[Federal Register Volume 59, Number 73 (Friday, April 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9242]


[[Page Unknown]]

[Federal Register: April 15, 1994]


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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 is in the process of implementing a voice mail telephone system 
which will allow the public to obtain information regarding advisory 
committee meetings. The public will be able to access the use of this 
information system by calling 1-800-741-8138. The project 
implementation date is May 1, 1994.
MEETINGS: The following advisory committee meetings are announced:
Circulatory System Devices Panel of the Medical Devices Advisory 
Committee
    Date, time, and place. May 2, 1994, 8:30 a.m., and May 3, 1994, 8 
a.m., Holiday Inn--Bethesda, Versailles Ballroom I, 8120 Wisconsin 
Ave., Bethesda, MD. A limited number of overnight accommodations have 
been reserved at the Holiday Inn--Bethesda. Attendees requiring 
overnight accommodations must contact the hotel at 301-652-2000 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, May 2, 
1994, 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 3 p.m.; closed 
committee deliberations, 3 p.m. to 5 p.m.; open public hearing, May 3, 
1994, 8 a.m. to 9:30 a.m., unless public participation does not last 
that long; open committee discussion, 9:30 a.m. to 1 p.m.; Ramiah 
Subramanian, Center for Devices and Radiological Health (HFZ-450), Food 
and Drug Administration, 1390 Piccard Dr., Rockville, MD 20850, 301-
594-2623.
    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 27, 1994, 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 coronary 
interventional device and a dysrhythmia treatment device.
    Closed committee deliberations. The committee may discuss trade 
secret and/or confidential commercial information. This portion of the 
meeting will be closed to permit discussion of this information (5 
U.S.C. 552b(c)(4)).
General Hospital and Personal Use Devices Panel of the Medical Devices 
Advisory Committee
    Date, time, and place. May 10, 1994, 1 p.m., and May 11, 1994, 8 
a.m., Bethesda Ramada Hotel and Conference Center, Ambassador Ballrooms 
I and II, 8400 Wisconsin Ave., Bethesda, MD.
    Type of meeting and contact person. Closed committee deliberations, 
May 10, 1994, 1 p.m. to 5 p.m.; open public hearing, May 11, 1994, 8 
a.m. to 10 a.m., unless public participation does not last that long; 
open committee discussion, 10 a.m. to 5 p.m.; Janet L. Scudiero, Center 
for Devices and Radiological Health (HFZ-410), Food and Drug 
Administration, 1390 Piccard Dr., Rockville, MD 20850, 301-594-1307.
    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 2, 1994, 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 May 11, 1994, the committee will 
discuss the: (1) Draft Supplementary Guidance on the Content of 
Premarket Submissions (510(k)) for Medical Devices with Sharps Injury 
Prevention Features, and (2) Reclassification of the Infant Radiant 
Warmer. A copy of the draft guidance is available from the Division of 
Small Manufacturers Assistance, Center for Devices and Radiological 
Health (HFZ-220), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 800-638-2041 or 301-443-6597.
    Closed committee deliberations. On May 10, 1994, the committee will 
discuss trade secret and/or confidential commercial information. This 
portion of the meeting will be closed to permit discussion of this 
information (5 U.S.C. 552b(c)(4)).
Ophthalmic Devices Panel of the Medical Devices Advisory Committee
    Date, time, and place. May 20, 1994, 8:30 a.m., Bethesda Ramada 
Hotel and Conference Center, Embassy Ballrooms II and III, 8400 
Wisconsin Ave., Bethesda, MD. A limited number of overnight 
accommodations have been reserved at the Bethesda Ramada Hotel and 
Conference Center. Attendees requiring overnight accommodations must 
contact the hotel at 301-654-1000 and reference the FDA Ophthalmic 
Panel meeting block. Reservations will 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 4:30 p.m.; closed committee 
deliberations, 4:30 p.m. to 5 p.m.; Daniel W. C. Brown, Center for 
Devices and Radiological Health (HFZ-460), Food and Drug 
Administration, 1390 Piccard Dr., Rockville, MD 20850, 301-594-1744.
    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 6, 1994, 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 relating to premarket approval applications for: (1) A retinal 
tamponade used for the treatment of complicated retinal detachments, 
and (2) an intraocular lens. There will be an update presented to the 
panel on the policy initiatives in the contact lens area to include the 
current status of the November 1993 ``Premarket Notification (510(k)) 
Guidance Document for Daily Wear Contact Lenses.'' Updates on any 
intraocular implants issues are tentatively planned.
    Closed committee deliberations. The committee may discuss trade 
secret and/or confidential commercial information relevant to premarket 
approval applications for surgical and diagnostic devices or 
intraocular implants. This portion of the meeting will be closed to 
permit discussion of this information (5 U.S.C. 552b(c)(4)).
Biological Response Modifiers Advisory Committee
    Date, time, and place. May 25, 1994, 10:30 a.m., and May 26, 1994, 
8 a.m., Bethesda Ramada Hotel and Conference Center, Embassy Ballrooms 
I, II, and III, 8400 Wisconsin Ave., Bethesda, MD.
    Type of meeting and contact person. Open public hearing, May 25, 
1994, 10:30 a.m. to 11:15 a.m., unless public participation does not 
last that long; open committee discussion, 11:15 a.m. to 5:30 p.m.; 
open public hearing, May 26, 1994, 8 a.m. to 8:45 a.m., unless public 
participation does not last that long; open committee discussion, 8:45 
a.m. to 4 p.m.; closed committee deliberations, 4 p.m. to 5 p.m.; open 
committee discussion, 5 p.m. to 6 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-
594-1054.
    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 May 18, 1994, 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 May 25 and 26, 1994, the committee 
will discuss issues related to the safety and efficacy of hematopoietic 
support regimens in the setting of myelotoxic chemotherapy. On May 26, 
1994, the committee will receive an update on issues related to 
myoblast transfer for the treatment of muscular dystrophy.
    Closed committee deliberations. The committee will discuss trade 
secret and/or confidential commercial information relevant to pending 
investigational 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 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: April 13, 1994.
 Linda A. Suydam,
 Interim Deputy Commissioner for Operations.
[FR Doc. 94-9242 Filed 4-14-94; 8:45 am]
BILLING CODE 4160-01-F