[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]
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