70 FR 68 pg. 18407 - Advisory Committee for Pharmaceutical Science; Notice ofMeeting
Type: NOTICEVolume: 70Number: 68Page: 18407
FR document: [FR Doc. 05-7129 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
Advisory Committee for Pharmaceutical Science; Notice ofMeeting
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 : Advisory Committee for PharmaceuticalScience.
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 3 and 4,2005, from 8:30 a.m. to 5 p.m.
Location : Food and Drug Administration, Center for DrugEvaluation and Research Advisory Committee Conference Room, rm. 1066, 5630Fishers Lane, Rockville, MD.
Contact Person : Hilda Scharen, 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, e-mail: scharenh@cder.fda.gov , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572) in theWashington, DC area), code 3014512539. Please call the Information Linefor up-to-date information on this meeting.
Agenda : On May 3, 2005, the committee will: (1) Receivean update from the Clinical Pharmacology Subcommittee and (2) discuss andprovide comments on the general topic of establishing drug release ordissolution specifications. On May 4, 2005, the committee will: (1)Receive an update on current activities of the Parametric ToleranceInterval Test Workgroup, (2) discuss and provide comments on the generaltopic of considerations for assessment of pharmaceutical equivalence andproduct design, and (3) discuss criteria for establishing a working groupfor review and assessment of Office of Pharmaceutical Science researchprograms.
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 April25, 2005. Oral presentations from the public will be scheduled betweenapproximately 1 p.m. and 2 p.m. each day. Time allotted for eachpresentation may be limited. Those desiring to make formal oralpresentations should notify the contact person before April 25, 2005, andsubmit a brief statement of the general nature of the evidence or argumentsthey wish to present, the names and addresses of proposed participants, andan indication of the approximate time requested to make theirpresentation.
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 Hilda Scharen at least 7 days in advance ofthe 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. 05-7129 Filed 4-8-05; 8:45 am]
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