24318 Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Notices

1. The date an exemption under

section 505(i) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 355(i))

became effective: March 11, 1989. FDA

has verified the applicant’s claim that

the date that the investigational new

drug application (IND) became effective

was March 11, 1989.

2. The date the application was

initially submitted with respect to the

human drug product under section

505(b) of the Federal Food, Drug, and

Cosmetic Act: December 10, 1993. FDA

has verified the applicant’s claim that

the new drug application (NDA) for

TRUSOPT (NDA 20–408) was initially

submitted on December 10, 1993.

3. The date the application was

approved: December 9, 1994. FDA has

verified the applicant’s claim that NDA

20–408 was approved on December 9,

1994.

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.

However, the U.S. Patent and

Trademark Office applies several

statutory limitations in its calculations

of the actual period for patent extension.

In its application for patent extension,

this applicant seeks 1,232 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before July 15, 1996, submit to the

Dockets Management Branch (address

above) written comments and ask for a

redetermination. Furthermore, any

interested person may petition FDA, on

or before November 12, 1996, 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: April 26, 1996.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 96–12093 Filed 5–13–96; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[ORD–086–N]

New and Pending Demonstration

Project Proposals Submitted Pursuant

to Section 1115(a) of the Social

Security Act: February and March 1996

AGENCY: Health Care Financing

Administration (HCFA).

ACTION: Notice.

SUMMARY: This notice lists new

proposals for Medicaid demonstration

projects submitted to the Department of

Health and Human Services during the

months of February and March 1996

under the authority of section 1115 of

the Social Security Act. This notice also

lists proposals that were approved,

disapproved, pending, or withdrawn

during this time period. (This notice can

be accessed on the Internet at HTTP://

WWW.HCFA.GOV/ORD/

ORDHP1.HTML.)

COMMENTS: We will accept written

comments on these proposals. We will,

if feasible, acknowledge receipt of all

comments, but we will not provide

written responses to comments. We

will, however, neither approve nor

disapprove any new proposal for at least

30 days after the date of this notice to

allow time to receive and consider

comments. Direct comments as

indicated below.

ADDRESSES: Mail correspondence to:

Susan Anderson, Office of Research and

Demonstrations, Health Care Financing

Administration, Mail Stop C3–11–07,

7500 Security Boulevard, Baltimore, MD

21244–1850.

FOR FURTHER INFORMATION CONTACT:

Susan Anderson, (410) 786–3996.

SUPPLEMENTARY INFORMATION:

I. Background

Under section 1115 of the Social

Security Act (the Act), the Department

of Health and Human Services (HHS)

may consider and approve research and

demonstration proposals with a broad

range of policy objectives. These

demonstrations can lead to

improvements in achieving the

purposes of the Act.

In exercising her discretionary

authority, the Secretary has developed a

number of policies and procedures for

reviewing proposals. On September 27,

1994, we published a notice in the

Federal Register (59 FR 49249) that

specified (1) The principles that we

ordinarily will consider when

approving or disapproving

demonstration projects under the

authority in section 1115(a) of the Act;

(2) the procedures we expect States to

use in involving the public in the

development of proposed demonstration

projects under section 1115; and (3) the

procedures we ordinarily will follow in

reviewing demonstration proposals. We

are committed to a thorough and

expeditious review of State requests to

conduct such demonstrations.

As part of our procedures, we publish

a notice in the Federal Register with a

monthly listing of all new submissions,

pending proposals, approvals,

disapprovals, and withdrawn proposals.

Proposals submitted in response to a

grant solicitation or other competitive

process are reported as received during

the month that such grant or bid is

awarded, so as to prevent interference

with the awards process.

II. Listing of New, Pending, Approved,

and Withdrawn Proposals for the

Months of February and March 1996

A. Comprehensive Health Reform

Programs

1. New Proposals: The following

comprehensive health reform proposal

was received during the month of

February.

Demonstration Title/State: Medicaid

Demonstration Project for Los Angeles

County—California.

Description: The State is pursuing a

section 1115 demonstration designed to

stabilize the Los Angeles County health

care system, and to foster a restructuring

process that is responsive to the needs

of the community in the development of

a more cost effective system.

Date Received: February 29, 1996.

State Contact: John Rodriguez, Deputy

Director, Medical Care Services,

Department of Health Services, 714/744

P Street, P.O. Box 942732, Sacramento,

CA 94234–7320, (916) 654–0391.

Federal Project Officer: Gina Clemons,

Health Care Financing Administration,

Office of Research and Demonstrations,

Office of State Health Reform

Demonstrations, Mail Stop C3–18–26,

7500 Security Boulevard, Baltimore, MD

21244–1850.

No new proposals were received

during the month of March.

2. Pending, Approved, and

Withdrawn Proposals: We did not

approve or disapprove any proposals

during February or March nor were any

proposals withdrawn during those

months. The one new pending proposal

added to the month of March is:

Medicaid Demonstration Project for Los

Angeles County—California. See above

II.A.1. for further description. Pending

proposals for the month of November

1995 published in the Federal Register

on January 23, 1996, 61 FR 1769, remain

unchanged with the addition of above

for the months of February and March.
Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Notices 24319

B. Other Section 1115 Demonstration

Proposals

1. New Proposals: The following new

proposal was received during the month

of February.

Demonstration Title/State: Wisconsin

Partnership Program—Wisconsin.

Description: Wisconsin has submitted

Medicare section 222 demonstration

and Medicaid section 1115 waiver

requests to implement the ‘‘Wisconsin

Partnership Program’’ in specific

counties of the State. This program will

test two innovative models of care, one

for frail elderly and one for persons with

disabilities, utilizing a multidisciplinary team to manage care. The

team is to include the beneficiary, a

nurse practitioner, the beneficiary’s

choice of primary care physician, and a

social worker or independent living

coordinator. Consumer choice of care,

settings and the manner of service

delivery is a key component of the

program. The demonstration will test

the use of consumer-defined quality

indicators to measure and improve the

quality of service provided to people

who are elderly and people with

disabilities.

Date Received: February 28, 1996.

State Contact: Mary Rowin, State of

Wisconsin, Department of Health and

Social Services, 1 West Wilson Street,

P.O. Box 7850, Madison, WI 53707,

(608) 261–8885.

Federal Contact: William Clark,

Health Care Financing Administration,

Office of Research and Demonstrations,

Office of Beneficiary and Program

Research and Demonstrations, Mail Stop

C3–21–06, 7500 Security Boulevard,

Baltimore, MD 21244–1850.

No new proposals were received in

March.

2. Pending, Approved, and

Withdrawn Proposals: We did not

approve or disapprove any

Comprehensive Health Reform Programs

or Other Section 1115 Demonstration

Proposals during February or March nor

were any proposals withdrawn during

those months. The one new pending

proposal added to the month of March

is: Wisconsin Partnership Program—

Wisconsin. See above II.B.1. for further

description. Pending proposals for the

month of November 1995 published in

the Federal Register on January 23,

1996, 61 FR 1769, remain unchanged

with the addition of above for the

months of February and March.

III. Requests for Copies of a Proposal

Requests for copies of a specific

Medicaid proposal should be made to

the State contact listed for the specific

proposal. If further help or information

is needed, inquiries should be directed

to HCFA at the address above.

(Catalog of Federal Domestic Assistance

Program, No. 93.779; Health Financing

Research, Demonstrations, and Experiments.)

Dated: April 24, 1996.

Barbara Cooper,

Acting Director, Office of Research and

Demonstrations.

[FR Doc. 96–12018 Filed 5–13–96; 8:45 am]

BILLING CODE 4120–01–P

Health Resources and Services

Administration

Advisory Council; Notice of Meetings

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Public Law 92–463), announcement is

made of the following National

Advisory bodies scheduled to meet

during the month of June 1996.

Name: National Advisory Council on the

National Health Service Corps.

Date and Time: June 6–9, 1996.

Place: Adams Mark Denver Hotel, 1550

Court Place, Denver, Colorado.

The meeting is open to the public.

Agenda: Agenda items include status of

NHSC programs and budget, reports on the

NHSC alumni study and the NHSC alumni

and support network, meetings of NHSC

workgroups on State activities, health

systems liaison, and alliance development,

and site visits to community health centers

in the Denver area.

The meeting will begin on Thursday, June

6 at 4:00 p.m. and adjourn at 8:00 p.m. Site

visits will occur on Friday morning followed

by an afternoon business meeting which will

conclude about 5:00 p.m. On Saturday, the

meeting will begin at 8:00 a.m. and adjourn

at 5:00 p.m. and Sunday’s meeting will begin

at 8:00 a.m. and adjourn at 12:00 noon.

The meeting is open to the public;

however, no transportation will be provided

for the site visits. For further information,

call Ms. Jewel Davis at (301) 594–4144.

Anyone requiring information

regarding the subject Council should

contact Ms. Jewel Davis, National

Advisory Council on the National

Health Service Corps, 8th floor, 4350

East West Highway, Rockville,

Maryland 20857, Telephone (301) 594–

4144.

Name: Council on Graduate Medical

Education.

Date and Time: June 12, 1996, 1:00 p.m.–

5:00 p.m.; June 13, 1996, 8:30 a.m.–4:00 p.m.

Place: Omni Shoreham Hotel, 2500 Calvert

Street, N.W., Washington, D.C. 20008.

This meeting is open to the Public.

Agenda: The agenda will include two

plenary panels to discuss (1) Minorities in

Medicine and (2) Medical Education

Consortia. There will be reports and updates

on the Work Groups: Minorities in Medicine;

Geographic Distribution/Medical Education

Consortia; Physician Competencies in a

Managed Care World; and IMG entry and

Participation in the physician workforce.

Anyone requiring information

regarding the subject should contact F.

Lawrence Clare, M.D., M.P.H., Deputy

Executive Secretary, telephone (301)

443–6326, Council on Graduate Medical

Education, Division of Medicine,

Bureau of Health Professions, Health

Resources and Service Administration,

Room 9A–27, Parklawn Building, 5600

Fishers Lane, Rockville, Maryland

20857.

Agenda Items are subject to change as

priorities dictate.

Dated: May 9, 1996.

Jackie E. Baum,

Advisory Committee Management Officer,

HRSA.

[FR Doc. 96–12094 Filed 5–13–96; 8:45 am]

BILLING CODE 4160–15–P

National Institutes of Health

National Cancer Institute; Notice of

Closed Meeting

Notice is hereby given of the meeting

of the National Cancer Institute Board of

Scientific Advisors Cancer Centers

Program Working Group, May 24, 1996

at the Crystal City Marriott, 1999

Jefferson Davis Highway, Arlington, VA.

This meeting will be closed to the

public from 8:30 am to adjournment for

discussion of confidential issues

relating to the review, discussion and

evaluation of individual programs and

projects conducted by the Cancer

Centers Extramural Program. These

discussions will reveal confidential

trade secrets or commercial property

such as patentable material, and

personal information including

consideration of personnel

qualifications and performance, the

competence of individual investigators

and similar matters, the disclosure of

which would constitute a clearly

unwarranted invasion of personal

privacy.

Information pertaining to the meeting

may be obtained from Dr. Paulette Gray,

Executive Secretary, National Cancer

Institute Board of Scientific Advisors,

National Cancer Institute, 6130

Executive Blvd., EPN, Rm. 600,

Bethesda, MD 20892, (301–496–4218).

Dated: May 8, 1996.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 96–12059 Filed 5–13–96; 8:45 am]

BILLING CODE 4140–01–M