RFA-DP-25-043_20241105.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR CHRONIC DISEASE PREVENTION AND HEALTH

PROMOTION

Comprehensive Analysis, Surveillance, and Statistics Initiative for Diabetes in the Young

(CASSIDY)

RFA-DP-25-043

01/10/2025

Table of Contents Section I. Funding Opportunity Description

Section II. Award Information

Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information

Overview

Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Components of Participating Organizations:

National Center for Chronic Disease Prevention and Health Promotion Notice of Funding Opportunity (NOFO) Title Comprehensive Analysis, Surveillance, and Statistics Initiative for Diabetes in the Young

(CASSIDY)

Activity Code U18

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-DP-25-043

Assistance Listings Number(s) 93.945 Category of Funding Activity HL - Health NOFO Purpose The objective of this NOFO is to conduct surveillance of diabetes in youth (< 18 years) and young adults (18–44 years) across health system and/or health plan membership-based centers to provide estimates of diabetes incidence and prevalence in the United States. These estimates are sought by diabetes type, demographic traits, health insurance status, and geographic area to identify disparities in diabetes burden. The prevalence of diabetes complication risk factors, acute and chronic diabetes complications, and use of diabetes medications among youth and young adults with diabetes will also be ascertained.

This project has two (2) components to achieve the purpose of the program. Component A focuses on surveillance of diabetes among youth (< 18 years) and young adults (18–44 years).

Component B serves as a Coordinating Center to provide an infrastructure for standardized approaches, analytical methods, and measures to be used for surveillance across sites. It will also develop validation protocols, serve as a data repository, and provide statistical expertise.

Key Dates Publication Date:

To receive notification of any changes to RFA-DP-25-043, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link.

An email address is needed for this service.

Letter of Intent Due Date:

12/10/2024

Application Due Date:

01/10/2025

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 11:59 PM U.S. Eastern Time.

Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission and prevents errors.

For more information on accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via http://grants.nih.gov/support/index.html.

• E-mail: commons@od.nih.gov

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552

• Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review:

03/12/2025 This date is an estimate.

https://www.grants.gov/ http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov

Secondary Review:

04/29/2025 This date is an estimate.

Estimated Start Date:

09/30/2025 Expiration Date:

02/09/2025 Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note:The Research Strategy component of the Research Plan is limited to 12 pages.

Page Limitations: Pages that exceed the page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

Applications that do not comply with these instructions may be delayed or may not be accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary

• Purpose: This NOFO aims to conduct diabetes surveillance across health system and/or health plan membership-based centers to:

1. Estimate incidence and prevalence of diabetes in youth (< 18 years) and young adults (18–44 years) in the United States. These estimates are sought by diabetes type, demographic traits, health insurance status, and geographic area to identify disparities in diabetes burden.

2. Ascertain the prevalence of risk factors for diabetes complications, occurrence of acute and chronic diabetes complications, and use of diabetes medications among youth and young adults with diabetes.

This NOFO has two (2) components to achieve the purpose of the program.

1. Component A focuses on surveillance of diabetes among youth (< 18 years) and young adults (18–44 years).

2. Component B serves as a Coordinating Center to provide an infrastructure for standardized approaches, analytical methods, and measures to be used for surveillance across sites. It will also develop validation protocols, serve as a data repository, and provide statistical expertise.

• Mechanism of Support: U18 https://grants.nih.gov/grants/how-to-apply-application-guide.html

• Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire four (4)-year period of performance is $12,800,000.00. There will be up to six (6) awards total, including up to five (5) awards under Component A and one (1) award under Component B. Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded, and the number of awards will depend upon the number, quality, duration and cost of the applications received.

• Budget and Period of Performance: The estimated total funding (direct and indirect) for the first year (12-month budget period) will be $3,200,000.00. During FY25, the anticipated funding amounts for the individual awards will be as follows:

• Component A: It is anticipated that up to five (5) awards will be made for up to $500,000.00 (direct and indirect) each in FY25.

• Component B: It is anticipated that one (1) award will be made for up to $700,000.00 (direct and indirect) in FY25.

The estimated total funding (direct and indirect) for the entire Period of Performance will be $12,800,000.00. The period of performance is anticipated to run from 09/30/2025 to 09/29/2029.

• Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. “Application and Submission Information” of this announcement.

• Eligible Institutions/Organizations: Institutions/organizations listed in Section III of this announcement are eligible to apply.

• Eligible Project Directors/Principals Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. CDC does not make awards to individuals directly. Individuals from organizations that are uniquely prepared to examine research relevant to undeserved groups, including sexual orientation and gender identity minorities as well as individuals with disabilities are always encouraged to apply.

• Number of PDs/PIs: Applications may include more than one PI; however, the first PI listed on the application will be the “contact PI” for all correspondence.

• Number of Applications: Only one application per institution (normally identified by having a unique UEI number) is allowed. Applicants can apply for Component A or Component B; however, applicants cannot apply for both Component A and Component B.

• Application Type: New

• Application Materials: See Section IV.1 for application materials. Please note that

SF424 (R&R) Form H is to be used when completing the application package. Please see https://grants.nih.gov/grants/how-to-apply-application-guide.html

Section I. Funding Opportunity Description

Statutory Authority

Awards are made under the authorization of 317(k) (2) of the Public Health Service Act (PHS Act), 42 U.S.C. 247b(k)(2) and 301(a) of the PHS Act, 42 U.S.C. 241(a).

1. Background and Purpose Public health surveillance of diabetes and its complications is crucial for tracking and characterizing the burden of the disease, formulating health care policy, identifying high-risk groups, developing strategies to reduce the burden of this disease, and monitoring progress of primary and secondary prevention programs. Diabetes mellitus is one of the most common chronic diseases in the United States, with over 38 million people having the disease in 2021 (1).

While the prevalence and incidence of diabetes is higher among older adults, diabetes is one of the most common chronic diseases in childhood and young adulthood.

The SEARCH for Diabetes in Youth study (Population Based Registry of Diabetes in Youth) found that the incidence of both type 1 and type 2 diabetes in the United States is increasing (2).

Between 2002 and 2018, incidence of type 1 diabetes in children and adolescents aged <20 years increased by 2% per year and incidence of type 2 diabetes increased by 5% per year (2). In 2017- 2018 there were 22.2 new cases/100,000 youth with type 1 and 17.9 new cases/100,000 youth per year with type 2 diabetes. The study also found that annual increases in type 1 diabetes incidence were generally higher among American Indian (+1.8%), Asian or Pacific Islander (+4.8%), Hispanic (+4.1%), and non-Hispanic Black (+2.9%) youth than the annual increases in type 1 diabetes observed among non-Hispanic White (+0.6%) youth. Similarly, annual increases in type 2 diabetes incidence were also found to be greater among American Indian (+3.5%), Asian or Pacific Islander (+8.9%), Hispanic (+7.2%), and non-Hispanic Black (+6.0%) youth than non-Hispanic White (+1.8%) youth.

National Health Interview Survey (NHIS) analyses suggest that trends in diabetes incidence among young adults have been relatively stable (3, 4), with a nonsignificant annual decrease of - 1.2% among adults aged 18–44 years in 2008–2021 NHIS data (4). However, these results from the NHIS do not distinguish diabetes type. Estimates of diabetes incidence and prevalence by type from national surveys rely on various algorithms that include age at diabetes onset, insulin use and self-report of diabetes type (5). Because type 1 diabetes can occur at any age and people with type 2 diabetes often need insulin treatment to control hyperglycemia, such algorithms are prone to misclassification bias (5). There is however no currently accepted method to separate type 2 from type 1 diabetes in data from national surveys, so there are fewer estimates of diabetes incidence by type among young adults in the United States.

The rising incidence of diabetes among youth is a significant driver of diabetes prevalence in this segment of the population. Among youth under 20 years of age, 2.15/1,000 had type 1 diabetes and 0.67/1,000 had type 2 diabetes in 2017 (6). This represented a 45% and 95% relative increase since 2001, respectively. National estimates indicated that 5.8 million young adults aged 18-44 years had diabetes in 2021 (1). Since diabetes requires lifelong treatment, management, and care, understanding the burden of diabetes in the younger population will assist with future health care planning and public health prevention efforts.

Since 2000, the Centers for Disease Control and Prevention (CDC) collaborated with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to fund three initiatives that address surveillance of diabetes among children, adolescents and young adults: 1) SEARCH for Diabetes in Youth (Population Based Registry of Youth with Diabetes), 2) the study to Assess the Incidence of Type 1 Diabetes in Young Adults (DiYA), and 3) Assessing the Burden of Diabetes by Type in Children, Adolescents and Young Adults (DiCAYA) study.

The SEARCH study has conducted active diabetes surveillance in five geographic areas of the U.S. (Cincinnati, Ohio; Colorado; Seattle, Washington; South Carolina; and Southern California) and ascertained incident cases of diabetes in individuals < 20 years of age annually from 2002 to 2018 (2). The SEARCH study also developed algorithms for electronic health records to minimize bias in identifying cases of diabetes and to distinguish these cases by diabetes type.

While the SEARCH study provided invaluable information about diabetes among youth, it did not address gaps in knowledge around diabetes in young adults.

The DiYA study was funded to determine the incidence of type 1 diabetes in the young adult population. The study developed methods to identify young persons with diabetes and distinguish between type 1 and type 2 or other diabetes types in electronic health records and developed algorithms validated with diabetes autoantibodies (7). The DiYA study found that type 1 diabetes may account for approximately 8% of incident diabetes cases among young adults (7). However, the DiYA study was limited to young adults in the Kaiser Permanente population in southern and northern California and only provided information for 2017.

The DiCAYA study was funded in 2020 to build upon the methods established in the SEARCH and DiYA studies and continue to estimate the prevalence, incidence, and trends of diabetes among youth and young adults (0–44 years) by diabetes type, age, sex, race and ethnicity, and geographic area (8). It includes eight surveillance centers that are either geographical, health system, or membership-based and conducts diabetes surveillance across geographically diverse populations in the United States. Moreover, the study is further refining and validating electronic health record-based computable phenotype algorithms to identify type 1 and type 2 diabetes from previous studies, testing and validating bias correction methods to adjust for differences between the patient population and general target population of inference.

In addition to the methodological contributions, the DiCAYA study has also revealed challenges in conducting surveillance across diverse centers. The differences between centers (e.g., denominators) have limited the study’s ability to systematically apply methods across the network. For example, health system and membership-based centers may rely on statistical approaches such as multilevel regression with poststratification to adjust for potential differences between their patient populations and the target populations of inference, whereas geographical centers may explore capture-recapture methods to estimate completeness of case ascertainment.

Due to the different denominators, it is also unclear if incidence and prevalence estimates from all three types of centers can be combined to provide a composite estimate for the entire network.

Thus, the DiCAYA study has reinforced the need to obtain generalizable estimates from a more homogeneous network.

Given the challenges listed above, the current NOFO is designed to use knowledge gained from the DiCAYA study and its predecessors while addressing DiCAYA’s limitations, including improved methodological alignment and data harmonization across participating centers. Thus, this new NOFO aims to conduct surveillance of diabetes strictly across demographically and geographically representative health system and/or health plan membership-based centers to estimate the incidence and prevalence of diabetes among youth and young adults overall and by age, sex, race and ethnicity, geographic area, and diabetes type. The NOFO also intends to estimate the prevalence of risk factors for diabetes complications, occurrence of acute and chronic diabetes complications, and use of diabetes medications among youth and young adults with diabetes. This NOFO will establish a systematic, comprehensive, and sustainable surveillance system capable of providing timely information on the burden of diabetes among youth and young adults in the United States.

References:

1. Centers for Disease Control and Prevention. National Diabetes Statistics Report website [Available from: https://www.cdc.gov/diabetes/php/data-research/index.html.

2. Wagenknecht LE, Lawrence JM, Isom S, Jensen ET, Dabelea D, Liese AD, et al.

Trends in incidence of youth-onset type 1 and type 2 diabetes in the USA, 2002-18:

results from the population-based SEARCH for Diabetes in Youth study. Lancet Diabetes Endocrinol. 2023;11(4):242-50.

3. Benoit SR, Hora I, Albright AL, Gregg EW. New directions in incidence and prevalence of diagnosed diabetes in the USA. BMJ Open Diabetes Res Care.

2019;7(1):e000657.

4. Saelee R, Hora IA, Pavkov ME, Imperatore G, Chen Y, Benoit SR, et al. Diabetes Prevalence and Incidence Inequality Trends Among U.S. Adults, 2008-2021. Am J Prev Med. 2023;65(6):973-82.

5. Casagrande SS, Lessem SE, Orchard TJ, Bullard KM, Geiss LS, Saydah SH, et al.

Comparison of several survey-based algorithms to ascertain type 1 diabetes among US adults with self-reported diabetes. BMJ Open Diabetes Res Care. 2020;8(2).

6. Lawrence JM, Divers J, Isom S, Saydah S, Imperatore G, Pihoker C, et al. Trends in Prevalence of Type 1 and Type 2 Diabetes in Children and Adolescents in the US, 2001-2017. JAMA. 2021;326(8):717-27.

7. Lawrence JM, Slezak JM, Quesenberry C, Li X, Yu L, Rewers M, et al. Incidence and predictors of type 1 diabetes among younger adults aged 20–45 years: The diabetes in young adults (DiYA) study. Diabetes research and clinical practice. 2021;171:108624.

8. Hirsch AG, Conderino S, Crume TL, Liese AD, Bellatorre A, Bendik S, et al.

Using electronic health records to enhance surveillance of diabetes in children, https://www.cdc.gov/diabetes/php/data-research/index.html adolescents and young adults: a study protocol for the DiCAYA Network. BMJ open.

2024;14(1):e073791.

Healthy People 2030 and other National Strategic Priorities This NOFO supports the following diabetes Health People 2030 objectives: 1) reduce the number of diabetes cases diagnosed yearly (D-01); and 2) reduce the proportion of adults with diabetes who have an A1c value above 9 percent (D-03). This project will support these objectives by providing data on the burden of diabetes among US youth and young adults by age, sex, race and ethnicity and diabetes type as well as the prevalence of elevated glycemia (i.e., A1c ≥ 9.0%) among youth and young adults with diabetes.

The measurable outcomes of this NOFO will be in alignment with the Division of Diabetes Translation mission statement, “to reduce the preventable burden of diabetes through public health leadership, partnership, research, program, and policies that translate science into practice.”

Public Health Impact This NOFO directly supports the Division of Diabetes Translation’s mission by assessing the burden of diabetes among youth and young adults in the United States. This study will provide valuable estimates of diabetes incidence and prevalence among youth and young adults by diabetes type, demographic traits, health insurance status, and geographic area to identify health disparities. The study will also apply surveillance methods to provide information on the prevalence of diabetes complication risk factors, acute and chronic diabetes complications, and use of diabetes medications among youth and young adults with diabetes. Results from this NOFO will assist with the achievements of measuring how diabetes and its complications affect populations in the United States, reducing the preventable burden of diabetes, and health equity.

This information will be used to inform decision-making and prioritize national public health objectives.

Relevant Work This NOFO is associated with DP-20-001, Assessing the Burden of Diabetes by Type in Children, Adolescents and Young Adults (DiCAYA). The DiCAYA study was funded to estimate the prevalence, incidence, and trends of diabetes among youth and young adults (0–44 years) by diabetes type, age, sex, race and ethnicity, and geographic area. It includes eight surveillance centers that are either geographical, health system, or membership-based and conduct diabetes surveillance across geographically diverse populations in the United States.

This NOFO builds upon the methods and lesson learned during the DiCAYA study on how to use electronic health records to conduct diabetes surveillance among youth and young adults.

Specifically, this NOFO aims to utilize the tested methods established in DiCAYA across a more homogeneous surveillance system to provide network-wide estimates of diabetes incidence and prevalence among youth and young adults. In addition, this NOFO aims to focus on important attributes of public health surveillance methods including simplicity, flexibility, data quality, representativeness, timeliness, and stability over time. Applicants are encouraged to review methods reported from DP-20-001 in developing their proposals.

2. Approach This NOFO aims to conduct diabetes surveillance across health system and/or health plan membership-based centers to:

1. Estimate incidence and prevalence of diabetes in youth (< 18 years) and young adults (18–44 years) in the United States. These estimates are sought by diabetes type, demographic traits, health insurance status, and geographic area to identify disparities in diabetes burden.

2. Ascertain the prevalence of risk factors for diabetes complications, occurrence of acute and chronic diabetes complications, and use of diabetes medications among youth and young adults with diabetes.

There are two components in this NOFO:

• Component A (Youth and Young Adult Diabetes Surveillance Centers): Component A applicants should be able to create health system or health plan membership-based surveillance centers capable of identifying youth (< 18 years) and young adults (18–44 years) with incident or prevalent diabetes. Component A applicants are expected to have established access to diabetes cases among youth (< 18 years) and young adults (18–44 years) and standard operating procedures in place that allow for the development of protocols/agreements that are necessary for participation in a multi-center study (e.g., data sharing agreements).

Awarded centers will conduct standardized ascertainment, validation, and classification of diabetes cases across their respective source population to estimate the incidence and prevalence of diabetes among youth and young adults by age, sex, race and ethnicity, diabetes type, health insurance coverage, and geographic area. Awarded centers will also characterize clinical aspects of diabetes among youth and young adults in the United States, including risk factors for diabetes complications, the occurrence of acute and chronic diabetes complications, and use of diabetes medications.

Component A applicants are expected to have access to a large population under surveillance (i.e., denominator greater than 500,000 people) for both age groups constructed using methods such as health system utilization or health plan membership enrollment. It is expected that Component A applicants include detailed information of the population under surveillance and its representativeness to the population of youth and young adults residing within the center’s geographic catchment area. This includes a complete description of the population under surveillance by age, sex, race and ethnicity, health insurance coverage, and geographic area. Component A applicants are expected to describe completeness (i.e., level of missingness) of the data across these key characteristics as well.

Possible data sources include electronic health records, administrative claims, and diabetes registries. Component A applicants are also expected to be able to implement Common Data Models (i.e., community data standards) to allow for harmonization across heterogenous data sources and improve analytic efficiency.

• Component B (Coordinating Center): Component B will serve as the Coordinating Center and will provide an infrastructure for standardized approaches, analytical methods, and measures to be used for surveillance across Component A centers (common protocol). This includes creating data validation protocols and mechanisms to secure transmission of data and relevant data management reports between Component A awardees. The Coordinating Center will also create and maintain a central data repository for the study and ensure the training and certification of staff at Component A centers on

1) the procedures stated in the protocols corresponding to definitions for diabetes and diabetes related outcomes and 2) the transfer of data to a central data repository.

The Coordinating Center will also provide innovative statistical and analytic support including the development of analytic methods to identify incident and prevalent diabetes cases, validate diabetes cases by type, correct for potential sources of bias, and aggregate and harmonize data across Component A centers. It will support the timely dissemination of network-wide results describing the incidence, prevalence, and clinical characteristics of diabetes among youth and young adults in the United States.

The Coordinating Center will conduct administrative functions to support the coordination of the Component A centers, including maintaining internal and external websites, disseminating information to study investigators and to the public, and providing consolidated estimates of the study’s outcomes. It will also be responsible for developing a Steering Committee, the main governing body for the study (please refer to Section VI.4 for more information).

Applicants can apply for Component A or Component B; however, applicants cannot apply for both Component A and Component B.

Objectives/Outcomes Component A:

The objective of Component A is for health system and/or health plan membership-based centers to identify diabetes cases among persons aged 0–44 years in their respective source populations to:

• Estimate the incidence and prevalence of diabetes among youth (< 18 years) and young adults (18–44 years) in the United States.

o Diabetes incidence and prevalence will be estimated overall and by age, sex, race and ethnicity, diabetes type, and geographic area.

• Provide a comprehensive clinical description of youth and young adults with diabetes including, but not limited to, the prevalence of:

o Risk factors for diabetes complications such as poor glycemic control (i.e., A1c ≥ 9.0%), hypertension, dyslipidemia, medication non-compliance, and obesity.

o Acute and chronic diabetes complications such as hyperglycemic crisis (diabetic ketoacidosis and hyperosmolar hyperglycemic state), retinopathy, nephropathy, and neuropathy.

o Diabetes medication use such as insulin, metformin, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists, sodium-glucose transporter 2 inhibitors, sulfonylureas, and thiazolidinediones.

Component B:

The objective of Component B is to serve as a Coordinating Center to develop and support a common protocol for the Component A centers. This will include the following activities:

• Provide expertise and leadership in diabetes surveillance development, methodology, implementation, and evaluation. Lead the development and standardization of methods to:

o Identify incident and prevalent diabetes cases.

o Validate diabetes cases by type.

o Correct for potential sources of bias or ascertainment issues.

o Aggregate data across Component A centers in a statistically reliable manner.

• Create and maintain a central data repository.

• Create protocols and mechanisms to secure transmission of data and relevant data management reports between Component A awardees.

• Ensure the training and certification of staff at Component A sites on all study protocols.

• Provide statistical expertise and support timely dissemination of network-wide results describing the incidence, prevalence, and clinical characteristics of diabetes among youth and young adults in the United States.

• Maintain internal and external website(s) for dissemination of information among study investigators and to the public.

• Process requests from external researchers interested in collaborating on ancillary studies, including potential development of restricted (deidentified) datasets with documentation (e.g., codebooks).

• Create a harmonized, deidentified dataset to be shared with CDC.

• Develop a Steering Committee for the study (please refer to Section VI.4 for more information).

Component A and B awardees are expected to communicate results to the broader scientific and public health communities through peer-reviewed journals, presentations at scientific meetings, and other means. Awardees are also expected to provide relevant results to CDC to support the National Diabetes Statistics Report.

Population of Focus The target population is youth (< 18 years) and young adults (18–44 years) in the United States.

Per the objectives of the NOFO, Component A applicants will need to identify a population for surveillance (i.e., denominator) from which incident and prevalent diabetes cases can be ascertained among youth and young adults. The population under surveillance at each Component A center should be demographically and geographically representative of the youth and young adults residing within the center’s geographic catchment area.

Collaboration/Partnerships Component A:

• Applicants should demonstrate partnerships with health systems or health plan membership networks to be able to identify diabetes cases and describe the sociodemographic and clinical characteristics among youth and young adults affected by diabetes. Applicants should demonstrate experience in working collaboratively with research partners.

• Applicants should provide evidence of established and well-defined working relationships with organizations and/or outside entities expected to participate in the proposed research.

• Applicants are expected to have standard operating procedures in place that allow for participation in a multi-center study and the development of necessary protocols such as data sharing agreements.

Component B:

• Applicants are expected to collaborate with members in Component A and other partners to accomplish the goals and objectives of the study.

• Applicants should demonstrate experience in coordination of multi-center studies, data management, and analysis. Applicants should demonstrate experience in working collaboratively with research partners. Applicants should demonstrate experience in coordination of multi-center studies, large data management, and innovative analysis.

Applicants should demonstrate experience in working collaboratively with research partners.

Evaluation/Performance Measurement Component A:

• Selected evaluation/performance measures are expected to include a description of the population under surveillance how it will be used to identify cases of diabetes among youth and young adults. Selected evaluation measures should provide an assessment of consistency of methods over time and completeness of case ascertainment.

• Applicants are expected to incorporate evaluation/performance measures that include approaches for identifying incident and prevalent cases of diabetes, validating diabetes type, and characterizing clinical aspects of diabetes among youth and young adults.

Emphasis should be on rigorous scientific approaches and methodologies.

• Evaluation /performance measures are expected include methods to assess sensitivity, specificity, and positive predictive value of diabetes case ascertainment overall and by diabetes type. Selected evaluation methods should provide an assessment of whether the accuracy of methods differ by age group, race and ethnicity, health insurance coverage, or geographic area.

Component B:

• Evaluation/performance measures are expected to include quality assurance and quality control measures. Description of activities for on-going study progress, oversight, data management, and quality control and assurance measures should include metrics that will be used to ensure high data quality and accuracy.

• Performance measurements should include statistical approaches to account for data limitations and/or combine Component A data sources to produce reliable network-wide estimates for all study outcomes.

Components A and B: For all performance/evaluation measurements, please upload all documents in the “Other Attachments” section of the application.

Translation Plan

Awardees are expected to work collaboratively with each other and in consultation with CDC to develop methods to provide reliable network-wide results that describe the incidence, prevalence, and clinical characteristics of diabetes among youth and young adults in the United States. Awardees are expected to communicate the findings to the larger scientific and public health communities. The results are expected to be communicated through peer-reviewed journals, presentations at scientific meetings, and other means. Awardees will provide relevant results to CDC to support the National Diabetes Statistics Report. Awardees are expected to engage with public health entities to translate findings for state and local communities.

Components A and B: For all translation plans, please upload all documents in the “Other Attachments” section of the application.

3. Funding Strategy N/A

Section II. Award Information

Funding Instrument Type:

CA (Cooperative Agreement) A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding:

$12,800,000 Funding for the first 12-month budget period by Component is expected to be as follows (including both direct and indirect):

• Component A: (up to five awards) at $500,000 per award.

• Component B: (up to one award) $700,000.

If an applicant requests a funding amount greater than the ceiling of the award range for the first year (for Component A $500,000 and for Component B $700,000), CDC will consider the application non-responsive and will not enter into the review process. CDC will notify the applicant that the application did not meet submission requirements.

Awards issued under this NOFO are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Throughout the period of performance, CDC's commitment to continuation of awards will be conditional on the availability of funds, 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.

Anticipated Number of Awards:

Awards issued under this NOFO are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award Ceiling:

$700,000 Per Budget Period

Award Floor:

$0 Per Budget Period

Total Period of Performance Length:

4 year(s)

Throughout the Period of Performance, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to 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.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category:

00 (State governments)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education)

07 (Native American tribal governments (Federally recognized))

08 (Public housing authorities/Indian housing authorities)

11 (Native American tribal organizations (other than Federally recognized tribal governments)) https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

12 (Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education)

13 (Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education)

20 (Private institutions of higher education)

22 (For profit organizations other than small businesses)

23 (Small businesses)

99 (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:

The following types of Higher Education Institutions are encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions

Historically Black Colleges and Universities (HBCUs)

Tribally Controlled Colleges and Universities (TCCUs)

Alaska Native and Native Hawaiian Serving Institutions

Nonprofits (Other than Institutions of Higher Education):

Nonprofits (Other than Institutions of Higher Education)

Governments:

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other:

Faith-based or Community-based Organizations

Regional Organizations

Bona Fide Agents: A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms."

Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to https://gov.ecfr.io/cgi-bin/searchECFR.

2. Foreign Organizations Foreign Organizations are not eligible to apply.

Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Additional Information on Eligibility

4. Justification for Less than Maximum Competition N/A

5. Responsiveness If your application is incomplete or deemed non-responsive for these requirements, it will not enter into the review process.

Component A:

• Applicants must provide evidence of continued access to health information data among youth (< 18 years) and young adults (18–44 years) during the period of performance for the purposes of diabetes surveillance. Evidence of data access can be in the form of letter(s) of agreement with home institution or data use agreements (if obtained from other sources). The letter(s) must specify that data will be available for the duration of the period of performance. Evidence must be provided in an Appendix.

• Letter(s) of agreement from the institution(s) providing data for the project that permit the applicant to participate in a multi-center study that will require data sharing with other institutions. Evidence must be provided in an Appendix.

• Applicants may not request funding above $500,000 (including both direct and indirect) in the first 12-month budget period.

• Applicants must specify they are applying for Component A in the specific aims.

Component B:

• Applicants may not request funding above $700,000 (including both direct and indirect) in the first 12-month budget period.

• Applicants must specify they are applying for Component B in the specific aims.

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Unique Entity Identifier (UEI) number in order to begin each of the following registrations.

PLEASE NOTE: Effective April 4, 2022, applicants must have a Unique Entity Identifier (UEI) at the time of application submission. The UEI replaced the Data Universal Numbering https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true

System (DUNS) and is generated as part of SAM.gov registration. Current SAM.gov registrants have already been assigned their UEI and can view it in SAM.gov and Grants.gov. Additional information is available on the GSA website, SAM.gov, and Grants.gov-Finding the UEI.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: NCAGE Tool / Products / NCS Help Center (nato.int).

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, SAM.gov.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The one-time registration process will take three to five days to complete.

However, it is best to start the registration process at least two weeks prior to application submission.

All Senior/Key Personnel (including Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principal Investigator (PD/PI) eRA Commons account is affiliated with the eRA commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have an active eRA Commons account in order to prepare an application. It also requires that the applicant organization's Signing Official have an active eRA Commons Signing Official account in order to initiate the submission process.

During the submission process, ASSIST will prompt the Signing Official to enter their Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active.

7. Universal Identifier Requirements and System for Award Management

(SAM)

All applicant organizations must obtain a Unique Entity Identifier (UEI) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The UEI number is a twelve-digit number assigned by SAM.gov. An AOR should be consulted to determine the appropriate number. If the organization does not have a UEI number, an AOR should register through SAM.gov. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a UEI number.

Additionally, organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later.

https://www.gsa.gov/about-us/organization/federal-acquisition-service/technology-transformation-services/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-id-is-here https://sam.gov/content/home https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://sam.gov/content.gov https://grants.gov https://public.era.nih.gov/commons https://www.Grants.gov

SAM.gov is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient.

Additional information about registration procedures may be found at SAM.gov and the SAM.gov Knowledge Base.

If an award is granted, the recipient organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its UEI number to the recipient organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. CDC does not make awards to individuals directly. Individuals from organizations that are uniquely prepared to examine research relevant to undeserved groups, including sexual orientation and gender identity minorities as well as individuals with disabilities are always encouraged to apply.

9. Cost Sharing This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Number of Applications Allowed:

• Only one application per institution (normally identified by having a unique entity identifier [UEI]) is allowed.

Applicants can apply for Component A or Component B; however, applicants cannot apply for both Component A and Component B.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because, unlike other platforms, it provides a validation of all requirements prior to submission and prevents errors.

https://sam.gov/content/home https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fsd.gov%2Fgsafsd_sp%3Fid%3Dgsa_kb_view2%26kb_id%3Df66d8e6cdb76d4100d73f81d0f9619c6&data=04%7C01%7Ccshifflett%40dminc.com%7C8eee7a2adab549a3b3c008d925e9a364%7Cdb7ac9ef779d46e59bca00509580ad6b%7C0%7C0%7C637582507851821018%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=UrR%2B%2FM2wWF2fZG05Z8O6JS2C3FXXSl%2F7B3%2FB45XHRrg%3D&reserved=0

To use ASSIST, applicants must visit https://public.era.nih.gov where you can login using your eRA Commons credentials, and enter the Notice of Funding Opportunity Number to initiate the application, and begin the application preparation process.

If you experience problems accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via: http://grants.nih.gov/support/index.html

• Email: commons@od.nih.gov

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552.

Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays.

2. Content and Form of Application Submission Application guides for FORMS-H application packages are posted to the How to Apply -…