764 Federal Register / Vol. 62, No. 3 / Monday, January 6, 1997 / Notices

any interested person may petition FDA,

on or before July 7, 1997, for a

determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period. To meet its burden, the petition

must contain sufficient facts to merit an

FDA investigation. (See H. Rept. 857,

part 1, 98th Cong., 2d sess., pp. 41–42,

1984.) Petitions should be in the format

specified in 21 CFR 10.30.

Comments and petitions should be

submitted to the Dockets Management

Branch (address above) in three copies

(except that individuals may submit

single copies) and identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: November 25, 1996.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–138 Filed 1–3–97; 8:45 am]

BILLING CODE 4160–01–F

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:

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 AntiInfective 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 healthcare 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.
Federal Register / Vol. 62, No. 3 / Monday, January 6, 1997 / Notices 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

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces a

forthcoming meeting of a public

advisory committee of the Food and

Drug Administration (FDA). This notice

also summarizes the procedures for the

meeting 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.

MEETING: The following advisory

committee meeting is announced: