[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