[Federal Register: March 9, 2005 (Volume 70, Number 45)]
[Notices]
[Page 11678-11679]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09mr05-91]
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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 5, 2005, from 8
a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg, The Ballrooms,
620 Perry Pkwy., 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: The committee will discuss supplemental new drug
application (sNDA) S-036 to approved new drug application (NDA) 19-787,
NORVASC (amlodipine besylate) Tablets (2.5 milligrams (mg), 5 mg, and
10 mg), Pfizer Inc., proposing a change in labeling for the following
two additional indications of: (1) Reducing the risk of fatal coronary
heart disease and nonfatal myocardial infarction and (2) reducing the
risk of stroke, based on the effectiveness demonstrated in the
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antihypertensive and lipid lowering treatment to prevent heart attack
trial (ALLHAT).
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 March 29,
2005. 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 March 29, 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
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 John Lauttman 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: March 2, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-4522 Filed 3-8-05; 8:45 am]
BILLING CODE 4160-01-S