[Federal Register Volume 62, Number 19 (Wednesday, January 29, 1997)]
[Notices]
[Pages 4301-4303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2168]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Advisory Committees; Notice of Meetings
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces forthcoming meetings of public advisory
committees of the Food and Drug Administration (FDA). This notice also
summarizes the procedures for the meetings and methods by which
interested persons may participate in open public hearings before FDA's
advisory committees.
FDA has established an Advisory Committee Information Hotline (the
hotline) using a voice-mail telephone system. The hotline provides the
public with access to the most current information on FDA advisory
committee meetings. The advisory committee hotline, which will
disseminate current information and information updates, can be
accessed by dialing 1-800-741-8138 or 301-443-0572. Each advisory
committee is assigned a 5-digit number. This 5-digit number will appear
in each individual notice of meeting. The hotline will enable the
public to obtain information about a particular advisory committee by
using the committee's 5-digit number. Information in the hotline is
preliminary and may change before a meeting is actually held. The
hotline will be updated when such changes are made.
MEETINGS: The following advisory committee meetings are announced:
Drug Abuse Advisory Committee
Date, time, and place. February 10, 1997, 8:30 a.m., and February
11, 1997, 9 a.m., Holiday Inn--Gaithersburg, Grand Ballroom, Two
Montgomery Village Ave., Gaithersburg, MD.
Type of meeting and contact person. Open public hearing, February
10, 1997, 8:30 a.m. to 9:30 a.m.; unless public participation does not
last that long; open committee discussion, 9:30 a.m. to 11 a.m.; closed
presentation of data, 11 a.m. to 2 p.m.; closed committee
deliberations, 2 p.m. to 5:30 p.m.; open public hearing, February 11,
1997, 9 a.m. to 10 a.m., unless public participation does not last that
long; open committee discussion, 10 a.m. to 5:30 p.m.; Kimberly L.
Topper, Center for Drug Evaluation and Research (HFD-21), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5455,
or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Drug Abuse Advisory Committee, code
12535.
[[Page 4302]]
Please call the hotline for information concerning any possible
changes.
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 January 27, 1997, 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.
This statement may be faxed to Kimberly L. Topper at 301-443-0699, or
E-mailed to [email protected].
Open committee discussion. On February 10, 1997, the committee will
discuss QuitTM Brand silver acetate lozenges, New Life Health
Products, for smoking cessation. On February 11, 1997, the committee
will discuss new drug application (NDA) 11-792, Soma
(carisoprodol generic tablets, Wallace Laboratory), for muscle
relaxation and generic drugs containing carisoprodol. The committee
will consider a Drug Enforcement Administration petition regarding
scheduling of carisoprodol under the Controlled Substances Act.
Closed presentation of data. On February 10, 1997, the committee
will hear trade secret and/or confidential commercial information
relevant to pending investigational new drugs (IND's) and NDA's. This
portion of the meeting will be closed to permit discussion of this
information (5 U.S.C. 552b(c)(4)).
Closed committee deliberations. On February 10, 1997, the committee
will review trade secret and/or confidential commercial information
relevant to pending IND's or NDA's. This portion of the meeting will be
closed to permit discussion of this information. (5 U.S.C. 552b
(c)(4)).
Endocrinologic and Metabolic Drugs Advisory Committee
Date, time, and place. February 20 and 21, 1997, 8 a.m., Holiday
Inn--Bethesda, Versailles Ballrooms I and II, 8120 Wisconsin Ave.,
Bethesda, MD.
Type of meeting and contact person. Open public hearing February
20, 1997, 8 a.m. to 9 a.m.; unless public participation does not last
that long; open committee discussion, 9 a.m. to 4 p.m.; closed
presentation of data, February 21, 1997, 8 a.m. to 1 p.m.; closed
committee deliberations, 1 p.m. to 4 p.m.; Kathleen R. Reedy or LaNise
S. Giles, Center for Drug Evaluation and Research (HFD-21), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-
5455, or FDA Advisory Committee Information Hotline, 1-800-741-8138
(301-443-0572 in the Washington, DC area), Endocrinologic and Metabolic
Drugs Advisory Committee, code 12536. Please call the hotline for
information concerning any possible changes.
General function of the committee. The committee reviews and
evaluates data on the safety and effectiveness of marketed and
investigational human drugs for use in endocrine and metabolic
disorders.
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 February 14, 1997, 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 February 20, 1997, the committee will
hear presentations and discuss data submitted regarding NDA 20-560/S-
003, Fosamax (alendronate sodium tablets, Merck & Co.) for an expansion
of the indication to include the prevention of postmenopausal
osteoporosis.
Closed presentation of data. On February 21, 1997, the committee
will hear trade secret and/or confidential commercial information
relevant to pending IND's and NDA's. This portion of the meeting will
be closed to permit discussion of this information (5 U.S.C.
552b(c)(4)).
Closed committee deliberations. On February 21, 1997, the committee
will discuss trade secret and/or confidential commercial information
relevant to pending IND's and NDA's. This portion of the meeting will
be closed to permit discussion of this information (5 U.S.C.
552b(c)(4)).
Each public advisory committee meeting listed above 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. The dates and times reserved for the separate portions of
each committee meeting are listed above.
The open public hearing portion of the meeting(s) 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, 5600 Fishers Lane, rm. 12A-16, 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,
[[Page 4303]]
12420 Parklawn Dr., rm. 1-23, 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.
The Commissioner has determined for the reasons stated that those
portions of the advisory committee meetings so designated in this
notice shall be closed. The Federal Advisory Committee Act (FACA) (5
U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings
in certain circumstances. Those portions of a meeting designated as
closed, however, shall be closed for the shortest possible time,
consistent with the intent of the cited statutes.
The FACA, as amended, provides that a portion of a meeting may be
closed where the matter for discussion involves a trade secret;
commercial or financial information that is privileged or confidential;
information of a personal nature, disclosure of which would be a
clearly unwarranted invasion of personal privacy; investigatory files
compiled for law enforcement purposes; information the premature
disclosure of which would be likely to significantly frustrate
implementation of a proposed agency action; and information in certain
other instances not generally relevant to FDA matters.
Examples of portions of FDA advisory committee meetings that
ordinarily may be closed, where necessary and in accordance with FACA
criteria, include the review, discussion, and evaluation of drafts of
regulations or guidelines or similar preexisting internal agency
documents, but only if their premature disclosure is likely to
significantly frustrate implementation of proposed agency action;
review of trade secrets and confidential commercial or financial
information submitted to the agency; consideration of matters involving
investigatory files compiled for law enforcement purposes; and review
of matters, such as personnel records or individual patient records,
where disclosure would constitute a clearly unwarranted invasion of
personal privacy.
Examples of portions of FDA advisory committee meetings that
ordinarily shall not be closed include the review, discussion, and
evaluation of general preclinical and clinical test protocols and
procedures for a class of drugs or devices; consideration of labeling
requirements for a class of marketed drugs or devices; review of data
and information on specific investigational or marketed drugs and
devices that have previously been made public; presentation of any
other data or information that is not exempt from public disclosure
pursuant to the FACA, as amended; and, deliberation to formulate advice
and recommendations to the agency on matters that do not independently
justify closing.
This notice is issued under section 10(a)(1) and (a)(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: January 22, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-2168 Filed 1-28-97; 8:45 am]
BILLING CODE 4160-01-F