32446 Federal Register / Vol. 61, No. 122 / Monday, June 24, 1996 / Notices

therapy versus empiric therapy since

widespread empiric use may decrease

the drug’s potential usefulness for

treating MDR organisms. The agency

encourages investigators, academicians,

and members of the pharmaceutical

industry with information relevant to

the treatment of infections caused by

MDR organisms, including current

approaches to antimicrobial drug

development, 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

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

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: June 14, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 96–15942 Filed 6–21–96; 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:

Psychopharmacologic Drugs Advisory

Committee

Date, time, and place. July 15, 1996,

8:30 a.m., Holiday Inn—Silver Spring,

Main Ballroom, 8777 Georgia Ave.,

Silver Spring, 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.;

Kennerly Chapman, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 1901

Chapman Ave., rm. 200, Rockville, MD

20852, 301–443–5455, or FDA Advisory

Committee Information Hotline, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area),

Psychopharmacologic Drugs Advisory

Committee, code 12544. 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

marketed and investigational human

drugs for use in the practice of

psychiatry and related fields.

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 must notify the

contact person before July 10, 1996, 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 safety and

effectiveness of Serlect (sertindole),

new drug application (NDA) 20–644,

Abbott Laboratories, for use in the

treatment of psychotic disorders.

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
Federal Register / Vol. 61, No. 122 / Monday, June 24, 1996 / Notices 32447

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

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, 5600 Fishers Lane, rm.

12A–16, 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: June 14, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 96–15943 Filed 6–21–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96D–0067]

Guidance for Industry in Designing

Clinical Programs for Developing

Human Drugs, Medical Devices, or

Biological Products Intended for the

Treatment of Rheumatoid Arthritis;

Availability of Draft Guidance; Notice

of Public Workshop on Juvenile

Rheumatoid Arthritis

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance

document entitled ‘‘Discussion for

Designing Clinical Programs for

Developing Drugs, Devices, or Biological

Products Intended for the Treatment of

Rheumatoid Arthritis (RA).’’ On March

27, 1996, the agency held a public

workshop to discuss the draft guidance.

The agency is now announcing a second

public workshop to discuss the draft

guidance as it pertains to juvenile

rheumatoid arthritis (JRA). The draft

guidance was prepared by the

Rheumatology Working Group

comprised of members from: The Center

for Drug Evaluation and Research

(CDER), the Center for Biologics

Evaluation and Research, and the Center

for Devices and Radiological Health.

The workshop will enable experts in

rheumatology clinical trials and

interested representatives of industry,

academia, and the public to exchange

ideas on developing and assessing new

treatment modalities for JRA and to

discuss the types of claims that might be

reasonably pursued, and evidence

necessary to support such claims.

DATES: The public workshop will be

held Tuesday, July 23, 1996, from 8 a.m.

to 6 p.m. There is no registration fee for

the workshop, but registration is

requested before July 12, 1996.

Interested parties are encouraged to

register early because space is limited.

Written comments on the draft guidance

for consideration at the workshop

should be submitted by July 12, 1996.

The administrative docket will remain

open until August 30, 1996, for the

submission of written comments, data,

information, or views on the draft

guidance or the workshop.

ADDRESSES: The public workshop will

be held at the Holiday Inn— Bethesda,

Versailles III and IV, 8120 Wisconsin

Ave., Bethesda, MD 20814. Persons

interested in attending should Fax their

registration to Rose E. Cunningham at

301–594–5493. The Fax should include

the participant’s name and title;

organization name, if any; address; and

telephone and Fax numbers.

A copy of the draft guidance

document entitled ‘‘Discussion for

Designing Clinical Programs for

Developing Drugs, Devices, or Biological

Products Intended for the Treatment of

Rheumatoid Arthritis (RA)’’ is available

through CDER’s Fax-on-Demand, 301–

827–0577 or 800–342–2722, under the

index ‘‘Guidance to industry,’’

document no. 0806. The agenda for the

workshop is available as document no.

0504. The draft guidance, agenda, and

registration are also available on the

CDER Home Page on the World Wide

Web at http://www.fda.gov/cder/

jraworkshop.htm (these must be lower

case). A transcript of the workshop will

be available from the Freedom of

Information Office (HFI–35), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857,

approximately 15 business days after

the workshop at a cost of 10¢ per page.

Written comments on the draft

guidance or the workshop should be

submitted to the Dockets Management

Branch (HFA–305), 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. Received comments may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Rose

E. Cunningham, Center for Drug

Evaluation and Research (HFD–6), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

5470.