01-13738. Cancer Surveillance Research With Data Enhancement and Utilization, Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announce the availability of fiscal year (FY) 2001 funds for a cooperative agreement program to support priority cancer surveillance research with data enhancement and utilization activities. This program addresses the “Healthy People 2010” priority areas related to Cancer.

The purpose of this program is to utilize data from the National Program of Cancer Registries (NPCR) to perform enhanced surveillance and operational research to include developing, conducting and evaluating cancer surveillance research projects targeting breast, colorectal, prostate, ovarian, and oral/pharyngeal cancers.

Applicants with interest in innovative cancer surveillance research activities are encouraged to apply under this announcement and, if appropriate, to partner with universities.

This program consists of 4 parts:

Part I—Breast/Colorectal/Prostate (BCP) Cancer Patterns of Care (POC), Recurrence, and Survival (Optional Breast Cancer Screening Linkage Component)

The purpose of Part I is to conduct cancer surveillance research by comparing detailed clinical information including stage, diagnostic investigations used to assess stage (determinants of stage), and treatment in large, random samples of patients with female breast, prostate and colorectal cancers.

The purpose of the Optional Breast Cancer Screening Linkage Component is to validate and assess the completeness and accuracy of information contained in the state Breast and Cervical Cancer Early Detection Program (BCCEDP) minimum data elements (MDE's) and to sample for comparison of treatment of early stage breast cancer.

Part II—Reporting Pathology Protocols (colon and rectum)

The purpose of Part II is to implement The College of American Pathologists (CAP) Reporting Protocol for cancers of the colon and rectum.

Part III—Ovarian Cancer Patterns of Care

The purpose of Part III is to evaluate specific information related to the diagnosis and treatment of ovarian cancer, including: physician specialty, accuracy of staging and treatment data, chemotherapy treatment data, survival rates, and recurrence.

Part IV—Oral/Pharyngeal Cancer: Data Completeness and Quality

The purpose of Part IV is to evaluate the completeness, timeliness and quality of oral and pharyngeal cancer and to apply methods to improve data collection, reliability, and validity.

B. Eligible Applicants

Part I—Eligibility is limited to those population-based cancer registries (hereafter referred to as NPCR registries) listed in Appendix B. Determination of eligibility is based upon silver or gold certification by the North American Association of Central Cancer Registries (NAACCR) (with the exception of the timeliness standard) for diagnosis year 1997. This diagnosis year certification is the most recent available from NAACCR.

Part II—Eligible applicants are limited to NPCR registries which can demonstrate through a letter of support at least one effective partnership with a laboratory or laboratory vendor providing pathologic diagnostic services in a National Cancer Institute (NCI) designated comprehensive cancer or clinical cancer center facility in their state. Eligible states are listed in Appendix C.

Part III—Eligibility for Part III is limited to NPCR registries listed in Appendix B. Determination of eligibility is based upon NAACCR silver or gold certification (with the exception of the timeliness standard) for diagnosis year 1997.

Part IV—Eligibility for Part IV is limited to NPCR registries listed in Appendix B. Determination of eligibility is based upon NAACCR silver or gold certification (with the exception of the timeliness standard) for 1997. Multiple registries may submit a joint application.

C. Availability of Funds

Approximately $3,151,000 is available in FY 2001 to fund the following categories.

Part I—BCP Cancer Patterns of Care, Recurrence, and Survival

Approximately $2,056,000 is available in FY 2001 to fund approximately eight to ten awards. It is expected that the average award will be $293,000, ranging from $260,000 to $325,000.

Part II—Reporting Pathology Protocols

Approximately $300,000 is available in FY 2001 to fund approximately two awards. It is expected that the average award will be $150,000, ranging from $125,000 to $175,000.

Part III—Ovarian Cancer Patterns of Care

Approximately $670,000 is available in FY 2001 to fund approximately three awards. It is expected that the average award will be $235,000, ranging from $200,000 to $270,000.

Part IV—Oral/Pharyngeal Cancer: Data Completeness and Quality

Approximately $125,000 is available in FY 2001 to fund up to two awards. It is expected that the average award will be $92,000, ranging from $60,000 to $125,000.

Applicants may apply for one or more parts depending upon eligibility. It is expected that 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 three years. Funding estimates may change.

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

D. Program Requirements

In conducting activities to achieve the purposes of Parts I-IV 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

Recipients for all parts will be responsible for the following activities:

a. Collaborate with other successful recipients in part-specific activities.

b. Participate in protocol development to include the design of the study, design of the instruments, development of methods and procedures for the study, collection of the data, analysis and interpretation of the data, and dissemination of results.

c. Assist in the development of a research protocol for Institutional Review Board (IRB) review by all cooperating institutions participating in the research project. The CDC IRB will review and approve the protocol initially and on at least an annual basis until the research project is completed.

d. Assure and maintain the confidentiality of all study data.

e. Develop technical reports or manuscripts for peer-reviewed publications as appropriate.

Specific activities for each part are as follows:

Part I

a. Participate in a collaborative North American/European project between population-based cancer registries such as Phase 2 of the Concord Study found in Appendix G.

b. Participate in additional studies of patterns of care for cancers of high public health importance in the U.S., including early stage female breast cancer, stage III colon cancer, and prostate cancer.

c. Identify appropriate number of cases as specified in Appendix E.

d. Provide study data to the Data Analysis Centre, located at the Istituto Superiore di Sanita in Rome, Italy, with no direct identifying information, such as name, address or any public identification code.

e. Perform joint analysis with data from other registries and other countries.

Part I (Option)

a. Conduct a probabilistic linkage between the state BCCEDP and the state cancer registry.

b. Resolve potential matched records identified by the probabilistic linkage.

C. Identify appropriate number of cases as specified in Appendix E.

d. Collaborate with other successful recipients of the Part I option in the resolution of data quality issues and conduct special analyses relevant to the linkage of registry and BCCEDP files.

Part II

a. Develop, in collaboration with other successful recipients, strategies to implement the CAP reporting protocols for cancers of the colon and rectum.

b. Develop electronic reporting capacities to relate data from the protocols to an appropriate cancer registry.

c. Implement CAP's reporting protocol for cancers of the colon and rectum.

d. Participate with other successful applicants and other key groups to share expertise and experiences.

e. Provide written feedback and recommendations regarding the protocols to improve the protocols for cancers of the colon and rectum that will meet the needs of pathologists and cancer registries.

Part III

a. Identify a minimum of 1,500 ovarian cancer cases diagnosed between January 1, 1995, and December 31, 1999 within the state.

b. Evaluate medical records to identify information related to the diagnosis and treatment of ovarian cancer, such as: physician specialty, accuracy of staging and treatment data, chemotherapy treatment data, survival rates, and recurrence. chemotherapeutic drugs provided to the patient.

c. Conduct a linkage between the state cancer registry file and the state mortality file to identify deaths that have occurred among ovarian cancer patients diagnosed in 1995-1999.

d. Evaluate differences between cancer stage and treatment data identified during this study and the stage of ovarian cancer and cancer treatment initially reported to the cancer registry.

Part IV

a. Develop a protocol for auditing completeness and quality of oral cancer data, including at a minimum, an assessment of the quality of the following variables: stage at diagnosis, diagnosis year, diagnosis day, date of birth, race, site, subsite, histology, grade, sequence, laterality, gender, and treatment.

b. Determine completeness, timeliness, and quality of the registry data on oral and pharyngeal cancers (defined by ICD-O-2 as C00-C14; ICD-9 as 140-149; or as defined by other codes) at several time intervals.

c. Identify any unique problems associated with reporting and tabulating data on oral and pharyngeal cancers, including assessment of source data and reporting from non-hospital facilities, such as pathology laboratories, dental clinics, and oral surgeons.

d. Estimate the number of oral and pharyngeal cases diagnosed and treated in non-hospital facilities.

e. Evaluate any deficiencies in completeness, timeliness, and quality of oral/pharyngeal cancer data, and the potential effects of such deficiencies on the reliability and validity of incidence and survival estimates. Propose specific solutions to the deficiencies identified.

f. Evaluate potential strategies for collapsing data in order to obtain reliable and stable estimates of incidence, e.g., by combining data for anatomical sites or across years.

g. Identify the resources necessary to maintain completeness, timeliness, and quality of registry data on oral and pharyngeal cancer.

h. Serve as the focal point for the development and dissemination of media releases, reports and publications.

2. CDC Activities

CDC will be responsible for the following activities for all parts:

a. Participate in a post-award meeting for information sharing, problem solving, and research protocol development.

b. Provide ongoing consultation and technical assistance to successful recipients.

c. Collaborate in the design of studies, to include development of sampling procedures, design of the instruments, development of methods and procedures for the studies, collection of data, analysis and interpretation of data, resolution of data quality issues and dissemination of results.

d. Assist in the development of a research protocol for IRB review by all cooperating institutions participating in the research project. The CDC IRB will review and approve the protocol initially and on at least an annual basis until the research project is completed.

e. Obtain an assurance of confidentiality, clearance from CDC's Office of Management and Budget (OMB), and other clearances as appropriate.

f. Collaborate to produce technical reports or manuscripts for peer-reviewed publications as appropriate.

E. Content

Letter of Intent (LOI)

A LOI is optional for this program. However, a non-binding LOI to apply is requested from potential applicants. The narrative should be no more than 2, single-spaced pages, printed on one side, with one inch margins, and unreduced font. Your letter should include the following information: announcement number, name of the principal investigator, and specifically which Parts the applicant plans to apply for.

Pre-application Conference Call

A pre-application conference call is scheduled for June 20th at 1:00 p.m. Eligible applicants are invited to participate in this conference call. The purpose of the conference call will be to communicate the logistics of the application process and to respond to any questions applicants may have regarding this announcement. Participation in this conference call is optional. A summary of the questions and answers will be made available for those unable to participate. Registration information for this conference call will be sent to all eligible applicants by June 15th.

Applications

Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections for Parts I-IV 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. The narrative for each Part should be no more than 25 double-spaced pages, printed on one side, with one inch margins, and unreduced font. The original and each copy of the application must be submitted unstapled and unbound. Pages should be clearly numbered and a complete index to the application and any appendices included.

Applicants may apply for support under one or more of the four Parts. Only one application should be submitted. For each Part include a separate and complete narrative, separate budget, and justification that can stand alone as an application for review purposes.

Include funding for staff for Parts I, II, III, and IV to attend (1) a 1-day, post-award meeting in Atlanta; and (2) an additional 2-day meeting in a city to be determined later.

The narrative should consist of, at a minimum, a Plan, Objectives, Methods, Evaluation and Budget.

F. Submission and Deadline

Letter of Intent (LOI)

On or before June 8, 2001, submit the LOI to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Application

Submit the 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:http://www.cdc.gov/​od/​pgo/​forminfo.htm.

On or before July 1, 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 independent 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 shall not be acceptable as proof of timely mailing.)

Late: Applications which do not meet the criteria in 1. or 2. above 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.

Budget (not scored)

The extent to which the budget is reasonable, clearly justified, consistent with the demonstrated need and proposed activities, and likely to lead to program success.

Human Subjects (not scored)

Does the application adequately address the requirements of Title 45 CFR Part 46 for the protection of human subjects? (Not scored; however, an application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable.)

Specific evaluation criteria for each part are as follows:

Part I

1. Program Need (5 points)

a. The extent to which the applicant demonstrates an effective understanding of the background of the problem (variable quality of patterns of care and validity of stage and treatment data in the registry), a need for the project, and a commitment to its execution. (3 points)

b. The degree to which the applicant has met the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. This includes:

(1) The proposed plan for the inclusion of both sexes (not applicable for Breast or Prostate sites) and racial and ethnic minority populations for appropriate representation.

(2) The proposed justification when representation is limited or absent.

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

(4) 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. (2 points)

2. Objectives (10 points)

a. The extent to which the applicant demonstrates that the proposed program objectives are measurable, specific, time-phased, and related to the recipient activities, program purpose, and program need. (3 points)

b. The extent to which a description regarding the feasibility of implementing a North American/European study protocol such as the Concord study protocol and U.S. point of contact activities, including collecting and reporting data from medical abstract review and processing and reporting data to the Concord Analytic Data Center in Rome, Italy, and the extent to which feasibility is demonstrated by the description. (7 points)

3. Methods (40 points)

a. The extent to which the applicant describes strengths and limitations for implementing a North American/European study protocol such as the Concord study, the U.S. patterns of care activities, and (optional) breast cancer screening linkage study. (10 points)

b. The extent to which the applicant demonstrates sufficient knowledge, capacity and plans to implement and coordinate data collection, data reporting, and data linkage, given the strengths and limitations described. (20 points)

c. The extent to which the applicant describes appropriate use of technology to apply to the collection, linkage and processing of the data. (5 points)

d. The extent to which plans for collaborative data analysis and manuscript preparation are included. (5 points)

4. Evaluation (20 points)

The extent to which the applicant describes adequate plans for providing on-going communication including feedback and quality control suggestions for improvement and implementation of study protocols.

5. Program Management and Staffing Plan (25 points)

The extent to which proposed staffing, management and organizational structure, staff background and experience, job descriptions and resumes with qualifying experience of key personnel indicate an ability to carry out the project.

Part II

1. Program Need (15 points)

a. The extent to which the applicant demonstrates an effective commitment and understanding to the project, as documented through letters of support, background and need for a standardized pathology report. (5 points)

b. The extent to which a description regarding the impact of using standardized content in the collection and reporting of pathology data in general, and specifically for the targeted cancer sites, colon and rectum, is provided. (5 points)

c. The extent to which a description of the need for standardized, electronic reporting of pathology data for the targeted cancers to cancer registries is provided. (5 points)

2. Plan of Operation (45 points)

a. The extent to which a plan is provided to determine the strengths and limitations for implementation of the SNOMED-encoded CAP protocols for the target sites, for both clinical purposes and cancer surveillance purposes. (5 points)

b. The extent to which the applicant proposes to apply clinical ANSI standards and others, such as HL7, SNOMED and Logical Identifiers, Names, and Codes (LOINC), to the implementation of the protocols and subsequent data reporting for surveillance purposes. (7 points)

c. The extent to which the applicant provides sufficient knowledge, capacity and plans to work with clinical ANSI standards and others, such as HL7, SNOMED and LOINC. (7 points)

d. The extent to which the applicant proposes methodologies for implementation of the protocols, which are standards-based, flexible, and portable for other protocols and data reporting environments. (6 points)

e. The extent to which the applicant addresses the electronic reporting challenges, needs, and strategies to implement the protocol. (6 points)

f. The extent to which the applicant plans to follow through with the electronic reporting of the protocol. (5 points)

g. The extent to which the applicant proposes to use technologies for the implementation of the protocol. (3 points)

h. The extent to which proposed technologies are linked with existing capacities. (4 points)

i. The degree to which the applicant has met the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. This includes:

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

(2) The proposed justification when representation is limited or absent.

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

(4) 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. (2 points)

3. Evaluation (20 points)

a. The extent to which the applicant describes plans providing feedback and quality control suggestions to the improvement and implementation of the protocol for the needs of pathologists and cancer registries. (10 points)

b. The extent to which the applicant plans to analyze and document the impact of the protocol on the collection and reporting of timely, complete, accurate, and uniform pathology-related data. (10 points)

4. Project Management and Staffing Plan (20 points)

a. The extent to which proposed staffing, management and organizational structure, staff background and experience, job descriptions and resumes with qualifying experience of key personnel indicate an ability to carry out the project. (10 points)

b. The extent to which the applicant provides appropriate documentation regarding key partners (including pathologists and/or registry personnel) and their involvement in the project. (10 points)

Part III

1. Program Need (5 points)

The extent to which the applicant demonstrates an effective understanding of the background of the problem (variable quality of patterns of care and validity of stage and treatment data in the registry), a need for the project, and a commitment to its execution.

2. Objectives (10 points)

The extent to which the applicant demonstrates that the proposed program objectives are measurable, specific, time-phased, and related to the recipient activities, program purpose, and program need.

3. Methods (40 points)

a. The extent to which the applicant demonstrates sufficient knowledge, capacity and plans to implement and coordinate data collection, data reporting activities, and data linkage, given the strengths and limitations described. (20 points)

b. The extent to which the applicant describes appropriate use of technology to apply to the collection, linkage and processing of the data. (10 points)

c. The extent to which plans for collaborative data analysis and manuscript preparation are included. (5 points)

d. The degree to which the applicant has met the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. This includes: (5 points)

(1) The proposed plan for the inclusion of racial and ethnic minority populations for appropriate representation.

(2) The proposed justification when representation is limited or absent.

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

(4) 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.

4. Evaluation (20 points)

The extent to which the applicant provides an evaluation plan that is appropriate for measuring progress toward achieving objectives and identifying contributing factors when objectives are not met.

5. Project Management and Staffing Plan (25 points)

The extent to which proposed staffing, management and organizational structure, staff background and experience, job descriptions and resumes with qualifying experience of key personnel indicate an ability to carry out the project.

Part IV

1. Program Need (15 points)

The extent to which the applicant demonstrates eligibility as required under this program announcement, describes existing strengths and limitations of the registry, and provides evidence of access to adequate numbers of oral and pharyngeal cancer cases by race and gender to support accomplishment of the project purpose.

2. Objectives (15 points)

The extent to which the applicant demonstrates that the proposed program objectives are measurable, specific, time-phased, and related to the recipient activities, program purpose, and program need.

3. Methods (35 points)

a. The extent to which the applicant adequately describes (23 points)

(1) The methods that will be used to accomplish the objectives of the project, including plans to sample an adequate number of cases for assessing completeness and data quality.

(2) Proposed strategies and activities that are appropriate and feasible to achieve the project.

b. The extent to which the timetable incorporates project activities and milestones and is specific, measurable, and realistic. (10 points)

c. The degree to which the applicant has met the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. This includes:

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

(2) The proposed justification when representation is limited or absent.

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

(4) 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. (2 points)

4. Evaluation (15 points)

The extent to which the applicant provides an evaluation plan that is appropriate for measuring accomplishment of project objectives and identifying contributing factors when objectives are not met.

5. Project Management and Staffing Plan (20 points)

The extent to which proposed staffing, management and organizational structure, staff background and experience, job descriptions and resumes with qualifying experience of key personnel indicate ability to carry out the project.

H. Other Requirements

Provide CDC with original plus two copies of

1. an annual progress report, addressing progress toward achieving objectives detailed in the application, due 90 days after the end of each budget period;

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

3. a final financial 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-7 Executive Order 12372 Review

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-22 Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under section 399H-399L of the Public Health Service Act, [42 U.S.C. sections 280e-280e-4; Public Law 102-515], as amended. The Catalog of Federal Domestic Assistance number is 93.283.

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.”

To obtain business management technical assistance, contact:

Jesse Robertson, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention, Announcement 01102, 2920 Brandywine Road, Room 3000, MS-E18, Atlanta, GA 30341-4146, Telephone number: [phone], Email address: [e-mail]

For program technical assistance, contact:

Part I

Hannah Weir, PhD, Cancer Surveillance Branch, Division of Cancer Prevention and Control, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Hwy., NE, MS-K53, Atlanta, GA 30341-3717, Telephone number: [phone], Email address: [e-mail]

Part II

Warren Williams, MPH, Cancer Surveillance Branch, Division of Cancer Prevention and Control, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Hwy., NE, MS-K53, Atlanta, GA 30341-3717, Telephone number: [phone], Email address: [e-mail]

Part III

Pamela Logan, MD, MPH, Cancer Surveillance Branch, Division of Cancer Prevention and Control, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Hwy., NE, MS-K53, Atlanta, GA 30341-3717, Telephone number: [phone], Email address: [e-mail]

Part IV

Claudia Vousden, RN, MPH, Program Services Branch, Division of Oral Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Hwy., NE, MS-F10, Atlanta, GA 30341-3717, Telephone number: [phone], Email address: [e-mail]

Dated: May 25, 2001.

Henry S. Cassell, III,

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