Federal Register / Vol. 61, No. 18 / Friday, January 26, 1996 / Notices 2515

Dated: January 22, 1996.

Roberta Katson,

Director, Division of Information Resource

Management Services.

[FR Doc. 96–1339 Filed 1–25–96; 8:45 am]

BILLING CODE 4184–01–M

Centers for Disease Control and

Prevention

Injury Research Grant Review

Committee: Conference Call Meeting

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

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following conference call

committee meeting.

Name: Injury Research Grant Review

Committee (IRGRC).

Time and Date: 2 p.m.–5 p.m., February

12, 1996.

Place: National Center for Injury

Prevention and Control (NCIPC), CDC, Koger

Center, Vanderbilt Building, 1st Floor,

Conference Room 1006, 2939 Flowers Road,

South, Atlanta, Georgia 30341. (Exit

Chamblee-Tucker Road off I–85.)

Status: Open: 2 p.m.–2:15 p.m., February

12, 1996. Closed: 2:15 p.m.–5 p.m., February

12, 1996.

Purpose: This committee is charged with

advising the Secretary of Health and Human

Services, the Assistant Secretary for Health,

and the Director, CDC, regarding the

scientific merit and technical feasibility of

grant applications relating to the support of

injury control research projects and injury

prevention research centers.

Matters To Be Discussed: Agenda items for

the meeting will include announcements,

discussion of review procedures, future

meeting dates, and review of grant

applications.

Beginning at 2:15 p.m., through 5 p.m.,

February 12, the Committee will meet to

conduct a review of grant applications. This

portion of the meeting will be closed to the

public in accordance with provisions set

forth in section 552b(c) (4) and (6), title 5

U.S.C., and the Determination of the

Associate Director for Management and

Operations, CDC, pursuant to Pub. L. 92–463.

Agenda items are subject to change as

priorities dictate.

Contact Person for More Information:

Richard W. Sattin, M.D., Executive Secretary,

IRGRC, National Center for Injury Prevention

and Control, CDC, 4770 Buford Highway, NE,

M/S K58, Atlanta, Georgia 30341–3724,

telephone (770) 488–4580.

Dated: January 23, 1996.

Julia M. Fuller,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–1495 Filed 1–25–96; 8:45 am]

BILLING CODE 4163–18–M

Savannah River Site Environmental

Dose Reconstruction Project: Public

Workshops

The National Center for

Environmental Health (NCEH) of the

Centers for Disease Control and

Prevention (CDC) announces the

following meeting.

Name: Savannah River Site Environmental

Dose Reconstruction Project: Public

Workshops.

Date: Wednesday, February 14, 1996.

Time: 7 p.m.–9 p.m.

Place: Holiday Inn Express, 1350 Whiskey

Road, Aiken, South Carolina 29803.

Date: Thursday, February 15, 1996.

Time: 7 p.m.–9 p.m.

Place: Hilton—The DeSoto, 15 East Liberty

Street, Savannah, Georgia 31401.

Status: Open to the public for observation

and comment, limited only by the space

available. The meeting room will

accommodate approximately 50 people.

Background: Under a Memorandum of

Understanding (MOU) signed in December

1990 with the Department of Energy (DOE),

the Department of Health and Human

Services (HHS) has been given the

responsibility and resources for conducting

analytic epidemiologic investigations of

residents of communities in the vicinity of

DOE facilities and other persons potentially

exposed to radiation or to potential hazards

from non-nuclear energy production and use.

HHS delegated program responsibility to

CDC.

In addition, an MOU was signed in October

1990 and renewed in November 1992

between ATSDR and DOE. The MOU

delineates the responsibilities and

procedures for ATSDR’s public health

activities at DOE site required under sections

104, 105, 107, and 120 of the Comprehensive

Environmental Response, Compensation, and

Liability Act (CERCLA, or ‘‘Superfund’’).

These activities include health consultations

and public health assessments at DOE sites

listed on, or proposed for, the Superfund

National Priorities List and at sites that are

the subject of petitions from the public; and

other health-related activities such as

epidemiologic studies, health surveillance,

exposure and disease registries, health

education, substance-specific applied

research, emergency response, and

preparation of toxicological profiles.

Purpose: The purpose of these meetings is

to support research which evaluates past

releases of radioactive materials and

chemicals from the SRS to the surrounding

environment. The Project has already

undergone a first phase. Phase I involved

searching the site to identify and retrieve

important documents to be used for dose

reconstruction. Phase II will use this

information to calculate chemical and

radiological source terms and identify

possible intake pathways (eating, drinking,

and inhalation) for people who have lived in

the SRS area.

Agenda items are identical for each

meeting, and subject to change as priorities

dictate.

Contact Person for More Information: Paul

G. Renard, Project Manager, Radiation

Studies Branch, Division of Environmental

Hazards and Health Effects, NCEH, CDC,

4770 Buford Highway, NE, (F–35), Atlanta,

Georgia 30341–3724, telephone 770/488–

7040, FAX 770/488–7044.

Dated: January 22, 1996.

Julia M. Fuller,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–1365 Filed 1–25–96; 8:45 am]

BILLING CODE 4163–18–M

Food and Drug Administration

[Docket No. 96N–0012]

Animal Drug Export; ANIPRYL

Tablets

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Deprenyl Animal Health, Inc., has

filed an application requesting approval

for export of the animal drug

ANIPRYL (l-selegiline hydrochloride,

l-deprenyl hydrochloride) tablets to

Canada.

ADDRESSES: Relevant information on

this application may be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857, and to the contact

person identified below. Any future

inquiries concerning the export of

nonfood animal drugs under the Drug

Export Amendments of 1986 should

also be directed to the contact person.

FOR FURTHER INFORMATION CONTACT:

Gregory S. Gates, Center for Veterinary

Medicine (HFV–114), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1617.

SUPPLEMENTARY INFORMATION: The drug

export provisions in section 802 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 382) provide that

FDA may approve applications for the

export of drugs that are not currently

approved in the United States. Section

802(b)(3)(B) of the act sets forth the

requirements that must be met in an

application for approval. Section

802(b)(3)(C) of the act requires that the

agency review the application within 30

days of its filing to determine whether

the requirements of section 802(b)(3)(B)

have been satisfied. Section 802(b)(3)(A)

of the act requires that the agency

publish a notice in the Federal Register

within 10 days of the filing of an

application for export to facilitate public

participation in its review of the
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.