[Federal Register Volume 60, Number 77 (Friday, April 21, 1995)]
[Notices]
[Pages 19949-19951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9889]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Advisory Committees; Notice of Meetings
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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:
Subcommittee Meeting of the Food Advisory Committee -
Date, time, and place. May 8 and 9, 1995, 8:30 a.m., Days Inn--
Downtown Convention Center, Franklin Square I Ballroom, 1201 K St. NW.,
Washington, DC.
Type of meeting and contact person. Open subcommittee discussion,
May 8, 1995, 8:30 a.m. to 5:15 p.m.; open subcommittee discussion, May
9, 1995, 8:30 a.m. to 10 a.m.; open public hearing, 10 a.m. to 11 a.m.,
unless public participation does not last that long; open subcommittee
discussion, 11 a.m. to 2 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, Catherine M. DeRoever,
Advisory Committee Staff (HFS-22), 202-205-4251, FAX 202-205-4970, or
FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Food Advisory Committee, code 10564.
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 May 1, 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. If necessary, comments may be limited to 5 minutes.-
Open committee discussion. The subcommittee will review the Center
for Food Safety and Applied Nutrition's Microbiology Research Program
in the context of the Center's science program. A peer review panel
will be asked to present its findings to the subcommittee. More
detailed information regarding the meeting agenda that may become
available prior to the meeting will be provided to the public via the
800 number listed above.
Circulatory System Devices Panel of the Medical Devices Advisory
Committee
Date, time, and place. May 8 and 9, 1995, 8:30 a.m., Holiday Inn--
Gaithersburg, Walker and Whetstone Ballrooms, Two Montgomery Village
Ave., Gaithersburg, MD. A limited number of overnight accommodations
have been reserved at the Holiday Inn--Gaithersburg. Attendees
requiring overnight accommodations may 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 8,
1995, 8:30 a.m. to 9:30 a.m., unless public
[[Page 19950]] participation does not last that long; open committee
discussion, 9:30 a.m. to 4:30 p.m.; open public hearing, May 9, 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 4:30 p.m.; Ramiah
Subramanian, Center for Devices and Radiological Health (HFZ-450), Food
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850,
301-443-8320, or FDA Advisory Committee Information Hotline, 1-800-741-
8138 (301-443-0572 in the Washington, DC area), Circulatory System
Devices Panel, code 12625.
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 April 28, 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 four premarket approval applications;
on May 8, 1995, the committee will discuss two hemostasis devices and
on May 9, 1995, two pacemaker devices.
Veterinary Medicine Advisory Committee
Date, time, and place. May 10 and 11, 1995, 8:30 a.m., Holiday
Inn--Bethesda, Versailles Ballroom III, 8120 Wisconsin Ave., Bethesda,
MD.
Type of meeting and contact person. Open committee discussion, May
10, 1995, 8:30 a.m. to 10:30 a.m.; open public hearing, 10:30 a.m. to 3
p.m., unless public participation does not last that long; open
committee discussion, 3 p.m. to 4:30 p.m.; open committee discussion,
May 11, 1995, 8:30 a.m. to 9:30 a.m.; open public hearing, 9:30 a.m. to
11 a.m., unless public participation does not last that long; open
committee discussion, 11 a.m. to 12 m.; Gary E. Stefan, Center for
Veterinary Medicine (HFV-244), 7500 Standish Pl., Rockville, MD 20855,
301-594-1769, or FDA Advisory Committee Information Hotline, 1-800-741-
8138 (301-443-0572 in the Washington, DC area), Veterinary Medicine
Advisory Committee, code 12546.
General function of the committee. The committee reviews and
evaluates available data concerning the 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.
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 9, 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 amount of time required to make their comments.
Open committee discussion. On May 10, 1995, the committee will
discuss veterinary medical issues related to implementation of the
Animal Medicinal Drug Use Clarification Act of 1994 (extra-label animal
drug use). On May 11, 1995, the committee will discuss options for
obtaining approvals for minor use (orphan) animal drugs.
Science Board to the Food and Drug Administration
Date, time, and place. May 16, 1995, 8:30 a.m., Holiday Inn--
Eisenhower Metro, Eisenhower Ballroom, 2460 Eisenhower Ave.,
Alexandria, VA.
Type of meeting and contact person. Open committee discussion, 8:30
a.m. to 2:30 p.m.; open public hearing, 2:30 p.m. to 3:30 p.m., unless
public participation does not last that long; open committee
discussion, 3:30 p.m. to 5 p.m.; Anita O'Connor, Office of Science (HF-
33), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-443-5839, or FDA Advisory Committee Information Hotline, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), Science Board
to the Food and Drug Administration, code 12603.
General function of the board. The board shall provide advice
primarily to the agency's Senior Science Advisor and, as needed, to the
Commissioner and other appropriate officials on specific complex and
technical issues as well as emerging issues within the scientific
community in industry and academia. Additionally, the board will
provide advice to the agency on keeping pace with technical and
scientific evolutions in the fields of regulatory science; on
formulating an appropriate research agenda; and on upgrading its
scientific and research facilities to keep pace with these changes. It
will also provide the means for critical review of agency sponsored
intramural and extramural scientific research programs.
Agenda--Open public hearing. Interested persons may present data,
information, or views, orally or in writing, on issues pending before
the board. Those desiring to make formal presentations must notify the
contact person before May 2, 1995, and submit a brief statement of the
general nature of the evidence or arguments they wish to present, and
the names and addresses of proposed participants. Each presenter will
be limited in time and not all requests to speak may be able to be
accommodated. All written statements submitted in a timely manner will
be provided to the board.
Open committee discussion. The board will discuss issues related to
the testing strategy for toxicity and carcinogenicity of substances
regulated by FDA. The discussion is designed to give the agency
direction for future program development.
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 [[Page 19951]] 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 17, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-9889 Filed 4-20-95; 8:45 am]
BILLING CODE 4160-01-F
