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.
32448 Federal Register / Vol. 61, No. 122 / Monday, June 24, 1996 / Notices

SUPPLEMENTARY INFORMATION: In the

Federal Register of March 6, 1996 (61

FR 8961), FDA announced 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)’’ also

referred to as ‘‘Draft Guidance for

Industry in Designing Clinical Programs

for Developing Human Drugs, Medical

Devices, or Biological Products Intended

for the Treatment of Rheumatoid

Arthritis.’’ The agency also announced

that it was holding a public workshop

on March 27, 1996, to discuss the draft

guidance. The agency is now

announcing a second public workshop

to discuss the draft guidance as it

pertains to JRA.

New treatment modalities being

developed for JRA may have beneficial

effects that are different from traditional

agents. However, uncertainty exists

among experts in rheumatology clinical

trials about the types of labeling claims

that might be reasonably pursued for

these agents and what evidence would

be necessary to support such claims. In

addition, there is a need to discuss

endpoints for JRA trials, and whether

functional/quality-of-life or

radiographic claims are appropriate.

FDA, through its Rheumatology

Working Group, has developed a draft

guidance document for industry that

provides an overview of some design

problems that are encountered in JRA

trials intended for product

development. FDA is sponsoring a

public workshop to provide an

opportunity for experts in rheumatology

clinical trials and interested

representatives of industry, academia,

and the public to discuss the working

draft of the guidance document and to

exchange ideas on developing and

assessing new treatment modalities for

JRA as well as the types of claims that

might be reasonably pursued and the

evidence necessary to support such

claims.

After consideration of all data,

information, or views submitted on the

draft guidance at the workshop, FDA

will issue a final guidance document

and announce its availability with a

notice published in the Federal

Register.

Dated: June 17, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–15991 Filed 6–21–96; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

National Institute of Mental Health;

Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meetings of the National Institute of

Mental Health Special Emphasis Panel:

Agenda Purpose: To review and evaluate

grant applications.

Committee Name: National Institute of

Mental Health Special Emphasis Panel.

Date: July 2, 1996.

Time: 3 p.m.

Place: Parklawn Building, Room 9C–26,

5600 Fishers Lane, Rockville, MD 20857.

Contact Person: Phyllis D. Artis, Parklawn

Building, Room 9C–26, 5600 Fishers Lane,

Rockville, MD 20857, Telephone: 301, 443–

6470.

Committee Name: National Institute of

Mental Health Special Emphasis Panel.

Date: July 3, 1996.

Time: 3 p.m.

Place: Parklawn Building, Room 9C–26,

5600 Fishers Lane, Rockville, MD 20857.

Contact Person: Phyllis D. Artis, Parklawn

Building, Room 9C–26, 5600 Fishers Lane,

Rockville, MD 2087, Telephone: 301, 443–

6470.

The meetings will be closed in

accordance with the provisions set forth

in secs. 552b(c)(4) and 552b(c)(6), Title

5, U.S.C. Applications and/or proposals

and the discussions could reveal

confidential trade secrets or commercial

property such as patentable materials

and personal information concerning

individuals associated with the

applications and/or proposals, the

disclosure of which would constitute a

clearly unwarranted invasion of

personal privacy.

This notice is being published less

than fifteen days prior to the meeting

due to the urgent need to meet timing

limitations imposed by the review and

funding cycle.

(Catalog of Federal Domestic Assistance

Program Numbers 93.242, 93.281, 93.282)

Dated: June 17, 1996.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 96–15931 Filed 6–21–96; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4056–N–02]

Office of the Assistant Secretary for

Policy Development and Research; FY

1996 Funding Availability for the

Community Outreach Partnership

Centers (COPC) Program: Notice of

Correction of Eligibility

AGENCY: Office of the Assistant

Secretary for Policy Development and

Research, HUD.

ACTION: FY 1996 funding availability;

notice of correction.

SUMMARY: On May 16, 1996, HUD

published a notice that announced the

availability of $7.4 million for the

Community Outreach Partnership

Centers program. The purpose of this

notice is to revise the eligibility criteria

for first-round COPC grantees applying

for Institutionalization Grants. The

notice also revises the amount set aside

for these grants.

DATES: The notice does NOT revise the

application deadline of July 25, 1996,

set forth in the May 16, 1996 Notice of

Funding Availability (NOFA).

FOR FURTHER INFORMATION CONTACT: Jane

Karadbil, Office of University

Partnerships, U.S. Department of

Housing and Urban Development, Room

8110, 451 Seventh Street, SW.,

Washington, DC 20410; telephone (202)

708–1537; (TTY (202) 708–0770, or 1–

800–877–8399). Other than the ‘‘800’’

number, these are not toll-free numbers.

SUPPLEMENTARY INFORMATION: On May

16, 1996, HUD published a notice that

announced the availability of $7.4

million in funding for the Community

Outreach Partnership Centers (COPC)

program. The NOFA added a new type

of grant under the program—

Institutionalization Grants—for which

only first-round (FY 1994) COPC

grantees are eligible to compete. The

NOFA placed two further conditions on

eligibility for these grants. First,

universities awarded Joint Community

Development (JCD) grants are not

eligible for Institutionalization Grants.

Second, institutions of higher education

that received grants as consortia in the

first-round are required to apply again

as consortia, with all current member

institutions participating in the

proposed Institutionalization Grant, and

with the same lead applicant as the

current COPC.

A problem has arisen with these two

criteria, which unfairly eliminates a

consortium from the competition. A

consortium, composed of three

universities, won a first-round grant.