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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
NOTICE: NOTICES
ACTION: Meetings:
DOCUMENT ACTION: Notice.
SUBJECT CATEGORY: Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
DOCUMENT SUMMARY:
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 January 17 and 18, 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, Center for Drug Evaluation and Research, (HFD21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301827 7001 or FDA Advisory Committee Information Line, 18007418138 (301 4430572 in the Washington, DC area), code 12533. Please call the Information Line for uptodate information on this meeting.
Agenda: On January 17, 2002, the committee will discuss new drug application (NDA) 20757/S021, AVAPRO (irbesartan), SanofiSynthelabo (c/o BristolMyers Squibb), for the treatment of hypertensive patients with type 2 diabetic renal disease. On January 18, 2002, the committee will discuss NDA 21387, pravastatin/aspirin, BristolMyers Squibb, co package, for longterm management to reduce the risk of death, nonfatal myocardial infarction, myocardial revascularization procedures, and ischemic stroke in patients with clinically evident coronary heart disease.
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 January 7, 2002. Oral presentations from the public will be scheduled each day 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 January 7, 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.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Dated: December 14, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 0131879 Filed 122701; 8:45 am]
BILLING CODE 416001S
SUMMARY: Cardiovascular and Renal Drugs Advisory Committee,
DOCUMENT BODY:
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 January 17 and 18, 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, Center for Drug Evaluation and Research, (HFD21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301827 7001 or FDA Advisory Committee Information Line, 18007418138 (301 4430572 in the Washington, DC area), code 12533. Please call the Information Line for uptodate information on this meeting.
Agenda: On January 17, 2002, the committee will discuss new drug application (NDA) 20757/S021, AVAPRO (irbesartan), SanofiSynthelabo (c/o BristolMyers Squibb), for the treatment of hypertensive patients with type 2 diabetic renal disease. On January 18, 2002, the committee will discuss NDA 21387, pravastatin/aspirin, BristolMyers Squibb, co package, for longterm management to reduce the risk of death, nonfatal myocardial infarction, myocardial revascularization procedures, and ischemic stroke in patients with clinically evident coronary heart disease.
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 January 7, 2002. Oral presentations from the public will be scheduled each day 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 January 7, 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.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Dated: December 14, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 0131879 Filed 122701; 8:45 am]
BILLING CODE 416001S
Common CFR Searches
14 CFR Part 39 40 CFR Part 52 14 CFR Part 71 33 CFR Part 165 50 CFR Part 679 26 CFR Part 1 40 CFR Part 180 47 CFR Part 73 50 CFR Part 17 33 CFR Part 117 44 CFR Part 67 50 CFR Part 648 14 CFR Part 97 33 CFR Part 100 40 CFR Part 63 50 CFR Part 622 26 CFR Part 301 39 CFR Part 111 40 CFR Part 300 50 CFR Part 660 44 CFR Part 65 40 CFR Parts 52 and 81 40 CFR Part 271 47 CFR Part 64 50 CFR Part 665 47 CFR Part 76 50 CFR Part 229 14 CFR Part 23 14 CFR Part 25 21 CFR Part 522