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

This FOA invites Large Research Demonstration and Dissemination (R18) Project applications that focus on AHRQ's mission and/or any aspect of its specific priority areas, described in detail below.. The Research Demonstration and Dissemination Grant (R18) is an award made by AHRQ to an institution/organization to support a discrete, specified health services research project. The R18 research plan proposed by the applicant institution/organization must be related to the mission and portfolio priority research interests of AHRQ. Although the PD/PI is responsible for conducting and supervising the research, the actual applicant is the research institution/organization legally accountable for the performance of the award and the expenditure of funds.

The AHRQ mission is to produce evidence to make health care safer, higher quality, more ac cessible, equitable and affordable, and to work with HHS and other partners to make sure that the evidence is understood and used. Within the mission, AHRQ’s specific priority areas of focus are:

• Research to improve health care patient safety.
• Harnessing data and technology to improve health care quality and patient outcomes and to provide a 360-degree view of the patient.
• Research to increase accessibility and affordability of health care by examining innovative market approaches to care delivery and financing.

Patient safety is defined as the freedom from accidental or preventable injury produced by health care as well as the practices that create a safe environment of care. The ultimate goal of AHRQ-supported Patient Safety research is to improve the safety of health care delivery. Patient safety research initiatives that lead to this goal can be considered in three different stages:

• Identification of risks, hazards, and patient harm.
• Design, implementation, dissemination and spread, and evaluation of interventions to improve patient safety.
• Establishment of strategies to sustain patient safety improvements such as just culture, incident/event reporting, measurement, monitoring, and surveillance.

AHRQ's Patient Safety Research Program: (1) identifies specific areas of focus through targeted grant funding announcements (i.e., Program Announcements, Requests for Applications, and Special Emphasis Notices) and (2) encourages investigators to utilize the Agency's general funding announcements to apply this research framework in response to other patient safety threats and opportunities for improvement.

The Patient Safety Portfolio will support research projects to create new knowledge by identifying the risks, hazards, and harm encountered by patients as a result of health care. The Portfolio will also support projects that mitigate those risks, hazards, and harm including the design, implementation and evaluation of strategies (patient safety practices) and the adaptation, refinement, and sustainment of those strategies. These initiatives are part of the Agency's overall mission to improve the quality of health care.

AHRQ encourages an interdisciplinary, systems science patient safety approach. In addition to health services research, perspectives from organizational theory, human factors, industrial engineering, facilities design, education, and other disciplines can be incorporated in research plans.

Projects may address important topics such as: the surveillance, measurement, detection, and reporting of patient safety events; the impact of human performance, work flow, and working conditions on patient safety; the patients' role and contribution to patient safety; health care safety culture, leadership, communication, teamwork, and simulation; prevention and control of healthcare-associated infections (HAIs); diagnostic safety and quality; the safe use of medical devices and medications, including safely prescribing opioids; the role of Patient Safety Organizations; and the challenges inherent in transitions of care in the same setting and between settings and handoffs between health care providers.

Research related to the prevention and control of HAIs is an instructive example of AHRQ’s Patient Safety research interests. AHRQ supports research whose short-term or long-term aim is to develop improved methods for preventing HAIs and to develop effective implementation strategies for HAI prevention in all health care settings. Accordingly, AHRQ’s foci of interest in HAI research are the following broad areas:

• Determination of the clinical efficacy and effectiveness of preventive interventions, including unintended adverse consequences.
• Characterization and assessment of relevant epidemiological aspects of HAIs, including but not limited to patient risk factors, clinical presentation, and sources of antibiotic-resistant organisms involved in the development of HAIs.
• Demonstration, dissemination, and evaluation of strategies and approaches for prevention and reduction of HAIs.
• Research regarding adoption and implementation (including sustainment, spread, and scale-up) of evidence-based approaches for prevention of HAIs.

The HAI research portfolio also encompasses generation of knowledge for combating antibiotic resistant bacteria. AHRQ is interested in studies to promote appropriate antibiotic use, reduce the transmission of resistant bacteria, and prevent HAIs in the first place. The last contributes to antibiotic stewardship by avoiding the need for antibiotic therapy and precludes the possibility of a resistant infection.

Clinical investigations that seek to establish the efficacy or effectiveness of preventive interventions, as noted above, typically involve a comparison of the intervention in question to routine care or, less frequently, to a placebo (when the latter is ethical). Such clinical studies are included in the scope of AHRQ’s HAI research portfolio. The HAI Portfolio does not fund comparisons of two interventions of known efficacy or effectiveness to determine which is more efficacious or effective. Such studies are comparative effectiveness research, which is more appropriately funded by other funding sources.

The Portfolio supports research in all health care settings including the hospital, long-term care, ambulatory care, home health care, pharmacy, and transitions of care between settings.

Patient safety research involves many stakeholder groups including patients, families, clinicians, non-clinical health care staff, policymakers, payers, and health care organizations including providers and accreditors, local and State governments, and the Federal Government, Patient Safety Organizations, and many others.

Projects in this area may also address patient characteristics that might influence the risk of experiencing a patient safety event, for example, attributes of AHRQ's priority populations that can impact patient safety and address strategies to address barriers to safe care.

AHRQ is interested in research to: advance the methods of evidence synthesis to ensure scientific rigor and unbiased reviews, make evidence-based recommendations on clinical preventive services, conduct research on how health information technology can improve the quality of health care, advance the science of clinical practice improvement, evaluate and support innovative models of practice transformation in primary care and other ambulatory settings, and facilitate communities of learning to promote the implementation of evidence for practice improvement. Further, AHRQ is interested in studying and improving upon the process by which health systems and ambulatory care practices select evidence to implement and how to determine what strategies are used to implement the evidence into everyday practice. The study of implementation strategies and processes is critical because interventions developed in the context of publically funded efficacy and effectiveness trials are rarely scalable without adaptations to specific settings and additional tools and guidance to support uptake and implementation. AHRQ is also interested in research that advances whole-person, 360-degree care especially those with multiple chronic conditions and/or socioeconomic disadvantage. Whole person, 360-degree care is defined as the coordination of health, behavioral health, intellectual/developmental disabilities, and social services in a person-centered manner with the goals of improved health outcomes and more efficient and effective use of resources in the context of people’s lives and the communities they live in. Emphasis is on the orientation of the health care team to consider all domains of a person s life when assessing and addressing needs. The following lists examples of AHRQ research priorities:

Improving health care quality outcomes by providing integrated, coordinated whole-person, 360-degree care to optimize individual and population health outcomes:

• Generation of knowledge about how clinical teams can most effectively elicit and use a patient’s values; preferences; and personal, social, and clinical context to formulate and use plans of care in partnership with patients, caregivers, and families. Preferences, values, and context may be specific to the situation and also can change over time. Therefore, proposals that address how the process of care planning and the care plans themselves will identify and respond to the specific and dynamic nature of patients circumstances are of interest.
• Development of information and data to create/foster/support partnerships and linkages between health care and human service systems (community-based organizations and public health) to improve whole-person care. These could be focused on improving care coordination and strengthening care transitions, ensuring that care is fully integrated to support the whole person and family.
• Improvement of health care quality through the use of information systems and data resources that both provide meaningful clinical decision support to health care professionals and patients and families at the point of care and that capture important actions and outcomes of health care to increase evidence on effective practices and support clinical and organizational improvement.
• Implementation of clinical prevention guidelines into learning health systems with innovative ways to include patients preferences and values in order to empower whole person-centered care.
• Development and study of models of shared decision making that are tailored to the needs of disadvantaged populations.
• Development of whole-person care research to improve health and health services efforts in persons with multiple chronic conditions.
• Development, implementation, and evaluation of models of primary care for individuals with complexity, including multiple chronic conditions, disability, and socioeconomic disadvantage that improve individual and population health while reducing disparities.

Implement research findings in order to accelerate the spread of evidence-based practices by:

• Implementation of evidence-based approaches to identify, understand, and overcome barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, tools, policies, and guidelines.
• Research on de-implementation of the use of health system procedures and clinical practices that are ineffective, have been prematurely widely adopted, or are harmful or wasteful.
• Development of a parsimonious set of meaningful measures to evaluate implementation and impact of whole-person care.
• Development of innovative ways to use data and health information technology (IT) in primary care practices in order to increase uptake and implementation of preventive services, especially those involving behavioral change (e.g. obesity prevention, substance use prevention).
• Development of methods underlying the fields of evidence synthesis, stakeholder and patient engagement, decision making, and practice improvement.

Accelerating the ability of health care organizations to evolve as learning health systems that effectively apply data and evidence to improve patient outcomes by:

• Synthesizing, translating, and communicating complex scientific evidence to facilitate informed care planning and health care decision making by patients, families, and health care professionals at the individual level and informed policy decision making at the health system and population level.
• Discovering, testing, and spreading methods and strategies for health care practice improvement to improve health care quality, including accelerating the sustainable implementation of evidence-based practice. AHRQ has particular interest in practice improvement in primary care and ambulatory settings.
• Demonstrating the effectiveness of synthesizing, translating, and communicating complex scientific evidence to facilitate informed care planning and health care decision making by patients, families, and health care professionals at the individual level and informed policy decision making at the health system and population level.

Producing evidence that can be used to increase the affordability and efficiency of health care for all Americans is a major AHRQ priority. Potential research areas and questions include but are not limited to the following:

Reducing Cost Growth: In order to make health care more affordable, we must understand the drivers of those costs and their growth, as well as the relationship between cost and quality.

Comparing Performance of Systems and Providers: AHRQ is interested in research that will allow comparison of delivery system and provider performance by health care stakeholders such as consumers, providers, payers, insurers, and policymakers.

Incentives for Improving Performance: Public and private payers have provided a variety of financial and nonfinancial incentives to improve the performance of health care providers and systems. AHRQ is interested in research on the impacts of these changes both intended and otherwise as well as how to improve incentive programs.

Interventions to Improve Performance: While alignment with external incentives is very important, it is the provider or system that implements interventions to increase performance. AHRQ is interested in research on how interventions to improve quality or cost are best implemented within and spread across providers and systems.

Access to health insurance coverage remains a critical public policy issue. Health insurance helps people get timely access to medical care and protects them against the risk of expensive and unanticipated medical events. Accurate and informed public policy analysis and policy design require precise estimates of the size and composition of the insured and uninsured populations, as well as information on how demographic characteristics, economic factors and health insurance subsidies affect health plan eligibility, decisions to enroll in health insurance plans and trends in health care expenditures and affordability. Evaluation of the equity and stability of the health insurance market requires information on the ease with which health insurance transitions are made and how satisfied individuals are with their plans, as well as the affordability of coverage.

Understanding how changes in policy affect the evolution of health insurance markets and the health insurance landscape is an important area for study. For example, innovations in health insurance markets, such as the increasing use of high-deductible health plans or changes in the cost-sharing structure of plans, are important developments to be analyzed. Other issues of interest include the relationship between changing health insurance markets and structural changes in the American workplace; analyses to improve our understanding of the impact of health care reform on coverage, access, and affordability; and evaluating the effects of changes in health insurance benefits on consumers' financial burdens and access to care.

AHRQ is engaged in efforts to provide evidence related to topics such as health insurance coverage, access to care and health care costs. Potential research areas and questions include, but are not limited to:

• What is the impact of Medicaid and private health insurance coverage changes on enrollment, access, health care use and expenditures, health care disparities, affordability. and outcomes?
• What methods are most effective in assisting people to understand health insurance coverage options and to enroll in coverage?
• How will changes in the demographics of the population affect health care access, coverage decisions, and health care expenditures?
• What factors affect the decisions that employers and employees make about employer-sponsored coverage, such as those related to plan characteristics, offer, and take-up rates?
• What is the impact of health IT innovation and health information exchanges on costs?

AHRQ informs the research community of priorities for comparative effectiveness research (CER). CER is research that compares and evaluates the benefits and risks of two or more health care options. CER projects that seek to compare different ways of organizing and delivering health care are a priority for AHRQ. These studies may consider health outcomes, patient and family experience, staff satisfaction, and health care utilization among other research outcomes. CER proposals that seek to compare the clinical effectiveness of specific medications and treatments, diagnostic tools, technologies, procedures, surgeries and other specific preventive, diagnostic, or therapeutic services are not a priority of AHRQ.

These areas, relevant to Research Demonstration and Dissemination Grant (R18) applications submitted to AHRQ, are also articulated at (http://www.ahrq.gov/funding/policies/foaguidance/index.html). Applicants may contact a member of AHRQ's program staff if they would like help focusing the research plan based on an understanding of the AHRQ mission and research priorities. AHRQ staff contacts can be found at http://www.ahrq.gov/fund/staffcon.htm.

AHRQ is interested in funding research that will have an important impact on health care practice and policy. Applicants to this FOA are encouraged to submit a structured abstract of the potential findings that might arise from the planned research proposed. If a structured abstract is included as part of the grant application, it should be submitted as an appendix.

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:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• 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

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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.

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 (https://www.sam.gov/portal/SAM/#1) (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 a 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. See also AHRQ's NOT-HS-16-018 related to Multiple PD/PI via https://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-018.html.

This FOA does not require cost sharing.

While there is no cost sharing requirement included in this RFA, 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 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-14-074).

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.

A letter of intent is NOT required for this funding opportunity.

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 applying 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.

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

• Introduction (required for a resubmission or revision application) is limited to 1 page.
• Specific Aims is limited to 1 page.
• Research Strategy section, including tables, graphs, figures, diagrams, and charts, is limited to 12 pages.

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:

• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

AHRQ is interested in funding research that will have an important impact on health care practice and policy. Applicants to this FOA are encouraged to submit a structured abstract of the potential findings that might arise from the planned research proposed. Suggested structured abstract components include background, methods, results, and conclusion sections. If a structured abstract is included as part of the grant application, it should be submitted as an 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-18-126

When involving human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) 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 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.

See Part 2. 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. AHRQ 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.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.

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.

The applicant should pay particular attention to the application guide instructions concerning letters of support (including web link to the instructions). Letters of support, recommendation, or affirmation from any entity or individual not directly participating in the project should not be included.

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

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

Applicants are required to follow the instructions for post-submission materials, as described in the policy. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-066 . Any instructions provided here are in addition to the instructions in the policy.

AHRQ supports research, evaluations, and demonstration projects concerning the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations. Priority populations include low income groups, minority groups, women, children, the elderly, and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. 42 USC 299(c). Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate, e.g. because of the lack of connection between the study and the health of women or particular minorities. Investigators should review the document entitled, AHRQ Policy on the Inclusion of Priority Populations, which is available at 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.

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.

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data should describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools 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.

The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute. 42 USC 299c-3(d). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164.

The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

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 Federal purposes, and to authorize others to do so. In accordance with AHRQ's research dissemination mandate, such products and materials will be made available to the public and the health care community. AHRQ purposes may include but are not limited to making project materials, databases, results, and algorithms available for verification or replication by other researchers. 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 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 [email protected] at least four to six weeks in advance of the journal’s expected publication date.

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

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:

• Research to improve health care patient safety.
• Harnessing data and technology to improve health care quality and patient outcomes and to provide a 360-degree view of the patient.
• Research to increase accessibility and affordability of health care by examining innovative market approaches to care delivery and financing.

As part of this mission, applications submitted to AHRQ to support health services research are evaluated for scientific and technical merit through the AHRQ peer review system.

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

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

• Undergo a selection process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score;
• Receive a written critique.
• Merit Review Criteria: Merit Review Criteria, as described below, will be considered in the review process.

For this particular announcement, note the following:

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?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? 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?

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?

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? Have the investigators presented adequate plans to address human subjects?

If the project involves human subjects and/or clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as AHRQ's Priority Populations justified in terms of the scientific goals and research strategy proposed?

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?

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 Guidelines for the Review of Human Subjects see 45 CFR 46 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

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?

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.

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.7 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.

For Renewals, the committee will consider the progress made in the last funding period.

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not applicable.

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

As part of the scientific peer review, all applications:

• 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 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.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement (see https://www.ahrq.gov/funding/policies/hhspolicy/index.html).

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" (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 AHRQ Grants Management Officer is the authorizing document and will be sent via email to the e-mail 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.grants.gov/web/grants/applicants/organization-registration.html.

All AHRQ grant and cooperative agreement awards are subject to 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), 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 (NoA). As necessary, additional Terms and Conditions will be incorporated into the NoA.

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 under 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/fact-sheet-guidance/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/index.html Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/. l. 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 o 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.

For details regarding annual progress report submission, refer to https://www.ahrq.gov/funding/grant-mgmt/noncomp.html. If instructions on the AHRQ website are different from the RPPR Instructions, follow the instructions on the AHRQ website. Annual progress reports are due 3 months before the anniversary of the award. In addition to the annual progress report, recipients may be required to submit quarterly progress reports to AHRQ. If applicable, detailed instructions on additional reporting requirements will be provided with the grant award.

Grantees are required to submit expenditure data on the Federal Financial Report (FFR; SF 425) annually.

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 (https://www.ahrq.gov/funding/policies/hhspolicy/index.html). 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 https://www.ahrq.gov/funding/grant-mgmt/closeout.html.

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 (https://www.ahrq.gov/funding/policies/hhspolicy/index.html) 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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Direct your questions regarding program matters to the AHRQ staff by specific program and portfolio area, which can be found at: http://www.ahrq.gov/funding/priorities-contacts/contacts/index.html.

Division of Scientific Review
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
Email: [email protected]

Office of Management Services
Division of Grants Management
Agency for Healthcare Research and Quality (AHRQ)
Email address: [email protected]

Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided at https://www.ahrq.gov/funding/policies/polnotice/index.html.

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 in accordance with 45 CFR Part 75 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.