[Federal Register Volume 59, Number 244 (Wednesday, December 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-31296]
[[Page Unknown]]
[Federal Register: December 21, 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 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:
Nonprescription Drugs Advisory Committee
Date, time, and place. January 13, 1995, 8 a.m., Holiday Inn--
Bethesda, Versailles Ballrooms I and II, 8120 Wisconsin Ave., Bethesda,
MD.
Type of meeting and contact person. Open public hearing, 8 a.m. to
9 a.m., unless public participation does not last that long; open
committee discussion, 9 a.m. to 4 p.m.; Lee L. Zwanziger or Liz
Ortuzar, Center for Drug Evaluation and Research (HFD-9), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5455,
or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Nonprescription Drugs Advisory
Committee, code 12541.
General function of the committee. The committee reviews and
evaluates available data concerning the safety and effectiveness of
over-the-counter (nonprescription) human drug products for use in the
treatment of a broad spectrum of human symptoms and 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 6, 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 pediatric
dosing (use by children under 12 years of age) of over-the-counter
(OTC) drug products. The committee will address topics such as: (1)
What is the most preferred and practical basis for determining and
labeling OTC systemic pediatric dosages, e.g., age, weight, height
(length), body surface area, or a combination of these? (2) Is the
dosing approach (adult--1 full dose, children 6 to 12--\1/2\ adult
dose, and children 2 to 6--\1/4\ adult dose) currently being used for
most OTC oral drugs an adequate method of dosing? (3) Should there be
differences in systemic pediatric dosing ranges for specific
ingredients or different classes of OTC drug products? If yes, for
which specific ingredients or classes of products? (4) Should
calibrated dosage devices be required for (specific or all) pediatric
products? If yes, for which product(s) and how should they be
calibrated (e.g., devices expressing dosage levels in teaspoon or
milliliter units)? (5) What are the lowest limits (e.g., age, weight,
etc.) for which specific dosing instructions should appear in OTC
product labeling? Would these limits be different for certain classes
of OTC drugs, such as internal analgesics, antihistamines, etc.?
Elsewhere in this issue of the Federal Register, the agency is
announcing the availability of a summary information document for this
meeting.
National Task Force on Aids Drug Development
Date, time, and place. January 19, 1995, 8:30 a.m., Holiday Inn--
Bethesda, Versailles Ballrooms I through III, 8120 Wisconsin Ave.,
Bethesda, MD.
Type of meeting and contact person. Open task force discussion,
8:30 a.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; Jean H. McKay or
Kimberley M. Miles, Office of AIDS and Special Health Issues (HF-12),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-443-0104, or FDA Advisory Committee Information Hotline, 1-800-741-
8138 (301-443-0572 in the Washington, DC area), National Task Force on
AIDS Drug Development, code 12602.
General functions of the task force. The task force identifies any
barriers and provides creative options for the rapid development and
evaluation of treatments for human immunodeficiency virus (HIV)
infection and its sequelae. It also advises on issues related to such
barriers and provides options for the elimination of these barriers.
Open task force discussion. The task force will present, hear, and
discuss issues on the barriers to acquired immunodeficiency syndrome
(AIDS) drug development from the perspective of task force members,
members of the Federal Government, and the public. The task force will
determine how to proceed with overcoming the barriers to AIDS drug
development.
Agenda--Open public hearing. Interested persons may present data,
information, or views, orally or in writing, on issues pending before
the task force. Those desiring to make formal presentations should
notify the contact person before January 5, 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.
Endocrinologic and Metabolic Drugs Advisory Committee
Date, time, and place. January 19 and 20, 1995, 8:30 a.m., Holiday
Inn--Silver Spring, Plaza Ballroom, 8777 Georgia Ave., Silver Spring,
MD.
Type of meeting and contact person. Open committee discussion,
January 19, 1995, 8:30 a.m. to 5 p.m.; open public hearing, January 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 4 p.m.; Kathleen R.
Reedy, Center for Drug Evaluation and Research (HFD-9), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5455,
FAX 301-443-0699 or FDA Advisory Committee Information Hotline, 1-800-
741-8138 (301-443-0572 in the Washington, DC area), Endocrinologic and
Metabolic Drugs Advisory Committee, code 12536.
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 endocrine and metabolic
disorders.
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 12, 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 hear presentations
and discuss guidance criteria for the development of safe and effective
medications for the treatment of obesity.
Anesthesiology and Respiratory Therapy Devices Panel of the Medical
Devices Advisory Committee
Date, time, and place. January 20, 1995, 9 a.m., 9200 Corporate
Blvd., Main Conference Room, 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 301-590-0044 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, 9 a.m. to
10 a.m., unless public participation does not last that long; open
committee discussion, 10 a.m. to 4:30 p.m.; Michael G. Bazaral, Center
for Devices and Radiological Health (HFZ-450), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8610, or FDA Advisory Committee Information Hotline, 1-800-741-8138
(301-443-0572 in the Washington, DC area), Anesthesiology and
Respiratory Therapy Devices Panel, code 12624.
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, 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 general
issues relating to the review of a premarket approval application
supplement for a high frequency ventilator.
National Mammography Quality Assurance Advisory Committee
Date, time, and place. January 23, 24, and 25, 1995, 9 a.m., Dupont
Plaza Hotel, Embassy Room, 1500 New Hampshire Ave. NW., Washington, DC.
A limited number of overnight accommodations have been reserved at the
Dupont Plaza Hotel. Attendees requiring overnight accommodations may
contact the hotel at 202-483-6000 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 committee discussion,
January 23, 1995, 9 a.m. to 5 p.m.; open committee discussion, January
24, 1995, 9 a.m. to 5 p.m.; open public hearing, January 25, 1995, 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.; Charles K. Showalter,
Center for Devices and Radiological Health (HFZ-240), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3311, 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 January 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. The committee will discuss the draft
final standards for accreditation bodies and the draft final standards
for facilities. Specific topics to be discussed include: (1) Standards
for accreditation bodies, (2) personnel standards, (3) quality
assurance standards, (4) equipment standards, (5) medical audit and
mammography reports, (6) consumer complaint mechanism, and (7) implant
imaging.
Ophthalmic Devices Panel of the Medical Devices Advisory Committee
Date, time, and place. January 26, 1995, 8 a.m., 9200 Corporate
Blvd., Main Conference Room, Rockville, MD. A limited number of
overnight accommodations have been reserved at the Woodfin Suites, 1380
Piccard Dr., Rockville, MD. Attendees requiring overnight
accommodations may contact the hotel at 301-590-9880 and reference the
FDA Ophthalmic Devices Panel meeting block. Reservations will be
confirmed at the group rate based on availability.
Type of meeting and contact person. Open public hearing, 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.; 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 December 31, 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 the development of guidance on clinical studies for
extended wear contact lenses. There will also be a discussion of the
multifocal intraocular lens guidance document and announcements
concerning other intraocular implants and diagnostic and surgical
devices updates. The committee will review and recommend the
classification status for currently unclassified devices which may
include plastic contact lens cases, vision tester trainers,
epikeratophakia, intraocular lens folders, ophthalmic endoilluminators,
refractive lasers, therapeutic corneal lasers, and scanning laser
ophthalmoscopes.
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.
Dated: December 14, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-31296 Filed 12-20-94; 8:45 am]
BILLING CODE 4160-01-F