RFA-DP-17-002.pdf

Centers for Disease Control

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

Validation of survey questions to distinguish type 1 and type 2 diabetes among adults with diabetes

RFA-DP-17-002

Application Due Date: 02/21/2017

Validation of survey questions to distinguish type 1 and type 2 diabetes among adults with diabetes

RFA-DP-17-002

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 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 Validation of survey questions to distinguish type 1 and type 2 diabetes among adults with diabetes Activity Code U01

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-DP-17-002

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.068 Category of Funding Activity:

Health FOA Purpose Type 1 (~5% of diagnosed cases of diabetes) and type 2 diabetes (90-95% of diagnosed cases of diabetes) are distinct diseases with a different epidemiology and pathophysiology. Currently, the health-related data sources used to monitor trends in diabetes prevalence and incidence are unable to distinguish between types of diabetes. Therefore, the purpose of the FOA is to explore the development and validation of a set of questions that can be used on future surveys to indicate whether diabetic respondents have type 1 or type 2 diabetes. A secondary goal is to validate definitions of type of diabetes using electronic health record algorithms.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-17-002, 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: 01/21/2017

Application Due Date: 02/21/2017

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).

http://www.grants.gov

Scientific Merit Review: 04/07/2017

Secondary Review: 05/12/2017

Estimated Start Date: 09/30/2017

Expiration Date: 02/22/2017 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. Type 1 (~5% of diagnosed cases of diabetes) and type 2 diabetes (90-95% of diagnosed cases of diabetes) are distinct diseases with a different epidemiology and pathophysiology. Currently, the health-related data sources used to monitor trends in diabetes prevalence and incidence are unable to distinguish between types of diabetes. Therefore, the purpose of the FOA is to explore the development and validation of a set of questions that can be used on future surveys to indicate whether diabetic respondents have type 1 or type 2 diabetes. A secondary goal is to validate definitions of type of diabetes using electronic health record algorithms.

Mechanism of Support. Cooperative Agreement Funds Available and Anticipated Number of Awards. The estimated total level of funding (direct and indirect for entire project period) anticipated for the FOA is $1,000,000. It is anticipated that one award will be made and the award under this FOA is contingent upon availability of funds and a meritorious application.

Budget and Project Period. The estimated total funding (direct and indirect) for the first budget period, 09/30/2017-09/29/2018, is $500,000. The estimated total funding (direct and indirect) for the entire project period, 09/30/2017-09/29/2019, is $1,000,000.

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 identified by having a unique DUNS number) is allowed.

Application Type. New (type 1) http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV http://era.nih.gov/commons/index.cfm#SectionIII1A

Special Date(s). None Application Materials. See Section IV.1 for application materials. Please note that Form C is to be used when downloading the application package.http://grants.nih.gov/grants/funding/424/index.htm #inst 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 Section 301(a) of the Public Health Service Act, 42 U.S.C. 241(a).

1. Background and Purpose The two major types of diabetes are type 1 diabetes (in which the pancreas produces little or no insulin usually due to destruction of beta cells by the body’s immune system) and type 2 diabetes (usually due to combination of insulin resistance, beta cell dysfunction or both). It is estimated that type 2 diabetes accounts for 90-95% of all diabetes and that type 1 accounts for about 5%. The data sources used to monitor trends in diabetes prevalence and incidence, its risk factors and outcomes using a variety of data sources. However, the data sources CDC currently uses are unable to distinguish between types of diabetes. Further, electronic health record (EHR) data are likely to play a major role in future surveillance activities but no validated method of distinguishing diabetes type exists. The inability of surveillance data sources to distinguish type of diabetes is problematic because the etiology, treatment and outcomes of diabetes vary by type of diabetes.

Also, because the number of people with type 2 diabetes vastly outnumber the people with type 1 diabetes, the data and trends that are currently reported are more reflective of the experience of people with type 2 diabetes and may not be reflective of people with type 1 diabetes. Surveillance data by type of diabetes are important to allow for type-specific information about morbidity, mortality, medical care costs, and health-related quality of life. This information is important for CDC’s surveillance of diabetes, other state and federal agencies, diabetes researchers, various diabetes stakeholders, and people with diabetes.

Most survey-based prevalence estimates of type 1 diabetes among adults have been based on self-reported information about a young age at diagnosis (e.g., <30 years and <40 years) and insulin use within a year of diagnosis. However, this estimation approach misses type 1 diabetes in adults with older age of onset and may misclassify some cases of type 2 diabetes as type 1 if insulin use begins soon after diagnosis. A set of questions that can be used in national surveys to distinguish type 1 and type 2 diabetes is needed to improve national surveillance of diabetes and to be responsive to stakeholders and the American public. This set of questions could include questions on type of diabetes, insulin use, and the length of time between diagnosis and insulin use, other medications, and cessation of insulin for more than six months. Various combinations/algorithms of survey questions could be used to define type of diabetes but need to be validated across demographic strata.

In addition, EHR data have not been used to examine diabetes prevalence and outcomes among adults by diabetes type. Because of the increased use of EHR data for surveillance, validated methods for doing so are needed.

The major goal of this project is to explore and evaluate the validity of survey questions (or algorithms based on them) to distinguish between adults (aged ≥18 years of age) with type 1 and type 2 diabetes in a representative sample of adult diabetic patients in a diabetes patient registry or database. A secondary goal is to validate definitions of type of diabetes using electronic health record algorithms. Using a gold standard, as defined by the awardee, validity will be assessed by examining the sensitivity, specificity, and positive predictive value of algorithms to identify type of diabetes across demographic strata such as age, sex, and race.

http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm#SectionIV1 http://grants.nih.gov/grants/funding/424/index.htm#inst http://grants.nih.gov/grants/funding/424/index.htm#inst race.

Healthy People 2020 and other National Strategic Priorities The proposed FOA will support the Diabetes Healthy People 2020 objective to “Reduce the disease and economic burden of diabetes mellitus (DM) and improve the quality of life for all adults overall and by diabetes type.”

The announcement supports the nutrition and physical activity CDC Winnable Battle by enabling monitoring of the prevalence and incidence of type 1 and type 2 diabetes among adults. Type 2 diabetes can result from obesity, poor nutrition, and lack of physical activity.

Measurable outcomes of the FOA 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 FOA will support the Division of Diabetes Translation strategic goal to conduct surveillance and research to identify and prioritize effective approaches and target sub-populations with diabetes.

Public Health Impact This study is the first step in creating a set of questions for the identification of type of diabetes and may be added to future surveys thus enabling – for the first time – the estimation of the prevalence of diabetes by type in the United States. This will significantly improve our knowledge of the burden of diabetes by type and allow type-specific analyses of morbidity, mortality, medical care costs, and health-related quality of life. Similarily, creating validated electronic health record definitions of diabetes type will eventually permit the estimation and monitoring of outcomes and care of diabetes by type of diabetes in health care systems.

This, in turn, would facilitate assessment of the long-term cost-effectiveness of public health interventions and policies used to manage and prevent diabetes, inform public health decision making, and prioritize national public health objectives.

Relevant Work The CDC Division of Diabetes Translation and National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Disease (NIH/NIDDK) supported the inclusion of questions related to diabetes type and insulin requirements in a supplement to the National Health Interview Survey in 2016 and 2017.

These questions may begin to provide a picture of diabetes prevalence by type among adults but have not been validated. However, there has been no validity study of any survey questions to distinguish diabetes type among adults.

2. Approach The major goal of the project is to explore and evaluate the validity of survey questions (or algorithms based on them) to identify adults with type 1 and type 2 diabetes in a sample of diverse patients in a diabetes patient registry or diabetes patient database. A secondary goal of the project would be to design and test algorithms for identifying diabetes type using electronic health record data. These studies should assess validity across demographic strata such as age and race. Using a gold standard of type of diabetes (e.g., physician report or medical record review), validity will be assessed by examining such measures as the sensitivity, specificity, and positive predictive power of the questions/algorithms to identify type of diabetes.

These validation studies are expected to use diabetes patient registry data or diabetes patient databases from large health care organizations or other health care related organizations. Any source, patient registry or database, should include all major race/ethnic groups of the US population as well as all ages from young adults to elderly people. The awardee will be responsible for the design of the study, methodology, and analysis of the data. For example, one possible approach would be to create a sample of diabetic patients from a selected registry or database for the validity studies. Electronic health record data would be obtained for the sample and the sample would be surveyed with a set of questions designed to identify type of diabetes. These questions could include type of diabetes, insulin use patterns and age at diagnosis. The sample of patients should be of sufficient size to develop and test algorithms for diabetes type within demographic strata (e.g., age and race/ethnicity). Using physician report via survey or medical chart/record review as a possible gold standard , the best algorithm(s) for classifying type of diabetes will be identified and validated (based on sensitivity, specificity and positive predictive value). Similarly, for the second objective, elements in electronic health records will be tested against a gold standard to determine the most accurate way to identify diabetes type using these data.

Objectives/Outcomes

1) Design and implement a validation study of survey questions to identify type of diabetes among a representative sample of patients.

2) Design and implement a validation study of electronic health record data to identify type of diabetes among a representative sample of patients

3) Develop a report of findings (including lessons learned) and summarize these findings in a manuscript suitable for publication.

Target Population The target population is not expected to be nationally representative of the U.S. population with diabetes.

However, the sample from the patient registry or database should include all major race/ethnic groups of the US population as well as all ages of adults (e.g., from young adults to elderly people).

Collaboration/Partnerships The applicant is expected to establish collaborations with other partners as needed to accomplish the goals of the study. For example, the applicant may need to collaborate with an agency or organization with experience in conducting surveys. However, the applicant is expected to have access to diabetes registry data or diabetes patient databases that can be used to sample patients.

Evaluation/Performance Measurement Evaluation/performance measurements should include quality assurance and quality control measures.

These activities should be on-going and should also include approaches to report on study progress, oversight, data management and quality control and assurance measures.

Translation Plan Applicants are expected to validate questions for use in surveys to distinguish type of diabetes in surveys.

Applicants are expected to communicate their findings to scientific, public health and health care communities through publication in peer reviewed journals, presentations at scientific meetings, and other means. Applicants are also expected to provide a report of the “lessons learned” from this project to inform future surveillance efforts of type of diabetes.

OMB/PRA.

OMB/PRA is not expected to apply.

References:

Menke A, Orchard TJ, Imperatore G, et al. The prevalence of type 1 diabetes in the United States. Epidemiology. 2013;24(5):773-774.

United States Diabetes Surveillance System. Centers for Disease Control and Prevention. http://www.cdc .gov/diabetes/data/

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: $1,000,000 The estimated total funding (direct and indirect costs) for the first budget period is $500,000 and the estimated total funding (direct and indirect) for the entire 2-year project period (09/30/2017-09/29/2019) is $1,000,000.

Anticipated Number of Awards:

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

Award Ceiling: $500,000 Per Budget Period Award Floor: $100,000 Per Budget Period Total Project Period Length:

2 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/sites/default/files/grants/grants/policies-regulations/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: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) http://www.cdc.gov/diabetes/data/ http://www.cdc.gov/diabetes/data/ 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

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:

Native American tribal organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Bona Fide Agents: a Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" 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 agency. For more information on FFRDCs, go to https://dap.dau.mil/acquipedia/Pages/ArticleDetails.aspx?aid=5e3079b8-44f2-43df-a0e7-9f379e8c48ed https://dap.dau.mil/acquipedia/Pages/ArticleDetails.aspx?aid=5e3079b8-44f2-43df-a0e7-9f379e8c48ed

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 include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements

For an applicant to be considered they must be responsive to the information here.

Because a validity study of survey questions of diabetes type requires a population of known patients with diabetes, applicants must have access to a diabetes patient registry or diabetes patient database with identifiable information that would allow them to contact patients and their physicians. Also, applicants must have access to electronic health records in order to meet the FOA objective of validating diabetes type using electronic health record data.

1.

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.

4. Justification for Less than Maximum Competition N/A

5. Responsiveness To be considered responsive to this announcement, Applicants must provide a letter or other official documentation of access to their intended data sources (e.g., diabetes registry or database and electronic health record data), including access to identifiable information with which to contact patients, and any necessary permission to contact patients or their physicians.

An application that exceeds the upper value of the specified dollar range will be considered non-responsive and will not receive further review.

Applicants must present documentation of responsiveness 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/#1.

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

10. Number of Applications As defined in the HHS Grants Policy Statement,(http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/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.

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

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 Office of Grants Services (OGS) Technical Information Management Section (TIMS) staff at (770) 488-2700 or ogstims@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern 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/how-to-apply-application-guide.htm and here:

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.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. These forms can be downloaded from http://grants.nih.gov/grants/forms.htm

3. Letter of Intent Due Date for Letter of Intent: 01/21/2017 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 Descriptive title of proposed research 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 the following point of contact:

Marcella Law

Scientific Program Official

Extramural Research Program Operations and Services http://www.Grants.gov mailto:pgotim@cdc.gov http://grants.nih.gov/grants/how-to-apply-application-guide.htm http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf http://grants.nih.gov/grants/forms.htm

Centers for Disease Control and Prevention

4770 Buford Highway, NE

Mailstop F-80

Atlanta, GA 30342

Telephone: (770)-488-5416

Email: mah7@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 the SF 424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here:

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.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 (R&R) 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 mailto:mab5@cdc.gov http://grants.nih.gov/grants/how-to-apply-application-guide.htm http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf 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 (R&R) Application Guide unless otherwise specified in the FOA. All instructions in the SF424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf must be followed along with any additional instructions provided in the FOA.

Applicants that plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application. A DMP is required for each collection of public health data proposed. Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds.

The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

• Descriptions of the data to be produced in the proposed project

• How access will be provided to the data (including provisions for protection of privacy, confidentiality, security, intellectual property, or other rights)

• Use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use

• Plans for archival and long-term preservation of the data, or explaining why long-term preservation and access cannot be justified Examples of DMPs may be found here: University of California https://dmp.cdlib.org/, or USGS, http://www.usgs.gov/datamanagement/plan/dmplans.php

Research Plan

The applicant’s research plan should address activities that will be conducted over the entire project period.

The Research Plan narrative is comprised of components 2 and 3 above. NOTE: that the research Strategy is divided into three parts: 1)Significance, 2) Innovation, and 3) Approach.

The applicants’ research plan must address activities that will be conducted during the 2-year project period and must include the following items:

Approach:

Describe the patient population to be used in the validation study in terms of demographic characteristics including age, sex, and race/ethnicity and, if feasible, socio-economic characteristics such as education and income to demonstrate a diverse racial/ethnic population with all adult age groups. Describe the number and characterisitcs of the clinical practices represented in the sample.

1.

Describe the methods that were used to identify patients with diabetes in their registry or patient database and the accuracy of those methods.

2.

Describe an approach for conducting the validation studies to accomplish FOA objectives3.

Describe statistical plans, including a discussion of sample size for reliable estimates of demographic subpopulation of interest.

4.

Describe the approach for surveying patients about type of diabetes, including the approach to develop survey questions for distinguishing type of diabetes.

5.

Describe the approach to identify data elements of electronic health records to distinguish type of diabetes.

6.

Describe possible gold standard for use in validation and how the gold standard might be collected, e.g. physician survey, medical record review.

7.

Describe plans for quality control of all data collection and for minimizing or addressing non-response.8.

Describe plans to validate diabetes type, including proposed analyses using appropriate statistical9.

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 https://dmp.cdlib.org/ http://www.usgs.gov/datamanagement/plan/dmplans.php methods.

Describe any partnerships that will utilized in the study, including network of providers or health care system.

10.

Staffing and Milestones:

Describe the experience and expertise of key proposed staff in diabetes public health or health services research, including study design, project management, data management, statistical analysis, and dissemination of findings in publications.

1.

Describe staffing and management plans including plans for data collection, management, and analysis.

2.

Provide a timeline for key milestones to occur in the first 12 months of the project. Include milestones that will be used to demonstrate progress toward having an Institutional Review Board (IRB) approved protocol and, if required, an OMB approved protocol.

3.

Identify key milestones for the second year of funding.4.

Institutional support

Describe the institutional research infrastructure and ability to carry out population-based projects and validity studies.

1.

Provide letter of commitment (in Appendix B) 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) approval to travel to CDC Atlanta or local commute area for required staff and PIs to attend project meetings; and

(e) maintain IRB protection of human subjects.

2.

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.

Appendix A. To be considered responsive to this announcement, applicants must present documentation of meeting the special eligibility criteria (listed in Section III, number 3) in Appendix A. If your application is incomplete or non-responsive to these requirements, it will not enter into the review process.

Appendix B. Provide letter of commitment from the applicant’s institution (See Section IV, research plan) 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) approval to travel to CDC Atlanta or local commute area for required staff and PIs to attend project meetings;

and (e) maintain IRB protection of human subjects.

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 http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.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).

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. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free. Applicants who encounter system errors when submitting their applications must attempt to resolve them by contacting the Grants.gov Contact Center ( 1-800-518-4726; support@grants.gov). If the system errors cannot be resolved, applicants must contact TIMS at 770-488-2700; ogstims@cdc.gov for guidance at least 3 calendar days before the deadline date.

After submission of your application package, applicants will receive a “submission receipt” email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. This validation process may take as long as two (2) business days. A third and final e-mail message is generated once the applicant’s application package has passed validation and the grantor has confirmed receipt of the application.

Unsuccessful Submissions: If an application submission was unsuccessful, the applicant must:

1. Track his/her submission and verify the submission status (tracking should be done initially regardless of rejection or success).

a. If the status states “rejected,” do #2a or #2b.

2. Check his/her emails from both Grants.gov and eRA Commons for rejection notices.

a. If the deadline has passed, he/she should email the Grant Management Specialist listed in the FOA http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.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 mailto:support@grants.gov mailto:www.pgotim@cdc.gov

a. If the deadline has passed, he/she should email the Grant Management Specialist listed in the FOA (pgotim@cdc.gov) explaining why the submission failed. b. If there is time before the deadline, he/she should correct the problem(s) and resubmit as soon as possible.

Due Date for Applications: 02/21/2017

Electronically submitted applications must be submitted no later than 5:00 p.m., ET, on the listed application due date.

10. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review (http:// www. whitehouse.gov/ omb/ grants_spoc).

11. Funding Restrictions

All HHS/CDC awards are subject to the federal regulations, 45 CFR 75, terms and conditions,and other requirements described in the HHS Grants Policy Statement. Pre-award costs may be allowable as an expanded authority, but only if authorized by CDC.

For more information on expanded authority and pre-award costs, go to:

http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf .

CDC requires that mechanisms for, and cost of, public health data sharing be included in grants,cooperative agreements, and contracts. The cost of sharing or archiving public health data may also be included as part of the total budget requested for first-time or continuation awards.

Fulfilling the data-sharing requirement must be documented in a Data Management Plan (DMP) that is developed during the project planning phase prior to the initiation of generating or collecting public health data and must be included in the Resource Sharing Plan(s) section of the PHS398 Research Plan Component of the application.

Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds (for example, privacy and confidentiality considerations, embargo issues).

Awardees who fail to release public health data in a timely fashion will be subject to procedures normally used to address lack of compliance (for example, reduction in funding, restriction of funds, or award termination) consistent with 45 CFR 74.62 or other authorities as appropriate. For further information, please see: http://www.cdc.gov/grants/additionalrequirements/index.html for revised AR-25.

Applicants are advised that any activities involving standard information collection (i.