Federal Register, Volume 70 Issue 99 (Tuesday, May 24, 2005)

[Federal Register Volume 70, Number 99 (Tuesday, May 24, 2005)]
[Notices]
[Pages 29747-29759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-10296]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Colorectal Cancer Screening Demonstration Program

Announcement Type: New.
Funding Opportunity Number: RFA AA030.
Catalog of Federal Domestic Assistance Number: 93.283.
Key Dates: Letter of Intent (LOI) Deadline: June 8, 2005.
Application Deadline: July 8, 2005.
Executive Summary: Colorectal Cancer (CRC) is the second leading
cause of cancer-related deaths in the United States, following lung
cancer (1-American Cancer Society 2005, see Attachment D). Strong
scientific evidence indicates that regular screening is effective in
reducing CRC incidence and mortality (2--Mandel 1993, 3--Mandel 2000,
4--Selby 1992, 5--Kronburg 1996, 6--Hardcastle 1996, see Attachment D).
Screening rates for CRC are currently lower than other cancer
screening services (7--Seeff 2004). CRC screening is already occurring
in some communities, either in an organized or an opportunistic
setting. Some communities are planning to begin screening, but are
still building their infrastructure and/or resources.
The Centers for Disease Control and Prevention (CDC) announce the
availability of funds in fiscal year (FY) 2005 for three to five
cooperative agreements to implement demonstration programs designed to
increase population-based CRC screening among persons 50 years and
older in a geographically defined area, with screening efforts focused
on persons 50 years and older with low incomes and inadequate or no
health insurance coverage for CRC screening (priority population).
Applicants will need to define the geographic area that their program
will cover. Applicants will be asked to describe their current CRC
screening efforts and to define what they need to increase CRC
screening rates in these two populations: (1) The larger
geographically-defined population; and (2) the priority sub-population
within that geographically-

[[Page 29748]]

defined area. CDC will choose among applicants based on specific
evaluation criteria described in this RFA. These will be three year
demonstration programs, pending availability of funds.

I. Funding Opportunity Description

Authority: This program is authorized under section 317(k)(2) of
the Public Health Service Act, [42 U.S.C. section 247b(k)(2)], as
amended.
Background: Colorectal Cancer (CRC) is the second leading cause of
cancer-related deaths in the United States, following lung cancer (1).
Screening for CRC works both through the identification and removal of
precancerous polyps, and the early detection of cancers. Strong
scientific evidence indicates that regular screening is effective in
reducing CRC incidence and mortality (2-6). Randomized controlled
trials have demonstrated a reduction in CRC incidence and mortality
with annual and biennial fecal occult blood testing (FOBT) and case-
control studies have shown a reduction in CRC mortality associated with
the use of sigmoidoscopy. Indirect evidence supports the effectiveness
of colonoscopy and double-contrast barium enema (DCBE) for use as CRC
screening tests.
Based on scientific evidence, national guidelines have been
developed recommending regular CRC screening for average-risk persons
with one or more of the following options: FOBT, sigmoidoscopy, FOBT
and flexible sigmoidoscopy in combination; colonoscopy, and/or DCBE.
The U.S. Preventive Services Task Force (USPSTF) strongly recommends
that clinicians screen men and women 50 years of age or older for CRC
and give an ``A'' recommendation to regular CRC screening with one of
the above listed testing options. Fecal Immunochemical Testing (FIT) is
considered an acceptable alternative to FOBT. These tests vary in their
costs, availability, and associated risks, and current evidence does
not clearly demonstrate which of these tests is most effective.
National survey data show that only approximately half of eligible
adults have been screened for CRC according to recommended guidelines.
A number of factors are likely contributing to low screening rates
including: (1) Lack of knowledge by the public that CRC is common and
screening is effective; (2) lack of physician recommendations to get
regular screening; (3) lack of a regular health care provider; (4)
patient embarrassment, fear of cancer, poor reimbursement; (5) limited
insurance coverage for CRC screening or lack of insurance; and (6) lack
of organized systems where screening and follow-up may be conducted.
Other barriers may exist which are recognized in community settings but
not documented in published literature.
Purpose: The purpose of this program is to establish demonstration
programs to increase population-based CRC screening among persons 50
years and older in a geographically defined area, and to focus
screening efforts on persons with low incomes and inadequate or no
health insurance coverage for CRC screening. This program addresses the
``Healthy People 2010'' focus area Cancer, specifically to increase the
proportion of adults who receive a colorectal screening examination.
http://www.healthypeople.gov/Document/pdf/Volume1/03Cancer.pdf.
Measurable outcomes of the program will be: To increase the CRC
screening rate among persons 50 years and older in a geographically
defined area overall (as defined by the applicant), and among persons
50 years and older within that geographically-defined area with low
incomes and inadequate or no health insurance coverage for CRC
screening in particular. The CRC screening demonstration programs will
need to set their own goal for a projected increase in the number or
percentage of CRC screens. Screening rates using one or a combination
of the following tests will be measured: FOBT or FIT annually,
sigmoidoscopy every 5 years, FOBT and flexible sigmoidoscopy in
combination; colonoscopy every 10 years, and/or DCBE every 5 years. No
CDC Government Performance and Results Act (GPRA) measure currently
addresses CRC screening.
This announcement is only for non-research activities supported by
CDC/ATSDR. If research is proposed, the application will not be
reviewed. For the definition of research, please see the CDC Web site
at the following Internet address: http://www.cdc.gov/od/ads/opspoll1.htm.
Special Guidance for Technical Assistance: Technical assistance
will be available for potential applicants on two one-hour conference
calls, one morning and one evening, scheduled one week after the LOIs
are due. Please call 1-888-455-5920 and enter conference passcode 50260
at 3 p.m. EST on Wednesday June 22, 2005 or 1-888-455-5920 and enter
conference passcode 32070 at 9 a.m. on Thursday June 23, 2005.
Activities: Cooperative agreement applicants do not have to request
funding for each of the program components described below. Awardee
activities for this program may include, but are not limited to the
activities listed below:

1. Program Management

a. Establish specific, measurable, and realistic short-term (one
year) and long-term (three year) objectives consistent with the purpose
of this program announcement for the accomplishment of the program
activities, including the establishment of realistic screening goals.
b. Recruit and develop staff to maintain the program.
c. Develop a fiscal system that tracks and monitors program
expenditures and ensures the accurate and timely reimbursement of
services provided by the program.
d. Develop accurate budget requests that correspond with program
workplans and prepare/submit required reports on a timely basis.
Performance will be measured by the extent to which the program (1)
establishes specific, measurable and realistic objectives (including
realistic screening goals); (2) hires/identifies and maintains
qualified staff; (3) spends funding efficiently and effectively; and
(4) effectively addresses problems as they arise.

2. Provision of Screening and Diagnostic Follow-up Services

a. Provide CRC screening and diagnostic follow-up services for
persons 50 years and older with low incomes and inadequate or no health
insurance coverage for CRC screening in organized, CRC screening
demonstration programs. A more specific priority population can be
proposed if this can be justified. The level of poverty of the priority
population will be defined by the applicant (typically at or below 250
percent or 200 percent of the Federal poverty level). In the absence of
data suggesting which screening test is most effective, grantees will
be given flexibility in the selection of screening tests with two
important caveats: (1) Grantees can only offer screening tests for
which test availability has been assessed and capacity has been
demonstrated; and (2) grantees can only offer screening tests
recommended by the U.S. Preventive Services Task Force (USPSTF). Since
FIT is considered an acceptable alternative to FOBT, it will be a
reimbursable service within these programs as an alternative to FOBT,
if the program desires. Acceptable tests include:
Guaiac-based FOBT annually (at-home only).

[[Page 29749]]

Immunochemical FOBT (FIT annually will be considered as an
alternative to FOBT).
Flexible sigmoidoscopy every five years.
Double-contrast barium enema every five years.
Colonoscopy every ten years.
b. Implement a program design that offers a single screening test
or multiple screening tests. The selection of screening tests offered
in the demonstration program may change over the three year period
pending prior approval and availability of funds, if a program finds
that a test is not in demand among the priority populations or if a
newer test is added to USPSTF guidelines during the funding period.
c. Demonstrate readiness to begin offering screening services
within six months of award. Elements which will be evaluated to
determine readiness include: (1) The identification of providers to
perform screening and follow-up service, and to provide care in the
event of unanticipated complications; (2) a plan to recruit persons for
screening from the larger geographically-defined population and the
priority population; (3) a final set of data quality indicators,
defined in collaboration with CDC, to be used by the grantees and CDC
in assessing the quality of the services provided within the
demonstration programs; (4) a final data collection and tracking
system; and (5) a plan and funding sources to provide treatment for
those persons in whom cancers are identified. CDC will make a site
visit within six months of award to assess readiness and approve
commencement of screening activities.
Performance will be measured by the extent to which the applicant
(1) increases the number of people screened within both the defined
geographic area and the priority population; and (2) meets the
projected number of screens or the proportional increases in screening
as set by the program.

3. Public Education and Outreach

a. Develop and carry out strategies to increase awareness about CRC
screening including building on existing public education efforts at
the local, state and national level that are consistent with evidence-
based interventions recommended in the Community Guide to Preventive
Services. Programs may utilize campaign materials from CDC's Screen for
Life: National Colorectal Cancer Action Campaign ``Screen for Life,''
which can be tagged for individual program use.
b. Develop and implement an outreach workplan that includes a mix
of broad-based activities and one-on-one outreach, using methods known
to be effective in reaching priority populations for CRC screening.
Performance will be measured by the extent to which (1) the program
can demonstrate the appropriate and effective use of public education
and outreach strategies and (2) CRC screening rates are increasing in
both the geographically defined area and the priority population.

4. Quality Assurance/Professional Development

a. Establish standards, systems, policies and procedures to
maintain quality services, including tracking and follow-up systems to
assure the provision of appropriate and timely follow-up of all
abnormal screening results and/or diagnoses of cancer.
b. Change/develop systems or policies to better support high
quality CRC screening and related care based on an assessment and
prioritization of needs.
c. Identify a plan and funding sources to provide treatment for
anyone diagnosed with cancer in the demonstration program.
d. Identify a plan to provide treatment for anyone who incurs an
unanticipated medical complication from services offered within the
demonstration program.
e. Convene a medical advisory board to provide oversight of the
quality of services being delivered throughout the three year funding
period. CDC will be providing medical and clinical technical assistance
to individual programs, and will convene a federal-level CRC
Demonstration Screening Program Workgroup to assist in the development
of overall program policies and procedures.
f. Develop or enhance initiatives to educate and train health
professionals in the detection and control of CRC, including quality of
screening and follow-up care.
Performance will be measured by the extent to which the program (1)
establishes and uses quality indicators, systems and policies/
procedures to monitor and measure the quality of services provided,
including a medical advisory board and; (2) successfully conducts
appropriate and timely follow-up of abnormal test results and provides
referrals to treatment, staging, clinical evaluation of symptoms or
treatment of unanticipated complications.

5. Partnership Development and Maintenance

a. Maintain a relationship with the CDC-funded comprehensive cancer
control (CCC) implementation program(s) (and their coalitions) within
the applicant's state(s) to ensure coordination and integration of
program activities with related CCC activities, including alignment of
program activities with CCC plans.
b. Develop and maintain collaborative partnerships with a diverse
set of entities (such as patients, cancer survivors, community-based
organizations, groups that serve or represent priority populations,
human service agencies, public health agencies, voluntary agencies,
public and private local businesses and employers, nonprofit agencies
and institutions, medical providers and health care system
representatives) to enhance the design and implementation of the
program.
Performance will be measured by the extent to which the program:
(1) Demonstrates a strong association with the CCC program/coalition;
(2) has included any appropriate and diverse additional partners in
program planning; (3) has obtained and can show commitment from
participating partners; (4) has documented the roles that partners and
CCC Coalition members will play; (5) has obtained representation from
the priority populations and has clearly defined a role for
representatives from priority populations in program design and
implementation. A listing of all CDC-funded CCC programs
(implementation level) is provided with this RFA as Attachment A.

6. Data Collection and Tracking

a. Adapt current data collection system and develop data reports to
be submitted to CDC related to CRC screening and other clinical and
program activities that are part of this demonstration project. Please
see Attachment B, Tables B-1 and B-2. These tables represent draft data
items that CDC is proposing should be collected by the grantees to
assess the quality and appropriateness of the services provided within
the demonstration programs. Grantees will be asked to propose data
items they feel would be most effective in showing an increase in
screening in both the geographically-defined population and the
priority population. Grantees will also be asked to propose the best
manner in which to collect these data. Using the information proposed
by grantees and the draft tables in Attachment B, grantees will work
with CDC to finalize an agreed upon set of data items, similar to those
in the draft tables. Grantees must assure that the data collected at
the individual patient-level will be sufficient for grantees to be able
to track the quality and timeliness

[[Page 29750]]

of care (including treatment and routine recall) and will adhere to
current standards related to data-sharing, data security and patient
confidentiality. All submitted data must be de-identified.
Some applicants may only request funds for components of this
program other than screening service delivery. Even if an applicant
chooses to use non-CDC funding sources to fund their screening service
delivery component, all grantees will be required to submit data on the
CRC screening and diagnostic services delivered as part of this
demonstration project.
b. For grantees that request CDC funds for the screening service
delivery component of this program: Collect individual patient-level
data to capture clinical services and outcomes and submit aggregate
data to CDC. Aggregated data reports will include the proportion of
persons within the geographic area defined by the grantee receiving the
specific clinical services offered within this program, by each of the
demographic variables (for example, a report may include the proportion
of persons within the defined geographic area receiving FOBT by age,
gender, race, ethnicity, and income level). Develop data quality
indicators, in conjunction with CDC, to be used by the grantees and CDC
in assessing the quality of the services provided within the
demonstration programs. Grantees may be asked by CDC to submit
individualized data if submitted aggregate data do not meet data
quality indicator standards. The data included in Attachment B, Draft
Table B-1, ``Patient-Related Data Elements,'' variable domains 1-7,
represent the type of information submitted by the program to CDC that
CDC will use to monitor the quality of services delivered (1-unique
identifiers, 2-demographics, 3-screening history, 4-screening
information, 5-diagnostic procedures provided, 6-cancer/polyp
diagnosed, 7-treatment). Final data elements used to obtain this
information will be agreed upon by CDC and the grantees. During the
three year program period, CDC may begin requiring all data submissions
from grantees that receive CDC funds for screening services to be
individual patient-level data, pending approval from the Office of
Management and Budget (OMB).
c. For grantees that do NOT request CDC funds for the screening
service delivery component of this program: collect individual patient-
level data but submit aggregate patient-level data to CDC. Develop data
quality indicators, in conjunction with CDC, to be used by the grantees
and CDC in assessing the quality of the services provided within the
demonstration programs. Submissions will be similar to data received
from grantees described above in (b), but will be aggregate, and not
individual-level. Grantees may be asked by CDC to submit individualized
data if submitted aggregate data do not meet quality indicator
standards.
d. All programs will submit annual program-level data to CDC to be
used to monitor cost and cost-effectiveness, funding sources, program
design and an increase in population-based screening over the three
year program period for the geographically-defined area chosen by the
grantee. The types of data included in Draft Table B-2, ``Program-
Related Data Elements,'' variable domains 1-4, will be required for
submission to CDC (program costs, funding sources, description of
health care delivery systems and population-level screening prevalence
data). Final data elements used to obtain this information will be
agreed upon by CDC and the grantees.
e. The remaining variable domains from both tables are proposed
items that grantees may choose to collect. If programs would like to
collect data items beyond those outlined in Attachment B, they will
need to provide justification.
Performance will be measured based upon: (1) The extent to which
tracking and data collection procedures are in use and form the basis
for quality assurance processes; and (2) the submission of timely and
complete data to CDC.

7. Patient Support

Programs will establish a patient support system to assure that
appropriate screening services are offered, appropriate diagnostic
follow-up is received, appropriate treatment is begun, and that any
appropriate services necessary but not provided by the program are
begun, such as triaging patients with GI symptoms out of the screening
program, to be seen immediately for appropriate diagnostic testing. A
system for the follow-up and referral of a person whose screening test
results are abnormal or suspicious is an essential component of any
comprehensive early detection program. In some instances, diagnostic
testing can be accomplished during the screening test (e.g., if
colonoscopy is used). Clients needing treatment services should be
counseled about their eligibility for public-supported third party
payment and reimbursement programs, if such programs exist. Activities
under patient support should include:
Follow-up of positive screening test results. If any of
the program-selected screening tests other than colonoscopy are
positive, they should be followed by a diagnostic colonoscopy.
Triage of patients to the appropriate health care provider
if they are found to have GI symptoms at program enrollment.
Triage of patients to the appropriate health care provider
if they are found to be at increased risk for CRC at program
enrollment.
Referral of patients for staging or treatment. Programs
must provide appropriate referrals for medical treatment of persons
screened in the program and must ensure, to the extent practicable, the
provision of appropriate follow-up services.
Performance will be measured by the extent to which the program
establishes a system for patient support to assure appropriate follow-
up and referral.

8. Evaluation of the Effectiveness of the Program

Design an evaluation plan to be used to conduct evaluation of
demonstration program activities and improve the quality, effectiveness
and efficiency of program operations.
Performance will be measured by the extent to which programs use
objective, quantitative measures to demonstrate the accomplishment of
program goals, objectives, and intended outcomes and to make program
improvements.

9. Other

Programs may identify other activities that they must pursue in
order to effectively increase CRC screening in their geographically-
defined area and the priority population. Such activities, along with
their justification, must be fully described in the application,
particularly if funding for those activities is being sought.
We anticipate that all funded programs will include the same basic
program activities, although the focus of the activities may differ
slightly across programs. Because applicant needs may differ, not all
programs will require funding for every program activity.
In a cooperative agreement, CDC staff is substantially involved in
the program activities, above and beyond routine grant monitoring.
CDC Activities for this program are as follows:
Provide technical assistance to recipients in the
development, administration, and evaluation of the program efforts to
implement organized community-based CRC screening demonstration
programs.
Assist in the adaptation of existing data collection
strategies and tools to be able to collect data to monitor program

[[Page 29751]]

effectiveness and tracking for this CRC screening demonstration
program. Before screening services are offered under this program, CDC
will evaluate proposed data collection plans.
Evaluate aggregate patient and program-level data received
by the grantees and use the results so that CDC can follow program
activities and provide quality assurance, help grantees strengthen
their programs, make mid-course corrections and document successes. For
grantees who only submit aggregate patient-level data (those who do NOT
receive CDC funds for screening), if submitted aggregate patient-level
data do not meet quality indicator standards, CDC may request
individualized data and will work with the grantee to resolve data
questions.
Review and assist with refining the evaluation plan
designed/proposed by the grantee to make sure it will be adequate to
monitor the goals and objectives of this program. Work closely with
grantees throughout the three year funding period to assist programs
with evaluation of their demonstration programs and to assure adequate
documentation of successes and sharing of applicable strategies and
tools across programs.
Work with grantees to finalize a set of data quality
indicators to be used by the grantees and CDC in assessing the quality
of the services provided within the demonstration programs.
Within the first six months, advise on the design of a
data collection approach, to make sure that the proposed approach is
reasonably certain to achieve the goals of this program. Determine with
the funded program that screening services and data collection are
ready to begin.
Provide patient and health care provider education
materials from CDC's Screen for Life: National Colorectal Cancer Action
Campaign, such as brochures, fact sheets, medical office displays, etc.
which can be adapted as necessary.
Regularly review the literature to ensure that grantees
are being provided technical assistance and consultation that reflects
the most up-to-date science and practice.
Convene a CRC Demonstration Screening Program Workgroup,
to help oversee program activities and address clinical and other
issues.
Convene a meeting of the funded programs for information
sharing, problem solving, and training at least annually.
Conduct a site visit within the first six months of award
to assure program readiness, and subsequently, to assess program
progress and mutually resolve problems, as needed.
Assess program readiness by addressing the following
issues: (1) The identification of providers to perform screening and
follow-up service, and to provide care in the event of unanticipated
complications; (2) a final data collection and tracking system; (3) a
plan and funding sources to provide treatment for those persons in whom
cancers are identified; (4) a plan for the use of quality indicators to
evaluate the appropriate use of clinical services and (5) a plan for
recruiting individuals for screening in their geographically-defined
area and the priority population.

II. Award Information

Type of Award: Cooperative Agreement. CDC involvement in this
program is listed in the Activities Section above.
Fiscal Year Funds: 2005.
Approximate Total Funding: $2,000,000.
Approximate Number of Awards: Three to Five.
Approximate Average Award: $600,000. (This amount is for the first
12-month budget period, and includes both direct and indirect costs.)
Floor of Award Range: None.
Ceiling of Award Range: None.
Anticipated Award Date: August, 2005.
Budget Period Length: 12 months.
Project Period Length: Three years.
Throughout the project period, CDC's commitment to continuation of
awards will be conditioned on the availability of funds, evidence of
satisfactory progress by the recipient (as documented in required
reports), and the determination that continued funding is in the best
interest of the Federal Government.

III. Eligibility Information

III.1. Eligible Applicants

To be eligible, applicants must demonstrate a relationship with a
CDC funded CCC program (implementation level) within their state(s).
Applicants will need to clearly define the geographic area covered by
their proposed program.
Applications may be submitted by public and private nonprofit
organizations and by governments and their agencies, such as:
Public nonprofit organizations
Private nonprofit organizations
Universities
Colleges
Research institutions
Hospitals
Community-based organizations
Cancer Centers
Community Health Centers
Regional Hospital Systems
Large Physician Group Practices
Health Maintenance Organizations
Large Public Employers, that do not provide coverage for
cancer screenings
Defined Metropolitan Areas
Rural health organizations/consortia
Multi-federal agency consortium covering a defined
geographic area
Other large defined health care systems
Federally recognized Indian tribal governments
Indian tribes
Indian tribal organizations
State and local governments or their Bona Fide Agents
(this includes the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, the Commonwealth of the Northern Marianna
Islands, American Samoa, Guam, the Federated States of Micronesia, the
Republic of the Marshall Islands, and the Republic of Palau)
Political subdivisions of States (in consultation with
States)
A Bona Fide Agent is an agency/organization identified by the state
as eligible to submit an application under the state eligibility in
lieu of a state application. If you are applying as a bona fide agent
of a state or local government, you must provide a letter from the
state or local government as documentation of your status. Place this
documentation behind the first page of your application form.

III.2. Cost Sharing or Matching

Matching funds are not required for this program.

III.3. Other

Special Requirements
If your application is incomplete or non-responsive to the special
requirements listed in this section, it will not be entered into the
review process. You will be notified that your application did not meet
submission requirements.
Late applications will be considered non-responsive. See
section ``IV.3. Submission Dates and Times'' for more information on
deadlines.
To be eligible, applicants must demonstrate a relationship
with a CDC-funded CCC program (implementation level) within their
state(s) by providing a letter of support (in the application
appendices) from the CDC funded CCC program (implementation level)
indicating support for the CRC

[[Page 29752]]

demonstration screening program. Applications that do not contain a
letter of support from the CDC funded CCC program (implementation
level) will not be considered for review. More than one application can
be submitted per state, but only one application per state will be
selected by CDC. Applicants will need to clearly define the geographic
area that their program will cover.

Note: Title 2 of the United States Code Section 1611 states that
an organization described in Section 501(c)(4) of the Internal
Revenue Code that engages in lobbying activities is not eligible to
receive Federal funds constituting an award, grant, or loan.

IV. Application and Submission Information

IV.1. Address To Request Application Package

To apply for this funding opportunity use application form PHS
5161-1.
CDC strongly encourages you to submit your application
electronically by utilizing the forms and instructions posted for this
announcement at http://www.grants.gov.
Application forms and instructions are available on the CDC Web
site, at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
If you do not have access to the Internet, or if you have
difficulty accessing the forms on-line, you may contact the CDC
Procurement and Grants Office Technical Information Management Section
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to
you.

IV.2. Content and Form of Submission

Letter of Intent (LOI): Your LOI must be written in the following
format:
Maximum number of pages: Two
Font size: 12-point unreduced
Single spaced
Paper size: 8.5 by 11 inches
Page margin size: One inch
Printed only on one side of page
Written in plain language, avoid jargon
Your LOI must contain the following information:
Program title and number listed in this RFA
Type of organization submitting the application
Name of the organization submitting the application
Amount of funding request
Official contact person's name, telephone number, fax
number, mailing address and e-mail address
Application: You must submit a project narrative with your
application forms. The narrative must be submitted in the following
format:
Maximum number of pages: 30. If your narrative exceeds the
page limit, only the first pages which are within the page limit will
be reviewed.
Font size: 12 point unreduced
Double spaced
Paper size: 8.5 by 11 inches
Page margin size: One inch
Printed only on one side of page
Held together only by rubber bands or metal clips; not
bound in any other way.
All activities designed to reach the objectives of the RFA need to
be described. Even if an applicant determines that one or several pre-
existing program activities do not require CDC resources, a description
of those activities must be included in the application, and those
elements will be evaluated.
Your narrative should address activities to be conducted over the
entire project period, and must include the following items in the
order listed:
Executive Summary
Applicants should provide a clear, concise one to two page summary
to include:
Description of the community where the program will take
place, including the geographic boundaries.
A short description of existing or proposed CRC screening
program, including priority population to be screened.
Amount of funding requested.
Background and Need
Describe the need for this program within the proposed
geographically-defined population and among the priority population.
The following information should be included:
Description and size of larger geographically-defined
population and the priority population for the program (if a different
priority population is chosen from what is defined in this RFA, the
applicant must provide a justification for choosing that priority
population).
Description of the burden of CRC within the community/
population.
Proportion of the priority population currently screened.
Existing and Proposed Program Description (including Capacity)
Describe the existing and/or proposed program in detail including:
All program components, including those outlined in the
``Activities'' section of this RFA and any additional activity proposed
by the applicant.
Which program activities are already existing (if any) and
which will/will not be supported by CDC funding.
Methods for data collection designed to show an increase
in screening in both the geographically defined population and the
priority population. Include a list of proposed data elements, a
proposed plan to gather those data, and plans for assuring data
security, protecting patient confidentiality and de-identifying data.
Which screening and diagnostic tests will be used and the
rationale for the selection of screening and diagnostic tests.
The number of new clients expected to be screened.
A description of how the priority population will be
reached.
Overall capability of providing the program, including the
applicant's history and experience with proposed activities and
services related to providing colorectal screening.
The capacity to offer these tests to the intended
audience, including the identification of providers and a follow-up/
referral plan.
Program Management
Describe the organization's structure and function, size,
activities and methods of routine communication with staff. Describe
each current or proposed staff position for this initiative by job
title, function, education and experience, general duties, and
activities with which that position will be involved. Describe a
proposed fiscal system to track and monitor program expenditures and to
ensure the accurate and timely reimbursement of services provided by
the program.
Workplan
The applicant should provide a detailed work plan for the first
year that describes how the proposed activities will be conducted. The
work plan should include the following:
Objectives: Specific, realistic, time-phased and
measurable short-term (one year) and long-term (three year) objectives
consistent with the intent of this program announcement, including
targets for screening. The first six months will be for start up, to
include finalizing the data collection system with CDC, finalizing the
evaluation plan with CDC, and implementing all start up activities so
that service delivery may begin within six months of award.
Activities: Specific activities and strategies that will
be undertaken to achieve each of the proposed short-term objectives
during the budget period.
Time Line: A time line for assessing progress in meeting
objectives.
Staff Responsibility: Staff responsible for completion of
activities.

[[Page 29753]]

Measures of Effectiveness: How activities and their impact
will be evaluated, including indicators of program success.
Data: A list of sources that will be used to gather
information on measures of effectiveness.
Grantees may choose to use the attached work plan format to present
this information (See Attachment C of this RFA).
Collaborative Activities
Describe existing or proposed partnership to support the program,
including linkages with the appropriate CCC implementation program(s)
and coalition partners. Describe a process for maintaining a
relationship with the CCC program/coalition and ensuring that program
activities are aligned with CCC plan strategies related to CRC. Provide
a letter of support from the CCC Coalition that: (1) Verifies that the
applicant's proposal aligns with CRC priorities as defined in the
Cancer Plan; and (2) describes methods by which Coalition or individual
members will be engaged in the demonstration CRC screening program.
Evaluation
The applicant should describe existing or proposed evaluation
activities. Using this outline and CDC's draft evaluation plan, the
applicant will work with CDC to finalize an evaluation plan to be
completed within the first six months of award. This evaluation plan
will be used by the program with CDC to evaluate each program goal and
objective and to use the evaluation results to improve program
effectiveness. Describe who will be responsible for conducting
evaluation activities and working with CDC on a formal evaluation of
the program.
Budget and Justification (Narrative Justification Will Not Be Counted
Toward Application Page Limit)
Provide a detailed line item budget and narrative justification of
all operating expenses consistent with the proposed objectives and
planned activities. Each budget item should be clearly related to a
stated activity.
Participation in CDC sponsored training, workshops, or meetings is
essential to the effective implementation of this program. Travel funds
should be budgeted for the following meetings:
One to two persons to Atlanta, Georgia to discuss program
implementation progress (reverse site visit) and for consultation and
technical assistance (two days, one trip per year.)
Up to two additional two-person trips to Atlanta, or other
destinations to attend or assist with national workgroups, task forces,
or committees (one to three days.)
Additional information may be included in the application
appendices. The appendices will not be counted toward the narrative
page limit. This additional information includes:
Curriculum vitae.
Job descriptions.
Organizational charts.
Letters of support.
Any other supporting documentation.
You are required to have a Dun and Bradstreet Data Universal
Numbering System (DUNS) number to apply for a grant or cooperative
agreement from the Federal government. The DUNS number is a nine-digit
identification number, which uniquely identifies business entities.
Obtaining a DUNS number is easy and there is no charge. To obtain a
DUNS number, access http://www.dunandbradstreet.com or call 1-866-705-
5711. For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.htm.
If your application form does not have a DUNS number field, please
write your DUNS number at the top of the first page of your
application, and/or include your DUNS number in your application cover
letter.
Additional requirements that may require you to submit additional
documentation with your application are listed in section ``VI.2.
Administrative and National Policy Requirements.''

IV.3. Submission Dates and Times

LOI Deadline Date: June 8, 2005.
CDC requests that you send a LOI if you intend to apply for this
program. Although the LOI is not required, is not binding, and does not
enter into the review of your subsequent application, the LOI will be
used to gauge the level of interest in this program, and to allow CDC
to plan the application review.
Application Deadline Date: July 8, 2005.
Explanation of Deadlines: Applications must be received in the CDC
Procurement and Grants Office by 4 p.m. Eastern Time on the deadline
date.
You may submit your application electronically at http://www.grants.gov. Applications completed online through Grants.gov are
considered formally submitted when the applicant organization's
Authorizing Official electronically submits the application to
www.grants.gov. Electronic applications will be considered as having
met the deadline if the application has been submitted electronically
by the applicant organization's Authorizing Official to Grants.gov on
or before the deadline date and time.
If you submit your application electronically with Grants.gov, your
application will be electronically time/date stamped, which will serve
as receipt of submission. You will receive an e-mail notice of receipt
when CDC receives the application.
If you submit your application by the United States Postal Service
or commercial delivery service, you must ensure that the carrier will
be able to guarantee delivery by the closing date and time. If CDC
receives your submission after closing due to: (1) Carrier error, when
the carrier accepted the package with a guarantee for delivery by the
closing date and time, or (2) significant weather delays or natural
disasters, you will be given the opportunity to submit documentation of
the carriers guarantee. If the documentation verifies a carrier
problem, CDC will consider the submission as having been received by
the deadline.
If you submit a hard copy of your application, CDC will not notify
you upon receipt of your submission. If you have a question about the
receipt of your LOI or application, first contact your courier. If you
still have a question, contact the PGO-TIM staff at: 770-488-2700.
Before calling, please wait two to three days after the submission
deadline. This will allow time for submissions to be processed and
logged.
This announcement is the definitive guide on LOI and application
content, submission address, and deadline. It supersedes information
provided in the application instructions. If your submission does not
meet the deadline above, it will not be eligible for review, and will
be discarded. You will be notified that you did not meet the submission
requirements.

IV.4. Intergovernmental Review of Applications

Executive Order 12372 does not apply to this program.

IV.5. Funding restrictions

Restrictions, which must be taken into account while writing your
budget, are as follows:
Funds may not be used for research.
Reimbursement of pre-award costs is not allowed.
Funds may not be used for the purchase or lease of land or
buildings, construction of facilities, renovation of existing space.
Funds may not be used for the endorsement or promotion of
any drugs,

[[Page 29754]]

health products, or medical supplies and equipment.
Funds may be used to support personnel and to purchase
supplies and services directly related to program activities consistent
with the scope of this announcement. While the purchase of equipment is
discouraged, it will be considered for approval if justified on the
basis of being essential to the program and not available from another
source.
If you are requesting indirect costs in your budget, you must
include a copy of your indirect cost rate agreement. If your indirect
cost rate is a provisional rate, the agreement should be less than 12
months of age.
Guidance for completing your budget can be found on the CDC Web
site, at the following Internet address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

IV.6. Other Submission Requirements

LOI Submission Address: Submit your LOI by express mail, delivery
service, fax, or E-mail to: Tanya Hicks, Centers for Disease Control
and Prevention, National Center for Chronic Disease Prevention and
Health Promotion, 4770 Buford Highway, MS K-57, Atlanta, Georgia 30341.
Telephone: (770) 488-4325. Fax: (770) 488-3230. E-mail: [email protected].
Application Submission Address: CDC strongly encourages applicants
to submit electronically at: http://www.grants.gov. You will be able to
download a copy of the application package from http://www.grants.gov,
complete it offline, and then upload and submit the application via the
Grants.gov site. E-mail submissions will not be accepted. If you are
having technical difficulties in Grants.gov, they can be reached by e-
mail at [email protected] or by phone at 1-800-518-4726 (1-800-518-
GRANTS). The Customer Support Center is open from 7 a.m. to 9 p.m.
Eastern Time, Monday through Friday.
CDC recommends that you submit your application to Grants.gov early
enough to resolve any unanticipated difficulties prior to the deadline.
You may also submit a back-up paper submission of your application. Any
such paper submission must be received in accordance with the
requirements for timely submission detailed in Section IV.3. of the
grant announcement. The paper submission must be clearly marked:
``BACK-UP FOR ELECTRONIC SUBMISSION.''
The paper submission must conform to all requirements for non-
electronic submissions. If both electronic and back-up paper
submissions are received by the deadline, the electronic version will
be considered the official submission.
It is strongly recommended that you submit your grant application
using Microsoft Office products (e.g., Microsoft Word, Microsoft Excel,
etc.). If you do not have access to Microsoft Office products, you may
submit a PDF file. Directions for creating PDF files can be found on
the Grants.gov Web site. Use of file formats other than Microsoft
Office or PDF may result in your file being unreadable by our staff;

Submit the original and two hard copies of your application by mail
or express delivery service to: Technical Information Management-RFA
AA030, CDC Procurement and Grants Office, 2920 Brandywine Road,
Atlanta, GA 30341.

V. Application Review Information

V.1. Criteria

Applicants are required to provide measures of effectiveness that
will demonstrate the accomplishment of the various identified
objectives of the cooperative agreement. Measures of effectiveness must
relate to the performance goals stated in the ``Purpose'' section of
this announcement. Measures must be objective and quantitative, and
must measure the intended outcome. These measures of effectiveness must
be submitted with the application and will be an element of evaluation.
Your application will be evaluated against the following criteria:
Existing and Proposed Program Description (Including Capacity) (30
Points)
(a) Overall preparedness (5 points): Does the applicant describe
its capability to carry out the proposed objectives of this program,
including demonstrating past success with similar programs?
(b) Reaching population to be served (5 points): Does the applicant
propose a projected number of screens or a proportional target increase
in screening? Does the applicant outline a plan to reach and recruit
both the larger population in the geographically defined area and the
priority population?
(c) Description of program components (10 points): Does the
applicant include a description of all program components (including
data collection and tracking, quality assurance and professional
development, case management, public education and outreach, and other
proposed activities) and indicate which will/will not be supported by
CDC funding? Are methods for data collection designed to show an
increase in screening in both the geographically defined population and
the priority population described? Are a list of proposed data
elements, a proposed plan to gather those data elements, and plans for
assuring data security, protecting patient confidentiality and de-
identifying data included?
(d) Description of tests to be used within demonstration program (5
points): Are the screening and diagnostic tests selected adequately
described, including a rationale for selection? Are the proposed tests
consistent with USPSTF guidelines? Does the applicant describe adequate
availability of selected tests and demonstrate the capacity to offer
these tests?
(e) Treatment and complications (5 points): Has the applicant
addressed how clients will be offered treatment if a cancer is
detected, and how complications will be managed?
Work Plan (20 Points)
(a) Appropriate objectives (10 points): Are proposed short-term
(one year) and long-term (three year) objectives specific, time-phased,
measurable, realistic, related to identified needs and consistent with
the purpose of this program announcement?
(b) Appropriate strategies (10 points): Does the applicant's plan
for achieving the proposed activities appear realistic and feasible and
relate to the programmatic requirements and purposes of this program
announcement?
Collaborative Activities (20 Points)
(a) Linkage with CCC (10 points): Is a linkage established with a
CDC-funded CCC implementation program(s) and coalition? Does the
applicant provide a letter of support from the CCC program/coalition
providing details of its relationship to the applicant and commitment
to ensuring linkages to CCC plan implementation?
(b) Working with diverse partners (10 points): Does the applicant
describe clear and complete plans to develop or maintain active working
relationships with other organizations, agencies, or partners in the
design and implementation of the program?
Evaluation (10 Points)
Do the proposed evaluation activities address progress toward
meeting goals and objectives, describe indicators of program success,
and appear to be reasonable and feasible? Does the

[[Page 29755]]

applicant describe how evaluation results will be used to improve
program effectiveness? Do they describe who will be responsible for
evaluation activities?
Program Management (10 Points)
Does the applicant describe the organization's size, structure and
function? Does the applicant demonstrate ability to manage the project,
including clear lines of communication and organizational support? Is
each current or proposed staff position for this initiative described
(including job title, function, required education and experience,
general duties, and activities with which that position will be
involved)? Does the applicant describe a proposed fiscal system to
track and monitor program expenditures and to ensure the accurate and
timely reimbursement of services provided by the program?
Background and Need (10 Points)
For applicants addressing population-based CRC screening among
persons 50 years and older in a geographically defined area, and
focusing screening efforts on persons 50 years and older with low
incomes and inadequate or no health insurance coverage for CRC
screening (priority population):
Does the applicant adequately describe the need for this program?
Does the applicant define the geographic area that their program will
cover? Are the characteristics and the size of the defined priority
population described? Is the burden of cancer among the community and
the priority population described? Is the current CRC screening test
prevalence of persons in the defined geographic area and the priority
population described?

Or,

For applicants addressing population-based CRC screening among
persons 50 years and older in a geographically defined area, and
focusing screening efforts on a priority population other than persons
50 years and older with low incomes and inadequate or no health
insurance coverage for CRC screening:
Does the applicant adequately describe the need for this program?
Does the applicant define the geographic area that their program will
cover? Are the characteristics and the size of the defined priority
population described? Does the applicant provide a justification for
selecting a priority population different from the priority population
defined in this RFA? Is the burden of cancer among the community and
the priority population described? Is the current CRC screening test
prevalence of persons in the defined geographic area and the priority
population described?
Executive Summary (Not Scored)
Does the applicant provide an executive summary that describes the
community the program will cover, a short description of the proposed
program and the amount of funding requested?
Budget and Justification (Not Scored)
Is the budget well defined, reasonable, and consistent with the
purpose of the program and the activities proposed? Is a narrative
justification provided? Are required travel funds requested?

V.2. Review and Selection Process

Applications will be reviewed for completeness by the Procurement
and Grants Office (PGO) staff and for responsiveness by the Division of
Cancer Prevention and Control. Incomplete applications and applications
that are non-responsive to the eligibility criteria will not advance
through the review process. Applicants will be notified that their
application did not meet submission requirements.
An objective review panel will evaluate complete and responsive
applications according to the criteria listed in the ``V.1. Criteria''
section above. Applications will be funded in order by score and rank
determined by the review panel.

V.3. Anticipated Announcement and Award Dates

Anticipated date of award is August 31, 2005.

VI. Award Administration Information

VI.1. Award Notices

Successful applicants will receive a Notice of Award (NoA) from the
CDC Procurement and Grants Office. The NoA shall be the only binding,
authorizing document between the recipient and CDC. The NoA will be
signed by an authorized Grants Management Officer, and mailed to the
recipient fiscal officer identified in the application.
Unsuccessful applicants will receive notification of the results of
the application review by mail.

VI.2. Administrative and National Policy Requirements

45 CFR Part 74 and Part 92
For more information on the Code of Federal Regulations, see the
National Archives and Records Administration at the following Internet
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
The following additional requirements apply to this project:
AR-8 Public Health System Reporting Requirements.
AR-9 Paperwork Reduction Act Requirements.
AR-10 Smoke-Free Workplace Requirements.
AR-11 Healthy People 2010.
AR-12 Lobbying Restrictions.
AR-14 Accounting System Requirements.
AR-15 Proof of Non-Profit Status.
AR-24 Health Insurance Portability and Accountability Act
Requirements.
AR-25 Release and Sharing of Data.
Additional information on these requirements can be found on the
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
An additional Certifications form from the PHS 5161-1 application
needs to be included in your Grants.gov electronic submission only.
Refer to http://www.cdc.gov/od/pgo/funding/PHS5161-1Certificates.pdf.
Once the form is filled out, attach it to your Grants.gov submission as
Other Attachment Forms.

VI.3. Reporting Requirements

You must provide CDC with an original, plus two hard copies of the
following reports:
1. Interim progress report, due no less than 90 days before the end
of the budget period. The progress report will serve as your non-
competing continuation application, and must contain the following
elements:
a. Current Budget Period Activities Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Budget for new budget period.
e. Measures of Effectiveness.
f. Additional Requested Information.
2. Financial status report and annual progress report, no more than
90 days after the end of the budget period.
3. Final financial and performance reports, no more than 90 days
after the end of the project period.
These reports must be mailed to the Grants Management or Contract
Specialist listed in the ``Agency Contacts'' section of this
announcement.
Additional Reporting Requirements
Patient-related and program-related data (as defined in the
``Activities,'' ``Data Collection and Tracking'' section of this RFA)
is due to CDC on a routine basis.

[[Page 29756]]

All programs will submit program-related data annually
(June 1).
Programs receiving CDC funds for screening services will
submit aggregate patient-related data quarterly (March 1, June 1,
October 1 and December 1), but be required to switch to submission of
individual patient-related data during the 3 year program period,
pending approval from OMB.
Programs NOT receiving CDC funds for screening services
will submit aggregate patient-related data quarterly (March 1, June 1,
October 1 and December 1).
In year 01 of the program, the first patient-level data
will be due March 1, 2006 and first program-related data will be due
June 1, 2006.

VII. Agency Contacts

We encourage inquiries concerning this announcement. For general
questions, contact: Technical Information Management Section, CDC
Procurement and Grants Office, 2920 Brandywine Road. Atlanta, GA 30341.
Telephone: 770-488-2700.
For program technical assistance, Laura Seeff, MD, Centers for
Disease Control and Prevention, National Center for Chronic Disease
Prevention and Health Promotion, 4770 Buford Highway, MS K-55, Atlanta,
Georgia 30341. 770-488-3223. E-mail address: [email protected];

Leslie Given, MPA, Centers for Disease Control and Prevention,
National Center for Chronic Disease Prevention and Health Promotion,
4770 Buford Highway, MS K-57, Atlanta, Georgia 30341. Telephone: (770)
488-3099. E-mail address: [email protected].
For financial, grants management, or budget assistance, contact:
Barbara Rene Benyard, Grants Management Specialist, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770/
488-2757. E-mail: [email protected].

VIII. Other Information

This and other CDC funding opportunity announcements can be found
on the CDC Web site, Internet address: http://www.cdc.gov. Click on
``Funding'' then ``Grants and Cooperative Agreements.'' Additional
information about CRC can be found at the CDC Division of Cancer
Prevention and Control Web site http://www.cdc.gov/cancer/colorctl/index.htm.

William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.

Attachment A--CDC National Comprehensive Cancer Control Program
Implementation Programs (as of March 1, 2005)

Alabama
Arkansas
California
Colorado
Florida
Georgia
Hawaii
Iowa
Kentucky
Louisiana
Maine
Maryland
Massachusetts
Michigan
Missouri
Nebraska
New Jersey
New Mexico
New York
North Carolina
Northwest Portland Area Indian Health Board
Ohio
Pennsylvania
Rhode Island
Texas
Utah
Virginia
Washington
West Virginia

Attachment B

Table B-1.--DRAFT Patient-Related Data Elements
------------------------------------------------------------------------
Samples of potential
Variable domains Possible data use of data elements
elements for evaluation
------------------------------------------------------------------------
1. Unique Identifiers....... Patient
identifier.
Record
identifier.
2. Demographics............. Date of Proportion
birth. of individuals
screened within the
specified program
catchment area.
Gender.
Race/
ethnicity
(collected as
separate fields)..
County of
residence, state,
zip code..
3. Screening History........ Previous Proportion
CRC test (FOBT, of rarely/never
FIT, colonoscopy screened
etc.). participants.
Date
performed (month,
year for each)
Results for
each (most recent
result for each
test).
4. Screening Information.... Date and Types of
type of procedure providers
provided. performing
enrollment and
providing screening
services patients).
Data on Types of
completion of screening tests
screening provided.
(completed, refused
etc.).
Screening
location (code for Characteristics of
location). participants by
type of screening
tests.
Frequency
Complication of of tests provided
screening procedure. over time (e.g.,
annual FOBT).
Date of Barriers to
complication. providing certain
tests (i.e., what
types of procedures
are refused by.
Results of
tests.
Recommended
follow-up tests/
diagnostic
procedures (if any).

[[Page 29757]]

5. Diagnostic Procedure(s) Data on Proportion
Provided (repeat for completion of of individuals with
additional procedures). diagnostic abnormal results.
procedures
(completed, refused
etc.).
Date and Number of
type of follow-up diagnostic tests
procedure(s) (e.g., performed.
colonoscopy, DCBE).
Diagnosis Specificity
location (code for of screening tests,
location). given results of
follow-up (i.e.,
proportion of
abnormal FOBTs that
colonoscopy,
require follow-up
and are shown to be
``false
positive'').
....................
Complication of
diagnostic
procedure & date..
Results of ....................
tests..
....................
Recommendations for
additional follow-
up procedures.
6. Cancer/Polp Diagnosis.... Status of Proportion
final diagnosis. of participants who
are diagnosed with
CRC.
Date & Proportion
final diagnosis of participants who
(polyp, cancer are identified with
etc.). polyps.
Location of ....................
lesion..
Histology.. ....................
Number of ....................
polyps & size of
largest lesion..
Behavior ....................
(in-situ,
invasive)..
Stage of ....................
diagnosis (cancer
only)..
Indicate ....................
how stage was
determined..
Stage from ....................
registry..
7. Treatment................ Status of Proportion
treatment.. of participants who
receive treatment
as indicated by
guidelines.
Date ....................
treatment started..
Who is ....................
paying for
treatment?
8. Program and Enrollment Program.... Proportion
Location. of individuals
enrolled at
specific locations.
Enrollment ....................
site (code for
location)..
9. CRC Cancer Risk Factors.. Family Proportion
history of CRC. of people in high
risk categories.
Personal Effect of
history of CRC. outreach efforts on
recruiting high
risk individuals.
Personal
history of polyps. Relationship of
personal and family
history on
screening behavior.
Personal
history of high
risk factors (e.g.,
IBD, genetic
syndromes)..
10. Reason for Obtaining Reason for Proportion
Current Screening Test. current visit of participants
(specific symptoms, currently
routine screening, experiencing
follow-up on symptoms.
previous abnormal
test).
Did doctor Knowledge
recommend CRC and attitude toward
screening? obtaining CRC
screening.
------------------------------------------------------------------------

Table B-2.--DRAFT Program-Related Data Elements
------------------------------------------------------------------------
Samples of potential
Variable domains Possible data use of data elements
elements for evaluation
------------------------------------------------------------------------
1. Program Costs............ Staff Variation
salary costs. in costs per person
screened by the
program.
Consultant Factors
costs. influencing
increases in cost.
Cost of Cost-
contracts (linked effectiveness of
with by the program innovative
specific strategies used by
activities). the programs.
Start-up Assessing
costs (e.g., staff potential economy
recruitment, of scale of program
equipment). structures.
Training ....................
costs..
Screening ....................
(FOBT, strategies
used by
sigmoidoscopy,
colonoscopy, DCBE)
and diagnosis
costs.
CM costs. ....................
....................
Administrative
costs.
Costs to ....................
patients (e.g., co-
pays).
Cost or ....................
preparation for
endoscopy.
Cost of ....................
biopsies.
Cost of ....................
complications.

[[Page 29758]]

2. Funding Sources.......... Federal Sources of
dollars. funding for
programs.
State Proportion
funding. of in-kind
contributions.
Private ....................
foundations.
In-kind ....................
contributions (type
kind contributions
and duration).
How/with
whose dollars is
each program area
being paid for
(FTEs, screening
services, etc).
3. Description of Health Types of
Care Delivery System. providers (e.g., Relationship of
physicians--primary provider specialty
care or specialist-- with screening
non-physician behavior, types of
provider) systems follow-up
delivering procedures
screening (e.g. provided, etc.
HMO, cancer center,
clinic, hospital)
and diagnostic
tests (does this
belong here?)
Cost-
Reimbursement effectiveness of
mechanisms. service delivery
structures.
Program
administrative.
Past
experience with CRC
screening.
4. Population-level......... E.g., BRFSS Population
or other population level measure of
level data. increase in
screening rates.
5. Outreach/Recruitment General and
Process Talk to Ingrid Hall priority population Effectiveness of
in EARB about how she for outreach. each type of
captures outreach outreach effort.
categories.
Types of
outreach efforts Effectiveness of
used (e.g., health outreach in
fair). recruiting priority
populations.
6. Eligibility Requirements. Age, family Differences
income, and in insurance status
insurance status criteria
criteria eligibility
established by criteria between
programs. programs.
(see note Number and
about FPL). types of patients
recruited based on
the eligibility
criteria
established.
7. Professional Education... Topics of
trainings provided. Relationship of
trainings offered
and the patterns of
care over time
(appropriateness of
tests recommended;
compliance with CRC
screening
guidelines).
Target
audience of
training..
Number of ....................
attendees and
sessions.
8. Quality.................. Use of Proportion
Medical Advisory of an active MAC.
Committee (Mac) by
grantees.
Description Extent to
of MAC activities. which a MAC is
providing oversight
to services
provided (e.g.,
reviewing
guidelines).

Relationship of MAC
involvement to
types of tests
delivered.
9. Case Management (CM)..... Description Proportion
of model used to of participants in
deliver CM services. need of CM services
who actually
receive them.
Barriers to CM models
tracking those with that are cost-
abnormal results. effective.
Duration of Factors
CM services (until influencing
diagnosis, effective CM that
treatment, or can be translated
thereafter. into strategies for
all the programs to
implement.
10. Partnerships............ Types of Identify
partnerships efforts undertaken
established (e.g., to screen priority
community centers, populations.
minority
organizations.
------------------------------------------------------------------------

Attachment C

Workplan Template
--------------------------------------------------------------------------------------------------------------------------------------------------------
Goal
---------------------------------------------------------------------------------------------------------------------------------------------------------
Measures of Timeframe for Team members
Objectives Activities effectiveness Data assessing progress responsible
--------------------------------------------------------------------------------------------------------------------------------------------------------

------------------------------------
Goal
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 29759]]

--------------------------------------------------------------------------------------------------------------------------------------------------------

Workplan--Definition of Terms

Goals

Goals are general, ``big picture'' statements of outcomes a
program intends to accomplish to fulfill its mission.

Objectives

Objectives are the ``big steps'' a program will take to attain
its goals. Objectives should be S.M.A.R.T. (specific, measurable,
achievable, realistic, and time-phased).

Activities

Activities are the ``smaller steps'' a program takes to meet its
objectives. Examples include reviewing data and research,
identifying resources and staff for program implementation and
evaluation, creating Public Service Announcements about screening
recommendations, and health provider training about screening
technology.

Measures of Effectiveness

Measures of effectiveness, or indicators, translate program
concepts and expected impacts into specific measures that can be
analyzed and interpreted. There should be at least one measure of
effectiveness for each objective. The change measured by an
indicator should represent progress a program has made toward
achieving goals and objectives.
Examples of indicators include: participation rates, individual
behavior, health status, and attitude. Success in achieving the goal
of maintaining coalition partnerships could be measured by analyzing
participation rates or the number of members at the beginning,
throughout and near the end of plan implementation. An increase (or
decrease/no change) in participation rate indicates level of
progress toward meeting the goal.

Data

Data is a list of sources that will be used to gather
information on measures of effectiveness. Data sources may include:
People, observations and documents. Examples of data sources
include: Behavioral Risk Factor Surveillance System (BRFSS),
Surveillance, Epidemiology, and End Results (SEER), needs and
satisfaction assessments, program records and reports, cancer
registries, interviews, focus groups, and medical claims data.

Attachment D--References for Centers for Disease Control and Prevention
RFA AA030, Colorectal Cancer Screening Demonstration Program

1. American Cancer Society. Cancer Facts and Figures, 2005.
Atlanta, Georgia: American Cancer Society, 2005 (publication no.
5008.05).
2. Mandel JS, Bond JH, Church TR, Snover DC, Bradley GM, Schuman
LM, Ederer F. Reducing mortality from colorectal cancer by screening
for fecal occult blood. Minnesota Colon Cancer Control Study. N Engl
J Med 1993;328:1365-71.
3. Mandel JS, Church TR, Bond JH, et al. The effect of fecal
occult-blood screening on the incidence of colorectal cancer. N Engl
J Med 2000;343:1603-7.
4. Selby JV, Friedman GD, Quesenberry CP Jr, Weiss NS. A case-
control study of screening sigmoidoscopy and mortality from
colorectal cancer. N Engl J Med 1992; 326:653-657.
5. Hardcastle JD, Chamberlain JO, Robinson MH, et al. Randomised
controlled trial of faecal-occult-blood screening for colorectal
cancer. Lancet 1996; 348:1472-1477.
6. Kronborg O, Fenger C, Olsen J, Jorgensen OD, Sondergaard.
Randomised study of screening for colorectal cancer with faecal-
occult-blood test. Lancet 1996; 348:1467-1471.
7. Seeff LC, Nadel MR, Klabunde C, Thompson T, Shapiro JA,
Vernon SW, Coates RJ. Patterns and Predictors of Colorectal Cancer
Test Use in the Adult U.S. Population. Cancer 2004;100:2093-103.

[FR Doc. 05-10296 Filed 5-23-05; 8:45 am]
BILLING CODE 4163-18-P