://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 15, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-15019 Filed 6-21-10; 8:45 am]
BILLING CODE 4160-01-S