DP18-1802.pdf

Centers for Disease Control

National Center for Chronic Disease Prevention and Health Promotion

National Partnerships to Promote Cancer Surveillance Standards and Support Data Quality and

Operations of National Program of Cancer Registries

CDC-RFA-DP18-1802

Application Due Date: 04/20/2018

National Partnerships to Promote Cancer Surveillance Standards and Support Data Quality and

Operations of National Program of Cancer Registries

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Catalog of Federal Domestic Assistance (CFDA) Number F. Dates G. Executive Summary

Part II. Full Text A. Funding Opportunity Description B. Award Information C. Eligibility Information D. Required Registrations E. Review and Selection Process F. Award Administration Information G. Agency Contacts H. Other Information I. Glossary

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-DP18-1802. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) B. Notice of Funding Opportunity (NOFO) Title:

National Partnerships to Promote Cancer Surveillance Standards and Support Data Quality and Operations of National Program of Cancer Registries

C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https ://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf.

Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (See section 45 CFR 46.102(d)).

D. Agency Notice of Funding Opportunity Number:

E. Catalog of Federal Domestic Assistance (CFDA) Number:

93.283 Additional CFDA Number: 93.422 F. Dates:

1. Due Date for Letter of Intent (LOI): [Insert 30 days from date of publication]

Is a LOI: Recommended but not Required A LOI is recommended but not required. If an LOI is submitted, it must be emailed to Dr.

Loria Pollack, CDC/Division of Cancer Prevention and Control (Email: lop5@cdc.gov) by March 14, 2018, 11:59 p.m. U.S. Eastern Standard Time.

2. Due Date for Applications: 04/20/2018, 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Date for Informational Conference Call: 03/07/2018 March 7, 2017 at 1:00 p.m. Eastern Daylight Savings This conference call can be accessed by calling 1-877-953-6028. The participant passcode is 3179196.

G. Executive Summary:

1. Summary Paragraph:

Since the passage of the Cancer Registries Amendment Act in 1992, Centers for Disease Control and Prevention (CDC) supports the collection of cancer surveillance data through the National Program of Cancer Registries (NPCR). Cancer registries in 47 states, the District of Columbia, Puerto Rico, the U.S. Pacific Island Jurisdictions, and the U.S. Virgin Islands https://www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html collect, consolidate, and submit data on cancer occurrence, extent, treatment and outcomes of all newly diagnosed cancers. These data represent 97% of the U.S. population. CDC has established successful partnerships with national organizations to define standardized cancer surveillance practices in the U.S. and assure complete, timely, and high-quality data for the official federal U.S. Cancer Statistics.

The purpose of this Notice of Funding Opportunity (NOFO) is to fund national organizations with demonstrated expertise and capacity in cancer surveillance to enhance NPCR’s data quality and operational efficiency. This program will support up to three organizations involved directly in cancer surveillance to focus on one of three essential components: 1) Education, Standards and Translation of cancer surveillance best practices; 2) Cancer Staging Collaboration and Implementation; and 3) Standardization and Support for Laboratory and Biomarker Electronic Reporting.

The overarching goal of this project is to collaboratively define and promote uniform standards in cancer staging, collection and reporting. Funded entities will identify and address specific enhancement needs of cancer registries to attain the following outcomes: increased timeliness, completeness, and quality of data reported to NPCR; increased competency of NPCR central cancer registry staff; enhanced interoperability of NPCR software; and increased electronic submission of laboratory data to NPCR registries.

a. Eligible Applicants: Open Competition

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 3

d. Total Period of Performance Funding: $5,225,000

e. Average One Year Award Amount: $325,000

f. Number of Years of Award: 5

g. Estimated Award Date: 09/28/2018

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text Executive Summary Since the passage of the Cancer Registries Amendment Act in 1992, Centers for Disease Control and Prevention (CDC) supports the collection of cancer surveillance data through the National Program of Cancer Registries (NPCR). Cancer registries in 47 states, the District of Columbia, Puerto Rico, the U.S. Pacific Island Jurisdictions, and the U.S. Virgin Islands collect, consolidate, and submit data on cancer occurrence, extent, treatment and outcomes of all newly diagnosed cancers. These data represent 97% of the U.S. population. CDC has established successful partnerships with national organizations to define standardized cancer surveillance practices in the U.S. and assure complete, timely, and high-quality data for the official federal

U.S. Cancer Statistics.

The purpose of this Notice of Funding Opportunity (NOFO) is to fund national organizations with demonstrated expertise and capacity in cancer surveillance to enhance NPCR’s data quality and operational efficiency. This program will support up to three organizations involved directly in cancer surveillance to focus on one of three essential components: 1) Education, Standards and Translation of cancer surveillance best practices; 2) Cancer Staging Collaboration and Implementation; and 3) Standardization and Support for Laboratory and Biomarker Electronic Reporting.

The overarching goal of this project is to collaboratively define and promote uniform standards in cancer staging, collection and reporting. Funded entities will identify and address specific enhancement needs of cancer registries to attain the following outcomes: increased timeliness, completeness, and quality of data reported to NPCR; increased competency of NPCR central cancer registry staff; enhanced interoperability of NPCR software; and increased electronic submission of laboratory data to NPCR registries.

A. Funding Opportunity Description

1. Background

a. Overview Cancer is the second leading cause of death in the United States. In 2014, approximately 1.6 million people were diagnosed with cancer and more than 584,000 people died of cancer.

Complete, timely, and accurate cancer surveillance data is necessary to inform cancer care and interventions, plan cancer control programs, and inform health policy. Since 1992, CDC has administered National Program of Cancer Registries (NPCR), a federally mandated program which supports population-based cancer surveillance systems. Currently, NPCR supports cancer registries in 47 states, the District of Columbia, Puerto Rico, the U.S. Pacific Island Jurisdictions, and the U.S. Virgin Islands to collect data on the type and extent of cancer, demographics on the person affected, and planned treatment. Each year NPCR data are combined with the National Cancer Institute's Surveillance, Epidemiology, and End Results program (NCI's SEER program) data to produce U.S. Cancer Statistics, the official federal source of cancer statistics. This information is used to understand temporal, geographic, and demographic occurrence of cancer, measure progress in cancer control, and direct prevention efforts nationally and within states and jurisdictions.

The data collected for the NPCR cancer surveillance system aligns with the diagnosis and staging of cancer by physicians in clinical settings. To ensure cancer data are of high quality, comparable and useful to both clinical and public health practice, the NPCR cancer surveillance system is highly standardized. Multiple organizations are involved in classifying, defining, collecting, and submitting data standards. Cancer surveillance standard setter organizations in the U.S include: CDC, NCI, the American College of Surgeons Commission on Cancer, and a convening umbrella organization, North American Association of Central Cancer Registries (NAACCR). These standard-setting agencies/organizations have developed collaborative relationships over the years to develop consensus standards and best practices in cancer surveillance. As cancer care becomes increasingly complex, the cancer surveillance community must continue to work together to mutually develop new and refine existing standards that can, in turn, be efficiently implemented to maintain the collection of high-quality data.

Knowledgeable cancer registrars and central cancer registries are fundamental to this endeavor.

In addition, in the near future, use of electronic data exchange to capture cancer data directly from laboratories and Electronic Health Record (EHR) systems will provide cancer registries with more efficient data collection while greatly impacting cancer registry operations.

This funding opportunity is designed to support activities to develop, disseminate, implement, and enhance data standards and best practices for improved operations of cancer registries in the United States. Awardee(s) will be charged to ensure collaboration among standard setting agencies and organizations involved in cancer surveillance across the United States; provide education and subject matter expertise to the cancer surveillance community (i.e., cancer registrars and registries) and advance the implementation of electronic reporting of laboratory data directly to central cancer registries.

b. Statutory Authorities CDC's National Program of Cancer Registries (NPCR) authorized under the Public Health Service Act, (42 USC 280e-280e-4; Public Law 102-515). The activities of this project address a subsection of this cancer registry authorization (42 USC 280e-2, Section 399D of the Public Health Service Act) that authorizes CDC to make grants to “provide technical assistance to States in the establishment and operation of statewide registries . . . .” In addition, Section 301(a) of the Public Health Service Act, 42 U.S.C. 241(a) applies to some of the outcomes that may result from this NOFO.

c. Healthy People 2020 Healthy People 2020 Cancer Objectives

C1 Reduce the overall cancer death rate C2-8: Reduce the [lung, female breast, uterine cervix, colorectal cancer, oropharyngeal, prostate, and melanoma] cancer death rate C-9-11: Reduce [invasive colorectal cancer, invasive uterine cervical cancer, and late-stage female breast cancer) C-12: Increase the number of central, population-based registries from the 50 States and the District of Columbia that capture case information on at least 95 percent of the expected number of reportable cancers

d. Other National Public Health Priorities and Strategies HHS Priority Goals:

Improve health care and population health through meaningful use of health information technology

Improve laboratory, surveillance, and epidemiology capacity Ensure efficiency, transparency, accountability, and effectiveness of HHS Programs Enhance access to and use of data to improve HHS programs and to support improvements in the health and well-being of the American people https://www.healthypeople.gov/2020/topics-objectives/topic/cancer/objectives

CDC Division of Cancer Prevention and Control?s Strategic Priority: Improve the integration of public health data sources to support data-driven decisions by providers and state health departments

e. Relevant Work This work will align and enhance the following program activities that support NPCR operations:

DP13-1308: Cancer Surveillance Data Standards & Best Practices;

DP13-1310: Collaboration for Improving and Promoting Standardized Cancer Staging

Using the Collaborative Stage Data Collection System DP13-1311: Standardize Electronic Laboratory and Biomarker Reporting

Relevant background references:

North American Association of Central Cancer Registries. Standards for Cancer Registries.Volume I. Data Exchange Standards and Record Descriptions; Volume II.

Data Standards and Data Dictionary and Volume V, Pathology Laboratory Electronic Reporting.

Ryerson AB, Massetti GM. CDC's Public Health Surveillance of Cancer. Prev Chronic Dis. 2017 May;14:E39

Amin, MB et al. (eds), AJCC Cancer Staging Manual, Eighth Edition. American Joint Committee on Cancer, 2017.

O'Sullivan B, et al. The TNM classification of malignant tumours-towards common understanding and reasonable expectations. Lancet Oncol. 2017:18(7):849-851.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

https://www.naaccr.org/data-exchange-standards-record-description/ https://www.naaccr.org/data-standards-data-dictionary/ https://www.naaccr.org/data-standards-data-dictionary/ https://cancerstaging.org/references-tools/deskreferences/Pages/default.aspx

This NOFO may fund health information systems infrastructure, including workforce, to support the specific strategies, activities, and outcomes described in this NOFO.

i. Purpose The purpose of NOFO is to enhance the data quality and operational efficiency of CDC?s National Program of Cancer Registries (NPCR). This NOFO will ensure the development and dissemination of uniform standards in cancer staging, data collection, and data reporting to ensure NPCR registries submit complete and timely data to CDC. High quality cancer surveillance data will measure progress in cancer prevention and control and inform activities to improve the public?s health.

ii. Outcomes This NOFO aims to support central cancer registries that comprise CDC?s NPCR. Outcomes awardees are expected to achieve by the end of the project period include the following:

Enhance standards and operations for collecting and reporting of cancer surveillance data.

Increase timeliness, completeness, and quality of data reported to NPCR registries.

Increase competency of NPCR registry staff, particularly Education and Training

Coordinators Improve interoperability of NPCR software with AJCC TNM cancer staging system.

Increase electronic submission of laboratories data into NPCR registries.

iii. Strategies and Activities The program strategies described in the NOFO are intended to direct organizations to focus their strengths and experience to support improving data quality and the operations of NPCR.

Multiple stakeholders contribute to population-based cancer data collection and registries therefore a major focus of this work is two-fold: (1) to enhance NPCR within the context of their organization?s mission and (2) to ensure national cancer surveillance partners coordinate their respective activities to advance cancer surveillance standards through collaboration.

Collaboration entails the following, at a minimum:

All recipients will be asked to contribute their subject matter expertise to define and implement cancer surveillance data standards in collaboration with multiple stakeholders.

All recipients will contribute to the education and training of central cancer registries on current surveillance standards and best practices. Specifically, recipients will be expected to coordinate and incorporate educational into the training and activities of other component recipients.

All recipients will be expected to develop and/or reinforce working relationships among other component recipients, national cancer surveillance partners and professional organizations through invitations and participation to meetings and workgroups.

In addition, to meet future NPCR needs and facilitate efficient operations, recipients are expected to develop and promote innovative ways to collect NPCR data, including electronic reporting. The strategies described in the logic model will be framed as three program components: (1) Education, Standards and Translation; (2) Cancer Staging Collaboration and Implementation; and (3) Standardization and Support for Laboratory and Biomarker Electronic Reporting. Successful recipients will each lead a (one) specific component.

For Education, Standards and Translation (Component 1), recipient will improve NPCR registry operations through the development, dissemination, translation and maintenance of consensus for national data standards and best practices for population-based central cancer registration. Translation means increasing the ability of NPCR registries to implement what is updated or new in registry operations (e.g. revised cancer staging and biomarker reporting).

Recipient will support activities to document best practices developed by assigned work-groups/committees that are comprised of other cancer surveillance partners. The recipient will be responsible for development and maintenance of a working relationship with other national organizations to better facilitate the collection, processing, and reporting of cancer surveillance data. The recipient will provide educational opportunities to NPCR registries, particularly focusing on increasing the competency of NPCR Education and Training Coordinators.

For Cancer Staging Collaboration and Implementation (Component 2), recipient will be charged with ensuring that the cancer staging system commonly used by clinicians to describe the type, size and extent of spread of cancer (i.e., AJCC TNM staging) aligns with the operations of NPCR and that NPCR has adequate time to understand, evaluate, and implement any changes. The recipient must already have established expert-level knowledge on the AJCC TNM staging system rationale and rules so that they can provide consultation for educational offerings to NPCR registries and provide timely, accurate responses to questions on AJCC TNM staging directly from cancer registrars at either central registries or reporting facilities.

Expert level knowledge means they have worked directly in the development of TNM staging or have provided consultation of the interpretation of TNM staging to cancer registrars for at least two editions of the published manual. Recipient will actively inform and engage cancer surveillance standard setters in the development and updates of the AJCC TNM staging system.

Recipient will ensure content of manuals can be transmitted and updated through a shared dynamic link library that can be imported into, and used by CDC?s software applications to allow seamless integration for any changes.

For Standardization and Support of Electronic Laboratory and Biomarker Reporting (Component 3), recipient will use strategies to improve the quality and timeliness of laboratory data reporting by implementing discrete real-time data reporting to NPCR cancer surveillance programs.

Strategies and Activities by Component Specifically, successful recipient for Education, Standards and Translation (Component 1) will:

Ensure current and developing cancer surveillance standards and best practices can be utilized efficiently by NPCR and its funded central cancer registries.

o Facilitate, manage, and support committees and associated workgroups that through consensus develop and promote best practices for central cancer registry operations and uniform data standards for cancer surveillance in the United States.

o Evaluate upcoming changes in cancer surveillance in order to assess need and direct committees to address gaps and current issues in cancer reporting standards.

o Develop and disseminate documented best practices by work-groups/committees comprised of other surveillance partners.

o Establish and maintain relationships with national organizations to promote support of population-based central cancer registries in the United States.

Develop and provide educational opportunities to NPCR registries that clarifies and supports cancer surveillance standards and practice.

o Develop an education plan for NPCR grantees for the next 5 years.

o Assess the educational needs of NPCR grantees that informs the educational plan.

o Utilize evaluation/assessment data from national data submissions result to inform education plans.

o Provide an infrastructure (e.g., website; webinars; print and electronic resources) for the development, delivery, and storage of education and training programs for NPCR registries.

o Conduct educational and training sessions for NPCR registries, particualry Education and Training Coordinators.

o Convene a periodic in-person educational meeting of NPCR registries based on content developed in collaboration with CDC staff and focused on registry operations, data standards and quality, and challenges in cancer surveillance practice that need to be addressed.

o Evaluate the effectiveness of the education and training activities.

Specifically, successful recipients for Cancer Staging Collaboration and Implementation (Component 2) will:

Collaborate with cancer surveillance experts to develop, update, and implement AJCC TNM staging standards.

o Convene cancer surveillance experts at least annually to facilitate a collaborative approach to develop, update, and implement AJCC TNM staging standards.

Respond to questions and consultations from the cancer registry community concerning AJCC TNM staging.

o Assess/evaluate the effectiveness of current inquiry systems for AJCC TNM staging-related questions in terms of ease of use, authority of answers, speed of response, effectiveness of search capabilities, and suitability as a repository of documentation.

o Ensure that the inquiry system has a user-friendly interface to facilitate access to questions and answers and robust search capabilities, including tagging of each question by AJCC Cancer Staging Manual chapter, disease, staging time period, and other relevant categories.

o Provide timely and accurate guidance and response to questions and consultations to the cancer registry community concerning AJCC TNM staging.

Ensure that content of AJCC Cancer Staging Manual can be incorporated into CDC's software for NPCR registries.

Specifically, successful recipient for Standardization and Support of Electronic Laboratory and Biomarker Reporting (Component 3) will:

Develop recommendations and coding specifications for standardized reporting of pathology and biomarker data from laboratories to NPCR registries.

o Convene national workgroup(s) with representatives from key partner groups and others with expert-level knowledge of anatomic pathology, molecular and genetic testing methods; clinical application of information related to the staging of cancer; and informatics/information technology.

o Update and enhance cancer pathology and biomarker templates to be consistent with clinical care, staging, and cancer surveillance reporting requirements.

o Participate in testing and demonstration activities to identify new innovative methods for standardized reporting of cancer pathology and biomarker data.

Engage and assist laboratories with implementation of standardized electronic pathology and biomarker reporting to central cancer registries.

o Identify and recruit laboratories to participate.

o Develop a tool that will enable laboratories, with limited capabilities, to map their laboratory system data to a structured data capture form for reporting to central cancer registries.

o Evaluate efforts and update the project as appropriate.

Support NPCR registries in activities to standardize reporting of anatomic pathology, molecular and genetic laboratory reports for the purposes of facilitating electronic reporting of critical data to central cancer registries.

o Provide education to staff at CDC, central cancer registries, pathologists, and laboratories on the collection and reporting of pathology and biomarker data to central cancer registries.

o Collaborate with other standard setters to ensure coordination where appropriate.

1. Collaborations Coordination and agreement on cancer surveillance standards among recipients is a central goal of this project. Applicants must describe proposed partnerships and collaborations, along with previous experience and activities with organizations that support NPCR cancer registries standards and operations.

a. With other CDC programs and CDC-funded organizations:

Applicants must describe plans to collaborate with CDC to improve technical assistance, program guidance, and implementation of CDC?s NPCR, specifically partnerships that allow for meaningful input into the development or updates of cancer staging standards; NAACCR surveillance standards (Vol II, Vol 5) and education to the cancer surveillance and laboratory community.

Successful collaboration entails evidence of working with CDC, NPCR registries, and cancer surveillance stakeholders to develop 1) data items and rules for the cancer staging system used by NPCR, including associated edits to ensure data quality; 2) data architecture to collect and transmit cancer surveillance data; and 3) training programs and materials focused on accurate and timely submission of NPCR cancer data. Applicants are encouraged to engage NPCR registries and CDC-funded organizations:

North American Association of Central Cancer Registries;

National Cancer Registrars Association;

American Joint Committee of Cancer;

https://www.naaccr.org/ http://www.ncra-usa.org/ https://cancerstaging.org

College of American Pathologists.

Applicants must also describe their willingness and capacity to lead and/or participate in stakeholder meetings and training (virtual and in-person). Additionally, applicants are encouraged to work with other programs within CDC?s Division of Cancer Prevention and Control, CDC's Center for Surveillance, Epidemiology, and Laboratory Services and other collaborative efforts with CDC-funded public health partners.

b. With organizations not funded by CDC:

Applicants are encouraged to foster collaborative relationships with organizations that can improve the completeness, timeliness and quality of NPCR. External collaborative partners can include entities from many sectors (governmental, non-profit, professional societies, business, education, and others) that have a common interest in maintaining an efficient and effective sharing electronic medical data and in exploring new, innovative, or efficient means to improve upon capture of data and efficiency of NPCR.

To achieve the goals of this NOFO, applicants should, at a minimum, have pre-existing relationships and be able to demonstrate outcomes resulting from successful collaborations with individuals and organizations integral to reporting, abstracting, or collecting cancer surveillance data submitted to CDC.

Applicants under Component 1 (Education, Standards and Translation) are asked to demonstrate relationships/collaborations with population-based central cancer registries;

national cancer organizations; and cancer registrars.

Applicants under Component 2 (Cancer Staging Collaboration and Implementation) are asked to demonstrate relationships/collaborations with clinicians who provide direct cancer care, including cancer staging and treatment; hospital cancer programs; and cancer registrars.

Applicants under Component 3 (Standardization and Support of Electronic Laboratory and Biomarker Reporting) are asked to demonstrate relationships/collaborations with broad network of pathologists and laboratories throughout the U.S.; organizations responsible for defining pathology and biomarkers standards; and health care vendors with extensive experience in computer medical vocabularies and/or natural language processing.

Applicants are encouraged to submit MOUs or MOAs, as appropriate; name the file MOUs/MOAs, and upload it as a PDF file at www.grants.gov

2. Target Populations The target population that will benefit from this NOFO is all residents who live in a geographic area covered by NPCR, this includes members of tribes or tribal organizations. The aim of this NOFO is to ensure support for all federally-funded statewide and established territorial NPCR cancer registries in the United States (including DC) as well as cancer registrars and clinicians who collect and submit cancer surveillance data from healthcare facilities and laboratories across the U.S.

http://www.cap.org http://www.grants.gov/

a. Health Disparities Populations at risk for health inequity will benefit from the availability of standardized, population-based cancer surveillance data which can be used to focus public health action and measure progress in addressing known inequity. Moreover, improved quality and timeliness of cancer surveillance data is critical to identifying differences in cancer outcomes.

iv. Funding Strategy (for multi-component NOFOs only) Up to three awards are available for this program; one applicant will be selected for each component. Eligible applicants should request funding for only one component; decisions should be made based on organizational capacity; pre-existing partnerships; prior experience;

and previous similar activities related to the support of cancer surveillance. If applicants apply for more than one component, the first application received will be reviewed, and any subsequent applications will be considered non-responsive.

For Component 1 (Education, Standards and Translation), funding may range up to $495,000; the funding range for Component 1 reflects proper resource allocation for education of NPCR registries, leading collaborative standard development, and translation of standards into best practices.

For Component 2 (Cancer Staging Collaboration and Implementation), funding may range up to $250,000; the funding range reflects proper resource allocation for expertise, involvement and consultation on cancer staging and integration of AJCC TNM staging standards into CDC software/informatics.

For Component 3 (Standardization and Support of Electronic Laboratory and Biomarker Reporting), funding may range up to $300,000; the funding range reflects proper resource allocation for code specification, testing, demonstration and support of direct reporting from laboratories to NPCR registries.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy CDC will evaluate the extent to which activities were successfully implemented and led to expected outcomes using an evaluation strategy and performance measurements that are based on the logic model. The evaluation activities conducted by CDC will: 1) assess the extent to which the activities and strategies were successfully implemented; 2) demonstrate whether activities led to expected outcomes; 3) inform program planning for technical assistance, changes or activities by CDC to better support its NPCR registries. Data sources available to CDC to monitor the progress and impact of this NOFO include NPCR program standards, annual reports from NPCR registries, and results from the NPCR Program Evaluation Instrument survey.

Core Measure: Increased timeless, completeness, and quality of data CDC will use the NPCR National Data Quality Standards to assess progress towards the intermediate outcome of increased timeliness, completeness, and quality of data submitted to CDC by end of the project:

Increased timeliness (Increase by 10% from baseline, the number of NPCR registries that meet the NPCR data standards at 12-month)

Increased completeness of the data (<5% missing/unknown data items in 12- and 24-month submissions)

Increased quality (95% of key data items passing a CDC-prescribed set of standard edits)

The performance measures for this project are primarily associated with short- or intermediate-term outcomes which lay the foundation for a robust, efficient national cancer surveillance system. Over 1.6 million cancer cases are submitted annually from 47 NPCR registries. The long term outcomes of reducing cancer mortality and availability of high-quality cancer data to inform public health, policy, research and clinical decisions can only be accomplished with clearly defined and synchronized data collected by knowledgeable cancer registrars using a surveillance system that employs advanced informatics processing. The core measures below are integral to these achieving long-term outcomes.

Core Performance Measures: All awardees are expected to report on the following performance measures below:

Enhanced standards and operations for collecting and reporting cancer surveillance data

Number of new, revised or improved standards, guidelines, and resources available for NPCR Registries to achieve complete, timely, and high quality collection of cancer surveillance data.

Number and extent of participation of cancer surveillance standard setters and stakeholders in development of the above standards, guidelines, and resources.

Number of meetings held with cancer surveillance standard setters to discuss new requirements and guidelines.

Increased competency of NPCR staff, particularly Education and Training Coordinators

Number of NPCR registries reporting increased capacity to deliver educational programs and provide assistance on questions related to cancer data collection as a result of education and training provided by awardees.

Number of trainings and outreach offered by NPCR registries to registrars and facilities that incorporate focused area on NOFO component (i.e., standards, best practices, AJCC TNM staging, and electronic reporting).

Number of NPCR registries with improved overall score on correctly coded cancer surveillance coding and staging scenarios completed by NPCR central cancer registry staff.

Component-specific measures: Recipients are also asked to implement the component-specific performance measures below that align with their project focus of their application. Recipients are encouraged to review their proposed activities and suggest additional performance measures as appropriate. CDC will provide assistance with determining baseline and finalizing for the proposed measure after the NOFO is awarded.

Increased access and uptake of registry training and resources for NPCR registries

(Component 1)

Number of educational sessions (hours) provided to NPCR registries.

Number and percent of NPCR registry that participate in training.

Improved interoperability between NPCR software with AJCC TNM cancer staging system (Component 2)

Number of AJCC Staging Manual chapters that machine-readable and processable AJCC TNM staging tables (clinical, pathological, and post-neoadjuvant) with a row for each combination of input values.

Increased availability of dynamic link library (DLL) and application program interface (API) that include coding tables, descriptions, and content of the AJCC cancer staging manual.

Increased reported ease {Excellent, Very good, Good, Fair, or Poor} in extent to which specifications for use of the content management system optimum for use reported by cancer registry software developers.

Increased electronic submission of laboratories data into NPCR registries (Component 3)

Number of laboratories the have successfully transmitted records to NPCR registries.

Number of NPCR registries that receive direct electronic submission of laboratories data direct to NPCR registry.

Number of cancer cases that have received information via direct electronic reporting from laboratories.

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant)

Plans for updating the Data Management Plan (DMP), if applicable, for accuracy throughout the lifecycle of the project. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans.

For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, within the first 6 months of award, as described in the Reporting Section of this NOFO.

Moreover, the applicant is encouraged to specify in the plan clear monitoring and evaluation procedures which address the following:

Level and impact of key stakeholder engagement in planning and implementation of cancer surveillance standards;

Content of and extent to which educational activities meet needs of NPCR registries and registrars and yield the intended outcomes; and

Improvement in electronic capture of cases.

The applicants evaluation plan should describe specific, measurable, and realistic short-term and long-term program objectives consistent with the intent of this NOFO.

c. Organizational Capacity of Recipients to Implement the Approach Successful applicants should have program infrastructure, organizational capacity and existing experience to develop and implement the strategies as outlined in NOFO Program infrastructure will be evidenced by:

An established national infrastructure with local, state, or regional reach (e.g., constituencies, facilities) including active relationships with clinical and cancer surveillance professionals across the entire U.S.;

A management plan that ensures core staffing with clearly defined roles, adequate management structure/staffing and fiscal management (i.e., financial reporting, budget management) to achieve proposed activities;

Ability to conduct a partnership evaluation that will serve as the foundation for engaging and sustaining new and existing partnerships for the achievement of project outcomes;

A communication and coordination plan that will be used to engage key stakeholders in development and dissemination of cancer staging and surveillance standards;

Staffing and technology that will be used to develop, deliver and archive educational offerings to central cancer registries and cancer registrars; and

Ability to collect relevant data elements needed to support program evaluation and performance measurements.

https://www.cdc.gov/grants/additionalrequirements/ar-25.html

Organizational capacity and experience to develop and implement strategies as specified in the NOFO will be evidenced by:

All components:

Documented history of establishing and maintaining productive and effective partnerships NPCR-funded cancer registries; cancer registrars; cancer surveillance standard setters and with members of the stakeholder community;

Documented history of the development and dissemination of cancer staging and surveillance standards, such as publication of manuals, definitions, implementation guidance and/or templates to collect data items required for submission to CDC;

Formalized partnership via MOA, MOUs, or letters of agreement from cancer surveillance standard setters that document a formal commitment to complete the proposed work.

Previous experience leading national meeting and committees that develop and disseminate standards, evaluations, guidance relevant to central cancer registry operations; and

Documentation of successful development and delivery of training on data collection for cancer staging and/or surveillance and central cancer registries operations.

Component 1: Education, Standards, and Translation

At least 10 years prior experience in development, maintenance, and updating of cancer surveillance definitions, abstraction from primary source, and/or collection of cancer data reported to CDC;

Documentation of 10 years or more of prior experience of assessing educational needs and developing and implementing effective cancer surveillance education/training.;

Communication infrastructure and experience to ensure dissemination of cancer surveillance education to all NPCR registries and the broader cancer registry community;

A national certification program related to the collection of information used directly in standardized cancer staging and surveillance; and

Established relationship of 10 years or more with NPCR registries and with National Standard Setters.

Ten years of experience is suggested due to the extensive clinical and historical knowledge in cancer surveillance needed to effectively perform the strategies and activities outlined in the logic model. Applicants would need to know changes and impact on registries of at least two major transitions in the cancer staging (occurred in 2009 and 2016). Without this level, the CDC project officer and subject matter experts would need to invest in inordinate amount of time to educate a less experienced applicant.

Component 2: Cancer Staging Collaboration and Implementation

Documented history of development and updating AJCC TNM Cancer Staging Standards;

Subject matter expertise and prior experience training on AJCC TNM Cancer Staging

Standards;

Established relationship with a national network of hospitals and physicians which use cancer staging for care of patients, research, and health care quality improvement efforts;

Ability to lead projects that complex projects that involve achieving consensus among clinical, public health, and other relevant professional organizations; and

Prior experience in the development, updating, and dissemination of Application Programming Interface (API) and/or dynamic-link library (or DLL) enabling interoperability in standardized data capture and transmission.

Component 3: Standardization and Support for Laboratory and Biomarker Electronic Reporting

Established relationships with pathologists and laboratories from across the country;

Prior experience with development of Structured Data Capture (SDC) XML-standardized reporting templates;

Knowledge of ePath reporting specification;

Prior experience with mapping standardized pathology and biomarker templates to the

NAACCR Volume V Pathology Electronic Reporting Standard specification;

Existing infrastructure to develop, enhance, evaluate, and distribute cancer templates for pathologists to use in reporting to central cancer registries;

Knowledge of what educational information is required for laboratories, laboratory information systems vendors and pathologists to implement the standardized cancer reporting templates;

Previous participation in integrating the Healthcare Enterprise (IHE) and Healthcare Information and Management Systems Society (HIMSS) activities.

Applicants are encouraged to submit CVs/Resumes and Organizational Charts by naming the files as "CVs/Resumes" or "Organizational Charts" and uploading them at www.grants.gov .

d. Work Plan Applicants are encouraged to provide a detailed work plan describing the strategies and activities that will be accomplished during the first year along with a high-level work plan of activities to be conducted in subsequent years that are essential to the achievement of long-term outcomes at the end of the funding period. Applicants are encouraged to identify process measures corresponding to the work plan, such as:

Description of specific strategies and activities to be conducted during the first year of the project period.

o Proposed activities to achieve collaboration on cancer surveillance data standards and partnerships with stakeholders and NPCR registries;

o Specific, measurable, achievable, realistic time-phased (SMART) objectives that are consistent with the short-term outcomes in logic model outlined in the ?Approach? section of this NOFO;

Description of the development, delivery, and support of education to central cancer registries, registrars, and reporting facilities that aligns with the short- and long-term outcomes.

http://www.grants.gov/

Description of the strategies along with how the applicant will monitor and report progress on long-term outcomes related to the advancement of cancer surveillance standards and operations.

Activities must be in alignment with the proposed outcomes and the program strategies and activities list. Applicants are encouraged to present an organized work plan with the following components:

Project Outcomes Strategies/Activities Process Measures Staff responsible for completion of activities Timeline and Completion Date Collaborators and Partners

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and recipients, site visits, and recipient reporting (including work plans, performance, and financial reporting).

Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking recipient progress in achieving the desired outcomes.

Ensuring the adequacy of recipient systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities deemed necessary to monitor the award:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.

Ensuring that recipients are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with recipients on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk recipients.

Other activities deemed necessary to monitor the award include the following:

Monthly conference calls and email communication with assigned CDC project officer Review of progress reports and other data reports to support NOFO activities

f. CDC Program Support to Recipients (THIS SECTION APPLIES ONLY TO

COOPERATIVE AGREEMENTS)

In a cooperative agreement, CDC staff are substantially involved in the program activities, above and beyond routine grant monitoring. CDC involvement in this NOFO will include:

Subject matter expertise and technical assistance in the areas of NPCR surveillance program standards, operations, including software programs for collecting, receiving, validating, processing, and analyzing cancer registry data;

Identification of collaboration and coordination opportunities to facilitate the exchange of information between awardees, NPCR registries, and partners, as needed;

Ongoing guidance and consultation to support the development, implementation, monitoring, and evaluation of the work plan;

Technical assistance and support to pathologists and laboratories to structure and transmit electronic pathology/biomarker reports directly to NPCR registries, and support central cancer registries to receive reports;

NPCR Cancer Surveillance System quality control analytic datasets, as available and allowable, to assess the quality of central cancer registry data for Data Quality Evaluations of NPCR data items.

B. Award Information

1. Funding Instrument Type: Cooperative Agreement CDC's substantial involvement in this program appears in the CDC Program Support to Recipients Section.

2. Award Mechanism: U58 Chronic Dis

3. Fiscal Year: 2018 Estimated Total Funding: $5,225,000

4. Approximate Total Fiscal Year Funding: $1,045,000

This amount is subject to the availability of funds.

5. Approximate Period of Performance Funding: $5,225,000

6. Total Period of Performance Length: 5

7. Expected Number of Awards: 3

8. Approximate Average Award: $325,000 Per Budget Period

This amount is subject to the availability of funds.

9. Award Ceiling: $1,045,000 Per Budget Period

Award ceiling for Component 1 (Education, Standards and Translation) may range up to $495,000; For Component 2 (Cancer Staging Collaboration and Implementation) may range up to $250,000; and for Component 3 (Standardization and Support of Electronic Laboratory and Biomarker Reporting) may range up to $300,000;

10. Award Floor: $0 Per Budget Period

11. Estimated Award Date: 09/28/2018

Throughout the period of performance, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by…