2516 Federal Register / Vol. 61, No. 18 / Friday, January 26, 1996 / Notices

application. To meet this requirement,

the agency is providing notice that

Deprenyl Animal Health, Inc., 10955

Lowell, suite 710, Overland Park, KS

66210, has filed application number

8008 requesting approval for export of

the animal drug ANIPRYL (l-selegiline

hydrochloride, l-deprenyl

hydrochloride) tablets to Canada. The

drug is administered orally for the

treatment of uncomplicated canine

pituitary dependent

hyperadrenocorticism. The tablets are

not indicated for treatment of other

forms of Cushing’s syndrome. The

application was received and filed in

the Center for Veterinary Medicine on

January 4, 1996, which shall be

considered the filing date for purposes

of the act.

Interested persons may submit

relevant information on the application

to the Dockets Management Branch

(address above) in two copies (except

that individuals may submit single

copies) and identified with the docket

number found in brackets in the

heading of this document. These

submissions may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

The agency encourages any person

who submits relevant information on

the application to do so by February 5,

1996, and to provide an additional copy

of the submission directly to the contact

person identified above, to facilitate

consideration of the information during

the 30-day review period.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(sec. 802 (21 U.S.C. 382)) and under

authority delegated to the Commissioner

of Food and Drugs (21 CFR 5.10) and

redelegated to the Center for Veterinary

Medicine (21 CFR 5.44).

Dated: January 18, 1996.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center of Veterinary Medicine.

[FR Doc. 96–1321 Filed 1–25–96; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[ORD–078–N]

Medicare Program; Announcement of

Funding Availability for a Cooperative

Agreement for an End-Stage Renal

Disease (ESRD) Managed Care

Demonstration

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice is to inform

interested parties of an opportunity to

apply for funds for a cooperative

agreement from HCFA’s Office of

Research and Demonstrations for the

‘‘End-Stage Renal Disease (ESRD)

Managed Care Demonstration.’’

FOR FURTHER INFORMATION, CONTACT:

Bonnie Edington (410) 786–6617.

SUPPLEMENTARY INFORMATION:

I. Background

Section 2355 of the Deficit Reduction

Act of 1984 (Pub. L. 98–369) required

the Secretary to grant demonstration

waivers for social health maintenance

organization (SHMO) projects that

provide for the integration of health and

social services at a fixed annual prepaid

capitation rate.

Section 4207(b)(4)(B) of the Omnibus

Budget Reconciliation Act of 1990 (Pub.

L. 101–508) amended section 2355 of

Pub. L. 98–369 to include a requirement

that the Secretary conduct up to four

additional SHMO projects to

demonstrate the effectiveness and

feasibility of innovative approaches to

refining current targeting and financing

methodologies and benefit design for

SHMOs.

Section 13567(b) of the Omnibus

Budget Reconciliation Act (OBRA) of

1993 (Pub. L. 103–66) further amended

section 2355 of Pub. L. 98–369,

requiring the Secretary to include the

integration of acute and chronic care

management for patients with end-stage

renal disease through expanded

community care case management

services in at least one of the four

additional SHMO projects.

II. Provisions of this Notice

This notice is to inform interested

parties of the opportunity to apply for

funds for a cooperative agreement to

operate an ‘‘End-Stage Renal Disease

(ESRD) Managed Care Demonstration,’’

involving the treatment of Medicareeligible ESRD patients in a managed

care setting as required by OBRA 1993.

Interested parties are required to submit

an offical application for consideration

for grant funding and commencement of

site development activities. Subject to

funds availability, a one-time award of

approximately $175,000 is expected to

be given to each selected awardee.

HCFA expects to award one or more

demonstrations through the application

process.

Any organizational entity may apply.

However, the applicant must be capable

of assuring that the service delivery

system under the demonstration will

integrate acute and chronic care

services, through expanded community

care case management services, for

ESRD patients. In addition, the

applicant must meet all applicable State

requirements for bearing financial risk.

Awardees are expected to have a 9 to

12-month development period

subsequent to award and prior to service

delivery. In the three-year service

delivery phase of the demonstration,

awardees will be paid on a capitation

basis in which the capitation amount

will be adjusted to reflect treatment

status (that is, maintenance dialysis,

transplant, or functioning graft.

Potential applicants who wish to

request the full solicitation and

application packet should call Ms.

Edington at the above telephone

number, send an E–mail message to

BEDINGTON@HCFA.GOV, or write to

the following address: Bonnie Edington,

Health Care Financing Administration,

Office of Research and Demonstrations,

Mail Stop C3–24–07, 7500 Security

Boulevard, Baltimore, MD 21244–1850.

These packets will be mailed to all

requestors within approximately 10

days from the date of this notice.

Completed applications, including full

proposals, will be due approximately 70

days following the date of this notice.

The exact due date for applications will

be specified in the application packet.

Awards are expected to be made in

1996.

Authority: Section 402 of the Social

Security Amendments of 1967, as amended

(42 U.S.C. 1395b-1); section 222(a) of the

Social Security Amendments of 1972, as

amended (42 U.S.C. 1395–1(note)); section

2355 of the Deficit Reduction Act of 1984, as

amended; section 4207(b)(4)(B) of the

Omnibus Budget Reconciliation Act of 1990;

section 13567(b) of the Omnibus Budget

Reconciliation Act of 1993.

In accordance with the provisions of

Executive Order 12866, this notice was

reviewed by the Office of Management

and Budget.

(Catalog of Federal Domestic Assistance

Program No. 93.779 Health Financing

Research, Demonstrations and Experiments)

Dated: October 3, 1995.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

[FR Doc. 96–1261 Filed 1–25–96; 8:45 am]

BILLING CODE 4120–01–P

[BPO–134–NC]

Medicare Program; Revised Criteria

and Standards for Evaluating Durable

Medical Equipment, Prosthetics,

Orthotics, and Supplies Regional

Carriers’ Performance Beginning

February 1, 1996

AGENCY: Health Care Financing

Administration (HCFA), HHS.