[Federal Register: May 6, 2005 (Volume 70, Number 87)]
[Page 24079]
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 June 15 and 16, 2005, 
from 8 a.m. to 5 p.m.
    Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Cathy Groupe, 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, e-mail: groupec@cder.fda.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.
    Agenda: On June 15, 2005, the committee will discuss class labeling 
of antihypertensive drugs based on the proximity of their data to 
outcome trials. On June 16, 2005, the committee will discuss new drug 
application (NDA) 20-727, proposed trade name BIDIL (hydralazine 
hydrochloride/isosorbide dinitrate) (tablets are 37.5 milligrams (mg) 
hydralazine hydrochloride/20 mg isosorbide dinitrate), NitroMed, Inc., 
proposed for the indication of heart failure, based on the results from 
the African American Heart Failure Trial.
    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 by June 8, 2005. 
Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on both days. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before June 8, 2005, 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.
    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 Beverly O'Neil at 
301-827-7001 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: April 28, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-9010 Filed 5-5-05; 8:45 am]