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 (AHRQ)

Funding Opportunity Title

Evaluation of AHRQ Initiative to Accelerate the Dissemination and Implementation of PCOR Findings into Primary Care (R01) 

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-HS-14-009

Companion Funding Opportunity

RFA-HS-14-008:  Accelerating the Dissemination and Implementation of PCOR Findings into Primary Care Practice (R18)

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

 93.226 

Funding Opportunity Purpose

This AHRQ Funding Opportunity Announcement (FOA) invites applications to conduct a rigorous external evaluation of an AHRQ grant-funded initiative to disseminate and implement PCOR findings to improve heart health and to improve the capacity of primary care practices to implement PCOR findings into practice.

Key Dates
Posted Date

March 11, 2014

Open Date (Earliest Submission Date)

June 3, 2014

Letter of Intent Due Date(s)

May 23, 2014

Application Due Date(s)

July 3, 2014, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Estimated to be September, 2014  

Advisory Council Review

Not Applicable

Earliest Start Date

Estimated to be February, 2015.

Expiration Date

July 4, 2014

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

This Funding Opportunity Announcement (FOA) solicits Large Research (R01) Project applications to conduct a comprehensive, multi-year evaluation of AHRQ’s three-year grant-funded initiative to accelerate the dissemination and implementation of patient-centered outcomes research (PCOR) findings into primary care practice.

Background:

Through a separate funding announcement, RFA-HS-14-008, AHRQ is soliciting proposals to disseminate PCOR evidence directly to primary care practices and to support the practices in implementing evidence-based clinical and organizational findings.   Applicants to RFS-HS-14-008 will propose comprehensive approaches that utilize evidence-based quality improvement techniques, such as practice facilitation, that are designed to improve the capacity of primary care practices to implement new PCOR evidence into the delivery of care.  Funded projects will work with primary care practices over a three-year period to disseminate PCOR findings and support primary care practices in implementing them to improve heart health with a focus on the ABCS (Aspirin use by high risk individuals, Blood pressure control, Cholesterol management, and Smoking cessation).  The primary objectives of that separate funding announcement are: 1) to disseminate and implement PCOR findings particularly related to the ABCS, and 2) to build primary care practices’ capacity to receive and incorporate other PCOR clinical and organizational findings in the future.   Each project will conduct a broad internal evaluation that includes routine measurement of the ABCS, measurement of practice capacity to implement PCOR findings, analysis of internal and external contextual factors, and evaluation of the processes of implementation.  Each grant will also include some form of control or comparison group.  AHRQ intends to make separate awards to fund up to eight cooperatives that will each work with a minimum of 250 small to medium–sized primary care practices.  To learn more, please review the full FOA HS-14-008 (see [***NOTE:  please insert link to HS-14-008]).

Purpose of this FOA (RFA-HS-14-009):

The purpose of this FOA is to invite applications that propose to conduct an overarching evaluation of the AHRQ initiative to disseminate and implement PCOR findings in primary care practices, which is described above.  This overarching evaluation will be funded through the Patient Centered Outcomes Research (PCOR) Trust Fund, consistent with the statutory requirement in The Affordable Care Act (P.L. 111-148) that AHRQ establish a process to receive feedback about the value of the information disseminated and the assistance provided under relevant provisions of the law.

While the implementation grantees will be performing their own internal evaluations of their delivery of ABCS and of improvements in their practices’ ability to incorporate new PCOR findings, the goal of this overarching evaluation is to:

1) provide a summative evaluation of the findings from each individual implementation grantee,

2) extract, examine, and rapidly report key themes and findings from across the implementation grantees, and

3) evaluate the comparative effectiveness of the dissemination and implementation strategies utilized by the different implementation grantees with particular attention to analysis of the contextual and environmental factors and their influences. 

This overarching evaluation should be summative and complementary to the individual evaluations and will require close collaboration with the implementation grantees.

The overarching evaluation will include the following:

In developing the overarching evaluation plan, AHRQ encourages applicants to consider all important implementation domains - intervention characteristics, outer setting, inner setting, characteristics of the individuals involved, and the process of implementation as described by Damschroder and colleagues in the Consolidated Framework for Implementation Research (CFIR).

In order to accomplish the major goals of this initiative it is important the results of this multi-level evaluation be clearly communicated with multiple stakeholders.  It is equally important that these results and insights be shared in a timely manner.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

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

AHRQ anticipates investing up to $ 3,500,000 in the first year of this initiative and up to $14 million over four years to support one award.

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

Award Budget

The total costs (direct and indirect) for a project awarded under this FOA will not exceed $3,500,000 in any given year or $14,000,000 for the entire project period.

Award Project Period

 The project period may not exceed 4 years.  

Title 42 USC, section 299b—37(a)-(c) authorizes AHRQ to make these awards to support the agency’s dissemination of comparative clinical effectiveness research findings.

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.  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.

Foreign Institutions

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

Required Registrations

Applicant Organizations

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.

Program Directors/Principal Investigators (PD/PI)

The PD/PI must have an eRA Commons account.  The PD/PI should work with his/her organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, he/she must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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.

Only one PD/PI may be designated on the application.

An individual may not be the PD/PI for both an application submitted to this FOA and the related FOA RFA-HS-14-008.

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.

Applicant organizations may submit applications to both this FOA and the related FOA RFA-HS-14-008.  As noted above, however, an individual may not be the PD/PI on applications submitted to both FOAs. 

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 can be sent electronically, and it should be sent to:

Phillip Jordan
Email: Phillip.Jordan@ahrq.hhs.gov

Technical Assistance Conference Call

AHRQ encourages applicants to take advantage of a technical assistance conference call sponsored by AHRQ program staff. The purpose of the conference call is to provide potential applicants with background information and respond to questions about the preparation of an application in response to this FOA. The conference call will take place on April 24, 2014 at 3:30 p.m. Eastern time. To register to participate in the conference call, please send an e-mail request to Phillip.Jordan@ahrq.hhs.gov by April 21, 2014.  All registrants will be sent an e-mail reply which will contain information on the call, including call-in information, by COB April 23, 2014.  Registrants will also be sent call-in information for a related AHRQ technical assistance call (beginning at 2:00 pm on April 24, 2014) focused on the initiative’s related Dissemination and Implementation FOA.  AHRQ strongly encourages any individuals or organizations planning to submit an application to this FOA to listen to Implementation FOA technical assistance call as well.  Potential applicants are encouraged to contact AHRQ staff with any questions (see Section VII, Agency Contacts, below).

The conference call is open to any individual or organization intending to apply. Participation is not a prerequisite to applying. Participants are encouraged to submit questions via email prior to the conference call. Please submit up to five questions with your name and the name of your institution to Phillip Jordan by April 21, 2014. Please include the phrase “EVALUATION QUESTIONS” in the subject line.  Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff. Notes from the conference call will be posted on the AHRQ web site.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required 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.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.  

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed. 

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

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.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide that are not otherwise specified within this Funding Opportunity Announcement must be followed, with the following additional instructions:

Research Strategy:

The research strategy section of the application is limited to 30 total pages.  Applications that exceed 30 pages will not undergo peer review.  Below are maximum page limits for each component of the research plan, which are intended to allow flexibility in developing the research plan.

The research plan section must include the following sections:

1. Understanding of the Issues (maximum length 3 pages)

2. Organization and Team (maximum length 5 pages)

3. Evaluation Plan (maximum length 20 pages)

4. Project Timeline (maximum length 2 pages)

5. Dissemination Strategy (maximum length 3 pages)

Section 1: Understanding of the Issues

This section should be no longer than 3 pages and should accomplish the following:

Demonstrate a thorough understanding of PCOR, the national context of health system change in which the initiative will be implemented, the state of primary care practice, the field of quality improvement in primary care, and AHRQ’s goals for the initiative.

Section 2:  Organization and Team

This section should be no longer than 5 pages and should accomplish the following:

Describe the project’s organizational structure, including:

The resources and expertise that key personnel and organizations bring to the project in the following areas:

Section 3:  Evaluation Plan

This section should be no longer than 20 pages and accomplish the following:

Detail a comprehensive evaluation plan that includes:

an assessment of improvements in the delivery of the ABCS by primary care practices across implementation grantees supported by the initiative;

an assessment of changes in primary care practice capacity to implement new PCOR findings into practice across implementation grantees supported by the initiative;

a process evaluation of the implementation of each grantee’s quality improvement support approach; and

an evaluation of the relative effectiveness of different approaches across primary care practices within each implementation grantee project and across implementation grantees to disseminate and implement PCOR findings to improve heart health and build practice capacity.  This portion of the evaluation should include analyses of the heterogeneity of effects due to variation in context across implementation grantees and differences across primary care practices within each grant.

The comprehensive plan should also demonstrate consideration of issues related to health and health care disparities across all aspects of the planned evaluation.

Describe a plan for developing a productive relationship with all of the implementation grantees (which is expected to be 8) whose efforts will be evaluated.  The application should describe a plan for working with the implementation grantees throughout the enactment of their grants and for minimizing the burden placed on them in relation to the overarching evaluation.  The requirements for cooperation or collaboration with the overarching evaluation that AHRQ is asking of the implementation grantees are described in the Implementation FOA (HS-14-008).  Because the grants that will be evaluated will not have been awarded at the time this application is submitted, it is not expected that the application will include letters of support from the groups whose work will be evaluated.  Given the simultaneous timeframe with the implementation grant, applicants should discuss how they will establish relationships with implementation grantees, refine data collection approaches, and execute the evaluation within the timeframe of the evaluation grant.  Each implementation grantee will have to dedicate a minimum of 20% FTE of a senior evaluator and 40% FTE of a research assistant in each year of their project to work with the external overarching evaluator. 

Detail plans for data standardization, collection, quality assurance, and management.  Applicants may assume that they will be provided with de-identified data sets of up to six measures of the ABCS and two measures of practice capacity at regular intervals, as described in the Implementation FOA (HS-14-008), by AHRQ or the grantees.  Applicants may budget funds to compensate implementation grantee organizations for efforts related to additional data collection for the overarching evaluation.  If applicants propose to reimburse implementation grantee organization for these efforts, the application budget justification must include a clear explanation of how the amount proposed per grantee was calculated.

Describe plans for additional data collection to support a robust process evaluation of each implementation grantee’s work and comparative evaluation of the effectiveness of different comprehensive approaches and individual techniques for disseminating and supporting implementation of PCOR findings. 

Applicants should plan on conducting site visits to all implementation grantees.

Applicants should also plan to conduct site visits to multiple primary care practices throughout the project period.  In addition to collecting data for the parts of the evaluation already described, AHRQ encourages applicants to consider conducting external data validation related to the ABCS measures reported by the implementation grantees on a meaningful sample of practices.  Applicants may also consider collecting other practice or patient level data in order to produce a richer overall evaluation of how disseminating and implementing PCOR findings in primary care practices may improve health and health care.  For example, an applicant might collect data on what type of support patients who use tobacco are given or clinician, staff, and patient attitudes towards PCOR.

Applicants may budget funds to compensate primary care practices for efforts for data collection activities related to the overarching evaluation.  If applicants propose to reimburse individual practices for these efforts, the application budget justification must include a clear explanation of how the amount proposed per practice was calculated.

Given the complex and changing health care context and the challenge of incorporating the work of multiple independent implementation grantees, the application must describe a plan for maintaining flexibility and allowing for the adaptation of the evaluation approach in order to continue meeting the aims and objectives of the project over time.

Section 4:  Project Timeline

This section should not be more than 2 pages and should accomplish the following:

Provide a project timeline showing the major scheduled milestones (events, activities, data gathering, analysis, and reporting) for the project.

A more detailed Gantt chart should be included as an appendix.

Describe the applicant's plan for obtaining Institutional Review Board (IRB) approval of the project.  AHRQ encourages applicants to consider approaches that increase the chance that data collection will not be delayed.

Applications must include a plan and budget for six team members, including the PD/PI, to travel to the Washington, DC area once a year for each year of the first three years of the grant to participate in a two-day meeting with the Implementation grantees.  The first meeting is expected to be held in the spring, 2015.

Section 5:  Dissemination Strategy

This section should not be longer than 3 pages and accomplish the following:

Describe plans for sharing results of the evaluation with stakeholders including health care decision makers, organizations dedicated to primary care quality improvement, primary care practices and professionals, and the public.  It is expected that results will be shared in a timely manner, with updates at least quarterly, and not only through peer-reviewed publications and presentations. 

Plans should include dissemination activities to convey evaluation results regarding ABCS delivery, development of practice capacity for PCOR finding implementation, the process of implementing comprehensive approaches to quality improvement in primary care, and insights into the relative effectiveness of different approaches and specific techniques, and the effect of internal and external contextual factors on implementation and effectiveness.

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, with the following modification:

An appendix should be used to include a detailed project Gantt chart.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report 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 due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date 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/funding/grants/policies/hhspolicy.html.

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. See Section III of this FOA for information on registration requirements.

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. 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 non-responsive 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 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 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.

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, 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.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR) 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-13-030.

Section V. Application Review Information


1. Criteria

The mission of AHRQ is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work with the U.S. Department of Health and Human Services (HHS) and other partners to make sure that the evidence is understood and used.  

AHRQ's priority areas of focus are:

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.  Only the review criteria described below will be considered in the review process.

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 research field(s) involved, 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

 Will the proposed evaluation produce information useful to others who disseminate PCOR evidence and support its implementation, researchers studying effective methods to spread evidence-based findings, and implementers who seek to enhance practices’ QI capacity?

Investigator(s)    

 Are the PD/PI, collaborators, and other researchers appropriately trained and well suited to the project?

Do the investigators have expertise in the methods of evaluation of large scale demonstration projects? 

Do the investigators have experience conducting external evaluations? 

Do investigators and other team members have appropriate skills and experience for their roles in the project?

Are the total hours described for all key personnel appropriate to the level of effort required for the performance of their responsibilities?

Innovation

 This FOA requires a robust multi-level evaluation, but does not specifically require innovation. 

Approach

Is the overall strategy for engaging with the implementation grantees well-reasoned, realistic, and appropriate? 

Is a well-conceived and appropriate evaluation framework presented?

Does the applicant demonstrate flexibility and the ability to adapt the approach as the project progresses to account for changes in context, the environment, and the work of implementation grantees while continuing to meet the aims and objectives of the project?

Does the application clearly articulate evaluation questions, and are the measurement, data collection and management, and analytic plans adequate to answer those questions?

Does the evaluation plan address all of the required areas including delivery of ABCS, development of practice capacity for the incorporation of PCOR findings into practice, process of grantee implementation, relative effectiveness of grantee approaches and techniques (across primary care practices within each implementation grantee project and across implementation grantees) to disseminate and implement PCOR findings and build practice capacity, and understanding of the relationship of internal and external context to implementation and outcomes? 

Has the applicant considered issues related to health and health care disparities across all aspects of the proposed approach including data collection and analysis?

Is the evaluation plan strengthened through the collection at appropriate intervals of additional measures and the use of both quantitative and qualitative methods? Is the choice of measures and measurement instruments well justified?  

Are plans for site visits to implementation grantees and primary care practices both adequate enough to meet the objectives of the project and well justified?

If implementation grantees or primary care practices are expected to participate in measurement activities, data collection, data sharing, or other related activities, is there a plan for appropriately compensating them for their efforts?  Are compensation amounts well justified in the budget?

Are appropriate plans for data validity and data quality assurance in place, including plans for assuring the quality and validity of quantitative and qualitative data across grantees and over time?

Is the management approach and organizational structure appropriate for the project?

Is a feasible plan in place for obtaining necessary IRB approvals that will allow the project to begin on-time?

Are potential problems and alternative strategies presented?

How likely is it that the dissemination proposed will provide results and findings in a timely manner to a variety of stakeholders throughout the course of the project?

Environment

Will the environment in which the work will be done contribute to the probability of success?

Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?

Will the project benefit from unique features of the scientific environment?     

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 Guidelines for the Review of Human Subjects.

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? [NOTE: Information may be added here]

Inclusion of Priority Populations 

Reviewers will assess the adequacy of plans to address the needs of both genders, 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 whether 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 initial merit review, all applications will:

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:

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 and budgetary issues, and certification of IRB approval of the project's proposed use of human subjects.  For details regarding IRB approval, 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/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of  Award.

A standard term and condition of award will be included in the notice of award; all applicants will be subject to a term and condition that applies the terms of 48 CFR section 3.908 to the award, and requires that grantees inform their employees in writing of employee whistleblower rights and protections under 41U.S.C. 4712 in the predominant native language of the workforce.

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

3. Reporting

Grantee will be required to submit quarterly progress reports through the AHRQ on-line project reporting system ARRS.

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 does not currently limit the length of the progress report to 2 pages. AHRQ will provide the due date for submitting annual progress reports.  In addition to the annual progress report, recipients may be required to submit quarterly progress reports to AHRQ. Detailed instructions on reporting requirements will be provided with 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.  All final reports are due within 90 days of the project period end date.  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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: http://grants.nih.gov/support/index.html

TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support(Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

Scientific/Research Contact(s)

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

Phillip E. Jordan, M.A.
Agency for Healthcare Research and Quality (AHRQ)
Center for Primary Care, Prevention, and Clinical Partnerships
Telephone: 301-427-1035
E-mail address: Phillip.Jordan@ahrq.hhs.gov

Peer Review Contact(s)

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

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

Financial/Grants Management Contact(s)

Direct your questions regarding fiscal matters to:

Galen Gregor
Office of Management Services
Grants Management
Agency for Healthcare Research and Quality
Telephone: (301) 427-1457
Fax: (301) 427-1462
E-mail address:  galen.gregor@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.

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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