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Federal Register / Vol. 59. No. 133 / Wednesday. luly 13. 1994 / ^Jotices 



Food and Drug Administration 

 Advisory Committee; Notice o( Meeting 



agency: Food and Drug Administratioa. 



HHS. 



*CTio«: Notice. 



summary: This notice announces a 

 forthcoming meeting of a public 

 advisory committee of the Food and 

 Drug Administiation CFDA). This ootice 

 also summarizes the procedures for the 

 meeting and methods by which 

 interested persons may participate in 

 open public hearings before FDA's 

 advisory committees. 

 MErriNG: The following advisory 

 committee meeting U announced: 



Drug Abuse Advisory Ccmmltte« 



Date, time, and place. August 1. 2. 

 and 3, 1994, 9 a.m.. Holiday Inn. Plaza 

 Ballroom. 8777 Georgia Ave.. Silver 

 Spring. MD. 



Type of meeting and contort person. 

 Open public hearing. August 1. 1994. 9 

 am to 10 a.m., unless ptiblic 

 participation does not last that long: 

 open committee discussion. 10 a.m. to 

 S pjn: open committee discussion, 

 August 2. 1994. 9 a.m. to 1 p.m.; open 

 public hearing. 1 p.m. to 2 p m., tinli^^s 



f>ublic partidpatioQ does not last thai 

 ong: open committee discussion, 2 p.m. 

 to S p.m; open public hearing. August 

 3. 1994. 9 a.m. to 10 a.m.. unless pubUc 

 partLCipatioD does not last that long; 

 open committee discussion. 10 a.m. to 

 5 p.m.: Ennona B. McCk>odwin or Isaac 

 F Roubein. Center for Drug Evaluation 

 and Research (HFD-009). Food and 

 Drug Administratioo, 5600 Fishers 



Lane. RocVville. MD 20857. 301-443- 

 5455. 



General function of the committee. 

 The committee advises on the scientific 

 and medical evaluation of information 

 gathered by the Department of Health 

 and Human Services and the 

 Department of Justice on the safety, 

 efficacy, and abuse potential of drugs 

 and recommends actions to be taken on 

 the marketing. Investigation, and control 

 of such drugs. 



Agenda—Open public hearing. 

 Interested persons may present data, 

 information, or views, orally or in 

 writing, on issues pending before the 

 dtnraittee. Those desiring to make 

 formal presentations should notify the 

 contact person before July 25. 1994. 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 

 required to make their comments. 



Open committee discussion. On 

 August 1. 1994. the committee will 

 discuss the abuse babiUty assessment 

 and related issues of the new drug 

 application (NDA) 20-385. nicotine 

 nasal spray. Kabi Pharmacia. Inc., an aid 

 to smoking cessation. On August 2. 

 1994. the committee will discuss issues 

 related to nicotine and smoking, 

 including the relationship between 

 nicotine dose and addiction in smokers. 

 On August 3. 1994. the committee virill 

 djscuss the abuse liability assessment of 

 NDA 20-281. Ultram® (tramadol 

 hydrochloride tablets). R. W. Johnson 

 Pharmaceutical Research Institute, for 

 treatment of pain. 



FDA pubbc icTvisory committee 

 meetings may have as many as four 

 separable portions: (1) An open public 

 hearing. (2) an open conur'tee 

 discussion. (3) a closed presentation of 

 data, and (4) a closed committee 

 deliberation. Every advisory committee 

 meeting shall have an open public 

 hearing portion. Whether or not it also 

 Includes any of the other three portions 

 will depend upon the specific meeting 

 involved. There are no closed i^rtions 

 for the meetings announced in this 

 notice. The dates and times reserved for 

 the open portions of each committee 

 meeting are listed above. 



The open public hearing portion of 

 each meeting shall be at least 1 hour 

 long unless public participation does 

 not last that long. It is emphasized, 

 however, that the 1 hour time limit for 

 an open public hearing represents a 

 Tninimnm rather than a maximum time 

 for public participation, and an open 



fiublic hearing may last for whatever 

 onger period the committee 



chairperson determines will facilitate 

 the committee's work. 



Public hearings are subject to FDA's 

 guideline (subpart C of 21 CFR part 10) 

 concerning the policy and procedures 

 for electronic media coverage of FDA's 

 public administrative proceedings, 

 including hearings before public 

 advisory committees under 21 CFR part 

 14. Under 21 CFR 10.205. 

 representatives of the electronic media 

 may be permitted, subject to certain 

 limitations, to videotape, film, or 

 otherwise record FDA's public 

 administrative proceedings, including 

 presentations by participants. 



Meetings of advisory committees shall 

 be conducted, insofar as is practical, in 

 accordance with the agenda pubUshed 

 in this Federal Register notice. Changes 

 in the agenda will be announced at the 

 beginning of the open portion of a 

 meeting 



Any interested person who tvishes to 

 be assured of the right to make an oral 

 presentation at the open public hearing 

 portion of a meeting shall inform the 

 contact person listed above, either orally 

 or in writing, prior to the meeting. Any 

 person attending the hearing who does 

 not in advance of the meebng request an 

 opportunity to speak will be allowed to 

 make an oral presentaboo at the 

 bearing's conclusion, if time permits, at 

 the chairperson's discrebon. 



The agenda, the quesbons to be 

 addressed by the committee, and a 

 current Ust of committee members will 

 be available at the meeting location OD 

 the day of the meeting. 



Transcripts of the open portion of the 

 meeting may be requested in writing 

 from the Freedom of InformaUon Office 

 (HFI-35). Food tr. " Jrug 

 Administrabca. rm. 12A-16. 5600 

 Fishers Lane, Rockville, MD 20857. 

 approximately 15 working days after the 

 meeting, at a cost of 10 cents per page. 

 The transcript may be viewed at the 

 Dockets Management Branch (HFA- 

 305). Food ana Drug Adminislrabon. 

 rm. 1-23. 12420 Parklawn>Dr.. 

 Rockville, MD 20857. approximately 15 

 working days after the meeting, between 

 the hours of 9 a.m. and 4 p.m.. Monday 

 through Friday. Summary minutes of 

 the open portion of the meeting may be 

 requested in writing from the Freedom 

 of Informaboo Office (address above) 

 begiiming approximately 90 days after 

 the meeting. 



This notice Is issued under section 

 1 0(a)( 1) and (2) of the Federal Advisory 

 Committee Act (5 US C app 2). and 

 FDA's regulations (21 CFR part 14) on 

 advisory committees. \ 



Dated. July 7. 1994 

 Linda A. Suydam. \ 



tt.tenm Deputy Commtmoner for Opentions. 

 IFR Doc 9+-159:6 Filed 7-8-94. 12 48 pm| 

 • 'LUMC COOC *^tO~Ot-f 



