[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