[Federal Register Volume 60, Number 190 (Monday, October 2, 1995)]
[Notices]
[Pages 51481-51483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24354]



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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:
Gastroenterology and Urology Devices Panel of the Medical Devices 
Advisory Committee
    Date, time, and place. October 20, 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 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, 8 a.m. to 
9 a.m., unless public participation does not last that long; open 
committee discussion, 9 a.m. to 3 p.m.; closed committee deliberations, 
3 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 October 13, 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 a premarket approval application for an 
electromagnetic device intended to treat benign prostatic hyperplasia 
using localized heat.
    Closed committee deliberations. FDA staff will present to the 
committee 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. October 23, 1995, 8:30 a.m., and October 24, 
1995, 7:30 a.m., DoubleTree Hotel, Ballroom, 1750 Rockville Pike, 
Rockville, MD. A limited number of overnight accommodations have been 
reserved at the hotel. Attendees requiring overnight accommodations may 
contact the hotel

[[Page 51482]]

at 301-468-1100 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, October 
23, 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, October 24, 1995, 7:30 a.m. to 8:30 a.m.; 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 5 
p.m.; Alfred W. Montgomery, 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 October 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. On October 23, 1995, the committee will 
consider a list of devices used for in vitro fertilization and other 
assisted reproduction technologies. The committee will provide expert 
advice on these devices that will be used to develop 510(k) guidance. 
On October 24, 1995, the committee will consider a draft guidance 
document on the preparation of an investigational device exemption for 
thermal endometrial ablation devices. Single copies of the list of in 
vitro fertilization devices and the guidance document for thermal 
endometrial ablation devices are available to the public after October 
1, 1995, by contacting the Division of Small Manufacturers Assistance, 
1350 Piccard Dr., Rockville, MD 20851, 1-800-638-2041.
    Closed committee deliberations. On October 24, 1995, FDA staff will 
present to the committee 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)).
Vaccines and Related Biological Products Advisory Committee
    Date, time, and place. October 26 and 27, 1995, 8 a.m., Parklawn 
Bldg., conference rooms D and E, 5600 Fishers Lane, Rockville, MD.
    Type of meeting and contact person. Open committee discussion, 
October 26, 1995, 8 a.m. to 8:15 a.m.; open public hearing, 8:15 a.m. 
to 8:45 a.m., unless public participation does not last that long; open 
committee discussion, 8:45 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 6 p.m.; closed committee deliberations, October 27, 1995, 8 
a.m. to 12:30 p.m.; open public hearing, 12:30 p.m. to 1 p.m., unless 
public participation does not last that long; open committee 
discussion, 1 p.m. to 5:15 p.m.; Nancy T. Cherry or Sandy M. Salins, 
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), Vaccines and Related Biological 
Products Advisory Committee, code 12388.
    General function of the committee. The committee reviews and 
evaluates data on the safety and effectiveness of vaccines 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 October 18, 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 October 26, 1995, the committee will 
hear presentations on recent acellular pertussis trials sponsored by 
the Public Health Service, and on a new strategic plan for the year 
2004 developed by the Center for Biologics Evaluation and Research. The 
committee will also consider whether a single formulation for 
pneumococcal conjugate vaccines should be adopted for children in the 
United States. On October 27, l995, the committee will discuss a draft 
Points to Consider document addressing the evaluation of combination 
vaccines. Copies of the document will be available at the meeting.
    Closed committee deliberations. On October 26 and 27, l995, the 
committee will review trade secret and/or confidential commercial 
information relevant to pending investigational new drug applications 
or product licensing applications. These portions of the meeting will 
be closed to permit discussion of this information (5 U.S.C. 
552b(c)(4)).
 Medical Imaging Drugs Advisory Committee
    Date, time, and place. October 26 and 27, 1995, 8 a.m., Holiday 
Inn, Plaza Ballroom, 8777 Georgia Ave., Silver Spring, MD.
    -Type of meeting and contact person. Open public hearing, October 
26, 1995, 8 a.m. to 9 a.m., unless public participation does not last 
that long; closed committee deliberations, 9 a.m. to 11 a.m.; open 
committee discussion, 11 a.m. to 4 p.m.; open committee discussion, 
October 27, 1995, 8 a.m. to 4 p.m.; Leander B. Madoo (HFD-9), Center 
for Drug Evaluation and Research, 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), Medical Imaging Drugs Advisory Committee, code 
12540.
    General function of committee. The committee reviews and evaluates 
data concerning the safety and effectiveness of marketed and 
investigational human drug products for use in diagnostic and 
therapeutic procedures using radioactive pharmaceuticals and contrast 
media used in diagnostic radiology.
    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 October 12, 1995, and submit a brief 
statement of the general nature of the evidence or 

[[Page 51483]]
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 hold a preliminary 
discussion in preparation for drafting of future ``Points to Consider 
for Diagnostic Imaging Agents''.
    Closed committee deliberations. The committee will be briefed on 
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 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 FDA's regulations (21 CFR 
part 14) on advisory committees.

    Dated: September 26, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 95-24354 Filed 9-29-95; 8:45 am]
BILLING CODE 4160-01-F