RFA-DP-17-001PUBLICATION.pdf

Centers for Disease Control

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

Community Characteristics Associated with Geographic Disparities in Diabetes and Cardiometabolic Health

RFA-DP-17-001

Application Due Date: 02/14/2017

Community Characteristics Associated with Geographic Disparities in Diabetes and Cardiometabolic Health

RFA-DP-17-001

TABLE OF CONTENTS

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

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information

Participating Organization(s)

Centers for Disease Control

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

Community Characteristics Associated with Geographic Disparities in Diabetes and Cardiometabolic Health

Activity Code

U 01

Funding Opportunity Announcement Type

New

Funding Opportunity Announcement Number

RFA-DP-17-001

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.068

Category of Funding Activity:

Health

FOA Purpose

This FOA has two components, A and B.

Component A supports applications aimed at examination of county-level disparities in type 2 diabetes and cardiometabolic conditions to enhance understanding of disease determinants. Applicants will test hypotheses aimed at clarifying the contribution of environmental or socioeconomic circumstances to diabetes geographic disparities. As part of this initiative, Component A awardees will also be asked to form a common protocol for a selected subset of variables to permit multi-center analyses.

Component B of this FOA solicits applications for a study Coordinating Center (CC) to provide logistics, data management, and analysis support to the multi-center research study.

Key Dates

Publication Date: To receive notification of any changes to RFA-DP-17-001, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 01/13/2017 01/13/17

Application Due Date: 02/14/2017 02/14/17

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: 04/03/2017

Secondary Review: 05/15/2017

Estimated Start Date: 09/29/2017

Expiration Date: 02/15/2017 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. This FOA has two components, A and B. Component A supports applications aimed at examination of the modifiable characteristics at the http://www.grants.gov http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

Purpose. This FOA has two components, A and B. Component A supports applications aimed at examination of the modifiable characteristics at the community, environmental, and individual level that explain large disparities in type 2 diabetes and related chronic conditions across counties in the United States. Following the award, grantees will collaborate to establish a common protocol and data management plan for the collection of a core set of exposure and outcome variables to permit multi-center analyses.

Component B of this FOA solicits applications for a study Coordinating Center (CC) to provide logistics, data management and analysis support to the multi-center research study funded under component A.

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 in dollars) that is available for the FOA for the entire project period,9/30/2017 - 09/29/2022, is $20,000,000. It is estimated that 5 awards will be made under this FOA, four under component A and one under component B. Awards issued under this FOA are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period. The estimated total funding (direct and indirect) for the first budget period, 9/30/2017 - 09/29/2018, is $4,000,000. The estimated total funding (direct and indirect) for the entire project period,9/30/2017 - 09/29/2022, is $20,000,000. Under both component A and B, the estimated average award for year 1 will be $800,000.

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. An institution (normally identified by having a unique DUNS number) may submit no more than one application for Component A and no more than one for Component B. However, no institution will receive more than one award under this funding announcement. That is, the awardee for Component B will not also receive an award for Component A.

Application Type. New Special Date(s) 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 This program is authorized under sections Section 301(a) of the Public Health Service Act, 42 U.S.C. 241(a).

1. Background and Purpose

Comprehensive public health programs may be improved by incorporating measures that address socioeconomic factors and community contexts, as well as individual counseling or clinical interventions (1, 2). This comprehensive balance may be especially important in settings where poverty, low educational attainment and social deprivation are common. To maximize a program’s population impact, it may help to identify which environmental or socioeconomic circumstances (contexts) could have the greatest influence on health outcomes. A related challenge is to understand the mechanisms or pathways through which contexts may exert their effects, positive or negative, on the etiology of specific diseases so as to intervene effectively on a community level to reduce disease burdens.

It is unlikely that a single research initiative will identify a unique intervention that could reduce the burden of every disease in every community setting (3). Faced with this reality, this FOA focuses attention on type 2 diabetes, an increasingly common disease of adults that is closely linked to obesity, ectopic fat accumulation and processes of atherosclerosis, e.g., coronary heart disease, stroke. Based on observable disparities in diabetes prevalence and incidence across the 3000+ counties in the United States, this FOA will focus on the study of community contexts scaled to counties. Public health interventions applied at the county level might be relatively amenable to implementation and evaluation.

By narrowing its objectives in these ways, the purpose of this funding opportunity is to understand better the mechanisms or pathways through which environmental or socioeconomic circumstances (contexts) have their greatest influence on a community’s exposure specifically to type 2 diabetes.

Component A of this research initiative will support parallel studies based on different hypotheses in distinct community settings. Each of the parallel studies will have achievable objectives that may incrementally advance public health knowledge related to diabetes and related cardiometabolic conditions.

Component B will provide coordinating services to all the awardees under Component A to maximize the statistical power and generalizability of their aggregated results.

As outlined in following sections of this FOA, applicants for Component A should develop an epidemiologic research design that will seek to understand substantial geographic disparities between counties selected for study because they are at high- or low-risk of diabetes. Hypotheses should be proposed to describe the contextual factors, harmful or protective, that contributed to these disparities. Tests of these hypotheses should proceed through focused data collection and appropriate use of analytic methods that acknowledge multiple sources or levels of data. As part of this research initiative, the Component A awardees will also be asked to form a collaborative protocol that contains a selected subset of variables common to other awarded sites, as well as site-specific protocol with exposures and outcomes particularly relevant to the awardee’s target population.

Component B of this FOA will support a Coordinating Center to manage the collaborative work among Component A awardees. The awardee for Component B will not also receive an award for Component A.

Healthy People 2020 and other National Strategic Priorities This FOA supports or addresses at least four topics outlined in the program of “Healthy People 2020” (http://www.healthypeople.gov/2020/topics-objectives):

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV http://era.nih.gov/commons/index.cfm#SectionIII1A http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm#SectionIV1 http://grants.nih.gov/grants/funding/424/index.htm#inst http://grants.nih.gov/grants/funding/424/index.htm#inst http://www.healthypeople.gov/2020/topics-objectives

This FOA supports or addresses at least four topics outlined in the program of “Healthy People 2020” (http://www.healthypeople.gov/2020/topics-objectives):

Social Determinants of Health: Identify aspects of social and physical environments that can be improved to promote good health for all. This topic is identified as an overarching goal for the decade: “Achieve health equity, eliminate disparities, and improve the health of all groups”.

Nutrition and Weight Status: Promote health and reduce chronic disease risk through the consumption of healthful diets and achievement and maintenance of healthier body weights and distributions of body fat.

Diabetes: Reduce the disease and economic burden of diabetes mellitus (DM) and improve the quality of life for all persons who have, or are at risk for, DM.

Heart Disease and Stroke: Improve cardiovascular health and quality of life through identifying and modifying contextual factors associated with county-level rates of heart attack and stroke.

The FOA also responds to an objective of CDC Winnable battles:

Nutrition, Physical Activity, and Obesity

FOA is aligned with at least three priorities of the CDC Division of Diabetes Translation:

Prevent type 2 diabetes: Conduct surveillance and applied research to identify and prioritize effective approaches and targeted sub-populations for diabetes prevention.

Prevent complication, disabilities and burden associated with diabetes: Conduct surveillance and applied research to identify and prioritize effective approaches and targeted sub-populations for diabetes.

Promote health equity by reducing disparities that affect diabetes and its burden.

Public Health Impact Starting with the identification of geographic disparities in cardiometabolic health this research initiative will use related contextual information to identify modifiable pathways by which county-level characteristics contribute to disparities in disease burden. Data collected from counties at high- and low-cardiometabolic risk will test hypothesized relationships between area characteristics and disease outcomes. To the extent that the contexts are modifiable, the findings will help to design and justify public health programs that are equitable (serving the general population as well as those deemed at high-risk) and also designed to require relatively little use of personal resources or individual agency (4). Success in these research projects will point the way to future epidemiologic research in which the study of geographic disparities in disease risk could enhance the public-health approaches to other major disease groups.

Relevant Work In 2015 the National Committee on Vital and Health Statistics convened a workshop dedicated to the development of community indicators that would increase opportunities to improve health at the local level. The Workshop Summary (5) presented a preliminary list of contextual domains that included modifiable factors through which community partnerships might measure and improve local health. Others have proposed a “Health in All Policies” framework recognizing that many determinants of health come from outside of the traditional health sector (6). Partnership with non-health sectors is needed to address a variety of structural, intermediary, and cross-cutting contextual domains associated with health inequities.

2. Approach

This FOA is comprised of two components. Component A supports applications aimed at examination of the modifiable characteristics at the community, environmental, and individual level that explain large disparities in type 2 diabetes and related chronic conditions across counties in the United States. Following the award, grantees will collaborate to establish a common protocol and data management plan for the collection of a core set of exposure and outcome varaibles to permit multi-center analyses.

Component B of this FOA solicits applications for a study Coordinating Center (CC) to provide logistics, data management and analysis support to the multi-center research study funded under component A.

Component A of this FOA focuses its research interest in three ways:

a. Concentration on type 2 diabetes and cardiometabolic conditions that frequently occur together after childhood. These include (but are not limited to) gestational diabetes, coronary heart disease, hypertension, stroke, obesity, and ectopic fat accumulation (e.g., fatty liver). Proposals should investigate community-level disparities defined by relatively high or low prevalence (or incidence) of type 2 diabetes along with at least one related cardiometabolic condition.

b. In order to define pertinent geographic disparities, the proposed research should focus on counties (or comparable jurisdictions designated as “Parish” or “City”) in the United States characterized as having a high or low prevalence or incidence of type 2 diabetes and cardiometabolic conditions. Counties chosen for study might be unique examples or combinations of counties (not necessarily contiguous). The choice of these disparate counties should be driven by an intention to test one or more pre-specified hypotheses that could identify or confirm mechanisms/pathways by which environmental or socioeconomic circumstances (contexts) in those counties have influenced cardiometabolic health. The hypothesized mechanisms might act through pathways that tend to increase or decrease risk of disease. The choice of counties should also consider the availability of data and the feasibility of obtaining the required information.

c. In the selected counties, hypotheses about one or more pertinent contextual factors may be considered from a wide variety of domains (see examples below). In many instances, assessments of such factors at the county level are openly available on the internet. Proposals will need to consider carefully the relevance, timeliness, and quality of such published assessments. Existing county-level sources often cannot reflect the depth or detail needed for understanding pathways and mechanisms. Thus, an applicant should propose to complement available county-level data with the collection of new primary data through focused surveys of individuals, families, institutions, or physical sources (e.g., air, water).

The list of domains (below) is offered only by way of providing examples. Individual awardees will possibly choose to pursue only one or up to four such domains.

The domains listed here are not intended to be prescriptive or exclusive.

Example domains: Examples of features to explore:

• Ambient pollution water sources, atmospheric particulate matter

• Anthropometry body fat distribution, leg/trunk ratio

• Built environment physical activity resources, greenspaces

• Education school dropouts, enrollment stability

• Employment wages, work conditions, job stability, unionization, vacations

• Food patterns of consumption, availability, barriers to access

• Housing occupant density, noise level, segregation practices

• Metabolomes insulin resistance, hepatic steatosis, dietary deficiencies

• Microbiomes species richness http://www.healthypeople.gov/2020/topics-objectives

• Microbiomes species richness

• Sleep experience histories by age, prospective diaries, nocturnal blood pressure

• Stress or depression interview instruments, cortisol assays, social supports

• Tobacco exposures smoking initiation, taxation & prices, public policies

• Toxic exposures occupational & residential histories, hair or nail clippings

• Transportation travel to work, to school Within these research boundaries (a-c; above), the four awards under Component A will likely cover a range of etiologic concepts, study hypotheses and distinct panels of counties selected for study. Through the engagement of multi-disciplined researchers working in different parts of the USA, this FOA presents an opportunity to strengthen the overall research initiative through collaboration among the awardees and eventual integration of their epidemiologic databases.

Component B of this FOA, with such cooperation in mind, will establish a data management, analysis, and study Coordinating Center (CC) to collaborate with award recipients from Component A. The sole awardee for Component B shall work with the Component A awardees to identify core, shared elements of population selection and recruitment and a subset of exposure and outcome variables that lend themselves to multi-center analyses. The CC will also facilitate the formation of a Steering Committee consisting of the Principal Investigators from each study site. The awardee for Component B will not also receive an award for Component A.

Objectives/Outcomes The four Principal Investigators from Component A and the Principal Investigator from Component B (Coordinating Center) will have shared responsibilities to develop and sustain collaborative efforts for this research program. The Cooperative Agreement Terms and Conditions of Award (Section IV., 4) outline these obligations in substantial detail.

Component A:

The specific objectives under Component A are to:

Identify potentially modifiable pathways by which environmental or socioeconomic circumstances (contexts) may contribute to county-level disparities in type 2 diabetes and related cardiometabolic diseases.

Evaluate such pathways by developing testable research hypotheses.

Collaborate with related, parallel projects so as to enhance the power and generalizability of research findings.

Mitigate eventually those harmful pathways and adverse consequences related to one or more contextual factors.

Strengthen eventually those salutary pathways and favorable consequences related to one or more contextual factors.

Component B:

The specific objectives under Component B are to:

Create and 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 study sites under Component A.

Develop and implement the plan for selecting core variables during Year 1 that will facilitate data sharing among the Component A awardees.

Determine the need for shared laboratory facilities that could collect, analyze and archive laboratory specimens and related biomarker or environmental materials.

Ensure the training and certification of staff at the study sites on measurement and study procedures as outlined in the protocol and manual of operations.

Provide statistical and other analytic support to the multi-center study.

Establish and maintain a study website and organize the steering committee meetings, external advisory board meetings, and workshop meetings.

At the end of the funding cycle the CC will also be responsible for the preparation and release of data sets to appropriate repositories for public use.

Act, directly or through a subcontractor, as a central laboratory for the analyses of specimens from the study sites and ensure rapid transmission of the results.

Target Population Component A:

By way of defining a community, Component A of this FOA focuses on counties (or comparable jurisdictions designated as “Parish” or “City”). There are 3,143 counties in the United States (7) from which may be chosen unique examples or combinations of counties (not necessarily contiguous) characterized as having high- or low-risk of type 2 diabetes and at least one related cardiometabolic condition.

The identification of eligible counties based on their high or low risk of diabetes may be guided by critical reading of recent articles in the peer-reviewed literature or review of authoritative datasets. Recent compilations of county-level mortality statistics attributed to all causes, the underlying cause, or multiple-cause listings

(8) may help to confirm the validity of the county selections. An epidemiologic comparison of the selected counties may require consideration of variations between counties according to characteristics other than those defined by health outcomes. County-level sociodemographic descriptors (e.g., age structure, educational attainment, income levels, distribution of ancestral groups) are often available and may be used as covariates. Systems describing, comparing, or grouping US counties have been developed by the Department of Agriculture (7), the Centers for Disease Control and Prevention (9), the Census Bureau (10), and other organizations. In the application and research plan, the applicant should clearly describe the counties or jurisdictions and the size of the sub-populations included in the proposed research/study, with special emphasis on underserved and at-risk populations.

Component B: Not applicable

Collaboration/Partnerships Component A:

Investigators under Component A are encouraged to form or expand collaborations/partnerships with researchers or agencies (e.g., local governments, voluntary organizations, community-based institutions) that have established interests in reducing the chronic-disease burden. Such relationships could be useful for planning and/or execution of their focused research plans. It may be appropriate alternatively to engage private agencies equipped to collect items (e.g., questionnaire responses; biological or environmental specimens) from designated locations and individuals in sites distributed across multiple US counties.

Component B:

As described throughout this FOA, Component B will establish a Coordinating Center to promote collaboration among the awardees to Component A. This collaboration will form a common protocol for a selected subset of exposure and outcome variables to permit multi-center analyses. Applicants are expected to identify key partners and form or expand collaborations/partnerships that will facilitate accomplishment of study objectives.

Component A and B:

After awards are made under this FOA, scientific or program staff at CDC’s National Center for Chronic Disease Prevention and Health Promotion will be available as requested to assist in any aspects of the project.

Evaluation/Performance Measurement Component A:

Internal evaluation during the first project year should be measured by the refinements made to its study design, commitments made to professional staffing and potential collaborators, and updated reviews of existing data that describe contextual factors in each of the selected counties.

In subsequent funded years, success should be measured by execution of the study protocol, procurement and/or collection of necessary data, appropriate validation of data elements, timeliness of epidemiologic analyses, and participation in the collaborative, multi-center analyses.

Component B:

Evaluation/performance should address measurements of quality of promoting and facilitating a multi-center and collaborative environment among the award recipients, providing statistical and analytical support to the multi-center study, the coordination of study meetings, conference calls, development and execution of a communication plan including development of a study website, distribution of meeting reports, tracking and management of and coordination of committee activities.

Applicants for Component B shall have sufficient staff available to plan, coordinate, and resolve day-to-day issues of the network; to maintain study-wide timeline management; and to facilitate the exchange of abstracts, manuscripts, presentations, fact sheets, and other scientific materials among the collaborating centers and the funding agency.

Translation Plan Component A and B:

Awardees will be expected to present findings at professional meetings and at formal briefings for health and policy makers. They should submit results to peer-reviewed journals, and also disseminate aspects of their work through diverse media such as a study website and policy briefs.

OMB/PRA may not apply.

References:

1. Commission on the Social Determinants of Health. Closing the gap in a generation: Health equity through action on the social determinants of health Geneva: World Health Organization; 2008 [Available from: http://www.who.int/social_determinants/thecommission/finalreport/en/.]

2. Frieden TR. A framework for public health action: the health impact pyramid. Am J Public Health. 2010;100(4):590-5.

3. Braveman P, Egerter S, Williams DR. The social determinants of health: coming of age. Annu Rev Public Health. 2011;32:381-98.

4. Adams J, Mytton O, White M, Monsivais P. Why are some population interventions for diet and obesity more equitable and effective than others? The role of individual agency. PLoS Med [Internet]. 2016; accessed 04 October 2016; 13(4):[e1001990]. Available from: http://journals.plos.org/plosmedicine/article ?id=10.1371/journal.pmed.1001990 .

5. National Committee on Vital and Health Statistics (NCVHS), Walter G. Suarez, Raj Chanderraj, Bruce B. Cohen, Llewellyn J. Cornelius, Nicholas L.

Coussoule, et al. Advancing Community-Level Core Measurement: A Progress Report and Workshop Summary Hyattsville, MD: National Center for Health Statistics, CDC; 2016 [(33 pp)]. Available from: http://www.ncvhs.hhs.gov/wp-content/uploads/2013/12/CoreMeasuresWorkshop.pdf.

6. Hall M, Graffunder C, Metzler M. Policy Approaches to Advancing Health Equity. J Public Health Manag Pract. 2016;22 Suppl 1:S50-S9.

7. USDA Economic Research Service. County Typology Codes Washington: USDA; 2015 [updated December 07, 2015. Available from: http://www.ers.usda .gov/data-products/county-typology-codes.aspx .

8. Centers for Disease Control & Prevention. WONDER Online Databses Atlanta: US Department of Health and Human Services; 2016 [updated July 12, 2016. Available from: http://wonder.cdc.gov/.

9. Centers for Disease Control and Prevention. How to Use CHSI 2015 Atlanta: US Department of Health and Human Services; 2015 [Available from: http ://wwwn.cdc.gov/CommunityHealth/info/HowtoUseReport .

10. U.S. Census Bureau. American Community Survey - Data Tables & Tools Washington: U.S. Department of Commerce; 2016 [updated 19 September 2016. Available from: http://www.census.gov/acs/www/data/data-tables-and-tools/index.php.

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: $20,000,000 Funds Available and Anticipated Number of Awards. The estimated total level of funding (direct and indirect for entire project period in dollars) that is available for the FOA for the entire project period,9/30/2017 - 09/29/2022, is $20,000,000.

It is estimated that 5 awards will be made under this FOA, four under component A (total funding $16,000,000) and one under component B (total funding $4,000,000). Awards issued under this FOA are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period. The estimated total funding (direct and indirect costs) for the first budget period is $4,000,000 ($3,200,000 for Component A;

$800,000 for Component B), The estimated total funding (direct and indirect) for the entire project period,9/30/2017 - 09/29/2022, is $20,000,000. Under both component A (first budget period funding $3,200,000) and B (first budget period $800,000), the estimated average award for year 1 will be $800,000.

Anticipated Number of Awards: 5 http://www.who.int/social_determinants/thecommission/finalreport/en/ http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001990 http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001990 http://www.ncvhs.hhs.gov/wp-content/uploads/2013/12/CoreMeasuresWorkshop.pdf http://www.ers.usda.gov/data-products/county-typology-codes.aspx http://www.ers.usda.gov/data-products/county-typology-codes.aspx http://wonder.cdc.gov/ http://wwwn.cdc.gov/CommunityHealth/info/HowtoUseReport http://wwwn.cdc.gov/CommunityHealth/info/HowtoUseReport http://www.census.gov/acs/www/data/data-tables-and-tools/index.php

Award Ceiling: For both Components A and B no award for the first 12-month project period will exceed $800,000.

Award Floor: For both Components A and B no award for the first 12-month project period will be made for less than $400,000.

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

Award Ceiling: $800,000 Per Budget Period Award Floor: $400,000 Per Budget 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/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) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Small businesses Others (see text field entitled "Additional Information on Eligibility" for clarification) Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Additional Eligibility Category:

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

Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education:

Nonprofits (Other than Institutions of Higher Education)

Governments:

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

Other:

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.

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

Component A:

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

(1) The applicant must clearly identify that the geographic regions chosen for analysis are US counties (or comparable US jurisdictions).

(2) For each county chosen, an applicant should provide a current estimate of the resident population, including distributions by sex, age groups and major ancestral groups.

(3) The applicant must describe the burden of type 2 diabetes in each county chosen as being either high or low risk as documented within the most recent five years.

(4) The applicant must describe the burden of a cardiometabolic condition related to type 2 diabetes in each county chosen as being either high or low risk as documented within the most recent ten years.

(5) If collaborating partners are proposed, applicants must provide letters of support from these proposed partners specifying the commitment of the parties involved including the terms of access to data and populations and any specified limits to collaboration.

(6) An application that exceeds the ceiling value of the specified award range will be considered non-responsive and will not receive further review.

Component B:

(1) An applicant must include a research team with one or more statisticians or epidemiologists with established interests in multilevel analysis, that is, the creation and interpretation of statistical models including parameters that vary at more than one level. Prior published experience with such statistical methods (e.g., nested or hierarchical modeling) should be described in regard to the study of variations by geographical place.

(2) An applicant must include a research team that includes staff with training and/or expertise relevant to developing an active website for the coordination of research protocols and parallel data collection by scientific staff located in varied research environments.

(3) An application that exceeds the ceiling value of the specified award range will be considered non-responsive and will not receive further review.

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

Evidence of 3. Special Eligibility Criteria listed above must be presented in Appendix A. If your application is incomplete or non-responsive to these requirements, it will not enter into the review process.

Component A:

(1) Is each of the counties (or comparable US jurisdictions) proposed for study identified consistently by its name and state?

(2) For each county chosen, are current population estimates provided in tabular or graphic form, including distributions at least by sex, age, and major ancestral groups?

(3) For each county chosen is evidence provided (in a table or list) establishing a high or low burden within the past five years of type 2 diabetes, as might be illustrated by diabetes prevalence, incidence, cause-specific mortality, or claims for medical care?

(4) For each county chosen, is evidence provided (in a table or list) establishing a high or low burden within the past ten years of a related cardiometabolic condition, as might be illustrated by prevalence, incidence, or other data collected through systematic sampling of the community?

(5) Does the applicant identify external or institutional partners associated with the research proposal? If yes, is there a recent letter of support from that proposed partner which details the terms of access to data and populations and any specified limits to collaboration?

(6) Is the amount requested by the applicant for year one or for the total award period not greater than the ceiling amount specified for that period?

Component B:

(1) Consistent with information in the Research & Related Senior/Key Person Section of the SF424 (R&R), does the application support one or more statisticians or epidemiologists with established interests in multilevel analysis? For at least one of these researchers is there a referenced publication that addresses statistical methods (e.g., nested or hierarchical modeling), including the study of variations by geographical place?

(2) Consistent with information in the Research & Related Senior/Key Person Section of the SF424 (R&R), does the application support at least one staff member with training and/or expertise relevant to developing an active website for the coordination of research protocols and parallel data collection by scientific staff located in varied research environments?

(3) Is the amount requested by the applicant for year one or for the total award period not greater than the ceiling amount specified for that period?

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.

https://en.wikipedia.org/wiki/Statistical_model https://en.wikipedia.org/wiki/Parameter 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

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) per component is allowed. If an applicant organization intends to apply to more than one component in this FOA, applicant must submit separate applications for each component applying to.

Applications should clearly indicate the Component for which the applicant is applying and should include at the beginning of the title, the respective component under which the application should be considered (i.e., Component A or Component B.)

As defined in the HHS Grants Policy Statement, (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html), 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.

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: 01/13/2017 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 1/13/17 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) http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform…