03-14671. Standards Development and Maintenance for Cancer Surveillance; Notice of Availability of Funds

A. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under sections 301 and 317(k)(2) of the Public Health Service (PHS) Act, (42 U.S.C. sections 241 and 247b(k)(2)), as amended. The Catalog of Federal Domestic Assistance number is 93.283.

B. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2003 funds for a cooperative agreement program for Standards Development and Maintenance for Cancer Surveillance. This program addresses the “Healthy People 2010” focus area of Cancer.

This program will promote the development and maintenance of standards, which can be utilized by the National Program of Cancer Registries (NPCR) network of hospitals, free-standing pathology laboratories, central cancer registries, and software developers, to collect, edit, and transmit data.

This program consists of 2 parts:

Part I—Standard-setting activities related to the operation of population-based cancer registries.

The purpose of Part I is to support efforts to improve the quality of population-based central cancer registry data and operations through data item and transmittal standards, to facilitate coordination and communication from health care facilities to (and among) central cancer registries, and to promote the use of cancer incidence data for cancer control such as health care interventions planning, resource allocation, program evaluation, and research.

Part II—Standardized reporting and Encoding of surgical pathology reports.

The purpose of Part II is to support and promote the development of a controlled medical vocabulary for: encoding pathology data elements, indexing the entire medical vocabulary, and establishing guidelines for standardizing the reporting of surgical specimens.

This program announcement addresses the National Center for Chronic Disease Prevention and Health Promotion performance goal to improve the quality of state-based cancer registries.

C. Eligible Applicants

Part I—Eligible applicants for Part I are non-profit, non-governmental organizations with a nationwide organizational infrastructure and the capacity to bring together cancer registry standard-setting organizations, central cancer registries, hospital cancer registries, and software developers in order to attain consensus on data item definitions, codes, format, transmission record layouts, and time line for implementation of new standards.

Applicants ideally should have local, state, or regional constituencies representing all states and territories, but at minimum representing 25 states/territories.

Part 2—Eligible applicants for Part 2 are non-profit, non-governmental organizations with a nationwide organizational infrastructure and the capacity to develop standardized medical vocabularies and structures for encoding the content of pathology reports; to obtain consensus from the clinical and anatomic pathology community; and to provide education and technical assistance to promote and encourage consistent pathology reporting throughout the United States.

Applicants ideally should have local, state, or regional constituencies representing all states and territories, but at minimum representing 25 states/territories.

D. Funding

Availability of Funds

Approximately $900,000 is available in FY 2003 to fund the following categories:

Part I—Standard-setting activities related to the operation of population-based cancer registries: Approximately $600,000 is available in FY 2003 to fund a single award.

Part II—Standardized reporting and encoding of surgical pathology reports: Approximately $300,000 is available in FY 2003 to fund a single award.

Applicants may apply for Part I, Part II, or both based on eligibility. It is expected that awards will begin on or about September 15, 2003 and will be made for a 12-month budget period within a project period of up to five 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, program progress, and the availability of funds.

Recipient Financial Participation

Matching funds are not required.

E. Program Requirements

In conducting activities to achieve the purposes of Parts I and/or II, 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

Part I

a. Develop and provide infrastructure and management to address cancer registration issues including standards for completeness, timeliness, and quality (CTQ) for central cancer registries in the collection and processing of cancer incidence data. Performance will be measured by the extent to which the applicant develops, maintains, and promotes such standards.

b. Develop and provide infrastructure for the development of educational materials, guidance, and forums that promote the use of cancer registry data for the purposes of cancer control and prevention. Performance will be measured by the extent to which the applicant participates in or develops forums to either gain information or to educate constituents in cancer registry data use.

c. Coordinate and facilitate regional and national meetings of central cancer registry staff and related partners for consensus building, model development, and guidance development in the areas of central cancer registry operations, standard data item definitions, formats for the electronic transmittal of data, use of mortality data, cancer incidence and mortality rates, and mechanisms to share cancer reports with the community.

Performance will be measured by the extent to which the applicant participates in or coordinates such regional and national meetings to gain information; facilitate consensus; develop models and guidance; and to educate constituents in the accomplishment of program goals and objectives.

d. Participate in CDC-sponsored meetings and events. Performance will be measured by the extent to which the applicant attends and participates in NPCR-CDC conferences.

e. Participate in a post-award meeting (to occur no later than 45 days after the notice of award) to share information, clarify expectations, and establish regular conference call and face-to-face meetings (to occur at a minimum of every two months) to discuss issues and report progress.

Part II

a. Facilitate and promote the development, enhancement, and use of a controlled medical vocabulary to allow the encoding of information in a pathology report, typically a key component of a cancer patient's medical record, from a synoptic checklist as opposed to the traditional narrative-style report. Performance will be measured by the extent to which the applicant develops, enhances, and promotes the use of controlled medical vocabulary and site-specific synoptic checklists.

b. Monitor and evaluate the use of vocabulary among pathologists, registries, and pathology laboratory software vendors to identify inconsistent uses and new pathological trends in order to adjust and update the controlled medical vocabulary. Performance will be measured by the extent to which the applicant identifies inconsistencies and new trends and updates the controlled medical vocabularies.

c. Work to enhance the ability to reflect cancer protocols, as identified by committees of pathologists representing the United States, in the controlled medical vocabularies and the site-specific synoptic checklist. Performance will be measured by the extent to which the applicant's controlled medical vocabularies and site-specific synoptic checklist reflect nationally recognized cancer protocols.

d. Identify, attend, and facilitate educational meetings and provide technical assistance to promote the use of controlled medical vocabularies and site-specific synoptic checklists in the pathologist community. Performance will be measured by the extent to which the applicant attends and facilitates educational meetings and provides technical assistance to promote the use of controlled medical vocabularies and site-specific synoptic checklists.

e. Participate in CDC-sponsored meetings and events. Performance will be measured by the extent to which the applicant attends and participates in NPCR-CDC conferences.

f. Participate in a post-award meeting (to occur no later than 45 days after the notice of award) to share information, clarify expectations, and establish regular conference call and face-to-face meetings (to occur at a minimum of every two months) to discuss issues and report progress.

2. CDC Activities

Part I

a. Participate in a post-award meeting (to occur no later than 45 days after the notice of award) to share information, clarify expectations, and establish regular conference calls and face-to-face meetings (to occur at a minimum of every two months) to discuss issues and report progress.

b. Enhance standards for completeness, timeliness, and quality (CTQ) for central cancer registries in the collection and process of cancer incidence data to ensure that CDC funded cancer registries continue to meet program standards.

c. Develop educational materials that promote the use of cancer registry data for the purposes of cancer control and prevention to ensure that CDC funded cancer registries continue to meet program standards.

d. Attend and participate in regional and national meetings of central cancer registry staff and related partners for consensus building, model development, and guidance development.

e. Monitor attendance of applicant at NPCR-CDC meetings and events.

Part II

a. Participate in a post-award meeting to share information, clarify expectations, and establish routine meetings to discuss issues and report progress.

b. Develop controlled medical vocabulary and site-specific synoptic checklists to promote the use of electronic data submissions from pathology laboratories to CDC funded cancer registries.

c. Monitor the development, publication, and use of controlled medical vocabulary and site-specific synoptic checklists to promote the use of electronic data submissions from pathology laboratories to CDC funded cancer registries.

d. Monitor and attend educational conferences and meetings where controlled medical vocabularies and site-specific synoptic checklists are promoted.

F. Content

Letter of Intent (LOI)

A LOI is requested from potential applicants. The non-binding LOI will be used to determine the level of interest for this program announcement. The narrative should be no more than two, single-spaced pages, printed on one side, with one-inch margins, and unreduced 12-point font. Your letter should include the following information: Program announcement number, name of the principal investigator, and specifically which Part(s) the applicant plans to apply for.

Pre-Application Conference Call

A Pre-application conference call is scheduled for [Fill in after HHS review]. Eligible applicants are invited to participate in this conference call. The purpose of the conference call will be to communicate the specifics 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. Information for this conference call will be sent to all eligible applicants that have submitted an LOI by [Fill in after HHS review].

Applications

Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections for Parts I-II 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 Part I and Part II should be no more than 30 double-spaced pages, printed on one side, with one inch margins, and unreduced 12-point 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 should be included.

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

Include funding for staff for Parts I and II to attend the following meetings: (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. The program Plan should address activities to be conducted over the entire five-year project period.

G. Submission and Deadline

Letter of Intent (LOI) Submission

On or before June 25, 2003, submit the LOI to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Application Form

Submit the signed original and two copies of PHS 5161 (OMB 0348-0043). Forms are available at the following Internet address: http://www.cdc.gov/​od/​pgo/​forminfo.htm.

If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) at: 770-488-2700. Application forms can be mailed to you.

Submission Date, Time, and Address

The application must be received by 4 p.m. Eastern Time July 28, 2003. Submit the application to: Technical Information Management—PA#03121, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146.

Applications may not be submitted electronically.

CDC Acknowledgment of Application Receipt

A postcard will be mailed by PGO-TIM, notifying you that CDC has received your application.

Deadline

Letters of intent and applications shall be considered as meeting the deadline if they are received before 4 p.m. Eastern Time on the deadline date. Any applicant who sends their application by the United States Postal Service or commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an application is received after closing date 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, CDC will upon receipt of proper documentation consider the application as having been received by the deadline.

Any application that does not meet the above criteria will not be eligible for competition, and will be discarded. The applicant will be notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Application

Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objective 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.

An independent review group appointed by CDC will evaluate each application individually against the following criteria.

Specific evaluation criteria for each part are as follows:

Part I—Evaluation Criteria

1. Methods (31 points total)—

a. The extent to which the applicant adequately describes the methods that will be used to accomplish the objectives of the project. (20 points)

b. The extent to which the timetable incorporates project activities and milestones and is specific, measurable and realistic (11 points)

2. Program Need (24 points total)—

a. The extent to which the applicant demonstrates the ability to provide infrastructure and management to address cancer registration issues including standards for completeness, timeliness, and quality for cancer incidence data. (6 points)

b. The extent to which the applicant demonstrates the ability to participate in activities that promote States' accessibility and use of cancer registry data for cancer control activities. (6 points)

c. The extent to which the applicant demonstrates the ability to convene regional and national meetings of central cancer registry staff and partner organizations for consensus building, model development, and guidance development in the areas of central cancer registry operations, standard data item definitions, formats for the electronic transmittal of data, use of mortality data, cancer incidence and mortality rates, and mechanism to share cancer reports with the community. ( 6 points)

d. The extent to which the applicant demonstrates the ability to participate in NPCR-CDC sponsored meetings and events. (6 points)

3. Objectives (20 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.

4. Evaluation (15 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 project objectives.

5. Program Management and Staffing Plan (10 points)—The extent to which proposed staffing and management is adequate as defined by:

a. Job descriptions for existing and proposed positions.

b. Descriptions of background, experience and qualification for the proposed responsibilities; education, experience and licensure requirements, and curriculum vitae for each staff member.

c. An organizational chart that identifies lines of communication, accountability and reporting authority.

6. 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.

7. Requirements concerning the inclusion of women, racial, and ethnic groups (not scored)—Does the application adequately address 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.

8. 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.

Part II—Evaluation Criteria

1. Methods (31 points total)—

a. The extent to which the applicant adequately describes the methods that will be used to accomplish the objectives of the project. (20 points)

b. The extent to which the timetable incorporates project activities and milestones and is specific, measurable, and realistic. (11 points)

2. Program Need (24 points total)—

a. The extent to which the applicant demonstrates an ability to facilitate and foster development, revision, and enhancement of controlled medical vocabulary to encode the information in a pathology checklist report, which constitutes an essential part of a cancer patient's medical record. (6 points)

b. The extent to which the applicant describes a need to monitor the use of the vocabulary by clinical groups members, pathology laboratories, registries, and laboratory information system vendors to detect problems and address needs in implementation of a medical vocabulary. (6 points)

c. The extent to which the applicant describes a need to facilitate and foster the development, revision, and enhancement of cancer protocols by pathology laboratories, including automation of data entry, coding, and storage. (6 points)

d. The need to target appropriate educational and technical assistance interventions and workshops that would increase the use of encoded pathology reports and other data, including standardized reports that use cancer protocols. (6 points)

3. Objectives (20 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.

4. Evaluation (15 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 project objectives.

5. Project Management and Staffing Plan (10 points)—The extent to which proposed staffing and management is adequate as defined by:

a. Job descriptions for existing and proposed positions.

b. Descriptions of background, experience and qualification for the proposed responsibilities; education, experience and licensure requirements, and curriculum vita for each staff member.

c. An organizational chart that identifies lines of communication, accountability, and reporting authority.

6. 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.)

7. Requirements concerning the inclusion of women, racial, and ethnic groups (not scored)—Does the application adequately address 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.

8. 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.

I. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. An interim progress report. The interim progress report will be due on the 15th of March each year through 2008. This interim progress report will serve as your non-competing continuation application. A second report is due 90 days after the end of each budget period. These reports must include the following elements:

a. A succinct description of the program accomplishments and progress made in meeting each Current Budget Period Activities Objectives during the previous six months of the budget period.

b. A succinct description of the program accomplishments/narrative and progress made in meeting each Current Budget Period Activities Objectives during the previous six months of the budget period.

c. The reason(s) for not meeting established program objectives and strategies to be implemented to achieve unmet objectives.

d. Current Budget Period Financial Progress.

e. New Budget Period Proposed Activities and Objectives.

f. Detailed Line-Item Budget and Justification.

g. For all proposed contracts, provide the name of contractor, method of selection, period of performance, scope of work, and itemized budget and budget justification. If the information is not available, please indicate “To Be Determined” until the information becomes available; it should be submitted to CDC Procurement and Grants Management Office contact identified in this program announcement.

2. Financial status report, no more than 90 days after the end of the budget period. The financial status report should include an attachment that identifies unspent balances for each program component.

3. Final financial and performance reports, 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.

Additional Requirements

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

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.”

For general questions about this announcement, contact: Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: [phone].

To obtain business management and budget assistance, contact:

Glynnis Taylor, Grants Management Specialist, Centers for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone number: [phone], E-mail address: [e-mail].

For business management and budget assistance in the territories, contact:

Charlotte Flitcraft, Centers for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone number: [phone], E-mail address: [e-mail].

For program technical assistance, contact:

Part I

Faye Floyd, 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], E-mail address: [e-mail].

Part II

Ken Gerlach, 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], E-mail address: [e-mail].

Dated: June 3, 2003.

Sandra Manning,

Director, Procurement and Grants Office, Center for Disease Control and Prevention.