National Program of Cancer Registries

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

RIN 0905-ZA40

[Announcement--426]

National Program of Cancer Registries

Introduction

The Centers for Disease Control and Prevention (CDC) announces the

availability of fiscal year (FY) 1994 funds for cooperative agreements

to support statewide cancer registries. The program will serve two

purposes:

Part I: To support and enhance existing State cancer registries so that

they are statewide and population-based.

Part II: To plan, implement, and support statewide population-based

cancer registries where State registries do not currently exist.

The Public Health Service (PHS) is committed to achieving the

health promotion and disease prevention objectives of ``Healthy People

2000,'' a PHS-led national activity to reduce morbidity and mortality

and to improve the quality of life. This announcement is related to the

priority areas of Cancer and Surveillance and Data Systems. (For

ordering a copy of ``Healthy People 2000,'' see the section ``Where To

Obtain Additional Information.'')

Authority This program is authorized by sections 399H, 399I,

399J, and 399L [42 U.S.C. 280e, e-1 and e-4] of the Public Health

Service Act, as amended by Public Law 102-515, the Cancer Registries

Amendment Act.

Smoke-Free Workplace

The Public Health Service strongly encourages all grant recipients

to provide a smoke-free workplace and promote the non-use of all

tobacco products. This is consistent with the PHS mission to protect

and advance the physical and mental health of the American people.

Eligible Applicants

Eligible applicants for part I or for part II are the official

public health agencies of States, or academic or nonprofit

organizations designated by the State to operate the State's cancer

registry. This includes the District of Columbia, American Samoa, the

Commonwealth of Puerto Rico, the Virgin Islands, the Federated States

of Micronesia, Guam, the Northern Mariana Islands, the Republic of the

Marshall Islands, and the Republic of Palau. Competition is limited to

these States in accordance with the authorizing legislation, the Cancer

Registries Amendment Act of 1992.

Eligible applicants may apply for either part I or part II.

Part I: Applicants applying for part I must have a central registry at

the State level, continuous and recent data collection efforts,

existing core staff, and policies and procedures in place. State health

agencies or their designees requesting funds to support and enhance

existing State cancer registries (part I) are not eligible to apply for

funds for planning and implementation of statewide cancer registries

(part II).

Part II: Only States with a limited or no established State cancer

registry are eligible to apply for funds for planning and

implementation of a statewide cancer registry. State health agencies or

their designees requesting funds for planning and implementing a

statewide, population-based cancer registry (part II) are not eligible

to apply for funds for the support and enhancement of existing State

cancer registries (part I).

Availability of Funds

Approximately $14 million is available in FY 1994 to fund programs

under parts I and II of this announcement:

Part I: Support and enhancement of existing State cancer registries

(Section 399H). Approximately $11 million is available in FY 1994 to

fund up to 40 States to support and enhance existing State registries.

It is expected that the average award to support and enhance an

existing State registry will be $300,000, ranging from $150,000 to

$1,000,000.

Part II: Planning and implementation of statewide cancer registries

(Section 3991). Approximately $3 million is available in FY 1994 to

fund approximately 10 awards to plan and implement a statewide cancer

registry in States where one does not exist. It is expected that the

average award will be $300,000, ranging from $150,000 to $400,000.

Awards for both Part I and Part II are expected to begin on or

about September 1994 and will be made for a 12-month budget period

within a project period of up to 5 years. Funding estimates may vary

and are subject to change.

Continuation awards within the project period will be made on the

basis of satisfactory progress and the availability of funds.

Additional funds may become available in support of building public

health information infrastructure in FY 1994.

Recipient Financial Participation

Recipient financial participation is required for this program

announcement in accordance with the authorizing legislation for Part I

applicants only:

A. Recipients of funds under Part I must agree, with respect to the

costs of the program, to make available (directly or through donations

from public or private entities) non-Federal contributions toward such

costs in an amount that is not less than 25 percent of such cost or $1

for every $3 of Federal funds provided in the grant. [Sec. 399H(b)(1)]

B. In determining the amount of non-Federal contributions under A.

(above), the recipient may include only such contributions as are in

excess of the amount of such contributions made by the State toward the

collection of data on cancer for the fiscal year preceding the first

year of funding under this announcement. CDC may decrease the amount of

non-Federal contributions required if the State can demonstrate that

decreasing such amount is appropriate because of financial hardship.

[Sec. 399H(b)(2)].

Applicants will be notified of the details regarding criteria for

defining ``financial hardship'' and the process for deciding

eligibility when they become available.

Non-Federal contributions may be in cash or in kind, fairly

evaluated, including plant, equipment, or services. Amounts provided by

the Federal Government, or services assisted or subsidized to any

significant extent by the Federal Government, may not be included in

determining the amount of such non-Federal contributions.

Purpose

The purpose of these awards is to establish a national program of

cancer registries by supporting States in their efforts to (Part I)

enhance State cancer registries to become statewide, population-based,

registries that meet minimum standards of completeness, timeliness, and

quality, and (Part II) plan and implement statewide, population-based

cancer registries where they do not currently exist.

The national goals of this program are to rapidly establish and

standardize the reporting of cancer among the States in order to

provide: (1) Timely feedback for evaluating progress toward achieving

cancer-control objectives that include the ``Healthy People 2000''

objectives; (2) data to identify cancer incidence variation for ethnic

groups and for regions within a State, between States, and between

regions; (3) guidance for health resource allocation; (4) data to

evaluate State cancer-control activities; and (5) information to

improve planning for future health care needs.

Program Requirements

In conducting activities to achieve the purpose of this program,

the recipient will be responsible for the activities under A.

(Recipient Activities), and CDC will be responsible for the activities

listed under B. (CDC Activities).

A. Recipient Activities

Recipients of funds under Part I are expected to support and

enhance, and recipients under Part II are expected to plan, implement,

and support the operation of population-based, statewide cancer

registries in order to collect data concerning each form of invasive

cancer with the exception of basal cell and squamous cell carcinoma of

the skin and each form of in-situ cancer except for carcinoma in-situ

of the cervix uteri. Data on carcinoma in-situ of the cervix uteri is

not being collected at this time because it has been well documented

that routine collection of such data is incomplete due to inconsistent

collection of other High Grade Neoplasia. In addition, these data are

not comparable over time because of changing terminology and diagnostic

criteria. (Working Group on Pre-Invasive Cervical Neoplasia and

Population-Based Cancer Registries Final Subcommittee Report, April

1993.)

Data to be collected for invasive and in-situ cancers include:

1. Demographic information about each case of cancer including at a

minimum:

(a) Last name, first name, middle initial.

(b) Address at diagnosis, including city, county, State, and zip

code (or zip + 4 where available).

(c) Census tract.

(d) Race and Spanish/Hispanic origin.

(e) Sex.

(f) Birth date.

(g) Social security number.

2. Information on the industrial or occupational history of the

individual with the cancers, to the extent such information is

available from the same record.

3. Administrative information, including at a minimum:

(a) Date of diagnosis.

(b) Date of admission.

(c) Source of information.

4. Pathological data characterizing the cancer, including at a minimum:

(a) Primary site.

(b) Morphology type, behavior, and grade.

(c) Sequence number.

(d) Laterality.

(e) Diagnostic confirmation.

(f) Stage of disease (pursuant to Summary Staging Guide).

(g) Date and type of first course of definitive treatment when

available in the medical record.

(h) Date of death.

(i) Underlying cause of death.

B. CDC Activities

1. Convene a meeting of the funded States for information sharing,

problem solving, and training at least annually.

2. Provide funded States with ongoing consultation for effective

program planning and management, including, but not limited to,

assistance in the development of model legislation for statewide cancer

registries, assistance in establishing a computerized reporting and

data processing system, and assistance in monitoring completeness,

timeliness, and quality of data.

3. Collaborate in establishing or endorsing program requirements

for completeness, timeliness, and accuracy of data, and monitor to

assure compliance with program requirements.

4. Collaborate in reporting of cancer rates and other components of

an annual report on cancer occurrence in the State.

5. Conduct site visits to assess program progress and mutually

resolve problems, as needed.

Evaluation Criteria

(Total 100 Points Plus 10 Optional Points)

Evaluation criteria are compared against specific information

requested in the corresponding component of the ``Application Content''

section of the Program Announcement Number 426. A copy of the program

announcement will be included in the application kit.

Applications for Part I

Applications will be reviewed and evaluated according to the

following criteria for programs to enhance an existing statewide cancer

registry: (Maximum 110 points).

A. Resources and Needs Assessment: (25 Points--Allocated as Noted

Below)

The extent to which the applicant describes current activities and

existing limitations of the State-level cancer registry, and addresses

the following issues: a description of all existing and potential

sources of cancer cases (5 points); a description of existing

computerized cancer reporting systems in the State (2 points); a

description of centralized cancer reporting in the State including

assessment of data items, completeness, timeliness and quality, data

processing and use of data (5 points); a description of cancer data

currently collected (5 points); a review of ``enabling'' legislation

and regulations (4 points); and, a description of existing computer

hardware and software (4 points).

B. Collaboration: (15 Points)

The extent to which the applicant describes past, current, and

proposed collaboration with the relevant organizations and agencies

within the State; with other States or national organizations; with

federally-funded health care programs such as the Breast and Cervical

Cancer Early Detection Program, Department of Veterans Affairs,

Military and Armed Forces Facilities, the National Cancer Institute's

Surveillance, Epidemiology, and End Results Program, and Indian Health

Service in States with Native American populations.

C. Proposed Objectives: (20 Points)

The extent to which objectives are specific, measurable, time-

phased, and realistic; provide for outcome and process objectives which

meet the requirements of Pub. L. 102-515; and are derived from needs

identified in the resources and needs assessment.

D. Proposed Implementation Schedule: (15 Points)

The extent to which the major steps required for project

implementation are described and the project timetable displays dates

for the accomplishment of specific project activities.

E. Data Utilization: (10 Points)

The extent to which the applicant provides a relevant and realistic

plan to use cancer registry data within the State for cancer control.

F. Project Management and Staffing Plan: (15 Points)

The extent to which proposed staffing, organizational structure,

staff experience and background, identified training needs or plan, and

job descriptions and curricula vitae for both proposed and current

staff indicate ability to carry out the purposes of the program.

G. Budget: (Not Scored)

The extent to which the applicant provides a detailed budget and

justification consistent with the stated objectives and program

activities.

H. (OPTIONAL) Operational Plan for Building Public Health Information

Infrastructure: (10 Points--Scored Separately)

The extent to which objectives and plans:

1. Increase the technical capacity in their State cancer registry

to link databases;

2. Complete retrospective case ascertainment and data abstraction

for diagnosis years 1990, 1991, 1992 and 1993; or

3. Establish a statewide electronic network.

(No penalty for NOT undertaking OPTIONAL activities).

Applications for Part II

Applications for programs to plan and implement a statewide,

population-based cancer registry will be reviewed and evaluated

according to the following criteria: (Maximum 110 points)

A. Resources and Needs Assessment: (25 Points--Allocated as Noted

Below)

The extent to which the applicant describes current and proposed

activities for, and existing limitations to, the statewide cancer

registry and extent to which the applicant addresses the following

issues: A description of all potential sources of cancer cases (5

points); a description of all existing computerized cancer reporting

systems in the State (2 points); a description of cancer reporting in

the State including data items, assessment of completeness, timeliness

and quality, staff, data processing and use of data (5 points); a

description of cancer data currently collected (5 points); a review of

``enabling'' legislation and regulations (4 points); and, a description

of computer hardware and software needs (4 points).

B. Collaboration: (20 Points)

The extent to which the applicant describes proposed collaboration

with relevant organizations and agencies, such as an advisory

committee; other organizations within the State; universities, the

health care community, hospital associations, and professional

associations such as the American Cancer Society; other States or

national organizations; and federally-funded health care programs such

as the Breast and Cervical Cancer Early Detection Program, Department

of Veterans Affairs, Military and Armed Forces Facilities, the National

Cancer Institute's Surveillance, Epidemiology, and End Results Program,

and Indian Health Service in States with Native American populations.

C. Proposed Objectives: (25 Points)

The extent to which objectives are specific, measurable, time-

phased, and realistic; provide for outcome and process objectives which

meet the requirements of Pub. L. 102-515; and are derived from needs

identified in the resources and needs assessment.

D. Proposed Implementation Schedule: (10 Points)

The extent to which the major steps required for project

implementation are described and the project timetable displays dates

for the accomplishment of specific project activities.

E. Data Utilization: (10 Points)

The extent to which the applicant provides a relevant and realistic

plan to use cancer registry data within the State for cancer-control.

F. Project Management and Staffing Plan: (10 Points)

The extent to which proposed staffing, organizational structure,

staff experience and background, identified training needs or plan, job

descriptions and resumes for both proposed and current staff indicate

ability to carry out the purposes of the program.

G. Budget: (Not Scored)

The extent to which the applicant provides a detailed budget and

justification consistent with the stated objectives and program

activities.

H. (OPTIONAL) Operational Plan for Building Public Health Information

Infrastructure: (10 Points--Scored Separately)

The extent to which objectives and plans:

1. Increase the technical capacity in their State cancer registry

to link databases;

2. Complete retrospective case ascertainment and data abstraction

for diagnosis years 1990, 1991, 1992 and 1993; or

3. Establish a statewide electronic network.

(No penalty for NOT undertaking OPTIONAL activities).

Funding Priorities

Priority will be given to Part I or Part II applications providing

evidence for authorization under State law of the statewide cancer

registry and regulations providing for cancer reporting, case

confidentiality and use of cancer data for research as specified in

Pub. L. 102-515, Sec. 399H(b)(2)(D).

Notice of Typographical Error in Public Law 102-515

In Sec. 399I. Planning Grants Regarding Registries. (a)(1),

``section 399B(c)(2)'' should read ``section 399H(c)(2)''.

Executive Order 12372 Review

Applications are subject to Intergovernmental Review of Federal

Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets

up a system for State and local government review of proposed Federal

assistance applications. Applicants should contact their State Single

Point of Contact (SPOC) as early as possible to alert them to the

prospective applications and receive any necessary instructions on the

State process. For proposed projects serving more than one State, the

applicant is advised to contact the SPOC for each affected State. A

current list of SPOCs is included in the application kit. If SPOCs have

any State process recommendations on applications submitted to CDC,

they should send them to Edwin L. Dixon, Grants Management Officer,

Grants Management Branch, Procurement and Grants Office, Centers for

Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE.,

Atlanta, GA 30305. (The receipt date for SPOC comments will be 60 days

after the application deadline date.) The Program Announcement Number

and Program Title should be referenced on the document. The granting

agency does not guarantee to ``accommodate or explain'' the State

process recommendations it receives after that date.

Public Health System Reporting Requirements

This program is not subject to the Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic Assistance Number is 93.283.

Other Requirements

Program Assurance

Recipients of funds for both Part I or Part II must provide as part

of their application for such funds assurances that:

1. The recipient will comply with the peer review requirements

under Sections 491 and 492 of the Public Health Service Act

(Institutional Review Board; Ethics Guidance Program, 42 U.S.C. 289 and

Peer Review Requirement 42 U.S.C. 289a). [Sec. 399 H(c)(1)]

2. Recipients of funds under Part I or Part II must provide, as

part of their application, assurances they will comply with the

requirements listed below (Items ``A'' through ``D''):

A. Provide for the establishment and support of a registry in

accordance with the requirements of this program announcement.

B. Comply with the following standards of completeness, timeliness,

and quality of population-based cancer registry data:

(1) Data completeness: 95% of unduplicated, expected malignant

cases of reportable cancer occurring in State residents in a diagnosis

year are reported to the State cancer registry.

(2) Data timeliness: cancer cases will be reported to the State

registry within six months of diagnosis date.

(3) Data quality: comply with standards for data quality including

standardized data format as promulgated by the American Association of

Central Cancer Registries (AACCR) as stated in ``Standards for

Completeness, Quality, Management, and Analysis of Data, Standards for

Cancer Registries'', Volume III, (December 1993).

C. Within one year of the close of the diagnosis year,

(1) Provide for annual reports of cancer data, including a

published report, that conforms to standards for completeness and

timeliness (as listed under ``Program Assurances''), and

(2) Prepare and maintain ``in house'', a corresponding minimal data

set that meets uniform data standards recommended by AACCR (Reference

AACCR Standards, Volumes II and III).

D. Provide for the authorization under State law of the statewide

cancer registry, including the promulgation of regulations that:

(1) Assure complete reporting by hospitals and other facilities.

(2) Assure complete reporting by physicians, surgeons, and all

other health care practitioners diagnosing or providing treatment for

cancer patients.

(3) Permit the statewide cancer registry to access all records that

would identify cases of cancer or would establish characteristics of

the cancer, treatment of the cancer, or medical status of any

individual patient.

(4) Report cancer case data to the statewide cancer registry in

such a format, with such data elements, and in accordance with such

standards of quality, timeliness, and completeness, as may be

established by CDC.

(5) Protect the confidentiality of all cancer data reported to the

statewide registry, including a prohibition on disclosure to any person

of information reported to the statewide registry that identifies or

could lead to the identification of an individual cancer patient,

except for disclosure to other State cancer registries and local and

State health officials.

(6) Disclose confidential case data, in accordance with State law,

to cancer researchers.

(7) Authorize the conduct, by the statewide cancer registry or

other persons and organizations, of studies utilizing statewide cancer

registry data.

(8) Protect individuals complying with the law, including

provisions specifying that no person shall be held liable in any civil

action with respect to a cancer case report provided to the statewide

cancer registry, or with respect to access to cancer case information

provided to the statewide cancer registry. [Sec. 399H(c)(2)(D)].

Recipients of funds under Part I or Part II must provide, as part

of their application, assurances that they will provide for the

authorization under State law of the statewide cancer registry,

including the promulgation of regulations within one year and within

two years, respectively. Continued funding will be contingent on the

enactment of authorizing State legislation and promulgation of all

required State regulations.

Human Subjects

If the proposed project involves research on human subjects, the

applicant must comply with the Department of Health and Human Services

Regulations, 45 CFR part 46, regarding the protection of human

subjects. Assurance must be provided to demonstrate that the project

will be subject to initial and continuing review by an appropriate

institutional review committee. The applicant will be responsible for

providing assurance in accordance with the appropriate guidelines and

form provided in the application kit.

Application Submission and Deadline

The Program Announcement and application kit were sent to all

eligible applicants in March 1994.

Where To Obtain Additional Information

A complete program description, information on application

procedures, an application package and business management technical

assistance may be obtained from Leah D. Simpson, Grants Management

Specialist, Grants Management Branch, Procurement and Grants Office,

Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry

Road, NE., room 314, Mailstop E-18, Atlanta, GA 30305, telephone (404)

842-6803.

Programmatic technical assistance may be obtained from Rosemarie

McIntyre, M.S., Epidemiology and Statistics 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-55, Atlanta, GA 30341-3724,

telephone (404) 488-4682.

Please refer to Announcement 426 when requesting information and

submitting an application.

Potential applicants may obtain a copy of ``Healthy People 2000''

(Full Report, Stock No. 017-001-00474-0) or ``Healthy People 2000''

(Summary Report, Stock No. 017-001-00473-1) referenced in the

``Introduction'' through the Superintendent of Documents, Government

Printing Office, Washington, DC 20402-9325, telephone (202) 783-3238.

Copies of the following may be obtained by calling DeVicki Willis,

Centers for Disease Control and Prevention (CDC) at (404) 488-4682:

(1) American Association of Central Cancer Registries, ``Working

Group on Pre-Invasive Cervical Neoplasia and Population-Based Cancer

Registries, Final Subcommittee Report,'' (April 1993);

(2) American Association of Central Cancer Registries, ``Data

Standards, Standards for Cancer Registries,'' Volume II, (September

1993);

(3) American Association of Central Cancer Registries, ``Standards

for Completeness, Quality, Management, and Analysis of Data, Standards

for Cancer Registries,'' Volume III, (December 1993).

Dated: May 18, 1994.

Ladene H. Newton,

Acting Associate Director for Management and Operations, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 94-12596 Filed 5-23-94; 8:45 am]

BILLING CODE 4163-18-P