[Federal Register Volume 59, Number 133 (Wednesday, July 13, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16936]
[[Page Unknown]]
[Federal Register: July 13, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: This notice announces a forthcoming meeting of a public
advisory committee of the Food and Drug Administration (FDA). This
notice also summarizes the procedures for the meeting and methods by
which interested persons may participate in open public hearings before
FDA's advisory committees.
MEETING: The following advisory committee meeting is announced:
Drug Abuse Advisory Committee
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 contact person. Open public hearing, August 1,
1994, 9 a.m. to 10 a.m., unless public participation does not last that
long; open committee discussion, 10 a.m. to 5 p.m; open committee
discussion, August 2, 1994, 9 a.m. to 1 p.m.; open public hearing, 1
p.m. to 2 p.m., unless public participation does not last that long;
open committee discussion, 2 p.m. to 5 p.m; open public hearing, August
3, 1994, 9 a.m. to 10 a.m., unless public participation does not last
that long; open committee discussion, 10 a.m. to 5 p.m.; Ermona B.
McGoodwin or Isaac F. Roubein, Center for Drug Evaluation and Research
(HFD-009), Food and Drug Administration, 5600 Fishers Lane, Rockville,
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 committee. 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 liability 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 will discuss the abuse liability assessment of
NDA 20-281, Ultram (tramadol hydrochloride tablets), R. W.
Johnson Pharmaceutical Research Institute, for treatment of pain.
FDA public advisory committee meetings may have as many as four
separable portions: (1) An open public hearing, (2) an open committee
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 portions 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 minimum rather than a maximum time for public
participation, and an open public hearing may last for whatever longer
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 published 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 wishes 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 meeting request an opportunity to speak will
be allowed to make an oral presentation at the hearing's conclusion, if
time permits, at the chairperson's discretion.
The agenda, the questions to be addressed by the committee, and a
current list of committee members will be available at the meeting
location on the day of the meeting.
Transcripts of the open portion of the meeting may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 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 and Drug Administration, 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 Information Office (address above) beginning
approximately 90 days after the meeting.
This notice is issued under section 10(a)(1) and (2) of the Federal
Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR
part 14) on advisory committees.
Dated: July 7, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-16936 Filed 7-8-94; 12:48 pm]
BILLING CODE 4160-01-F
