[Federal Register Volume 60, Number 55 (Wednesday, March 22, 1995)]
[Notices]
[Pages 15147-15150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7078]



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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:
Drug Abuse Advisory Committee
    Date, time, and place. April 6 and 7, 1995, 8 a.m., Parklawn Bldg., 
conference rooms D and E, 5600 Fishers Lane, Rockville, MD.
    Type of meeting and contact person. Closed committee deliberations, 
April 6, 1995, 8 a.m. to 5 p.m.; open public hearing, April 7, 1995, 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.; Stephen P. Pollitt, 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), Drug Abuse Advisory Committee, code 12535.
    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, [[Page 15148]] 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 March 23, 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.
    Closed committee deliberations. On April 6, 1995, the committee 
will review trade secret and/or confidential commercial information 
relevant to pending investigational new drug applications (IND's). This 
portion of the meeting will be closed to permit discussion of this 
information (5 U.S.C. 552b(c)(4)).
    Open committee discussion. On April 7, 1995, the committee will 
discuss the 1995 Institute of Medicine Report on the Development of 
Medications for the Treatment of Opiate and Cocaine Addiction.
Biological Response Modifiers Advisory Committee
    Date, time, and place. April 10 and 11, 1995, 8 a.m., Parklawn 
Bldg., conference rooms D and E, 5600 Fishers Lane, Rockville, MD.
    Type of meeting and contact person. Open public hearing, April 10, 
1995, 8 a.m. to 8:30 a.m., unless public participation does not last 
that long; open committee discussion, 8:30 a.m. to 5:30 p.m.; open 
public hearing, April 11, 1995, 8 a.m. to 8:30 a.m., unless public 
participation does not last that long; open committee discussion, 8:30 
a.m. to 1 p.m.; closed committee deliberations, 1 p.m. to 5 p.m.; 
William Freas or Pearline Muckelvene, Center for Biologics Evaluation 
and Research (HFM-21), Food and Drug Administration, 1401 Rockville 
Pike, Rockville, MD 20852, 301- 827-0314, or FDA Advisory Committee 
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), Biological Response Modifiers Advisory Committee, code 12388.
    General function of the committee. The committee reviews and 
evaluates data relating to the safety, effectiveness, and appropriate 
use of biological response modifiers which are intended for use in the 
prevention and treatment of a broad spectrum 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 April 3, 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 April 10, 1995, the committee will 
discuss: (1) Product license application supplement, reference number 
94-0381, for Roferon A (Interferon-alpha-2a) Hoffman La Roche Inc., for 
treatment of chronic phase, Philadelphia chromosome positive chronic 
myelogenous leukemia; and (2) product license application supplements 
94-0291 and 93-0287, for Sargramostim (GM-CSF), Immunex Corp., for 
acceleration of neutrophil recovery following chemotherapy in acute 
nonlymphoblastic leukemia and for chemotherapy-induced neutropenia 
(this discussion will continue on the following morning). On the 
morning of April 11, 1995, the committee will also discuss perspectives 
on xenotransplantation. In the afternoon, the committee will discuss 
the intramural scientific program of the Laboratory of Bone Marrow 
Growth Factors and research programs of individuals in the Division of 
Hematologic Products and Division of Cytokine Biology.
    Closed committee deliberations. On April 11, 1995, the committee 
will discuss the intramural scientific program. This portion of the 
meeting will be closed to prevent disclosure of personal information 
concerning individuals associated with the research program, disclosure 
of which would constitute a clearly unwarranted invasion of personal 
privacy (5 U.S.C. 552b(c)(6)).
Gastroenterology and Urology Devices Panel of the Medical Devices 
Advisory Committee
    Date, time, and place. April 21, 1995, 8 a.m., Corporate Bldg., 
Main Conference Room, 9200 Corporate Blvd., Rockville, MD. A limited 
number of overnight accommodations have been reserved at the 
Gaithersburg Marriott Washingtonian Center, 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.
    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 5 p.m.; closed committee deliberations, 
5 p.m. to 6 p.m.; Mary J. Cornelius, Center for Devices and 
Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2194, or FDA Advisory 
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area) Gastroenterology and Urology Devices Panel, code 
12523.
    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 April 14, 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 general 
issues related to two premarket approval applications for devices 
intended for the extracorporeal removal of low-density lipoprotein 
(LDL) to lower LDL cholesterol in patients with familial 
hypercholesterolemia.
    Closed committee deliberations. The committee may discuss trade 
secret and/or confidential commercial information regarding medical 
devices. This portion of the meeting will be closed to permit 
discussion of this information (5 U.S.C. 552b(c)(4)).
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory 
Committee
    Date, time, and place. April 24, 1995, 8:30 a.m., Corporate Bldg., 
Main Conference Room, 9200 Corporate Blvd., Rockville, MD. A limited 
number of overnight accommodations have been reserved at the 
Gaithersburg Marriott Washingtonian Center, 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 [[Page 15149]] be confirmed at the group rate 
based on availability.
    Type of meeting and contact person. Open public hearing, 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 2 p.m.; closed committee 
deliberations, 2 p.m. to 4 p.m.; Colin M. Pollard, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1180, or FDA Advisory 
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), Obstetrics and Gynecology Devices Panel, code 
12524.
    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 April 10, 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 general 
issues regarding home uterine activity monitors (HUAM's), in light of 
new published information on HUAM's.
    Closed committee deliberations. The committee may discuss trade 
secret and/or confidential commercial information regarding various 
medical devices used in obstetrics and gynecology that are currently 
being evaluated by FDA. 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, 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 [[Page 15150]] FDA's 
regulations (21 CFR part 14) on advisory committees.

    Dated: March 16, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-7078 Filed 3-21-95; 8:45 am]
BILLING CODE 4160-01-F