[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