[Federal Register Volume 59, Number 73 (Friday, April 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9243]
[[Page Unknown]]
[Federal Register: April 15, 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 is in the process of implementing a voice mail telephone
system which will allow the public to obtain information regarding
advisory committee meetings. The public will be able to access the use
of this information by calling 1-800-741-8138. The projected
implementation date is May 1, 1994.
MEETINGS: The following advisory committee meetings are announced:
National Mammography Quality Assurance Advisory Committee
Date, time, and place. May 2, 1994, 9:30 a.m., and May 3 and 4,
1994, 9 a.m., Grand Ballroom, Holiday Inn, Two Montgomery Village Ave.,
Gaithersburg, MD. A limited number of overnight accommodations have
been reserved at the Holiday Inn. Attendees requiring overnight
accommodations must contact the hotel at 301-948-8900 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, May 2,
1994, 9:30 a.m. to 10:30 a.m., unless public participation does not
last that long; open committee discussion, 10:30 a.m. to 5:30 p.m.;
open committee discussion, May 3, 1994, 9 a.m. to 5 p.m.; open
committee discussion, May 4, 1994, 9 a.m. to 5 p.m.; Charles K.
Showalter, Center for Devices and Radiological Health (HFZ-240), Food
and Drug Administration, 1901 Chapman Ave., Rockville, MD 20857, 301-
594-3311.
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 27, 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. On May 2 through 4, 1994, the committee
will discuss the interim final standards for accreditation bodies and
the interim final standards for facilities. Specific topics to be
discussed include: (1) The Mammography Quality Standards Act (MQSA)
inspection process, (2) mammography report requirements, (3) clinical
outcomes audit requirements, (4) MQSA inspector qualifications, and (5)
stereotactic unit and personnel requirements.
General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee
Date, time, and place. May 6, 1994, 8 a.m., Admiralty Ballroom,
Stouffer Concourse Hotel, 2399 Jefferson Davis Hwy., Arlington, VA.
Type of meeting and contact person. Open public hearing, May 6,
1994, 8 a.m. to 10 a.m., unless public participation does not last that
long; open committee discussion, 10 a.m. to 5 p.m.; Wolf Sapirstein,
Center for Devices and Radiological Health (HFZ-450), Food and Drug
Administration, 1390 Piccard Dr., Rockville, MD 20850, 301-594-2717.
General function of the committee. The committee reviews and
evaluates available 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 April 29, 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 the draft
revision of a guidance document on the content and organization of a
premarket notification (510(k)) for medical laser devices. Copies of
the draft document can be obtained by contacting Kathy Pointer,
Sociometrics at 1-800-729-0890 or FAX 301-608-3542.
Food Advisory Committee
Date, time, and place. May 9 and 10, 1994, 8:30 a.m., Capitol
Hilton, South American Room (A and B), 16th and K St. NW., Washington,
DC 20024.
Type of meeting and contact person. Open committee discussion, May
9, 1994, 8:30 a.m. to 4 p.m.; open public hearing, 4 p.m. to 5 p.m.
unless public participation does not last that long; open working group
discussions, May 10, 1994, 8:30 a.m. to 4:30 p.m.; Lynn A. Larsen,
Center for Food Safety and Applied Nutrition (HFS-5), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, 202-205-4727, or
Catherine M. DeRoever, Advisory Committee Staff (HFS-22), 202-205-4251,
FAX 202-205-4970.
General function of the committee. The committee provides advice
on emerging food safety, food science, and nutrition issues that FDA
considers of primary importance in the next decade.
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 by close of business April 28, 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. If necessary, comments may be limited to 5
minutes.
Open committee discussion. On May 9, 1994, the committee will be
briefed on current high priority activities in the Center for Food
Safety and Applied Nutrition. On May 10, 1994, the committee will
continue with its working group discussions on: (1) The agency's food
research activities, (2) the scientific and technical expertise needed
to support the agency's regulatory mission, and (3) the criteria for
risk-based inspections.
Joint Meeting of the Veterinary Medicine and Anti-Infective Drugs
Advisory Committees
Date, time, and place. May 11 and 12, 1994, 8 a.m., Grand Ballroom,
Holiday Inn, Two Montgomery Village Ave., Gaithersburg, MD.
Type of meeting and contact person. Open committee discussion, May
11, 1994, 8 a.m. to 3:30 p.m.; open public hearing, 3:30 p.m to 5:30
p.m., unless public participation does not last that long; open
committee discussion, May 12, 1994, 8 a.m. to 4:30 p.m.; Gary E.
Stefan, Center for Veterinary Medicine (HFV-244), 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1769.
General functions of the committees. The Veterinary Medicine
Advisory Committee reviews and evaluates available data concerning
safety and effectiveness of marketed and investigational new animal
drugs, feeds, and devices for use in the treatment and prevention of
animal disease and increased animal production. The Anti-Infective
Drugs Advisory Committee reviews and evaluates data relating to the
safety and effectiveness of marketed and investigational human drugs
for use in infectious and ophthalmic 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 May 4, 1994, and submit a brief
statement of the general nature of the evidence or argument 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 May 11 and 12, 1994, the committees
will discuss the relative benefits and risks to animals and humans of
the use of fluoroquinolones in food animals, in light of possible
concerns about microbial resistance to fluoroquinolones.
Antiviral Drugs Advisory Committee
Date, time, and place. May 20, 1994, 7:30 a.m., Parklawn Bldg.,
conference rms. D and E, 5600 Fishers Lane, Rockville, MD.
Type of meeting and contact person. Open committee discussion, 7:30
a.m. to 11 a.m.; open public hearing, 11 a.m. to 12 m., unless public
participation does not last that long; open committee discussion, 12 m.
to 4 p.m.; Lee L. Zwanziger or Valerie Mealy, Center for Drug
Evaluation and Research (HFD-9), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-4695.
General function of the committee. The committee reviews and
evaluates available data concerning the safety and effectiveness of
marketed and investigational human drug products for use in the
treatment of acquired immune deficiency syndrome (AIDS), AIDS-related
complex (ARC), and other viral, fungal, and mycobacterial infections.
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 a contact person before May 13, 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 data
submitted regarding new drug applications (NDA's) 20-412 and 20-413 for
Zerit (stavudine or D4T, Bristol-Myers Squibb) for the
treatment of human immunodeficiency virus (HIV) infection.
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: April 13, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-9243 Filed 4-14-94; 8:45 am]
BILLING CODE 4160-01-F
