CDC-RFA-DD-24-0083.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER ON BIRTH DEFECTS AND DEVELOPMENTAL DISABILITIES

Documenting outcomes associated with Persistent Tic Disorders (including Tourette Syndrome) in Children, Adolescents, and Young Adults through Surveillance

CDC-RFA-DD-24-0083

04/15/2024

Table of Contents 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 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- DD-24-0083. 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:

Documenting outcomes associated with Persistent Tic Disorders (including Tourette Syndrome) in Children, Adolescents, and Young Adults through 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 purposes of this NOFO, research is defined as set forth in 45 CFR 75.2 and, for further clarity, as set forth in 42 CFR 52.2 (see eCFR :: 45 CFR 75.2 -- Definitions and https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR- 2007-title42-vol1-sec52-2.pdf. In addition, for purposes of research involving human subjects and available exceptions for public health activities, please see 45 CFR 46.102(l) (https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section- 46.102#p-46.102(l)).

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-DD-24-0083

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.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l)

E. Assistance Listings Number:

93.073

F. Dates:

1. Due Date for Letter of Intent (LOI):

The LOI date will generate once the Synopsis is published if Days or a Date are entered.

2. Due Date for Applications:

04/15/2024 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

2/29/2024 2-3 PM EST

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G. Executive Summary:

1. Summary Paragraph The NOFO aims to describe the public health impact of persistent tic disorders (PTD) including Tourette syndrome (TS) among diverse populations of children and adolescents ages 4-17 years identified in clinical settings; inclusion of young adults aged 18-26 years with PTD/TS is https://www.grants.gov/ https://cdc.zoomgov.com/j/1614835451?pwd=czVVU3lwUTBiWGxQSnJpVTMrTkFOUT09&from=addon tel:+16692545252,,1614835451#,,,,*07051334# tel:+16469641167,,1614835451#,,,,*07051334# https://cdc.zoomgov.com/j/1614835451?pwd=czVVU3lwUTBiWGxQSnJpVTMrTkFOUT09&from=addon encouraged but not required. Funded sites will assess priority outcomes of cost, suicidality, transition to adult healthcare, and co-occurring conditions. These data will inform education and outreach activities to improve the health and well-being of individuals with PTD/TS.

Recipients will collaborate with CDC and other NOFO recipients to develop and execute plans for data collection, including finalization of survey measures, recruitment of eligible individuals and their caregivers (for children under 18 years), survey administration, data linkage for census tract-level socioeconomic indicators and clinical information, data management, data sharing, data analysis, and dissemination of multi-site data.

Project evaluation will include process and outcome measures for improved capacity for collaboration and data sharing, improved data on priority outcomes and inequities, increased understanding of the strengths and limitations of clinic-based surveillance, availability of new information on the priority outcomes and inequities for a variety of audiences, and to establish procedures and protocols that could be replicated or continued in the future.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

$3,750,000

e. Average One Year Award Amount:

$250,000

f. Total Period of Performance Length:

5 year(s)

g. Estimated Award Date:

August 30, 2024

h. Cost Sharing and / or Matching Requirements:

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.

Part II. Full Text

A. Funding Opportunity Description

1. Background

a. Overview

There are an estimated 1.4 million people in the U.S. affected by persistent tic disorders (PTD), including Tourette syndrome (TS). To support people with these conditions, the impact of PTD/TS must be understood. Although data on the impact of PTD/TS on social relationships and education are available, other potential outcomes associated with PTD/TS have not been well-documented, including costs, suicidality, health care transition, and the role of co-occurring disorders on these outcomes. Limited data are available on how these outcomes may differ among sub-populations (e.g., by sex, race/ethnicity, age group, and geography [e.g., urban/rural]). Data will be used to inform where resources for families and healthcare providers (e.g., professional trainings) are most needed to support people with PTD/TS and their families and to address health inequities among the population.

This NOFO aims to: 1) conduct surveillance of PTD/TS among children and adolescents aged 4- 17 years, including data collection to document associated costs, co-occurring conditions, prevalence of suicidality risk, and transition to adult healthcare (inclusion of young adults aged 18-26 years is encouraged but not required), and 2) generate data that can be used to inform equitable and effective education and outreach activities to improve the health and well-being of individuals with PTD/TS and their families.

It is anticipated that the primary mode of data collection will be surveys administered to caregivers (for children with PTD/TS under 10 years), children with PTD/TS and their caregivers (for children ages 10-17 years), and to adults with PTD/TS only (for those age 18-26 years), and these data will be supplemented with clinical data and linkage to census tract-level data.

Recipients will collaborate with CDC and other NOFO recipients to finalize measures for priority outcomes, to develop a standard survey and surveillance data collection protocol across sites, to establish a data sharing approach, and to analyze, summarize, and disseminate multi-site findings. Recipients will finalize a data management plan and implement a process to share data with both CDC and among NOFO recipients.

Final measures should complement and supplement currently available data. Measures with available population-based data for comparison will be prioritized (e.g., healthcare transition questions from the National Survey of Children’s Health questions], suicide questions from Youth Risk Behavior Survey, healthcare use questions from the National Health Interview Survey, employment/income questions from Current Population Survey). Assessment of costs can include outcomes such as education level, employment (of parent or young adult with PTD/TS), and healthcare costs (beyond those available in claims data). Assessment of suicidality risk can include outcomes such as suicidal ideation, plans, or attempts. CDC has identified potential measures which are included in the Appendix in the announcement. Applicants can propose alternate measures or elect the measures identified by CDC. Applicants should provide justification for measures described in their application.

b. Statutory Authorities Sections 301(a) and 317C of the Public Health Service Act, [42 U.S.C. Sections 241(a) and 247b-4, as amended].

c. Healthy People 2030 AHSR01: Increase the ability of primary care and behavioral health professionals to provide more high-quality care to patients who need it https://health.gov/healthypeople/objectives-and-data/browse-objectives/health-care/increase-ability-primary-care-and-behavioral-health-professionals-provide-more-high-quality-care-patients-who-need-it-ahs-r01 https://health.gov/healthypeople/objectives-and-data/browse-objectives/health-care/increase-ability-primary-care-and-behavioral-health-professionals-provide-more-high-quality-care-patients-who-need-it-ahs-r01

MHMD-03: Increase the proportion of children with mental health problems who get treatment

d. Other National Public Health Priorities and Strategies In 2009, CDC funded RFA-DD-09-004 “Impact of Tic Disorders, including Tourette Syndrome, in Youth, on Individuals, Families, and Communities.” Two funded sites documented impacts associated with tic disorders including social functioning (http://www.ncbi.nlm.nih.gov/pubmed/23806708), quality of life, and family functioning. This NOFO also builds on and supports current and future programmatic funding to improve the health and well-being of individuals with tic disorders (CDC-RFA-DD19-1904, CDC-RFA-DD- 24-0055), “Implementing evidence-based health promotion programs for children with attention-deficit/hyperactivity disorder or Tourette syndrome”.

e. Relevant Work This NOFO builds on the National Stakeholder Strategy for Achieving Health Equity and the HHS Strategic Goal 3: Strengthen Social Well-being, Equity, and Economic Resilience.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Objective: Establish surveillance to document outcomes associated with persistent tic disorders including Tourette syndrome (PTD/TS) across multiple sites that include a diverse population

Strategies and Activities Outputs Short Term Outcomes

Intermediate Outcomes

Long Term Outcomes

Strategy 1. Program Planning and Capacity Building

A1. Collaborate with CDC and other NOFO recipients to determine surveillance data collection approach, recruitment plan, and finalize survey measures.

A2. Collaborate with CDC to build a sustainable data collection system

A3. Collaborate with CDC to develop data linkage plan for census tract-level

Regular progress reports submitted to CDC including successes and challenges in implementing clinic-based surveillance

Data collection approach, recruitment plan, and survey measures developed

Plans to link Census, clinical, and survey data developed

Improved capacity for collaboration and data sharing

Improved data on priority outcomes and inequities for children, adolescents, and young adults with PTD/TS and their caregivers

Increased understanding

Established surveillance system for timely information on priority outcomes among children, adolescents, and young adults with PTD/TS that could be replicated or continued ability to implement

Continued surveillance of outcomes among children, adolescents, and young adults with

PTD/TS

health, well-being, and quality of life among children, adolescents, and young https://health.gov/healthypeople/objectives-and-data/browse-objectives/mental-health-and-mental-disorders/increase-proportion-children-mental-health-problems-who-get-treatment-mhmd-03 data and clinical information.

A4. Coordinate with CDC and other NOFO recipients to plan and prepare for surveillance data exchange/sharing.

A5. Develop regular progress reports and share with CDC.

A6. Develop an evaluation and monitoring plan in collaboration with CDC, within 6 months of the award.

Strategy 2: Data Collection and Management

A1. Recruit children, adolescents, and young adults diagnosed with PTD/TS from clinic populations and caregivers for those under 18 years.

A2. Systematically collect data relevant to priority outcomes for diverse populations of children, adolescents, and young adults with PTD/TS

A3. Develop data management plan; monitor and manage data, including data cleaning

Data sharing plans developed with CDC and other recipients

Evaluation and monitoring plans developed with CDC and other recipients

Procedures and protocols that could be replicated or continued among CDC and other recipients are proposed

2.1 Common

database developed in collaboration with

CDC

2.2 Surveillance data

on priority outcomes among diverse populations of children, adolescents, and young adults with PTD/TS collected and linked to census and clinical information

2.3 Ongoing data

management and monitoring of the strengths and limitations of clinic-based surveillance for priority outcomes among children, adolescents, and young

Availability of new information on the priority outcomes and inequities for a variety of audiences secondary prevention strategies equitably and effectively (e.g., education and outreach) to improve outcomes associated with PTD/TS

Enhanced knowledge to inform evidence-based practice ability of policy makers to make data-informed decisions to equitably improve outcomes and address inequities among children, adolescents, and young

Enhanced evidence-based care for individuals with PTD/TS

Reduced health inequities among children, adolescents, and young

A4. Link survey data with clinical data and census tract-level data pertaining to residence at time of survey recruitment

A5. Assess site-specific and pooled datasets for data quality and completeness; collaborate with other recipients and CDC on data formatting and cleaning decisions

A6. Share standardized, individual-level data with CDC following established and agreed-upon timeline, using a common database, in a secure manner, and according to applicable regulations.

2.4 Standardized

individual-level data cleaned and entered in a database, quality and completeness assessed, and submitted to CDC

3.1 Surveillance data

analysis and dissemination plans developed

3.2 Analysis results

characterize the priority outcomes among children, adolescents, and young adults with PTD/TS and within subgroups

3.3 Data are

interpreted and summarized

3.4 Products

(including surveillance reports) produced and disseminated to variety of audiences

Strategy 3: Data analysis and Reporting

A1. Develop and implement data analysis plan; analyze and interpret data to characterize priority outcomes;

compare and assess differences between survey respondents and non-respondents/national data

A2. Develop and implement dissemination plan; develop surveillance reports and disseminate widely to key partners/priority audiences

i. Purpose The NOFO will support children, adolescents, and young adults with persistent tic disorders including Tourette syndrome (PTD/TS), outcomes associated with PTD/TS must be understood.

The NOFO will conduct surveillance of PTD/TS among children, adolescents, and young adults, across multiple clinical sites that include a diverse population to collect data to document associated costs, co-occurring conditions, suicidality, and transition to adult healthcare. These data will inform future activities to support children, adolescents, and young adults with PTD/TS, including to address disparities.

ii. Outcomes The expected NOFO outcomes are:

Improved capacity for collaborations and data sharing

Improved data on priority outcomes and inequities for children, adolescents, and young adults with PTD/TS, as well as selected impacts for caregivers of children <18 years

Increased understanding of the strengths and limitations of clinic-based surveillance of outcomes among children, adolescents, and young adults with PTD/TS

Availability of new information on the priority outcomes and inequities for a variety of audiences

Established surveillance system for timely information on priority outcomes among children, adolescents, and young adults with PTD/TS that can be replicated and sustained

iii. Strategies and Activities Strategy 1. Program Planning and Capacity Building

Activity 1: Collaborate with CDC and other NOFO recipients to determine surveillance data collection approach (e.g. online and/or paper surveys), recruitment plan, and finalize survey measures with emphasis on the priority outcomes of cost, healthcare transition, suicidality, and co-occurring disorders (measures with population-based data available for comparison will be prioritized; a limited number (e.g., 1-3) of measures for non-priority outcomes can be proposed) minimizing participant burden

Activity 2: Collaborate with CDC to build a sustainable data collection system

Activity 3: Collaborate with CDC to develop data linkage plan to link survey data to census tract-level data and clinical information

Activity 4: Coordinate with CDC and other NOFO recipients to plan and prepare for surveillance data exchange/sharing

Activity 5: Develop regular progress reports and share with CDC

Activity 6: Develop an evaluation and monitoring plan in collaboration with CDC, within 6 months of the award.

Strategy 2: Data Collection and Management

Activity 1: Recruit children, adolescents, and young adults (i.e., <27 years) diagnosed with a persistent tic disorder including Tourette syndrome (PTD/TS) from clinic populations, as well as caregivers for those under 18 years. Recruitment of individuals aged 18-26 years is encouraged, but not required.

Activity 2: Systematically collect data relevant to priority outcomes for diverse populations of children, adolescents, and young adults with PTD/TS as well as data on selected impacts (e.g., employment) for caregivers of children and adolescents

Activity 3: Develop data management plan; monitor and manage data, including data cleaning

Activity 4: Geocode participant address data and link census tract-level data pertaining to socioeconomic indicators based on residence at time of survey recruitment with survey and clinical information

Activity 5: Before and after submission to CDC, assess site-specific and pooled datasets for data quality and completeness; collaborate with other recipients and CDC on data formatting and data cleaning decisions

Activity 6. Following an established and agreed-upon timeline, share standardized individual-level data with CDC, including standardized data elements using a common database in a secure manner. [Note: CDC has a secure network that will be used for this project and recipients will need to obtain and maintain access. Under applicable grant regulations in 45 CFR 75.322, CDC is authorized to collect data first produced under a funded award. All data submitted to CDC becomes subject to applicable federal law, including but not limited to the Freedom of Information Act and Federal Records Act.]

Strategy 3: Data analysis and Reporting

Activity 1: Develop and implement data analysis plan; analyze and interpret data to characterize priority outcomes; compare and assess differences between survey respondents and non-respondents/national data

Activity 2: Develop and implement dissemination plan for multi-site data; develop surveillance reports and disseminate widely to key partners/priority audiences

1. Collaborations

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

Collaborations with interested CDC programs and CDC-funded programs that address children and youth are encouraged. The funding office (NCBDDD) will link recipients with applicable CDC programs, as needed. The linkages will provide the recipient with information and resources to assist with implementing activities to achieve the NOFO period of performance outcomes, including health equity-related outcomes. The exact nature and activities within these collaborations will be determined post-award. Award recipients are expected to collaborate with each other and CDC to determine the surveillance data collection approach (e.g., online and/or paper surveys), recruitment plan; finalize survey measures; develop a data linkage plan for census tract-level data and clinical information; plan and prepare for surveillance data exchange/sharing.

b. With organizations not funded by CDC:

Collaborations with interested partners, educational institutions, non-profit agencies, resource centers, and other entities with an interest in the population of children, adolescents, and young adults with PTD/TS are encouraged, and may assist with recruitment or other activities. These may include partners who are and are not funded by CDC. Partners who can enhance outreach to minority-serving institutions, enhance outreach for geographic diversity, community or faith groups serving the affected population, and persons with relevant lived experiences are also encouraged. Applicants are encouraged to establish or engage with an established local advisory board that includes people with lived experience, clinicians, and public health professionals for input on project planning, promotion, and dissemination of findings. The applicant should provide a letter of support describing how each collaboration will assist the recipient in implementing activities and achieving the NOFO period of performance outcomes, including health equity-related outcomes. If partnering with a specialty clinic for data collection, a letter of support must be included that clearly states ability to recruit clinic patients, link clinic records to survey data, and send linked data to the CDC. The applicant should provide internet links for the organizations and programs, if applicable. The applicant must file the letters of support, name the file “Letters of Support” and upload as a PDF, Word, or Excel file format at grants.gov.

2. Population(s) of Focus The population of focus for this NOFO is children, adolescents, and young adults (i.e., < 27 years) diagnosed with persistent tic disorders (PTD) including Tourette syndrome (TS) and their caregivers.

This NOFO, including funding and eligibility, is not limited based on, and does not discriminate on the basis of race, color, national origin, disability, age, sex (including gender identity, sexual orientation, and pregnancy) or other constitutionally protected statuses.

a. Health Disparities The goal of health equity is for everyone to have a fair and just opportunity to attain their highest level of health. Achieving this requires focused and ongoing societal efforts to address historical and contemporary injustices; overcome economic, social, and other obstacles to health and healthcare; and eliminate preventable health disparities.

Broadly defined, social determinants of health are non-medical factors that influence health outcomes. They are the conditions in which people are born, grow, work, live, and age, and the wider set of forces and systems shaping the conditions of daily life. These forces (e.g., racism, climate) and systems include economic policies and systems, development agendas, social norms, social policies, and political systems. See content below and in other sections (e.g., Approach, Collaborations, Populations of Focus) for information on how this specific NOFO affects social determinants of health.

A health disparity is a preventable difference in the burden of disease, injury, violence, or opportunities to achieve optimal health that are experienced by populations that have been socially, economically, geographically, and environmentally disadvantaged. Health disparities are inextricably linked to a complex blend of social determinants that influence which populations are most disproportionately affected by these diseases and conditions.

Individuals with persistent tic disorders including Tourette syndrome (PTD/TS) have increased needs in healthcare and in the classroom compared to their peers, and therefore need systematic clinical and educational supports. Individuals with PTD/TS are also at higher risk than their peers for specific public health outcomes, including feelings of isolation, problems with social relationships, school problems, and suicidal ideation. Although some areas of the public health impact of PTD/TS have been described, less is known about the impact among sub-populations of individuals, including females, LGBTQIA+ individuals, racial/ethnic minorities, and individuals living in different geographic settings (e.g., urban, rural). This NOFO aims to document the public health impact and associated health disparities among children, adolescents, and young adults with PTD/TS by conducting surveillance across multiple sites to increase knowledge of the overall population, and the sub-populations noted above. An improved understanding of the outcomes associated with PTD/TS overall as well as disparities in the prevalence of priority outcomes can be used to educate individuals, families, educators, and healthcare professionals to address identified needs of the population and sub-populations.

Applicants should describe their approach and capacity to recruit a diverse population of individuals with PTD/TS.

iv. Funding Strategy N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

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, including, as applicable to the award, how findings will contribute to reducing or eliminating health disparities and inequities.

• 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).

• How evaluation findings will be disseminated to communities and populations of interest in a manner that is suitable to their needs.

• Plans for updating the Data Management Plan (DMP) as new pertinent information becomes available. If applicable, throughout the lifecycle of the project. Updates to DMP should be provided in annual progress reports. 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/additional-requirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, the applicant 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.

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

Recipients will be required to submit a detailed Evaluation and Performance Measurement plan (Evaluation Plan), including any needed revisions to the Data Management Plan, within the first 6 months of award, as described in the Reporting Section of this NOFO. The recipient's Evaluation Plan must describe how the recipient will fulfill the NOFO evaluation and performance measurement requirements described in this section.

Upon award, CDC will work with recipients to identify process and outcome evaluation measures and potential data sources they can use to track key evaluation outcomes and will provide technical assistance to recipients to identify additional indicators and measures that support the evaluation of the specific NOFO activities. Recipients will be required to submit a draft of the evaluation plan within the first 45 days of award (including potential indicators) which should be finalized by six months post award, as described in the Reporting and CDC Evaluation and Performance Measurement Sections of the NOFO.

Upon award, CDC will provide a recommended template, along with guidance and technical assistance, to develop a collective evaluation plan. Recipients' evaluation activities may include collecting additional qualitative and quantitative data to measure program efforts.

CDC expects recipients to identify, measure, track, and report on:

Process evaluation measures on activities related to implementing a comprehensive surveillance approach for priority outcomes among children, adolescents, and young adults with PTD/TS, including strategies for program planning and capacity building, data collection and management, and data analysis and reporting.

Outcome evaluation measures on the impact of NOFO activities on short-term and intermediate outcomes which build surveillance capacity for collaboration and data sharing, improve data on priority outcomes and inequities, document the reliability and sustainability of clinic-based surveillance for children, adolescents, and young adults with PTD/TS, including information on priority outcomes and inequities.

Example Process Evaluation Measures:(Note: final process measures will be determined post-award in collaboration with CDC.)

Strategy 1: Program Planning and Capacity Building

Recipients will be required to submit a detailed Evaluation and Performance Measurement plan (Evaluation Plan), including any needed revisions to the Data Management Plan, within the first 6 months of award, as described in the Reporting Section of this NOFO. The recipient's Evaluation Plan must describe how the recipient will fulfill the NOFO evaluation and performance measurement requirements described in this section.

Upon award, CDC will work with recipients to identify process and outcome evaluation measures and potential data sources they can use to track key evaluation outcomes and will provide technical assistance to recipients to identify additional indicators and measures that support the evaluation of the specific NOFO activities. Recipients will be required to submit a draft of the evaluation plan within the first 45 days of award (including potential indicators) which should be finalized by six months post award, as described in the Reporting and CDC Evaluation and Performance Measurement Sections of the NOFO.

Upon award, CDC will provide a recommended template, along with guidance and technical assistance, to develop a collective evaluation plan. Recipients' evaluation activities may include approach for priority outcomes among children, adolescents, and young adults with PTD/TS, including strategies for program planning and capacity building, data collection and management, and data analysis and reporting.

Outcome evaluation measures on the impact of NOFO activities on short-term and intermediate outcomes which build surveillance capacity for collaboration and data sharing, improve data on priority outcomes and inequities, document the reliability and sustainability of clinic-based surveillance for children, adolescents, and young adults with PTD/TS, including information on priority outcomes and inequities.

Example Process Evaluation Measures:(Note: final process measures will be determined post-

Strategy 1: Program Planning and Capacity Building

# of meetings attended with CDC and other recipients

# of regular progress reports submitted to CDC on time

Data collection approach, recruitment plan, and survey measures developed in collaboration with CDC and other recipients

Survey measures finalized that include validated questions to measure priority outcomes and demographic characteristics to measure inequities

Data sharing and linkage plans for census tract-level data developed in collaboration with CDC and other recipients

Evaluation and monitoring plan developed in collaboration with CDC and other recipients within 6 months post-award

Procedures and protocols proposed that could be replicated or continued in the future

Strategy 2: Data Collection and Management

Applicants should include the following DMP requirements, at a minimum:

• 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

According to recruitment, data collection, and data management plans:

# of participants overall (including by age, sex, race/ethnicity, metro-status, and census-level indicators) compared to recruitment goal

# of participants in current reporting period (including by age, sex, race/ethnicity, and census-level indicators) compared to recruitment goal

% of participants with complete data

Data standardized following proposed protocol

Data entered in a database, addresses geocoded, cleaned, and shared with CDC based on agreed upon schedule

# of data quality checks implemented

Information on respondents and non-respondents has been compared and documented.

Strategy 3: Data Analysis and Reporting

Data analysis and dissemination plan developed in collaboration with CDC and other recipients

Descriptive statistics generated on outcomes associated with PTD/TS, including by age, sex, race/ethnicity and census level indicators

Results interpreted and summarized in collaboration with CDC and other recipients

Surveillance reports for each priority outcome created and disseminated

# and type of dissemination channels or products (e.g., abstracts, presentations, publications)

# and type of dissemination audiences

Example Outcome Evaluation Measures: (Note: final outcome measures will be determined post-

Short-term outcome 1: Improved capacity for collaboration and data sharing

Procedures established for data sharing between recipients and CDC

Short-term outcome 2: Improved data on priority outcomes and inequities for children, adolescents, and young adults with PTD/TS

Calculated the proportion of individuals with PTD/TS experiencing priority outcomes

Calculated the proportion of individuals with PTD/TS experiencing priority outcomes stratified by demographic characteristics, including race/ethnicity, sex, geography (e.g., urban, rural), and census-level indicators

Short-term outcome 3: Increased understanding of the strengths and limitations of clinic-based surveillance for children, adolescents, and young adults with PTD/TS

Lessons-learned (i.e., strengths and limitations) summarized and communicated to CDC and other recipients via interim or final reports

Short-term outcome 4: Availability of new information on the priority outcomes and inequities for a variety of audiences

Multi-site findings on priority outcomes and inequities for individuals with PTD/TS shared with and made widely available to a variety of audiences

# and type of audiences for whom the findings are available

Intermediate outcome 1: Established surveillance system for timely information on priority outcomes among children, adolescents, and young adults with PTD/TS that could be replicated or continued

Procedures and protocols established and documented for a surveillance system on priority outcomes among individuals with PTD/TS that could be replicated or continued in the future

A Data Management Plan (DMP) is required as part of the application, and must include:

A draft description of the data to be collected or generated in the proposed project, including proposed outcome and process evaluation measures, and priority outcome measures (final description of the data to be collected will be determined post-award in collaboration with CDC;

measures with population-based data available for comparison will be prioritized)

How data will be stored securely at the site, including 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

Plans to geocode residential data and link with census-tract level data

Data suppression standards to ensure dissemination of data do not compromise confidentiality

A plan to securely provide data to CDC

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

Plans for archiving and long-term preservation of the data or explaining why long-term preservation and access are not justified.

Recipients will finalize a data management plan and implement a process to share data with both CDC. Data to be shared with CDC and other recipients will exclude the majority of the standard HIPAA identifiers. Full dates may be needed for certain variable calculations (e.g., age at diagnosis needing date of birth and data of diagnosis). Information on age, sex, race/ethnicity, and other demographic information is expected to be shared with CDC and NOFO recipients.

The data management plan may involve a two-step data release process in which only fully de-identified data are shared more widely, and any data containing a HIPAA identifier (e.g., date) is restricted to a smaller group.

For more information, see CDC’s DMP policy: https://www.cdc.gov/grants/additional-requirements/ar-25.html.

c. Organizational Capacity of Recipients to Implement the Approach Applicants must demonstrate relevant experience and capacity (management, administrative, and technical) to:

Provide expertise in the identification and diagnosis of PTD/TS

Access a clinic that specializes in tic disorders; if partnering with a specialty clinic, a letter of support must be included that clearly states ability to recruit clinic patients, link clinic records to survey data, and send linked, data to the CDC. The clinic should serve children and adolescents under 18 and can also serve young adults; the applicant should document the number of children, adolescents, and young adults with PTD/TS seen in the clinic annually (e.g., for 2021, 2022, or 2023), including information on the patients’ race, ethnicity, and metro-status (it is recommended this information is presented in a table).

Reach and maximize recruitment and participation of a diverse clinic population of children, adolescents, (and young adults if included in proposal) diagnosed with persistent tic disorders (PTD) including Tourette syndrome (TS), and caregivers for those under 18 years, and effectively implement surveillance (i.e., collect data to describe prevalence of priority outcomes), as applicable to this NOFO

Collaborate with CDC and NOFO recipients to finalize appropriate measures/methods to assess the four priority outcomes (i.e., costs [e.g., healthcare, employment, educational supports], healthcare transition, co-occurring disorders, suicidality). Measures with population-based data available for comparison will be prioritized

Collaborate in the collection, analysis, and dissemination of data; letters of support or other documentation can be included to show previous collaborative work

Link data across multiple sources (e.g., survey, clinical, Census)

Geocode address data

Share data outside the recipient’s institution. Applicants should describe a plan to share all data collected under this cooperative agreement with CDC every 6 months following the beginning of data collection and document their ability to share data. Applicants should demonstrate, through memorandums of understanding/agreement (MOUs/MOAs) and/or letters of support from the owners of the data and/or any relevant authorities, the ability to access and share the data per the NOFO guidelines. Applicants must file the MOUs or MOAs, as appropriate, name the file “MOUs/MOAs”, and upload it as a PDF file at www.grants.gov. Applicants must address HIPAA and IRB requirements for sharing data. All data submitted to CDC becomes subject to applicable federal law, including but not limited to the Freedom of Information Act and Federal Records Act.

Disseminate multi-site findings through presentations, reports, and publications

Implement the activities and achieve the project outcomes to enhance public health surveillance for individuals with PTD/TS

Implement the evaluation plan

Create and maintain a staffing plan (clearly defined staff roles) and project management structure sufficient to achieve the project outcomes. Management must describe skills in program planning, program evaluation, performance monitoring, financial reporting, budget management and administration, and personnel management. For any positions to be filled post-award the applicant should address both the recruiting strategies and estimated timeline for filling the position(s).

If recipient uses a sub-recipient for all or part of the workplan activities the recipient must demonstrate adequate staffing and capacity to supervise sub-recipient's activities and products.

Applicants should provide documentation that they have a financial management system that will allow proper funds management and segregation of funds by program, including sub-awards, and meet the requirements as stated in the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards found at: “https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75#se45.1.75_1302 45 CFR Part 75.302. The financial system should permit the preparation of reports required by general and program-specific terms and conditions; and the tracing of funds to a level of expenditure adequate to establish that such funds have been used according to the federal statutes, regulations, and terms and conditions of the federal award.

Applicants must demonstrate their ability to manage the required procurement efforts, including the ability to write and award contracts in accordance with applicable grants regulations.

Applicants must provide CV/Resumes of key staff (i.e., project manager, principal investigator, epidemiologist/statistician) and name this file "CVs/Resumes" or "Organizational Charts" and upload it at www.grants.gov. Attachments can be submitted using PDF, Word, or Excel file formats.

d. Work Plan https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75#se45.1.75_1302 https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75#se45.1.75_1302 http://www.grants.gov/

The applicant must provide a detailed work plan for the first year of the project and a high-level work plan for subsequent years to track and monitor implementation of activities and progress on period of performance outcomes.

The recommended work plan format is a table listing the strategies and activities, outcomes, and evaluation and performance measures as presented in the logic model and the narrative sections of the NOFO. The applicant may choose to track strategies, activities, and outcomes in the work plan table by color.

The work plan for year 1 must include activities and timelines to support the achievement of the NOFO outcomes. These activities must align with the NOFO logic model and should have performance measures or milestones for accomplishing tasks and

Include measurable outcomes.

Describe staff and administrative roles and functions to support the implementation of the award.

Specify management and leadership positions and qualifications for those roles; and

Describe administration and assessment processes to ensure successful implementation and quality assurance.

The work plan format should align with the logic model and narrative and can be used for year 1.

In this format, the table should be completed for each period of performance outcome. If a particular activity leads to multiple outcomes, it should be described under each outcome measure.

Sample:

Period of Performance Outcome:

[from Outcomes section and/or logic model]

Outcome Measure:

[from Evaluation and Performance Measurement section]

Strategies and Activities

Process Measure [from Evaluation and Performance Measurement section]

Responsible Position / Party

Completion Date

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

In a cooperative agreement, CDC staff members are substantially involved in the program activities, above and beyond routine grant monitoring. CDC’s involvement beyond monthly calls, site visits, and regular performance and financial monitoring may include specific subject matter expertise regarding documenting the impact of persistent tic disorders (PTD) including Tourette syndrome (TS) in a population of children, adolescents, and young adults, and providing consultation on:

finalization of common measures to identify areas of impact, specifically the priority outcomes of cost, suicidality, co-occurring conditions, and care transition in adulthood finalization of the data management plan and process to share data with CDC data collection, data sharing, and data analysis strategies to recruit the priority populations evaluation performance measurement work plan modifications and capacity building assistance.

The program and all recipients will share information, practices, lessons learned, and evaluation results between recipients (e.g., through conference calls, guidance, material development, data sharing), and externally (e.g., conferences, webinars, publications, social media).

B. Award Information

1. Funding Instrument Type:

CA (Cooperative Agreement) CDC's substantial involvement in this program appears in the CDC Program Support to Recipients Section.

2. Award Mechanism:

NU38DD Documenting Outcomes Associated with Persistent Tic Disorders (including Tourette Syndrome)

3. Fiscal Year:

4. Approximate Total Fiscal Year Funding:

$750,000

5. Total Period of Performance Funding:

$3,750,000 This amount is subject to the availability of funds.

Estimated Total Funding:

$3,750,000

6. Total Period of Performance Length:

5 year(s) year(s)

7. Expected Number of Awards:

8. Approximate Average Award:

$250,000 Per Budget Period

9. Award Ceiling:

$750,000 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor:

$150,000 Per Budget Period

11. Estimated Award Date:

August 30, 2024

12. Budget Period Length:

12 months month(s)

Throughout the period of performance, 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 (period of performance) 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 available through this NOFO.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

C. Eligibility Information

1. Eligible Applicants

Eligibility Category:

00 (State…