[Federal Register Volume 60, Number 162 (Tuesday, August 22, 1995)]
[Notices]
[Pages 43599-43602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20730]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration


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:
Generic Drugs Advisory Committee
    Date, time, and place. September 6 and 7, 1995, 8:30 a.m., Holiday 
Inn--Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD.
    Type of meeting and contact person. Open committee discussion, 
September 6, 1995, 8:30 a.m. to 11 a.m.; open public hearing, 11 a.m. 
to 12 m., unless public participation does not last that long; open 
committee discussion, 12 m. to 5 p.m.; open committee discussion, 
September 7, 1995, 8:30 a.m. to 12 m.; closed committee deliberations, 
12 m. to 5 p.m.; Kimberly L. Topper or Angie Whitacre, Center for Drug 
Evaluation and Research (HFD-9), 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), Generic Drugs Advisory Committee, code 12539.
    General function of the committee. The committee gives advice on 
scientific and technical issues concerning the safety and effectiveness 
of human generic drug products for use in the treatment of a broad 
spectrum of human diseases and makes appropriate recommendations to the 
Secretary of Health and Human Services, the Assistant Secretary for 
Health, the Commissioner of Food and Drugs, and the Director of the 
Center for Drug Evaluation and Research. The committee may also review 
agency-sponsored intramural and extramural biomedical research programs 
in support of FDA's generic drugs regulatory responsibilities.
    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 August 22, 1995, 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 September 6 and 7, 1995, the 
committee will review and advise on the status of Center for Drug 
Evaluation and Research (CDER) quality and performance initiatives 
related to formulation dissolution and bioequivalence. The committee 
will also discuss its relationship to, and interaction with, CDER's new 
Office of Pharmaceutical Sciences.
    Closed committee deliberations. On September 7, 1995, the committee 
will discuss trade secret and/or confidential commercial information 
relevant to pending abbreviated new drug applications (ANDA's). This 
portion of the meeting will be closed to permit discussion of this 
information (5 U.S.C. 552b(c)(4)).
Radiological Devices Panel of the Medical Devices Advisory Committee
    Date, time, and place. September 11, 1995, 9:30 a.m., Corporate 
Bldg., conference room 20B, 9200 Corporate Blvd., Rockville, MD. A 
limited number of overnight accommodations have been reserved at the 
Gaithersburg Marriott 

[[Page 43600]]
Washingtonian Hotel, 9751 Washingtonian Blvd., Gaithersburg, MD. 
Attendees requiring overnight accommodations may contact the hotel at 
301-590-0044 and reference the FDA panel meeting block. Reservations 
will be confirmed at the group rate based on availability. Attendees 
with a disability requiring special accommodations should contact Ed 
Rugenstein, Sociometrics, Inc., 301-608-2151. The availability of 
appropriate accommodations cannot be assured unless prior written 
notification is received.
    Type of meeting and contact person. Open public hearing, 9:30 a.m. 
to 10:30 a.m., unless public participation does not last that long; 
open committee discussion, 10:30 a.m. to 12 m.; closed committee 
deliberations, 12 m. to 1 p.m.; open committee discussion, 1 p.m. to 4 
p.m.; John C. Monahan, Center for Devices and Radiological Health (HFZ-
470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 
20850, 301-594-1212, or FDA Advisory Committee Information Hotline, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), Radiological 
Devices Panel, code 12526. -
    General function of the committee. The committee reviews and 
evaluates data on the safety and effectiveness of marketed and 
investigational devices and makes recommendations for their regulation.
    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 September 6, 1995, 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. The committee will discuss a draft 
guidance document entitled ``Magnetic Resonance Imaging Guidance Update 
for Rate of Change of Gradient Fields.'' Single copies of the draft 
guidance are available from John C. Monahan (address above).
    Closed committee deliberations. FDA staff will present to the 
committee trade secret and/or confidential commercial information 
regarding present and future FDA issues. This portion of the meeting 
will be closed to permit discussion of this information (5 U.S.C. 
552b(c)(4)).
Neurological Devices Panel of the Medical Devices Advisory Committee
    Date, time, and place. September 15, 1995, 8 a.m., Corporate Bldg., 
ground floor conference room, 9200 Corporate Blvd., Rockville, MD. A 
limited number of overnight accommodations have been reserved at the 
Gaithersburg Marriott Washingtonian Hotel, 9751 Washingtonian Blvd., 
Gaithersburg, MD. Attendees requiring overnight accommodations may 
contact the hotel at 301-590-0044 and reference the FDA Panel meeting 
block. Reservations may be confirmed at the group rate based on 
availability. Attendees with a disability requiring special 
accommodations should contact Ed Rugenstein, Sociometrics, Inc., 301-
608-2151. The availability of appropriate accommodations cannot be 
assured unless prior notification is received.
    Type of meeting and contact person. Open public hearing, 8 a.m. to 
9 a.m., unless public participation does not last that long; open 
committee discussion, 9 a.m. to 1:30 p.m.; closed committee 
deliberations, 1:30 p.m. to 4 p.m.; Jerilyn K. Glass, Center for 
Devices and Radiological Health (HFZ-450), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8517, or FDA Advisory Committee Information Hotline, 1-800-741-8138 
(301-443-0572 in the Washington, DC area), Neurological Devices Panel, 
code 12513.
    General function of the committee. The committee reviews and 
evaluates data on the safety and effectiveness of marketed and 
investigational devices and makes recommendations for their regulation.
    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 September 4, 1995, 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. The committee will discuss the following 
topics: (1) Clinical perspectives on the use of balloon catheters, 
coils, and liquid occlusive devices for the treatment of aneurysms, 
arterio-venous malformations, or bleeding in the cerebrovascular 
circulation; and (2) research considerations when designing studies to 
evaluate these devices.
    Closed committee deliberations. FDA staff will present to the 
committee trade secret and/or confidential commercial information 
regarding present and future FDA issues. This portion of the meeting 
will be closed to permit discussion of this information (5 U.S.C. 
552b(c)(4)).
Immunology Devices Panel of the Medical Devices Advisory Committee
    Date, time, and place. September 21 and 22, 1995, 8 a.m., Holiday 
Inn--Gaithersburg, Walker and Whetstone Ballrooms, Two Montgomery 
Village Ave., Gaithersburg, MD. A limited number of overnight 
accommodations have been reserved at the hotel. Attendees requiring 
overnight accommodations may contact the hotel at 301-948-8900 and 
reference the FDA Panel meeting block. Reservations will be confirmed 
at the group rate based on availability. Attendees with a disability 
requiring special accommodations should contact Ed Rugenstein, 
Sociometrics, Inc., 301-608-2151. The availability of appropriate 
accommodations cannot be assured unless prior written notification is 
received.
    Type of meeting and contact person. Open public hearing, September 
21, 1995, 8 a.m. to 9 a.m., unless public participation does not last 
that long; open committee discussion, 9 a.m. to 1:30 p.m.; open public 
hearing; 1:30 p.m. to 2:30 p.m., unless public participation does not 
last that long; open committee discussion, 2:30 p.m. to 6 p.m.; closed 
committee deliberations, September 22, 1995, 8 a.m. to 9 a.m.; open 
public hearing, 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.; Peter E. 
Maxim, Center for Devices and Radiological Health (HFZ-440), Food and 
Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-
1293, or FDA Advisory Committee Information Hotline, 1-800-741-8138 
(301-443-0572 in the Washington, DC area), Immunology Devices Panel, 
code 12516.
    General function of the committee. The committee reviews and 
evaluates data on the safety and effectiveness of marketed and 
investigational devices and makes recommendations for their regulation.
    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 September 1, 1995, and submit a brief 
statement of 

[[Page 43601]]
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. The committee will discuss general 
issues relating to the review of three premarket approval applications 
for: (1) An in situ hybridization assay to measure a prognostic marker 
in breast tumor tissues; (2) a serum tumor marker to aid in the 
detection of recurrence in Stage 2 and 3 breast cancer patients; and 
(3) an assay to measure a urinary marker to aid in the detection of 
recurrence in bladder cancer patients.
    Closed committee deliberations. FDA staff will present to the 
committee trade secret and/or confidential commercial information 
regarding pending or future device submissions. This portion of the 
meeting will be closed to permit discussion of this information (5 
U.S.C. 552b(c)(4)).
Joint Meetings of Nonprescription Drugs Advisory Committee with 
Endocrinologic and Metabolic Drugs Advisory Committee, Drug Abuse 
Advisory Committee, and Gastrointestinal Drugs Advisory Committee
    Date, time, and place. September 27 and 28, 1995, 8:30 a.m., and 
September 29, 1995, 3 p.m., conference rms. D and E, Parklawn Bldg., 
5600 Fishers Lane, Rockville, MD.
    Type of meeting and contact person. Open public hearing, September 
27, 1995, 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 5 p.m.; closed 
committee deliberations, 5 p.m. to 6 p.m.; open public hearing, 
September 28, 1995, 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 4 
p.m.; open public hearing, 4 p.m. to 4:30 p.m., unless public 
participation does not last that long; open committee discussion, 4:30 
p.m. to 6:30 p.m.; open committee discussion, September 29, 1995, 3 
p.m. to 4 p.m.; Lee L. Zwanziger, Stephen Pollitt, or Liz Ortuzar, 
Center for Drug Evaluation and Research (HFD-9), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-4695, 
or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Nonprescription Drugs Advisory 
Committee, code 12541.
    General functions of the committees. The Nonprescription Drugs 
Advisory Committee reviews and evaluates data concerning the safety and 
effectiveness of over-the-counter (nonprescription) human drug products 
for use in the treatment of a broad spectrum of human symptoms and 
diseases. The Endocrinologic and Metabolic Drugs Advisory Committee 
reviews and evaluates data on the safety and effectiveness of marketed 
and investigational human drugs for use in endocrine and metabolic 
disorders. The Drug Abuse Advisory 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. The 
Gastrointestinal Drugs Advisory Committee reviews and evaluates data on 
the safety and effectiveness of marketed and investigational human 
drugs for use in gastrointestinal diseases.
    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 September 19, 1995, 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 September 27, 1995, the 
Nonprescription Drugs Advisory Committee and some members of the 
Endocrinologic and Metabolic Drugs Advisory Committee will discuss 
public health issues relevant to cholesterol lowering regimens and data 
relevant to new drug application (NDA) 16-640 for cholestyramine 
(Questran powder) and NDA 19-669 for cholestyramine 
(Questran Light with aspartame), sponsored by Bristol-Myers 
Squibb to switch the products from prescription to over-the-counter 
marketing status for use as adjunctive therapy to diet for the 
reduction of elevated serum cholesterol in patients with primary 
hypercholesterolemia (elevated low density lipoprotein (LDL) 
cholesterol) who do not respond adequately to diet. On September 28, 
1995, the Nonprescription Drugs Advisory Committee and the Drug Abuse 
Advisory Committee will discuss data relevant to NDA 20-066 
(Nicorette 4 milligrams (mg) and NDA 18-612 
(Nicorette 2 mg) to switch nicotine polacrilex 
(Nicorette, SmithKline Beecham Consumer Healthcare Products) 
from prescription to over-the-counter status for use as an aid to 
smoking cessation for the relief of nicotine withdrawal symptoms. Later 
on September 28, 1995 the Nonprescription Drugs Advisory Committee and 
some members of the Gastrointestinal Drugs Advisory Committee will 
discuss data relevant to NDA 20-555 for nizatidine tablets, 75 mg, 
sponsored by Whitehall-Robins Healthcare to switch the product from 
prescription to over-the-counter status for the prevention of meal and 
beverage induced heartburn. During the afternoon of September 29, 1995, 
the Nonprescription Drugs Advisory Committee will discuss issues raised 
during the Public Hearing before the Commissioner on Over-The-Counter 
Drug Labeling held earlier during the same day.
    Closed committee deliberations. On September 27, 1995, the 
Nonprescription Drugs Advisory Committee will discuss trade secret and/
or confidential commercial information relevant to pending new drug 
applications. 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 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 

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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.
    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 (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: August 16, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95-20730 Filed 8-21-95; 8:45 am]

BILLING CODE 4160-01-F