Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Notices 7789

Food and Drug Administration

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:

Anti-Infective Drugs Advisory

Committee

Date, time, and place. March 5, 1997,

8:30 a.m., Bethesda Ramada, Embassy

Ballroom, 8400 Wisconsin Ave.,

Bethesda, MD, and March 6 and 7, 1997,

8:30 a.m., Holiday Inn—Bethesda,

Versailles Ballrooms I and III, 8210

Wisconsin Ave., Bethesda, MD. The

hotels are in close proximity and have

parking available. In addition, there is a

public parking garage nearby at 8216

Woodmont Ave.

Type of meeting and contact person.

Open public hearing, March 5, 1997,

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.; open committee discussion,

March 6, 1997, 8:30 a.m. to 5 p.m.; open

committee discussion, March 7, 1997,

8:30 a.m. to 2 p.m.; Ermona B.

McGoodwin or Danyiel 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), AntiInfective Drugs Advisory Committee,

code 12530. Please call the hotline for

information concerning any possible

changes.

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 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 February 28, 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. On the

morning of March 5, 1997, the

committee will discuss supplemental

new drug application (NDA) 50–679/

S002 Maxipime for Injection (cefepime

hydrochloride, Bristol-Myers Squibb), in

the treatment of febrile episodes in

neutropenic patients. In the afternoon of

March 5, 1997, and on March 6 and 7,

1997, the committee will discuss the

draft guidance document entitled

‘‘Evaluating Clinical Studies of

Antimicrobials in the Division of AntiInfective Drug Products,’’ which is

currently in the Draft-Not for

Implementation stage. Copies of this

draft guidance document can be

obtained 2 weeks before the meeting

from the Drug Information Branch,

Division of Communications

Management (HFD–210), Center for

Drug Evaluation and Research, Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

4573, FAX: 301–827–4577. An

electronic version of this draft guidance

document will be available 2 weeks

before the meeting via the World Wide

Web. To access the draft guidance

document on the Internet, connect to

CDER’s home page at http://

www.fda.gov/cder/guidance.htm.

FDA regrets that it was unable to

publish this notice 15 days prior to the

March 5, 6, and 7, 1997, Anti-Infective

Drugs Advisory Committee meeting.

Because the agency believes there is

some urgency to bring these issues to

public discussion and qualified

members of the Anti-Infective Drugs

Advisory Committee were available at

this time, the Commissioner concluded

that it was in the public interest to hold

this meeting even if there was not

sufficient time for the customary 15-day

public notice.

Science Board to the Food and Drug

Administration

Date, time, and place. March 13,

1997, 9 a.m. to 3 p.m., Sheraton

National Hotel, North Ballroom, 900

South Orme St. (Columbia Pike and

Washington Blvd.), Arlington, VA.

Type of meeting and contact person.

Open committee discussion, 9 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 3 p.m.; Susan A.

Homire, Office of Science (HF–33), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

3340, 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.

Please call the hotline for information

concerning any possible changes.

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 should notify the contact

person before March 3, 1997, 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

accommodated. All written statements

submitted in a timely fashion will be

provided to the board.

Open board discussion. The Science

Board Subcommittee on Toxicology,

which has been established to address
7790 Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Notices

issues related to toxicological testing

methods, will provide an update on its

activities. The Science Board

Subcommittee on FDA Research will

present a report to the board on a

strategy for optimizing the quality and

mission relevance of agency research

programs.

Vaccines and Related Biological

Products Advisory Committee

Date, time, and place. March 14,

1997, 12:30 p.m., National Institutes of

Health, Bldg. 29, conference room 121,

8800 Rockville Pike, Bethesda, MD.

Type of meeting and contact person.

This meeting will be held by a

telephone conference call. A speaker

telephone will be provided in the

conference room to allow public

participation in the meeting. Open

committee discussion, 12:30 p.m. to 2

p.m.; open public hearing, 2 p.m. to 3

p.m., unless public participation does

not last that long; Nancy T. Cherry or

Denise A. Royster, Center for Biologics

Evaluation and Research (HFM–21),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852,

301–827–0314, or FDA Advisory

Committee Information Hotline, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), Vaccines and

Related Biological Products Advisory

Committee, code 12388. Please call the

hotline for information concerning any

possible changes.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

vaccines intended for use in the

diagnosis, prevention, or treatment of

human diseases.

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 March 1, 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

committee will discuss the influenza

virus vaccine’s formulation for 1997 and

1998.

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: February 12, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–4305 Filed 2–18–97; 11:00 am]

BILLING CODE 4160–01–F

[Docket No. 97N–0042]

Review of the Adverse Event Reporting

System for Postmarketing

Surveillance; Public Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public meeting to provide the

pharmaceutical industry and other

interested persons with information on

the plans, progress, and technical

specifications developed under the

reengineering of the Center for Drug

Evaluation and Research’s (CDER’s)

postmarketing surveillance program.

The primary focus of the meeting will

be the electronic submission of adverse

drug reaction (ADR) reports under the

new adverse event reporting system

(AERS), which is currently under

development as a major component of

the reengineering effort.

DATES: The public meeting will be held

on Monday, March 17, 1997, from 9:30

a.m. to 5 p.m. There is no registration

fee for the meeting. Because space is

limited, interested persons are

encouraged to register by March 7, 1997.

ADDRESSES: The public meeting will

held at the DoubleTree Hotel, 1750

Rockville Pike, Rockville, MD 20852.

Persons interested in attending should

fax their registration to Robert Nelson at

301–480–2825. The facsimile should

include the participant’s name and title;

organization name, if any; address; and

telephone and fax numbers.

Three weeks prior to the public

meeting, a copy of the meeting agenda

will be available through CDER’s Faxon-Demand, 301–827–0577 or 800–342–