[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]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Advisory Committees; Notice of Meetings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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.

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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