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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, Organization, and Markets (CDOM) , (http://www.ahrq.gov)

Title:  ARRA OS: Recovery Act 2009 Limited Competition: Accelerating Implementation of Comparative Effectiveness Findings on Clinical and Delivery System Interventions by Leveraging AHRQ Networks (R18)   

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-10-014

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
Release/Posted Date: February 5, 2010
Opening Date:   February 24, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(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 24, 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 25, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

This funding opportunity announcement (FOA) solicits Research Demonstration and Dissemination Projects (R18) grant applications from applicant organizations that propose to develop and implement strategies for the widespread utilization of evidence-based clinical findings or delivery system practice innovations by patients and providers.

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 Demonstration and Dissemination grant (R18) applicationsto promote the increased implementation and widespread use of findings from comparative effectiveness research (CER) that have been demonstrated to improve the prevention, diagnosis, management or treatment of a clinical condition or to otherwise improve care quality, improve access to care, reduce disparities, or improve population-based measures of health outcomes. For purposes of this FOA, the scope of CER findings includes not only clinical findings but also findings on the effectiveness of implementation approaches, including behavioral change and delivery system strategies, as spelled out in the Federal Coordinating Council recommendations and Institute of Medicine (IOM) recommendations. This FOA also reflects HHS recognition that, for the CER enterprise to be successful, funds must be directed at accelerating the dissemination and translation of CER findings into health care practice improvement. To achieve maximum impact, applicants will leverage broad-based, multi-stakeholder or multi-site collaborations or partnerships to develop and implement comprehensive initiatives composed of one or more interventions and strategies, including, but not limited to, those listed below (see below, Nature of this Funding Opportunity.

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 CER

The Department of Health and Human Services (HHS) will use the definition of comparative effectiveness research (CER) used in the Federal Coordinating Council’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 CER-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 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 and Purpose:

Recent increases in investment in CER have led to mounting calls for more rapid identification and implementation of strategies that will increase the use of CER evidence in clinical practice, care delivery, or patient or provider decision-making. There is growing concern that a great deal of available evidence that has emerged from CER and other research is not being widely used -- that our expanded investment in such research will yield limited returns in improved quality or value unless more effort is invested in developing appropriate strategies for ensuring the use and spread of evidenced-based findings and practices. For this reason, HHS highlighted the need to direct a portion of ARRA funding to accelerating the dissemination and translation of CER findings into health care practice improvement. HHS has called for the development and use of a variety of methods to actively disseminate and implement research findings. This FOA will fund the development and implementation of initiatives to promote the wider use of CER findings at the delivery system and/or community levels.

The overall goal of the HHS’s investment in CER is to promote high quality care through broad availability of information that helps clinicians and patients match the best science to individual needs and preferences. There are many ways that findings generated by CER can support his goal. CER findings can help patients and their doctors choose the most effective course of treatment for clinical conditions such coronary artery disease or low back pain; CER can identify the most effective method of screening for a particular disease in a specific population (e.g., screening for colorectal cancer). Additionally, a growing number of behavioral and organizational practices focused on changing processes of care delivery (e.g., methods for reducing preventable admissions, rehospitalizations and delays in time-sensitive care; methods for promoting self-management of chronic diseases), have been demonstrated to improve the quality of care, and their spread can also play a key role in meeting the FCC s overarching goals. Many of these practices are not necessarily targeted at a specific clinical condition, but rather at the processes for providing care within a given setting or across settings. In sum, if effectively implemented, the evidence that has been generated from clinical research and behavioral or organizational research can improve health outcomes across multiple diseases.

Broad implementation of findings from comparative effectiveness research also has the potential to improve value and reduce costs, by increasing awareness of ineffective clinical interventions and by improving organizational efficiency (e.g., reducing the number of repeat tests or reducing waiting times). Addressing existing uncertainty within the clinical and public health communities regarding management decisions and variability in practice may yield further reductions in cost or increases in value. For example, the spread of comparative effectiveness findings may result in the reduction of variations in certain practice patterns which have been demonstrated to increase costs without improving quality.

Broader use of CER findings would thus clearly serve the interests of all stakeholders involved in delivering, receiving or paying for care -- clinicians/providers, patients/consumers, employers, other payers, and health plans and efforts to increase their use could well be undertaken by any single one of them. Ultimately, however, the sustained use of CER findings in a way that might truly transform the way care is delivered -- and its associated clinical and cost outcomes -- is most likely to result from collaborative, coordinated efforts among key stakeholder groups and/or across multiple delivery or geographic sites.

Toward this end, AHRQ is inviting applications that would leverage the strengths and capabilities of 3 networks with which it has been partnering to support diverse quality improvement activities: Accelerating Change and Transformation in Organizations and Networks (ACTION), primary care Practice-Based Research Networks (PBRNS), and Chartered Value Exchanges (CVEs). These three networks are composed of providers, payers, academic researchers, health plans, health data organizations, public advocacy and consumer organizations and others that together represent an enormous cross-section of stakeholders with a keen, mutual interest in shaping the way health care is delivered, and with the collective ability to do so.

While this competition hopes to leverage the capabilities, resources and strengths of these AHRQ networks, other applicants are also eligible to apply, if they:

Objectives:

The objectives of this AHRQ FOA are to:

Proposals to implement comparative effectiveness findings within and across safety net institutions or priority populations are particularly encouraged.

Definitions of Key Terms

Nature of this Funding Opportunity

This solicitation provides funding for initiatives that will significantly increase the implementation and widespread use of comparative effectiveness research findings that have been demonstrated to improve the prevention, diagnosis, management or treatment of a health condition or to otherwise improve health or health care outcomes. Outcomes of interest include not only improved quality but also improved access, reduction of disparities, improvement of population-based measures of health outcomes, and improved value (controlling or reducing costs while providing patients with care of the same or better quality than they currently receive).

To achieve maximum impact, applicants must design initiatives that will:

Applicants must make a clear and compelling case, based on solid empirical documentation, that the selected findings or practices have already been demonstrated to improve outcomes as described above.

Following are a few examples of potential initiatives that seek broad implementation of existing comparative effectiveness findings. Proposals might include, but are not limited to, these illustrations.

As noted above, applicants are strongly encouraged to develop initiatives that use combinations of strategies to increase use of evidence-based findings and practices, including, but not limited to:

Proposals to implement comparative effectiveness findings within and across safety net institutions or priority populations are particularly encouraged.

Where appropriate, applicants are especially encouraged to identify synergies with other ARRA-funded CER or Health IT activities in their communities. (Note: While innovative or expanded use of Health IT may be included as one component of a broader initiative, new or expanded use of Health IT should not be the focus of the initiative. For Health IT focused initiatives, applicants are encouraged to pursue funding under the Health Information Technology for Economic and Clinical Health Act (HITECH) portion of ARRA (http://healthit.hhs.gov/portal/server.pt).

Finally, in keeping with the third objective of this Funding Opportunity ( generating and providing information about the effectiveness of strategies and techniques for promoting the use of CER findings ), applicants must demonstrate an ability to clearly and fully document all activities undertaken by all involved parties in planning and implementing their initiatives and must specify the data that will be available to enable AHRQ to assess impacts and outcomes. To the extent possible, applicants are encouraged to collect data that will support the use of nationally recognized (e.g., National Quality Forum (NQF)-endorsed) clinical and process measures. If these are not available, applicants are encouraged to use other commonly used evidence-based measures.  However, AHRQ recognizes that new outcome measures may need to be developed in order to provide improved clarity and assessment of impacts and outcomes.

Specific Requirements of this Solicitation

Applicants must meet the following requirements, which are described more fully below:

1.     Document the problem that your proposal seeks to address.

2.     State the specific quality improvement goal and/or the clinical outcomes you seek to achieve AND/OR explain the nature of the cost savings or increase in value you expect to achieve. If cost savings are the goal, provide evidence to demonstrate that quality of care will not be adversely affected. Estimate/quantify the size and/or scope of the impact of the expected improvement in quality or cost savings and explain the basis for that estimate.

3.     Describe the CER finding/s whose use or spread you will be promoting, and explain how it is expected to improve care quality and/or how it will control/reduce costs or improve value without adversely impacting care quality. Describe the nature, extent and strength of the evidence for the selected finding or practice.

4.     Describe the population that is expected to benefit from the increased use of the CER finding/s and estimate its size.

5.     Describe the proposed initiative for increasing the use or spread of the selected CER finding/s; explain how and why the proposed initiative will increase use or spread of the selected findings or practices; explain how collaboration across multiple stakeholders or multiple sites will contribute to the overall impact of the initiative.

6.     Provide a complete operational plan for how the proposed initiative will be implemented; list all participating organizations, institutions and other entities and describe their specific roles and responsibilities.

7.     Document the capacity and commitment of all participating organizations or institutions to achieve project goals.

8.     Identify the operational leadership and other key personnel (e.g., the project lead, PI, project manager and the project team) associated with implementing the initiative and provide evidence of their ability to successfully perform the work.

9.     Identify the metrics, data and documentation processes that will be used to report progress in meeting project objectives.

10.  Identify the individual(s) who shall be responsible for tracking and documenting and reporting on the implementation activities and on progress towards achieving quality improvement goals; provide evidence of their ability to successfully perform this work.

11.  Provide a dissemination plan.

Requirement #1: Document the problem that your proposal seeks to address.

Describe the health condition for which prevention, diagnosis or treatment will be improved and/or how other quality of care deficiencies (e.g., deficiencies in care delivery, access, population-based health outcomes) will be addressed. Use specific measures to define the problem (e.g., show how outcome or process measures, trends or practice patterns in your community diverge from relevant benchmarks or achievable performance).

Requirement #2: State the specific quality improvement goal and/or the clinical outcomes you seek to achieve AND/OR explain the nature of the cost savings or increase in value you expect to achieve. If cost savings are the goal, provide evidence to demonstrate that quality of care will not be adversely affected. Estimate/quantify the size and/or scope of the impact of the expected improvement in quality or cost savings and explain the basis for that estimate.

State the goal and expected impacts in quantifiable terms and describe the specific measures you propose for tracking progress in achieving stated goals.

Requirement #3: Describe the CER finding/s whose use or spread you will be promoting, and explain how it will improve care quality and/or value (e.g., how it will control/reduce costs or without adversely impacting care quality.) Describe the nature, extent and strength of the evidence for the selected finding or practice.

Provide a clear and compelling case documenting how the selected CER finding/s will improve care quality and/or improve value or control or reduce costs. Describe the specific nature of the improvement/s that will occur in the prevention, diagnosis, management and/or treatment of a clinical condition; and/or in access to care or the reduction of disparities; and/or in population-based measures of health outcomes; and/or in the processes for delivering patient care; and/or in the value of the care; and/or in controlling costs. Where appropriate, document how and why the proposed clinical or care delivery is superior to competing approaches.

Describe the evidence base for the selected finding or practice; address the nature, extent and strength of the evidence. Explain how the nature and strength of the evidence justifies the proposed scope or breadth of increased use of the finding or practice.

NOTE: Applicants must make a clear and compelling case that the research finding to be implemented is based on solid empirical documentation of sufficient strength, clarity and technical merit to convince reviewers of the likelihood of its success in improving outcomes. However, applicants may draw on findings that have been disseminated outside of peer-reviewed literature, as documentation of some delivery-based studies is often reported in other venues.

Requirement #4: Describe the population that is expected to benefit from the increased use of the CER finding/s and estimate its size.

Describe clinical/demographic characteristics of the population that will benefit from the increased use of the CER finding/s. Highlight benefits to AHRQ’s priority populations. Describe any other potential beneficiaries (e.g., if cost savings are anticipated, to whom will they accrue?) Cite the specific data sources used to develop clinical, demographic, and cost information. Explain what data sources and methods were used in generating population estimates and estimates of the size and scope of impact/benefit. If any stakeholder group or its members is expected to be adversely impacted by this initiative, describe the type, scope, and size of that potential impact (e.g., will the initiative result in increased costs to one group while providing savings to another?).

Requirement #5: Describe the proposed initiative for increasing the use or spread of the selected CER finding/s. Explain how and why the proposed initiative will increase use or spread of the selected finding or practice by providers, patients, or other stakeholders; explain how collaboration across multiple stakeholders or multiple sites will contribute to the overall impact of the initiative.

Describe the proposed initiative and each of its component strategies or interventions. Explain why and how the proposed set of strategies/interventions will increase use or spread of the selected CER finding/s. Explain the nature of the collaboration or coordination that will occur among multiple stakeholders or across a geographic area or a large number of delivery sites. Describe the specific roles that each of the collaborating organizations, institutions, or other entities will play, as well as each of the activities they will undertake as part of this effort.

Estimate the likelihood that any increase in the use of the CER finding/s will be sustained once the project itself is concluded. Explain the basis for this estimate. In addition or alternatively, estimate the degree to which measureable quality improvements, cost reductions or other improved outcomes will continue once the project has concluded. Explain the basis for this estimate.

Justify the selected strategies based on prior research, prior experience of the participating organizations, and/or documented experiences of other organizations that have experimented with the proposed approaches. Describe current projects and sites that have applied strategies that are similar or closely related to those proposed in this application. Based on empirical research and appropriate theories and findings, explain how proposed changes are expected to produce the desired outcomes. Draw on theories and findings from health services; behavioral, social, organizational and engineering sciences and other fields, as appropriate. Use logic models (http://www.cdc.gov/eval/resources.htm#logic%20model; http://www.uwex.edu/ces/pdande/evaluation/evallogicmodel.html), or other appropriate schematics to present underlying assumptions about the sequence of actions which are expected to lead to attainment of the initiative s objectives.

Requirement #6: Provide a complete operational plan for how the proposed strategy will be implemented; list all participating organizations, institutions and other entities and describe their specific roles and responsibilities.

Provide a complete operational plan for the implementation of the proposed initiative and each of its component strategies and/or interventions. List all participating organizations, institutions and other entities; describe their specific roles, responsibilities, and activities in as much detail as possible. Explain how these responsibilities and activities will lead to the desired outcomes. The operational plan should specify the members of the project management team (who will have oversight responsibilities on operational issues), all key tasks and milestones, and the leaders for all key tasks. The plan should present a clear breakdown of the number of hours/level of effort that all key personnel will devote to carrying out each of their responsibilities.

The plan should also provide detail about the steps that will be taken to ensure cooperation and coordination of all participating organizations, institutions or other entities. Potential challenges associated with the need for close cooperation and coordination among different stakeholder groups should be identified and ways of avoiding them or mitigating their impact should be discussed.

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

Provide details on key resources needed -- including information and data, information processing systems, expertise, staff, and equipment -- and indicate which resources will be acquired through the funded project, which will be provided in kind, and which will be obtained from other funding sources.

Requirement #7: Document the capacity and commitment of all participating organizations or institutions to achieve project goals.

Document the capacity and commitment of all participating organizations and entities to fulfill their roles and responsibilities. Document the track record of the lead agency with successfully taking proven practices to scale and/or implementing broad delivery system change. Describe the participating organizations resources, capabilities, and past performance relevant to the proposed project. Address each organization’s capacity for collaboration; capacity to promote the spread of knowledge; project management capabilities; information infrastructure.

Provide evidence of agreement among participating organizations about their intention to collaborate on the project. This agreement can take the form of letters signed by authorized representatives of each participating organization specifying the contributions of each organization in terms of personnel, expertise, money, equipment, data, facilities or other important resources.

Requirement #8: Identify the operational leadership and other key personnel (e.g., the project lead, PI, project manager and the project team) associated with implementing the initiative and provide evidence of their ability to successfully perform the work.

Provide evidence of the demonstrated capacity of the project lead to successfully oversee and implement an initiative of the given size and scope. Provide descriptions of the backgrounds and capabilities of the individuals responsible for operational oversight of the implementation effort and for the leaders of individual tasks. Include information on expertise, skill sets and experience directly relevant to the tasks they will carry out. Provide evidence of the inclusion within the project team of individuals who collectively have all necessary expertise and experience, including but not limited to, expertise and experience with taking proven practices to scale and/or implementing broad delivery system change; management and oversight of broad-based collaboration; implementation of quality improvement initiatives; and the relevant clinical area and delivery system/practice site.

Requirement #9: Identify the metrics, data and documentation processes that will be used to report progress in meeting project objectives.

The ability to track, document and describe the implementation activities and associated outcomes and impacts of the initiative will be critical to spreading actionable knowledge to others around the country interested in tackling similar challenges. Grantees will be expected to submit quarterly progress reports to AHRQ through the AHRQ Research Reporting System (ARRS) http://www.ahrq.gov/fund/arrareg.htm. ARRS progress reports require electronic reporting of:

In anticipation of these reporting requirements and of AHRQ’s desire to be able to synthesize and widely spread knowledge gained from FOA-supported initiatives, applicants must:

Additional reporting requirements for grantees funded by ARRA may be specified at a later date.

Grantees will not be responsible for the distillation and dissemination of lessons learned, nor for the analysis of outcomes and impacts. These tasks will be undertaken by AHRQ based on the information and data reported by the grantees. Technical assistance will be available for the grantees to support their reporting activities on an as-needed basis from the outset through the completion of the grant.

Requirement #10: Identify the individual(s) who shall be responsible for tracking, documenting and reporting on the implementation activities and on progress towards achieving quality improvement goals; provide evidence of their ability to successfully perform this work.

Identify the individuals who shall be responsible for the execution of relevant information gathering and reporting activities; provide evidence of their expertise, capabilities, relevant experience, suitability and capacity for successfully performing these functions.

Requirement # 11: Provide a dissemination plan

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

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 Demonstration and Dissemination Projects Grant (R18) award mechanism.  The individual researcher sponsored by each organizational grantee will be solely responsible for planning, directing, and executing his or her proposed projects.

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. AHRQ has designated $13 million to fund up to 10 grants, contingent upon the submission of a sufficient number of scientifically meritorious applications.

Budget proposals are limited to $1.666 million in total costs per year for a total of $5 million total costs over 3 years. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation. Applications with project periods that exceed 3 years or budgets that exceed $1.666 million total costs in any given year or $5 million total costs over the 3 year project period will be returned without review. Any applicant wishing to budget the total grant award unevenly over the 3 year period must explain how this would best support the aims of the project.

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.

Funding for this program is provided under the American Recovery and Reinvestment Act of 2009 (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, territories or 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.

This solicitation particularly seeks to leverage the capabilities, resources and strengths of the following 3 existing AHRQ networks (note, however, that a member of one of these networks may only apply if it also meets one of the organizational/institutional characteristics listed above):

Other applicants which are not members of one of these named networks will be considered eligible if they:

To reduce fragmentation of effort, any community collaborative that applies from a geographic area that significantly overlaps with an area represented by a Chartered Value Exchange, but which is not itself a designated CVE, must provide written evidence of support for its application from the CVE leadership.

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 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 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 can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.

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: [email protected].

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 24, 2010 (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s): March 24, 2010
Peer Review Date(s): Generally three months after receipt date
Earliest Anticipated Start Date(s): Not earlier than 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 [email protected].  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 [email protected] 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.

o 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

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 travel to and attend at least three days of the AHRQ annual meeting or another appropriate AHRQ meeting as determined by the program officer. 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.

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.

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

The NIH 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.

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), 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. Applicants using state data are encouraged to involve the HCUP state partner listed at this same address.

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.

2. 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: If the aims of the proposed project are achieved, how and to what degree will clinical practice, patient and/or practitioner decision-making, the delivery of patient care, or the value of patient care be advanced or improved? How strong is the evidence base for the proposed change? How likely is it that any resulting quality improvements resulting from this initiative will be sustained beyond the period of the grant? What is the size of the population likely to be impacted by this effort and what are the clinical/demographic characteristics of this population? Does the strength of the evidence for the selected finding or practice merit its spread, and the proposed degree of spread (i.e., size and scope of the project)? How likely is it that the project will meet all three of the FOA’s objectives, including providing useful information about the effectiveness of varying approaches or techniques for promoting the use evidence-based findings? How likely is it that increases in the use of CER findings, or associated quality improvements, costs reductions or other outcomes will be sustained once the project has concluded?

Investigators: What evidence is provided of the suitability of the PI, and other key personnel to carry out all aspects of the work (consider the strength of the evidence with regard to appropriate skills, training, expertise and experience)? Does the PI have the needed skills and experience to manage a large scale project? Are the skills and experience of project leaders and other key personnel well-aligned with the task they are assigned? Are the total hours budgeted for all key personnel appropriate to the level of effort required for the performance of their responsibilities? Does the project team have an appropriate and complementary mix of skills, experience and expertise in all necessary areas, including, but not limited to:

Innovation: How original and innovative is the project? For example: Does the project challenge existing patterns of clinical practice, decision-making or care delivery; use an innovative approach for increasing the use of comparative effectiveness findings or removing barriers to their use? Does the project develop or employ novel concepts, approaches or methodologies, collaborations, tools, or technologies?

Approach: How likely is it that the proposed initiative will promote the desired use of the selected finding or practice? How likely is the proposed strategy to lead to meaningful and sustained change in clinical practice, practitioner or provider behavior, patient decision-making or behavior? How likely is it to lead to meaningful and sustained change in outcomes such as quality, value, access, and/or reduction in disparities within and across delivery systems and/or broad geographic areas?

If this is a multi-stakeholder effort, how strong is the evidence of demonstrated commitment to the project on the parts of all stakeholder groups/entities/organizations whose participation would be critical to the project’s success? If this initiative will be spread across multiple sites, how strong is the commitment from each of them? Does the project lead have demonstrated support from the collaborating organizations? How clearly spelled out are the roles and responsibilities of all participating organizations, institutions or other entities? How strong a history of collaboration is there among the participating organizations? Have problems with coordination or other any potential challenges (e.g. technical constraints, resource limitations, other) been acknowledged/ properly anticipated; are possible resolutions proposed?

Given the operational plan for implementing the initiative, how likely is it to lead to success in meeting the project’s stated goals? In assessing the likelihood for success, consider the following criteria:

If any component critical to the success of the initiative is proprietary in nature, will it be made available at little or no cost to future actors who may wish to replicate the project elsewhere? Reviewers will reject applications containing any components (e.g., tools, products, technologies) that would due to legal or cost constraints -- significantly deter or prevent the replication of strategies or interventions by others tackling similar challenges.

How likely is it that the proposed methods for tracking and documenting progress and collecting data will yield information that will benefit others around the country wishing to take on similar challenges?

How likely is it that any resulting changes and outcomes will be sustained? How likely is it that knowledge gleaned form this project will be successfully spread to other regions, populations or delivery systems?

Environment: How well can one expect that the environment in which the work will be done will contribute to the probability of success? How will the proposed initiative benefit from unique features of the clinical environment(s), political environments, or subject populations? How strong are the proposed collaborative arrangements? How strong is the evidence of key stakeholders interest in the problem being addressed? Is there strong evidence of support from all stakeholder groups whose participation is likely to be necessary for the success of this project?  How strong is the evidence of past cooperation or of mutual interest in achieving project goals and objectives? Have potential environmental obstacles (e.g., political/interest group opposition; regulations) and the means for avoiding or mitigating their effects been identified?

How extensive are the capacities, experience, expertise and other resources of the participating organizations, institutions, and other entities? How well-aligned are they with the needs and aims of the project? How likely are they to lead to the project’s success?

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), and applicability of particular interventions to safety net institutions.  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 size and budget commensurate with the expected level of impact (e.g., improvement in quality and/or reduction in disparities and/or increased value)? Is the size and budget of the project commensurate with the strength of the evidence and with the expected degree of spread (e.g. by the number of sites involved or the number of potentially affected patients/consumers)? Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research? Does the budget account for all needed resources and expenditures?

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?

The review criteria listed in the Priority-Setting Process and Inputs for Use of ARRA OS Funds (Section I) 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, unless otherwise provided in grant awards, 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).

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 Recovery Act of 2009: AHRQ Announces Suspension of Grants Funding Appeals Process (see NOT-HS-09-011, http://grants.nih.gov/grants/guide/notice-files/NOT-HS-09-011.html).

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 HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (ARRA). The full text of these terms approved for AHRQ awards can be found in the following document: Department of Health and Human Services Standard Terms and Conditions American Recovery and Reinvestment Act of 2009 (see 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

When multiple years are involved, 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 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. Accordingly, 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. Recipients will be expected to follow the most current OMB reporting requirements.

In addition, 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.

Recovery Act-related reporting requirements will be incorporated as a special term of award.

A final Progress Report, Final Invention Statement, and 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:

Dina K. Moss
Center for Delivery, Organization, and Markets
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1574
Fax: (301) 427-1430
E-mail address: [email protected]

2. Peer Review Contact(s):

Direct your questions about peer review issues of grant applications made in response to this FOA to:

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: [email protected]

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to:

Al Deal
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1806
Fax: (301) 427-1462
E-mail address: [email protected]

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 (DHHS) "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information.  It is administered and enforced by the DHHS 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.  AHRQ 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 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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