[Federal Register Volume 62, Number 3 (Monday, January 6, 1997)]
[Notices]
[Pages 764-765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-92]
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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:
Joint Meeting of the Nonprescription Drugs and Anti-Infective Drugs
Advisory Committees
Date, time, and place. January 22, 1997, 8:30 a.m., Holiday Inn--
Gaithersburg, Grand Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD.
Type of meeting and contact person. Open public hearing, 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.; Ermona B. McGoodwin or
Danyiel A. D'Antonio, Center for Drug Evaluation and Research (HFD-21),
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, or Anti-Infective Drugs Advisory
Committee, code 12530. Please call the hotline for information
concerning any possible changes.
General function of the committee. The Nonprescription Drugs
Advisory 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. The Anti-Infective Drugs Advisory Committee
reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of infectious diseases and 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 13, 1997, 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 joint committees will discuss issues
relating to a health-care continuum model. In the Federal Register of
June 17, 1994 (59 FR 31402 through 31452) the agency published a
proposed rule for OTC health-care antiseptic drug products, i.e.,
patient preoperative skin preparations, surgical hand scrubs, and
health-care personnel and antiseptic handwashes. In response to the
proposed rule, the agency received a number of requests to consider a
health-care continuum as a model for the regulation of OTC health-care
antiseptic drug products. The proposed model defines six drug product
categories (preoperative skin preparation, surgical hand scrub, health-
care personnel handwash, food handler handwash, antimicrobial handwash,
and antimicrobial body wash) and proposes testing requirements, key
characteristics, and labeling for each of the categories. The model
also proposes that the public health impact of these products is the
lowest for consumer use products and continuously increases through the
model as follows: Antimicrobial hand washes, antimicrobial body washes,
food handler handwash, health-care personnel handwash, surgical hand
scrub, and preoperative skin preparation. Conversely, the model
proposes that the size of the population impacted by these products
continuously decreases from consumer use products to professional use
products. FDA is seeking an evaluation of the model's impact on public
health in light of the isolation of pathogenic bacteria-bearing
plasmids encoding for both topical antiseptic and multiple antibiotic
resistance and is soliciting the advice and opinions from the advisory
committees on this issue. The agency encourages investigators,
academicians, and manufacturers of these products to respond to this
notice with information bearing on this issue and to present their
views on this issue before the committees.
A Joint Meeting of the Nonprescription Drugs Advisory Committee and the
Cardiovascular and Renal Drugs Advisory Committee
Date, time, and place. January 23, 1997, 8:30 a.m., Holiday Inn--
Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD.
Type of meeting and contact person. Open public hearing, 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.; Tracy K. Riley or Joan C.
Standaert, Center for Drug Evaluation and Research (HFD-21), 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, or Cardiovascular and Renal Drugs
Advisory Committee, code 12533. Please call the hotline for information
concerning any possible changes.
[[Page 765]]
General function of the committee. The Nonprescription Drugs
Advisory 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. The Cardiovascular and Renal Drugs Advisory
Committee reviews and evaluates data on the safety and effectiveness of
marketed and investigational human drugs for used in cardiovascular and
renal 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 8, 1997, 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 committees will jointly discuss
issues relevant to professional labeling indications for aspirin. A
citizen petition requested that the Commissioner of Food and Drugs
approve various vascular professional labeling indications for aspirin.
FDA has already acted on some of the issues raised, while others have
not been resolved. FDA is now soliciting advice and opinions from the
advisory committees regarding the use of aspirin for expanded
professional labeling indications for aspirin. Issues to be discussed
include the use of aspirin in patients deemed to be at elevated risk of
cardiovascular events due to some form of vascular disease or other
conditions implying an increased risk of occlusive vascular disease
(i.e., patients undergoing coronary, cerebral, or peripheral arterial
revascularization procedures; patients with chronic nonvalvular atrial
fibrillation; patients requiring hemodialysis access with a fistula or
shunt; patients with chronic stable angina; and other patients deemed
to be at elevated risk). The agency encourages investigators,
academicians, and members of the pharmaceutical industry with
information about the use of aspirin in patients at increased risk of
cardiovascular events to respond to this notice.
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 the meeting(s) 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, 12420 Parklawn Dr., rm. 1-23,
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 (a)(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 20, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-92 Filed 1-3-97; 8:45 am]
BILLING CODE 4160-01-F