RFA-DP-17-003.pdf

Centers for Disease Control

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

Natural Experiments of Policy and Built Environment Impact on Diabetes Risk

RFA-DP-17-003

Application Due Date: 02/13/2017

Natural Experiments of Policy and Built Environment Impact on Diabetes Risk

RFA-DP-17-003

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 Natural Experiments of Policy and Built Environment Impact on Diabetes Risk Activity Code U18

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-DP-17-003

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.945 Category of Funding Activity Health FOA Purpose This FOA has two components, A and B.

Component A: To support a 5-year multi-center research network of innovative, non-health system-based, natural experiments approaches to alter the diabetogenic characteristics of US communities. 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 diabetes.

Component B: To fund a Central Coordinating Center (CCC) to provide organizational, logistic and communication support to enhance the efficiency, productivity, and 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-17-003, 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: 01/09/2017 Is a LOI: Recommended but not Required

Application Due Date: 02/13/2017

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

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

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

Scientific Merit Review: 04/01/2017

Secondary Review: 05/01/2017

Estimated Start Date: 09/30/2017

Expiration Date: 02/14/2017 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. Component A: To support a 5-year multi-center research network of innovative, non-health system-based, natural experiments approaches to alter the diabetogenic characteristics of US communities. 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 diabetes. Component B: To fund a Central Coordinating Center (CCC) to provide organizational, logistic and communication support to enhance the efficiency, productivity, and impact of the Natural Experiments research centers that are funded as part of Component A.

Mechanism of Support. Cooperative Agreement Funds Available and Anticipated Number of Awards. It is anticipated up to 4 awards will be issued under Component A and one award under Component B in response to this FOA. For Component A, an applicant may request up to $675,000 per year for up to five years. For Component B, an applicant may request up to $300,000 per year for up to five years. These estimates include direct and indirect costs. 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 Component A and B) for the first budget period, September 30, 2017 to September 29, 2018, will be $3,000,000. For Component A, the estimated funding per award in the first year is $675,000. For Component B, the estimated funding per award in the first year is $300,000. The estimated total funding (direct and indirect) for the entire project period will be $15,000,000. The entire 5 year project period will run http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf from September 30, 2017 to September 29, 2022.

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.

Number of Applications. Only one application per institution (normally identified by having a unique DUNS number) per component is allowed. Eligible applicants may apply for Component A or both components (A and B). If an applicant organization intends to apply to more than one component in this FOA, the applicant must submit separate applications for each component. Applicants must submit an eligible application under Component A in order to apply under Component B. The PI for Component A may be different than the PI for Component B.

Application Type. New Special Date(s). N/A.

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 Section 301(a) of the Public Health Service Act (PHS Act), 42 U.S.C.

241.(a) and 247(b).

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 decline in the rates of diabetes-related complications, there remains a considerable preventable burden of diabetes complications and continued high rates of diabetes prevalence nationally. Altering the course of the diabetes epidemic will require a diverse armamentarium of effective changes in policies as well as 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.

While prevention of type 2 diabetes 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. In particular, diet and physical activity play major roles in the development, and thus the potential prevention of type 2 diabetes and its complications. As such, food and agricultural policies and programs, as well as legislative and community-based approaches that alter the environment to promote active living and enhance physical activity levels, may play a large role in affecting diabetes risk at the individual and population levels. Many innovative approaches to change the availability 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 of healthy foods through incentives and taxation, and efforts to improve food and physical activity environments through neighborhood and urban planning, have not been rigorously examined. For example, 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 will all benefit from rigorous evaluation of the behavioral, economic, health impact, or unintended consequences.

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 initiative by the Department of Housing and Urban Development (HUD)1, 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.

The lack of evidence for the health impact of such population-targeted policies is in part due to the types of research that have been traditionally employed in public health sciences. Observational epidemiologic studies are not optimal, 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 diverse data sources, including surveys, administrative, and non-traditional data sources that may be useful in assessing the impact of health policies – 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. Rigorous scientific evaluation of such policies or programs can help build an evidence base to better inform public policy approaches to prevent type 2 diabetes by encouraging healthier diets and increased physical activity, and ultimately improving diabetes-related health outcomes. This FOA is designed to promote rigorous study of high impact programs or policy interventions for prioritization in the public health response to prevent type 2 diabetes and its complications.

This FOA is designed to stimulate and support natural experiments of population-targeted policies and large-scale interventions to prevent type 2 diabetes and its complications. Specifically, the purposes of this FOA are to: (1) Component A: support a 5-year multi-center research network of innovative, non-health system-based, natural experiment approaches to alter the diabetogenic characteristics of US communities;

and (2) Component B: improve the methods and infrastructure for natural experiments in public health.

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. The overall goal is 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, community organizations, or businesses.

Policies to be evaluated 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, worksites or school districts. Examples include, but are not limited to, the development of supermarkets in underserved areas (or the development of poorer neighborhoods in general), calorie labeling requirements, taxes on foods and/or beverages, modification/improvements to environments that promote active living, such as zoning/laws that include cycling paths/lanes, parks, or sidewalks, or incentives – either financial or otherwise

– to encourage people to use active transport (walking and cycling) over cars. Programs are defined as a set of activities initiated by governmental or other organizational bodies, with the potential to contribute to diabetes prevention and control. Examples might include programs implemented in communities that can be expected to improve diet- and physical activity- related type 2 diabetes prevention behaviors. This FOA is not intended to support the initiation and delivery of new programs; rather, it is intended to support evaluation of the effectiveness of programs and/or policies that are being or will be implemented regardless of CDC grant funding. In addition, this FOA is not intended to support the evaluation of policies implemented in health-care systems.

There are two components to this FOA. Component A will fund a network of independent research centers to conduct novel non-health system-based natural experiments. Component B will fund a coordinating center to provide logistical and communications support to the network to enhance the methodological quality and public health impact of the natural experiments.

Healthy People 2020 and other National Strategic Priorities Component A and B:

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

Determinants of Health: Identify aspects of social and physical environments that can be improved to promote good health for all.

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

The 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.

It is also aligned with the following performance goal for the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP):

Monitor, prevent, delay, detect and control chronic disease, to achieve health equity by eliminating health disparities and achieving optimal health for all Americans.

Public Health Impact This activity is designed to impact population health by identifying and prioritizing large-scale diet- and

This activity is designed to impact population health by identifying and prioritizing large-scale diet- and physical activity-related strategies to reduce type 2 diabetes risk factors and 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 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 FOA builds on prior work funded by CDC and NIH (FOA #DP10-002), including the Natural Experiments in Translation for Diabetes (NEXT-D), a multi-center network of natural experiments, and its follow-up network (FOA #DP15-001). The former network has published a manuscript on this work.

However, these two focused mainly on natural experiments within health care settings, and thus major gaps remain in how natural experiments outside of health care settings might impact health behaviors and diabetes-related health outcomes. This FOA aims to fill those gaps by focusing on natural experiments that occur outside of the health sector (e.g., in the food/agricultural policy and built environment policy arena).

2. Approach This FOA is comprised of two components. Component A (Natural Experiment Research Centers): Supports Natural Experiments Research Centers to design and conduct rigorous longitudinal studies of naturally occurring, population-targeted, non-health system-based policies and large scale interventions on the risk of diabetes, its complications, and economic impact. Component B (Coordinating Center): supports a Coordinating Center to provide logistic and communications support to the full network of Natural Experiments Research Centers funded through this FOA. Applicants may apply for Component A alone or both Components A and B. For those who apply for both, a separate application is required for each submission. In addition, applicants for Component B must have an eligible application under Component A in order to apply for and be awarded under Component B. In order for an institution to be awarded funds for Component B, it must also have been successfully awarded funding for Component A.

For Component A, studies should focus on ongoing, naturally occurring, or imminently available policy or population-level interventions or on quasi-experimental designed studies that target large populations (minimum population size affected should be 10,000 individuals). Policies or interventions may include 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. 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.

Investigators are particularly encouraged to identify opportunistic, 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 and impact of 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. Innovative scientific partnerships between researchers and public or private partners (e.g., community based organizations, local governments, employers) are also encouraged.

Examples of research topics may include, but are not limited to:

Economic incentives and disincentives, such as subsidies, taxes, and vouchers, to promote healthy lifestyle and community programs.

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

Laws aimed at consumer information such as citywide menu labeling statutes.

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.

Infrastructure initiatives, such as retailers offering healthier food options in underserved areas.

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

Laws, policies, and interventions that shape the built environment (e.g., urban planning, land use, and transportation-related laws) to increase physical activity.

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

Improvements or modifications in housing and urban development policies, either those that explicitly seek to improve health behaviors and 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.

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

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

Investigators are encouraged to assemble diverse sources of data, including those available from public survey data. Applicants should have ready access to essential data on exposure and outcomes at the outset of the funding period. Interventions to be evaluated should be assessed at multiple levels where possible: e.g., system-wide, communities, or clusters of individuals. Studies are expected to assess population-targeted policies as well as indicators of uptake and health at the population-level. Studies should also examine the costs, adverse effects, and unintentional consequences of policies. 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, usage statistics on public structures to promote physical activity (e.g., sidewalk, bicycle paths, bicycle lanes). Cohort and panel survey data may be employed, provided they permit examination of study interventions that are applied and targeted at large segments of the population. Applicants are also strongly encouraged to incorporate data from non-traditional sources.

Component A of this FOA 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, nor intended to fund the implementation of new programs or interventions.

Objectives/Outcomes This announcement will fund and support a 5-year multi-center research network of innovative, non-health system-based, natural experiment approaches to alter the diabetogenic characteristics of US communities.

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.

Component A (Natural Experiments Research Centers)

Specific objectives are to:

design and develop studies to test the effectiveness of an identified policy or population-level intervention.

1.

identify a target population2.

evaluate/test the effectiveness of policy/system change, focusing on diabetes and cardiometabolic risk3.

factors or intermediate outcomes of behavior change.

analyze and disseminate study findings 4.

Studies should investigate the effects of policies on systems changes, changes in uptake on the intervention (for example, increased population use of a newly designed bike/walking path); behavioral changes;

physiological risk factors; and the risk of type 2 diabetes and its complications, including the effects on morbidity, age of onset, and quality of life.

Component B: (Coordinating Center)

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 between collaborating centers 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:

Design and develop an approach for establishing an ongoing network structure of Component A grantees and institutions, and the funding agency.

1.

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.

2.

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.

3.

Work with the full network of cooperative agreement grantees and the funding agency 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.

4.

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

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

5.

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 public access section to the website.

6.

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

7.

Target Population Component A: Proposals should examine exposures and outcomes across broad populations, 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. Similarly, the impact of natural experiments on diabetes, its risk factors, and complications, should be expressed at the community or population level. Applicants are encouraged to aim for a minimum impacted population size of 10,000 individuals.

Component B: Not applicable.

Collaboration/Partnerships Component A: Evaluation/performance measurements should include quality and completeness of study

Component A: Evaluation/performance measurements should include quality and completeness of study design approaches, study and analytic protocol, procurement and/or collection of key data, timely conduct of analyses, and dissemination of data in the form of peer-reviewed publications and scientific presentations.

Evaluation should include assessment of degree to which the research fills important research gaps and assess outcomes of important health impact, including risk of diabetes, its complications, and cardiovascular disease.

Specifically, research should focus on approaches to reduce type 2 diabetes and cardiometabolic risk factors (e.g., reduced HbA1c, blood pressure, cholesterol levels, weight/BMI) 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 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 methods such as the International Physical Activity Questionnaire, 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.

Component B: Evaluation/performance should address measurements of quality of the coordination of network 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, travel to face to face meetings, and resolve day-to-day issues of the network and to maintain study-wide timeline management.

Facilitate the exchange of abstracts, manuscripts, presentations, fact sheets, and other scientific materials among the collaborating centers and the funding agency.

Evaluation/Performance Measurement

Translation Plan Component A: Applicants for Component A will be expected to publish findings in peer-reviewed publications, present findings at scientific meetings, formal briefings for health and public policy makers, and use diverse methods, including the study website, policy briefs, and social media to disseminate findings widely to diverse policy makers. The rigorous scientific evaluation of food policies and built environment interventions will provide an evidence base to better inform public health policy approaches to prevent type 2 diabetes and its complications.

Component B: 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.

OMB/PRA is not expected to apply.

Section II. Award Information

Funding Instrument Type: Cooperative Agreement A support mechanism used when there will be substantial Federal

A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

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

Estimated Total Funding: $15,000,000 The estimated total funding (direct and indirect costs) for the first budget period is $3,000,000, and the estimated total funding (direct and indirect) for the entire 5 year project period is $15,000,000.

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

Anticipated Number of Awards: 5 Component A: It is anticipated that each budget year up to 4 award(s) of approximately $675,000 per recipient (direct and indirect costs) will be made under this RFA-DP-17-003.

Component B: It is anticipated that each budget year up to 1 award of approximately $300,000 will be made to a single grantee (direct and indirect costs).

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

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

Award Ceiling: $675,000 Per Budget Period The ceiling amounts for the first 12-month budget period are (including both direct and indirect costs):

Component A: $675,000

Component B: $300,000

Applications with budget requests greater than the ceiling will be considered non-responsive and will not be reviewed. This ceiling is only for the first 12-month project period.

Award Floor: $0 Per Budget Period There is no floor amount for this funding opportunity announcement.

Total Project Period Length: 5 year(s) The project period for this FOA is 5 years and will run from September 30, 2017 to September 29, 2022.

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.

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

Section III. Eligibility Information

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

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

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

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

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

3. Special Eligibility Requirements

Component A: Applicants must have letters of commitment from partners to show continuous access to datasets and/or data systems proposed for the study), or access to other data sources or populations needed to accomplish study objectives (i.e. data use agreements) for ready access to data in order to assess the uptake/usage, behaviors, and health status impact for populations of at least 10,000 individuals. Agreements must also be in place that allow for unrestricted publication of findings regardless of study outcomes.

Component B: Applicants must have an eligible application under Component A to apply for Component B, and must be awarded under Component A in order to be awarded under Component B.

Evidence of these Special Eligibility Requirements should be placed in Appendix A of the application.

4. Justification for Less than Maximum Competition N/A

5. Responsiveness Component A: Applicants should show evidence of a data use agreement (in the form of a letter of commitment or memorandum of understanding) that demonstrates continuous access to datasets and/or data systems needed to accomplish study objectives.

Applicants must also provide verification (in the form of a table) that the data for the proposed study meets minimum sample size (i.e., 10,000 individuals).

Component B: Applicants must provide a statement of submission of application for Component A under the current RFA and include the principal investigator (PI) name and title of the application.

Evidence of these Special Eligibility Requirements should be placed in Appendix A of the application.

Applications with budgets exceeding the ceiling will be deemed non-responsive and not entered into the review process.

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

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato. int/AC135Public/Docs/US%20Instructions%2 0for%20NSPA%20NCAGE.pdf System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed 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 system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/#1.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes.

The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

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

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

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

Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

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

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

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

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.

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: 01/09/2017 Is a LOI: Recommended but not Required Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.

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

Name of the Applicant

Descriptive title of proposed research (include the Component applying to)

Name, address, and telephone number of the PD(s)/PI(s)

Names of other key personnel

Participating institutions http://www.Grants.gov mailto:pgotim@cdc.gov http://grants.nih.gov/grants/how-to-apply-application-guide.htm http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf http://grants.nih.gov/grants/forms.htm

Participating institutions

Number and title of this funding opportunity

The letter of intent should be sent electronically to:

Natalie J Darling

Scientific Program Official

Extramural Research Program Operations and Services

Centers for Disease Control and Prevention

4770 Buford Highway, NE

Mailstop F-80

Atlanta, GA 30342

Telephone: (770)-488-5740

Email: ndh6@cdc.gov

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

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here:

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description).

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

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research…