[Federal Register: March 6, 2002 (Volume 67, Number 44)]
[Notices]
[Page 10222]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06mr02-72]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Cardiovascular and Renal Drugs Advisory Committee; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 April 12, 2002, from
8:30 a.m. to 4:30 p.m.
Location: Holiday Inn, Kennedy Ballroom, 8777 Georgia Ave.,
Silver Spring, MD.
Contact: Jaime Henriquez or La'Nise S. Giles, 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, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 12533. Please call the Information Line for up-to-date
information on this meeting.
Agenda: The committee will discuss new drug application (NDA)
20-386/S028, COZAAR (losartan potassium), Merck and Co., Inc., for
the treatment of type II diabetic patients with nephropathy.
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 April 4,
2002. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations
should notify the contact person before April 4, 2002, 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 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 Jaime Henriquez
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: February 27, 2002.
Linda A. Suydam,
Senior Associate Commissioner for Communications and Constituent
Relations.
[FR Doc. 02-5300 Filed 3-5-02; 8:45 am]
BILLING CODE 4160-01-P