PKG00256906-instructions.pdf

Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion Extramural Research

Program Office

Natural Experiments of the Impact of Population-targeted Policies to Prevent Type 2 Diabetes and Diabetes Complications

RFA-DP-20-002

Application Due Date: 02/04/2020

Natural Experiments of the Impact of Population-targeted Policies to Prevent Type 2 Diabetes and Diabetes Complications

RFA-DP-20-002

TABLE OF CONTENTS

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

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

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations National Center for Chronic Disease Prevention and Health Promotion Notice of Funding Opportunity (NOFO) Title Natural Experiments of the Impact of Population-targeted Policies to Prevent Type 2 Diabetes and Diabetes Complications Activity Code U18

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

RFA-DP-20-002

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

Health NOFO Purpose

Component A: Natural Experiment Research Centers to support a 5-year multi-center network of independent research centers to evaluate innovative, health system and non-health system-based natural experimental approaches that alter the diabetogenic characteristics of US communities. Applicants must select only one of the following two tracks:

o Track 1 Evaluation of population-level programs or policies that affect population-level risk factors for type 2 diabetes (such as diet or physical activity, as well as other health behaviors; glucose; prediabetes), or o Track 2 Evaluation of programs or policies aimed at improving care and management of diabetes, and the risk for diabetes complications.

Component B: Coordinating Center to provide organizational, logistic and communication support to enhance the efficiency, productivity, and public health impact of the Natural Experiments research centers that are funded as part of Component A.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-20-002, 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.

https://www.grants.gov

Letter of Intent Due Date: 01/06/2020

Application Due Date: 02/04/2020

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

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

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

Scientific Merit Review: 03/31/2020

Secondary Review: 05/12/2020

Estimated Start Date: 09/30/2020

Expiration Date: 02/05/2020 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

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

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

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

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

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

Executive Summary o Purpose.

Component A: Natural Experiment Research Centers to support a 5-year multi-center network of independent research centers to evaluate innovative, health system and non-health system-based natural experimental approaches that alter the diabetogenic characteristics of US communities. Applicants must select only one of the following two tracks: Track 1 Evaluation of population-level programs or policies that affect population-level risk factors for type 2 diabetes (such as diet or physical activity, as well as other health behaviors; glucose; prediabetes), or Track 2 Evaluation of programs or policies aimed at improving care and management of diabetes, and the risk for diabetes complications.

Component B: Coordinating Center to provide organizational, logistic and communication support to enhance the efficiency, productivity, and public health impact of the Natural Experiments research centers that are funded as part of Component A.

o Mechanism of Support. Cooperative Agreement o Funds Available and Anticipated Number of Awards. The estimated total funding (direct and indirect) for the 5-year period of performance, September 30, 2020 to September 29, 2025, is $12,500,000 to fund up to six (6) awards in two Components:

Component A: Natural Experiment Research Centers Number of Awards - Up to five (5), however, there is the possibility of more awards, should additional funding becoming available.

Estimated total funding: $11,250,000 Component B: Coordinating

Number of Awards - One (1) Estimated total funding: $ 1,250,000

Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded, and the number of awards will depend upon the number, quality, duration and cost of the applications received.

o Budget and Period of Performance. For Component A: Natural Experiment Research Centers, the estimated funding per award in the first budget year is $450,000 (direct and indirect). For Component B: Coordinating Center, the estimated funding per award in the first budget year is $250,000 (direct and indirect). The estimated total funding (direct and indirect) for the 5-year period of performance, September 30, 2020 to September 29, 2025, is $12,500,000.

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

o Eligible Institutions/Organizations. Institutions/organizations listed in Section III are eligible to apply.

o 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.

o 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.

o Number of Applications. 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 NOFO, the applicant must submit separate applications for each component. To be funded for Component B, applicants must apply for and be funded for Component A. The PI for Component A may be different from the PI for Component B.

o Application Type. New o Special Date(s). N/A o Application Materials. See Section IV.1 for application materials. Please note that Form E is to be used when downloading the application package.

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

TTY: 1-888-232-6348.

The link to this NOFO is available at https://www.cdc.gov/chronicdisease/programs-impact/nofo/index.htm

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority This program is authorized under Section 317(k)(2) of the Public Health Service Act (PHS Act), 42 U.S.C. 247b(k)(2) and Section 301(a) of the PHS Act, 42 U.S.C. 241(a).

https://www.cdc.gov/chronicdisease/programs-impact/nofo/index.htm https://www.cdc.gov/chronicdisease/programs-impact/nofo/index.htm

1. Background and Purpose Diabetes is one of the nation's leading public health threats and a key target of public health interventions and policy reform. Despite improvements in clinical care and the rates of diabetes-related complications, there remains a considerable preventable burden of diabetes and its complications. Altering the course of the diabetes epidemic will require a diverse array of effective changes in policies and the environments in which people live, work, and play. Such changes may be achieved via population health promotion, improving community resources, enabling access and delivery of preventive services, or policies to change the diabetogenic aspects of U.S. communities, and policies and practices to improve care and management of diabetes.

In particular, diet and physical activity play major roles in the development and potential prevention of type 2 diabetes and diabetes complications. Food and agricultural policies and programs, as well as public policy, planning, legislative, and community-based initiatives that alter the built environment to enhance physical activity levels, may play a large role in affecting diabetes risk at the individual and population levels. However, while prevention of type 2 diabetes and diabetes complications is a critical public health goal, relatively little is known about the effectiveness of large-scale policies and programs that could help achieve this goal at the population level, or any differential effects on sub-populations. Rigorous scientific evaluation of such policies and programs can help build an evidence base to inform public policy approaches to prevent type 2 diabetes and diabetes complications by encouraging healthier diets and increased physical activity.

To date, studies evaluating innovative policy approaches to change the availability of healthy foods through incentives and taxation, or efforts to improve food and physical activity environments through neighborhood and urban planning, have been limited, and relatively scattered across the landscape. For example, sugar-sweetened beverage taxes have received a relatively large evaluation focus in recent years, from US cities like Berkeley and Philadelphia, to Mexico – while recent legislation for menu or front-of-package calorie and nutrition labelling, school food programs (including school fruit and vegetable gardens), and changes to foods eligible for Supplemental Nutritional Assistance Program (SNAP) benefits, such as Wholesome Wave, have all proceeded with little empirical evaluation of the behavioral, economic, and health impact, or unintended consequences.

The Community Preventive Services Task Force recommends built environment strategies that combine one or more interventions to improve pedestrian or bicycle transportation systems with one or more land use and environmental design interventions to increase physical activity.

There are several evidence gaps however that remain to be filled through longitudinal assessments of policy, systems, and environmental intervention approaches. Studies describing both the implementation and evaluation of coordinated built environment approaches, such as Complete Streets, would strengthen the evidence base and provide direct guidance and support to help community, urban, and regional planners. More studies are needed to evaluate combinations of micro-scale interventions in different settings and populations. Additional research is needed to assess intervention effectiveness among different populations including racial and ethnic minorities and people with lower socioeconomic status, and in different settings that may lack activity-supportive environments and services.

Additionally, public policy approaches that may not have the primary goal of changing health behaviors nor health outcomes, but that nonetheless have implicit health-related impacts, are important to consider as potentially large levers in impacting individual and population health behaviors and outcomes. One such example is the 1994-1998 Moving to Opportunity for Fair Housing (MTO) initiative by the Department of Housing and Urban Development (HUD), a designed experiment whereby women with children living in public housing in high-poverty urban census tracts (in which 40% of residents had incomes below the federal poverty threshold) were randomly assigned to one of three groups: (1) received housing vouchers, which were redeemable only if they moved to a low-poverty census tract (where <10% of residents were poor), and counseling on moving; (2) received unrestricted, traditional vouchers, with no special counseling on moving; and (3) offered neither of these opportunities. Although health was not the primary motivation for the initiative, results showed that the opportunity to move from a neighborhood with a high level of poverty to one with a lower level of poverty was associated with significant reductions in the prevalence of extreme obesity and diabetes. [1] The lack of evidence for the health impact of population-targeted policies and changes to the built environment is in part due to the types of research that have been traditionally employed in public health sciences. Observational epidemiological studies are not optimal, and randomized controlled trials and cluster-randomized trials are not feasible to study the impact of large-scale health policy interventions. However, novel methods — particularly those employing the use of 'big data' — exist to rigorously examine the impact of naturally occurring interventions through elements of the study design, sample selection, evaluation and control for bias and confounding, and statistical analyses.

This NOFO is designed to promote rigorous study of high impact programs and policy interventions for prioritization in the public health response to prevent type 2 diabetes and diabetes complications. This NOFO builds upon previous work from the Division of Diabetes Translation (RFA #DP-15-001) using the Natural Experiments approach, which focused on healthcare and health sector policies such as Medicaid expansion and Health Homes, new models of coordinated health care, high deductible health plans, obesity counseling in primary care settings, and State Innovation Models for healthcare payment and delivery systems. This NOFO will fill the gap in evaluation of non-health sector policies, with an emphasis on community-based, upstream policies and approaches, while continuing to build evidence for clinical care improvement practices to reduce complications in people with diabetes.

This NOFO aims to promote and provide a platform and framework for the rigorous study of the health impact of new and imminently available population-targeted diabetes-related programs and policy innovations by federal, state, local governments, healthcare organizations, community organizations, or businesses. A major goal is to construct an optimal multi-sectoral approach to preventing type 2 diabetes and diabetes complications – whether in the form of a set of multi-sectoral evidence-based strategies and interventions, or a toolkit for integrated approaches for population-wide policies – that is guided by key organizations or multi-sectoral entities that might be motivated to act. A secondary goal is to reduce disparities in diabetes-related risk factors, as well as type 2 diabetes itself and diabetes complications.

Healthy People 2020 and other National Strategic Priorities This NOFO supports the Diabetes Healthy People 2020 objectives D1: "To reduce the number of new cases of diabetes in the population by 10%" to D-16: "Increase prevention behaviors in persons at high risk for diabetes with prediabetes by 10%."

The NOFO supports the CDC strategic framework to reduce the number of new diabetes diagnoses from 1.4M in 2018 to 1.1M cases per year by 2025 (https://www.cdc.gov/about/organ ization/strategic-framework/index.html)

Public Health Impact This NOFO is designed to impact population health by identifying and prioritizing large-scale strategies that reduce type 2 diabetes-related risk in the population (including diet and physical activity), and policies to improve care and management of diabetes, and to reduce the risk for diabetes-related complications. Specifically, results from this work could point to key interventions that have the impact to shift entire populations towards healthier diet- and physical activity-related behaviors, and subsequent diabetes-related health outcomes. The focus of Track 1 on policies and interventions that lay outside of health systems will provide the opportunity for learning how communities and societies might improve health behaviors and outcomes through non-traditional pathways.

Relevant Work This NOFO builds upon previous NOFOs sponsored by the CDC’s Division of Diabetes Translation using the Natural Experiments approach, which focused on healthcare and health sector policies such as Medicaid expansion and Health Homes, new models of coordinated health care, high deductible health plans, obesity counseling in primary care settings, and State Innovation Models for healthcare payment and delivery systems. Specifically, this work was part of the Natural Experiments in Translation for Diabetes (NEXT-D) , RFA #DP10-002 and NEXT-D2 (RFA #DP15-001) multi-center research networks, funded by CDC in partnership with National Institutes of Health/National Institute of Diabetes, Digestive, and Kidney Diseases (NIH/NIDDK) and Patient-Centered Outcomes Research Institute (PCORI; NEXT-D2 only). This new NOFO will fill the gap in evaluation of non-health sector policies, with an emphasis on community-based, upstream policies and approaches, along with clinical care improvement practices to reduce complications in people with diabetes. A major goal for this NOFO is to construct an optimal multi-sectoral approach to preventing type 2 diabetes, as well to address disparities in type 2 diabetes and risk factors, and to reduce diabetes-related complications. This particular NOFO is intended to complement but be fully non-redundant with the other program while taking advantage of the experience in organization and methodology gained by NEXT-D and NEXT-D2.

2. Approach There are two components to this NOFO.

Component A: Natural Experiment Research Centers will fund a network of independent research centers to conduct novel health system and non-health system-based natural experiments through the rigorous health and economic evaluation of ongoing, new, or imminently available population-targeted diabetes-related programs and policies by federal, state, local governments, healthcare organizations, community organizations, or businesses.

Component B: Coordinating Center will fund a coordinating center to provide logistical and communications support to the network to enhance the methodological quality and public health https://www.cdc.gov/about/organization/strategic-framework/index.html https://www.cdc.gov/about/organization/strategic-framework/index.html impact of the natural experiments. Awardees for both Component A: Natural Experiment Research Centers and Component B: Coordinating Center will actively participate in the research network, including the Network Steering Committee and network subcommittees.

Applicants may apply for Component A alone or both Component A and Component B. If applicants choose to apply for both Component A and B, a separate application must be submitted for each Component. To be funded for Component B, applicants must apply for and be funded for Component A.

Component A: Natural Experiment Research Centers Independent Natural Experiments Research Centers will design and conduct rigorous evaluation or comparative effectiveness research studies of naturally-occurring ongoing, new, or imminently available population-level, health system or non-health system-based policies and large-scale intervention programs on the risk of diabetes and its complications. Each applicant for Component A must select only one program or policy to evaluate. Alternatively, applicants may choose to focus on comparative effectiveness research, by designing their evaluation to compare the implementation of different programs or policies.

Policies may include both formal public policies at local, state and federal levels of government, and organizational level policies, such as those implemented by large organizations (including companies or businesses), worksites, or school districts. Program is defined as a set of activities initiated by governmental or other organizational bodies, with the potential to contribute to type 2 diabetes prevention and/or diabetes control. The policy or program to be evaluated should be ongoing (naturally occurring), new, or imminently available, and expected to reasonably affect behaviors relevant to type 2 diabetes prevention and/or prevention of diabetes-related complications, either explicitly (by design) or implicitly (as a more secondary, passive health impact).

Specific objectives are to:

1. design and develop evaluation or comparative effectiveness research studies to test the effectiveness of an ongoing (naturally occurring), new, or imminently available population-level policy or program

2. identify a target population (minimum population size affected should be 10,000 individuals)

3. evaluate/test the effectiveness of policy/system change at multiple levels where possible (e.g., system-wide, communities, or clusters of individuals), focusing on diabetes and cardiometabolic risk factors or intermediate outcomes of behavior change

4. analyze and disseminate study findings

Applicants are encouraged to identify opportune, natural experiments wherein accessible comparable control data can be assembled and confounders and biases can be limited through study design, sample selection, and to a lesser extent, statistical analysis. Studies should employ rigorous designs that provide inferences about the effectiveness/comparative effectiveness and impact of health sector policies, food/agricultural policies or changes to the built environment, or public policies that may not explicitly intend to improve health behaviors and diabetes-related health outcomes. Investigators are encouraged to propose both quasi-experimental studies such as pre-post intervention designs with concurrent control conditions where possible, historical trends or interrupted time series designs. Studies are expected to assess population-level policies as well as indicators of uptake (including health care) and health at the population-level. Studies should also examine the costs, adverse effects, and unintentional consequences of policies. Applicants should plan to engage stakeholders (including patients, where applicable) in their research process (planning and execution) and to ensure that stakeholders support the selected study outcomes.

Applicants should have ready access to essential data on exposure and outcomes at the outset of the funding period, and are encouraged to assemble diverse sources of data, including but not limited to:

o public survey data o medical information systems such as electronic medical records o non-traditional sources (including big data) o cohort and panel survey data (provided the data permit examination of study interventions that are applied and targeted at large segments of the population)

This NOFO is not intended to fund cross-sectional studies, cohort studies with only individual-level exposure and outcomes, simple pre-post designs without an appropriate comparison. This NOFO is not intended to support the initiation and delivery of new programs; rather, it is intended to support rigorous evaluation of the effectiveness of programs and/or policies that are being or will be implemented regardless of CDC grant funding.

Component A: Natural Experiment Research Centers is divided into two tracks: Track 1 will be focused on programs or policies that affect type 2 diabetes-related risk in the population (including diet or physical activity or other health behaviors; glucose; prediabetes) and Track 2 will be focused on programs or policies aimed at improving care and management of diabetes, and the risk for diabetes complications. Applicants must focus their research plans on only one of these two tracks.

Track 1:

Applicants under Track 1 should target policies and interventions that are outside of the health sector. Priority areas include population-level approaches to the promotion of healthy eating and active living by evaluating the impact of environmental and policy interventions on population-level risk factors for type 2 diabetes.

Policies or programs may include public policy, planning, legislative, and community-based initiatives that are aimed at influencing overall health promotion, type 2 diabetes prevention behaviors, and the health of broad segments of the population. Examples of programs might include those implemented in communities that can be expected to improve diet- and physical activity-related type 2 diabetes prevention behaviors. Public policies that do not have the primary purpose of improving health may also be studied. However, the policy or program to be evaluated should reasonably be expected to affect behaviors relevant to type 2 diabetes prevention (i.e., diet/nutrition and physical activity).

Examples of Track 1 programs and policies may include, but are not limited to:

o Economic incentives and disincentives, such as pricing strategies (e.g., increasing the price of unhealthy foods/beverages/ultra-processed foods or decreasing the price of healthy foods like fruits and vegetables) or other price changes/incentives (e.g. vouchers or subsidies) to promote healthy lifestyle and community programs;

o Policies expected to influence available options and purchasing, such as menu or food product reformulation, and supermarket layout or pricing strategies;

o Laws aimed at consumer information and labeling (e.g., menu labeling, calorie labeling, warning labels, the upcoming added sugars label on the nutrition facts panel);

o Federal and state policies, regulations, and licensing fees on agricultural production, packaging, marketing, and availability of fruits and vegetables and the dietary practices of high-risk individuals;

o Infrastructure initiatives (such as the development of farmers markets or food co-ops) to offer healthier food options in underserved areas;

o Population-level approaches undertaken by large employers and institutions to promote healthy eating and/or active living;

o Incentive-schemes (either financial or otherwise) to encourage active transport, such as walking or cycling, over motorized transport;

o Laws, policies, and interventions that modify the built environment to encourage walking or cycling for transportation or leisure (such as the implementation of bike lanes in urban areas, multi-use trails, subsidies for public transit, upgrades of sidewalks, improved access to parks and recreation facilities, or housing and urban development policies);

o Zoning/laws to include parks or walking and cycling paths/lanes in new construction developments;

o Improvements or modifications in housing and urban development policies, either those that explicitly seek to improve health behaviors and type 2 diabetes-related health outcomes (such as the implementation of bike lanes in urban areas, multi-use trails, subsidies for public transit, upgrades of sidewalks, improved access to parks and recreation facilities) or those that seek to improve neighborhood environments independent of health behaviors and outcomes;

o Public policies or initiatives that seek to improve neighborhood environments and conditions through economic, environmental, or other approaches.

Studies should focus on approaches to reduce type 2 diabetes and cardiometabolic risk factors (e.g., reduced HbA1c, blood pressure, cholesterol levels, weight, body mass index) or improve intermediate outcomes of behavioral changes (e.g., decreased purchases of sugar-sweetened beverages; increased purchases of healthier foods like fruit and vegetables, or whole grains;

increased use of resources intended for physical activity), and/or improved individual- or population-level food consumption and physical activity (e.g., improved nutritional status or, where appropriate, reduced energy intake; activity changes such as reduced sedentary behavior or increased physical activity). Furthermore, proposed research should demonstrate that measures collected and evaluated will allow for meaningful and scientifically valid conclusions to be made about the effects of the policy or program on nutrition/physical activity and type 2 diabetes indicators. In the case of dietary intake, standardized and comprehensive methods (such as 24-hour recalls or food frequency questionnaires, for example) should be used as the primary measure of the outcome.

In the case of physical activity, standardized methodologies such as the recently-developed ACT24 web-based physical activity instrument or wearable activity monitors (i.e., accelerometers or pedometers) should be employed. Additional measures that provide information about the mechanism of effect, such as increased enrollment in fitness classes or increased number of fitness facilities, as well as evidence of the potential sustainability of the effects of the policies or programs, may also be used as secondary measures.

Data sources may include, but are not limited to, publicly available population survey data and special population surveys adapted for this project, sales data from large-scale chain supermarkets or other food outlets, and usage statistics on public structures to promote physical activity (e.g., sidewalk, bicycle paths, bicycle lanes).

Track 2 Applicants under Track 2 may target policies and interventions that are outside of the health sector or may involve interventions that are directly aimed at health systems and health care practices. Priority areas include population-level approaches to improving diabetes care and management, as well as prevention of complications, in either health care or community-based settings.

Policies or interventions may include legislative, health system-based, and community-based initiatives that are likely to influence health care practices that impact individuals with diabetes, management of diabetes and its complications. Applicants for Track 2 may choose to focus on public policy approaches (such as reimbursement policies by Centers for Medicare and Medicaid Services (CMS) and Medicaid aimed at screening, behavioral change for individuals with diabetes, or other aspects of diabetes care and complications) or on health system-community partnerships, defined as formal partnerships between clinical settings and community organizations, including employers (such as health system policies to reimburse for diabetes care services provided in communities, referral programs to community programs, and partnerships to improve diabetes care and management in communities).

Examples of Track 2 programs or policies may include, but are not limited to:

o Novel managed care and employer-based disease management approaches o Statutory and regulatory laws at all levels of government on access, delivery, outcomes, and cost of diabetes care o Insurance reimbursement policies and benefit designs on adoption, adherence, and effectiveness of health behavior improvement programs among those with diabetes o Changes in Medicare and Medicaid reimbursement policies on care and outcomes to manage diabetes and prevent complications o Economic incentives (such as subsidies or vouchers) to promote healthy lifestyle and community programs among the diabetes population o Population screening approaches implemented in health systems, employers, and community settings on changes in behavior, risk, and morbidity for individuals with diabetes o Complications prevention-focused quality improvement and disease management programs o Employer-based policies and incentives on health promotion, including 4-day work weeks, health club vouchers, etc.

o Population disease stratification, management and feedback tools, including laboratory-based registries and electronic health records o Management-focused quality improvement and disease management programs

Studies should investigate the effects of policies on systems changes; changes in health promotion for individuals with diabetes; care/management practices (quality, levels of implementation and coverage, costs); changes in uptake on the intervention; physiological risk factors; the risk of complications, including the effects on morbidity and age of onset; and/or quality of life. Although not required, applicants for Track 2 are encouraged to include patient-reported outcomes (physical and emotional).

Data sources may include health plan-based registries, administrative outcomes databases such as Medicare and Medicaid, and Healthcare Management Organizations (HMO) databases.

Component B: Coordinating Center will provide logistic and communications support to the full network of Natural Experiments Research Centers funded under Component A of this NOFO.

Objectives/Outcomes The objective of this component is to facilitate the interaction, productivity, and communication of a network of investigators conducting natural experiments to maximize study quality and impact. The Coordinating Center is expected to facilitate linkages among Component A:

Natural Experiment Research Centers awardees and other partners and provide a coordinated forum for communication and transfer of methodological advances in study design and analyses of natural experiments. Activities include:

1. Design and develop an approach for establishing an ongoing network structure of Component A: Natural Experiment Research Centers awardees and institutions, partner awardees and institutions, and the funding agency.

2. Develop and plan for maintenance of a governance and organizing structure for the network, including an executive committee, steering committee, communications committee, and a publications, presentation and ancillary committee.

3. Coordinate collaborative activities that will optimize the ability of the network to develop and use state-of-the-art methodological approaches for conducting natural experiments.

4. Work with the full network of cooperative agreement awardees, partner awardees, and the CDC to prepare meeting logistics for the study including agendas, securing meeting facilities such as negotiating and reserving hotel rooms; leasing of meeting rooms with meeting equipment for annual face-to-face meetings; and planning and preparing weekly and biweekly Executive and sub-committee meeting minutes, etc.

5. Arrange and conduct conference calls, webinars, and meetings for the network and committees.

6. Generate key points and action items from meetings; and facilitate communication between groups.

7. Develop and maintain an internal and external website for the study in accordance with CDC IT standards. Project website must be password protected for Study Group members and include a publicly accessible section.

8. Coordinate communication and dissemination activities for the network, including tracking of study publications and presentations, to maximize impact of study findings.

Target Population Component A: Natural Experiment Research Centers: Proposals under Track 1 and 2 should examine exposures and outcomes across broad populations of at least 10,000 individuals, including communities, states, or regions, and present background, pilot data on the characteristics of denominators, and where possible, levels of exposure to the policy interventions being examined. The impact of the natural experiment on type 2 diabetes risk factors and diabetes complications should be expressed at the community or population level.

Applicants are also encouraged to examine sub-populations of interest where known disparities exist, so that outcomes in these vulnerable populations may be compared to the population changes as a whole.

Component B: Coordinating Center: Not applicable.

Collaboration/Partnerships Component A: Natural Experiment Research Centers: Investigators are encouraged to form or expand innovative scientific collaborations/partnerships with researchers or agencies (e.g., community based organizations, local governments, employers) that have established interests in reducing the diabetes burden, or that do not have established interests but nonetheless may influence key levers in reducing the diabetes burden (such as influencing food or physical activity patterns). Such relationships could be useful for planning and/or execution of their focused research plans. Where applicable, applicants are encouraged to also engage with patients in their research process (including planning and execution).

Component B: Coordinating Center: As described throughout this NOFO, Component B will establish a Coordinating Center to promote collaboration among the awardees of Component A with the overall goal of accomplishing study goals, including planning and organizing a kick-off meeting for the network within two months of award, together with the CDC. Applicants are also expected to identify key partners and form or expand collaborations/partnerships that will facilitate accomplishment of study objectives.

Evaluation/Performance Measurement Component A: Natural Experiment Research Centers: For both Tracks 1 and 2, internal evaluation during the first project year should be measured by the refinements made to its study design, analytic protocol, commitments made to professional staffing and potential collaborators, and updated reviews of existing data that are relevant to the selected program or policy being evaluated.

In subsequent funded years, success should be measured by execution of the research plan, procurement and/or collection of key data, appropriate validation of data elements, timeliness of epidemiologic analyses, dissemination of data in the form of peer-reviewed publications and scientific presentations, and participation in the collaborative, multi-center research network.

Evaluation should include assessment of the degree to which the research fills important research gaps and assesses outcomes of important health impact, including risk of type 2 diabetes (Track 1) and diabetes complications (Track 2).

Component B: Coordinating Center: Evaluation/performance should address measurements of quality of promoting and facilitating a multi-center and collaborative environment among the award recipients, coordination of network conference calls and in-person meetings, 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: Coordinating Center shall have sufficient staff available to plan, coordinate, and travel to face-to-face meetings, and to 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: Natural Experiment Research Centers: Applicants for Component A (Tracks 1 and 2) 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.

Component B: Coordinating Center: Applicants for Component B will be responsible for developing a detailed communication and dissemination plan and coordinate communication activities of the work group, including a web-site and communication materials.

Section II. Award Information Funding Instrument Type: Cooperative Agreement A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

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

Estimated Total Funding: $12,500,000 The estimated total funding (direct and indirect) for the first budget period is $2,500,000, and the estimated total funding (direct and indirect) for the 5-year period of performance is $12,500,000. The total estimated funding for Component A is $11,250,000 ($2,250,000 per budget period) and the estimated funding for Component B is $1,250,000 ($250,000 per budget period).

Anticipated Number of Awards: 6

Component A Anticipated Number of Awards: Five (5) Award ceiling: $450,000 Award floor: $0 Component B Anticipated Number of Awards: One (1) Award ceiling: $250,000 Award floor: $0

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

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

Award Ceiling: $450,000 Per Budget Period Award Floor: $0 Per Budget Period Total Period of Performance Length: 5 year(s)

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

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

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

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

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 Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Additional Eligibility Category:

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

Hispanic-serving Institutions Historically Black Colleges and

Universities (HBCUs) Tribally Controlled Colleges and

Universities (TCCUs) Alaska Native and Native Hawaiian

Serving Institutions

Nonprofits (Other than Institutions of Higher Education):

Nonprofits (Other than Institutions of

Higher Education)

Governments:

Eligible Agencies of the Federal

Government U.S. Territory or Possession

Other:

Faith-based or Community-based

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

Federally Funded Research and Development Centers (FFRDCs):

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

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

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

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

3. Additional Information on Eligibility

Special Eligibility

Component A: Natural Experiment Research Centers

1. Applicants must have continuous access to datasets and/or data systems needed to accomplish the study objectives, including verification that the data for the proposed study meets the minimum sample size of 10,000 individuals.

2. Applicants must have approval for unrestricted publication of the study findings, regardless of study outcomes.

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

Component B: Coordinating Center

1. Applicants for Component B must submit an application for Component A: Natural Experiment Research Centers.

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

4. Justification for Less than Maximum Competition N/A

5. Responsiveness Component A: Natural Experiment Research Centers (Tracks 1 and 2)

1. Provide a letter of commitment, memorandum of understanding, or a data use agreement that demonstrates continuous access to data sets and/or data systems needed to accomplish study objectives, including verification (in the form of a table) that the data for the proposed study meets minimum sample size of 10,000 individuals. This evidence should be placed in Appendix A of the application.

2. Provide a letter or agreement that allows unrestricted publication of findings regardless of study outcomes, in Appendix A of the application.

Component B: Coordinating Center

1. Provide a copy of the face page of the organization's Component A application in Appendix A of the Component B application.

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

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

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov.