70 FR 68 pgs. 18405-18406 - Antiviral Drugs Advisory Committee; Notice of Meeting
Type: NOTICEVolume: 70Number: 68Pages: 18405 - 18406
FR document: [FR Doc. 05-7132 Filed 4-8-05; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Antiviral Drugs Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
This notice announces a forthcoming meeting of a public advisorycommittee of the Food and Drug Administration (FDA). The meeting will beopen to the public.
Name of Committee : Antiviral Drugs AdvisoryCommittee.
General Function of the Committee : To provide advice andrecommendations to the agency on FDA's regulatory issues.
Date and Time : The meeting will be held on May 19, 2005,from 8 a.m. to 5 p.m.
Location : Hilton Washington DC North/Gaithersburg,Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person : Anuja Patel, Center for Drug Evaluationand Research (HFD-21), Food and Drug Administration, 5600 FishersLane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD20857, 301-827-7001, FAX: 301-827-6776, e-mail: patela@cder.fda.gov , or FDA Advisory Committee InformationLine, 1-800-741-8138 (301-443-0572 in theWashington, DC area), code 3014512531. Please call the Information Linefor up-to-date information on this meeting.
Agenda : The committee will discuss new drug application(NDA) 021-814, proposed trade name APTIVUS (Tipranavir) 250 milligramcapsules, Boehringer Ingelheim Pharmaceuticals, Inc., indicated for thetreatment of patients with human immunodeficiency virus (HIV).
Procedure : Interested persons may present data,information, or views, orally or in writing, on issues pending before thecommittee. Written submissions may be made to the contact person by May 6,2005. Oral presentations from the public will be scheduled betweenapproximately 1 p.m. and 2 p.m. Time allotted for each presentation may belimited. Those desiring to make formal oral presentations should notifythe contact person before May 6, 2005, and submit a brief statement of thegeneral nature of the evidence or arguments they wish to present, the namesand addresses of proposed participants, and an indication of theapproximate time requested to make their presentation.
Persons attending FDA's advisory committee meetings are advised that theagency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committeemeetings and will make every effort to accommodate persons with physicaldisabilities or special needs. If you require special accommodations dueto a disability, please contact Angie Whitacre 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 1, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-7132 Filed 4-8-05; 8:45 am]
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