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Part I Overview Information

Participating Organizations
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)

Components of Participating Organizations
Center for Delivery, Organizations, and Markets (CDOM), ( http://www.ahrq.gov)

Title: ARRA OS Recovery Act 2009 Limited Competition: Comparative Effectiveness Delivery System Evaluation Grants (R01)

Note: The policies, guidelines terms and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type

This funding opportunity announcement (FOA) is a new RFA.

Update: The following update relating to this announcement has been issued:

Request for Applications (RFA) Number: RFA-HS-10-012

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.715

Key Dates - New Dates
Release/Posted Date: February 12, 2010
Opening Date: February 18, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Dates(s):  Not applicable
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Due Date(s):  March 31, 2010
Peer Review Date(s): Generally three months after receipt date 
Earliest Anticipated Start Date(s): August 31, 2010 
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: April 1, 2010

Key Dates- Old Dates
Release/Posted Date: February 12, 2010
Opening Date: February 18, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Dates(s): Not applicable
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): March 18, 2010
Peer Review Date(s): Generally three months after receipt date
Earliest Anticipated Start Date(s): August 31, 2010
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: March 19, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose. This AHRQ Funding Opportunity Announcement (FOA), supported by funds provided to AHRQ under the American Recovery & Reinvestment Act of 2009 ( Recovery Act or ARRA ), Public Law 111-5, invites Research Project Grant (R01) applications from investigators seeking to conduct rigorous comparative evaluations of alternative system designs, change strategies, and interventions that have already been implemented in healthcare and are likely to improve quality and other outcomes. (For definitions of system design, strategies, and related terms, see below, Nature of this Funding Opportunity).

In specifying its requirements for using ARRA funds in support of Comparative Effectiveness Research (CER), the Department of Health and Human Services (HHS) adopts the definition of CER as the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat, and monitor health conditions in real world settings. HHS added that interventions compared may include medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies. The current FOA concentrates primarily on delivery system strategies, which in turn may affect other types of interventions. In formulating its requirements HHS drew on the recommendations of the Federal Coordinating Council for CER and on the 100 priority topics identified by the Institute of Medicine (IOM) (http://www.iom.edu/~/media/Files/Report%20Files/2009/ComparativeEffectivenessResearchPriorities/Stand%20Alone%20List%20of%20100%20CER%20Priorities%20-%20for%20web.ashx).

.Nearly one quarter of the priority topics specified by the IOM in that report are classified in the IOM’s broad health care delivery system (HCDS) research area. The proposed research should be aligned with the priorities for health care delivery system research articulated by HHS and the IOM report.

System designs and change programs that may be evaluated under this solicitation might include (but would not be limited to): (a) community collaboratives for disease prevention, care management, and patient activation, (b) systematic efforts to reduce hospital readmissions, (c) programs fostering self-management, (d) value-based insurance designs, utilization management, and cost-sharing, and (e) techniques for reducing patient waits in outpatient and emergency care. The evaluations will provide rigorous analysis of the comparative impact of these designs and changes and evaluate their applicability to multiple settings. Evaluation studies will compare selected existing system designs, strategies, and interventions on quality, cost, and efficiency, and -- where appropriate -- effects on access, diversity, and population health. Additionally, the studies will assess the applicability or adaptability of the selected designs, strategies, and interventions to multiple care settings and diverse patient subgroups. When it is possible, the studies will investigate how changes were implemented. Particular attention will be paid to the contribution of system improvements to chronic care and care for priority populations.

While grant awards are made to institutions rather than individuals, this announcement and its instructions are written to inform individual researchers of this funding opportunity and facilitate the submission of grant applications by their organizations.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

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 - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

HHS Definition of Comparative Effectiveness Research:

HHS will use the definition of comparative effectiveness research (CER) used in the Federal Coordinating Council’s (FCC s) Report to Congress to guide the HHS operational plan with regard to Office of the Secretary (OS) ARRA funds. The definition is as follows:

Comparative effectiveness research is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in real world settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.

Priority-Setting Process and Inputs for Use of ARRA OS Funds

There were four main inputs for priorities for ARRA OS CER funds: public input, an internal Departmental workgroup, the FCC report, and the IOM report. The FCC identified the following as minimum threshold criteria which must be met to be considered for funding:

1) Included within statutory limits of ARRA and the Council’s definition of CER;

2) Potential to inform decision-making by patients, clinicians or other stakeholders;

3) Responsiveness to expressed needs of patients, clinicians or other stakeholders;

4) Feasibility of research topic (including time necessary for research).

The Comparative Effectiveness Research-Coordination and Implementation Team will require the use of the FCC’s prioritization criteria for scientifically meritorious research and investments for all projects funded with OS ARRA funds. These criteria are:

1) Potential impact (based on prevalence of condition, burden of disease, variability in outcomes, costs, potential for increased patient benefit or decreased harm),

2) Potential to evaluate comparative effectiveness in diverse populations and patients sub-groups and engage communities in research,

3) Addresses existing uncertainty within the clinical and public health communities regarding management decisions and variability in practice,

4) Addresses a need or is unlikely to be addressed through other organizations,

5) Potential for multiplicative effect.

Finally, investments funded from this appropriation must address at least one of the following topic areas:

1) One of the 100 IOM topic recommendations;

2) An issue within one of the MMA 14 priority conditions identified by AHRQ (pursuant to Section 1013 of the Medicare Prescription Drug Improvement and Modernization Act of 2003) which are not currently addressed; and/or

3) Fall into one of the AHRQ identified evidence gaps

The current list of priority conditions includes:

Background: AHRQ’s Initiative for Comparative Effectiveness Research on Delivery Systems

This FOA is part of a broader initiative, which includes Recovery Act 2009 Limited Competition: Comparative Effectiveness Delivery System Demonstration Grants (R18) (RFA-HS-10-013). The initiative also includes an AHRQ Comparative Effectiveness Delivery System support center that will serve awardees under both FOAs.

The purpose of this FOA as well as HS-10-013 is to rapidly build and deploy an evidence base for successful, large-scale delivery system transformation and lay the infrastructure for further work in this area. While both the public and private sectors have been discussing and experimenting with new ways to deliver care, many of these ideas remain at the theoretical stage, and others have been implemented and shown to be beneficial in a very limited number of settings. There is a need for rigorous evaluations showing which system designs and improvement approaches are most effective, under what circumstances, and for whom and what it would take to replicate or scale up such approaches.

On June 30, 2009, the Institute of Medicine of the National Academies (IOM), after significant public and expert input, produced a report on recommended priorities for ARRA CER titled Initial National Priorities for Comparative Effectiveness Research. The HHS cited this report as a key input in framing its priorities for its entire ARRA CER investment. Nearly one quarter of the priority topics specified by the IOM in its report are classified in the IOM’s broad health care delivery system (HCDS) research area. In particular, the IOM calls for research on health care management -including quality improvement strategies (HCDS-K); redesign strategies for increasing providers compliance with evidence-based guidelines (HCDS-H); transition support [e.g., to and from hospitals] for patients with complex health care needs (HCDS-L); care coordination for chronic care patients (HCDS-N); and payment strategies for improving access and quality for patients with chronic illness (HCDS-P & HCDS-O). This initiative provides funding for evaluations in these HCDS areas and for studies of related delivery system features and improvements.

The initiative places particular emphasis on care for priority populations such as the elderly, people with multiple chronic conditions, racial and ethnic minorities, and children. For the purposes of this FOA, a patient with multiple chronic conditions is one with two or more chronic conditions.

This FOA solicits proposals for evaluations to build the evidence base for CER. The evaluations will compare innovative systems and processes of care delivery.

Objectives of This Funding Opportunity

This solicitation has the following objectives:

The following definitions are used in this FOA:

Nature of This Funding Opportunity

This solicitation provides funding for outstanding applications for research examining whether promising system designs, strategies, and interventions have actually improved the quality and efficiency of care and have affected related features of organizational or delivery system performance, including cost, access to care, reduction of disparities, and population-based health. The studies funded under this solicitation should compare designs, strategies, and interventions that are likely to promote sustainable improvement in these desirable outcomes and are likely to improve performance on one or more dimensions of care quality (IOM, 2001; www.nap.edu/catalog.php?record_id=10027) without undermining others. The research will examine the effects of implementation contexts on outcomes. Where possible, the research will examine implementation processes (i.e., how the strategy or intervention was implemented). AHRQ recognizes however that it may not be feasible to study the implementation of designs, strategies, and interventions that have been in place for several years or more.

The evaluations will provide rigorous comparative analysis of the quality impact of promising designs, strategies, and/or interventions that have already been implemented and will evaluate the applicability of these designs, strategies, and/or interventions to multiple settings and varying organizational and market or community contexts. Additionally, the evaluations will seek to obtain findings that provide lessons about implementation that may be useful to other sites and organizations seeking to introduce similar changes.

Examples of system designs, strategies, and interventions that might be investigated include, but are not limited to the following: a) use of community quality collaboratives in disease prevention, management of chronic conditions, and promotion of patient compliance with guideline-based regimens (IOM priority HCDS-F,H & HCDS-K); b) systematic efforts to reduce hospital readmissions, for example through discharge planning, redesign of discharge processes, care management of recently hospitalized and chronically ill patients (HCDS-L & K); c) programs fostering self-management (HCDS-F); d) value-based insurance designs, utilization management, cost-sharing and other insurance changes, with particular reference to patients with chronic diseases (HCDS-P); e) techniques for reducing patient waits in outpatient and emergency care (e.g., Advanced Access, systems engineering techniques for improving scheduling) (HCDS-K).

System designs, interventions and/or strategies to be investigated may be facilitated by health information technology (IT) applications or may incorporate new forms of health IT. However, the focus of the interventions/strategies should be on the redesign of delivery systems, organizations, and microsystems, rather than on the introduction and testing of a particular health IT application or IT system.

Evaluation studies will compare selected designs, strategies and/or interventions on established measures of quality, cost, and efficiency and, where appropriate, will compare effects on access, disparities, and population health. Additionally, the studies will examine the applicability or adaptability of the selected designs, strategies, and interventions to multiple care settings and diverse patient subgroups. Where possible, the research will investigate how changes were implemented and provide generalizable findings on implementation practices that facilitate adoption and successful implementation of change. Particular attention will be paid to the contribution of system change and care design to chronic care and care for priority populations. When possible, evaluations will make use of existing measures and data sets, which will be supplemented with new measures and additional data gathering. Most studies will use observational research designs involving cross-sectional or longitudinal comparisons.

The proposed research should be aligned with the priorities for health care delivery system research articulated in the IOM’s Initial National Priorities for Comparative Effectiveness Research. Following IOM guidelines for CER, the research should typically compare at least two alternative delivery system [designs, strategies and/or] interventions, each with the potential to be a best practice - for example, two designs, strategies or interventions for reducing hospital readmissions. When the design, intervention, or strategy under study introduces changes that are directly relevant to policy decisions, a comparator may be the status quo. (IOM, 2009, 2-7). Then differences between the status quo and the focal design or intervention must be clearly defined and measured.

Specific Requirements of This Research Solicitation

Applicant institutions must:

1. Review the evidence base, justify the selection of system designs, strategies, or interventions; provide hypotheses about their expected effects, and explain the logic behind the expected effects of the selected designs, strategies, or interventions.

2. Provide background on the study sites and the system designs, strategies, or interventions to be studied at those sites.

3. Provide a complete plan for research on the outcomes of the system designs, strategies, and interventions to be investigated, and on their implementation contexts. Where feasible, include plans for documenting and evaluating the processes used to implement system change.

4. Identify the research team.

5. Provide a dissemination plan.

6. Report periodically on progress and results.

Each of these requirements is explained below.

Requirement #1. Review the evidence base, justify the selection of system designs, strategies, or interventions; provide hypotheses about their expected effects, and explain the logic behind the expected effects of the selected designs, strategies, or interventions.

Describe clearly and specifically the designs, strategies, or interventions to be compared and state one or more hypotheses as to which alternatives are better at achieving specific outcomes. These planned comparisons and hypotheses should guide the background review, theoretical analysis, and discussion of evidence. AHRQ seeks applications focusing on designs, strategies, and interventions at the environment, delivery system, organizational, and/or microsystem levels which have been found to produce substantial improvements at the same level of analysis (e.g., insurance design impacts population outcomes) or other levels (e.g., environment-level changes improve the organization and its microsystems).

Include a clear explanation of the background on the proposed designs, strategies, and interventions to be studied, including evidence for them and an explanation of how these are hypothesized to produce expected improvements at one or more levels of analysis. This explanation may draw on theories and findings from fields such as behavioral, social, and organizational sciences; economics, and systems engineering; as well as from health services research.

Requirement #2. Provide background on the study sites and the system designs, strategies, or interventions to be studied at those sites.

Provide background on the participating delivery organizations and any other organizations to be studied (e.g., insurers, payers, community groups), planned cooperation among the sites and participating organizations, and means of assuring cooperation between these sites and the research team. This background information should make clear the suitability of the sites for the proposed study. For instance, explain how operations and logistics at the sites under investigation facilitate collaboration with the researchers and their access to needed data (see below, Review and Selection Criteria: Environment). Indicate when the system designs, strategies, and interventions to be studied were first introduced and/or how long the study sites have been engaged in improvement programs to implement change. Provide at least preliminary estimates of how intensively and extensively the selected designs, strategies, and interventions have been implemented within study sites.

Requirement #3. Provide a complete plan for research on the outcomes of the system designs, strategies, and interventions to be investigated, and on their implementation contexts. Where feasible, include plans for documenting and evaluating the processes used to implement system change and the effects of implementation contexts.

Present a complete research plan for comparing two or more system designs, strategies, or interventions or comparing policy changes with the status quo. Specify hypotheses about which alternatives are better for specific outcomes. The plan should specify methods to be used, research sites, research design for comparing interventions, data to be gathered, and analysis techniques. The plan should describe process and outcome measures for key quality domains, as well as any measures for cost, care access, disparities, and population-based measures of health. For clinical outcomes, the plan should specify how clinical measures will relate to the AHRQ’s priority conditions (listed at http://effectivehealthcare.ahrq.gov/FAQs.cfm#6). Whenever possible, the measures should be widely established and validated.

Include a plan for examining implementation contexts and effects and, where feasible, implementation processes (how changes were put in place). Since stable designs may have been in place for several years or more, investigation of how they were implemented is not likely to be feasible.

Specify data that are already gathered by the participating organizations, including sources of baseline, retrospective, and background data, and other data that can be accessed or gathered anew. Consider using mixed methods of data gathering and varying research designs in keeping with the specific aims of the research project. Data analysis will usually be cross-sectional or retrospective. Research designs may include experimental and quasi-experimental research designs, time series analysis, and qualitative case analysis.

Whenever possible the investigation should include measures of the intensity and extent of implementation of system designs, strategies, and/or interventions, rather than using dichotomous (presence/absence) measures. Additionally, there should be measurement of contextual factors -- such as (but not limited to) support by top leadership, prior site experience with similar programs, resources facilitating implementation (e.g., quality improvement skills, information systems, linguistic and educational supports for patients), structural and management characteristics of sites, patient populations, staff composition, and community and market conditions. Where it is feasible to examine implementation processes, investigators should explain how they propose to investigate key process domains -- including stages of implementation; nature and degree of change in targeted forms of care delivery, insurance, and/or payment; modifications and adaptations of the designs, interventions, or strategies during implementation; intermediate actions and steps specified in the program theory or logic model underlying the interventions/strategies; decision processes (e.g., user involvement); interactions among implementation participants; facilitators and barriers; and unanticipated consequences of changes. Investigation of implementation processes should lead to lessons that could be valuable to other organizations seeking to implement similar designs, strategies and interventions.

Include a governance plan for project oversight of operational issues, along with scientific and technical concerns related to research design, access to existing data, collection of new data, analysis, and reporting. Provisions to review possible conflicts of interest for research personnel should be included. The governance plan should also describe provisions for the research team to obtain feedback from the sites about any issues relating to data collection and any arrangements for the researchers to provide data or information to leaders at the sites.

Document the commitment of participating sites and organizations to cooperate with the research. Provide copies of agreements among participating organizations and the researchers that specify any responsibilities of the sites for data collection, analysis, or reporting. Specify how these activities will be funded.

Demonstrate that the leadership team will devote sufficient time to the project to ensure its strong scientific AND operational leadership. Other key research staff should also allocate substantial amounts of their total time to the study. For key personnel, provide information on external time commitments not shown in the operational plan (e.g., PD/PI spends 8 hours per week in clinical care, 8 hours teaching, and 8 hours on unrelated research ).

Include a timeline (Gantt chart) showing the major scheduled milestones (events, activities, and data gathering, and reporting) for the project. Provide the number of hours (or percent of time) that key project personnel will devote to each task shown on the timeline; justify the proposed levels of effort.

Requirement #4. Identify the research team

Provide complete information on the skills, experience, and capabilities of members of the research team. In addition to health care delivery and clinical expertise, AHRQ encourages inclusion of experts in the fields of quality improvement research, behavioral science, social science, management, systems engineering, business, and economics, as appropriate to the research plan.

Requirement # 5. Provide a dissemination plan

Provide a dissemination plan, including activities such as publishing in peer-reviewed and trade journals; preparation of briefings, visual and web-based materials, guides, tools for policy makers, providers who may wish to implement the selected changes within their own organizations, and other Comparative Effectiveness stakeholders (e.g., payers, insurer, community groups); and disseminating findings and tools through professional and other associations. The plan should describe the types of tools, activities, and products envisioned. The plan should also include submission of case materials (if any) to AHRQ’s Health Care Innovations Exchange (HCIE) (www.innovations.ahrq.gov), and any other form of anticipated contribution to the HCIE and other dissemination vehicles.

Requirement #6. Report periodically on progress and results

Research progress and interim research findings will be reported to AHRQ as specified in Section VI, 3 (Reporting), below. In addition, quarterly conference calls with the AHRQ program official and other individuals deemed necessary by the program official, are required. Technical and scientific documentation and any other details for these reports will be clarified after discussion with the program official.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the AHRQ Research Project (R01) grant mechanism. The individual researcher sponsored by each organizational grantee will be solely responsible for planning, directing, and executing his or her proposed project.

AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will not be reviewed.

2. Funds Available

This initiative is supported by funds provided to AHRQ under the American Recovery & Reinvestment Act of 2009 ( Recovery Act or ARRA ), Public Law 111-5. A total of $7,000,000 is available to fund applications under this solicitation. AHRQ anticipates making between six and ten awards. Awards issued under this FOA are contingent upon the availability of funds and the submission of sufficient scientifically meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

Budget and Project Period: The total costs for any grant awarded under this FOA will not exceed $500,000 annually for the entire project period. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation. The project period may not exceed 3 years. Typical costs in a single year are likely to range from $300,000 total costs to $400,000 total costs. Applicants may request varying levels of annual funding, but must justify their request. The total costs for any grant awarded under this FOA must not exceed $1.5 million for the entire project period. Applications with project periods that exceed 3 years or budgets that exceed $500,000 in any given year or $1.5 million total costs over the three year project period will not be reviewed.

The total costs for any grant awarded under this FOA must not exceed $1.5 million.

Funding for this program is provided under the Recovery Act. The purposes of the Recovery Act are to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health. Consistent with these goals, eligible domestic (United States) institutions/organizations who are planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested total costs or $25,000 total costs (aggregate total for a subcontract or multiple subcontracts), whichever is less. AHRQ awards under the Recovery Act will be for up to three years.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply. Consistent with the purposes of the Recovery Act (in particular, to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health), applicants must be a domestic (United States) institution/organization of one of the types listed below. The United States institution/organization must be located in the 50 states, or in the territories and possessions of the U.S., Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia. Foreign organizations/institutions are not permitted as the applicant organization.

You may submit an application(s) if your institution/organization has any of the following characteristics:

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus for the purpose of this FOA, AHRQ will make grants only to non-profit organizations. For-profit organizations may participate in projects as members of consortia or as subcontractors only. Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by for-profit organizations or foreign institutions will be returned without review. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with the applicant organization/institution to develop an application for support. The PD/PI may represent the lead delivery system or provider organization in the proposed evaluation or may be a researcher from a recognized research institution, who collaborates with the delivery system/organization. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.

2. Cost Sharing or Matching

This program does not require cost sharing for applications in response to this FOA.

While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions that plan to provide support should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be included in the detailed budget.

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

A PD/PI should work with his/her institution/organization to make sure he/she is registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-710-0267; Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to AHRQ. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by AHRQ (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Research & Related Budget

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: February 18, 2010 (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s): March 18, 2010
Peer Review Date(s): Generally three months after receipt date
Earliest Anticipated Start Date(s): August 31, 2010

3.A.1. Letter of Intent

Not applicable

3.A.2. Technical Assistance

Applicants may submit questions to AHRQ via email at AHRQDeliveryEval@ahrq.hhs.gov. AHRQ will respond to questions via email only. Please include your full name, title, and the name of your institution in your email. Based on inquiries received, AHRQ will post a list of Frequently Asked Questions (FAQs) and responses to these questions as appropriate, after the release of this FOA at http://www.AHRQ.gov/fund/grantix.htm. Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff.

3.B. Submitting an Application Electronically to AHRQ

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

In order to expedite the review, applicants are requested to notify the AHRQ Referral Office by email Gerald.Calderone@ahrq.hhs.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time :

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and AHRQ. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

AHRQ will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

Use of CMS Data

Purchase of Centers for Medicare & Medicaid Services (CMS) public-use data, if required, should be discussed in the application narrative and included in the budget. Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. However, for applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the Research Design and Methods section of the Research Plan (form 398) the specific files, time periods, and cohorts proposed for the research. In consultation with CMS, AHRQ will use this information to develop a cost estimate for obtaining the data. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made.

Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with the confidentiality provision in the AHRQ statute, 42 USC 299c-3(c); the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule at 45 CFR Parts 160 and 164, if applicable; and standards set out in OMB Circular A-130, Appendix III Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed.

Unless AHRQ is able to negotiate exceptional arrangements, the DUA will include the requirement that the data user agrees to submit to CMS, a copy of all findings within 30 days of making such findings, for the sole purpose of assuring CMS that data confidentiality is maintained. The user further agrees not to submit these findings to any third party (including but not limited to any manuscript to be submitted for publication) until receiving CMS's approval to do so.

In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take six months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff.

CMS data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats.

Questions regarding CMS data should be directed to the AHRQ program official listed under Agency Contacts (see Section VII).

To avoid double counting, applicants should not include the cost of identifiable CMS data in the budget. In the event the total costs of the project plus the cost of CMS data is greater than the total cost cap of this FOA, the budget for the project will be adjusted so that the total costs awarded to the recipient plus the CMS data costs do not exceed the cost cap.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm

Pre-award costs are allowable. A grantee may, at its own risk and without AHRQ prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs are necessary to conduct the project and would be allowable under the grant, if awarded, without AHRQ prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain AHRQ approval before incurring the cost. AHRQ prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on AHRQ either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.

6. Other Submission Requirements and Information

Provide a URL for access to any critical publications or supporting information (e.g., narrative or chronology of delivery system ’s prior quality improvement activities) that is not included in an appendix.

The sites studied under this solicitation should be located within the United States. Applicants should make explicit the relevance to the aims and research design of the study of any participating organizations from outside of the United States. Eligible domestic (United States) institutions/organizations who are planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested total costs or $25,000 total costs (aggregate total for a subcontract or multiple subcontracts), whichever is less.

Provide a thorough justification for any supplies and equipment requested in the project budget. All items must be allowable, reasonable, necessary, and allocable to the project.

For each year of funding, the budget must include funding to allow the Principal Investigator and up to two other key members of the project to attend at least three days of the AHRQ annual meeting or another appropriate AHRQ meeting as determined by the program official. The meetings will take place in the Washington, D.C. area.

The budget should include funds for an appropriate member of the team to work remotely (i.e., via telephone, email, or internet) for a total of at least 2 days with AHRQ’s Office of Communications and Knowledge Transfer staff and/or with AHRQ contractors including the Health Care Innovations Exchange.

Sufficient funds should be budgeted to ensure compliance with requirements for Section 508 compatibility for documents to be posted on federal government web sites. See Section 508 of the Rehabilitation Act, 29 USC 794d (http://www.Section508.gov.)

PD/PI Credential (e.g., Agency Login)

The AHRQ requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

All attachments must be provided to AHRQ in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Special Instructions for Modular Grant applications

AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R). Applications submitted in the Modular format will not be reviewed.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm). Also see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.

No supplemental/update information will be accepted.

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the Public Health Service Act, directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations. Priority populations include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. This authority is found at 42 USC 299(c). To implement this statutory mandate, AHRQ published a Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html). Applicants under this FOA should consider and discuss including priority populations in the research design as specified in this Notice.

Publication Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ-supported activities are accepted for publication in the professional literature. Grantees should also discuss any ideas about other dissemination and marketing efforts with OCKT staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a brief plan describing how the product will be publicized. An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media. The grantee shall be responsible for ensuring that content from any documents, slides or other deliverables to be posted on the AHRQ (or other Federal) website is compliant with Section 508 of the amended Rehabilitation Act.

Assessment of AHRQ Grant Programs

In carrying out its stewardship of research programs, AHRQ may request information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research.

AHRQ expects grant recipients to keep the Agency informed of publications, as well as the known uses and impact of their Agency-sponsored research. Applicants must agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active.

HCUP & MEPS

Applicants are encouraged to make use of AHRQ’s Healthcare Cost and Utilization Project (HCUP) or the Medical Expenditure Panel Survey (MEPS). HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership. HCUP databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data. HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place. HCUP include three nationwide databases, the Nationwide Inpatient Sample (NIS), and the Kids Inpatient Database (KID), and the Nationwide Emergency Department Sample (NEDS), and three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD). More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.

The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, non-institutionalized population. MEPS is composed of three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC). The Household Component is the core survey, and it forms the basis for the MPC sample and part of the IC sample. The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees. More information on the MEPS is available at http://www.meps.ahrq.gov.

Applicants use of HCUP and/or MEPS data does not preclude the use of secondary data sources or primary data collection.

Health Literacy

AHRQ encourages applicants to write Informed Consent (IC) and HIPAA Authorization documents for research to be understandable to all potential research participants, including those with low levels of literacy and limited English proficiency. AHRQ recommends that IC and Authorization documents be written in accordance with health literacy principles, and that IC and Authorization documents be available in multiple languages if potential research participants include individuals with limited English proficiency. AHRQ also recommends adopting a process to verify potential research participants understanding.

IC documents must provide information in language understandable to potential participants (45 CFR 46.116). For covered entities under the Privacy Rule, authorization documents must include core elements and required statements in (45 CFR 164.508(c) and must be written in plain language. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research (http://www.ahrq.gov/fund/informedconsent/) provides sample forms and guidance on adapting them, and also describes an appropriate process for obtaining informed consent and authorization.

Consumer Products

All consumer products produced under an AHRQ-funded grant should be appropriate for the target audience. This includes individuals from diverse cultural, language, and literacy backgrounds. Audience testing should be part of the development process. AHRQ’s Talking Quality website (http://www.talkingquality.gov/) and AHRQ’s guide and checklist for developers and purchasers of health information (IT) that is designed to be accessed and used by consumers (http://healthit.ahrq.gov and select Health IT Tools) are resources applicants can use to ensure appropriateness of consumer products.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Section V. Application Review Information

1. Criteria

Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness.

Merit Review Criteria are described below. The review criteria described below will be considered in the review process.

3. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will not be reviewed.

As part of the initial merit review, all applications will:

The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. As part of this mission, applications submitted to AHRQ in response to this FOA will be evaluated for scientific and technical merit through the AHRQ peer review system.

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance: How important are the problems addressed by this study? What will be the effect of these studies on the concepts, methods, technologies, and approaches that drive research in this field? If the aims of the application are achieved, to what extent will the findings advance scientific knowledge about the contribution of system designs, change strategies, and interventions to improving delivery-system quality, efficiency, cost, and, where appropriate, access, disparities, and population health? How readily might the system designs and changes being investigated in this research project be spread to other delivery systems and to other parts of the country? What is the likelihood that the project s findings will lead to lessons for policy makers and delivery system decision makers about successful designs, strategies, and interventions and how best to promote or implement them? To what extent are the findings likely to help other delivery systems introduce and sustain major care improvements?

Investigators: Are the PI/PD and other key research personnel appropriately trained and well suited to carry out this work? Do the PD/PI and other members of the leadership team plan to devote sufficient time to the project to ensure strong scientific and operational leadership? Will the external (i.e., not project-related) time commitments of the PD/PI, other members of the leadership team, and other key staff allow them to devote sufficient attention to the funded project? Are assignments of team members to specific research tasks appropriate? How strong was the researchers past performance in evaluations of delivery system/organizational change and large-scale quality improvement initiatives? Does the research team have an appropriate mix of skills and areas of expertise, including, where relevant, expertise in behavioral science, social science, economics, business, management, systems engineering, and quality improvement research? Is there an appropriate mix of senior and junior researchers?

Innovation: Is the project original and innovative? For example: To what extent does the project propose innovative and promising data, methods, or research designs? Is the project likely to address and overcome critical barriers to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area of research?

Approach: Are the empirical background, conceptual framework, research design, hypotheses, measures, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? How well developed and appropriate are plans, research designs, measures, and methods for assessing outcomes of selected system designs, strategies, and interventions; effects of implementation contexts; and, where feasible, the nature and effects of implementation processes? Are the proposed comparisons appropriate -- including comparisons between the status quo and innovative designs, strategies, or interventions? Are comparison groups delineated appropriately? Are the study sites appropriate, and is there sufficient information about them (see Requirement #2 under Specific Requirements of this Research Solicitation)? How adequate is the project management structure and plan including specification of project tasks and governance? How appropriate are the timeline and time allocations of key staff? How adequate are arrangements and agreements for governance and collaboration between researchers, sites to be investigated, and any other data sources? Does the applicant acknowledge potential problem areas and consider alternative tactics for overcoming problems? How satisfactory is the plan for disseminating the findings and other products resulting from the project?

Environment: Do the scientific environment(s) in which the work will be done and the sites under investigation contribute to the probability of success? To what degree will operations and logistics at the sites under investigation facilitate or hinder collaboration with the researchers and their access to needed data? How adequate are the resources needed to conduct the research (funds, information and data, information processing capabilities, on-site staff (if needed)?

2.A. Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R).

Inclusion: Adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups). Adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 Other Submission Requirements, and inclusion criteria included in section VIII of Required Federal Citations, below.)

Budget: Is the proposed budget reasonable and is the requested period of support appropriate to the proposed research? Does the budget account for all resources and expenditures needed to carry out the research, including travel to AHRQ meetings and cooperation with AHRQ staff and contractors?

Privacy and Security Protections for Patients: The resources and processes to be used to address privacy and security issues in the development and implementation of the intervention will be assessed.

Degree of responsiveness: How well does the application address the purpose and objectives of this FOA? How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?

In addition, the review criteria listed in the Priority-Setting Process and Inputs for Use of ARRA OS Funds section will also be used.

2.B. Additional Review Considerations

Not applicable

2.C. Resource Sharing Plan(s)

Data Confidentiality

Pursuant to 42 USC 299c-3(c), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute, 42 USC 299c-3(d). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164. These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers. Thus, health care plans ordinarily will require either patient authorization for disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators. The DHHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/

The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

Sharing Research Resources:

Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees may copyright or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ funds, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a worldwide irrevocable AHRQ license to use and permit others to use these products and materials for government purposes. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html).

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

Appeals will not be permitted. See http://grants.nih.gov/grants/guide/notice-files/NOT-HS-09-011.html, Recovery Act of 2009: AHRQ Announces Suspension of Grants Funding Appeals Process.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.

If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant. Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative issues, and certification of IRB approval of the project's proposed use of human subjects. For details, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

Once all administrative and programmatic issues have been resolved, a formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA will be generated via email notification from the awarding component to the grantee business official. The NoA signed by the grants management officer is the authorizing document

The terms of the NoA will reference the requirements of the Recovery Act.

In addition to the standard AHRQ terms of award, all funding provided under the Recovery Act will be subject to the Department of Health and Human Services Standard Terms and Conditions American Recovery and Reinvestment Act of 2009. The full text of these terms approved for AHRQ awards can be found in the following document: http://www.ahrq.gov/fund/arraterms.htm

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NOA are at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5., Funding Restrictions.

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, and are subject to the requirements of the HHS Grants Policy Statement that are applicable based on the recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

As necessary, additional Terms and Conditions will be incorporated into the award statement.

3. Reporting

Grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually.

The annual progress reports must include Section 2.2.6 items A through F as described in the general PHS form 2590 instructions. For details regarding annual progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm. If instructions on the AHRQ website are different from the PHS form 2590 instructions, follow the instructions on the AHRQ website.

The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future. At a minimum, the reports will include descriptive comments on: progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities. AHRQ will provide the timetable for these progress reports.

Financial Status Reports (FSRs; SF 269) are required annually by AHRQ for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm). This report must be submitted for each budget period no later than 90 days after the close of the budget period. A hard copy of the report should be submitted to the assigned grants management specialist.

Until such time as HHS has migrated to the SF 425 FFR, award recipients will utilize the SF 269 FSR.

Section 1512 of the Recovery Act requires prime recipients of the ARRA funds to submit quarterly reports. Future updates to recipient reporting guidance from OMB are likely and recipients will be expected to follow the most current OMB guidance for such reporting. In addition to the standard AHRQ terms of award, all funding provided under the Recovery Act must comply with the statutory reporting requirements and will be subject to the HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (ARRA) as described above and found on the AHRQ Website at http://www.ahrq.gov/fund/arraterms.htm.

Also, AHRQ is currently developing AHRQ-specific reporting requirements. Detailed information and requirements on the specific AHRQ reporting venues and reporting timeline will be included in the Notice of Grant Award and incorporated into AHRQ Terms and Conditions of Award.

A final Progress Report, Final Invention Statement, and final Financial Status Report are required when an award ends. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

Section VII. Agency Contacts

This FOA is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application (also including submission of a letter of intent) by an individual or entity and ending with the award of the competitive funds. Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a Recovery Act competitive grant or other competitive form of Federal financial assistance, whether or not the initiating party is a federally registered lobbyist. This restriction applies unless:

For additional information see: http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf

Please note, the President’s memorandum applies to communications prior to the award of a grant or other Recovery Act funding; it does not apply to communications with officials regarding the administration of a grant that has already been awarded.

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may be written or by telephone, and fall into three areas: scientific/research (program), peer review, and financial or grants management issues.

1. Scientific/Research Contact(s):

Direct your questions about general FOA issues, including information on the inclusion of priority populations to:

Michael Harrison
Center for Delivery, Organization, and Markets
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1434
Fax: (301) 427-1430
E-mail address: Michael.Harrison@ahrq.hhs.gov

2. Peer Review Contact(s):

Kishena Wadhwani, Ph.D.
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1556
Fax: (301) 427-1562
E-mail address: Kishena.Wadhwani@ahrq.hhs.gov

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to:

George Gardner
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1450
Fax: (301) 427-1462
E-mail address: George.Gardner@ahrq.hhs.gov

Or: Michelle Burr
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1451
Fax: (301) 427-1462
E-mail address: Michelle.Burr@ahrq.hhs.gov

Section VIII. Other Information

Required Federal Citations

The American Recovery And Reinvestment Act of 2009: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf

Standard Terms and Conditions for Recovery Act Awards: The full text of these terms approved for AHRQ awards can be found in the following document: http://www.ahrq.gov/fund/arraterms.htm .

Inclusion of Women and Minorities in Research Study Populations:

Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate, e.g., because of the lack of connection between the study and the health of women or particular minorities.

All investigators proposing research involving human subjects should read the updated "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ requires adherence to these NIH Guidelines.

Investigators may obtain copies from the above sources or from the NIH Guide Web site at http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also provide additional information concerning these policies (see Section VII, Agency Contacts).

Human Subjects Protection:

Federal regulations at 45 CFR Part 46 require that applications and proposals involving human subjects research must be evaluated in accordance with those regulations, with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Standards for Privacy of Individually Identifiable Health Information:

The Department of Health and Human Services (HHS) "Standards for Privacy of Individually Identifiable Health Information" regulation was mandated by the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which governs the protection of individually identifiable health information. It is administered and enforced by the HHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory. Decisions about applicability and implementation of the Privacy Rule reside with covered entities. Program officials will assist grantees in resolving questions about the applicability of HIPAA requirements.

Access to Research Data through the Freedom of Information Act:

The OMB Circular A-110 provides access to certain research data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation or administrative order) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement. Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data under FOIA, 5 USC 552(b), disclosure of confidential identifiable data from such study is statutorily protected under 42 USC 299c-3(c), and thus is exempted from disclosure under "the (b)(3) exemption in FOIA, 5 USC 552(b)(3). It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support. Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", 5 USC 552(b)(4) for example, if it constitutes trade secrets or commercial information. NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.

Should applicants wish to place data collected under this FOA in a public archive, which can provide protections for the data (e.g., as required by confidentiality provisions of the statute applicable to AHRQ-supported projects, 42 USC 299c-3(c), and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted.

Healthy People 2010:

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authority of 42 USC 299 et seq. and, 42 CFR Part 67 and in accordance with 45 CFR Parts 74 or 92 and other referenced applicable statutes and regulations. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the Public Health Service mission to protect and advance the physical and mental health of the American people.

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