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availability of a draft guidance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referred to as ‘‘Draft Guidance for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to discuss the draft guidance as it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draft guidance at the workshop, FDA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.