Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

Agency for Healthcare Research and Quality (AHRQ)

NOTE:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA. Also note that AHRQ may have different page limits than NIH for the application Research Strategy, which can be found within each individual FOA (see Section IV below). AHRQ Grants Policy and Information to applicants regarding Funding Opportunity Announcement procedures can be found at Funding Opportunity Announcement Guidance.

Components of Participating Organizations

Agency for Healthcare Research and Quality, Center for Delivery, Organization and Markets

Funding Opportunity Title

Disseminating Patient Centered Outcomes Research To Improve Healthcare Delivery (R18)

Activity Code

R18 Research Demonstration and Disseminations Projects

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HS-14-003

Companion Funding Opportunity

None

Number of Applications

See

Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.226 

Funding Opportunity Purpose

The purpose of this FOA is to disseminate and implement existing evidence for improving the quality of health care delivery.  Applicants are required to demonstrate the ability and commitment to leverage the capacities of existing broad-based networks of providers and other key stakeholders in their dissemination and implementation activities.

Key Dates
Posted Date

June 24, 2013

Open Date (Earliest Submission Date)

August 27, 2013

Letter of Intent Due Date(s)

August 26, 3013

Application Due Date(s)

September 27, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Generally, four months after receipt date

Advisory Council Review

Not Applicable

Earliest Start Date

Generally, four months after peer review date

Expiration Date

September 28, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

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

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the 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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

Purpose: The purpose of the FOA is to leverage the capacities of existing broad-based networks of providers and other key stakeholders to disseminate and implement existing evidence for improving the quality of care delivery.

Background:  Since the 2009 Recovery Act (ARRA), the scope of Comparative Effectiveness Research (CER) has expanded from its earlier focus on identifying improvements in clinical treatments to include improvements in care delivery.  Past AHRQ-supported delivery system improvement activities have revealed unique challenges associated with actual implementation of evidence in this domain. Spread of evidence to support change in care delivery requires coordination, buy-in and active participation by diverse providers across multiple settings of care, collaboration with other key stakeholders (including payers and consumers) who are instrumental in shaping care delivery, and adaptation of interventions to local conditions. In recognition of these well-documented challenges and needs, this FOA requires that applicants represent existing networks of providers and other stakeholders that have the knowledge, on-going relationships, expertise, infrastructures, past experience and understanding of local needs and constraints to maximize buy-in, collaboration, and appropriate adaptation to local conditions.

Method:

Applicants must:

Utilize the resources and capabilities of an existing network (as defined below under definitions and eligibility requirements) to support spread activities.

Applicants may propose either to

OR

All applicants are expected to:

Each successful applicant will represent an already established network with:

Each of these capacities should be described in detail in the grant application and the specific contribution of these elements to the proposed project must be discussed.  (For additional Applicant Eligibility Requirements, see section III below)

To achieve maximum impact, applicants are expected to design initiatives that:

Initiatives (coordinated, multi-stakeholder projects) that would fall within the scope of this FOA may aim to accomplish objectives such as (but not limited to) the following:

Applications which propose to implement findings within and across safety net institutions or priority populations are particularly encouraged.

Definitions of Key Terms -- For the purpose of this FOA, the following definitions apply:

Evidence-based interventions, practices, findings, care delivery improvements  (henceforth "interventions") --  For the purposes of this FOA, evidence and research findings about practices or interventions for improving clinical outcomes, care delivery, or the performance of delivery systems cover both broad improvement strategies and specific interventions or techniques. These strategies and interventions may aim for outcomes at the individual, group (a.k.a. team), organizational, population, delivery system, local community, or regional level. The objectives can focus on clinical, behavioral, or organizational change. The objectives may be broadly defined or narrowly focused. The evidence base for these strategies and interventions is empirical documentation of sufficient strength, clarity, and technical merit to produce strong expectations as to the likelihood of success in achieving improvement goals. Evidence about non-clinical interventions often derives from the social, behavioral, and management sciences. Evidence should be generated by comparing two or more methods designed to achieve the same goal. One of these methods may be current practice.

Initiative -- a comprehensive approach or set of approaches for spread (dissemination and implementation) undertaken in a coordinated fashion across multiple sites and among groups of stakeholders.

Intervention -- a specific activity, action, or technique that can be utilized individually or in combination in support of a broader strategy.

Strategy -- a set of practices, techniques or interventions with an underlying logic for improving the quality of clinical care or care delivery (e.g., introducing decision-support systems; fostering patient self-management; developing cross-disciplinary care teams).

Approach -- an explicit set of techniques or activities for achieving spread (dissemination and implementation) of interventions or strategies.

Delivery settings or sites -- any location where health care services are delivered or received including, but not limited to, hospitals, long term care facilities, doctors’ offices, primary care clinics, pharmacies, school or community health clinics, and home care.

Provider -- any individual or organization that provides care to patients (including, but not limited to, physicians, nurses, other healthcare practitioners, group practices, hospitals, ambulatory care centers, integrated delivery systems).

Stakeholder group -- any group, entity, or organization involved in providing, receiving or paying for health care; any group that represents or advocates on behalf of those who provide, receive, or pay for care.

Network – An established, broad-based association, coalition, or partnership of clinical practitioners, provider practices or organizations, or other groups, entities or organizations playing an influential role in health care delivery, with a  history of collaborative relationships directed at improving health care quality. Relationships among these linked actors can be formal or informal; capacities must include at a minimum: established channels for communication and data sharing and an infrastructure that has proven to be capable of supporting joint actions to improve care and collaborations for improvement and/or shared learning.

Dissemination -- purposeful distribution of information and guides to improvement interventions and strategies to specific audiences.

Implementation -- adoption and actual uptake or use of proposed interventions and strategies by individuals, sites, and organizations.

Spread (or scale-up) – the process of achieving uptake of one or more interventions that have been successfully tested in pilots or experimental sites to additional sites.  This process involves disseminating information about preferred practices, procedures, and organizational arrangements and actively supporting the implementation of the changes needed to put the interventions and strategies into practice.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon AHRQ appropriations and the submission of a sufficient number of meritorious applications.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration, and costs of the applications received.

AHRQ intends to fund 4-8 awards, at a total of $4 million total costs per year for the four year duration of this initiative.

Award Budget

Total costs (including both direct and indirect costs) will ordinarily be around $500,000 in any given year of the project period.  No single award may exceed $1 million total costs in any given year.  Applications will ordinarily not exceed $2 million total costs for the entire project period. In special cases AHRQ may consider submissions that exceed this amount due to project complexity and scope.

No single award shall exceed $1million total costs per year.              

Projects requesting in excess of $500,000 total costs in any given year will only be considered if they involve spread in multiple states, large geographic areas or areas across multiple delivery systems.  

Requests for awards totaling more than $2 million total costs over the four year project period must be justified in terms of the complexity of the proposed project aims and the initiative's potential to provide solutions to particularly challenging problems in care delivery, to affect the lives of large sectors of the population, and/or to demonstrate ways to better care for critical subgroups.  These larger projects should therefore be likely to provide models of spread initiatives of great importance to healthcare delivery system leaders and policy makers.  

Award Project Period

The project period for these applications must be from 2 to 4 years. 

These projects are being funded pursuant to 42 U.S.C. 299a, which provides that AHRQ shall conduct and support research, support demonstration projects, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness, and value of health care services.

All applications submitted and AHRQ grants made in response to this FOA are subject to AHRQ's grant regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html and  http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf), and the terms and conditions set forth in the Notice of Award.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

You may submit an application(s) if your institution/organization is a (an): 

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus 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 not be reviewed.  Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the grantee and what substantive role the applicant organization will play. Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application.  There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.

Any eligible institution may serve as the applicant for this announcement.  The proposed initiative must operate through an existing network with the capacities needed to meet all the requirements of the solicitation.  This network should have:

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Required Registrations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

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

2. Cost Sharing

This FOA does not require cost sharing.

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 should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.

3. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

AHRQ will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months, except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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

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

The letter of intent should be sent electronically to:

Michael I. Harrison
Email: Michael.Harrison@ahrq.hhs.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

SF424(R&R) Cover Component, SF424(R&R) Project/Performance Site Locations Component, SF424(R&R) Other Project Information Component, SF424(R&R) Senior/Key Person Profile Expanded Component, Research & Related Budget Component, PHS 398 Cover Letter Component, PHS 398 Cover Page Supplement, Optional: Research & Related Subaward Budget Attachment


Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

PHS 398 Research Plan Component

All application instructions outlined in the SF424 (R&R) Application Guide that are not otherwise specified within this Funding Opportunity Announcement must be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

For this FOA, applicants are expected to address each of the following in the research strategy section: 

1:  The problem, the proposed intervention/s, and the expected goals or outcomes

Briefly describe the finding(s), practice(s), interventions and/or strategies (hereafter “interventions”) whose use you will be promoting, and provide a clear and compelling case documenting how they are expected to improve clinical treatment and/or care delivery and resulting care quality. 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 efficiency of the care; and/or in controlling costs; and/or in other dimensions of value.  Where appropriate, document how and why the proposed form of care delivery is superior to competing approaches.  For expansions of existing spread initiatives, specify achievements that occurred under their existing projects and how, specifically these will be expanded (e.g., additional providers or populations that will be reached, outcomes that will be achieved, etc.).  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?).

2:  Complete project plan  

The project plan will be expected to:

Applicants are expected to include a timeline (e.g. a Gantt chart) showing the major scheduled milestones (events, activities, and data gathering, and reporting) for the project.

NOTE: The primary goal of this FOA is to disseminate and implement existing evidence for improving the quality of care delivery. Thus, grantees are not required to conduct analyses of outcomes and impacts. However, applicants may propose to engage in research about the progress and results of the spread project. In such cases the research activities must be addressed in detail in the project plan and associated costs must be clearly identified in the budget and budget justification.  If personnel are assigned research activities, clearly state the proportion of their time to be allocated to these activities. Applicants are to include a table in the budget justification section showing the amount of funds requested for research, itemized and by budget category, for each year of support in which they are requested.  The budget for research shall not exceed 15% of the total costs of the overall project period.

3:  Documented capacities of participating organizations and project personnel.

Applicants are expected to document fully the capacities and commitment of all participating organizations – including agencies and organizations that are not directly engaged in the spread but may influence its outcomes -- and of key personnel (See “Investigators” and “Environment “in Evaluation Criteria, below).  Provide details on the track record of the lead organization in successfully taking proven practices to scale and/or implementing broad delivery system change, as well as:

Additionally, include details on key resources needed – such as information and data, information processing systems, expertise, staff, and equipment -- and indicate how these will be secured. If spread requires authorizations, changes in regulation, training, payment or other relevant areas in the project’s external context, indicate how these will be obtained.

Similarly, if not evident in the attached biosketches, provide details on the operational experience and capabilities of the spread project’s operational leadership.

For expansions of existing spread initiatives, indicate how resources developed with previous funding will be leveraged in the proposed project; explain why additional funding is needed and what additional, specific capacities it will create.  There is not to be budgetary overlap between existing initiatives and the proposed project.

4:  Metrics, data, and processes for documenting the implementation and spread of the initiative and for tracking progress toward project objectives

AHRQ will analyze the outcomes and impacts of the funded projects and distill and disseminate lessons learned through information  reported by the grantees through quarterly progress reports to AHRQ using the AHRQ Research Reporting System (ARRS) http://www.ahrq.gov/fund/arrareg.htm.  Note that ARRS quarterly reporting is in addition to the required annual progress report (PHS 2590). In addition, grantees must state their willingness to cooperate with AHRQ (or its contractors) in its formative and/or summative evaluation activities, and in any associated efforts to spread actionable knowledge to others around the country who are interested in tackling similar challenges.

ARRS progress reports require electronic reporting of: progress towards meeting specific project aims; key findings; significant issues/changes in project goals, methods, study design, sample or subjects, interventions, evaluation, dissemination, training, key personnel, etc.; the reasons for each change; and the impact of each change; new collaborations/partnerships and the purpose of the collaboration/partnership.

In anticipation of these reporting requirements applicants are expected to:

Note:  Applicants are encouraged to collect data that will support use of nationally recognized clinical and process measures.  However, AHRQ recognizes that new outcome measures may need to be developed in order to provide improved clarity and assessment of implementation, spread, impacts, and outcome.

Budget Component:  Special Instructions for AHRQ 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

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.,

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the deadline in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
The PD/PI must include his/her eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH/AHRQ.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and for responsiveness by AHRQ.  Applications that are incomplete and/or nonresponsive will not be reviewed.

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

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.

Priority Populations

 AHRQ supports research, evaluations, and demonstration projects concerning 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.  42 USC 299(c).  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 is provided that inclusion is inappropriate, e.g. because of the lack of connection between the study and the health of women or particular minorities.  Investigators should review the document entitled, “AHRQ Policy on the Inclusion of Priority Populations,” which is available at 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.

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 should 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.

Data Confidentiality

The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied.  Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it.  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. 

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 applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

Sharing Research Resources:  Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses.  Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. 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) which incorporates additional applicable provisions on Rights in Data, including 45 CFR Part 74 and 37 CFR Part 401. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information


1. Criteria

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 to support health services research are evaluated for scientific and technical merit through the AHRQ peer review system. 

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:

Administrative Criteria:  Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and for responsiveness by AHRQ.

Merit Review Criteria:  Merit Review Criteria, as described below, will be considered in the review process.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the spread and implementation of the care/delivery system improvements that were focus of the initiative and other closely related improvements, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific 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 care delivery and/or delivery system quality and efficiency be advanced or improved?  How strong is the evidence base for the proposed change? 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 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? For expansions of existing spread initiatives, are the documented achievements that have occurred to date of sufficient impact to merit further investment? Are resources that were developed or obtained with previous funding being leveraged for maximal impact?

Investigator(s)

Are the PD/PI, collaborators, and other project members appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Do the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)? Are the leadership approach, governance and organizational structure all appropriate for the project? What evidence is provided of the suitability of the PD/PI, and other key personnel to carry out all aspects of the work (consider the strength of documentation with regard to appropriate skills, training, expertise and experience)? Does the PD/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 work 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:

design and execution of relevant data gathering and reporting activities?

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 or expand on an innovative approach for increasing the use of comparative effectiveness findings or removing barriers to their use? Does the project develop or employ or expand on 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 are the proposed strategies or interventions to lead to meaningful and sustained care/delivery system improvements? How likely are they to lead to meaningful, large-scale and sustained change in outcomes such as quality, value, access? How clearly spelled out are expected links between interventions and expected outcomes? Are the roles and responsibilities of all participating organizations, institutions or other entities clearly defined? Have potential problems with coordination or other any potential challenges (e.g. technical constraints, resource limitations, other) been acknowledged/ properly anticipated; are possible resolutions proposed? Are benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

How appropriate is the operational plan for implementing the initiative. How likely is it that the plan will lead to achievement of the project’s stated goals? If the applicant opts to engage in research and analysis, how well does their plan address these components? In assessing the likelihood for plan success, consider the following criteria:  

For expansions of existing spread initiatives, does the operational plan explicitly address methods for overcoming challenges that were previously encountered?

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? Do projections about sustainment consider possible costs of the initiative? If the proposed changes are likely to add to the costs of care providers or other delivery system actors (patients, payers, providers, community agencies), does the application provide a plausible scenario under which one or more system actors is likely to be willing to sustain these added costs?

How likely is it that knowledge gleaned from this project will be successfully spread to other regions, populations or delivery systems?

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.

If the project involves human subjects research, are there plans for 1) protection of human subjects from research risks, and 2) inclusion of AHRQ priority populations?

Environment

Do(es) the environment(s) in which the work will be done contribute to the probability of success? Is there evidence of institutional support?  To what extent can one expect that the environment in which the work will be done to contribute to the initiative’s success? How will the proposed initiative benefit from unique features of the clinical environment(s), political environments, community setting (e.g. medical neighborhoods), or subject populations? How strong is the evidence of key stakeholders’ interest in the problem being addressed? How strong are the proposed collaborative arrangements and how long and strong is the history of collaboration among the participating organizations? 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? 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? For expansions of existing spread initiatives, have problems with coordination or other any potential challenges (e.g. technical constraints, resource limitations, other) and learning from prior experience on this or related initiatives been acknowledged/ properly anticipated; are possible resolutions proposed?

Are proposed changes in the mix of participating organizations adequately explained and justified?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines

Degree of Responsiveness

Reviewers will assess how well the application addresses 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? Is the proposed project appropriately focused on spread of existing evidence, rather than research/generation of new evidence?

Inclusion of Priority Populations 

Reviewers will assess the adequacy of plans to address the needs of both genders, as well as racial and ethnic minorities (and subgroups).  Reviewers will assess the adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 “Other Submission Requirements”).

Budget and Period of Support

The committee will evaluate whether the proposed budget is reasonable and the requested period of support is appropriate in relation to the proposed research.

Privacy and Security Protections for Patients

Reviewers will assess the resources and processes to be used to address privacy and security issues in the development and implementation of the intervention.

Additional Review Considerations

Not Applicable

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group in accordance with AHRQ review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established AHRQ referral guidelines to the appropriate AHRQ Office or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA.  The following will be considered in making funding decisions:

Relevance and fit within AHRQ portfolio priorities, as well as overall programmatic balance.

3. Anticipated Announcement and Award Dates

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 eRA Commons

Generally, applicants should anticipate eight months between the application submission date and the earliest possible start date.

Section VI. Award Administration Information


1. Award Notices

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 for successful applications. The NoA signed by the AHRQ grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions.

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.”

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at http://www.ahrq.gov/fund/postawrd.htm#terms.

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, the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm), and the terms and conditions set forth in the notice of grant award.  

As necessary, additional Terms and Conditions will be incorporated into the Notice of Award.

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 Sections 2.2.6 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.  In addition to the annual progress report, recipients will be required to submit quarterly progress reports to AHRQ. Detailed instructions on reporting requirements will be provided within the grant award.

Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm).  AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project.  However, the due date for annual FFRs will be 90 days after the end of the calendar quarter in which the budget period ends.  Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter.  For example, if the budget period ends 4/30/2013, the annual FFR is due 9/30/2013 (90 days after the end of the calendar quarter of 6/30/2013).

A final Progress Report, final Federal Financial Report, and Final Invention Statement 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

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

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

Name: Michael I. Harrison, Ph.D.
Agency for Healthcare Research and Quality
Center for Delivery, Organization and Markets
Telephone: (301) 427- 1434
Fax: (301) 427-1430
E-mail address:  Michael.Harrison@ahrq.hhs.gov

Peer Review Contact(s)

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

Andrew Louden, Ph.D.
Agency for Healthcare Research and Quality
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Telephone: (301) 427-1183
Fax: (301) 427-1562
E-mail address: Andrew.Louden@ahrq.hhs.gov  

Financial/Grants Management Contact(s)

Direct your questions regarding fiscal matters to:

Steven Young
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
Telephone: (301) 427-1458
Fax: (301) 427-1462
E-mail address:  Steven.Young@ahrq.hhs.gov

Section VIII. Other Information

Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided in the NIH Guide for Grants and Contracts. Notices can also be found at AHRQ Grants Policy Notices.  All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

AHRQ Grants Policy and Information to applicants regarding Funding Opportunity Announcement procedures can be found at Funding Opportunity Announcement Guidance.

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 or Health Systems Agency review. 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.


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