Colorectal Cancer Screening Demonstration Program, 29747-29759 [05-10296]

Agencies

• Centers for Disease Control and Prevention
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 99 (Tuesday, May 24, 2005)]
[Notices]
[Pages 29747-29759]
From the Federal Register Online via the Government Printing 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. 
https://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: https://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 https://www.grants.gov.
    Application forms and instructions are available on the CDC Web 
site, at the following Internet address: https://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 https://www.dunandbradstreet.com or call 1-866-705-
5711. For more information, see the CDC Web site at: https://
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 https://
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: https://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: THicks@cdc.gov.
    Application Submission Address: CDC strongly encourages applicants 
to submit electronically at: https://www.grants.gov. You will be able to 
download a copy of the application package from https://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 support@grants.gov 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;

     Or

    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: https://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: https://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 https://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: lseeff@cdc.gov;

     Or

    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: lgiven@cdc.gov.
    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: bnb8@cdc.gov.

VIII. Other Information

    This and other CDC funding opportunity announcements can be found 
on the CDC Web site, Internet address: https://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 https://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