[Federal Register Volume 60, Number 120 (Thursday, June 22, 1995)]
[Notices]
[Pages 32529-32531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15240]



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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:
 Gastrointestinal Drugs Advisory Committee
     Date, time, and place. July 12, 1995, 9 a.m., Holiday Inn--
Bethesda, Versailles Ballroom, 8120 Wisconsin Ave., Bethesda, MD.
    Type of meeting and contact person. 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 5 p.m.; Joan C. Standaert, Center for 
Drug Evaluation and Research (HFD-180), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 419-259-6211, or Valerie M. 
Mealy, Advisors and Consultants Staff (HFD-9), 301-443-4695, or FDA 
Advisory Committee Information Hotline, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), Gastrointestinal Drugs Advisory Committee, 
code 12538.
     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 gastrointestinal 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 June 30, 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 new drug 
application (NDA) 20-458, Lemmon Co., zinc acetate to be indicated for 
use in Wilson's disease. The advisory committee will also consider 
draft ``Points to Consider'' from the Division of Anti-Infective Drug 
Products on Helicobacter pylori studies to prevent peptic ulcer 
recurrence.
National Mammography Quality Assurance Advisory Committee
     Date, time, and place. July 18 and 19, 1995, 9 a.m., Hyatt 
Regency--Bethesda, Cabinet-Judiciary Suite, One Bethesda Metro Center, 
Bethesda, MD. A limited number of overnight accommodations have been 
reserved at the hotel. Attendees requiring overnight accommodations may 
contact the hotel at 301-657-1234 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, July 18, 
1995, 9 a.m. to 10 a.m., unless public participation does not last that 
long; open subcommittee discussions, 10 a.m. to 5 p.m.; open 
subcommittee discussions, July 19, 1995, 9 a.m. to 2 p.m.; open 
committee discussion, 2 p.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 July 11, 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 July 19, 1995, the committee will 
discuss the ongoing work of the three subcommittees: Access to 
Mammography Services, Physicists Availability, and Cost Benefit of 
Compliance.
    Open subcommittee discussions. On July 18 and 19, 1995, the three 
subcommittees will meet concurrently. The subcommittees will discuss 
the ongoing work which is necessary to make the determinations and 
subsequently prepare the reports as mandated in the Mammography Quality 
Standards Act. Upon completion, the subcommittee reports will be 
reviewed by the committee prior to submission to the Secretary of 
Health and Human Services and Congress.
 Ophthalmic Devices Panel of the Medical Devices Advisory Committee
     Date, time, and place. July 20 and 21, 1995, 8:30 a.m., Bethesda 
Pooks Hill Marriott, Congressional Ballroom, 5151 Pooks Hill Rd., 
Bethesda, MD. A limited number of overnight accommodations have been 
reserved at the hotel. Attendees requiring overnight accommodations may 
contact the hotel at 301-897-9400 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, July 20, 
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.; open public 
hearing, July 21, 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 12 m.; Sara M. Thornton, Center for Devices and Radiological 
Health [[Page 32530]] (CDRH) (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 July 7, 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 July 20, 1995, the Division of 
Ophthalmic Devices will propose a redraft of the myopia refractive 
laser guidance document and request discussion and comments from the 
public and the panel and panel recommendations on designated sections. 
Single copies of the proposed redraft are available from Sara M. 
Thornton (address above). On July 21, 1995, the Contact Lens Branches 
will present an overview of the draft premarket notification (510(k)) 
guidance document for lens care products to be used as a special 
control for reclassification of contact lens care products. The 
committee will discuss and recommend the classification status for 
vision trainers. There will also be general updates from the Contact 
Lens Branches, Intraocular Implants Branch, and Diagnostic and Surgical 
Devices Branch within CDRH.
Oncologic Drugs Advisory Committee
     Date, time, and place. July 24 and 25, 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, July 24, 
1995, 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.; open committee 
discussion, July 25, 1995, 8 a.m. to 11:30 a.m.; Adele S. Seifried, 
Center for Drug Evaluation and Research (HFD-9), 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 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 July 19, 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 July 24, 1995, the committee will 
discuss: (1) NDA 20-036, Aredia (pamidronate disodium for 
injection, Ciba Pharmaceuticals Division, Ciba-Geigy Corp.), ``for the 
treatment of bone metastases associated with multiple myeloma,'' and 
(2) NDA 20-509, Gemzar (gemcitabine hydrochloride, Eli 
Lilly), ``as first line treatment for patients with advanced 
(nonresectable Stage II or Stage III) or metastatic (Stage IV) 
adenocarcinoma of the pancreas,'' and ``for patients with 5-FU-
refractory pancreatic cancer.'' On July 25, 1995, the committee will 
discuss product license application PLA 94-0799 IntronA, 
(interferon alpha 2b, recombinant, Schering, Inc.), for ``post-
operative adjuvant therapy in malignant melanoma.''
    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 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.

    [[Page 32531]] Dated: June 13, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-15240 Filed 6-21-95; 8:45 am]
BILLING CODE 4160-01-F