It is critical that applicants follow the Research (R) 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, and follow the AHRQ Grants Policy and Guidance found on the AHRQ website at http://www.ahrq.gov/funding/policies/foaguidance/index.html,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.

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

Purpose

This Funding Opportunity Announcement (FOA) invites R18 grant applications for developing new clinical decision support (CDS) to facilitate the dissemination and implementation of evidence-based research findings. The purposes of this FOA are to develop new, reliable, valid, and usable CDS from evidence-based research findings and then demonstrate its effectiveness to improve care in clinical practice.

Background

AHRQ has a history of making significant investments in CDS and is exploring how CDS can accelerate the movement of evidence into practice and can become more shareable, standards-based, and publicly available.

CDS provides patient-specific information and knowledge, enabled by health IT, to clinicians, patients, or other individuals to enhance health and health care (Mardon et al., 2014). CDS includes processes and mechanisms that aim to deliver the right information, to the right person, using the right format, in the right channel, and at the right time during workflow (often referred to as the "5 Rights" framework; Osheroff, 2009). Well-implemented, electronic CDS can improve health care processes (Bright, 2012, Lobach, 2012).

Incorporation of evidence-based research findings into clinical practice using CDS builds on a complex array of activities. These activities include generation of scientific evidence, synthesis, and review of the scientific evidence, development of evidence-based clinical practice guidelines, development and testing of CDS, improved clinical decision-making, and assessment of clinical performance using tools such as clinical quality measures. Further, much of the information that supports dissemination of best clinical practices appears in prose, narrative-based form. Transformation of evidence-based clinical practice guidelines into CDS, for example, involves a multi-step translation of guideline recommendations from their narrative form into semi-structured and semi-formal forms that are machine-interpretable (Mardon et al, 2014). Semi-structured and semi-formal forms of CDS build upon health IT standards such as the Guideline Elements Model (Shiffman, 2000), Arden Syntax (see http://www.hl7.org/special/Committees/arden/index.cfm), and more recently, Health eDecisions.

Efforts are currently underway to harmonize CDS standards with standards for electronic clinical quality measures (eCQMs). Harmonized CDS and quality measurement standards would ideally make for more efficient and more consistently implemented health IT designed to drive quality improvement (ONC, 2014). Common CDS and eCQM standards for metadata, a data model (e.g., Quality Improvement and Clinical Knowledge or QUICK), and an expression language (e.g., Clinical Quality Language or CQL) are being developed through Health Level 7 (HL7) and the Clinical Quality Framework (CQF) Initiative (https://oncprojectracking.healthit.gov/wiki/display/TechLabSC/CQF+Home).

Objectives and Scope

AHRQ funds the PCOR CDS Learning Network (Research Triangle Institute), which facilitates a community of stakeholders working towards disseminating and implementing evidence-based research findings to support patient-centered CDS. Additional information about the PCOR CDS Learning Network can be found here: http://cds.ahrq.gov.

CDS can improve health care processes and may increase the uptake of evidence-based research findings in clinical practice if effectively developed, implemented, and shared. This FOA is intended to support projects that will develop new, reliable, valid, and usable CDS from evidence-based research findings and then demonstrate its effectiveness to improve care in clinical practice. AHRQ seeks to fund a spectrum of CDS development projects that spans settings, institutions, health IT systems, and clinical conditions. The improvements in health IT systems for data collection, quality improvement analysis, and CDS support may increase access and improve quality of care and outcomes particularly among vulnerable population groups receiving care in under-resourced settings.

All proposed projects must:

• Describe the evidence-based research finding that forms the basis for the proposed CDS, including appropriate citations and a discussion of level of evidence;
• Incorporate the "5 Rights" framework of delivering the right information, to the right person(s), using the right format, in the right channel, and at the right time during workflow (Osheroff, 2009);
• Develop and implement electronic CDS that is based on evidence-based research finding(s);
• Evaluate the reliability, validity, and usability of the CDS among diverse populations;
• Incorporate health IT standards that harmonize CDS and quality measurement (e.g., those that have been piloted through the CQF Initiative);
• Include an evaluation of the approach;
• Be prepared to collaborate with AHRQ-funded contractors also working on CDS, such as those tasked with creating a repository of CDS, developing tools for CDS authoring and sharing, developing CDS based on evidence-based research findings, and evaluation. Additional information can be found here (https://cds.ahrq.gov/); and
• Applicants are strongly encouraged to:
• Partner with a stakeholder organization to deliver CDS to target audiences, including professional organizations focused on racial and ethnic minority health issues; thus leading to more widely used CDS and greater uptake of evidence-based research findings in clinical practice for diverse populations (e.g., CDS delivered to a professional society's membership); and
• Collaborate with the AHRQ PCOR CDS Learning Network and other efforts aimed at sharing and disseminating best practices across the CDS community.

AHRQ seeks to fund a diverse set of projects that:

• Collectively span a range of intended and diverse users of the CDS, e.g., CDS directed towards patients, clinicians, and professionals who may be managing populations or panels of patients;
• Collectively span a range of settings, especially those serving uninsured, Medicaid, immigrant, geographically or economically disadvantaged, child, racial and ethnic minority, elderly, chronically ill, persons with disabilities, and other vulnerable populations (e.g., partnering with a Health Center-Controlled Network [HCCN] funded by the Health Resources and Services Administration [HRSA] (http://www.hrsa.gov/healthit/networkguide/);
• Collectively span a range of clinical situations, e.g., acute conditions, chronic conditions, and preventive and primary care;
• Collectively include the integration of mental health and behavioral services with other health care settings; and
• Collectively include CDS that support implementation of the U.S. Preventive Services Task Force's recommendations that are A, B, or C grades. This CDS may be targeted at improving shared-decision making at the point of care.

References

Bright TJ, Wong A, Dhurjati R, Bristow E, Bastian L, Coeytaux RR, et al. Effect of Clinical Decision-Support Systems: A Systematic Review. Ann Intern Med. 2012;157:29-43. doi: 10.7326/0003-4819-157-1-201207030-00450

Lobach D, Sanders GD, Bright TJ, Wong A, Dhurjati R, Bristow E, Bastian

L, Coeytaux R, Samsa G, Hasselblad V, Williams JW, Wing L, Musty M, Kendrick AS.

Enabling Health Care Decisionmaking Through Clinical Decision Support and Knowledge

Management. Evidence Report No. 203. (Prepared by the Duke Evidence-based Practice Center

under Contract No. 290-2007-10066-I.) AHRQ Publication No. 12-E001-EF. Rockville, MD:

Agency for Healthcare Research and Quality. April 2012.

Mardon R, Mercincavage L, Johnson M, et al. Findings and Lessons From AHRQ’s Clinical Decision Support Demonstration Projects. (Prepared by Westat under Contract No. HHSA 290-2009-00023I). AHRQ Publication No. 14-0047-EF. Rockville, MD: Agency for Healthcare Research and Quality. June 2014.

Office of the National Coordinator for Health Information Technology (ONC), "Health IT Enabled Quality Improvement: A Vision for Better Health and Health Care", November 2014.

Osheroff JA, ed. Improving medication use and outcomes with clinical decision support: a step-by-step guide. Chicago, IL: HIMSS, 2009.

Shiffman RN, Karras BT, Agrawal A, Chen R, Marenco L, Nath S. GEM: a proposal for a more comprehensive guideline document model using XML. J Am Med Inform Assoc. 2000 Sep-Oct;7(5):488 498.

See Section VIII. Other Information for award authorities and regulations.

These projects are authorized by 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 45 CFR Part 75 (Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards; http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75) , 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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for AHRQ support as Public or Private Institutions of Higher Education:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

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.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) may participate in projects as members of consortia or as subcontractors only.

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their 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, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. The AHRQ multiple PDs/PIs policy can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-018.html.

Each PD/PI must devote a minimum of 20% annual full-time effort in each year of this project (i.e., at least 8 hours per week).

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.

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

AHRQ will not accept duplicate or highly overlapping applications under review at the same time. This means that the AHRQ will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

Not applicable.

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

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.

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

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

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

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

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

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.

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

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

Software, Hardware, and/or Equipment Purchases: Combined purchases for software, hardware, or any other equipment needed to conduct the project are expected to be less than 20% of the total direct costs of the project over the duration of the project. These purchases may include modest incremental software development to enable implementation of existing health IT in a new setting or to improve health IT functionality. If funds for such purchases are in excess of 20% of overall total direct costs budgeted for the duration of the project, an explicit justification must be included.

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

Research Strategy:

Applicants should describe their approach to developing new, reliable, effective, and usable CDS, and demonstrating its effectiveness to improve care in clinical practice. In describing this approach, applicants must address the following elements:

• Describe the evidence-based research finding that forms the basis for the proposed CDS, including appropriate citations and a discussion of level of evidence. This must be clearly delineated in the research strategy.
• How the approach of developing new, reliable, effective, and usable CDS based on evidence-based research finding(s) for dissemination and implementation in clinical practice is expected to impact outcomes.
• How the approach for translating evidence-based research finding(s) from their narrative form to their semi-structured and semi-formal forms for CDS is systematic and replicable.
• How the approach will build upon emerging health IT standards that harmonize CDS and quality measurement and that support sharing of interoperable CDS.
• How the project will be completed within the project period of 3 years, including CDS development, testing, validation, evaluation, and additional phases where necessary.
• How the approach considers the following design factors: current information needs and related processes; user needs, goals, and motivations; the environments and context in which the health IT application or system will be used; the need for training and testing; and impact on workflow and workload, efficiency, economic, and health or clinical outcomes.
• The scalability and sustainability of the approach.
• Any partnership(s) with stakeholder organization(s), including professional organizations that focus on racial or ethnic minority health issues; their role in this specific project, and how the partnership(s) will lead to more widely used CDS and to greater uptake of evidence-based research finding(s) in clinical practice. For example, applicants may wish to partner with a professional clinical association to scale the CDS and to make it available for use by the association's members. Partnerships are encouraged.

Evaluation

Applicants should describe their approach to evaluating new, reliable, effective, and usable CDS. Contextual and implementation factors associated with the CDS should be described. In addition, applicants should discuss how barriers and facilitators to the scaling effort will be identified.

• Applicants should consider a wide range of scientific methods, including quantitative, qualitative, and other innovative methods. The study design and analytical plan should be well-justified and consistent with the specific aims and study type.
• Grant applications must describe in sufficient detail the process and clinical outcome measures to be used, if any.

Project Administration:

• Grant applications must address the administration of the project. This is especially crucial for teams necessitating the coordination of multiple team members efforts across disciplines, institutions, and geographic regions.
• Grant applications must include a detailed project timeline.

Letters of Support:

• Applicants should include letters of support from stakeholder organizations (e.g., professional medical societies, patient/family representative organizations, provider organizations) who have agreed to participate in and collaborate as part of the proposed project.
• Letters of support, recommendation, or endorsement should NOT be included from any entity or individual who is not directly participating in the proposed project. These types of letters may impede the review and/or selection process.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• Resource Sharing Plans are not applicable for this FOA.

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. See NIH/NIOSH/AHRQ New Policy Appendix Guide located at NOT-OD-16-129 via https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-129.html

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

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

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

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

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) may participate in projects as member of consortia or as subcontractors only.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time. 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.

This initiative is not subject to intergovernmental review.

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.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their 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 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 and compliance with application instructions by the Center for Scientific Review, NIH and responsiveness by AHRQ. Applications that are incomplete or non-compliant 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 https://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 https://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.

Public Access to AHRQ-Funded Scientific Publications

Investigators should review the document titled AHRQ Announces new Policy for Public Access to AHRQ-Funded Scientific Publications which is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-008.html). For all research arising from AHRQ support, this policy requires that AHRQ-funded authors submit an electronic version of the author’s final peer-reviewed accepted manuscript to the National Library of Medicine's PubMed Central (PMC) to be made publicly available within 12 months of the publisher s date of publication.

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. GPO's website

AHRQ requests that grantees notify the Office of Communications (OC) when an AHRQ-funded research article has been accepted for publication in a peer-reviewed journal. Researchers should submit manuscripts that have been accepted for publication in a peer-reviewed journal to JournalPublishing@ahrq.hhs.gov at least four to six weeks in advance of the journal’s expected publication date.

Regulations applicable to AHRQ grantees concerning intangible rights and copyright can be found at 45 CFR 75.322.

Other Special Requirements

AHRQ Contractors:

Applicants should anticipate that some dissemination activities will be conducted in cooperation with AHRQ contractors responsible for monitoring project progress and/or updating content on the Health IT Web site, http://healthit.ahrq.gov. Awardees are required to cooperate with AHRQ staff and contractors in promoting their work and findings. Activities that the awardee may engage in with AHRQ contractors for the duration of the grant may include:

• Reviewing a project description or profile that a contractor develops for publication on the Health IT Web site and providing timely feedback;
• Providing brief, high-level quarterly updates on the progress of the grant;
• Sharing information on any grant outputs (e.g., publications, survey instruments) for inclusion in AHRQ output repositories, as appropriate, and so that the contractor(s) can update the project profile on an annual basis; and
• Assisting in disseminating project-specific CDS findings and/or CDS authoring lessons; informing the stakeholder engagement process; and/or supplying other relevant and reasonable content as requested to aid in the dissemination of evidence-based research findings through CDS.

AHRQ CDS Contractors:

AHRQ grantees funded under this FOA must collaborate with AHRQ contractors also working on CDS (currently as part of the AHRQ PCOR CDS initiative), specifically:

• Collaborating and interacting with contractors tasked with creating a repository of CDS, developing tools for CDS authoring and sharing, and developing CDS based on evidence-based research findings; and
• Participating in the evaluation.

AHRQ PCOR CDS Learning Network:

AHRQ grantees funded under this FOA are strongly encouraged to collaborate with the PCOR CDS Learning Network and other efforts aimed at sharing and disseminating best practices across the CDS community. Activities may include:

• Participating in meetings;
• Providing approaches to develop, evaluate, and implement CDS based on evidence-based research findings; and
• Providing updates on the progress of the grant.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-16-130

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 (http://www.ahrq.gov/funding/policies/foaguidance/index.html) of focus are:

• Improve health care quality by accelerating implementation of patient-centered outcomes research (PCOR).
• Make health care safer.
• Increase accessibility by evaluating coverage expansions.
• Improve health care affordability, efficiency, and cost transparency.

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.

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).

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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

• Is the CDS based on at least one evidence-based finding and if so, are citation(s) provided?
• Will the proposed approach to developing, implementing, and evaluating new CDS based on evidence-based research finding(s) likely have a significant and wide impact leading to more widely used CDS and greater uptake of evidence-based research findings in clinical practice as demonstrated by the proposed evaluation?
• Are there any partnership(s) with stakeholder organization(s) and if so, will their level of involvement likely have significant and wide impact leading to more widely used CDS and greater uptake of the evidence-based research findings in clinical practice?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

• Are the PD/PI, collaborators, and other researchers well suited to the project?
• 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?
• Is the leadership approach, governance, and organizational structure appropriate for the project?
• Is each PD/PI devoting a minimum of 20% annual full-time effort in each year of this project (i.e., at least 8 hours per week)?
• Are letters of support included for collaborating stakeholder organizations?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

• Is the project original and innovative?
• Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?
• Are there new methods for developing, implementing, and/or evaluating CDS in a sustainable and shareable approach to increase dissemination of evidence-based research findings in clinical practice?
• Are unique partnerships presented that could create a broader impact of CDS in clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and 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?

• Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
• Does the approach build on the "5 Rights" framework of delivering the right information, to the right person(s), using the right format, in the right channel, and at the right time during workflow (Osheroff, 2009)?
• Will this project build upon ongoing efforts to harmonize and to build on health IT standards (e.g., HL7) for CDS and for electronic clinical quality measurement?
• Are the plans for data collection/analysis, CDS design, CDS testing, and evaluation scientifically sound?
• Are the proposed metrics for evaluating impact appropriate?
• Is the approach realistic to be completed and demonstrate impact within the proposed timeframe?
• Does the approach adequately discuss scalability and sustainability of the CDS?
• Is the project management plan adequately developed?
• Does the approach include any partnership(s) with stakeholder organization(s), and if so, will the partnership(s) lead to more widely used CDS and to greater uptake of evidence-based research finding(s) in clinical practice?
• Are potential problems and alternative strategies presented?

Will the scientific 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, subject populations, or collaborative arrangements?

• Will the scientific environment in which the work will be done contribute to the probability of success?
• If the application indicates partnering organizations, is there a history of successfully working together?
• Is there evidence of institutional commitment and support from all proposed organizations?
• Is the scientific and organizational environment strong enough to support completion of the project as described and according to the timeline?
• Are the institutional support, equipment, and other resources available to the investigators adequate for the project proposed?

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.

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?

Does the approach use evidence-based research findings as the basis for the CDS?

Does the approach focus on the development of CDS?

Does the approach incorporate health IT standards that harmonize CDS and quality measurement?

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.

Is the budget allocation for purchase of health IT hardware, software, and support appropriate and well-justified?

Is the budget allocation for purchase of health IT software, hardware, and support less than 20% of the total costs of the project over the duration of the project? If not, is appropriate justification provided for exceeding the 20% limit on these costs?

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 ).

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Not Applicable.

Not applicable.

Not applicable.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by AHRQ, in accordance with AHRQ Review Policy (see https://www.ahrq.gov/funding/process/study-section/peerrev.html) , using the stated review criteria. AHRQ R18 applications are assigned to the Healthcare Information Technology Research (HITR) AHRQ study section (https://www.ahrq.gov/funding/process/study-section/peerdesc.html). If there is a conflict of interest, the AHRQ Referral Officer will make an alternate AHRQ study section assignment. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Responsiveness to goals and objectives of the FOA.
• Relevance and fit within AHRQ research priorities, as well as overall programmatic and geographic balance of the proposed project to program priorities.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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 regarding IRB approval of human subjects protocols, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

If all administrative and programmatic issues are 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 grants management officer is the authorizing document and will be sent via email to the email address designated by the recipient organization during the eRA Commons registration process.

Awardees must comply with any funding restrictions described in Section IV.6. 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.

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 https://www.ahrq.gov/funding/grant-mgmt/index.html. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

All AHRQ grant and cooperative agreement awards are subject to OMB's Uniform Grant Guidance, HHS’s Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards, (http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75), and 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. As necessary, additional Terms and Conditions will be incorporated into the award statement.

A standard term and condition of award will be included in the Notice of Award (NOA) that states: in any grant-related activity in which family, marital, or household consideration are, by statute or regulation, relevant for purposes of determining beneficiary eligibility or participation, grantees must treat same-sex spouses, marriages, and households on the same terms as opposite-sex spouses, marriages, and households, respectively. By same-sex spouses, HHS means individuals of the same sex who have entered into marriages that are valid in the jurisdiction where performed, including any of the 50 states, the District of Columbia, or a U.S. territory or in a foreign country, regardless of whether or not the couple resides in a jurisdiction that recognizes same-sex marriage. By same-sex marriages, HHS means marriages between two individuals validly entered into in the jurisdiction where performed, including any of the 50 states, the District of Columbia, or a U.S. territory or in a foreign country, regardless of whether or not the couple resides in a jurisdiction that recognizes same-sex marriage. By marriage, HHS does not mean registered domestic partnerships, civil unions or similar formal relationships recognized under the law of the jurisdiction of celebration as something other than a marriage.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to AHRQ grant programs, please contact the Scientific/Research Contact that is identified in Section VII Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/guidance-federal-financial-assistance-recipients-title-VI/. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), AHRQ awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgment about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all AHRQ grants and cooperative agreements except fellowships.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually unless specified otherwise in the terms of the award. Grantees are required to submit expenditure data on the Federal Financial Report (FFR; SF 425) annually.

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 RPPR Instructions, follow the instructions on the AHRQ website. Progress reports are due 3 months before the anniversary of the award.

In addition to the annual progress report, recipients must be submitted quarterly progress reports to AHRQ. If applicable, detailed instructions on additional 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 (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 is 90 days after the end of the calendar quarter in which the budget period ends. For example, if the budget period ends 4/30/2018, the annual FFR is due 9/30/2018 (90 days after the end of the calendar quarter of 6/30/2018).

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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable AHRQ grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the HHS Grants Policy Statement (http://www.ahrq.gov/fund/hhspolicy.htm) for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Shafa Al-Showk
Agency for Healthcare Research and Quality (AHRQ)
Email: ClinicalDecisionSupport@ahrq.hhs.gov

Boris Aponte, MPH, Ph.D.
Agency for Healthcare Research and Quality (AHRQ)
Telephone: (301) 427-1396
Email: Boris.Aponte@AHRQ.hhs.gov

Carol Kauffman
Agency for Healthcare Research and Quality (AHRQ)
Telephone: (301) 427-1448
Email: Carol.Kauffman@ahrq.hhs.gov

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.

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

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.

These projects are authorized by 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 RFA are subject to 45 CFR Part 75 (Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards; http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75), 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.