69946 Federal Register / Vol. 65, No. 225 / Tuesday, November 21, 2000 / Notices

suppliers on a capitated basis. The local

unit of government could select all

willing suppliers or use a limited

number of suppliers and use savings

from efficiencies to provide added

services.

The demonstration offers the selected

units of government a great deal of

flexibility, as long as the government

entity establishes a delivery system that

ensures access to care and quality

services under a budget neutral

capitated payment rate.

We will select up to three units of

local government, using a competitive

application process. A qualifying unit of

local government is defined as a city,

county, or incorporated town. A

demonstration project can only exclude

beneficiaries enrolled in Medicare Part

B who reside within the unit if

geographic features make coverage

impractical for a specified area. In such

case, up to 20 percent of the unit’s Part

B enrollees may be excluded.

An independent panel will review

proposals. Areas that will be examined

include: Statement of the Problem;

Organizational Capability; Service

Delivery, Operations, and Quality

Assurance; Payment Methodology and

Implementation.

IV. Final Selection

The final selection of up to three

demonstration projects will be made by

our Administrator from among the most

highly qualified applicants. The

Administrator will make the selection

giving greater emphasis to proposals

that have strong evidence of service

delivery, operations, and quality

assurance; the implementation plan;

organizational capability; and payment

methodology. The operational protocols

for the payment system, coverage

process, eligibility determination, and

claims payment must be approved by us

prior to implementation. We reserve the

right to conduct site visits to the

awardees’ location prior to making

awards. An independent contractor,

selected and funded by us, will design

and conduct an evaluation of the

demonstration after its conclusion. The

awardee will be required to cooperate

with the contractor conducting the

evaluation.

Authority: Section 4532 of the Balanced

Budget Act of 1997, (Pub. L. 105–33); and

Section 225 of the Balanced Budget

Refinement Act of 1999, (Pub. L. 106–113).

(Catalog of Federal Domestic Assistance

Program No. 93.779, Health Care Financing

Research, Demonstrations and Evaluations)

Dated: October 17, 2000.

Michael M. Hash,

Acting Administrator, Health Care Financing

Administration.

[FR Doc. 00–29755 Filed 11–20–00; 8:45 am]

BILLING CODE 4120–01–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–1157–N]

Medicare Program; December 12, 2000,

Meeting of the Competitive Pricing

Advisory Committee

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of meeting.

SUMMARY: In accordance with section

10(a) of the Federal Advisory Committee

Act, this notice announces a meeting of

the Competitive Pricing Advisory

Committee (the CPAC) on December 12,

2000. The Balanced Budget Act of 1997

(BBA) requires the Secretary of the

Department of Health and Human

Services (the Secretary) to establish a

demonstration project under which

payments to Medicare+Choice

organizations in designated areas are

determined in accordance with a

competitive pricing methodology. The

BBA requires the Secretary to create the

CPAC to make recommendations on

demonstration area designation and

appropriate research designs for the

project. The CPAC meetings are open to

the public.

DATES: The meeting is scheduled for

December 12, 2000, from 9 a.m. until 12

noon, e.s.t.

ADDRESSES: The meeting will be held at

the Marriott Wardman Park Hotel, 2660

Woodley Road N.W., Washington, D.C.

20008.

FOR FURTHER INFORMATION CONTACT:

Sharon Arnold, Ph.D., Executive

Director, Competitive Pricing Advisory

Committee, Health Care Financing

Administration, 7500 Security

Boulevard C4–14–17, Baltimore,

Maryland 21244–1850, (410) 786–6451.

Please refer to the HCFA Advisory

Committees Information Line (1–877–

449–5659 toll free) /(410–786–9379

local) or the Internet (http://www/

hcfa.gov/fac) for additional information

and updates on committee activities.

SUPPLEMENTARY INFORMATION: Section

4011 of the Balanced Budget Act of 1997

(BBA), Public Law 105–33, requires the

Secretary of the Department of Health

and Human Services (the Secretary) to

establish a demonstration project under

which payments to Medicare+Choice

organizations in designated areas are

determined in accordance with a

competitive pricing methodology.

Section 4012(a) of the BBA requires the

Secretary to appoint a Competitive

Pricing Advisory Committee (the CPAC)

to meet periodically and make

recommendations to the Secretary

concerning the designation of areas for

inclusion in the project and appropriate

research design for implementing the

project. The CPAC has previously met

on May 7, 1998, June 24 and 25, 1998,

September 23 and 24, 1998, October 28,

1998, January 6, 1999, May 13, 1999,

July 22, 1999, September 16, 1999,

October 29, 1999, January 12, 2000, and

May 23, 2000.

The CPAC consists of 15 individuals

who are independent actuaries; experts

in competitive pricing and the

administration of the Federal Employees

Health Benefit Program; and

representatives of health plans, insurers,

employers, unions, and beneficiaries.

The CPAC members are: James Cubbin,

Executive Director, General Motors

Health Care Initiative; Robert Berenson,

M.D., Director, Center for Health Plans

and Providers, HCFA; John Bertko,

Actuary Principal, Humana Inc.; David

Durenberger, Vice President, Public

Policy Partners; Gary Goldstein, M.D.,

Chief Medical Officer-Health Plans,

Humana Inc.; Samuel Havens,

Healthcare Consultant; Margaret Jordan,

Executive Vice President, Texas Health

Resources; Chip Kahn, President, The

Health Insurance Association of

America; Cleve Killingsworth, President

and CEO, Health Alliance Plan; Nancy

Kichak, Director, Office of Actuaries,

Office of Personnel Management; Len

Nichols, Principal Research Associate,

The Urban Institute; Robert Reischauer,

President, The Urban Institute; John

Rother, Director, Legislation and Public

Policy, American Association of Retired

Persons; Andrew Stern, President,

Service Employees International Union,

AFL–CIO; and Jay Wolfson, Director,

The Florida Information Center,

University of South Florida. The

Chairperson is James Cubbin and the

Co-Chairperson is Robert Berenson,

M.D. In accordance with section

4012(a)(5)of the BBA, the CPAC will

terminate on December 31, 2004.

The agenda for the December 12,

2000, meeting will include a continuing

discussion on the components of a

Report to Congress being prepared by

the CPAC. Section 533 of the Medicare,

Medicaid, and State Child Health

Insurance Program (SCHIP) Balanced

Budget Refinement Act of 1999, Public

Law 106–113, revised section 4011 of

Federal Register / Vol. 65, No. 225 / Tuesday, November 21, 2000 / Notices 69947

the BBA to require the CPAC to submit

a report on the following topics:

• Incorporation of original Medicare

fee-for-service into the demonstration.

• Requirements of quality activities

under the demonstration.

• Inclusion of a rural area in the

demonstration.

• Requirements of a benefit structure

under the demonstration.

The CPAC will also develop

recommendations for how it should

proceed in the future to carry out its

responsibilities under the BBA.

Individuals or organizations that wish

to make 5-minute oral presentations on

the agenda issues should contact the

Executive Director, by 12 noon,

December 7, 2000, to be scheduled. The

number of oral presentations may be

limited by the time available. A written

copy of the oral remarks should be

submitted to the Executive Director, no

later than 12 noon, December 11, 2000.

Anyone who is not scheduled to speak,

may submit written comments to the

Executive Director, by 12 noon,

December 11, 2000.

The meeting is open to the public, but

attendance is limited to the space

available. Individuals requiring sign

language interpretation for the hearing

impaired or other special

accommodation should contact the

Executive Director at least 10 days

before the meeting.

(Section 4012 of the Balanced Budget Act of

1997, Public Law 105–33 (42 U.S.C.1395w–

23 note) and section 10(a) of Public Law 92–

463 (5 U.S.C. App.2, section 10(a))

(Catalog of Federal Domestic Assistance

Program No. 93.773, Medicare—Hospital

Insurance; and Program No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: November 6, 2000.

Michael M. Hash,

Acting Administrator, Health Care Financing

Administration.

[FR Doc. 00–29754 Filed 11–20–00; 8:45 am]

BILLING CODE 4120–01–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute: Opportunity

for a Cooperative Research and

Development Agreement (CRADA)

Collaboration in the Identification,

Characterization and Development of

Inhibitors of the Smad3 Signaling

Protein for Use in the Treatment of

Wounds and Fibrotic Diseases

Characterized by Chronic Inflammation

AGENCY: National Institutes of Health,

PHS, DHHS.

ACTION: Notice.

The National Cancer Institute’s

Laboratory of Cell Regulation and

Carcinogenesis (LCRC) has

characterized the role of the Smad3

signaling molecule in wound healing

and has developed several mouse

models of fibrosis. NCI would like to

use its expertise of Smad3 biology in a

collaboration with an outside party to

identify and characterize inhibitors of

Smad3 activity.

SUMMARY: The National Cancer Institute

(NCI) seeks a Cooperative Research and

Development Agreement (CRADA)

Collaborator to aid NCI in the

identification and development of

inhibitors of the function of the Smad3

signaling protein. Smad3 and a closely

related gene, Smad2, act as nuclear

transcriptional activators in response to

intracellular signals from the

transforming growth factor betas (TGFbetas) and activin molecules (1,2). The

existence of these genes was first

proposed after a screen for

developmental mutations in the

nematode led to the identification of

three genes, sma-2, sma-3, and sma-4,

that were homologs of Drosophila MAD,

a protein with a role in the signaling of

a TGF-beta superfamily ligand (3). The

Smad2 and Smad3 signaling pathways

play important roles in the cellular

proliferation, differentiation and

migration crucial to cutaneous wound

healing and the induction of fibrosis in

diseases characterized by chronic

inflammation (4).

NCI has generated a line of mice that

are homozygously deleted in the Smad3

gene (Smad3ex8⁄ex8 mice). These mice

have made it possible for NCI to

examine the contribution of Smad3 in

cutaneous wound healing. Smad3ex8⁄ex8

mice survive into adulthood and show

accelerated cutaneous wound healing

characterized by an increased rate of reepithelialization and a reduced local

inflammatory infiltrate of monocytes

and neutrophils. Thus, Smad3 appears

to mediate in vivo signaling pathways

that mediate key aspects of wound

healing including influx of

inflammatory cells and control of

epithelial cell proliferation and

migration. NCI’s studies indicate that

inhibitors of Smad3 function, such as

specific, small molecule or antisenserelated compounds, may accelerate

cutaneous wound healing and may even

be beneficial to other processes such as

the treatment of extensive burns, the

suppression of radiation-induced

scarring, the growth of autologous skin

grafts and the treatment of fibrotic

diseases characterized by chronic

inflammation.

NCI is looking for a CRADA

Collaborator with a demonstrated record

of success in the isolation and

characterization of small molecule

protein inhibitors. The proposed term of

the CRADA can be up to five (5) years.

DATES: Interested parties should notify

this office in writing of their interest in

filing a formal proposal no later than

January 22, 2001. Potential CRADA

Collaborators will then have an

additional thirty (30) days to submit a

formal proposal. CRADA proposals

submitted thereafter may be considered

if a suitable CRADA Collaborator has

not been selected.

ADDRESSES: Inquiries and proposals

regarding this opportunity should be

addressed to Holly Symonds Clark,

Ph.D., Technology Development

Specialist (Tel. #301–496–0477, FAX

#301–402–2117), Technology

Development and Commercialization

Branch, National Cancer Institute, 6120

Executive Blvd., Suite 450, Rockville,

MD 20852. Inquiries directed to

obtaining patent license(s) for the

technology NIH reference No. E–070–

00/0, filed May 19, 2000 for ‘‘Inhibition

of Smad3 to Prevent Fibrosis and to

Improve Wound Healing’’ (Roberts and

Ashcroft), should be addressed to

Marlene Shinn M.S., J.D., Technology

Licensing Specialist, Office of

Technology Transfer, National Institutes

of Health, 6011 Executive Blvd., Suite

325, Rockville, MD 20852, (Tel. 301–

496–7056, ext. 285; FAX 301–402–

0220).

SUPPLEMENTARY INFORMATION: A

Cooperative Research and Development

Agreement (CRADA) is the anticipated

joint agreement to be entered into with

NCI pursuant to the Federal Technology

Transfer Act of 1986 and Executive

Order 12591 of April 10, 1987 as

amended by the National Technology

Transfer Advancement Act of 1995. NCI

is looking for a CRADA partner to aide

NCI in the characterization and

development of inhibitors of the

function of the Smad3 signaling protein.

The expected duration of the CRADA

would be from one (1) to five (5) years.

The members of the transforming

growth factor-beta (TGF-beta)

superfamily are multi-functional growth

factors that are responsible for a variety

of biological processes in tissue

homeostasis, differentiation,

morphogenesis and development of

multicellular animals (for reviews see 5,

6). They transduce their signals from the

plasma membrane to nuclei of target

cells through distinct combinations of a

family of serine/threonine kinase

receptors. Once activated by specific

phosphorylation events, these receptors