[Federal Register Volume 61, Number 102 (Friday, May 24, 1996)]
[Notices]
[Pages 26188-26191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13177]



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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

[[Page 26189]]

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: -
Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory 
Committee
    Date, time, and place. June 11, 1996, 8:30 a.m., Corporate Bldg., 
conference room 020B, 9200 Corporate Blvd., Rockville, MD. A limited 
number of overnight accommodations have been reserved at the Marriott 
Courtyard Hotel, 2500 Research Blvd., Rockville, MD. Attendees 
requiring overnight accommodations may contact the hotel at 301-670-
6700 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 notify the contact 
person listed below. The availability of special accommodations cannot 
be assured unless prior written notification is received.
    Type of meeting and contact person. Open public hearing, 8:30 a.m. 
to 9:45 a.m., unless public participation does not last that long; open 
committee discussion, 9:45 a.m. to 4 p.m.; closed committee 
deliberations, 4 p.m. to 5 p.m.; Marilyn N. Flack, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2080, or FDA Advisory 
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), Ear, Nose, and Throat Devices Panel, code 12522. 
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 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 May 29, 1996, 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 premarket 
approval application that seeks to substantiate the safety and 
effectiveness of a bronchoscope device utilizing autofluorescence to 
aid in detection of abnormal lung tissue.
    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)).---
Oncologic Drugs Advisory Committee
    Date, time, and place. June 13 and 14, 1996, 8:30 a.m., Holiday 
Inn--Gaithersburg, Walker and Whetstone Rooms, Two Montgomery Village 
Ave., Gaithersburg, MD.
    Type of meeting and contact person. Open public hearing, June 13, 
1996, 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 4:30 p.m.; open 
committee discussion, June 14, 1996, 8:30 a.m. to 1 p.m.; closed 
committee deliberations, 1 p.m. to 3:30 p.m.; Jannette O'Neill-
Gonzalez, 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), Oncologic Drugs Advisory 
Committee, code 12542. 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 treatment of cancer.
    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 June 7, 1996, 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 June 13, 1996, the committee will 
discuss: (1) New drug application (NDA) 20-571 CamptosarTM 
(irinotecan hydrochloride injection, The Upjohn Co.), indicated for the 
treatment of patients with metastatic carcinoma of the colon or rectum 
whose disease has recurred or progressed following 5-FU-based therapy; 
and (2) NDA 20-036/S-011 Aredia (pamidronate disodium for 
injection, Ciba-Geigy Corp.), indicated for use in conjunction with 
standard antineoplastic therapy for treatment of osteolytic bone 
metastases. On the morning of June 14, 1996, the committee will discuss 
NDA 20-637, Gliadel Wafer (polifeprosan 20 with carmustine, 
Guilford Pharmaceuticals), indicated for use as an adjunct to surgery 
to prolong survival in patients with a malignant glioma.
    Closed committee deliberations. On the afternoon of June 14, 1996, 
the committee will review trade secret and/or confidential commercial 
information relevant to pending investigational new drug applications 
and NDA's. This portion of the meeting will be closed to permit 
discussion of this information (5 U.S.C. 552b(c)(4)).
Blood Products Advisory Committee
    Date, time, and place. June 20 and 21, 1996, 8 a.m., Holiday Inn--
Bethesda, Versailles Ballrooms II and III, 8120 Wisconsin Ave., 
Bethesda, MD.
    Type of meeting and contact person. Open committee discussion, June 
20, 1996, 8 a.m. to 11 a.m.; open public hearing, 11 a.m. to 11:30 
a.m., unless public participation does not last that long; open 
committee discussion, 11:30 a.m. to 1:30 p.m.; closed committee 
deliberations, 1:30 p.m. to 2:30 p.m.; open committee discussion, 2:30 
p.m. to 3:30 p.m.; open public hearing, 3:30 p.m. to 4 p.m., unless 
public participation does not last that long; open committee 
discussion, 4 p.m. to 5:30 p.m.; open committee discussion, June 21, 
1996, 8 a.m. to 10:30 a.m.; open public hearing, 10:30 a.m. to 11:30 
a.m., unless public participation does not last that long; open 
committee discussion, 11:30 a.m. to 2:30 p.m.; open public hearing, 
2:30 p.m. to 3 p.m., unless public participation does not last that 
long; open committee discussion, 3 p.m. to 4 p.m.; Linda A. Smallwood, 
Center for Biologics Evaluation and Research (HFM-350), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-3514, 
or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Blood Products Advisory Committee, 
code 12388. Please call the hotline for information concerning any 
possible changes.

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    General function of the committee. The committee reviews and 
evaluates data on the safety and effectiveness, and appropriate use of 
blood products intended for use in the diagnosis, prevention, or 
treatment of human 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 June 14, 1996, 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 the morning of June 20, 1996, updates 
on relevant public health issues will be presented and an overview of 
draft reviewer guidance for blood establishment computer software will 
be presented and discussed. In the afternoon, there will be discussion 
of use of hemoglobin solutions in fluid rescuscitation from hemorrhagic 
shock; in particular, issues in clinical trials. On the morning of June 
21, 1996, proposed revisions to the human immunodeficiency virus (HIV) 
re-entry algorithm will be reviewed and discussed. In the afternoon, 
the Calypte Laboratories test for anti-HIV in urine will be presented 
and discussed.
    Closed committee deliberations. On June 20, 1996, the committee 
will review trade secret and/or confidential commercial information 
relevant to current or pending products. 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 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, 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.


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    Dated: May 20, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-13177 Filed 5-23-96; 8:45 am]
BILLING CODE 4160-01-F