cdc-rfa-dp15-001amend2publication.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 Health Policies to Prevent Diabetes and its

Complications

RFA-DP-15-001

Application Due Date: 03/24/2015

Natural Experiments of the Impact of Population-targeted Health Policies to Prevent Diabetes and its Complications

RFA-DP-15-001

TABLE OF CONTENTS

Part 1. Overview Information

Key Dates Required Application Instructions Executive Summary

Part 2. Full Text

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

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office

(NCCDPHP ERPO)

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) Funding Opportunity Announcement (FOA) Title Natural Experiments of the Impact of Population-targeted Health Policies to Prevent Diabetes and its Complications Activity Code Amendment 2. March 10, 2015

Appendix A: "Questions from Potential Applicants and CDC Responses" added to Section VIII. "Other Information" "Eligible applicant institutions may submit more than one application to a component, provided that each application is scientifically distinct" added under Executive Summary, Number of Applications

Amendment 1. February 19, 2015.

Correction for eligibility of foreign organizations made in Section III. "Eligiblity Information", 2. "Foreign Organizations"

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

(NIDDK)

U18

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-DP-15-001

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

Health FOA Purpose Component A: To fund rigorous natural experiments of impact of population-targeted health policies and large scale interventions on risk and complications of diabetes, and reducing disparities in these risks and complications. Specific goals of the research program are to: 1) Test the health impact of naturally occurring health policies and interventions, including public health policies, clinical-community partnerships, and health system-wide strategies; and 2) Improve the methods and research infrastructure for natural experiments in public health. Findings could be used to inform the prioritization of policies and interventions for policy-makers, health plan directors, and community leaders.

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-15-001, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 02/24/2015 January 20, 2015

Application Due Date: 03/24/2015

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: 06/01/2015

Secondary Review: 06/01/2015

Estimated Start Date: 09/30/2015

Expiration Date: 03/25/2015 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this FOA. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

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

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

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

Executive Summary

Purpose. Component A: To fund rigorous natural experiments of impact of population-targeted health policies and large scale interventions on risk and complications of diabetes, and reducing disparities in these risks and complications.Specific goals of the research program are to: 1) Test the health impact of naturally occurring health policies and interventions, including public health policies, clinical-community partnerships, and health system-wide strategies; and

2) Improve the methods and research infrastructure for natural experiments in public health.

Findings could be used to inform the prioritization of policies and interventions for policy-makers, health plan directors, and community leaders. Component B: To fund a http://www.grants.gov http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

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. The participating organizations, NCCDPHP and NIDDK, intend to commit approximately $2,500,000 in FY 2015 to fund up to five awards under component A and one award under component B in response to this FOA.

An applicant under Component A may request a project period of up to five years and a total budget of up to $450,000 including direct and indirect costs each year. An applicant under Component B may request a project period of up to five years and a total budget of up to $250,000 direct and indirect costs each year. Awards issued under this FOA are contingent upon availability of funds and a sufficient number of meritorious applications.

Funding Source: This FOA is funded by CDC/NCCDPHP and NIDDK. Specifically, grantees will be supported by $2,000,000 from CDC/NCCDPHP and $500,000 from NIDDK.

For Component A, five awards of up to $450,000 each ($350,000 from CDC/NCCDPHP and $100,000 from NIDDK) are supported by both the CDC/NCCDPHP and NIDDK in FY2015.

Specifically, under Component A, grantees will be awarded CDC/NCCDPHP funds of up to $350,000 (direct and indirect costs) to support the design, conduct, analysis, and dissemination of the health impact of the natural experiment of study and NIDDK funds of up to $100,000 (direct and indirect costs) to support the design, conduct, analyses and dissemination of the economic impact analyses. For Component B, one award of up to $250,000 is supported by

CDC/NCCDPHP.

Budget and Project Period. The project period will run from 09/30/2015 to 9/29/2020. The estimated total funding for this FOA in the first year is $2,500,000 (direct and indirect), including $2,000,000 from CDC and $500,000 from NIDDK. For Component A, the estimated total funding in the first year is $2,250,000 ($1,750,000 funded by CDC/NCCDPHP and $500,000 funded by the NIDDK). For Component B, the estimated total funding in the first year is $250,000 provided by CDC/NCCDPHP. The estimated total funding for the entire project is $12,500,000.

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

Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1 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 must designate a PI. Applications may designate co-PIs, however, the first PI listed will be the designated PI and official “contact PI” for all correspondence.

Number of Applications. Eligible applicant institutions may submit one application for Component A and a separate application for Component B, if applying to both components.

For component A, the applicants must select one of the two tracks. Eligible applicant institutions may submit more than one application to a component, provided that each application is scientifically distinct.

Application Type. New Special Date(s). Not Applicable.

Application Materials. See Section IV.1 for application materials.

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

(770) 488-2783.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority

Awards are made under the authorization of Sections of the Public Health Service Act as amended and under the Code Federal Regulations. This program is authorized under Sections 301, 317(k)(2), 405, and 426 of the Public Health Service Act (42 USC §§ 241, 247b(k)(2), 284, and 285c).

1. Background and Purpose

Diabetes is one of the nation’s leading public health threats and a key target of public health interventions and health care reform because of the high prevalence, diverse comorbidities and extensive need for health services that follow. Despite improvements in clinical care and the rates of diabetes-related complications, there remains a considerable preventable burden of diabetes complications and continued increases in diabetes prevalence. Randomized controlled trials and observational cohorts have established a diverse evidence base for clinical and behavioral interventions, including lifestyle interventions, glycemic and cardiovascular disease risk factors control, and early screening to reduce diabetes and its complications. However, reducing the incidence of diabetes, and further reducing its complications, will depend upon population-targeted strategies, or health policies, to alter the health systems, communities, and behaviors in the population.

Policy-level innovations may come from private or public sectors and may work through health systems, business and community organizations, and through laws, ordinances, regulations, and enforcement. Policies are frequently aimed at expanding, changing, re-organizing services or increasing or redirecting resources to change health by affecting the health care people receive, the behaviors they engage in, or the social factors underlying their condition. For example, legislation at state and local levels frequently affect the coverage of services for diabetes care and prevention, incentives and availability of healthy foods and programs for physical activity and positive lifestyle changes. Similarly, large employers and health plans implement policies that affect the provision of preventive care, wellness programs, and the connection to community services. Policies outside the health sector, including changes to education, employment, and housing, may also have important effects on health status. Despite the diversity of innovative policies, there has been little rigorous empirical examination of such approaches.

The Need for Rigorously Evaluated Natural Experiments:

The lack of evidence for population-targeted policies is in part due to the types of research that have been traditionally employed in public health sciences. Neither traditional cohort studies nor randomized controlled trials are practical to test large scale policies and often not flexible enough to test the continual innovation in strategies employed by health systems and communities. However, methods 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. Along these lines, natural experiments have been defined as studies of the impact of population-wide interventions or policies on health or health care that make use of naturally occurring events and compare the effects of variation in exposure to interventions without manipulation by the experimenter (Craig et al., 2012). Similarly, the Medical Research Council has defined natural experiments as experimental studies that exploit natural or unplanned variation in exposure (variation that is not manipulated for the purposes of research) using a combination of design and analytical features that are meant to allow causal inferences to be drawn. (Medical Research Council, 2012) This FOA is designed to stimulate and support natural experiments of population-targeted policies and large-scale interventions to prevent diabetes and its complications. Specific goals of the research program are to: 1) Test the health and economic impact of naturally occurring health policies and interventions, including public health policies, clinical-community partnerships, and health system-wide strategies; and 2) Improve the methods and research infrastructure for natural experiments in public health It is designed to promote efficient, rigorous examination of naturally occurring interventions using the strongest data sources available and state-of-the art analytic and statistical designs. Findings from the network should lead to a prioritization of policies and interventions for policy-makers, health plan directors, and community leaders. This FOA is also intended to strengthen methods for longitudinal experiments on health policies.

There are two components to this FOA. Component A will fund a network of independent research centers to conduct novel 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

This FOA will support the full spectrum of Diabetes Healthy People 2020 objectives D-1: “To reduce the number of new cases of diabetes in the population” to D-16: “Increase prevention behaviors in persons at high risk for diabetes with pre-diabetes.”

Public Health Impact

The research supported by this FOA is designed to enhance public health by improving and refining the evidence base whereby public health policy makers, including legislators, health plan directors, and community leaders and their constituents are better informed about what public health policies work to reduce (or improve) risk of diabetes and its chronic morbidities. Similarly, better prioritization of major population approaches may reduce risk factors and incidence, and improve quality of life. This research program is also designed to improve the methods for natural experiments of health policies, and thereby improve the quality of public health research for future public health impact.

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) manuscript by (Gregg et al., Prev Chronic Disease), a multi-center network of natural experiments.

It also builds upon the NIDDK PAR-13-365, the Evaluating Natural Experiments in Healthcare to Improve Diabetes Prevention and Treatment (R18) PAR-13-365.

2. Approach

This FOA is comprised of two components. Component A (Natural Experiment Sites): Supports Natural Experiments Research Centers to design and conduct rigorous longitudinal studies of naturally occurring, population-targeted health 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.

Because awardees, under Component A, will be funded with two sources or funds, applicants are expected to submit a single budget, but that budget must delineate and distinguish funds devoted to health impact and economic impact aspects of the study. Throughout the study period, the CDC/NCCDPHP funds are expected to support the design, conduct, analysis, and dissemination of the health impact of the natural experiment of study under Component A whereas the NIDDK funds are expected to support the design, conduct, analyses and dissemination of the economic impact analyses under Component A.

In order to ensure a diversity of policies being examined, Component A supports applications for natural experiments from two research tracks. Applicants will be asked to select from one of the tracks. 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 to apply and be awarded under Component B.

Objectives/Outcomes

The goal of this FOA is to fund rigorous natural experiments of the impact of population-targeted health policies on risk of diabetes and its complications. This will be achieved by supporting the assessment of the health policy and economic impacts from a portfolio of contemporary natural experiments and assembling a research network aimed at strengthening methods for conducting and evaluating natural experiments and promoting collaborative studies.

Component A (Natural Experiments Research Centers) The objective of this component is to design and conduct rigorous tests of the impact of one or more population-targeted health policies on diabetes risk, care, complications, and economic outcomes. Investigators will be expected to:

1) Design natural experiments of the health impact of ongoing health or public policy interventions and available data;

2) Identify, assemble, analyze and interpret data from appropriate sources to test natural experiments;

3) Publish and disseminate findings to inform policy-makers about effective and cost effective approaches to prevent diabetes and its complications;

4) Participate in a network of natural experiments to maximize quality of study designs and dissemination and impact of study findings and improve methods of conducting natural experiments.

Characteristics of Policies and Interventions for Examination:

Policies studied by the network may include legislative, health system-based, and community-based initiatives that are likely to influence health promotion, preventive care and the health of broad segments of the population. Studies should focus on ongoing, naturally occurring, or imminently available policy or systems-level interventions or on quasi-experimental designed studies that target large populations. Interventions of study may also be non-health related (i.e., educational, housing) but should have a strong rationale for why the policy would be expected to improve health status.

Applicants for component A will be expected to propose a natural experiment from one of two tracks:

Public policy approaches: involves legislative or other public approaches that could affect, whether beneficially or adversely, diabetes risk and health status in large segments of the community. This may involve changes to the food or built environment or nutritional or physical activity practices of large communities that in turn, affect the diabetes risk of populations. This may also include reimbursement policies by CMS and Medicaid aimed at screening, behavioral change, or other aspects of diabetes risk. In some cases, the principal goal of the policy may be non-health related (e.g., education, urban planning, economic development).

1.

Health system-community partnerships: are formal partnerships between clinical settings and community organizations, including employers. For example, this may include health system policies to reimburse for services provided in communities, referral programs to community programs, and partnerships to change the health context of communities.

2.

Examples of Public Policy Interventions include:

Statutory and regulatory laws at all levels of government on access, delivery, outcomes, and cost of diabetes care.

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

Food taxation and subsidies on diabetes-related health outcomes.

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

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

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.

Policies focusing on the economic or environmental characteristics of communities.

Laws, policies, and interventions aimed at improving the levels of education, living conditions, and economic well-being of large segments of the population.

Examples of health system-community partnerships include, but are not limited to:

Novel managed care and employer-based disease management and health promotion approaches.

Insurance reimbursement policies and benefit designs on adoption, adherence, and effectiveness of preventive health behavior programs.

Changes in Medicare and Medicaid reimbursement policies on preventive care and outcomes.

Population screening approaches implemented in health systems, employers, and community settings on changes in behavior, risk, and morbidity.

Prevention-focused quality improvement and disease management programs.

Employer-based policies and incentives on health promotion, including 4 day work weeks, health club vouchers, etc.

Population disease stratification, management and feedback tools, including laboratory based registries and electronic health records

Study Outcomes:

Studies should investigate the effects of policies on systems changes, changes in health promotion and care practices (quality, levels of implementation and coverage, costs); behavioral risk factors;

physiological risk factors; and the risk of diabetes and its complications, including the effects on morbidity, age of onset, and quality of life. Studies may target policies and interventions that are directly aimed at health systems and behaviors, or may involve interventions outside the health sector. Studies should also examine the costs, adverse effects, and unintentional consequences of policies.

Study Design, Data Sources, and Approach:

Studies should employ rigorous designs that can provide causal inferences about the effectiveness and health and economic impact of policies. Investigators should identify opportunistic, natural experiments that make use of longitudinal, quasi-experimental study designs using concurrent control conditions, historical trends or interrupted time series designs. Interventions should be assessed at multiple levels where possible: e.g., system-wide, communities, or clusters of individuals. Cohort and panel survey data may also be employed but should permit examination of study interventions that are applied and targeted at large segments of the population by health system or public policies. Proposals should not be based on cross-sectional studies, cohort studies with only individual level exposure and outcomes, or simple pre-post designs without an appropriate comparison.

Investigators are encouraged to assemble diverse sources of data, including those available from public survey data and/or medical information systems such as electronic medical records.

Applicants should have ready access to essential data on exposure and outcomes at the outset of the funding period. Studies are expected to assess population-targeted policies as well as indicators of care and health at the population-level. Data sources may include, among others, health plan based registries, administrative outcomes data bases such as Medicare and Medicaid, HMO databases, publicly available population survey data and special population surveys adapted for this project.

Applicants are also strongly encouraged to incorporate data sources from non-traditional sources.

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 Component1.

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

1.

Assists in the development of and 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 agencies to prepare meeting logistics for the study including i.e. agendas, securing meeting facilities such as negotiating and reserving hotel guests rooms; leasing of meeting rooms with meeting equipment for annual face to face meetings, preparing meeting minutes from the annual study group 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 web-site 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; health plans, 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, care, and complications, should be expressed at the community or population level.

Component B: Not applicable.

Collaboration/Partnerships

Component A: Investigators are encouraged to form or expand innovative scientific partnerships between researchers and public or private partners (e.g., community based organizations, local governments, employers). Applicants that have established data-sharing agreements and can demonstrate population level pilot data of baseline exposure and health status of target populations is desired.

Component B: The project director or principal investigator of this component shall establish partnerships with the study investigators and study partners under Component A to accomplish study goals; i.e. by first planning and organizing with the funding partners a kick-off meeting for the network within two weeks of award.

Evaluation/Performance Measurement

Component A: Evaluation/performance measurements should include quality and completeness of study designapproaches for case ascertainment, validation, and classification of diabetes type, 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 assesses outcomes of important health impact, including risk of diabetes and its morbidities, including cardiovascular disease.

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, 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 agencies.

Translation Plan

Component A: Applicants for components 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.

Component B: Applicants for components 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: $2,500,000

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

Component A: Average award size will be $450,000 per year with up to five awards to five different grantees. CDC/NCCDPHP will award $350,000 per year, and NIDDK will award $100,000 per year.

Component B: Average award size will be $250,000 per year for up to one award to a single grantee. CDC/NCCDPHP will award the $250,000 per year.

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: 6

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

Component A: $450,000 Component B: $250,000 Applications with budget requests greater than the ceiling will be considered non-responsive and will not be reviewed.

The floor amounts for the first 12 month budget period are (including both direct and indirect costs):

Component A: $350,000 Component B: $200,000 Applications with budget requests less than the floor amount will be considered non-responsive and will not be reviewed.

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

Award Ceiling: $0 Per Project Period Award Floor: $0 Per Project Period Total Project Period Length: 5 year(s) Throughout the project period, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/ asfr/ogapa/aboutog/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Small businesses Others (see text field entitled "Additional Information on Eligibility" for clarification)

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 (i.e. data use agreements) for ready access to data in order to assess the health care, behaviors, and health status impact for populations of at least 10,000 individuals.

Applicants must provide a written acknowledgement of receipt of funds from the two funding sources, (CDC and NIDDK) and commitment to adhere to budget requirements to delineate budget and expenditures by funding source. Evidence should be provided in the form of a letter from the applicant institution and should be included in Appendix A of the application.

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

4. Justification for Less than Maximum Competition

Not applicable1.

5. Responsiveness

Component A: Applicants must provide evidence in the form of background/preliminary data from the last 5 years related to the primary exposure data and characteristics of the population of at least 10,000 individuals.

Applicants should show evidence of ready access to data sets and systems necessary for execution of the study design, in the form of letters of commitment, memorandum of understanding, or other documents indicating data access exists prior to or at the time of the outset of the funding period.

Applicants must provide a written acknowledgement of receipt of funds from the two funding sources, (CDC and NIDDK) and commitment to adhere to budget requirements to delineate budget and expenditures by funding source. Evidence should be provided in the form of a letter from the applicant institution and should be included in Appendix A of the application.

Component B: Applicants must provide a statement of submission of application for Component A under RFA DP15-001 to include the principal investigator (PI) name and title of the application.

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

Incomplete applications, applications submitted after 5:00 PM on the listed application due date or non-responsive applications with budgets that exceed the ceiling or with budgets that are below the floor of the award will not be 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 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 https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM/%231 http://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons http://www.Grants.gov http://fedgov.dnb.com/webform

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/ asfr/ ogapa/ aboutog/ hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Section IV. Application and Submission Information

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

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

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

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

Please note that some components marked optional in the application package are required for submission of http://fedgov.dnb.com/webform https://www.sam.gov/index.html http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.Grants.gov mailto:pgotim@cdc.gov applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

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

3. Letter of Intent Due Date for Letter of Intent: 02/24/2015

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

By the date listed 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 (List Component Applying to) Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity

The letter of intent should be sent electronically to:

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

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

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

2, Section 1 (Funding Opportunity Announcement Description).

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

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

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

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

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

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

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

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

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

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

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

Both Component A and Component B:

Provide a staffing plan that defines the roles, responsibilities and qualifications of team and expected contributions of key/collaborative partners.

1.

Provide detailed timeline including realistic and measurable milestones for proposed project activities and include a budget plan that is linked to activities and milestones.

2.

Describe plans for producing reports: interim progress reports and a final report, as well as technical reports, professional presentations, and publications that will be produced

3.

collaboratively with CDC.

Component A:

Describe the scope, target population, and intended mechanism and impact of the health policy to be studied.

1.

Provide evidence of access to key data using pilot or baseline descriptive data. 2.

Describe the study design and methodological approach for testing the effectiveness of the policy of interest.

3.

Provide evidence of demonstrated partnerships, access to data and data use agreements for the proposed or existing collaborations to address the goals, objectives, and intent of the FOA.

4.

Describe access to existing and new data sources and patient populations. 5.

Describe the key data and variables to be used to assess the exposure to the policy of interest and the intermediate and long-term outcomes…