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###### Department of Health and Human Services

###### Centers for Disease Control and Prevention

          - [Program Announcement 01099]

## A. Purpose

                    The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2001 funds for a cooperative agreement program for Research on Community Cancer Control. This program addresses                           ( print page 32956)                        the “Healthy People 2010” focus area of Cancer.                

The purpose of this Cooperative Agreement is to increase the number of evidence-based intervention studies in the areas noted in Appendix A. This will be accomplished through solicitation of well-designed, methodologically-sound studies.

## B. Eligible Applicants

Applications may be submitted by public and private nonprofit organizations and by governments and their agencies; that is, universities, colleges, research institutions, hospitals, State, and local governments or their bona fide agents, and federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations.

## C. Availability of Funds

Approximately $2,900,000 is available in FY 2001 to fund six to 13 awards. It is expected that the awards will begin on or about September 30, 2001 and will be made for a 12-month budget period within a project period of up to five years. Funding estimates may change. Awards can be made to applicants for projects on breast cancer alone, cervical cancer alone, colorectal cancer alone, prostate cancer alone, or a combination of these.

### Breast and Cervical Cancer

Approximately $1,100,000 is available in FY 2001 to fund two to five awards. It is expected that the average award will be $550,000 ranging from $200,000 to $600,000. Awards can be made to applicants for projects on breast cancer alone, cervical cancer alone, or breast and cervical cancers together.

### Colorectal Cancer

Approximately $850,000 is available in FY 2001 to fund approximately two to four awards. It is expected that the average award will be $300,000 ranging from $200,000 to $400,000.

### Prostate Cancer

Approximately $500,000 is available in FY 2001 to fund approximately two to four awards. It is expected that the average award will be $250,000 ranging from $200,000 to $300,000.

Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and on the availability of funds.

## D. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities under 1. (Recipient Activities), and CDC will be responsible for the activities listed under 2. (CDC Activities).

### 1. Recipient Activities

#### a. Research Activities

(1) Develop a written research protocol according to the standards for effective intervention research in the Community Guide for testing the effectiveness of an intervention. The protocol should include hypotheses and research questions, literature review, study design, plans for sampling, data collection, and quantitative data analyses. Given the demonstrated need for effective interventions on breast, cervical, and colorectal cancer, recipient is encouraged to submit a protocol that combines two or more intervention strategies listed in Attachment B in which the effect of the entire intervention is measured as well as the independent effects of each component.

(2) Develop plans for peer-reviewed publications that will present, summarize, and interpret the results of the study.

#### b. Administrative activities

(1) Develop a time-table listing duration and expected completion dates for all major activities.

(2) Submit the research protocol for Institutional Review Board review by all cooperating institutions participating in the research project.

(3) Develop and submit the Office of Management and Budget package. (See AR-9 in Other Requirements section of this document.)

### 2. CDC Activities

a. Assist in the development of document for CDC's required IRB review. The CDC IRB will review and approve the protocol initially and on at least an annual basis until the research project is completed.

b. Provide consultation and technical assistance regarding the study.

c. Monitor the recipient's performance of project activities and attainment of project objectives through the provisions of technical assistance and progress reporting.

d. Collaborate with the preparation and publication of research findings.

## E. Content

### Letter of Intent (LOI)

An LOI is requested for this program. The narrative should be no more than two, double spaced pages, printed on one side, with one inch margins, and unreduced font. Your letter of intent will be used to enable CDC to determine level of interest in the announcement and should include the following information:

1. Priority area of application

2. Audience

3. Study design

4. Proposed outcomes

On or before June 29, 2001, submit the original and two signed copies of the LOI to the Program Technical Assistance contact identified in the “Where to Obtain Additional Information” section of this announcement.

### Applications

Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections in this program announcement to develop the application content. Your application will be evaluated on the criteria listed, so it is important to follow them in laying out your program plan. Number all pages clearly and sequentially and include a complete table of contents to the application and its appendices. The original and each copy of the application should be submitted unstapled and unbound. Print all materials single-spaced in a 12-point or larger font on 8.5 by 11 paper with at least one inch margins and printed on one side only. All graphics, maps, overlays, etc., should be in black and white and meet the above criteria. The narrative should be no more than 30 pages including budget and justification. Applicants should also submit appendices which should not exceed an additional 20 pages.

#### 1. Executive Summary

a. Provide a clear, concise one to two page summary of the proposed study.

b. State the need for the proposed study, the capacity of the investigators to carry out the research, the program announcement priority area(s) addressed, and the study design. Include descriptions of the intervention(s), exposures, outcomes, data collection procedures, and statistical analyses.

#### 2. Background

a. Demonstrate the need for the research study within the context of the priority area(s) and population(s) it is intended to address.

b. Provide a review of relevant research studies.

c. Present evidence for research gap(s) the proposed project will fill.

#### 3. Qualifications and experience

                    a. Provide evidence of qualifications and experience of research team, which should include but not be limited to a principal investigator, co-investigator,                           ( print page 32957)                        statistician or investigator with sufficient statistical background and experienced.                

b. Provide evidence of ability to access the population selected for study including

(1) Specific letters of support from named collaborators

(2) Descriptions of past research with intended collaborators

c. Identify level of effort and time commitments for key investigators and staff.

d. Provide resumes or curriculum vitae in appendices.

e. Describe the necessary qualifications, experience, and abilities for unassigned positions.

f. Describe team structure and methods of routine communication.

#### 4. Work plan and timetable

a. Provide evidence of research within priority areas.

b. Provide evidence that priority populations as defined within this announcement will be studied.

c. Provide specific objectives that are time-related, measurable, and consistent with the purpose of the cooperative agreement.

d. Provide specific and feasible time-lines specifying major milestones for the proposed research, including a schedule of detailed activities for the first 12 months of the project period, with milestones for the cooperative agreement five year project period.

e. Provide plans for feedback of results to community.

#### 5. Methods

a. Provide hypotheses and research questions in the context of the intervention strategy.

b. Describe study population(s) 

c. Describe sampling protocol 

d. Describe study design proposed from standards in Community Guide (see list in Appendix A), including:

(1) Experimental and comparison group(s)

(2) Exposures and outcomes

(a) Validity

(b) Reliability 

e. Describe data collection procedures

f. Provide a clear and appropriate plan for statistical analyses

#### 6. Inclusion of Women and Minorities

State the degree to which the proposed research will meet the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. This includes:

a. The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation.

b. The proposed justification when representation is limited or absent.

c. A statement as to whether the design of the study is adequate to measure differences when warranted.

d. A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits.

#### 7. Budget

The budget should be reasonable, clearly justified, and consistent with the intended use of funds. All budget categories should be itemized. Budgets should include travel for at least one investigator to travel to Atlanta each year for a reverse site visit. Proposed sub-contracts should identify the name of the contractor, if known; describe the services to be performed; provide an itemized budget and justification for the estimated costs of the contract; specify the period of performance; and describe the method of selection. If indirect costs are requested, a copy of the current Indirect Cost Rate Agreement should be included.

## F. Application submission and deadline

Submit original and five copies of PHS-398 (OMB Number 0925-0001) (adhere to the instructions on the Errata Instruction Sheet for PHS 398). Forms are available in the application kit and at the following Internet address: www.cdc.gov/​od/​pgo/​forminfo.htm.

On or before July 27, 2001, submit the application to the Grants Management Specialist identified in the Where to Obtain Additional Information section of this announcement.

Deadline: Applications shall be considered as meeting the deadline if they are either:

1. Received on or before the deadline date; or

2. Sent on or before the deadline date and received in time for submission to the objective review group.

(Applicants must request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or U.S. Postal Service. Private metered postmarks will not be accepted as proof of timely mailing.)

Late Applications: Applications that do not meet the criteria in 1. or 2. above are considered late applications and will be returned to the applicant.

## G. Evaluation Criteria

Each application will be evaluated individually against the following criteria by an independent review group appointed by CDC.

### 1. Background (5 points)

The extent to which the applicant;

a. demonstrates the need for the research study within the context of the priority area(s) and population(s) it is intended to address;

b. provides a review of relevant research studies; and

c. presents evidence for research gap(s) the proposed project will fill.

### 2. Qualifications and Experience (15 points) 

The extent to which the applicant: 

a. provides evidence of qualifications and experience of research team, which should include but not be limited to a principal investigator, co-investigator, statistician or investigator with sufficient statistical background and experienced; 

b. provides evidence of ability to access the population selected for study including letters of support from named collaborators; 

c. identifies level of effort and time commitments for key investigators and staff. 

### 3. Work Plan and Time Table (5 points) 

The extent to which the applicant: 

a. provides evidence of research within priority areas; 

b. provides evidence that priority populations will be studied; 

c. provides specific objectives that are time-related, measurable, and consistent with the purpose of the cooperative agreement; and 

d. provides specific and feasible time-lines specifying major milestones for the proposed research, including a schedule of detailed activities for the first 12 months of the project period, with milestones for the cooperative agreement five year project period. 

### 4. Methods (65 points) 

The extent to which the applicant: 

a. describes the hypotheses and research questions in the context of the intervention strategy (5 points); 

b. describes the study population(s) (5 points); 

c. describes sampling, including (15 points); 

(1) unit of analysis (entire population or sample) 

(2) type of sample (random, convenience, etc.) 

(3) potential selection biases 

(4) power calculations 

d. describes study design (from list in Appendix A), including (20 points): 

(1) experimental and comparison group(s); 

(2) Exposures and outcomes 

                    (a) Validity                           ( print page 32958)    

(1) Verifies by a variety of methods, if possible, that participants were exposed to the intervention. 

(2) Provides evidence of validity in the proposed population for existing interventions and instruments, including those newly developed. 

(b) Reliability provides evidence that the variables used to measure exposures and outcomes are consistent and reproducible. 

e. describes data collection procedures (5 points) 

f. provides a clear and appropriate plan for statistical analyses that includes: (15 points) 

(1) quantitative data analyses 

(2) statistical models 

(3) statistical approach to confounding and bias 

                    (4) statistical approach to complex sampling (                    *i.e.,*                    other than simple random sampling) and sample weighting, if relevant.                 

(5) discussion of other statistical issues, such as use of repeated measures analyses, where relevant. 

### 5. Inclusion of Women and Minorities (10 points) 

State the degree to which the proposed research will meet the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. This includes: 

a. the proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; 

b. the proposed justification when representation is limited or absent; 

c. a statement as to whether the design of the study is adequate to measure differences when warranted; and 

d. a statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits. 

### 6. Budget (reviewed, but not scored) 

The extent to which the budget is reasonable, clearly justified, and consistent with the intended use of funds. All budget categories should be itemized. 

### 7. Human Subjects Protection (not scored) 

Does the application adequately address the requirements of Title 45 CFR part 46 for the protection of human subjects? 

## H. Other Requirements 

Technical Reporting Requirements: 

Provide CDC with the original plus two copies of 

1. Semiannual progress reports; 

2. Financial status report, no more than 90 days after the end of the budget period; and 

3. Final financial report and performance report, no more than 90 days after the end of the project period. 

Send all reports to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement. 

The following additional requirements are applicable to this program. For a complete description of each, see Attachment I of the announcement.

AR-1 Human Subjects Requirements 

AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research 

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-22 Research Integrity 

## I. Authority and Catalog of Federal Domestic Assistance Number 

This program is authorized under sections 317(k)(2), 1507 [42 U.S.C. 247b(k)(2) and 42 U.S.C. 300n-3]; and 1501 [42 U.S.C. 300k] of the Public Health Service Act, as amended. The Catalog of Federal Domestic Assistance number is 93.919 for breast and cervical cancers and 93.283 for colorectal and prostate cancer. 

## J. Where to Obtain Additional Information 

This and other CDC announcements can be found on the CDC home page Internet address—http://www.cdc.gov. Click on “Funding”, then “Grants and Cooperative Agreements”. 

If you have questions after reviewing the contents of all the documents, business management technical assistance may be obtained from: Glynnis Taylor, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention, Announcement 01099, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146, Telephone number: 770-488-2752, Email address: gld1@cdc.gov. 

For program technical assistance, contact: Rosalind Breslow, Epidemiologist, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Highway, Mail Stop K-55, Atlanta, GA 30341-3717, Telephone number: 770-488-3086, Email address: zyd1@cdc.gov. 

 or 

Katherine Wilson, Public Health Educator, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Highway, Mail Stop K-48, Atlanta, Ga 30341-3717, Telephone number: 770-488-3079, Email address: kxw1@cdc.gov. 

Dated: June 13, 2001. 

John L. Williams, 

Director, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC). 

[FR Doc. 01-15389 Filed 6-18-01; 8:45 am] 

BILLING CODE 4163-18-P