[Federal Register Volume 61, Number 247 (Monday, December 23, 1996)]
[Notices]
[Pages 67560-67562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32427]



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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:
Ophthalmic Devices Panel of the Medical Devices Advisory Committee
    Date, time, and place. January 13, 1997, 9:30 a.m., and January 14, 
1997, 9 a.m., Holiday Inn--Gaithersburg, Walker and Whetstone Rooms, 
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 or 1-800-465-4329 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 Sue Bae, KRA Corp. at 301-495-1591, ext. 227. The availability 
of appropriate accommodations cannot be assured unless prior 
notification is received.
    Type of meeting and contact person. Open public hearing, January 
13, 1997, 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 1:30 p.m.; 
closed committee deliberations, 1:30 p.m. to 5:30 p.m.; open public 
hearing, January 14, 1997, 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.; Sara M. Thornton, Center for Devices and Radiological 
Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-2053, or FDA Advisory Committee 
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), Ophthalmic Devices Panel, code 12396. 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 January 6, 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 January 13, 1997, the committee will 
discuss general issues relating to a premarket approval application 
(PMA) for a retinal tamponade used for the treatment of complicated 
retinal detachments. On January 14, 1997, the committee will discuss 
general issues relating to a PMA supplement for an excimer laser for 
photorefractive keratectomy to correct low to moderate myopia with 
astigmatism.
    Closed committee deliberations. FDA staff will present to the 
committee trade secret and/or confidential commercial information 
relevant to investigational device exemption applications and PMA's for 
vitreo-retinal, surgical and diagnostic devices, intraocular and 
corneal implants, and contact lenses. This portion of the meeting will 
be closed to permit discussion of this information (5 U.S.C. 
552b(c)(4)).
Gastroenterology and Urology Devices Panel of the Medical Devices 
Advisory Committee
    Date, time, and place. January 16, 1997, 8 a.m., Corporate Bldg., 
conference room 020B, 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 800-228-9290 or 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 Alice Hall Hayes, KRA Corp. at 301-495-
1591, ext. 223. The availability of appropriate accommodations cannot 
be assured unless prior written notification is received.
    Type of meeting and contact person. Closed committee deliberations, 
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 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. 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 January 9, 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. The committee will hear a presentation 
on the revisions made in the Draft Guidance on Penile Rigidity Implants 
(November 1996). The committee will discuss general issues related to a 
PMA for a metallic mesh stent intended to relieve prostatic obstruction 
secondary to benign prostatic hyperplasia (BPH) or bladder neck 
contracture.
    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)).

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Vaccines and Related Biological Products Advisory Committee
    Date, time, and place. January 30, 1997, 8 a.m., Holiday Inn--
Bethesda, Versailles Ballrooms I and II, 8120 Wisconsin Ave., Bethesda, 
MD.
    Type of meeting and contact person. Open committee discussion, 8 
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 4:30 p.m.; open public 
hearing, 4:30 p.m. to 5:30 p.m., unless public participation does not 
last that long; Nancy T. Cherry or Denise H. Royster, 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. 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 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 January 23, 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. The committee will discuss the influenza 
virus vaccine formulation for 1997-1998. The committee will also hear 
briefings on a research program in the Division of Bacterial Products 
and on recent activities in the Center for Biologics Evaluation and 
Research.
    Closed committee deliberations. The committee will review data of a 
personal nature where disclosure would constitute a clearly unwarranted 
invasion of personal privacy. This portion of the meeting will be 
closed to permit discussion of this information (5 U.S.C. 552b(c)(6)).
Biological Response Modifiers Advisory Committee
    Date, time, and place. January 30, 1997, 3 p.m., Rockwall 1 Bldg., 
conference room 4108, fourth floor, 11400 Rockville Pike, Rockville, 
MD.
    Type of meeting and contact person. This meeting will be held by a 
telephone conference call. A speaker telephone will be provided in the 
conference room to allow public participation in the meeting. Open 
public hearing, 3 p.m. to 4 p.m., unless public participation does not 
last that long; open committee discussion, 4 p.m. to 4:30 p.m.; closed 
committee deliberations, 4:30 p.m. to 5:30 p.m.; William Freas, Sheila 
D. Langford, or Pearline K. 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. 
Please call the hotline for information concerning any possible 
changes.
    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 January 23, 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. The committee will discuss the 
intramural research program for the Laboratory of Cell Biology, 
Division of Cytokine Biology.
    Closed committee deliberations. 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)).
    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, 12420 Parklawn Dr., rm. 1-23,

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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: December 16, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-32427 Filed 12-20-96; 8:45 am]
BILLING CODE 4160-01-F