CDC-RFA-DD19-1906.pdf

Centers for Disease Control

National Center on Birth Defects and Developmental Disabilities

Capacity Building for Sickle Cell Disease Surveillance

CDC-RFA-DD19-1906

Application Due Date: 07/22/2019

Capacity Building for Sickle Cell Disease Surveillance

CDC-RFA-DD19-1906

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 "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-DD19-1906. 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:

Capacity Building for Sickle Cell Disease Surveillance 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-DD19-1906

E. Assistance Listings (CFDA) Number:

93.080 F. Dates:

1. Due Date for Letter of Intent (LOI): 06/14/2019

2. Due Date for Applications: 07/22/2019, 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:

06/04/19 Scheduled for 3:00 - 4:00 pm, Eastern Standard Time.

Skype 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:

Sickle cell disease (SCD), estimated to affect 90,000 to 100,000 Americans, is the most common inherited blood disorder in the United States. There are large gaps in our current understanding of the natural course of the disease and its variable manifestations from one 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 patient to the next. Furthermore, there is a lack of consistent scientific data to facilitate informed decision-making that may lead to significant health improvements in the SCD community.

Through this NOFO, CDC plans to fund up to seven recipients for a one-year period of performance to participate in a rigorous course of activities to build capacity for a state-wide SCD surveillance system. A population-based surveillance system will allow for the identification of individuals with SCD and the standardized collection of information about their clinical history. Each state has a unique demographic makeup, 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. By building capacity for states to implement SCD surveillance, this NOFO develops a framework and road map for gathering unique data and conducting in-depth analyses to inform SCD efforts and to compare and contrast SCD-related health care, health outcomes,and health disparities across states.

a. Eligible Applicants:

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 7 Component A: up to 5 awards Component B: up to 2 awards The final number of funded award recipients will be determined by the objective review scoring and available funding.

d. Total Period of Performance Funding: $775,000 Component A: $375,000 Component B: $400,000

e. Average One Year Award Amount: $100,000 Component A: $75,000 Component B: $200,000

f. Total Period of Performance Length: 1

g. Estimated Award Date: 09/15/2019

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 state wide, 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. The results of these analyses inform stakeholders about how these gaps can be filled through policy changes, improved health care practices, and new treatments. 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 HHS.

Through this NOFO, CDC plans to fund up to seven recipients for a one-year period of performance to participate in a rigorous course of activities to build capacity for a state-wide SCD surveillance system. CDC plans to fund up to five recipients to develop new frameworks for these surveillance systems (Component A). CDC also plans to fund up to two recipients to provide technical assistance to the Component A recipients based on their SCD surveillance knowledge (Component B). The capacity building will be 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. Applicants can apply for only Component A or Component B and must clearly state their choice in their application.

This NOFO will improve and expand the current SCDC efforts by building the capacity of additional states to implement 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 builds the framework and a road map for 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 Section 301(a) and 317C, 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 https://www.healthypeople.gov/2020/topics-objectives/topic/blood-disorders-and-blood-safety/objectives

/topics-objectives/topic/blood-disorders-and-blood-safety/objectives).

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

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

CDC-RFA-DD19-1906 Logic Model: Building Capacity for Sickle Cell Disease Surveillance

Strategies and Activities Short-term Outcomes

Intermediate Outcomes

Long-Term Outcomes

Component A Initiate the development of data use agreements for SCD surveillance data sources Participate in SCD surveillance

Components A&B Increased understanding of the utility of SCD surveillance data among patients, Components A&B Increased understanding among patients, family members, Components A&B Improved access to high-quality health care for individuals of all https://www.healthypeople.gov/2020/topics-objectives/topic/blood-disorders-and-blood-safety/objectives https://www.cdc.gov/ncbddd/hemoglobinopathies/scdc.html capacity building sessions Identify database capabilities, including but not limited to information technology (IT)-related and data security strengths, weaknesses, opportunities and challenges.

Component B Maintain existing data use agreements for SCD surveillance data sources

With CDC and other Component B recipient(s):

Co-develop a toolkit of materials for SCD surveillance capacity building Co-lead sessions to increase capacity for SCD surveillance Co-author white papers reporting on in-person sessions to increase capacity for SCD surveillance

Components A&B 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 SCD surveillance data Develop a final report on the ability to implement SCD surveillance within the recipient’s state during future funding cycles Co-author a final report on standardized methods for implementing SCD surveillance with CDC and all other DD19-1906 recipients family members, health care providers, and policy makers Increased standardization of methods for SCD surveillance health care providers, and policy makers of the prevalence of SCD and the patterns of health care utilization for individuals with

SCD

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

i. Purpose This NOFO supports the provision of technical assistance to guide the building of capacity for implementing state wide, population-based SCD surveillance. The tools and materials created by NOFO recipients, in collaboration with CDC, will allow for increased SCD-related partnership building within and among all recipients and standardization of methods for SCD surveillance. This will result in an expanded number of states with the fundamentals to participate in SCDC and the capacity to contribute in a meaningful way to the elimination of health disparities associated with SCD.

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

Components A&B:

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

Increased standardization of methods for SCD surveillance

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

Component A (Capacity Building):

Initiate the development of data use agreements for SCD surveillance data sources. 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 for the sharing of data with CDC.

Participate in individual, virtual, and in-person SCD surveillance capacity building sessions, and meet milestones related to the sessions

Identify database capabilities, including but not limited to, IT-related and data security strengths, weaknesses, opportunities and challenges

Component B (Technical Assistance):

Maintain existing data use agreements for SCD surveillance data sources, including any amendments that may be necessary for future funding cycles, as determined by lessons learned from this NOFO. Amendments to the data use agreements may be made needed, based on findings of the NOFO.

With CDC and other Component B recipient(s):

Co-develop a toolkit of materials for SCD surveillance capacity building Co-lead individual, virtual, and in-person sessions to increase capacity for SCD surveillance Co-author white papers reporting on in-person sessions to increase capacity for SCD surveillance

Components A&B:

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 SCD surveillance data

Develop a final report on the ability to implement SCD surveillance, including 1) the collection of de-identified, individual-level SCD surveillance data that may be submitted to CDC during future funding cycles and 2) plans for the storage and maintenance of SCD surveillance data, within the recipient’s state during future funding cycles

Co-author a final report on standardized methods for implementing SCD surveillance with CDC and all other DD19-1906 recipients including 1) list of variables to be submitted to CDC and data dictionary, 2) formatting of files to be submitted to CDC, and 3) contents of annual reports to be posted on project website

All toolkit materials, learning session contents, white papers, and reports will be developed with the intent of disseminating to the public in ways that are free and easily accessible.

1. Collaborations

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

Components A&B:

Work with CDC and other NOFO DD19-1906 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:

o Newborn screening o Death certificates (vital records) o Medicaid o Hospital discharge o Emergency department visits

A letter of support from a key contact for each of these data sources, indicating their willingness to explore access to the data for the purposes of SCD surveillance and sharing of data with CDC (Component A)

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 at least five years of individual-level, identifiable data for the purposes of SCD surveillance (Component B).

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 the number of individuals with SCD for whom they provide care and their willingness to explore access to their patients’ data and sharing of data with CDC for the purposes of SCD surveillance (Component A)

OR

A letter of support from the key contacts for each of these clinics, indicating the number of individuals with SCD for whom they provide care and their willingness to continue providing access to their patients’ data on an annual basis for the purposes of SCD surveillance (Component B).

Collaboration with individuals with expertise in areas such as:

o Chronic disease surveillance (SCD or other conditions) o Infectious disease surveillance o Clinical care for pediatric patients with SCD o Clinical care for adult patients with SCD o Health data IT o Community based organizations with a focus on SCD o 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 selected areas (Components A&B).

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 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 will build capacity for a system that may be used to address the challenges and health inequities of this chronic genetic disease that disproportionately burdens certain communities.

http://www.grants.gov/

This NOFO will also build capacity for a system that may 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 Component A (Capacity Building): up to five awards for 1 year period of performance; $75,000 average award Component B (Technical Assistance): up to two awards for 1 year period of performance;

$200,000 average award

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 provision of technical assistance increased capacity for implementing SCD surveillance?

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

3. To what extent has the NOFO increased standardization of methods for SCD surveillance so that additional states can implement SCDC?

4. To what extent has the NOFO increased understanding of database needs for

SCD surveillance?

3. Impact: To what extent has the NOFO contributed to a measureable 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 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 – Component A Strategy/Activity Measure

Initiate the development of data use agreements for SCD surveillance data sources

Monthly report on the development of data use agreements for SCD surveillance data sources, including 1) name of data source, 2) key contact(s), 3) years of data that will be made available to the recipient, 4) terms of agreement, and 5) approximate date of agreement execution

Participate in individual, virtual, and in-person SCD surveillance capacity building sessions and meet milestones related to the sessions within specified time period

Monthly report on virtual capacity building sessions, including 1) name of recipient’s team members who participated, 2) completed evaluation survey of the didactic portion of the session(s), and 3) progress on milestones presented during the session(s) Semi-annual report on in-person capacity building sessions, including 1) name of recipient’s team members who participated, 2) completed evaluation survey of the session, and

3) progress on milestones presented during the session Monthly report of engagement with Component B recipients for individual level technical assistance

Identify database capabilities, including but not limited to, IT-related and data security strengths, weaknesses, opportunities and challenges to the ability to link at least one year of data from at least two data sources

Semi-annual reports on 1) data sources selected for linkage, 2) linkage process, and 3) expected linkage time line

Process Measures – Component B Strategy/Activity Measure

Maintain existing data use agreements for SCD surveillance data sources, including any amendments that may be necessary for future funding cycles, as determined by lessons learned from this NOFO

Annual report on the maintenance of data use agreements for SCD surveillance data sources, including 1) name of data source, 2) key contact(s), 3) years of data that are available to the recipient, and 4) terms of agreement, and 5) approximate date of agreement execution

Co-develop a toolkit of materials for SCD surveillance capacity building

Monthly report on the development of toolkit materials for SCD surveillance capacity building, including 1) schedule of topic areas to be covered for all sessions of the period of performance, 2) didactic content, guiding questions for interactive portions, and milestones for upcoming virtual and in-person sessions, and 3) revisions to toolkit materials based on evaluation survey feedback

Co-lead individual, virtual, and in-person sessions to increase capacity for SCD surveillance

Monthly report on the virtual capacity building sessions, including 1) agenda for upcoming sessions, 2) name and number of participants, and 3) summary of interactive portion Semi-annual report on the in-person capacity building sessions, including 1) agenda for upcoming sessions, 2) name and number of participants, and 3) summary of interactive portion Monthly report on engagement with Component A recipients for individual level technical assistance

Co-author white papers reporting on in-person sessions to increase capacity for SCD surveillance

Quarterly report on the development of white papers describing in-person sessions to increase capacity for SCD surveillance

Process Measures – Components A&B Strategy/Activity Measure

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 SCD surveillance data

Quarterly report on engagement with multi-disciplinary team, including 1) name and role of team members, 2) upcoming meetings and agendas, and 3) summary notes from past meetings

Develop a final report on the ability to implement SCD surveillance during future funding cycles

Annual report on the recipient’s ability to implement SCD surveillance during future funding cycles, to include 1) plans for collecting, merging, and housing data, 2) feasibility of submitting individual-level, de-identified surveillance data to CDC, 3) potential barriers to implementing SCD surveillance, and 4) database capabilities, including but not limited to IT-related and data security strengths, weaknesses, opportunities and challenges

Co-author a final report on standardized methods for implementing SCD surveillance

Semi-annual report on standardized methods for implementing surveillance, to include 1) core data sources, 2) supplemental data sources, 3) patient identification from each data source, 4) case definition, 5) data dictionary for data maintained by recipients, 6) data dictionary for data submitted to CDC, 7) de-duplication and merging of data, and 8) core surveillance team roles

Short-Term Outcome Evaluation Measures – Components A&B Outcome Measure

Increased SCD-related partnership building [baseline #; increase over baseline #] of recipients who have established a multi-disciplinary team that convened at least four times during the period of performance (including one in-person meeting), with members representing: 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, and individuals living with SCD and/or their families

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 end of the period of performance

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.

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 during virtual and in-person capacity-building sessions. One site visit will be scheduled with each recipient.

Since this NOFO does not involve the generation or collection of public health data, a Data Management Plan is not required for this NOFO.

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

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

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

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

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

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

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

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

Describe key evaluation questions to be addressed by these evaluations.

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

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, 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 https://www.cdc.gov/grants/additionalrequirements/ar-25.html

Applicants should describe their organizational capacity to carry out the strategies included in Components A&B. 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. 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.

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

Name and role of at least two team members who will participate in virtual and in-person capacity building sessions and co-develop/author NOFO-related materials o Component A: A minimum of two staff members - one with surveillance data expertise and one staff member with SCD medical expertise o Component B: A minimum of two staff members - one with SCD surveillance methods expertise and one staff member with SCD surveillance data expertise

Component B only:

o 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.

Applicants should file the CVs/resumes for each team member, 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 the one year period of performance. 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 logical model and narrative. A separate table should be included in the work plan for each of the outcomes that will be completed during the one year period of performance. If a particular activity leads to multiple outcomes, it should 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).

http://www.grants.gov/

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.

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 virtual and in-person capacity building sessions, including the technology platform(s) needed Host two in-person capacity building sessions Work with recipients to create a web-based version of their toolkit of materials for SCD surveillance capacity building Work with recipients to co-lead virtual and in-person sessions to increase capacity for

SCD surveillance Work with recipients to co-author a final report on standardized methods for implementing SCD surveillance Work with recipients to ensure that all materials and lessons learned from the project are publicly available and widely disseminated Attend one in-person meeting of each recipient’s multi-disciplinary team 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: 2019

4. Approximate Total Fiscal Year Funding: $775,000

5. Approximate Period of Performance Funding: $775,000

This amount is subject to the availability of funds.

Component A: $375,000 Component B: $400,000

Estimated Total Funding: $775,000

6. Approximate Period of Performance Length: 1 year(s)

7. Expected Number of Awards: 7 Component A: up to 5 awards Component B: up to 2 awards

The final number of funded award recipients will be determined by the objective review scoring and available funding.

8. Approximate Average Award: $100,000 Per Project Period Component A: $75,000 Component B: $200,000

9. Award Ceiling: $300,000 Per Project Period

This amount is subject to the availability of funds.

Component A: $100,000 Component B: $300,000

10. Award Floor: $50,000 Per Project Period Component A: $50,000 Component B: $100,000

11. Estimated Award Date: 09/15/2019

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:

2. Additional Information on Eligibility Component A: Capacity Building Component B: Technical Assistance Applicants may apply to either Component A or Component B; not both. If an applicant applies to both Components, 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.

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, verify & update

1-2 Business Days

To confirm that you have been issued a new DUNS number check online at (http:// fedgov.dnb.com/ webform) or call 1-866-705-5711 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/ http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform information under DUNS number

2 System for Award Management

(SAM)

formerly Central Contractor Registration

(CCR)

1. Retrieve organizations DUNS number

2. Go to https://www.sam.gov/SAM/ and designate an E-Biz POC (note CCR username will not work in SAM and you will need to have an active SAM account before you can register on grants.gov)

3-5 Business Days but up to 2 weeks and must be renewed once a year

For SAM Customer Service Contact https://fsd.gov/ fsd-gov/ home.do Calls:

866-606-8220

3 Grants.gov 1. Set up an individual account in Grants.gov using organization new DUNS number to become an authorized organization representative (AOR)

2. Once the account is set up the E-BIZ POC will be notified via email

3. Log into grants.gov using the password the E-BIZ POC received and create new password

4. This authorizes the AOR to submit applications on behalf of the organization

Same day but can take 8 weeks to be fully registered and approved in the system (note, applicants

MUST

obtain a

DUNS

number and

SAM

account before applying on grants.gov)

Register early!

Log into grants.gov and check AOR status until it shows you have been approved

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 notice of funding opportunity at www.grants.gov.

4. Submission Dates and Times If the application is not submitted by the deadline published in the NOFO, it will not be processed. Office of Grants Services (OGS) personnel will notify the applicant that their application did not meet the deadline. The applicant must receive pre-approval to submit a paper https://www.sam.gov/SAM/ https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do 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

OGS.

a. Letter of Intent Deadline (must be emailed or postmarked by) Due Date for Letter of Intent: 06/14/2019

b. Application Deadline Due Date for Applications: 07/22/2019 , 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.

A Letter of Intent is requested but not required.

Date for Information Conference Call 06/04/19 Scheduled for 3:00 - 4:00 pm, Eastern Standard Time.

Skype Number: (877) 721-9741 Conference ID: 8946896

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

5. CDC Assurances and Certifications All applicants are required to sign and submit “Assurances and Certifications” documents indicated at http://wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa)) /Homepage.aspx.

Applicants may follow either of the following processes:

Complete the applicable assurances and certifications with each application submission, name the file “Assurances and Certifications” and upload it as a PDF file with 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.

Risk Assessment Questionnaire Requirement CDC is required to conduct pre-award risk assessments to determine the risk an applicant poses to meeting federal programmatic and administrative requirements by taking into account issues such as financial instability, insufficient management systems, non-compliance with award https://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx https://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx conditions, the charging of unallowable costs, and inexperience. The risk assessment will include an evaluation of the applicant’s CDC Risk Questionnaire, located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, as well as a review of the applicant’s history in all available systems; including OMB-designated repositories of government-wide eligibility and financial integrity systems (see 45 CFR 75.205(a)), and other sources of historical information. These systems include, but are not limited to: FAPIIS (https://www.fapiis.gov/), including past performance on federal contracts as per Duncan Hunter National Defense Authorization Act of 2009; Do Not Pay list; and System for Award Management (SAM) exclusions.

CDC requires all applicants to complete the Risk Questionnaire, OMB Control Number 0920- 1132 annually. This questionnaire, which is located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, along with supporting documentation must be submitted with your application by the closing date of the Notice of Funding Opportunity Announcement. If your organization has completed CDC’s Risk Questionnaire within the past 12 months of the closing date of this NOFO, then you must submit a copy of that questionnaire, or submit a letter signed by the authorized organization representative to include the original submission date, organization’s EIN and DUNS.

When uploading supporting documentation for the Risk…