[Federal Register Volume 61, Number 52 (Friday, March 15, 1996)]
[Notices]
[Pages 10769-10771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6373]



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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. April 1, 1996, 8:30 a.m., Holiday Inn--
Gaithersburg, Walker/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 Alice Hayes, 
Sociometrics, Inc., 8300 Colesville Rd., suite 550, Silver Spring, MD 
20910, 301-608-2151. The availability of appropriate accommodations 
cannot be assured unless prior notification is received.
    -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 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.
    -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 March 22, 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 Division of Ophthalmic Devices will 
present the proposed draft guidance document for Photorefractive 
Keratectomy (PRK) Laser Systems and request comments and 
recommendations from the Panel on designated sections. The scope of the 
discussion will include a proposal from the Division to expand the 
guidance to address high myopia, hyperopia, astigmatism, and Laser 
Assisted In Situ Keratomileusis (LASIK). Single copies of the proposed 
outline for the discussion are available from the contact person (see 
above).

[[Page 10770]]

-Technical Electronic Product Radiation Safety Standards Committee
    -Date, time, and place. April 9 and 10, 1996, 8:30 a.m., Corporate 
Bldg., 9200 Corporate Blvd., rm. 020B, Rockville, MD.
    -Type of meeting and contact person. Open committee discussion, 
April 9, 1996, 8:30 a.m. to 3:30 p.m.; open public hearing, 3:30 p.m. 
to 4:30 p.m., unless public participation does not last that long; open 
committee discussion, April 10, 1996, 8:30 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 3:30 p.m.; 
open public hearing, 3:30 p.m. to 4:15 p.m., unless public 
participation does not last that long; Orhan H. Suleiman, Center for 
Devices and Radiological Health (HFZ-240), Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3533, or 
call the FDA Advisory Committee Information Hotline, 1-800-741-8138 
(301-443-0572 in the Washington, DC area), Technical Electronic Product 
Radiation Safety Standards Committee, code 12399.
    -General function of the committee. The committee advises on 
technical feasibility, reasonableness, and practicability of 
performance standards for electronic products to control the emission 
of radiation under 42 U.S.C. 263f(f)(1)(A).
    -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 22, 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. A brief overview and update of issues 
associated with the Radiation Control for Health and Safety Act (Pub. 
L. 90-602) will be presented by FDA staff. The committee will 
specifically discuss draft amendments to the following performance 
standards for ionizing radiation emitting products: (1) Radiographic 
dental equipment (21 CFR 1020.30); (2) mammography equipment (21 CFR 
1020.30); and (3) laser products (21 CFR 1040.10). In addition, 
radiation exposure to patients during extended fluoroscopy procedures 
will be discussed.
-Oncologic Drugs Advisory Committee
    -Date, time, and place. April 19, 1996, 8:30 a.m., Holiday Inn--
Bethesda, Versailles Ballroom, 8120 Wisconsin Ave., Bethesda, MD.
    -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.; Adele S. Seifried, Center 
for Drug Evaluation and Research (HFD-21), 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), Oncologic Drugs Advisory Committee, 
code 12542.
    -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 the 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 April 12, 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: (1) New 
drug application (NDA) 20-671, HycamtinTM injection (topotecan 
HCl, SmithKline Beecham) for treatment of ovarian cancer after failure 
of first-line therapy; and (2) an update for the Committee on FDA 
Oncology activities, including the Cancer Liaison Program.
-National Mammography Quality Assurance Advisory Committee
    -Date, time, and place. April 23, 24, and 25, 1996, 9 a.m., 
Sheraton Hotel--Reston, rooms One and Two, 11810 Sunrise Valley Dr., 
Reston, VA. A limited number of overnight accommodations have been 
reserved at the hotel. Attendees requiring overnight accommodations may 
contact the hotel at 703-620-9000 and reference the FDA committee 
meeting block. Reservations will be confirmed at the group rate based 
on availability.
    -Type of meeting and contact person. Open public hearing, April 23, 
1996, 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.; open committee 
discussion, April 24, 1996, 9 a.m. to 1:15 p.m.; open subcommittee 
discussions, 1:15 p.m. to 5 p.m.; open committee discussion, April 25, 
1996, 9 a.m. to 5 p.m.; Charles K. Showalter, Center for Devices and 
Radiological Health (HFZ-240), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-594-3332, or FDA Advisory 
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), National Mammography Quality Assurance Advisory 
Committee, code 12397.
    -General function of the committee. The committee advises on 
developing appropriate quality standards and regulations for the use of 
mammography facilities.
    -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 16, 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 April 23, 24, and 25, 1996, the 
committee will discuss the proposed regulations under the Mammography 
Quality Standards Act (the MQSA) of 1992. Copies of the proposed 
regulations will publish in the Federal Register in the near future and 
may be obtained by submitting a written request to the MQSA, c/o 
SciComm, P.O. Box 30224, Bethesda, MD, 20824-9998, or faxing a request 
to 301-986-8015. On April 25, 1996, the committee will discuss the 
ongoing work of the three subcommittees: Access to Mammography 
Services, Physicists Availability, and Cost Benefit of Compliance.
    -Open subcommittee discussion. On April 24, 1996, the three 
subcommittees will meet concurrently. The subcommittees will discuss 
information which is necessary to make the determinations and 
subsequently prepare the reports as mandated in the MQSA. Upon 
completion, the subcommittee reports will be reviewed by the committee 
prior to submission to the Secretary of Health and Human Services and 
Congress.
    FDA public advisory committee meetings 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

[[Page 10771]]
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. There are no closed portions for the 
meetings announced in this notice. The dates and times reserved for the 
open 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.
    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: March 11, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-6373 Filed 3-14-96; 8:45 am]
BILLING CODE 4160-01-F