cdc-rfa-dd15-1506.pdf

Centers for Disease Control and Prevention

National Center on Birth Defects and Developmental Disabilities

Surveillance of Congenital Heart Defects Across the Lifespan

CDC-RFA-DD15-1506

Application Due Date: 06/01/2015

Surveillance of Congenital Heart Defects Across the Lifespan

CDC-RFA-DD15-1506

TABLE OF CONTENTS

Part I. Overview Information

Federal Agency NameA.

Funding Opportunity TitleB.

Announcement TypeC.

Agency Funding Opportunity NumberD.

Catalog of Federal Domestic Assistance (CFDA) NumberE.

Dates F.

Executive Summary G.

Part II. Full Text

Funding Opportunity Description A.

Award Information B.

Eligibility Information C.

Required Registrations D.

Review and Selection Process E.

Award Administration Information F.

Agency Contacts G.

Other Information H.

Glossary I.

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-DD15-1506. 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. Funding Opportunity Title:

Surveillance of Congenital Heart Defects Across the Lifespan C. Announcement Type: New - Type 1 This announcement is only for non-research domestic activities supported by CDC. If research is proposed, the application will not be considered Research for this purpose is defined at http://www.cdc.gov/od/science /integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

D. Agency Funding Opportunity Number:

CDC-RFA-DD15-1506

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

93.073 F. Dates:

1. Due Date for Letter of Intent (LOI): 04/27/2015

2. Due Date for Applications: 06/01/2015, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call: N/A

G. Executive Summary:

1. Summary Paragraph:

The proposed funding opportunity announcement (FOA) solicits non-research, cooperative agreement applications to develop accurate and complete, population-based surveillance of Congenital Heart Defects (CHDs).

Measurable outcomes of the program will be in alignment with the following performance goal for the National Center on Birth Defects and Developmental Disabilities (NCBDDD): 1) Enhance the quality and utility of birth defects surveillance systems. This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address:

http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch .pdf.

a. Eligible Applicants: Open Competition

b. FOA Type: Cooperative Agreement

c. Approximate Number of Awards: 6 Anticipate 4 - 6 awards comprised of Category A: 1 – 3 awards and Category B: 3 – 5 awards.

d. Total Project Period Funding: $9,600,000

e. Average One Year Award Amount: $400,000

f. Number of Years of Award: 4 https://foa.grantsolutions.gov/announcementmodule/www.grants.gov https://foa.grantsolutions.gov/announcementmodule/www.grants.gov http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.grants.gov http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf

f. Number of Years of Award: 4

g. Estimated Award Date: 09/01/2015

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 FOA exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview

This new, competitive FOA will expand the National Center on Birth Defects and Developmental Disabilities’ programs conducting birth defects surveillance with a focus on congenital heart defects (CHDs) among individuals of all ages.

The National Center on Birth Defects and Developmental Disabilities (NCBDDD), Division of Birth Defects and Developmental Disabilities (DBDDD) seeks to fund collaborative projects to:

1) Category A: Build on existing infrastructure for population-based CHDs surveillance to (i) link additional years of surveillance data for both adolescents and adults identified having a CHD, (ii) identify factors associated with optimal healthcare and improved outcomes, (iii) evaluate factors that impede appropriate transition from pediatric to adult care, (iv) expand surveillance activities to include the lifespan, if possible, and (v) develop pilot projects to translate public health best practices into action; and

2) Category B: Develop and implement innovative approaches for conducting population-based surveillance of CHDs in adolescents and adults, and if possible, across the lifespan, by linking existing data sources. Surveillance data will be used for descriptive epidemiology, to identify comorbidities, and examine healthcare utilization and referral to timely and appropriate services.

CHDs are one of the most prevalent birth defects in the United States affecting about one percent of all births and are a leading cause of birth defect-associated infant mortality, morbidity, and healthcare costs.

However, most current efforts to conduct population-based surveillance of CHDs have focused on monitoring newborns, and little data exist on the prevalence and descriptive epidemiology of CHDs beyond early childhood in the United States. Improvements in treatment of CHDs and consequently in survival have resulted in many individuals, even those affected by a very severe CHD, living into adolescence and adulthood. Current estimates suggest there are over 2 million people living with a CHD in the United States, including over one million adults; about 12% of these affected adults have a severe CHD. Despite the public health burden, the lack of population-based surveillance for CHDs among individuals of all ages in the United States precludes reliable data on the actual prevalence, and the type and number of health services required to address the health needs of these individuals, costs of such health services, and longer term outcomes including comorbidities and survival of individuals living with CHDs. Given that many individuals with CHD are living into adolescence and adulthood, they will need to transition their care from pediatric to adult-centered care. In the absence of structured programs to guide this transition, there can be delayed or inappropriate care, improper timing of the transfer of care, and undue emotional and financial stress on the patients, their families, and the healthcare system. Without appropriate transition, patients may not stay in care and be lost to follow-up. There is a need for furthered understanding of transition of care issues and perceptions of need for specialty care.

The federal Patient Protection and Affordable Care Act (PL 111-148, Section 10411) authorized CDC to “enhance and expand infrastructure to track the epidemiology of congenital heart disease and to organize such information into a nationally-representative, population-based surveillance system” for the purpose of facilitating “further research into the types of health services patients use and to identify possible areas for educational outreach and prevention.”

b. Statutory Authorities

This program is authorized under Sections 301, 317C and 399V-2 of the Public Health Service Act [42 U.S.C. 241, 247b-4 and 280g-13], as amended.

c. Healthy People 2020

The National Center on Birth Defects and Developmental Disabilities (NCBDDD) of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of “Healthy People 2020”.

This FOA addresses “Healthy People 2020” priority area of Maternal, Infant, and Child Health, and specifically MICH-1.7, reduce the rate of infant deaths related to birth defects (congenital heart defects) (http ://www.healthypeople.gov/2020/topics-objectives/topic/maternal-infant-and-child-health/objectives). This project will conduct surveillance among adolescents and adults, and, if possible, individuals of all ages to determine an overall prevalence of those living with CHD and will compare survivor characteristics to newborns with CHD.

d. Other National Public Health Priorities and Strategies

This program is aligned with CDC's mission of saving lives and protecting people from health threats (http ://www.cdc.gov/about/organization/mission.htm ). This program is also aligned with CDC's role of conducting critical science, providing health information that protects our nation against expensive and dangerous health threats, and responding when these arise.

e. Relevant Work

There is no single U.S. data system that can be used to accurately estimate the prevalence of CHDs among individuals of all ages, or to describe the affected population. Instead, multiple data sources must be linked to help develop statistically robust estimates of CHDs prevalence and provide information on healthcare utilization and longer term outcomes among children, adolescents, and adults. In FY12, CDC funded 3 grantees under FOA #DD12-1207 for a three year project to pilot innovative methods of conducting population-based surveillance of adolescents and adults with CHDs by linking existing data sources ( http ://www.cdc.gov/ncbddd/heartdefects/research.htm). Activities under FOA #DD12-1207 included development of a common case definition, core variable set, and an Access database for data transmission to CDC. Data sources identified have varied by site and include a combination of: birth defect surveillance data, Medicaid data, clinic/billing data, vital records, All Payer Claims Data, and hospital discharge data.

This FOA will allow sites to further develop and expand their CHDs surveillance system and share individual level, de-duplicated, de-identified data with CDC (Category A); and sites without an existing CHDs surveillance system to develop such a system and share individual level, de-duplicated, de-identified data with CDC (Category B). Refer to www.cdc.gov/ncbddd for a fact sheet describing the previous study, and for a copy of the variable list and case definition from FOA #DD12-1207 to be used for this study.

2. CDC Project Description

a. Approach

Logic Model CDC-RFA-DD15-1506: Surveillance of Congenital Heart Defects (CHDs) Across the Lifespan

Bolded text indicates outputs and outcomes the awardee is expected to achieve during the project period http://www.healthypeople.gov/2020/topics-objectives/topic/maternal-infant-and-child-health/objectives http://www.healthypeople.gov/2020/topics-objectives/topic/maternal-infant-and-child-health/objectives http://www.cdc.gov/about/organization/mission.htm http://www.cdc.gov/about/organization/mission.htm http://www.cdc.gov/ncbddd/heartdefects/research.htm http://www.cdc.gov/ncbddd/heartdefects/research.htm http://www.cdc.gov/ncbddd

Strategies and Activities

Outputs Short-Term Outcomes

(Categories A & B)

Intermediate Outcomes

(Categories A & B)

Long-Term Outcomes

(Categories A & B)

Categories A & B

Program Planning

Identify/engage partners Identify/prioritize program goals Define source population Identify data sources Characterize current efforts to serve population to facilitate case-finding

Project management

Document legal authority to access data Develop/implement communication plan

Data collection/reporting

Access & link existing data sources Collect/store standardized data

Submit de-identified, de-duplicated individual level encounter and summary level data to CDC

Assessment/Results

Assess quality of data sources Clinical record review to increase sensitivity of case ascertainment Describe population with CHD

Categories A & B

Population-based cohort of adolescents and adults (& others if possible) with CHD

Descriptive epidemiology and prevalence estimates

Additional information on health & non-health outcomes (e.g., educational)

Increased sensitivity of case ascertainment

Describe availability of specialty care in study area

Extended surveillance activities for one subpopulation of interest

Category A

Online educational modules for families/healthcare providers

Describe transition

Improved understanding of strengths & limitations of integrated surveillance for CHD among public health practitioners understanding of health outcomes of study population with CHD understanding of racial/ethnic or socioeconomic patterns in healthcare use or long-term outcomes in study population

Increased awareness among health service providers, patients, parents and public of nationwide CHD issues ability to calculate life expectancy for persons with

Informed public, patients, parents policy makers data-informed decision-making on policy and resource allocation among stakeholders

Develop effective secondary prevention strategies directed at reducing the public health impact of CHD continuity of care of individuals of all ages with

CHD

quality of life of individuals of all ages with morbidity/ mortality among individuals of all ages with with CHD

Develop & disseminate educational modules for families/healthcare providers Survey parents of adolescents Link additional data years and, if possible, additional data sources to existing surveillance system of care issues and perceptions of need for specialty care as reported by parents of adolescents persons with specific CHD

i. Purpose

The purpose of this program is to support development of population-based surveillance systems for persons with CHDs, using non-research CDC cooperative agreements. An estimated 2 million persons in the US are living with a CHD, yet little is known about their long-term outcomes. High-quality data will improve understanding the epidemiology and public health significance of CHDs. Surveillance data will also allow monitoring of special sub-populations with CHDs, and potentially identify risk factors and prognostic factors for identifying opportunities and developing effective secondary prevention strategies directed at reducing the personal and public health impact of congenital heart defects.

ii. Outcomes

As identified in the logic model, the following are the outcomes the awardee is expected to achieve during the project period:

Categories A & B

Improved understanding of strengths & limitations of integrated surveillance for CHD among public health practitioners Improved understanding of health outcomes of study population with CHD Improved understanding of health outcomes of a special population with CHD Improved understanding of racial/ethnic or socioeconomic patterns in healthcare use or long-term outcomes in study population Increased awareness among health service providers, patients, parents and public of nationwide CHD issues Improved ability to calculate life expectancy for persons with specific CHD Population-based cohort of adolescents and adults (& others if possible) with CHD Descriptive epidemiology and prevalence estimates Additional information on health & non-health outcomes (e.g., educational) Increased sensitivity of case ascertainment Describe availability of specialty care in study area Extended surveillance activities for one sub-population of interest

Category A Only

Online educational modules for families/healthcare providers

Describe transition of care issues and perceptions of need for specialty care as reported by parents of adolescents

iii. Strategies and Activities

The logic model presents the strategies and component activities to be undertaken to achieve the project period outcomes. In conducting activities to achieve the purpose of this program, Category A and B awardees will conduct the following:

Program Planning

• Identify/engage partners: Demonstrate effective relationships and cooperation with appropriate partners (i.e. state officials, cross-department personnel-including informatics personnel within state health department, community based organizations, academic medical center and/or treatment center specializing in CHDs).

• Identify/prioritize program goals: Identify goals and measurable objectives performance measures to support achieving the desired outcomes of the project.

• Define source population: Provide a clear definition of the source population (a minimum population size of the defined geographic region should equal 2 million individuals of all ages). For planning, a three year time period (calendar years 2011-2013) should be used.

• Identify data sources: Name and describe each data source that will be used to identify individuals with CHDs. Indicate those sources that can be accessed immediately and those that will need additional approvals. Describe any new datasets that might be used, and how access to those will be obtained. Data should be population-based, or information should be provided on how the data will provide estimates that approximate population-based estimates with respect to racial/ethnic and socioeconomic diversity.

• Characterize current efforts to serve population to facilitate case-finding: Characterize current statewide or regional efforts to serve individuals of all ages with CHDs including specialty clinics that exist and might facilitate case-finding activities.

Project management

• Document legal authority to access data: Provide evidence of legal authority (via letters of support or other documents) to access the relevant data sources and to share de-identified, de-duplicated individual-level data with CDC and other awardees of this cooperative agreement, including addressing any HIPAA and IRB requirements. Examples of past access and transmission should be described. Applicants must provide letters of support from agencies that house source data authorizing access and sharing of required data.

• Develop/implement communication plan: Describe how information about this project will be disseminated to stakeholders (meetings, leadership briefings, newsletters, web-site, etc.).

Data collection/reporting

• Access & link existing data sources: Demonstrate capacity to access, link, and use data from clinics, health providers, vital records, birth defect registries, hospital discharge, payers, and other sources. Utilize strengths of electronic health record systems when possible to facilitate identification of individuals with CHDs. Briefly describe the proposed linkage process, including how the data will be de-duplicated both within and across each data set. Describe past experience with linking the identified data sources, or linking other data sets of similar size and complexity.

• Collect/store standardized data: Collect and store data in a standardized manner with limited, common data elements that are agreed upon by CDC and all awardees. Follow the case definition developed under data elements that are agreed upon by CDC and all awardees. Follow the case definition developed under FOA #DD12-1207 posted on the www.cdc.gov/ncbddd website.

• Submit de-identified, de-duplicated individual level encounter and summary level data to CDC: The standardized data elements in an Access database will be transmitted to CDC via the CDC secure network, meeting deadlines specified by CDC. Since one individual may have multiple encounters across various data sets, both the encounter level and a summary record (combining and reconciling information across all encounters) will be transmitted. Awardees will complete the necessary requirements to gain access to the CDC secure network.

Assessment/Results

• Assess quality of data sources: Describe how the quality of the data source will be assessed. This could include determining the relative contribution of cases from each source, determining the percent of missing data for key variables, or calculation other quality metrics.

• Clinical record review to increase sensitivity of case ascertainment: While medical records will not be routinely abstracted, it may be necessary for certain defect codes or certain data sources to be sampled to determine the accuracy of the information provided in the data source. Validate a subset of the data through abstraction of detailed medical records (targeted in scope and number) to evaluate the quality of the clinical information captured from existing electronic data sources. Subsets of cases to be reviewed will be mutually agreed upon by the awardees. Describe how such activities could be accomplished, including access to dataset source information.

• Describe population with CHD: Determine prevalence of CHDs in adolescents and adults, and, if possible, in individuals of all ages including providing descriptive epidemiology of CHDs by available demographic factors. Describe the health care utilization and, if possible, the direct medical care costs for specified time periods. Describe the distribution of disease severity, co-morbidities, and longer term outcomes. Describe any racial/ethnic or socioeconomic disparities in healthcare use or long-term outcomes.

Monitor health outcomes in special populations such as pregnant women with CHDs, racial/ethnic minorities, or persons with CHDs covered by public insurance. Calculate survival and life expectancy for persons with specific types of CHDs. Describe availability of specialty care and referral patterns that are currently in place

• Develop & disseminate educational modules for families/healthcare providers: In collaboration with stakeholders, develop online educational modules for families or healthcare providers to address key knowledge and healthcare use gaps identified by surveillance efforts.

• Survey parents of adolescents: Conduct a brief survey for parents of those individuals with CHDs age 17 and younger to assess barriers to appropriate transition of care and parental understanding of the healthcare needs of their adolescent.

• Link additional data years and, if possible, additional data sources to existing surveillance system: The population-based cohort must include both adolescents and adults, and if possible, individuals of all ages with CHDs. The surveillance period needs to include, at a minimum, calendar years 2008-2013. In addition, sites may also add new data sources to increase the sensitivity of case ascertainment.

http://www.cdc.gov/ncbddd

1.Collaborations

a. With CDC-funded programs:

Category A and Category B:

Work with CDC and other awardees to agree on standardized processes, methods, standardization of data collection, and other project activities (required).

Participate on all cooperative agreement calls and on-site meetings (required). All sites will have at least one representative on all workgroups and will lead projects on a shared basis (required).

Join the CDC-shared project site where all project documents will be stored. All awardees are expected to post relevant documents to this site during the project. All awardees will have access to project materials from FOA #DD12-1207.

b. With organizations external to CDC:

Category A and Category B:

Demonstrate effective relationships and cooperation with appropriate partners (i.e. state officials, cross-department personnel-including informatics personnel within state health department, community based organizations, academic medical centers, physician groups, adult congenital heart specialists, and/or treatment centers specializing in CHDs). Past collaborations with these partners should be described. Letters of support from a minimum of 3 partners are required. If the applicant is not a state health department, then the applicant is required to include a letter of support from the state health department.

Collaborate and coordinate across state agencies and clinical settings for data collection. For all source data that the applicant does not “own”, a letter of support from the holder of the data must be included, that addresses access to the data and an understanding that individual level, de-duplicated, de-identified data from the relevant data sources will be shared with CDC and the other awardees.

Involve appropriate within-region partners, such as health care providers, community based organizations, academic medical centers and/or outpatient centers specializing in CHDs care, and other organizations to assist with data collection.

Identify and engage appropriate partners within the region such as health care providers, community based organizations, academic medical centers and/or outpatient centers specializing in CHDs care, and local advocacy groups to develop, implement, and expand activities to improve the access to quality, specialized care.

Provide evidence of legal authority to access and share individual level, de-duplicated, de-identified data from the relevant data sources for identification of cases.

2. Target Populations

Category A and Category B:

The focus of surveillance activities should be on individuals who have been diagnosed with a CHD and reside in the defined geographic area of the source population. The target population for educational activities will be patients with CHDs, families of those with CHDs, and/or healthcare providers.

a. Inclusion

Category A and Category B:

• Source population should include a population of at least 2 million individuals of all ages.

• Identify population living with a CHD.

• Describe one sub-population of interest (e.g., non-Hispanic Blacks, pregnant women, adults aged 40 and older, etc).

iv. Funding Strategy (for multi-component FOAs only)

Not Applicable

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

Evaluation and progress reports

Prepare a written assessment of the accomplishments, challenges and opportunities of the CHDs surveillance project including a description of the problems encountered, lessons learned, potential improvements, etc.

Draft evaluation measures are below. CDC will work with awardees to finalize measures within the first six months of the project period.

Activities (Category A & B):

Program planning activities: identify/engage partners, identify/prioritize program goals, define source population, identify data sources, characterize current efforts to serve population to facilitate case-finding

Indicators for success: partners are identified and letters of support are included in application; provide updates to CDC on routine partner meetings and calls, program goals are identified and prioritized, source population is defined, data sources are identified, and current efforts to serve source population have been described in the application.

Project management activities: document legal authority to access data, develop/implement communication plan

Indicators for success: legal authority to access data is documented and sent to CDC Project Officer;

communication plan is developed, submitted to CDC for review, and implemented.

Data collection/reporting activities: access & link existing data sources, collect/store standardized data, submit de-identified, de-duplicated individual level encounter and summary level data to CDC

Indicators for success: data sources have been accessed and linked, data standardization and storage processes are documented and sent to CDC, de-identified, de-duplicated individual level encounter and summary level data has been submitted to CDC within agreed upon benchmarks and timeframes.

Assessment/Results activities: assess quality of data sources, clinical record review to increase sensitivity of case ascertainment, describe population with CHD

Indicators for success: quality of data sources has been assessed, documented, and shared with CDC, select clinical records have been reviewed, findings documented, and shared with CDC, data analysis plan developed and descriptive statistics generated on population with CHD.

Activities (Category A only):

Activity: Develop & disseminate educational modules for families/healthcare providers

Indicator for success: educational modules developed and disseminated; routinely update CDC with development progress, provide details of disseminations, to include but not limited to: how modules were announced and distributed, distributed to how many, how participant learning was assessed/overall impact of module.

Activity: Survey parents of adolescents on transition of care issues and perceptions of need for specialty care

Indicators for success: survey instrument and dissemination plan developed and finalized. Parents of adolescents are surveyed. Describe results of survey to include reported transition of care issues and need for specialty care. Provide details on survey distribution and response rate.

Activity: Link additional data years and, if possible, additional data sources to existing surveillance system.

Indicators for success: additional years of data and data sources are added to existing surveillance system;

provide details on number of additional cases captured.

Outputs (Category A & B):

Output: Population-based cohort of adolescents and adults (& others if possible) with CHD

Indicator for success: population-based cohort of adolescents and adults with CHD has been developed, submitted to CDC, analyzed, and findings disseminated.

Output: Descriptive epidemiology and prevalence estimates

Indicator for success: report on descriptive epidemiology and prevalence estimates of adolescents and adults with CHD has been drafted and disseminated.

Output: Additional information on health & non-health outcomes (e.g., educational)

Indicator for success: report on health & non-health outcomes of adolescents and adults with CHD has been drafted and disseminated.

Output: Increased sensitivity of case ascertainment

Indicator for success: select clinical records have been reviewed and increased ascertainment of cases documented.

Output: Describe availability of specialty care in study area

Indicator for success: availability of specialty care in study area has been documented in application and disseminated in project reports and/or to stakeholders.

Output: Extended surveillance activities for one sub-population of interest

Indicator for success: surveillance activities have been extended to a sub-population of interest;

characteristics of sub-population (including descriptive epidemiology) have been described in application and project report.

Outputs (Category A only):

Output: Online educational modules for families/healthcare providers

Indicator for success: educational modules developed and disseminated; provide details of disseminations to include but not limited to how modules were announced and distributed, distributed to how many, how participant learning was assessed/overall impact of module.

Output: Describe transition of care issues and perceptions of need for specialty care

Indicators for success: results of survey, including transition of care issues and need for specialty care is documented and disseminated to stakeholders (e.g. report, peer-reviewed publication).

Project period outcomes (Category A & B):

Outcome: Improved understanding of strengths & limitations of integrated surveillance for CHD among public health practitioners

Indicator for success: dissemination of publication(s) and conference presentations/webinars describing the strengths and limitations of integrated surveillance for CHD.

Outcome: Improved understanding of health outcomes of study population with CHD

Indicator for success: dissemination of publication(s) and conference presentations/webinars for stakeholders that describe the health outcomes of the population with CHD.

Outcome: Improved understanding of racial/ethnic or socioeconomic patterns in healthcare use or long-term outcomes in study population

Indicator for success: dissemination of publication(s) and conference presentations/webinars for stakeholders that describe racial/ethnic or socioeconomic patterns in healthcare use or long-term outcomes of the population with CHD.

Outcome: Increased awareness among health service providers, patients, parents and public of nationwide CHD issues

Indicator for success: dissemination of publication(s) and conference presentations/webinars for stakeholders increase awareness of nationwide CHD issues.

Outcome: Improved ability to calculate life expectancy for persons with specific CHD

Indicator for success: dissemination of publication(s) and conference presentations/webinars that calculate the life expectancy for persons with CHD.

ii. Applicant Evaluation and Performance Measurement Plan

Applicants must provide a specific evaluation and performance measurement plan that is consistent with the above CDC Evaluation and Performance Measurement Strategy and logic model. At a minimum this plan must describe:

• Types of evaluation to be conducted

• Key evaluation questions to be answered

• Contribution of evaluation and performance measurement to further enrich the program’s evidence base, or to improve program effectiveness

c. Organizational Capacity of Awardees to Execute the Approach

Category A:

Applicants should possess the capacity to enhance an existing CHDs surveillance system, ensuring that both adolescents and adults are included, and if possible, individuals of all ages with CHDs. Successful applicants must describe the level of organizational capacity necessary to implement the FOA successfully.

Organizational capacity includes skill sets to implement the awards such as: program and performance management, CHDs clinical expertise, data analysis, data linkage, epidemiologic expertise, communication/material development, evaluation, performance monitoring, and financial reporting. CVs of existing staff should be included. If there are any vacant positions, the applicant should include a job description (including applicant qualifications) and address both the recruiting strategies and estimated timeline for filling the position.

The eligible organizations will have the capacity to include geographically representative source population (a minimum population size of the defined geographic region should equal 2 million individuals of all age) and have authority to access and share with CDC and other awardees individual level, de-duplicated, de-identified data from the relevant multiple data sources which have been linked and are inclusive of adolescents and adults, and, if possible, individuals of all ages with CHDs.

Category B:

Applicants should possess the capacity to create a CHDs surveillance system. Successful applicants must describe the level of organizational capacity necessary to implement the FOA successfully. Organizational capacity includes skill sets to implement the awards such as: program and performance management, CHDs clinical expertise, data analysis, data linkage, epidemiologic expertise, communication/material development, evaluation, performance monitoring, and financial reporting. CVs of existing staff should be included. If there are any vacant positions, the applicant should include a job description (including applicant qualifications) and address both the recruiting strategies and estimated timeline for filling the position.

The eligible organizations will have the capacity to include geographically representative source population (a minimum population size of the defined geographic region should equal 2 million individuals of all age) and have authority to access and share with CDC and other awardees individual level, de-duplicated, de-identified data from the relevant multiple data sources which have been linked and are inclusive of adolescents and adults, and, if possible, individuals of all ages with CHDs.

d. Work Plan

Category A and Category B:

Applicants are required to provide a work plan for the four-year program, with a more detailed description of the first year of the award, consistent with the logic model. Applicants are expected to use activities that are consistent with those indicated under the “Program Strategy” section. The work plan should provide outcomes and the related program strategies/activities and should be consistent with the narrative in the Approach and Performance Measurement and Evaluation sections. A sample work plan is provided below.

Project Period Outcome:

[from Outcomes section and/or logic model]

Outcome Measure:

[from Evaluation and Performance Measurement section]

Strategies/Activities Process Measure

[from Evaluation and Performance Measurement section]

Responsible Position / Party

Completion Date

1.

2.

3.

4.

5.

6.

7.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and awardees, site visits, and awardee 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 awardee progress in achieving the desired outcomes.

Ensuring the adequacy of awardee 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:

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

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

Working with awardees 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.

Other activities deemed necessary to monitor the award, if applicable.

These activities may include 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 grantees.

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

AGREEMENTS)

In a cooperative agreement, CDC staff is substantially involved in the program activities above and beyond routine grant monitoring.

1. Provide advisory technical assistance on key design and methodological issues.

2. Facilitate the communication/coordination among awardees regarding standardization of procedures and tools to improve the efficiency of activities.

3. Provide technical assistance for the development and refinement of the case definition for CHD and technical assistance for implementing this case definition.

4. Assist with the development of an algorithm for identifying adolescents and adults, and, if possible, individuals of all ages with a CHD.

5. Develop timelines for ongoing data transmission and other key activities.

6. Convene awardees regularly by conference call and in-person to support collaboration and shared learning.

7. If needed, provide on-line webinars and in-person training.

8. In collaboration with awardees, develop and provide a template for the central reporting of de-identified, individual-level data sets.

9. Assist in performing data analysis and/or quality assurance verification.

10. Assist with submission of data from each awardee to a central repository at least on a quarterly basis.

11. Develop and maintain the centralized database used by awardees for the transmission of de-identified, de duplicated individual level data. Compile data across sites, perform quality reviews of data, and disseminate data.

12. Work with awardees to develop priority reports and publications. Analyze data and author and coauthor reports and publications.

13. Assist with evaluation of the project.

14. Assist awardee with the process of obtaining Office of Management and Budget (OMB) approval for surveying parents of adolescents identified by the surveillance system about transition of care issues and perceptions of need for specialty care.

B. Award Information

1. Funding Instrument Type: Cooperative Agreement CDC's substantial involvement in this program appears in the

CDC Program Support to Awardees Section.

2. Award Mechanism: 93.073

3. Fiscal Year: 2015 Estimated Total Funding: $9,600,000

4. Approximate Total Fiscal Year Funding: $2,400,000

5. Approximate Project Period Funding: $9,600,000

6. Total Project Period Length: 4 year(s)

7. Expected Number of Awards: 6

Anticipate 4 - 6 awards comprised of Category A: 1 – 3 awards and Category B: 3 – 5 awards.

8. Approximate Average Award: $400,000 Per Budget Period

9. Award Ceiling: $500,000 Per Budget Period includes direct and indirect cost and is subject to the availability of funds.

10. Award Floor: $250,000 Per Budget Period includes direct and indirect cost and is subject to the availability of funds.

11. Estimated Award Date: 09/01/2015 Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the awardee (as documented in required reports), and the determination that continued funding is in the best interest of the federal government. The total number of years for which federal support has been approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. The total project period comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

12. Budget Period Length: 12 month(s)

13. Direct Assistance Direct Assistance (DA) is not available through this FOA.

C. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Small businesses Others (see text field entitled "Additional Information on Eligibility" for clarification) Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Government Organizations:

State (includes the District of Columbia) Local governments or their bona fide agents Territorial governments or their bona fide agents in the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.

State controlled institutions of higher education American Indian or Alaska Native tribal governments (federally recognized or state-recognized)

Non-government Organizations:

American Indian or Alaska native tribally designated organizations

Other:

Private colleges and universities Community-based organizations Faith-based organizations

2. Additional Information on Eligibility

Only 1 application per organization as determined by the organization's Dun & Bradstreet number will be accepted.

A Bona Fide Agent is an agency/organization identified by the state or local government as eligible to submit an application in lieu of a state or local government application. If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status. Attach this documentation behind the first page of your application form or for electronic applications, use a PDF file and attach as "Other Documents" and label as appropriate.

The award ceiling for this FOA is $500,000. CDC will consider any application requesting an award higher than this amount as non- responsive and it will receive no further review. If a pre-application is required, then specify here and include it in the special eligibility requirements section. (http:// www.hhs.gov/ asfr/ ogapa/ aboutog/ hhsgps107.pdf)

3. Justification for Less than Maximum Competition

Not Applicable

4. Cost Sharing or Matching Cost Sharing / Matching Requirement:

No

Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this FOA exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

5. Maintenance of Effort http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

5. Maintenance of Effort

Maintenance of effort is not required for this program.

D. Required Registrations

Additional materials that may be helpful to applicants: http://www.cdc.gov/od/pgo/funding/docs/Financial ReferenceGuide.pdf.

1. Required Registrations An organization must be registered at the three following locations before it can submit an application for funding at www.grants.gov.

a. Data Universal Numbering System: All applicant organizations must obtain a Data Universal Numbering System (DUNS) number. A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B). It will be used as the Universal Identifier when applying for federal awards or cooperative agreements.

The applicant organization may request a DUNS number by telephone at 1-866-705-5711 (toll free) or Internet at http:// fedgov.dnb.com/webform/displayHomePage.do. The DUNS number will be provided at no charge.If funds are awarded to an applicant organization that includes sub-awardees, those sub-awardees must provide their DUNS numbers before accepting any funds.

b. System for Award Management (SAM): The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as an awardee. All applicant organizations must register with SAM, and will be assigned a SAM number. All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC. If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process usually requires not more than five business days, and registration must be renewed annually. Additional information about registration procedures may be found at www.SAM.gov.

c. Grants.gov: The first step in submitting an application online is registering your organization through www.grants.gov, the official HHS E-grant website. Registration information is located at the "Get Registered" option at www.grants.gov.

All applicant organizations must register with www.grants.gov. The one-time registration process usually takes not more than five days to complete. Applicants must start the registration process as early as possible.

2. Request Application Package Applicants may access the application package at www.grants.gov.

3. Application Package Applicants must download the SF-424, Application for Federal Assistance, package associated with this funding opportunity at www.grants.gov. If Internet access is not available, or if the online forms cannot be accessed, applicants may call the CDC PGO staff at 770-488-2700 or e-mail PGO PGOTIM@cdc.gov for assistance. Persons with hearing loss may access CDC telecommunications at TTY 1-888-232-6348.

4. Submission Dates and Times If the application is not submitted by the deadline published in the FOA, it will not be processed. PGO personnel will notify the applicant that their application did not meet the deadline. The applicant must receive pre-approval to submit a paper application (see Other Submission Requirements section for additional details). If the applicant is authorized to submit a paper application, it must be received by the deadline provided by PGO.

http://www.cdc.gov/od/pgo/funding/docs/FinancialReferenceGuide.pdf http://www.cdc.gov/od/pgo/funding/docs/FinancialReferenceGuide.pdf http://www.grants.gov http://fedgov.dnb.com/webform/displayHomePage.do https://www.SAM.gov http://www.Grants.gov http://www.grants.gov http://www.grants.gov http://www.grants.gov http://www.grants.gov http://www.grants.gov https://foa.grantsolutions.gov/announcementmodule/PGOTIM@cdc.gov%20

a. Letter of Intent Deadline (must be emailed or postmarked by) Due Date for Letter of Intent: 04/27/2015

b. Application Deadline Due Date for Applications: 06/01/2015, 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov. If Grants.gov is inoperable and cannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted by the first business day on which grants.gov operations resume.

5. CDC Assurances and Certifications All applicants are required to sign and submit “Assurances and Certifications” documents indicated at http://www.cdc.gov/grants/interestedinapplying/applicationprocess.html.

Complete the applicable assurances and certifications on an annual basis, name the file “Assurances and Certifications” and upload it as a PDF file at www.grants.gov Complete the applicable assurances and certifications and submit them directly to CDC on an annual basis at http://wwwn.cdc. gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/ Homepage.aspx

Assurances and certifications submitted directly to CDC will be kept on file for one year and will apply to all applications submitted to CDC by the applicant within one year of the submission date.

6. Content and Form of Application Submission Applicants are required to include all of the following documents with their application package at www.grants.gov.

7. Letter of Intent

A LOI (1-2 pages) is requested and optional.