[Federal Register Volume 59, Number 99 (Tuesday, May 24, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12596]


[[Page Unknown]]

[Federal Register: May 24, 1994]


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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