PKG00256543-instructions.pdf

Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion Extramural Research

Program Office

Assessing the Burden of Diabetes By Type in Children, Adolescents and Young Adults

(DiCAYA)

RFA-DP-20-001

Application Due Date: 01/14/2020

Assessing the Burden of Diabetes By Type in Children, Adolescents and Young Adults

(DiCAYA)

RFA-DP-20-001

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text 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

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations National Center for Chronic Disease Prevention and Health Promotion Notice of Funding Opportunity (NOFO) Title Assessing the Burden of Diabetes By Type in Children, Adolescents and Young Adults (DiCAYA) Activity Code U18 Participating Organizations:

Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Division of Diabetes Translation (DDT) National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases

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

RFA-DP-20-001

Assistance Listings (CFDA) Number(s) 93.945 Category of Funding Activity:

Health NOFO Purpose The purpose of this NOFO is to assess the incidence and prevalence of diabetes among children, adolescents and young adults in the United States and provide estimates by diabetes type, age, sex, race/ethnicity and geographic area. Component A focuses on surveillance of incidence and prevalence of diabetes among children and adolescents (<18 years). Component B focuses on surveillance of incidence and prevalence of diabetes among young adults (18 to <45 years).

Component C serves as a Coordinating Center to provide an infrastructure for standardized approaches, analytical methods, and surveillance measures. It also serves as a repository for the Component A and B data and provides consolidated estimates by diabetes type, age, race/ethnicity and geographic area.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-20-001, 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.

https://www.grants.gov

Letter of Intent Due Date: 12/09/2019 12/09/2019

Application Due Date: 01/14/2020 01/09/2020

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 5:00 PM U.S.

Eastern Time. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

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: 03/10/2020

Secondary Review: 04/16/2020

Estimated Start Date: 09/30/2020

Expiration Date: 01/15/2020 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

It is critical that applicants follow the instructions in the SF 424 (R&R) 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 http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf 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 25 pages.

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

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

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

Executive Summary Purpose.

The purpose of this Notice of Funding Opportunity Announcement (NOFO) is to conduct surveillance to assess the incidence and prevalence of diabetes among children, adolescents and young adults in the United States and provide estimates by diabetes type, age, sex, race/ethnicity and geographic area.

This NOFO has three (3) components to achieve the purpose of the program:

Component A focuses on surveillance of incidence and prevalence of diabetes among children and adolescents (<18 years).

Component B focuses on surveillance of incidence and prevalence of diabetes among young adults (18 to <45 years).

Component C serves as a Coordinating Center to provide an infrastructure for standardized approaches, analytical methods, and surveillance measures. It also serves as a repository for the Component A and Component B data and provides consolidated estimates by diabetes type, age, sex, race/ethnicity and geographic area.

Mechanism of Support. Cooperative Agreement funding mechanism (CDC U-18).

Funds Available and Anticipated Number of Awards. The participating organizations, NCCDPHP and NIDDK, intend to commit approximately $3,000,000 in FY 2020 (direct and indirect) to fund up to five awards under Component A, up to five awards under Component B and one award under Component C.

Component A: It is anticipated that up to five awards will be made for up to $250,000 (direct and indirect) each in FY2020.

Component B: It is anticipated that up to five awards will be made for up to $250,000 (direct and indirect) each in FY2020.

Component C: It is anticipated that one award will be made for up to $500,000 (direct and indirect) in FY2020.

Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications

Budget and Project Period. The estimated total funding (direct and indirect) for all components for the first budget period, 09/30/2020 to 09/29/2021, is $3,000,000, including up to $594,000 from NIH and up to $2,406,000 from CDC. The estimated total funding (direct and indirect) for the entire project period, 09/30/2020 to 09/29/2025, is up to $15,000,000.

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, 1.A. are eligible to apply.

Eligible Project Directors/Principal 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. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups 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. Any additional PIs are permitted, but would be referred to as Co-PIs.

Number of Applications. Only one application per institution (normally defined as having a unique DUNS number) per component is allowed for this NOFO. Applicants must submit separate applications if applying to more than one component. Applicants can apply for Component A, or for Component B, or for Component A and B. Applicants applying for Component C cannot apply for Component A or Component B.

Application Type. New (type 1).

Special Date(s). None.

Application Materials. See Section IV.1 for application materials. Please note that Form D is to be used when downloading the application package. http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf%20 Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: 1- 888-232-6348.

NOFO is posted on https://www.grants.gov/

Part 2. Full Text 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 Diabetes mellitus is one of the most common chronic diseases in the United States, with over 30 million people having the disease in 2017. While the prevalence and incidence of diabetes is highest among older adults, diabetes is one of the most common chronic diseases in childhood and young adulthood. Among youth under 20 years of age, the prevalence in 2009 was 2.2 per 1,000 or 1 out of 455 youth. Among young adults 18-44 years, 3.0 million have diabetes.

Diabetes requires lifelong treatment, management and care to reduce the occurrence of http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV http://era.nih.gov/commons/index.cfm#SectionIII1A http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm#SectionIV1 http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf%20 http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf%20 complications and improve quality of life. Understanding the burden of diabetes in the younger population will assist with future health care planning and public health prevention efforts.

Diabetes is a spectrum of metabolic diseases caused by defects in insulin secretion, insulin action, or both. The majority of diabetes cases cluster into two categories: type 1 diabetes, caused by an absolute deficiency of insulin, usually due to the autoimmune destruction of the beta cells of the pancreas, and type 2 diabetes, resulting from a combination of insulin resistance and beta cell failure. The hallmarks of the underlying pathophysiologic process of type 1 diabetes are the loss of endogenous insulin secretion and presence of diabetes autoantibodies (DAA). While type 1 diabetes is typically thought of as occurring in childhood and type 2 diabetes is typically thought of as occurring in adulthood, both may occur at all ages.

Type 1 diabetes accounts for nearly 98% of diabetes in children < 10 years, 87% of cases in youth 10-19 years and 5% of cases among adults. Type 2 diabetes was previously thought to only occur during adulthood, but now accounts for approximately 15% of diabetes cases diagnosed in childhood and adolescence. For both type 1 and type 2 diabetes, the majority of new cases are diagnosed during adulthood.

The SEARCH for Diabetes in Youth Study (Population Based Registry of Diabetes in Youth), demonstrated that the incidence of both type 1 and type 2 diabetes in the U.S. is increasing. In children and adolescents aged <20 years, the SEARCH for Diabetes in Youth Study reported a 1.4% annual increase in the incidence of type 1 diabetes (from 19.5 cases/100,000 youth per year in 2002-2003 to 21.7 cases/100,000 youth per year in 2011-2012) and a 7.1% annual increase in type 2 diabetes (from 9.0 cases/100,000 youth per year in 2002-2003 to 12.5 cases/100,000 youth per year in 2011-2012). It is unknown whether this increase is due to a shift to a younger age of onset of both type 1 and type 2 diabetes.

Estimates from the National Health Interview Survey show the annual percent change of the incidence and prevalence of diabetes among young adults is + 3.2% and +4.3%, respectively.

However, whether this is type 1 or type 2 diabetes is unknown since there are fewer estimates of the incidence of diabetes by type among young adults (18 to 45 years). Recent estimates of the prevalence of diabetes by type among young adults are based on data collected in national health surveys using self-report of age of diabetes onset, insulin use and of diabetes type.

However, these criteria can lead to misclassification as type 1 diabetes can occur at any age, there is increasing prevalence of type 2 diabetes in adolescents, and often people with type 2 diabetes also need insulin treatment to control hyperglycemia. In addition, the sample size of national surveys will limit the capacity to assess incidence by age, sex, race/ethnicity, or geographic region.

Electronic health records are increasingly used for public health surveillance efforts and this includes their use in surveillance of type 1 diabetes. A number of published algorithms validate diabetes type and the identification of diabetes cases within electronic health records in a variety of settings. The accuracy of correctly identifying diabetes by type varies for type 1 and type 2 diabetes with higher sensitivities and positive predictive values for type 1 diabetes. Electronic health records, or administrative data, do have a number of limitations including potential misclassification or missing cases and population representativeness.

Continued surveillance allows us to track trends and is needed to assess future trends. CDC, in collaboration with NIDDK, previously funded two initiatives to address surveillance of diabetes among children, adolescents and young adults: 1) SEARCH for Diabetes in Youth (Population

Based Registry of Youth with Diabetes), NOFO PA 00097, DP-05-069, DP10-001, contract #2010-Q-12412 and DP15-002; 2) Study to Assess the Incidence of Type 1 Diabetes in Young Adults (Diabetes in Young Adults (DiYA) Study) DP16-005. The SEARCH Population-Based Registry ascertained incident cases of diabetes in individuals < 20 years of age annually from 2002 through 2019. The DiYA study assessed incidence of diabetes by type in young adults aged 20-45 years in 2017.

The SEARCH for Diabetes in Youth (Population Based Registry of Youth with Diabetes) has provided invaluable information on surveillance of both type 1 and type 2 diabetes among youth in the U.S. By the end of the current funding cycle, SEARCH will be able to assess trends in the incidence of type 1 and type 2 diabetes from 2002 to 2019 by age, sex, and race/ethnicity. 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).

Although the combined population of youth under surveillance at these centers presents similar demographic and socio-economic characteristics of the US youth population, a number of US Census regions including the Northeast (Middle Atlantic and New England areas), the West South Central, the East South Central, Pacific and West North Central are not represented.

There may be regional differences in the incidence of type 1 diabetes. It is also unknown whether the geographic distribution of type 2 diabetes among children and adolescents mirrors that observed among adults (https://gis.cdc.gov/grasp/diabetes/DiabetesAtlas.html). To address this limitation, this NOFO anticipates funding sites that are geographically representative of the US and US Census regions.

There are even fewer estimates of the incidence of type 1 and type 2 diabetes among young adults. The DiYA study was funded to determine the incidence of type 1 diabetes in the young adult population. This study was funded for two years and will provide estimates of the incidence of diabetes, overall and by type. It is limited to the Kaiser Permanente population in southern and northern California only for 2017. Therefore, there is a need for data for diabetes in young adults that will allow continuous monitoring of diabetes prevalence and incidence by type across all major US race/ethnicity groups and geographic regions.

Surveillance methods used for children, adolescents and young adults for this NOFO should build upon methods developed in these and other studies, including the use of electronic health information for surveillance, databases and data sources, as well as direct case reports from health care providers, a network of provider clinics, laboratory and pharmacy data or a network of health insurance providers. The goal of this study is to assess the incidence and prevalence of diabetes by type among children, adolescents and young adults. Applications submitted to this NOFO should build on past diabetes surveillance studies, particularly those that have developed algorithms to identify diabetes cases and distinguish diabetes type using electronic health records (EHRs). This new initiative includes surveillance of prevalence and incidence of diabetes in the population aged 0-45 years by diabetes type. Estimates include reports by diabetes type, age, sex, race/ethnicity and geographic area. This new NOFO will focus on important attributes of surveillance such as simplicity of surveillance methods, flexibility to incorporate emerging research, sustainability over time, data quality, representativeness, and timeliness of the methods to assess the burden of diabetes among children, adolescents and young adults.

Healthy People 2020 and other National Strategic Priorities https://gis.cdc.gov/grasp/diabetes/DiabetesAtlas.html

This NOFO supports the following diabetes Healthy People 2020 objective: To "reduce the disease and economic burden of diabetes mellitus (DM); and improve the quality of life for all people who have, or are at risk for, diabetes" by providing data on the burden of diabetes among U.S. children, adolescents and young adults (0 to 45 years of age) by age, sex, race/ethnicity and diabetes type.

This NOFO supports the CDC Strategic Framework to reduce the number of new diabetes diagnoses from 1.4M in 2018 to 1.1M cases per year by 2025. https://www.cdc.gov/about/organ ization/strategic-framework/index.html Measurable outcomes of this NOFO will be in alignment with the following performance goal for the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP): To monitor, prevent, delay, detect and control chronic disease, to achieve health equity by eliminating health disparities and achieving optimal health for all Americans.

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, programs and policies that translate science into practice.”

Public Health Impact This announcement directly supports the CDC Strategic Framework and Division of Diabetes Translation mission by assessing the burden of diabetes among children, adolescents and young adults to inform decision-making and prioritize national public health objectives. Results from this study will provide valuable estimates on the incidence and prevalence of type 1 and type 2 diabetes among children and adolescents and young adults. This announcement will assist in the achievement of health equity by identifying health disparities, and will assist in reducing the preventable burden of diabetes by applying surveillance and research to identify and prioritize sub-populations for diabetes prevention and prevention of co-morbidities.

Relevant Work CDC previously funded two initiatives to address surveillance of diabetes among children, adolescents and young adults: 1) SEARCH for Diabetes in Youth (Population Based Registry of Youth with Diabetes), Notice of Funding Opportunity Announcements (NOFO) PA 00097, DP- 05-069, DP10-001, contract #2010-Q-12412 and DP15-002; 2) Study to Assess the Incidence of Type 1 Diabetes in Young Adults (Diabetes in Young Adults (DiYA) Study) DP16-005. The SEARCH Population-Based Registry ascertained incident cases of diabetes in individuals < 20 years of age annually from 2002 through 2019. The DiYA study assessed incidence of diabetes by type in young adults aged 20-45 years in 2017.

This NOFO builds upon the methods and lessons learned in the SEARCH and DiYA studies in the use of electric health records as a method of surveillance. Specifically, this NOFO aims to utilize the tested methods established in SEARCH and DiYA, but expand the geographic representation for children, adolescents and young adults with type 1 and type 2 diabetes. In addition, this NOFO aims to focus on important attributes of a public health surveillance methods including simplicity, flexibility, and data quality; acceptability by system stakeholders;

sensitivity, positive predictive value (PPV), representativeness, timeliness and stability over time.

https://www.cdc.gov/about/organization/strategic-framework/index.html https://www.cdc.gov/about/organization/strategic-framework/index.html

Surveillance applicants are encouraged to review methods reported from DP15-002 and DP16- 005 in developing their proposals.

2. Approach The overall objective of this announcement is to assess the burden of diabetes by conducting surveillance for the incidence and prevalence of diabetes among children and adolescents (< 18 years) and young adults (18 to < 45 years) in the United States and provide estimates by diabetes type, age, sex, race/ethnicity and geographic area. It is expected that the population under surveillance should be well characterized by demographic factors, health insurance status and geographic region. There are three components in this NOFO:

1. Component A (Surveillance of Children and Adolescents): To conduct a standardized population-based approach to ascertainment, validation, and classification of diabetes aimed at gaining knowledge on incidence, prevalence, and secular trends of diabetes in children and adolescents (< 18 years) by age, sex, race/ethnicity, diabetes type, and geographic area;

2. Component B (Surveillance of Young Adults): To conduct a standardized population-based approach to ascertainment, validation, and classification of diabetes aimed at gaining knowledge on incidence, prevalence, and secular trends of diabetes in young adults (age 18 to <45 years) by age, sex, race/ethnicity, diabetes type, and geographic area;

3. Component C (Coordinating Center): To provide an infrastructure for standardized approaches, analytical methods, and measures to be used for surveillance. To provide statistical expertise and serve as a data repository. To conduct administrative functions to support the coordination of the multiple registries, including maintaining an internal and external website for data entry and for the dissemination of information among study investigators and to the public and provide consolidated estimates.

Applicants can apply for Component A, or for Component B, or for Component A and B.

Applicants applying for Component C cannot apply for Component A or B. Applicants must submit a separate application for each component they are applying to.

Objectives/Outcomes Component A and B:

The objective of Components A and B is to provide annual estimates of the incidence and prevalence of type 1 and type 2 diabetes among children and adolescents (Component A) and young adults (Component B) in the United States overall and by age group, sex, race/ethnicity and geographic area.

Possible approaches include the use of electronic health information and diabetes registries. The selected approach should use validated methods to identify and classify diabetes type. It is expected that each applicant for Component A and/or Component B will include detailed information on the denominator of the population under surveillance and its representativeness to the overall geographic population.

Information collected from medical records or electronic health records will be used for estimating the incidence and prevalence of diabetes by type. No direct contact with individuals diagnosed with diabetes as a means of data collection through surveys or biospecimens is anticipated under this announcement for standard surveillance methods.

Component C Through Component C, a Coordinating Center will support the population based registries of Components A and B. The main objectives of the coordination center related to support include

1. Maintain a central data repository and create data protocols and mechanisms to secure transmission of data and relevant data management reports between the awardees for Components A, B and C.

2. Maintain an internal and external website for data entry and dissemination of information among study investigators and to the public.

3. Ensure the training and certification of staff in Component A and B sites on (a) procedures stated in the protocol and manual of operation relating to standard definition for diabetes and (b) transfer of data to a central repository.

4. Provide expertise and leadership in population-based surveillance development, methodology, implementation, and evaluation.

5. Provide statistical and other analytic support including development of analytic methods for validation of diabetes by type.

6. Provide biostatistical expertise and support timely dissemination of study results and estimates of diabetes incidence and prevalence among children, adolescents and young adults.

Target Population Component A and B:

The target population is children and adolescents (< 18 years;Component A) and young adults (18 years to < 45 years; Component B) in the U.S. The population under surveillance at each applicant’s site should be demographically and geographically representative of the population of children, adolescents, and young adults included in the applicant’s site. The overall population under surveillance, that includes all awardees for Components A and B, should be demographically and geographically representative of the population of children, adolescents, and young adults in the United States.

Collaboration/Partnerships Component A:

Applicants are expected to have access to a research infrastructure and established access to diabetes cases among children and adolescents. This could include an established long-term population based childhood diabetes registry or access to longitudinal electronic health records.

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 should demonstrate partnerships with health care networks or systems to access information on cases of diabetes among children and adolescents. Applicants should demonstrate experience in working collaboratively with research partners.

Component B:

Applicants are expected to have access to a research infrastructure and established access to diabetes cases among young adults. This could include an established long-term population based diabetes registry or access to longitudinal electronic health records.

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 should demonstrate partnerships with health care networks or systems to access information on cases of diabetes among young adults. Applicants should demonstrate experience in working collaboratively with research partners.

Component C:

Applicants are expected to collaborate with members in Components A and B 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.

Evaluation/Performance Measurement Component A and B:

The applicants are expected to incorporate evaluation/performance measures that include approaches for identifying cases of diabetes and validation of diabetes by type.

Emphasis should be on rigorous scientific approaches and methodologies.

These evaluation/performance measures are expected to include methods to assess sensitivity, specificity and positive predictive value of diabetes case identification overall and by diabetes type. Selected evaluation methods should provide for assessment of whether the accuracy of the methods differ by race/ethnicity, socioeconomic status, insurance coverage or geographic area.

Further, selected evaluation/performance measures should provide an assessment of consistency of methods over time, and measurement of completeness of case ascertainment. Selected evaluation measures are expected to include a description of the population under surveillance and how it will be ascertained for estimation of incidence and prevalence.

Component C:

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 and methods to ensure high data quality and accuracy of incidence and prevalence results. Performance measurements should include statistical approaches to adjust for data limitations and/or combine data sources to produce estimates.

Translation Plan Applicants for Components A, B, and C are expected to work collaboratively with each other and in consultation with CDC to develop methods for aggregating data and presenting joint analyses that will produce results comparable across sites. Applicants 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. Applicants will provide relevant estimates to CDC to support the National Diabetes Statistical Report. Applicants are expected to engage with public health entities to translate the findings for the state or local communities.

OMB/PRA is not expected to apply.

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Saydah S, Imperatore G. Emerging Approaches in Surveillance of Type 1 Diabetes. Curr Diab Rep. 2018 Jul 11;18(9):61.

Teltsch DY, Fazeli Farsani S, Swain RS, Kaspers S, Huse S, Cristaldi C, Nordstrom BL, Brodovicz KG. Development and validation of algorithms to identify newly diagnosed type 1 and type 2 diabetes in pediatric population using electronic medical records and claims data.

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Section II. Award Information Funding Instrument Type: 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: $15,000,000 The estimated total funding (direct and indirect costs) for the first budget period is $3,000,000 (including up to $594,000 from NIH and $2,406,000 from CDC), and the estimated total funding (direct and indirect) for the entire project period is $15,000,000.

It is anticipated that 11 award(s) will be made under this NOFO RFA-DP 20-001.

Funding for the first 12 month budget period are (including both direct and indirect costs):

Component A: (up to five awards) $250,000 Component B: (up to five awards) $250,000 Component C: (up to one award) $500,000 Awards issued under this NOFO are contingent on the availability of funds and submission of 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.

Anticipated Number of Awards: 11 If an applicant requests a funding amount greater than the ceiling of the award range for the first year (for Components A and B $250,000 and for Component C $500,000), HHS/CDC will consider the application non-responsive and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements

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

Award ceiling and floor are for the first 12-month budget period only.

Award Ceiling: $500,000 Per Project Period Award Floor: $180,000 Per Project Period Total Period of Performance Length: 5 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 (http://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.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

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

Additional Eligibility Category:

The following types of Higher Education Institutions are always 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 Foreign Organizations: a Foreign

Organization is a public or private organization, whether non-profit or for-profit, located in a country other than the United States (U.S.) and its territories that is subject to the laws of the country in which it is located, irrespective of the citizenship of project staff or place of performance.

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 The following types of Higher Education Institutions are always 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:

Governments:

Eligible Agencies of the Federal Government U.S. Territory or Possession Other:

• Native American tribal organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations

• Regional Organizations

• Foreign Organizations: a Foreign Organization is a public or private organization, whether non-profit or for-profit, located in a country other than the United States (U.S.) and its territories that is subject to the laws of the country in which it is located, irrespective of the citizenship of project staff or place of performance.

• 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" when submitting via www.grants.gov.

• 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 https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true agency.

For an applicant to be even considered they must be responsive to the following.

Component A:

Applicants must provide evidence of access to population under surveillance (denominator) representative of the age group specified for population < 18 years of age.

Component B:

Applicants must provide evidence of access to population under surveillance (denominator) representative of the age group specified for population 18 to < 45 years of age.

If your application is incomplete or non-responsive to the special eligibility requirements listed in this section, it will not enter into the review process.

Component C:

Not Applicable

4. Justification for Less than Maximum Competition N/A

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

Component A/B/C:

Applicants may not request funding above the ceiling amount for the first 12 month budget period (includes direct and indirect costs).

Component A:

Applicants must provide evidence of access to population under surveillance (denominator) representative of the age group specified for population < 18 years of age. Evidence can be in the form of a letter(s) of agreement with home institution, data use agreements (if data obtained from other sources). Evidence should be placed in Appendix A.

Component B:

Applicants must provide evidence of access to population under surveillance (denominator) representative of the age group specified for population 18 to < 45 years of age. Evidence can be in the form of a letter(s) of agreement with home institution, data use agreements (if data obtained from other sources). Evidence should be placed in Appendix A.

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

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 Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https:// eportal.nspa.nato. int/ AC135Public/ Docs/ US%20Instructions%2 0for%20NSPA%20NCAGE.pdf

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

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 Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principle 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 active eRA Commons account in order to prepare an application.