dp15-002 amendment 3.12.15.pdf

Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office

Population-based Diabetes in Youth Registry

RFA-DP-15-002

Application Due Date: 03/31/2015

Population-based Diabetes in Youth Registry

RFA-DP-15-002

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 Extramural Research Program Office

(NCCDPHP ERPO)

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) Funding Opportunity Announcement (FOA) Title Population-based Diabetes in Youth Registry Activity Code AMENDMENT 1 made on March 11, 2015.

Appendix A "Questions from Potential Applicants and CDC Responses" added to Section VIII.

Other Information.

U18

National Institutes of Health, National Institute for Diabetes, Digestive and Kidney Diseases

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-DP-15-002

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.945 Category of Funding Activity:

Health FOA Purpose To assess prevalence, incidence, and temporal trends of diabetes in the US population aged < 20 years by age, sex, race/ethnicity and diabetes type.This FOA has two components, A and B. Component A solicits applications for a 5-year surveillance network of diabetes registries in racial/ethnic, socio-economic, and geographically diverse populations. Applicants are expected to provide population-based data on the incidence, prevalence, and temporal trends of diabetes among U.S. youth aged < 20 years by age, sex, race/ethnicity and diabetes type. Component B of this FOA solicits applications for a Coordinating Center (CC) to provide expertise in population-based surveillance, training, data management, quality control and analysis to the registry network.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-15-002, 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: 02/27/2015

Application Due Date: 03/31/2015

On-time submission requires that electronic applications be error-free and made available to CDC for http://www.grants.gov

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note:

HHS/CDC grant submission procedures do not provide a period of time beyond the application due date 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: 05/01/2015

Secondary Review: 06/01/2015

Estimated Start Date: 09/30/2015 This FOA has 2 components. The estimated start date is the same for both components.

Expiration Date: 04/01/2015 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this FOA. Conformance to all requirements (both in the Application Guide and the FOA) 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 25 pages.

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

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

Executive Summary Purpose. This FOA has two components, A and B. Component A solicits applications for a 5-year surveillance network of diabetes registries in racial/ethnic, socio-economic, and geographically diverse populations. Applicants are expected to provide population-based data on the incidence, prevalence, and temporal trends of diabetes among U.S. youth aged < 20 years by age, sex, race/ethnicity and diabetes type. Component B of this FOA solicits applications for a Coordinating Center (CC) to provide expertise in population-based surveillance, training, data management, quality control and analysis to the registry network.

Mechanism of Support. This funding opportunity will use the cooperative agreement funding mechanism (CDC U-18).

Funds Available and Anticipated Number of Awards. The participating organizations, NCCDPHP and NIDDK, intend to commit approximately $2,500,000 in FY 2015 to fund up to five awards under Component A and one award under Component B in response to this FOA. An applicant under Component A may request a project period of up to five years and a total budget of up to $380,000 including direct and indirect costs each year. An applicant under Component B may request a project period of up to five years and a total budget of up to $600,000 direct and indirect costs each year. Awards issued under this FOA are contingent upon availability of funds and a sufficient number of meritorious applications.

Budget and Project Period. The project period will run from 09/30/2015 to 9/29/2020. The estimated total funding for the first year is $2,500,000 (direct and indirect) including up to $300,000 from NIH and $2,200,000 from CDC. The estimated total funding for the entire project is $12,500,000.

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

Because awardees will be funded with two sources of funds, applicants are expected to submit a single budget, but that budget must delineate and distinguish surveillance network and validation of diabetes cases activities and related planned expenditures.

Application Research Strategy Length. Page limits for the Research Strategy are clearly specified in Section IV page 24. Application and Submission Information of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1 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 contain more than one PI, however, the first PI listed will be the “contact PI” for all correspondence.

Number of Applications. Only one application per institution (normally identified by having a unique DUNS number) is allowed. Applicant can only apply to one component.

Application Type. New (type 1).

Special Date(s). N/A Application Materials. See Section IV.1 for application materials.

Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY:

(770) 488-2783.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority

Awards are made under the authorization of Sections 301, 317(k)(2), 405, and 426 of the Public Health Service Act (42 USC §§ 241, 247b(k)(2), 284, and 285c).

1. Background and Purpose

Public health surveillance of diabetes and its complications is crucial to track and characterize the burden of the disease, formulate health care policy, identify high-risk groups, develop strategies to reduce the burden of this disease, and monitor progress of primary and secondary prevention programs. Diabetes is one of the most common chronic diseases of childhood with prevalence in 2009 of 2.2 per 1000 youth under 20 years of age (1 out of 455). Type 1 diabetes, the most common form of the disease in youth, results from the autoimmune destruction of the insulin producing beta cells in the pancreas leading to absolute insulin deficiency. Type 2 diabetes, characterized by insulin resistance and relative insulin deficiency, is the most common form of the disease in adults, but in the last two decades has been increasingly diagnosed in adolescence, as a result of the epidemic of obesity, especially among adolescents of racial/ethnic minority groups.

The CDC National Diabetes Surveillance System (NDSS) utilizes national surveys to monitor national diabetes burden and trends in adults. However, none of these surveys has samples large enough and collect data to adequately assess childhood diabetes prevalence or incidence by race/ethnicity subgroups and diabetes type. To fill these gaps, the Division of Diabetes Translation (DDT) of the CDC and the National Institute of Diabetes, Digestive, and Kidney Disease (NIDDK) of the National Institutes of Health (NIH) in 2000 launched the SEARCH for Diabetes in Youth study. SEARCH has established multisite diabetes registries for ongoing monitoring of the incidence and prevalence of type 1 and type 2 diabetes in youth SEARCH has provided estimates of the burden of diabetes in youth. In 2009, 191,986 youth in the US had diabetes, 166,984 with type 1 diabetes; 20,262 with type 2 diabetes and 4,740 with ‘other’ types. Each year ~18,400 youth are diagnosed with type 1 diabetes, ~5,100 youth are diagnosed with type 2 diabetes. Moreover, SEARCH found that from 2001 to 2009 the prevalence of type 1 diabetes in youth increased by 23%, and that of type 2 diabetes by 21%. These increases are likely due to increases in the number of new cases. Indeed, from 2002-2009 among non-Hispanic white youth SEARCH found that the incidence (per 100,000 per year) of type 1 diabetes increased from

24.1 in 2002 to 27.2 in 2009, a relative increase of 2.7% per year. 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 2013 by age, sex, and race/ethnicity.

However, continued surveillance of diabetes with onset in childhood and adolescence is crucial for understanding the disease burden at the population level, for identifying subgroups most at risk, for planning health care delivery, and for increasing our understanding of the pathogenesis of the disease.

Healthy People 2020 and other National Strategic Priorities

The FOA 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, DM” by providing data on the burden of diabetes among U.S. youth under 20 years of age by age, sex, race/ethnicity and diabetes type.

The FOA supports the CDC nutrition and physical activity winnable battle by monitoring prevalence and incidence of type 2 diabetes among youth. This form of diabetes results from obesity, poor nutrition, and lack of physical activity.

Measurable outcomes of the program 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 and to reduce the preventable burden of diabetes through public health leadership, partnership, research, programs and policies that translate science into practice.

This announcement directly supports the Strategic Plan of the Division of Diabetes Translation to prevent type 2 diabetes by conducting surveillance and applied research to identify and prioritize effective approaches and targeted sub-populations for diabetes prevention and develop a long-range plan for sustainable surveillance for risk factors, pre-diabetes and diabetes in youth.

Public Health Impact

This announcement directly supports the core function of surveillance through assessing the burden of diabetes among youth to inform decision making and prioritize national public health objectives.

Results from this study will provide valuable estimates on the incidence of diabetes among youth and will assist in the achievement of health equity by identifying health disparities, 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.As a part of this study, a long-range plan for sustainable surveillance for risk factors, pre-diabetes and diabetes in youth will be developed.

Relevant Work

This FOA builds upon the surveillance network of diabetes registries established by the SEARCH for Diabetes in Youth, Funding Opportunity Announcements (FOA) PA 00097, DP-05-069, DP10-001 and contract #2010-Q-12412. The overarching goal of SEARCH is to continue monitoring the incidence and prevalence of diabetes and its complications in U.S. youth population. Component A of this FOA will provide continued support to the five diabetes registries of the SEARCH network to assess temporal trends in the incidence and prevalence of diabetes by age, sex, race/ethnicity, and diabetes type. Component B of this FOA supports the SEARCH Coordinating Center.

2. Approach

The objective of this FOA is to provide population-based estimates of incidence and prevalence of diabetes among youth in the U.S. and assess temporal trends. This FOA comprises two components, Component A and B.

Applicants for Component A must address both surveillance network and validation activities to be considered responsive to the intent of this FOA.

Applicants for Component B must address both surveillance network and validation activities to be considered responsive to the intent of this FOA.

Applicants funded under this FOA, for Component A or Component B, must acknowledge receipt of funds from the two funding sources, NCCDPHP and NIDDK, and must address budget requirements to delineate and distinguish surveillance and validationI activities and expenditures.

Investigators may submit one application for either Component A or B, but not both under this funding announcement.

Objectives/Outcomes

Component A: Surveillance Network This FOA builds upon the long-term collaborative multisite project called SEARCH for Diabetes in Youth (www.searchfordiabetes.org). Through this FOA, SEARCH registries will continue surveillance of the burden of diabetes with onset in childhood and adolescence.

The main objectives of the surveillance effort are:

1) To estimate the incidence of diabetes among youth in the U.S. by diabetes type, and by demographics including age, sex, and race/ethnicity.

2) To assess temporal trends in diabetes incidence in the all major US racial/ethnic groups, including African Americans, Hispanics, American Indian Tribes, Asian Americans, Pacific Islanders, by age, sex, and diabetes type. In particular, the long-term observational period will allow the following questions to be answered:

Does the incidence of type 1 diabetes continue to rise across the five major race and ethnicity groups in the U.S., or is there a leveling off, as recently reported in northern Europe?

Does the incidence of type 2 diabetes raise across the five major race and ethnicity groups in the US, or is there a leveling off, particularly in the minority racial/ethnic groups at the highest risk of type 2 diabetes?

3) To assess changes in the prevalence of diabetes by age, sex, race/ethnicity, and diabetes type.

4) To rapidly identify diabetes cases in the population aged 0-19 years thru networks of or partnerships with health care providers and/or systems. This may include health plan based registries; pharmacy, hospital, clinic, and communities health centers administrative data bases, including Medicaid and Indian Health Services, or ad-hoc health care provider surveys.

5) Disseminate results of the study to the scientific, public health and general population through the publication in peer reviewed journals and inclusion into the CDC National Diabetes Surveillance System.

The main objectives for the diabetes case validation effort are:

1) Identify, generate and validate new methods to identify and register and classify cases for surveillance.

2) Validate diabetes cases in the population of 0-19 years identified thru networks or partnerships as described in surveillance efforts objective 4.

Component B: Coordinating Center (CC):

Through this FOA Component B, a Coordinating Center will support the population based registries of Component A. The main objectives of the coordination center related to support the Surveillance Network are to:

1) Maintain a central data repository and create protocols and mechanisms to secure transmission of data and relevant data management reports between the CC and the registry sites.

2) Ensure the training and certification of staff at the registry sites on measurements and procedures as outlined in the protocol and manual of operations.

3) Provide expertise and leadership in population-based surveillance development, methodology, implementation, and evaluation

4) Provide statistical and other analytic support to the registry network.

5) Act as a central laboratory for the analyses of biological specimens and ensure rapid transmission of the results.

The main objectives of the coordination center to support the validation of diabetes cases are to:

1) Develop analytic methods for case validation.

2) Provide statistical and analytic support for validation analysis.

3) Maintain diabetes case validation protocols.

Target Population

The target population for surveillance of diabetes is youth in the U.S. age 19 years and younger. The population under surveillance should be demographically and geographically representative of the population of youth in the United States age 19 years and younger.

Collaboration/Partnerships

The applicant should demonstrate partnerships with health care networks/systems to access information on cases of diabetes among youth.

Component A:

Access to a research infrastructure and an established long-term population-based childhood diabetes registry is expected. Effective and well-defined working relationships with organizations and/or outside entities expected to participate in the proposed research that will ensure implementation of the proposed activities is expected.

Component B:

Collaboration with the registry members in Component A and other partners to accomplish the goals of the study is expected.

Evaluation/Performance Measurement

Component A:

Evaluation/performance measurements will include validation of case ascertainment.

Approaches for case ascertainment, validation, and classification of diabetes type used by the registry network should take advantage of methodology and knowledge accumulated by the SEARCH study and at the same time validate new methods for case ascertainment and classification. Emphasis should be on rigorous scientific approaches and methodologies that should a) yield access to populations of diverse racial, ethnicity, socioeconomic status and insurance coverage; b) ensure complete case ascertainment; and c) ensure sustainability for the assessment of secular trends by diabetes type and race-ethnicity. Applicants must also describe how the size and race/ethnicity distribution of population under surveillance (denominator) will be ascertained for estimation of temporal trends and how cases of diabetes would be characterized to assess diabetes type.

Component B:

Evaluation/performance measurements will include quality assurance and quality control measures. These activities will be on-going and should include approaches to report on study progress, oversight, data management and quality control and assurance measures to the

External Scientific Evaluation Committee and the Steering Committee on an annual basis or as requested.

Translation Plan

Applicants for Components A and B, through joint analyses methods to aggregate the data, are expected to communicate the findings to the larger scientific and public health communities through the publication of peer reviewed journal articles, presentations at scientific meetings, and other means. Applicants will provide relevant estimates to the CDC to support the National Diabetes Statistical Report. Through participation on the Steering Committee, Publication and Presentation committee, plans and approaches for translating research findings will be determined for the registry members as a whole and by site.

An information collection has been approved under OMB Control Number 0920-0904, expiration date August 31, 2017. A revision may be developed for Components A and B.

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: $12,500,000

The estimated total funding (direct and indirect costs) for the first year (12 month budget period) is $2,500,000, including up to $300,000 from NIH and $2,200,000 from CDC. The estimated total funding for the entire project is $12,500,000.

Component A : Average award size will range from $280,000 to 380,000 per year with up to five awards. NCCDPHP will award $280,000 to $330,000 per year, and NIDDK will award $40,000 to $50,000 per year Component B. Average award size will range from $500,000 to 600,000 per year for up to one award. NCCDPHP will award $500,000 to $550,000 per year, and NIDDK will award $40,000 to $50,000 per year.

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

The ceiling amounts for the first 12-month budget period are (including both direct and indirect costs).

Component A $380,000 (including both direct and indirect costs) Component B: $600,000 (including both direct and indirect costs) Applications with budget requests greater than the ceiling will be considered non-responsive and will not be reviewed.

The floor amounts for the first 12 month budget period are:

Component A: $280,000 (including both direct and indirect costs).

Component B: $500,000 (including both direct and indirect costs).

Applications with budget requests less than the floor amount will be considered non-responsive and will not be reviewed.

Anticipated Number of Awards: 6

Component A : up to five awards.

Component B. up to one award

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

Award Ceiling: $380,000 Per Project Period Award Floor: $280,000 Per Project Period Total Project Period Length: 5 year(s) Throughout the project period, 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/ asfr/ogapa/aboutog/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: Others (see text field entitled "Additional Information on Eligibility" for clarification)

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. Special Eligibility Requirements

Eligible Organizations University of North Carolina, Chapel Hill, NC Children’s Hospital Medical Center, Cincinnati, OH University of Colorado Denver, Colorado School of Public Health, Aurora, CO Kaiser Permanente Southern California, Pasadena, CA University of Washington School of Medicine, Children's Hospital & Regional Medical Center, Seattle, WA http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

Center, Seattle, WA Wake Forest University School of Medicine, Winston-Salem, NC

Eligibility is limited to these applicants who have developed and maintained the SEARCH Registry for approximately 15 years and have institutional knowledge of the decisions that have been made by the study steering committee regarding the measurement and analytic methodology essential to the functioning and reporting of the registry data and trends.

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. Only eligible applicants listed in Section III, 1 are eligible to apply.

Applicants must provide a written acknowledgment of inclusion of surveillance network and validation activities and acknowledgment of two funding sources and commitment to adhere to budget requirements to delineate budget and expenditures by funding source. Evidence should be provided in the form of a letter from the applicant institution and should be included in Appendix A of the application.

4. Justification for Less than Maximum Competition

This is a unique research system and a comprehensive complex study that cannot be easily replicated. The currently funded clinical sites and coordinating center have demonstrated knowledge and proven experience working in a multi-center team and in the recruitment and retention of youth with diabetes, especially those from older adolescent populations, racial/ethnic minorities, and socio-economic disadvantaged populations. The multi-center study includes a common protocol, shared development of methods and procedures, design of instruments, collection, analyses and interpretation of data, and dissemination of results.

1.

The currently funded sites (University of North Carolina at Chapel Hill, Children's Hospital Medical Center Cincinnati, University of Colorado Denver, Colorado School of Public Health, Kaiser Permanente Southern California, University of Washington School of Medicine and Wake Forest University) have developed and maintained the SEARCH Registry for approximately 15 years and have institutional knowledge about the critical decisions that have been made by the study steering committee with regards to measurements and analytic methodology that is essential to the functioning and reporting of the data and trends that cannot be easily replaced by other applicants.

2.

5. Responsiveness

To be considered responsive to this announcement, applicants may not request funding above the ceiling amount of $380,000 for Component A or $600,000 for Component B per year (includes both direct and indirect costs). Incomplete applications or non-responsive applications with budgets that exceed the ceiling of the award will not be entered into the review process.

Applicants must provide a written acknowledgment of inclusion of surveillance network and validation activities and acknowledgment of two funding sources and commitment to adhere to budget requirements to delineate budget and expenditures by funding source. Evidence should be provided in the form of a letter from the applicant institution and should be included in Appendix A of the application.

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/#1.

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 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 registration process at least four (4) weeks prior to the application due date.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements.

The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM).

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. SAM 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 the SAM internet site at https://www.sam.gov/index.html.

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

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

9. Cost Sharing https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM/%231 http://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons http://www.Grants.gov http://fedgov.dnb.com/webform https://www.sam.gov/index.html

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http:// www.hhs.gov/ asfr/ ogapa/ aboutog/ hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), applications received in response to the same funding opportunity announcement 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 FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Only one application per institution (normally identified by having a unique DUNS number) is allowed.

Applicant can only apply to one component.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 or pgotim@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Standard Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/ 424/SF424_RR_Guide_General_VerC.pdf), except where instructed in this Funding Opportunity Announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional.

Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components.

3. Letter of Intent Due Date for Letter of Intent: 02/27/2015

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.

By the date listed above and in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Name of the Applicant http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.Grants.gov mailto:pgotim@cdc.gov

Descriptive title of proposed research (Component you are applying for) Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity

The letter of intent should be sent to:

Natalie J. Darling, MPH National Center for Chronic Disease and Health Promotion Extramural Research Program Operations and Services Centers for Disease Control and Prevention 4770 Buford Highway, NE M/S F-80 Atlanta, GA 30341 Telephone: (770) 488-5740 Email: ndarling@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the FOA. As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the FOA.

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.

3. Research Strategy – the research strategy should be organized under 3 headings: Significance, Innovation and Approach. Describe the proposed research plan, including staffing and timeline.

4. Inclusion Enrollment Report (Renewal and Revision applications ONLY)

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table (for New Application ONLY)

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 unless otherwise specified in the FOA.

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) must be followed along with any additional instructions provided in the FOA.

Research Plan:

The applicant’s research plan should address activities that will be conducted over the entire 5 year project period and should include the following items:

The research plan should describe system for surveillance of diabetes in youth in the U.S. age 19 years and younger. The population under surveillance should be demographically and geographically representative of the population of youth in the United States age 19 years and younger.

Component A:

For the proposed study site, describe: a) incidence rates of T1D and T2D b) the population source (including size, age, ethnicity, medical insurance status, socio-economic status, and geographic distribution); c) the partnership/network(s) which will provide access to information on the cases of diabetes within this population source; d) access to racial and ethnic minority and socio-economically disadvantaged populations; e) data sources (hospital and non-hospital) that will be used; and f) how the population size (denominator) will be ascertained for estimation of incidence and secular trends over the five years of the study.

Describe access to research infrastructure and an established population based childhood diabetes registry. A summary of site specific existing data collected in the last ten years which shows incidence and prevalence of diabetes in youth by age, sex, race/ethnicity and diabetes type should be provided.

Describe experience collaborating with other partners in a multi-center study that included a common protocol, development of methods and procedures, design of instruments, the collection, analyses and interpretation of data and dissemination of results. Include letters of support, publications, reports and abstracts demonstrating results of previous collaborations.

Describe applicant institutional research infrastructure to carry out large, complex, population based projects. Describe applicants’ physical facilities, data management and computer resources, and facilities for data retrieval and storage.

Provide a letter of support from the applicant’s institution that commits the institution to (a) ongoing research with this project; (b) a specified percentage of researchers’ time to be spent on this research project; (c) the continued access to and use of the dataset(s); (d) approving travel for required staffs to attend Steering Committee-related meetings; and (e) maintaining travel for required staffs to attend Steering Committee-related meetings; and (e) maintaining IRB protection of human subjects.

Describe proposed method of case registration and population under surveillance highlighting unique methods and validation of case registration. Applicants are encouraged to consider novel methods included use of electronic health records and pharmacy records.

Describe unique contribution to the multi-site study and plans for coordination with other sites.

Describe any innovations to improve study efficiency and reduce cost.

Provide proposed analysis and results and data dissemination plans. Include plans for coordination of analyses and results across sites and with Component B.

Describe training or developing doctoral, post-doctoral, and junior investigators, including investigators with a demonstrated interest and history working with populations with health disparities; i.e. through analyses and peer-review journal publications. Provide detailed plan for training and developing post-doctoral and junior investigators, including investigators with a demonstrated interest and history working with populations with health disparities.

Component B (the Coordinating Center):

Describe experience in directing and operating a coordinating center for collaborative, population based large-scale epidemiological research projects that included coordination of multi-site studies, development of training/certification programs, monitoring site performance and progress of studies and providing governance support.

Describe experience in providing data management, analysis and statistical support to multi-site research studies; include development and management of multi-site database, the design, analysis and interpretation of data and the development/production of data summaries and statistical reports.

Describe applicant institutional research infrastructure to carry out large, complex, population based projects.Describe applicants’ physical facilities, data management and computer resources, and facilities for data retrieval and storage.

Describe experience working with centralized laboratories and tracking of specimens.

Describe approach to develop and maintain a study-wide case registration database.

Propose methods to improve study-wide case registration efficacy and quality control.

Demonstrate understanding of surveillance activities including creation of appropriate denominator for incidence and prevalence estimates, potential problems and solutions of case registration.

Provide a letter of support from the applicant’s institution that commits the institution to (a) ongoing research with this project; (b) a specified percentage of researchers’ time to be spent on this research project; (c) the continued access to and use of the dataset(s); (d) approving travel for required staffs to attend Steering Committee-related meetings; and (e) maintaining IRB protection of human subjects.

Describe method for study-wide coordination of case registration and validation.

Describe unique contribution to the multi-site study and plans for coordination with other sites.

Describe any innovations to improve study efficiency and reduce cost.

Describe proposed analysis and results and data dissemination plans. Include plans for coordination of analyses and results with the sites from Component A.

Describe training or developing doctoral, post-doctoral, and junior investigators, including investigators with a demonstrated interest and history working with populations with health disparities; i.e. through analyses and peer-review journal publications. Provide detailed plan for training and developing post-doctoral and junior investigators, including investigators with a demonstrated interest and history working with populations with health disparities .

6. Appendix Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

7. Page Limitations All page limitations described in this individual FOA must be followed. For this specific FOA, the Research Strategy component of the Research Plan narrative is limited to 25 pages. Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 35 pages for all appendices.

8. Format for Attachments Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff. Applicants should ensure that all attachments are uploaded to the system.

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide (Part I, Section 2) (http://grants.nih.gov/ grants/funding/424/ SF424_RR_Guide_General_VerC.pdf).

9. Submission Dates & Times Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov (http://www.grants.gov), the online portal to find and apply for grants across all Federal agencies. The eRA Commons systems retrieve the application from Grants.gov and check the application against CDC business rules. If no errors are found, the application will be assembled in the eRA Commons for viewing by the applicant before moving on for further CDC processing.

If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Once you can see your application in the Commons, be sure to review it carefully as this is what the reviewer will see. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons (http:// grants.nih. gov/grants /guide/url_redirect .htm? id=11123).

Information on the submission process is provided in the SF424 (R&R) Application Guide.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant application due date 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).

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/guide/url_redirect.htm?id=11128 http://www.grants.gov/ http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123

The application package is not complete until it has passed the Grants.gov/eRA Commons validation process. This process and email notifications of receipt, validation or rejection may take two (2) business days.

Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process.