Federal Register / Vol. 65, No. 78 / Friday, April 21, 2000 / Notices 21443

actual or potential dealings by any

physician with any payer or provider.

The fifth provision listed above

(section II.A.5 of the proposed order)

ensures that communications between

any respondent and any payer within a

‘‘messenger model’’ arrangement be

conveyed by a neutral third party

(someone other than a physician with

an active practice in the Austin area). In

a messenger model arrangement,

physicians individually convey and

receive, through a third party,

information, offers, and responses from

and to payers or providers. See

Statements of Antitrust Enforcement

Policy in Health Care. Issued jointly by

the Federal Trade Commission and the

U.S. Department of Justice (August 28,

1996) at 43–52, 89–92, 125–27, 138–40,

4 Trade Reg. Rep. (CCH) ¶ 13,153. In

addition, section V.A.2 of the order

ensures that any respondent intending

to use a messenger model arrangement

provide prior notification to the

Commission.

Section II.B prohibits respondents

from exchanging, transferring, or

facilitating the exchange or transfer of

information among Austin area

physicians concerning: (1) Negotiation

with any payer or provider regarding

reimbursement terms; or (2) actual or

contemplated intentions or decisions

with respect to any terms, dealings or

refusals to deal with any payer or

provider. Section II.C prohibits

respondents from encouraging, advising,

or pressuring any person, other than the

government, to engage in any action that

would be prohibited if the person were

subject to the order.

Section II contains three provisos. The

first permits each respondent medical

practice group to participate in

arrangements for the provision of

physician services that are limited to

physicians from the same medical

practice group. The second proviso, as

noted above, permits respondents to

engage in conduct that is approved and

supervised by the State of Texas, so long

as that conduct is protected from

liability under the federal antitrust laws

pursuant to the state action doctrine.

The state action doctrine protects from

federal antitrust liability any private

conduct that is both: (1) in accordance

with a clearly articulated and

affirmatively expressed state policy to

supplant competition; and (2) actively

supervised by the state itself. See, e.g.,

FTC v. Ticor Title Insurance Co., 504

U.S. 621 (1992); California Retail Liquor

Dealers Ass’n v. Midcal Aluminum, Inc.,

445 U.S. 97, 105 (1980).

The third proviso allows respondents

to engage in conduct (including

collectively determining reimbursement

and other terms of contracts with

payers) that is reasonably necessary to

operate any ‘‘qualified risk-sharing joint

arrangement’’ or ‘‘qualified clinicallyintegrated joint arrangement,’’ provided

respondents comply with the prior

notification requirements set forth in

section V of the order. The prior

notification mechanism will allow the

Commission to evaluate a specific

proposed arrangement and assess its

likely competitive impact. This

requirement will help guard against any

recurrence of acts and practices that

have restrained competition and injured

consumers.

As defined in the order, a ‘‘qualified

risk-sharing joint arrangement’’ must

satisfy three conditions. First, all

physicians participating in the

arrangement must share substantial

financial risk from their participation in

the arrangement. The definition

illustrates ways in which physicians

might share financial risk, tracking the

types of financial risk-sharing set forth

in the 1996 FTC/DOJ Statements of

Antitrust Enforcement Policy in Health

Care. Second, any agreement on prices

or terms of reimbursement entered into

by the arrangement must be reasonably

necessary to obtain significant

efficiencies through the joint

arrangement. Third, the arrangement

must be non-exclusive—i.e., it must not

restrict the ability, or facilitate the

refusal, of physicians participating in

the arrangement to deal with payers

individually or through any other

arrangement.

A ‘‘qualified clinically-integrated joint

arrangement’’ pertains to arrangements

in which the physicians undertake

cooperative activities to achieve

efficiencies in the delivery of clinical

services, without necessarily sharing

substantial financial risk. As with risksharing arrangements, the definition of

clinically integrated joint arrangements

reflects the analysis contained in the

1996 FTC/DOJ Statements of Antitrust

Enforcement Policy in Health Care.

According to the order’s definition, the

participating physicians must have a

high degree of interdependence and

cooperation through their use of

programs to evaluate and modify their

clinical practice patterns, in order to

control costs and assure the quality of

physician services provided through the

arrangement. In addition, as with risksharing arrangements, the arrangement

must be non-exclusive and any

agreement on prices or terms of

reimbursement entered into by the

arrangement must be reasonably

necessary to obtain significant

efficiencies through the joint

arrangement.

Sections III.A and III.B require

respondents to distribute the order and

complaint to its members and other

specified persons, including payers.

Sections III.C and III.D require that each

respondent, for the next five years: (2)

Distribute copies of the order and

complaint to new members and other

specified persons; (2) publish annually

to members and owners a copy of the

order and complaint; and (3) brief

members and owners annually on the

meaning and requirements of the order

and the antitrust laws.

Sections IV and VI consist of standard

Commission reporting and compliance

procedures. Section IV specifies that

Texas Surgeons IPA must include in its

annual reports information identifying

each payer or provider that has

communicated with Texas Surgeons IPA

concerning a possible contract for

physician services, the proposed terms

of any such contract, and Texas

Surgeons IPA’s response to the payer or

provider.

Finally, section VII of the proposed

order contains a twenty year ‘‘sunset’’

provision under which the order

terminates twenty years after the date

the order was issued.

By direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 00–10009 Filed 4–20–00; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00037]

Cancer Prevention and Control

Activities; Notice of Availability of

Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2000

funds for a sole source cooperative

agreement program for Cancer

Prevention and Control Activities. This

program addresses the ‘‘Healthy People

2010’’ priority area(s) related to Cancer.

The purpose of the program is to

assist with the following:

1. Developing and disseminating

current national, state, and communitybased comprehensive information on

cancer prevention and early detection.

2. Developing and disseminating

professional education programs.

3. Promoting the analysis and

development of surveillance and

21444 Federal Register / Vol. 65, No. 78 / Friday, April 21, 2000 / Notices

research data, and its translation into

public health messages, practice and

programs.

4. Facilitating the exchange of

expertise and coordination of

programmatic efforts related to cancer

prevention and control among a variety

of public, private, and not-for-profit

agencies at the national, state, tribal,

and community level.

B. Eligible Applicants

Single Source

Assistance will be provided only to

the American Cancer Society (ACS). No

other applications are solicited. ACS is

uniquely qualified to conduct

information and education development

and dissemination activities under this

cooperative agreement because it has—

1. An extraordinary position as the

nation’s only voluntary, communitybased cancer prevention and control

organization dedicated to eliminating

cancer as a major health problem

through research, education, prevention,

early detection and treatment of all

cancers.

2. Access to cancer research,

prevention, education and treatment

programs and to the populations they

serve through an extensive network that

includes 2 million members, a National

Society, 17 Divisions covering all states,

5 metropolitan areas, the District of

Columbia and Puerto Rico, and more

than 3,400 community-based unit

offices.

3. Collaborative relationships with a

broad range of national, state, and

community-based public, private and

not-for-profit organizations to

disseminate information related to all

aspects of cancer prevention and

control; coordinate access to

information and services for cancer

patients, their families and others; and

provide guidance and consultation at

the national, state, and community level

for a coordinated and comprehensive

system of cancer activities. Therefore,

the American Cancer Society is the only

organization that can perform these

activities.

C. Availability of Funds

Approximately $755,000 is available

in FY 2000 to fund the projects listed

below. It is expected that the awards

will begin June 1, 2000, and will be

made for a 12-month budget period

within a project period of up to 3 years.

Funding estimates may change.

Continuation awards within an

approved project period will be made

on the basis of satisfactory progress as

evidenced by required reports and the

availability of funds.

Project 1. Coordinated School Health

Programs

Approximately $300,000 is available

to support coordinated school health

programs for cancer prevention and

control for school-aged populations,

parents, and relevant health and

education personnel.

Project 2. Comprehensive Cancer

Control Activities

Approximately $400,000 will be

available to plan, implement, and

evaluate cancer control activities for the

public (including minority, older, and

underserved populations), providers

(including physicians, nurses, physician

assistants, health educators, state health

department personnel, and others), and

decision makers (policy makers, state

health department administrators, and

others.)

Project 3. International Network of

Women Against Tobacco (INWAT)

Approximately $35,000 is available to

support activities which address the

complex issues of tobacco use among

women and girls internationally.

Project 4. Dissemination of Information

on Oral Cancer

Approximately $20,000 is available to

support the review and revision of

currently available information and

educational materials on oral cancer and

incorporate oral cancer issues into

educational outreach services and/or

activities for dental and other health

care providers.

Use of Funds

Cooperative agreement funds may not

be expended to provide inpatient

hospital or treatment services.

Treatment is defined as any service

recommended by a clinician, including

medical and surgical intervention

provided in the management of a

diagnosed condition.

D. Program Requirements

Projects should emphasize activities

in one or more of the following areas:

1. Development and dissemination of

materials, conferences, workshops, and

activities for public education on the

prevention and early detection of cancer

through behavior modification,

including utilization of proven

screening modalities for early detection

(e.g., fecal occult blood tests,

sigmoidoscopy, mammography, Pap

smears), avoidance of ultraviolet

radiation exposure, prevention and

cessation of tobacco use, improving

nutrition and dietary practices, and

increasing physical activity levels.

Materials should be culturally

competent, linguistically appropriate

and developed for a broad audience of

race/ethnic groups.

2. Coalition building, and

coordination of resources and activities

for adult and adolescent cancer

education, promotion of prevention and

early detection services, and referral to

treatment and follow-up services.

3. Epidemiologic and behavioral

research development and analysis of

data on factors related to cancer

outcomes and other diseases which may

be influenced by tobacco, early

detection (e.g., fecal occult blood tests,

sigmoidoscopy, mammography, Pap

smears), avoidance of ultraviolet

radiation exposure, nutrition and

dietary practices, and increasing

physical activity levels.

4. Development and dissemination of

materials, conferences, workshops and

activities for professional education in

cancer prevention and early detection,

and support of training opportunities in

cancer epidemiology, prevention, early

detection and program evaluation.

5. Development and evaluation of

materials and activities to improve

outreach to underserved populations for

cancer prevention, early detection and

follow-up services.

6. The grantee will participate in a

six-month progress review meeting with

appropriate representatives from CDC

within 30 days of the sixth month of

each budget period.

In conducting activities to achieve the

purpose of this program, the recipient

shall be responsible for activities under

1. (Recipient Activities), and CDC shall

be responsible for conducting activities

under 2. (CDC Activities.)

1. Recipient Activities

Project 1. Coordinated School Health

Programs

A. Collaborate with state and local

education agencies with data collection

around youth risk behavior, and school

policies and programs.

B. Support Coordinated School Health

Programs as a priority among American

Cancer Society’s constituents and the

public, with a special emphasis on four

risk factors: Tobacco use, excessive

consumption of fat and calories,

inadequate physical activity, and

obesity.

C. Support local, state, and national

coalitions to improve Coordinated

School Health Programs.

D. Collaborate with CDC funded and

other national, non-governmental

organizations in support of school

health programs.

E. Participate with other appropriate

agencies in planning the annual

Federal Register / Vol. 65, No. 78 / Friday, April 21, 2000 / Notices 21445

National School Health Leadership

Conference.

Project 2. Comprehensive Cancer

Control Activities

A. Collaborate with state health

departments on comprehensive cancer

control training, planning,

implementation, and evaluation

activities. Develop leadership models

for state health departments to utilize.

Assess comprehensive cancer control

collaboration models.

B. Coordinate and support activities

related to colorectal and prostate cancer

education and awareness. Collaborate

with state health departments in the

replication and evaluation of prostate

and colorectal cancer training for

providers and health care systems that

promotes informed decisions; provides

current, balanced information on the

benefits and limitations of screening

and treatment for these cancers; and

provides information that will enable

participants to overcome system barriers

to implementing screening. Collaborate

with appropriate agencies in reaching

primary care providers with written

information regarding screening for

colorectal cancer and messages for their

patients to raise awareness of the need

for colorectal cancer screening.

C. Identify the critical components of

effective breast and cervical cancer

screening outreach/education

partnerships between state health

departments and other organizations,

including ACS.

D. Develop evaluation measures to

determine the impact of project

activities and identify effective cancer

prevention and control projects for

future continuation, replication and/or

dissemination.

E. Develop clear cancer education

materials and/or other items that

accurately and effectively convey

appropriate health messages and

behaviors to the targeted populations

regarding lung, breast, cervical,

colorectal, prostate, and skin cancers.

F. Identify opportunities for cancer

issues management forums; coordinate

and support cancer issues management

forums among a variety of public,

private, and not-for-profit agencies at

the national, state, tribal, and

community level.

G. Develop and implement studies

that explore the effects and interactions

between various lifestyle factors and

health services on the risk of cancer and

cancer mortality.

Project 3. International Network of

Women Against Tobacco (INWAT)

A. Provide contacts primarily to

women, individuals, and organizations

working in tobacco control; collect and

distribute information regarding global

women and tobacco issues; and develop

strategies to counter tobacco advertising

and promotion. Strategies might include

maintaining a website, a member

directory and newsletter.

B. Provide assistance with the

organization and planning of

conferences on tobacco control such as

the World Tobacco Conference.

C. Collaborate with state health

departments to address tobacco use and

prevention among women and girls.

D. Provide presentations on women

and tobacco, with a strong emphasis on

tobacco company marketing tactics at

state and national meetings in the

United States.

E. Promote female leadership in

initiating the development of tobacco

control organizations internationally.

Project 4. Dissemination of Information

on Oral Cancer

A. Inventory and assess existing

educational materials and other forms of

information on oral cancer available to

the public and health care providers.

B. Based on the assessment, revise

educational materials and other forms of

information on oral cancer to reflect upto-date, science-based knowledge.

C. Conduct and evaluate outreach

activities to increase knowledge and

awareness among dental and other

health care providers of information

resources that address oral cancer

issues.

D. Coordinate these activities with

major organizations in dental health,

such as the American Dental

Association and its component state

associations, the National Institute of

Dental and Cranial Facial Research, and

the Association of State and Territorial

Dental Directors.

2. CDC Activities

A. Collaborate on and provide

technical assistance for program

activities.

B. Assist in the conduct of

epidemiologic studies, research, and

analysis using existing or newly created

databases.

C. Participate in the development of

plans for the sharing and dissemination

of research, data analysis, evaluation

efforts, demonstration projects and

interventions, and other cancer

information. Sponsor information

exchanges through workshops,

conferences, and other group

mechanisms as appropriate .

D. Assist in defining the scope,

development, and dissemination of

plans and education materials,

guidelines, and standards for cancer

prevention and control activities.

E. Assist in developing and evaluating

professional training opportunities for

cancer prevention and control,

particularly in the areas of prevention,

early detection, surveillance, data

analysis and cost-effectiveness.

F. Give guidance on cancer issues

management topics to be considered

and timing of consideration.

E. Application Content

Use the information in the ‘‘Program

Requirements,’’ ‘‘Other Requirements,’’

and ‘‘Evaluation Criteria’’ sections to

develop the application content. Your

application will be evaluated on the

criteria listed, so it is important to

follow them in laying out your program

plan. The narrative should be no more

than 20 (twenty) double-spaced pages,

printed on one side, with one-inch

margins, and unreduced font.

A separate narrative is required for

each Project which contains—

1. Statement of Need.—Identify

opportunities for enhancement/

improvement and existing gaps in the

support of comprehensive cancer

control and prevention activities.

Describe the extent to which the

proposed programs will fill existing

gaps and provide a brief description of

each programmatic plan or research

activity.

2. Objectives. Establish and submit

short- and long-term objectives for each

project proposed in Section 1 (statement

of need) above. Objectives must be

specific, measurable, attainable, time

phased, and realistic.

3. Operational Plan.—Submit an

operational plan that addresses means

for achieving each of the objectives

established in Section 2 (objectives)

above. Provide a concise description of

each component or major activity and

how it will be implemented. The plan

must identify and establish a time line

for the completion of each component

or major activity.

4. Evaluation Plan.—Submit a

quantitative plan for monitoring

progress toward achieving each of the

objectives stated in Section 2

(objectives) above.

5. Program Management.—Describe

the need, functions, and qualification

for each program or research personnel

requested.

6. Budget.—Submit a detailed budget

and narrative justification for each of

the projects that is consistent with the

purpose of the program and the

proposed activities.

21446 Federal Register / Vol. 65, No. 78 / Friday, April 21, 2000 / Notices

F. Submission and Deadline

Submit the original and two copies of

PHS 5161–1 (OMB Number 0937–0189).

By May 1, 2000, submit the

application to the Grants Management

Specialist identified in the ‘‘Where to

Obtain Additional Information’’ section

of this announcement.

1. Deadline: Applications will be

considered as meeting the deadline if

they are either:

a. Received on or before the stated

deadline date; or

b. Sent on or before the deadline date.

(Applicants must request a legibly dated

U.S. Postal Service postmark or obtain

a legibly dated receipt from a

commercial carrier or the U.S. Postal

Service.

Private metered postmarks shall not

be acceptable proof of timely mailing.)

2. Late Applications: Applications

which do not meet the criteria in 1(a) or

1(b) above are considered late

applications and will be returned to the

applicant.

G. Evaluation Criteria

The application will be evaluated

according to the following criteria by an

independent review group appointed by

CDC.

1. Need statement. The extent to

which the applicant identifies specific

opportunities and existing gaps related

to the purpose of the program. (10

points)

2. Objectives. The degree to which

short- and long-term objectives are

specific, measurable, attainable, time

phased, and realistic. (20 points)

3. Operational Plans. The adequacy of

the applicant’s plan to carry out the

proposed activities, including the extent

to which the applicant plans to work

collaboratively with other organizations

and individuals who may have an

impact on cancer prevention and

control objectives. (25 points)

4. Evaluation Plan. The extent to

which the evaluation plan appears

capable of monitoring progress toward

meeting project objectives. (25 points)

5. Program Management. The extent

to which proposed staff appear to be

qualified and possess capacity to

perform the project. (20 points)

6. Budget. The extent to which each

line-item budget and narrative

justification for Projects 1, 2, 3 and 4 are

reasonable and consistent with the

purpose and objectives of the program.

(Not weighted)

7. Human Subjects. Does the

application adequately address the

requirements of Title 45 CFR Part 46 for

the protection of human subjects? (Not

Weighted)

8. The degree to which the applicant

has met the CDC Policy requirements

regarding the inclusion of women,

ethnic, and racial groups in the

proposed research. This includes:

1. The proposed plan for the inclusion

of both sexes and racial and ethnic

minority populations for appropriate

representation.

2. The proposed justification when

representation is limited or absent.

3. A statement as to whether the

design of the study is adequate to

measure differences when warranted.

4. A statement as to whether the plans

for recruitment and research for study

participants include the process of

establishing partnerships with

community(ies) and recognition of

mutual benefits.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with the original plus

two copies of the following:

1. Annual written progress report

must be submitted 30 days after the end

of each budget period.

2. Financial status report (FSR) must

be submitted 90 days after the end of

each budget period.

3. Final financial and performance

reports, must be submitted 90 days after

the end of the project period.

Send all reports to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment I in the

application package.

AR–1 Human Subjects Requirement

AR–2 Requirements for Inclusion of

Women and Racial and Ethnic Minorities

in Research

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

AR–20 Conference Support

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

sections 301(a), 317(k)(2) of the Public

Health Service Act [42 U.S.C. 241(a) and

247b(k)(2)], as amended. The Catalog of

Federal Domestic Assistance Number

for this program is 93.283.

J. Where To Obtain Additional

Information

To obtain additional information

contact: Nealean K. Austin, Grants

Management Specialist Grants

Management Branch, Procurement and

Grants Office Announcement 00037

Centers for Disease Control and

Prevention (CDC) Room 3000, 2920

Brandywine Road, Atlanta, GA 30341,

telephone (770)–488–2754, E-mail

address nea1@cdc.gov

See also the CDC home page on the

Internet: http://www.cdc.gov

For program technical assistance,

contact: Corinne Graffunder, Chief,

Section A, Program Services Branch,

Division of Cancer Prevention and

Control, National Center for Chronic

Disease Prevention and Health

Promotion, Centers for Disease Control

and Prevention (CDC), 4770 Buford

Highway, NE., Mailstop K–57, Atlanta,

GA 30341–3724, telephone (770) 488–

4880, fax (770) 488–3230.

Dated: April 17, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–9956 Filed 4–20–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 93D–0139]

International Conference on

Harmonisation; Draft Revised

Guidance on Q1A(R) Stability Testing

of New Drug Substances and Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is publishing a

draft revised guidance entitled ‘‘Q1A(R)

Stability Testing of New Drug

Substances and Products.’’ The draft

revised guidance, which updates a

guidance on the same topic published in

the Federal Register of September 22,

1994 (the 1994 guidance), was prepared

under the auspices of the International

Conference on Harmonisation of

Technical Requirements for Registration

of Pharmaceuticals for Human Use

(ICH). The draft revised guidance

clarifies the 1994 guidance, adds

information, and provides consistency

with more recently published ICH

guidances. The draft revised guidance is

intended to reflect formal scientific

principles for stability testing of drugs

and should be useful to applicants

submitting new drug applications for

new molecular entities and associated

drug products.