[Federal Register: October 3, 2000 (Volume 65, Number 192)]
[Notices]
[Page 59005-59006]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03oc00-57]
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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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[[Page 59006]]
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). At least one
portion of the meeting will be closed.
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 October 19, 2000,
from 9 a.m. to 5 p.m., and on October 20, 2000, from 8:30 a.m. to 4
p.m.
Location: National Institutes of Health, 9000 Rockville Pike,
Bldg. 10, Clinical Center, Jack Masur Auditorium, Bethesda, MD.
Contact Person: Joan C. Standaert, Center for Drug Evaluation
and Research (HFD-110), Food and Drug Administration, Woodmont II
Bldg., 1451 Rockville Pike, Rockville, MD 20752, 419-259-6211, or
John M. Treacy, 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: On October 19, 2000, the committee will meet in closed
session. On October 20, 2000, the committee will discuss dose
response using data from approved antihypertensive drugs.
Procedure: On October 20, 2000, from 8:30 a.m. to 4 p.m., the
meeting will be open to the public. 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 October 12, 2000. Oral presentations from the public will
be scheduled between approximately 8:30 a.m. to 9:30 a.m. on October
20, 2000. Time allotted for each presentation may be limited. Those
desiring to make formal oral presentations should notify the contact
person before October 12, 2000, 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.
Closed Committee Deliberations: On October 19, 2000, from 9 a.m.
to 5 p.m., the meeting will be closed to permit discussion and
review of trade secret and/or confidential information regarding
pending investigational new drug applications and new drug
applications (5 U.S.C. 552b(c)(4)).
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: September 22, 2000.
Bernard A. Schwetz,
Acting Deputy Commissioner.
[FR Doc. 00-25284 Filed 10-2-00; 8:45 am]
BILLING CODE 4160-01-F