CDC-RFA-DD20-2003.pdf

Centers for Disease Control and Prevention

National Center on Birth Defects and Developmental Disabilities

Sickle Cell Data Collection Program

CDC-RFA-DD20-2003

Application Due Date: 05/11/2020

Sickle Cell Data Collection Program

CDC-RFA-DD20-2003

TABLE OF CONTENTS

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

Part II. Full Text A. Funding Opportunity Description B. Award Information C. Eligibility Information D. Application and Submission Information 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 "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- DD20-2003. 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) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

Sickle Cell Data Collection Program 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)).

New-Type 1

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-DD20-2003

E. Assistance Listings (CFDA) Number:

93.080 F. Dates:

1. Due Date for Letter of Intent (LOI): 04/06/2020

2. Due Date for Applications: 05/11/2020, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

A Letter of Intent is requested but not required.

3. Date for Informational Conference Call:

04/02/2020 Scheduled for 3:00 – 4:00 pm, Eastern Standard Time.

Conference Line Number: 877-721-9741 Conference ID: 8946896

Questions may be submitted to ibx5@cdc.gov as soon as the NOFO is released.

G. Executive Summary:

1. Summary Paragraph:

Through this funding opportunity, CDC plans to fund recipients for a three-year period of performance to implement sickle cell disease surveillance. Recipients will collect and submit aggregate SCD surveillance data to CDC (Core Component) and analyze the data in ways that https://www.grants.gov 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 https://www.grants.gov will provide information to stakeholders and result in policy changes, improved health care practices, and new treatments (Optional Component). Only those applicants selected for funding under the Core Component will be eligible for additional Optional Component funding.

Core Component:

the convening of a multi-disciplinary team in order to build relationships, review surveillance goals, and develop plans for utilization of SCDC findings the renewal or establishment of a document of legal authority for SCDC data sources, so as to collect and share aggregate level data with CDC the adherence to standardized methods for implementing SCDC the report of aggregate level data about the epidemiology of SCD to CDC for dissemination to the public the development of a plan for informing stakeholders about the epidemiology of SCD the co-authorship of publications about the epidemiology of SCD, based on aggregate level data participation in the evaluation and prioritization of requests for SCDC data analysis

Optional Component:

the co-authorship of publications about the epidemiology of SCD, based on individual-level data

a. Eligible Applicants: Open Competition

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 6 Core Component: approximately 4 awards Optional Component: approximately 2 awards The awards may be a mixture of Core Component only and Core & Optional Components. The final number of funded award recipients will be determined by the objective review scoring and available funding.

d. Total Period of Performance Funding: $4,500,000 Core Component: $3,000,000 Optional Component: $1,500,000

e. Average One Year Award Amount: $250,000 Core Component: $250,000 Optional Component: $250,000

f. Total Period of Performance Length: 3

g. Estimated Award Date: 09/30/2020

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 A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview Sickle cell disease (SCD), estimated to affect 90,000 to 100,000 Americans, is the most common inherited blood disorder in the United States. Major complications of SCD include anemia, debilitating pain, infection, stroke, and organ damage. Poor health outcomes may be a result of limited or no access to comprehensive care, especially during adulthood, and limited treatment options.

There is no national surveillance of SCD. Consequently, there are large gaps in our current understanding of the natural course of the disease and its variable manifestations from one patient to the next, including how vulnerable populations seek and receive SCD care. There is also a lack of consistent scientific data to facilitate informed decision-making that may lead to significant health improvements in the SCD community. A population-based surveillance system will allow for the identification of individuals with SCD and the standardized collection of information about their clinical history.

Since 2015, CDC has managed the Sickle Cell Data Collection (SCDC) program, a statewide, population-based surveillance system, in two states (https://www.cdc.gov/ncbddd/hemoglobinopathies/scdc.html). SCDC allows these states to analyze the health information of individuals with SCD and identify critical gaps in their diagnosis, treatment and access to care. SCDC data have played a role in the opening of new SCD clinics, the education of health care providers, and the enhancement of federally funded activities across the U.S. Department of Health and Human Services (HHS).

In 2019, a one-year program (CDC-RFA-DD19-1906) was launched so that more states could participate in a rigorous course of activities to build capacity for a state-wide SCD surveillance system. Seven recipients were funded to develop new frameworks for these surveillance systems in their states, and two additional recipients were funded to provide technical assistance. This was accomplished through a series of web-based learning sessions, in-person meetings, in-state and cross-state relationship building, and ongoing communications to create the partnerships, data sharing agreements, and data storage system needed to successfully implement a health equity focused SCD surveillance system.

Through this Notice of Funding Opportunity (NOFO), CDC plans to fund recipients for a three-year period of performance to implement the SCDC program. Recipients will be funded to collect and submit aggregate SCD surveillance data to CDC (Core Component) and analyze the data in ways that will provide information to stakeholders and result in policy changes, improved health care practices, and new treatments (Optional Component). The recipients will adhere to standardized methods for implementing SCDC which includes comprehensive data linkages of multiple population-based sources, develop strategies for effective communication with stakeholders from the SCD community, and produce peer-reviewed publications and other educational materials based on SCDC findings.

This NOFO will improve and expand the current SCDC efforts by including a greater number of states in the program. Each state has a unique demographic makeup, health disparities, distinct health care policies, and challenges related to access to care; all of these factors play a large role in the outcomes and experiences of individuals with SCD. This NOFO allows recipients to gather unique data and conduct in-depth analyses to inform their SCD efforts and to compare and contrast SCD-related health care and health outcomes across states and across population groups.

b. Statutory Authorities Public Health Service Act Sections 301(a) and 317C (42 U.S.C. Section 247b-4), as amended.

c. Healthy People 2030 All Healthy People 2020 objectives for the Hemoglobinopathies (BDBS1-10) section of the Blood Disorders and Blood Safety topic were archived (https://www.healthypeople.gov/2020/topics-objectives/topic/blood-disorders-and-blood-safety/objectives).

This NOFO may be relevant to additional Healthy People 2020 objectives, such as those for:

Blood Safety (BDBS-18; https://www.healthypeople.gov/2020/topics-objectives/topic/blood-disorders-and-blood-safety/objectives)

Social Determinants of Health, Health and Health Care (AHS3-6.1; HC/HIT-1.1 and 1.2; https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-of-health/objectives).

d. Other National Public Health Priorities and Strategies The U.S. Department of Health and Human Services is working to:

Break down barriers for those who seek treatment for SCD Find a cure beyond bone marrow or stem cell transplant for SCD Educate health care providers on how to identify and treat SCD patients in pain crisis Bridge the gap between SCD pediatric care to adult care for patients Connect across various HHS agencies and with SCD advocacy groups https://www.minorityhealth.hhs.gov/sicklecell/index.html

The National Institutes of Health's Cure Sickle Cell Initiative (https://curesickle.org/).

The World Health Organization’s principles for guiding health equity and Commission on Social Determinants of Health

(who.int/social_determinants/thecommission/finalreport/closethegap_how/en/index2.html).

e. Relevant Work This NOFO expands CDC’s Sickle Cell Data Collection (SCDC) program by providing the opportunity for additional states to participate and collect additional years of data. Since 2015, CDC has led the work of two states to develop and implement state-wide, population-based surveillance of individuals with SCD identified through newborn screening, clinics specializing in SCD care, or health care encounters with SCD codes from various administrative data sources (https://www.cdc.gov/ncbddd/hemoglobinopathies/scdc.html). In 2019, a one-year program (CDC-RFA-DD19-1906) was launched; 7 additional states participated in a rigorous course of activities to build capacity for a state-wide SCD surveillance system.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities

Short-term Outcomes Intermediate Outcomes Long-Term Outcomes

CORE

COMPONENT

Convene a multi-disciplinary team in order to build relationships, review surveillance goals, and develop plans for utilization of SCDC findings Renew or establish a document of legal authority for SCDC data sources Adhere to standardized methods for implementing SCDC Report aggregate level data about the epidemiology of SCD Develop a plan for informing stakeholders about the epidemiology of SCD

CORE

COMPONENT

Increased standardization of methods for SCD surveillance Increased understanding of the incidence and prevalence of SCD Increased understanding of the demographics of individuals with SCD

CORE & OPTIONAL

COMPONENTS

Increased understanding of healthcare utilization patterns for individuals with SCD

CORE

COMPONENT

Improved availability of aggregate level surveillance data for utilization in health care policy making decisions

CORE &

OPTIONAL

COMPONENTS

Increased understanding of the epidemiology of SCD among patients, family members, health care providers, and policy makers

CORE &

OPTIONAL

COMPONENTS

Improved access to high-quality health care for individuals of all ages with SCD Reduced SCD-related health complications for individuals with

SCD

Improved quality of life for individuals with

SCD

Increased length of life for individuals with

SCD

https://www.cdc.gov/ncbddd/hemoglobinopathies/scdc.html

Co-author publications about the epidemiology of SCD, based on aggregate level data Participate in the evaluation and prioritization of requests for SCDC data analysis

OPTIONAL

COMPONENT

Lead author publications about the epidemiology of SCD, based on individual-level data Co-author publications about the epidemiology of SCD, based on individual-level data

i. Purpose This NOFO will allow for participation in the Sickle Cell Data Collection (SCDC) program.

The activities of the NOFO recipients, in collaboration with CDC, will support increased SCD-related partnership building within and among all recipients, the implementation of standardized methods for SCD surveillance, and the communication of SCDC findings with stakeholders from the SCD community. This will result in an expanded number of programs who are able to contribute in a meaningful way to the elimination of health disparities associated with SCD.

ii. Outcomes This NOFO has two components: (1) a Core Component that is mandatory for all applicants and

(2) an Optional Component.

The following short-term outcomes will be achieved by the end of the period of performance:

Core Component:

Increased standardization of methods for SCD surveillance Increased understanding of the incidence and prevalence of SCD Increased understanding of the demographics of individuals with SCD

Core & Optional Components:

Increased understanding of healthcare utilization patterns for individuals with SCD

These short-term outcomes will lead to the following intermediate outcomes that will be achieved by the end of the period of performance:

Core Component:

Improved availability of aggregate level surveillance data for utilization in health care policy making decisions

Core & Optional Components:

Increased understanding of the epidemiology of SCD among patients, family members, health care providers, and policy makers

iii. Strategies and Activities The Core Component and Optional Component strategies are listed below. Applicants who choose to apply for both components are encouraged to implement strategies in ways that may be mutually advantageous to both components.

The strategies and component activities that should be undertaken to achieve the period of performance outcomes are:

Core Component:

Convene a multi-disciplinary team, with strategies for communication among team members, in order to build relationships, review surveillance goals, and develop plans for utilization of SCDC findings

Renew or establish a document of legal authority (data sharing agreement, MOU, etc.)

for SCDC data sources that are valid throughout the duration of the project period. Data sources should include newborn screening, death records, state Medicaid claims, hospital discharge, emergency department records, and SCD specialty clinics. These data use agreements should allow the recipient to have access to individual-level data with identifiers so that information from the various sources can be linked and de-duplicated. They should also allow for the sharing of aggregate-level data with CDC.

Adhere to standardized methods for implementing SCDC, including the maintenance of a data repository.

Report aggregate-level data about the incidence, prevalence, demographics, healthcare utilization patterns, and mortality of SCD to CDC on an annual basis.

Develop a culturally- and linguistically-appropriate communication strategy and dissemination plan for informing stakeholders about the epidemiology of SCD.

Co-author at least one peer-reviewed publication about SCDC methods and at least two peer-reviewed publications about the epidemiology of SCD, based on aggregate-level SCDC findings, with CDC and other Core Component recipients.

Participate, with CDC and other Core Component recipients, in the evaluation and prioritization of requests for individual-level data analysis to be completed by Optional Component recipient(s).

Optional Component:

Lead author at least one peer-reviewed publication per year about the epidemiology of SCD, based on individual-level SCDC findings, with CDC and other Optional Component recipient(s).

Co-author at least two peer-reviewed publications per year about the epidemiology of SCD, based on individual-level SCDC findings, with CDC and other Optional Component recipient(s).

In addition to the above activities, all recipients will be expected to participate in collaborative recipient calls and meetings, site visits by CDC staff at recipient location, as needed, and yearly reverse site visits in Atlanta. All SCDC data analyses findings will be shared with the public in ways that are free, easily accessible, and for use consistent with federal purposes.

1. Collaborations

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

Work with CDC and other NOFO DD20-2003 recipients to achieve the outcomes of this period of performance (required).

b. With organizations not funded by CDC:

Collaboration with key contacts for each of the following state-maintained data sources:

Newborn screening Death certificates (vital records) Medicaid or all-payers Hospital discharge Emergency department visits

A letter of support from a key contact for each of these data sources, indicating that the process for enacting a document of legal authority (data sharing agreement, MOU, etc.) for the purposes of SCD surveillance and sharing of data with CDC is currently in process should be included with the application. The letter should specifically state the date on which the process for initiating this document began and the expected completion date on which a fully executed and signed document will be available. The agreement should allow the recipient to have access to individual-level, identifiable data for the purposes of SCD surveillance.

OR

A document of legal authority (data sharing agreement, MOU, etc.) for each of these data sources that is valid for the duration of this NOFO’s period of performance and allows access to individual-level, identifiable data for the purposes of SCD surveillance.

**If a state-maintained data source is not available for hospital discharge or emergency department visits, the recipient should, instead, provide a letter of support or document of legal authority, as described above, from each of the individual institutions that provide SCD care. The applicant should clearly state this in their narrative and provide an estimate of the percentage of the state’s SCD population that is cared for in these individual institutions.

Collaboration with key contacts from at least two SCD specialty clinics within the applicant’s state, each of which provides care for a minimum of 50 individuals with SCD.

A letter of support from the key contacts for each of these clinics, indicating that the process for enacting a document of legal authority (data sharing agreement, MOU, etc.) for the purposes of SCD surveillance and sharing of data with CDC is currently in process should be included with the application. The letter should specifically state the date on which the process for initiating this document began and the expected completion date on which a fully executed and signed document will be available. The agreement should allow the recipient to have access to individual-level, identifiable data for the purposes of SCD surveillance and should indicate the number of individuals with SCD for whom the clinic provides care.

OR

A document of legal authority (data sharing agreement, MOU, etc.) for each of these clinics that is valid for the duration of this NOFO’s period of performance and allows access to individual-level, identifiable data for the purposes of SCD surveillance. The applicant should clearly state the number of individuals with SCD cared for at each of these clinics in their narrative.

Collaboration with a multi-disciplinary team consisting of individuals with expertise in areas such as:

Chronic disease surveillance (SCD or other conditions) Clinical care for pediatric patients with SCD Clinical care for adult patients with SCD Health data IT Community based organizations with a focus on SCD Individuals living with SCD and/or their families

A letter of support or inclusion in the budget narrative from/for at least one individual representing each of the above areas should be included with the application.

Applicants should file the evidence of legal authority, as appropriate, name the file “Appendix 1: Legal Authority”, and upload it as a PDF file at www.grants.gov Applicants should file the letters of support, as appropriate, name the file “Appendix 2: Letters of Support”, and upload it as a PDF file at www.grants.gov

2. Target Populations Individuals of all ages living with SCD.

a. Health Disparities http://www.grants.gov/ http://www.grants.gov/

Sickle cell disease disproportionately affects individuals of African ancestry as well as individuals of Hispanic, southern European, Middle Eastern, or Asian Indian backgrounds.

Moreover, some consider the condition, itself, to be an indicator of a health disparity. This NOFO provides support for a system that may be used to address the challenges and health inequities of this chronic genetic disease that disproportionately burdens certain communities.

This system may also be used to drive care for other high burden groups, including: youth transitioning to adulthood, Hispanics, the elderly, and racial and ethnic minorities.

iv. Funding Strategy There are two funding components for this NOFO. Applicants must apply for the Core Component. Additionally, applicants can choose to apply for the Optional Component via a single application that clearly identifies the two components to receive additional funds for the optional activities.

Applicants will be placed on a rank order list based on their score on the Core Component. If any of the applicants who are selected to be funded for the Core Component also include activities for the Optional Component in their application, those scoring highest in the Optional Component will be selected to be funded for both activities.

Applicants applying for both the Core and Optional Components:

Must submit a single application covering both components Must clearly label all activities as “Core Only,” “Optional Only,” or “Combined” in the

Work Plan Must provide two separate budgets, one for each component

Each component will be reviewed and scored separately, with a different score assigned to each component.

Core Component: Approximately four awards for a 3-year period of performance; $250,000 average award Optional Component: Approximately two awards for a 3-year period of performance; $250,000 average award No more than one applicant per state will be funded.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy Evaluation and Performance Measurement help demonstrate program accomplishments and determine whether the NOFO strategies and activities were implemented as expected.

Evaluation and Performance Measurement also tracks if the intended outcomes were achieved during the period of performance. This information is integral to help CDC keep NOFO recipients on track with implementation, to demonstrate the effectiveness of the NOFO on reaching outcomes, and to suggest ways to improve the program.

Evaluation and Performance Measurement will be approached through assessing process and outcome measures. Throughout the period of performance, CDC will work individually and collectively with recipients to track the implementation of recipient strategies and activities and assess progress in achieving NOFO outcomes. Process measures will inform CDC to what extent the recipient has implemented the activities as intended. Outcome measures will inform CDC if the recipient achieved the period of performance outcomes.

The evaluation will be guided by the following evaluation questions. Evaluation questions are pulled from the activities and outcomes. Both the process and outcome evaluations will seek to answer the following overarching evaluation questions:

1. Approach: To what extent have the recipients’ implementation approaches been successful in achieving the desired outcomes?

2. Effectiveness:

1. To what extent has the NOFO increased SCD-related partnership building?

2. To what extent has implementation of SCDC increased capacity for understanding the epidemiology of SCD?

3. To what extent has the NOFO increased the availability of data for health care policy decisions?

3. Impact: To what extent has the NOFO contributed to a measurable change in the health outcomes, quality of life, and length of life for individuals with SCD?

In order to answer the evaluation questions above, NOFO recipients will provide monthly/quarterly/semi-annual/annual reports on the process measures, as indicated below. An annual report will be provided on the evaluation measures. These reports will be submitted electronically to CDC and may be presented during virtual and in-person learning sessions. The data collected by CDC for performance measurement and evaluation are directly related to the implementation of the strategies and/or the desired outcomes indicated in the logic model. The data collected for this NOFO for performance measurement do not include any personally identifiable information. Data being collected are strictly related to the implementation of the NOFO strategies and shall be used for assessing and reporting progress, including reports to the Office of the Assistant Secretary of Health, and for other pertinent program improvement actions.

Process measures for each strategy/activity and evaluation measure for each outcome are described in the table below. The table aligns with the logic model.

Process Measures – Core Component Strategy/Activity Measure

Convene a multi-disciplinary team in order to build relationships, review surveillance goals, and develop plans for utilization of SCDC findings

Quarterly report on:

1. name and role of team members

2. upcoming meeting time, location, attendees, and agenda

3. summary notes from past meetings

4. areas or expertise represented by team members and gaps in representation

Renew or establish a document of legal authority for SCDC data sources

Quarterly (new) or annual (established) report on:

1. name of data source

2. key contact(s)

3. years of data that are available

4. terms of agreement, including names of variables that will be shared with the applicant

5. approximate date of document execution

Adhere to standardized methods for implementing SCDC

Quarterly report on:

1. implementation of SCDC case definition

2. patient identification variables to be used for linkage for each SCDC data source

3. progress toward de-duplication and merging of data

4. data dictionary for data submitted to

CDC

Report aggregate level data about the epidemiology of SCD

Quarterly report on ability to submit aggregate level data by the end of the budget period

Develop a plan for informing stakeholders about the epidemiology of SCD

Quarterly report on:

1. engagement with stakeholders outside of SCDC team

2. communications plan

3. development of SCDC materials

Co-author publications about the epidemiology of SCD, based on aggregate level data

Quarterly report on the development of publications about the epidemiology of SCD

Participate in the evaluation and prioritization of requests for SCDC data analysis

Quarterly report on:

1. proposed method for soliciting analysis requests

2. proposed method for evaluating and prioritizing analysis requests

Process Measures - Optional Component Strategy/Activity Measure

Co-author publications about the epidemiology of SCD, based on individual-level data

Semi-annual report on:

1. topic(s) of analysis

2. time-line for completion

3. table shells

4. authorship and responsibilities

5. literature search/review

6. submission for publication

7. dissemination plan

Short-Term Outcome Evaluation Measures – Core Component Outcome Measure

Increased standardization of methods for SCD surveillance

[baseline #; increase over baseline #] of recipients who have the capacity to implement standardized methods of SCD surveillance and submit individual-level, de-identified data to CDC within 12 months of the beginning of the first budget period and annually thereafter [baseline #; increase over baseline #] of individuals with SCD, their family members and caregivers, and community-based organizations who understand the incidence and prevalence of SCD in the recipient’s state [baseline #; increase over baseline #] of individuals providing healthcare to those with SCD who understand the incidence and prevalence of SCD in the recipient’s state

Increased understanding of the incidence and prevalence of SCD

[baseline #; increase over baseline #] of policy makers who understand the incidence and prevalence of SCD in the recipient’s state

[baseline #; increase over baseline #] of individuals with SCD, their family members and caregivers, and community-based organizations who understand the demographics of individuals with SCD living in the recipient’s state [baseline #; increase over baseline #] of individuals providing healthcare to those with SCD who understand the demographics of individuals with SCD living in the recipient’s state

Increased understanding of the demographics of individuals with SCD

[baseline #; increase over baseline #] of policy makers who understand the demographics of individuals with SCD living in the recipient’s state

Short-Term Outcome Evaluation Measures – Core & Optional Components Outcome Measure

[baseline #; increase over baseline #] of individuals with SCD, their family members and caregivers, and community-based organizations who understand the healthcare utilization patterns of individuals with SCD living in the recipient’s state [baseline #; increase over baseline #] of individuals providing healthcare to those with SCD who understand the healthcare utilization patterns of individuals with SCD living in the recipient’s state

Increased understanding of healthcare utilization patterns for individuals with SCD

[baseline #; increase over baseline #] of policy makers who understand the healthcare utilization patterns of individuals with SCD living in the recipient’s state

Intermediate Outcome Evaluation Measures – Core Component Outcome Measure

Improved availability of aggregate level surveillance data for utilization in health care policy making decisions

[baseline #; increase over baseline #] of years of aggregate level surveillance data available for utilization in health care policy making decisions in the recipient’s state

Intermediate Outcome Evaluation Measures – Core & Optional Components Outcome Measure

[baseline #; increase over baseline #] of individuals with SCD, their family members and caregivers, and community-based organizations who understand the epidemiology of individuals with SCD living in the recipient’s state [baseline #; increase over baseline #] of individuals providing healthcare to those with SCD who understand the epidemiology of individuals with SCD living in the recipient’s state

Increased understanding of the epidemiology of SCD among patients, family members, health care providers, and policy makers

[baseline #; increase over baseline #] of policy makers who understand the epidemiology of individuals with SCD living in the recipient’s state

CDC will work with recipients on operationalizing and further defining each performance measure, and guidance will be provided prior to the first month of reporting. Reports, based on the schedules listed above, will be provided to CDC, and CDC will manage and analyze the data to assess recipient program improvements, respond to broader technical assistance needs, and report to stakeholders.

Applicants should also include a Data Management Plan (DMP), that includes the following information:

A description of the data to be collected or generated in the proposed project;

The standards to be used for the collected or generated data;

Mechanisms for, or limitations to, providing access to the data, including a description for the provisions for the protection of privacy, confidentiality, security, and intellectual property, or other rights;

Statement of the use of data standards that ensure all documentation that describes the method of collection, what the data represent, and

Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified; and, Other additional requirements based on the program.

If all of this information is not available, applicants should include a DMP that is as complete as possible. The DMP may be submitted as a checklist, paragraph, or other format. An example DMP can be found here:: http://www.icpsr.umich.edu/icpsrweb/content/datamanagement/dmp /plan.html All evaluation findings produced by the recipients will contribute to: (1) continuous improvement of quality and effectiveness of recipient program strategies, (2) the evidence base of SCD surveillance, (3) documentation and sharing of lessons learned to support replication and scaling of these program strategies, and/or (4) future funding opportunities supported by

CDC.

CDC will review the work plan and evaluation and performance measurement plan and meet with the recipient throughout the project period. One site visit will be scheduled with each recipient on an annual basis.

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 http://www.icpsr.umich.edu/icpsrweb/content/datamanagement/dmp/plan.html http://www.icpsr.umich.edu/icpsrweb/content/datamanagement/dmp/plan.html 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, if applicable, within the first 6 months of award, as described in the Reporting Section of this NOFO.

CDC will review and approve the recipient’s monitoring and evaluation plan to ensure that it is appropriate for the activities to be undertaken as part of the NOFO and for compliance with the monitoring and evaluation guidance established by CDC or other guidance otherwise applicable to this Cooperative Agreement.

c. Organizational Capacity of Recipients to Implement the Approach Applicants should describe their organizational capacity to carry out the strategies included in the Core and Optional Components. CDC anticipates that all applicants will be able to demonstrate capacity to carry out the activities outlined over the period of performance.

Successful applicants will demonstrate the necessary skills, relevant experience, and capacity to successfully implement the strategies and activities listed above. Demonstrated readiness to implement the strategies includes the ability of applicants to describe the following:

Evidence that they have the organizational capacity to facilitate the program strategies and meet the period of performance outcomes by describing their program team structure, the role of each proposed team member, their relevant skills and experience, and the percent time expected of each team member for each major activity proposed in the work plan. A CV/Resume is required for each team member included in the Budget Narrative. If there are any vacant positions, the applicant should include a job description (including applicant qualifications) and address both the recruiting strategies and estimated time line for filling the position.

Evidence that they have the capacity to conduct SCD surveillance activities and examples of past experience in doing so

Experience and capacity to conduct program evaluation, both process and outcome, and implement the evaluation plan

Established organizational policies and procedures to ensure sufficient fiscal and budgetary oversight and capacity to provide required reports https://www.cdc.gov/grants/additionalrequirements/ar-25.html

Name and role of at least two team members who will participate in project-related meetings with CDC and other DD20-2003 recipients and co-develop/author NOFO-related materials. Each of these team members should have expertise in at least one of the following areas: SCD clinical care, SCD surveillance methods, or SCD surveillance data

Name and role of the one team member who will participate in the evaluation and prioritization of requests for SCDC data analysis

Optional Component only: Applicants should provide evidence of authorship of peer-reviewed publications using SCD surveillance data from multiple, linked data sources to illustrate their understanding of SCD in their state. These publications should be clearly referenced in the Organizational Capacity section of the application and show their ability to access and work with individual-level data.

Applicants should file the CVs/resumes for each team member included in the Budget Narrative, as appropriate, name the file “Appendix 3: CVs/resumes”, and upload it as a PDF file at www.grants.gov.

d. Work Plan Applicants must submit a detailed work plan for Year 1 of the award and a high-level work plan, in narrative form, for subsequent years. If the applicant is applying for both the Core and Optional component, a single work plan should be used for both components, with clear labeling of which table(s) applies to which component. Additionally, the work plan should demonstrate how any activities that address both components’ strategies will be implemented, so that work on these strategies may be mutually reinforcing. Cost sharing of positions to support multiple activities across components is encouraged.

The work plan should describe how the applicant plans to implement all of the required strategies and activities to achieve NOFO outcomes. A sample work plan format is presented below to show how a traditional work plan aligns with the logic model and narrative. A separate table should be included in the work plan for each of the outcomes that will be completed in Year 1 of the award. If a particular activity leads to multiple outcomes, it should be described under each outcome measure. Applicants are not required to use the example work plan format;

however, all work plans must contain all of the elements shown in the example (outcome(s), outcome measure(s), etc).

Example Work Plan Table Period of Performance Outcome: (from Logic Model) Outcome Measure: (from Evaluation and Performance Measurement)

Strategies and Activities

Process Measure (from Evaluation and Performance Measurement)

Responsible Team Member(s)

Population of focus

Scope Setting(s) Completion Date

1.

2.

3.

4.

5.

Applicants must include the Work Plan in the Project Narrative. CDC will provide feedback and technical assistance to award recipients to finalize the work plan activities post-award.

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.

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

COOPERATIVE AGREEMENTS)

The CDC program supporting this NOFO will be substantially involved in the activities and beyond routine grant monitoring.

Provide advisory technical assistance on key design and methodological issues Convene all recipients and facilitate their communication/coordination regarding project-related activities Work with recipients to create a standardized data dictionary for their aggregate data Work with recipients to co-author SCDC publications Work with recipients to ensure that all materials and lessons learned from the project are publicly available and widely disseminated

Work with recipients to evaluate and prioritize requests for SCDC data analysis Attend annual in-person meetings of each recipient’s multi-disciplinary team Host annual reverse site visits at CDC Assist with evaluation of the project

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 Disease Control

3. Fiscal Year: 2020

4. Approximate Total Fiscal Year Funding: $1,500,000

5. Approximate Period of Performance Funding: $4,500,000

This amount is subject to the availability of funds.

Core Component: $3,000,000 Optional Component: $1,500,000

Estimated Total Funding: $4,500,000

6. Approximate Period of Performance Length: 3 year(s)

7. Expected Number of Awards: 6 Core Component: approximately 4 awards Optional Component: approximately 2 awards The awards may be a mixture of Core Component only and Core & Optional Components. The final number of funded award recipients will be determined by the objective review scoring and available funding.

8. Approximate Average Award: $250,000 Per Budget Period Core Component: $250,000 Optional Component: $250,000

9. Award Ceiling: $500,000 Per Budget Period

This amount is subject to the availability of funds.

N/A

10. Award Floor: $100,000 Per Budget Period Core Component: $100,000 Optional Component: $100,000

11. Estimated Award Date: 09/30/2020

12. Budget Period Length: 12 month(s)

Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the recipient (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 period of performance comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

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

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"

Additional Eligibility Category:

Government Organizations:

State governments or their bona fide agents (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:

Ministries of Health

2. Additional Information on Eligibility Applicants must apply for the Core Component to be considered for the Optional Component.

If an applicant applies for the Optional Component only, their application will not be reviewed.

3. Justification for Less than Maximum Competition N/A

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

5. Maintenance of Effort Maintenance of effort is not required for this program.

D. Application and Submission Information

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-recipients, those sub-recipients 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 a recipient. 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 can require 10 or more business days, and registration must be renewed annually. Additional information about registration procedures may be found at https://www.sam.gov/SAM/.

c. Grants.gov:

The first step in submitting an application online is registering your organization at www.grants.gov, the official HHS E-grant Web site. Registration information is located at the "Applicant Registration" option at www.grants.gov.

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

https://www.grants.gov/ http://fedgov.dnb.com/webform/displayHomePage.do https://www.sam.gov/SAM/ https://grants.gov/ https://www.grants.gov/ http://www.grants.gov https://www.grants.gov/

Step System Requirements Duration Follow Up 1 Data

Universal Number System

(DUNS)

1. Click on http:// fedgov.dnb.com/ webform

2. Select Begin DUNS search/request process

3. Select your country or territory and follow the instructions to obtain your DUNS 9-digit #

4. Request appropriate staff member(s) to obtain DUNS number,…