Part I Overview Information  


Participating Organizations
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)

Components of Participating Organizations
Center for Primary Care, Prevention and Clinical Partnerships (CP3), ( http://www.ahrq.gov/)
Center for Outcomes and Evidence, (COE), (http://www.ahrq.gov/)

Title:  Recovery Act 2009 Limited Competition OS ARRA: Comparative Effectiveness Research to Optimize Prevention and Healthcare Management for the Complex Patient (R21)

Note:  The policies, guidelines terms and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type

Reissue: This Funding Opportunity Announcement (FOA) is a reissue of RFA-HS-08-003 and is funded under the American Recovery & Reinvestment Act of 2009 (Recovery Act).

Request for Applications (RFA) Number: RFA-HS-10-009 

NOTICE: Applications submitted in response to this FOA for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.715

Key Dates
Release/Posted Date: December 17, 2009
Opening Date:  December 20, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s):  January 8, 2010
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Due Date(s):  January 20, 2010
Peer Review Date(s): Generally four months after receipt date 
Earliest Anticipated Start Date(s): Generally four months after peer review date 
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date:  January 21, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose. This AHRQ FOA, supported by funds provided to AHRQ under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5, invites Exploratory/Developmental grant (R21) applications from organizations that aim to understand the comparative value of different strategies in the prevention and management of chronic illness in persons with specific constellations of co-morbid conditions.  Exploratory research studies will contribute evidence to help guide the appropriate integration (i.e., prioritization, timing, provision and coordination) of therapeutic and preventive services in individuals with multiple chronic conditions.  This work should improve our understanding of the comparative value of interventions to patients with multiple conditions, how the safety and effectiveness of specific interventions may be affected by co-morbid conditions, and how interventions may need to be modified for specific patient populations with multiple conditions.  This information should help clinicians better integrate care provided to such individuals, help patients make informed decisions about health care choices, and help policymakers identify better ways to measure and promote quality care for complex patients.

While grant awards are made to institutions rather than individuals, this announcement and its instructions are written to inform individual researchers of this funding opportunity and facilitate the submission of grant applications by their organizations.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description

Section II. Award Information


Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1.  Research Objectives

U.S. Department of Health & Human Services (HHS) Definition of Comparative Effectiveness Research

HHS will use the definition of comparative effectiveness research used in the Federal Coordinating Council’s (FCC’s) Report to Congress to guide the HHS operational plan with regard to Office of the Secretary (OS) ARRA funds. The definition is as follows:

Comparative effectiveness research is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in “real world” settings.  The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs about which interventions are most effective for which patients under specific circumstances.

Priority-Setting Process and Inputs for use of ARRA OS Funds

There were four main inputs for priorities for ARRA OS comparative effectiveness research funds:  public input, an internal Departmental workgroup, the FCC report, and the Institute of Medicine (IOM) report.  The FCC identified the following as minimum threshold criteria which must be met to be considered for funding:

1)  Included within statutory limits of ARRA and the Council’s definition of comparative effectiveness research;

2)  Potential to inform decision-making by patients, clinicians or other stakeholders;

3)  Responsiveness to expressed needs of patients, clinicians or other stakeholders;

4)   Feasibility of research topic (including time necessary for research).

The Comparative Effectiveness Research-Coordination and Implementation Team will require the use of the FCC’s prioritization criteria for scientifically meritorious research and investments for all projects funded with OS ARRA funds.  These criteria are:

1)  Potential impact (based on prevalence of condition, burden of disease, variability in outcomes, costs, potential for increased patient benefit or decreased harm),

2)  Potential to evaluate comparative effectiveness in diverse populations and patients sub-groups and engage communities in research,

3)  Addresses existing uncertainty within the clinical and public health communities regarding management decisions and variability in practice,

4)  Addresses a need or is unlikely to be addressed through other organizations,

5)  Potential for multiplicative effect.

Finally, investments funded from this appropriation must address at least one of the following topic areas: 

1)  One of the 100 IOM topic recommendations;

2)  An issue within one the MMA 14 priority conditions identified by AHRQ (pursuant to Section 1013 of the Medicare Prescription Drug Improvement and Modernization Act of 2003) which are not currently addressed; and/or 

3)  Fall into one of the AHRQ identified evidence gaps.

The current list of conditions includes:

AHRQ seeks research grant applications for projects in the area of comparative effectiveness research to respond to the Recovery Act.  In this FOA, AHRQ has operationalized the definition of comparative effectiveness research with the additional specification that evaluation of treatments includes any potential medical intervention under consideration, whether prognostic, preventive, diagnostic, therapeutic, or palliative.

In FY 2010, AHRQ intends to support research grants focusing on comparative effectiveness of different clinical treatments and services, as authorized by Section 1013 of the Medicare Prescription Drug Improvement and Modernization Act of 2003, Pub. L. No. 108-173.  The intent of these research project grants is to support research focusing on the generation and translation of new scientific evidence and analytic tools in an accelerated format and the integration of evidence into practice and decision-making in the health care system.  AHRQ is especially interested in studies that include under represented and AHRQ priority populations such that potential clinical heterogeneities and population subgroups are considered in study design and proposed methodologies, and that subgroup analyses can be performed and research results and findings are relevant for all populations.  The applicant’s specific plans for inclusion of priority populations will be evaluated by the scientific review committee and will be a component of the assigned priority score.

Background

Americans are growing older today in a way unlike any preceding generation.  The demographic swell of the post-war baby boom combined with medical advancements in the 20th century that led to declines in deaths from infectious diseases, and to a transition to chronic diseases as a primary cause of death in the United States will result in an unprecedented number of older Americans with chronic illnesses.  The health care system in this country is unprepared for the challenges posed by a growing population of patients with complex combinations of chronic diseases.  The complicated medical regimens, interactions of different diseases, and cumulative effect of different conditions on morbidity, mortality, and quality of life make it difficult to identify optimal approaches for such patients.

The past twenty years have brought significant efforts in the field of evidence-based medicine to optimize medical care provided to patients through the promulgation of guidelines by professional groups (e.g., American College of Cardiology), special expert bodies (e.g., United States Preventive Services Task Force, the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) and by the implementation of various quality metrics (for example the Healthplan Employer Data and Information Set (HEDIS) established by the National Committee on Quality Assurance).  Most guidelines and metrics focus on the simplest applicable case (e.g., anticoagulation in the patient with uncomplicated atrial fibrillation) and few, if any, of these efforts have considered explicitly how the guideline should be modified in order to be implemented in a complex patient.(1)  Further, most recommendations for preventive services target the healthy patient and fail to provide guidance on the preferred timing and relative appropriateness of these services for patients whose care is complicated as a result of multiple chronic conditions.  The lack of even primitive morbidity or mortality risk adjustment in guidelines and quality measures threatens to provide incentive for excess intervention in potentially inappropriate candidates.(2,3) Both patients and providers are burdened by this situation.  Patients with multiple chronic illnesses may end up on excessively complex medical regimens as clinicians continue to add or intensify therapies without good evidence that doing so will improve the quality or quantity of life.  Some patients with comorbid conditions may be at increased risk of the harms of preventive or therapeutic interventions, and at the same time less likely to attain the potential benefits associated with those interventions when applied to otherwise healthy individuals.  At present, few guidelines or quality measurement schemes, provide guidance in the care of complex patients or recognize the appropriateness of modification of standards developed for uncomplicated conditions.

Objectives of this FOA 

The objectives of this FOA are to:

It is expected that the work from this FOA will provide the foundation for further studies that test the impact of such adaptations, assess the barriers and facilitators to implementing adaptations, examine tools to implement tailored interventions, and investigate the implications for patient-centered health care of such personalized approaches to prevention and care management.

To achieve these objectives, expected research approaches include mathematical modeling, statistical modeling, or epidemiologic studies that may be based on data from population surveys, medical databases from electronic health records, and possibly insurance claims data.  Of interest are modeling projects that use newly developed or existing population-based datasets to estimate how the application and timing of specific, recommended therapeutic and preventive services will affect overall outcomes for the complex patient, especially as the patient ages.  Modeling studies must consider how to optimize the management of patients with at least two chronic co-morbid conditions and the provision of at least one preventive service or chronic disease intervention.  Studies focusing on AHRQ priority populations, including racial and ethnic groups, are encouraged (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html).  All types of studies are welcome to include a mental health co-morbidity. 

For the purposes of this FOA, the following definitions apply:

Comparative effectiveness research is the HHS definition described above under “HHS Definition of Comparative Effectiveness Research.” 

Specifically, AHRQ is interested in supporting efforts that:

1.    Conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions; and,

2.    Encourage the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data.

A complex patient is one with two or more chronic conditions where each condition may influence the care of the other condition(s) through limitations of life expectancy, interactions between drug therapies, difficulties in establishing adequate care coordination, and/or direct contraindications to therapy for one condition by other conditions themselves.  While challenges posed by demographic characteristics such as lack of insurance or poverty clearly affect complexity in clinical practice, for the purposes of this FOA, we focus on physical and mental/behavioral illnesses.  

Chronic conditions refer to physical and mental/behavioral illnesses or impairments that have persistent or recurring health consequences lasting for years and in most cases may contribute to increased risk of early mortality.

When selecting the two or more chronic conditions to be studied, applicants must include at least one of the targeted priority conditions established by the HHS Secretary under Section 1013 of the MMA of 2003. These fourteen conditions were identified through a process involving discussion with and extensive input from the public, as well as Federal agencies, and are relevant to the Medicare, Medicaid, and State Children's Health Insurance Program (CHIP) programs as listed above. 

Preventive services are of three types, primary, secondary and tertiary.  Primary preventive services are those provided to asymptomatic individuals to prevent the onset of a targeted condition, while secondary prevention serves to identify and treat persons who have already developed risk factors or preclinical disease but in whom the condition has not become clinically apparent.  Broad areas of primary and secondary prevention include screenings, behavioral counseling and preventive medication.  Specific services include, but are not limited to, colonoscopy, mammograms, Pap smears, counseling regarding obesity or smoking cessation, and aspirin use to prevent myocardial infarction (MI) in men or stroke in women. 

Chronic disease interventions, which might generically be referred to as tertiary prevention, refer to clinical testing or therapeutics aimed at slowing progression and managing symptoms of specific chronic disease processes and thereby preventing complications of the disease.  Examples include: monitoring and treatments to improve glycemic control in patients with diabetes, use of aspirin in individuals who have already suffered an MI, or prescription of anti-inflammatory, “controller” inhaled medications to someone with moderate to severe asthma.

While many types of projects and approaches may be responsive to this announcement, AHRQ will fund three types of projects: 

Project requirements:

Projects must identify which project type(s) are proposed.  For each project type, at least one of the chronic conditions under study must be selected from the list of priority conditions described above.  Additionally, at least one of the chronic conditions must be a physical, rather than mental or behavioral, illness or impairment.

Outcomes of interest include, but are not limited to, morbidity, mortality, quality of life, functional outcomes, benefits of interventions and harms of interventions.  Projects must describe which outcomes are being used and how each will be measured.  

Projects that propose epidemiologic descriptions using existing large datasets for the purpose of providing descriptions of the complex patient population must describe at least two, and preferably three, different conditions singly and in combination.  AHRQ expects inclusion of priority populations, including racial and ethnic groups when related data are available.

Analytic epidemiology studies should target at least one chronic disease or preventive intervention, and must describe the study population’s health status with regard to at least two additional co-morbid conditions.

Projects that propose modeling studies must use one of the following frameworks to structure this part of the research:

OR

With either framework, modeling studies must model simultaneously: 

Projects are further encouraged to incorporate patient age into the model.  Investigators are encouraged to select a mental health issue as one of the chronic conditions in both epidemiologic description projects and modeling projects. 

Recognizing that these are exploratory grants, applicants must describe next steps in translating their research into information that can improve healthcare decisions made by clinicians and their patients with multiple chronic conditions.  Applicants are encouraged to describe if and how current treatment guidelines and quality of care measures may need to be adjusted as a result of their findings.

The applicant must address the following project requirements in the Research Plan portion of the application:

In the Specific Aims Section:

The applicant must identify the chronic conditions and preventive services to be studied, explicitly noting the inclusion of one or more priority conditions.  Epidemiologic descriptive studies must identify at least two chronic conditions.  Analytic epidemiology studies must assess a therapeutic intervention in an index condition and describe two other chronic co-morbid conditions.  Modeling studies must identify at least two chronic conditions and at least one preventive or chronic disease intervention.  All studies must describe the selected outcomes of interest.

Whenever possible, all studies should provide a comparison of complex patients to healthy ones.  Analytic epidemiology studies and modeling studies should provide the relative effect of providing preventive services in patients with and without chronic conditions.  Quantification of the relative effective should be provided if possible.

In the Background and Significance Section:

The applicant must demonstrate an understanding of the current challenges in treating complex patients in primary care and provide the rationale for focusing on the specific chronic conditions and preventive services.  The applicant must describe the racial, ethnic, and gender characteristics of the population included in the study and provide the scientific reasoning and/or clinical considerations for the inclusion or exclusion of particular populations. 

In the Research Design and Methods Section:

The applicant must describe the proposed project type (descriptive epidemiologic, analytic epidemiologic, and/or modeling) and describe the methodology that will best enable the research objectives to be realized.  The design must include a conceptual or clinical framework and a timeline with specific milestones, covering all phases of the project.  The narrative should include a description of the dataset, data collection plans (if any) and a well-developed analysis plan.  Projects for modeling studies must include details of 1) the model structure, 2) the underlying assumptions, 3) discussion of how the natural history of the index condition and the comorbid conditions will be included in the model, and 4) possible data sources.  To the extent possible, applicants should discuss any anticipated limitations or cautions needing to be exercised in generalizing results.

Applicants must adequately discuss potential next steps; that is, how the expected results of this preliminary work will inform future comparative effectiveness and other research, and how results could be adapted and integrated into treatment guidelines for complex patients focusing on AHRQ priority populations, and quality improvement measures, both locally and nationally.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This FOA will use the AHRQ Exploratory/Developmental Research Grant (R21) award mechanism.  The individual researcher sponsored by each organizational applicant will be solely responsible for planning, directing, and executing his or her proposed projects.

AHRQ is not using the Modular Grant Application and Award Process.  Applications submitted in modular format will not be reviewed.

2. Funds Available

This initiative is supported by funds provided to AHRQ under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5.  AHRQ has designated $6,000,000 to fund 12-18 grants, contingent upon the submission of a sufficient number of scientifically meritorious applications.

There are three types of projects that will be funded under this FOA.  They are described in detail in Section I of the full text of this FOA.  These types of projects have varying project period duration limits and total cost budget limits (indirect costs are included in the total cost limitation).  Applications must clearly indicate which type of project or combination of types is proposed.  An application with a budget that exceeds the budget limit or the project period duration stated in the FOA for the type of project proposed will not be reviewed. 

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary.  Although the financial plans of AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. 

The total costs for a grant awarded under this FOA will not exceed $500,000 for the entire project period.

Funding for this program is provided under the American Recovery and Reinvestment Act of 2009 (Recovery Act).  The purposes of the Recovery Act are to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health.  Consistent with these goals, eligible domestic (United States) institutions/organizations who are planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested total costs or $25,000 (aggregate total for a subcontract or multiple subcontracts), whichever is less. AHRQ awards under the Recovery Act will be for up to two years.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply. Consistent with the purposes of the Recovery Act (in particular, to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health), applicants must be a domestic (United States) institution/organization of one of the types listed below. The United States institution/organization must be located in the 50 states, territories and possessions of the U.S., Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia.  Foreign organizations/institutions are not permitted as the applicant organization.

You may submit an application(s) if your institution/organization has any of the following characteristics:

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus for the purpose of this FOA, AHRQ will make grants only to non-profit organizations.   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.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. This individual should devote a considerable portion of his/her time to the project (at least 20% annually through the project duration).  If the Project Director/Principal Investigator devotes less than 20% of his/her time to the project, an explicit justification must be provided.  Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.

Cost Sharing or Matching

This program does not require cost sharing for applications in response to this FOA.

While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort.  An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project.  Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments.  Applicant institutions that plan to provide support should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project.  This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be included in the detailed budget request.

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application.  Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

A PD/PI should work with his/her institution/organization to make sure he/she is registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:  

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH and AHRQ will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-435-0714; Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to AHRQ.  Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by AHRQ (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide.  For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Research & Related Budget

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS  

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions 

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form. 

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:  December 20, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s):  January 8, 2010
Application Due Date(s): January 20, 2010
Peer Review Date(s): Generally four months after receipt date 
Earliest Anticipated Start Date(s): Generally four months after peer review date 

3.A.1. Letter of Intent

To allow AHRQ staff to estimate the potential peer review workload and plan the review (e.g., anticipate the nature of reviewer expertise to be required), prospective applicants may submit a letter of intent that includes an acknowledgement of interest in this funding opportunity (please refer to the number and title of this funding opportunity), a few comments on the subject of the proposed research, background expertise of key personnel, and the nature and role of participating institutions.  Please include the name and email address of the Principal Investigator.

This letter of intent is not required, is not binding, and is not considered in the review of a subsequent application.  However, these letters are administratively very helpful, as indicated above. To be most useful, the letter of intent is to be sent by the date listed above and at the beginning of this document.

The letter of intent can be sent electronically, and should be sent to:

Gloria Washington
Center for Primary Care, Prevention & Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1590
FAX: (301) 427-1595
E-mail address: healthcaremanagement@ahrq.hhs.gov

The letter of intent is to be sent by the date listed in Section IV.3.A

3.A.2. Technical Assistance

Applicants may submit questions to AHRQ via email at healthcaremanagement@ahrq.hhs.gov.   AHRQ will respond to questions via email only.  In addition, based on inquiries received, AHRQ will post a list of Frequently Asked Questions (FAQs) and responses to these questions, as appropriate, after the release of this FOA at http://www.AHRQ.gov/fund/grantix.htm.

Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff.

3.B. Submitting an Application Electronically to AHRQ

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp  and follow Steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

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.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and AHRQ.  Incomplete or non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

AHRQ will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an “Introduction” describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

Use of CMS Data

Purchase of Centers for Medicare & Medicaid Services (CMS) public-use data, if required, should be discussed in the application narrative and included in the budget. Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. However, for applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the “Research Design and Methods” section of the Research Plan (form 398) the specific files, time periods, and cohorts proposed for the research.  In consultation with CMS, AHRQ will use this information to develop a cost estimate for obtaining the data.  This estimate will be included in the estimated total cost of the grant at the time funding decisions are made.

Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with the confidentiality provision in the AHRQ statute, 42 USC 299c-3(c); the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule at 45 CFR Parts 160 and 164, if applicable; and standards set out in OMB Circular A-130, Appendix III–Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed.

Unless AHRQ is able to negotiate exceptional arrangements, the DUA will include the requirement that the data user agrees to submit to CMS, a copy of all findings within 30 days of making such findings, for the sole purpose of assuring CMS that data confidentiality is maintained. The user further agrees not to submit these findings to any third party (including but not limited to any manuscript to be submitted for publication) until receiving CMS's approval to do so.

In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take six months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff.

CMS data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats.

Questions regarding CMS data should be directed to the AHRQ program official listed under Agency Contacts (see Section VII).

To avoid double counting, applicants should not include the cost of identifiable CMS data in the budget.  In the event the total costs of the project plus the cost of CMS data is greater than the total cost cap of this FOA, the budget for the project will be adjusted so that the total costs awarded to the recipient plus the CMS data costs do not exceed the cost cap. 

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements

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

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS398 Research Plan Component Sections

Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide.  While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to AHRQ in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.   

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Warning:  Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements. 

Special Instructions for Modular Grant applications

AHRQ is not using the Modular Grant Application and Award Process.   Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R).  Applications submitted in the Modular format will not be reviewed.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm). Also see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not comply with the required page limitations may be delayed in the review process.  

No supplemental/updated information will be accepted.

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the Public Health Service Act, directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations.  Priority populations include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care.  This authority is found at 42 USC 299(c).  To implement this statutory mandate, AHRQ published a Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html).  Applicants under this FOA should consider and discuss including priority populations in the research design as specified in this Notice.

Publication Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ-supported activities are accepted for publication in the professional literature.  Grantees should also discuss any ideas about other dissemination and marketing efforts with OCKT staff.  The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers.  This is critical when outreach to the general and trade press is involved.  Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions.  In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a brief plan describing how the product will be publicized.  An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media.

Assessment of AHRQ Grant Programs

In carrying out its stewardship of research programs, AHRQ may request information essential to an assessment of the effectiveness of Agency research programs.  Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research.

AHRQ expects grant recipients to keep the Agency informed of publications, as well as the known uses and impact of their Agency-sponsored research. Applicants must agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active.

HCUP & MEPS

Applicants are encouraged to make use of AHRQ’S Healthcare Cost and Utilization Project (HCUP) or the Medical Expenditure Panel Survey (MEPS).  HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership.  HCUP databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data.  HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place.  HCUP includes three nationwide databases, the Nationwide Inpatient Sample (NIS), the Kids’ Inpatient Database (KID), and the Nationwide Emergency Department Sample (NEDS), and three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD).  More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.

The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, non-institutionalized population.  MEPS is composed of three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC).  The Household Component is the core survey, and it forms the basis for the MPC sample and part of the IC sample.  The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees.  More information on the MEPS is available at http://www.meps.ahrq.gov.

Applicants’ use of HCUP and/or MEPS data does not preclude the use of secondary data sources or primary data collection.

Health Literacy

AHRQ encourages applicants to write Informed Consent (IC) and HIPAA Authorization documents for research to be understandable to all potential research participants, including those with low levels of literacy and limited English proficiency.   AHRQ recommends that IC and Authorization documents be written in accordance with health literacy principles, and that IC and Authorization documents be available in multiple languages if potential research participants include individuals with limited English proficiency. AHRQ also recommends adopting a process to verify potential research participants’ understanding.

IC documents must provide information in language understandable to potential participants (45 CFR 46.116). For covered entities under the Privacy Rule, authorization documents must include core elements and required statements in (45 CFR 164.508(c) and must be written in plain language. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research (http://www.ahrq.gov/fund/informedconsent/) provides sample forms and guidance on adapting them, and also describes an appropriate process for obtaining informed consent and authorization.

Consumer Products

All consumer products produced under an AHRQ-funded grant should be appropriate for the target audience. This includes individuals from diverse cultural, language, and literacy backgrounds.  Audience testing should be part of the development process. AHRQ’s Talking Quality website (http://www.talkingquality.gov/) and AHRQ’s guide and checklist for developers and purchasers of health information (IT) that is designed to be accessed and used by consumers (http://healthit.ahrq.gov and select Health IT Tools) are resources applicants can use to ensure appropriateness of consumer products.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Section V. Application Review Information


1. Criteria 

Administrative Criteria:  Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness.

Merit Review Criteria are described below.  The review criteria described below will be considered in the review process.

2. Review and Selection Process

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:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

The reviewers will apply the FOA-specific review criteria.  Each application will be evaluated on its own merit.  There is no intrinsic difference in the scientific merit or potential impact of the three different types of studies anticipated.

AHRQ R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research.  It is important to remember that the content expectations and review criteria for this R21 mechanism are distinct from the more common R01 mechanism.  The R21 mechanism is an exploratory/developmental grant application and there is a 15-page limitation for Research Plan component.  This R21 mechanism does not require the presentation of pilot data, demonstrated generalizability of the results, nor the expectation of more extensive preliminary information that would be expected in a 25-page R01 application.  Preliminary data may be included if available.  Reviewers will carefully determine the scientific merit of the application based on the material presented in the application and will carefully consider the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding.  Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. 

In their written critiques, reviewers will be asked to assess the strengths and weakness of the application in terms of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of the FOA’s goals.  Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus warrant a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: How significant are the chronic diseases and preventive services selected? The criteria on which significance will be assessed are:

If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced?  What will be the effect of these studies on the concepts and methods of analysis used to understand and improve the care of complex patients?  How will this study improve the treatments, services, or preventive interventions provided to complex patients?  

Approach: To what extent has the applicant adequately addressed at least two chronic conditions (for descriptive epidemiology studies) or one index intervention and two other co-morbid conditions (for analytic epidemiology studies), or if a model is proposed, one or more preventive or therapeutic chronic disease interventions, and at least two other chronic conditions?  To what degree are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project?  To what extent has the applicant used up-to-date, evidence-based guidelines/recommendations where appropriate?  Has the applicant provided comparisons of patients with and without chronic conditions?  To the extent possible, has the applicant proposed quantifying the relative effect of providing a preventive service in individuals without chronic conditions to individuals with one or more chronic conditions?  Does the applicant acknowledge and show an understanding of potential problem areas and consider alternative tactics? 

Innovation: Because this is an exploratory grant, how does the applicant discuss the next steps?  How well has the applicant addressed how findings will inform current institutional/national quality improvement measures and treatment guidelines? 

Investigators: Are the PD/PI and other key personnel appropriately trained and well suited to carry out this work?  To what extent is the investigative team cross-disciplinary including members with clinical expertise as well as rigorous methodologic expertise and experience?  Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Is the PD/PI time commitment to the project at least 20% annually over the course of the award?

Environment: How is the project situated with regard to data availability, computing environment, and appropriate availability of statistical expertise?  Will the PI’s work with other investigators on the project team be facilitated or potentially hindered by the structures of his or her department or institution?   Is there evidence of appropriate support? 

Budget: Is the proposed budget reasonable and necessary and is the requested period of support appropriate in relation to the proposed research as described earlier in this announcement?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Degree of responsiveness:  How well does the application address the purpose and objectives of this FOA; how will results inform the prioritization, timing, provision and/or coordination of treatments and preventive services?  How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?  Does the application include one or more comparative effectiveness priority conditions?

Inclusion: Adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups).  Adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 “Other Submission Requirements,” and inclusion criteria included in section VIII of Required Federal Citations, below.)

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed.  See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).

Privacy and Security Protections for Patients:  The resources and processes to be used to address privacy and security issues in the development and implementation of the intervention will be assessed.

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

The AHRQ R21 provides support for projects designed to develop, test, and evaluate health services activities, and to foster the application of existing knowledge, in order to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. 

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

2.B. Additional Review Considerations

Not applicable

2.C. Resource Sharing Plan(s)

Data Confidentiality

Pursuant to 42 USC 299c-3(c), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data.  There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute 42 USC 299c-3(d).  In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected.  The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded.  Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164.  These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers.  Thus, health care plans ordinarily will require either patient authorization for disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators.  The HHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/

The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

Sharing Research Resources: 

Rights in Data

Unless otherwise provided in grant awards, AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ funds, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses.  Such copyrights and patents are subject to a worldwide irrevocable AHRQ license to use and permit others to use these products and materials for government purposes.  In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers.  In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits.  Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products.  AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities.  Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html).

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons. If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant.  Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative issues, and certification of IRB approval of the project's proposed use of human subjects.  For details, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). 

Once all administrative and programmatic issues have been resolved, a formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization.  The NoA will be generated via email notification from the awarding component to the grantee business official.  The NOA signed by the grants management officer is the authorizing document.

The terms of the NoA will reference the requirements of the Recovery Act.

In addition to the standard AHRQ terms of award, all funding provided under the Recovery Act will be subject to the HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (ARRA).  The full text of these terms approved for AHRQ awards can be found in the following document: Department of Health and Human Services Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (see http://www.ahrq.gov/fund/arraterms.htm).

Selection of an application for award is not an authorization to begin performance.  Any costs incurred before receipt of the NoA are at the recipient’s risk.  These costs may be reimbursed only to the extent considered allowable pre-award costs.  See also Section IV.5, “Funding Restrictions.”

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, and are subject to the requirements of the HHS Grants Policy Statement that are applicable based on the recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

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

3. Reporting

Grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually for awards with project periods that exceed 12 months.

The annual progress reports must include Section 2.2.6 items A through F as described in the general PHS form 2590 instructions.  For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm.  If instructions on the AHRQ website are different from the PHS form 2590 instructions, follow the instructions on the AHRQ website.

The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future.  At a minimum, the reports will include descriptive comments on:  progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities.  AHRQ will provide the timetable for these progress reports.

Financial Status Reports (FSRs; SF 269) are required annually by AHRQ for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm).  This report must be submitted for each budget period no later than 90 days after the close of the budget period.  A hard copy of the report should be submitted to the assigned grants management specialist.

Until such time as HHS has migrated to the SF 425 FFR, award recipients will utilize the SF 269 FSR.

Section 1512 of the Recovery Act requires prime recipients of the ARRA funds to submit quarterly reports, due no later than 10 calendar days after each calendar quarter in which the recipient receives the award (January 10, April 10, July 10, and October 10).  Accordingly, in addition to the standard AHRQ terms of award, all funding provided under the Recovery Act must comply with the statutory reporting requirements and will be subject to the HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (ARRA) as described above and found on the AHRQ Website at http://www.ahrq.gov/fund/arraterms.htm.

In addition, AHRQ is currently developing AHRQ-specific reporting requirements.  Detailed information and requirements on the specific AHRQ reporting venues and reporting timeline will be included in the Notice of Grant Award and incorporated into AHRQ Terms and Conditions of Award. 

A final Progress Report, Final Invention Statement, and Financial Status Report are required when an award ends.  For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

Section VII. Agency Contacts


This FOA is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application (also including submission of a letter of intent) by an individual or entity and ending with the award of the competitive funds.  Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a Recovery Act competitive grant or other competitive form of Federal financial assistance, whether or not the initiating party is a federally registered lobbyist.  This restriction applies unless:

For additional information see:  http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf

Please note, the President’s memorandum applies to communications prior to the award of a grant or other Recovery Act funding; it does not apply to communications with officials regarding the administration of a grant that has already been awarded.

Inquiries and questions from potential applicants concerning this funding opportunity are encouraged and welcome.  Inquiries may be made in writing or by telephone, and fall into three areas: scientific/research (program), peer review, and financial or grants management issues.

1. Scientific/Research Contact(s):

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

Mary Barton, MD, MPP
Center for Primary Care, Prevention & Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1638
Fax: (301) 427-1597.
E-mail address:  Mary.Barton@ahrq.hhs.gov

Or

Therese Miller, DrPH
Center for Primary Care, Prevention & Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1585
Fax: (301) 427-1597
E-mail address: Therese.Miller@ahrq.hhs.gov

2. Peer Review Contact(s):

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

Kishena Wadhwani, PhD., MPH.
Division of Scientific Review
Office of Extramural Research, Education and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1556
Fax: (301) 427-1562
E-mail address:  Kishena.Wadhwani@ahrq.hhs.gov

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to either George Gardner or Michelle Burr as described below: 

George Gardner
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1450
Fax: (301) 427-1462
E-mail address:  George.Gardner@ahrq.hhs.gov

Or

Michelle Burr
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1451
Fax: (301) 427-1462
E-mail address:  Michelle.Burr@ahrq.hhs.gov

 Section VIII.  Other Information


Required Federal Citations

The American Recovery And Reinvestment Act of 2009 (Pub. L. No. 111-5): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf

Standard Terms and Conditions for Recovery Act Awards: The full text of these terms approved for AHRQ awards can be found in the following document: http://www.ahrq.gov/fund/arraterms.htm

Inclusion of Women and Minorities in Research Study Populations:

Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate, e.g., because of the lack of connection between the study and the health of women or particular minorities.

All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ requires adherence to these NIH Guidelines.

Investigators may obtain copies from the above sources or from the NIH Guide Web site at http://grants.nih.gov/grants/guide/index.html.  AHRQ Program staff may also provide additional information concerning these policies (see Section VII, Agency Contacts).

Human Subjects Protection:

Federal regulations at 45 CFR Part 46 require that applications and proposals involving human subjects research must be evaluated in accordance with those regulations, with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Standards for Privacy of Individually Identifiable Health Information:

The HHS "Standards for Privacy of Individually Identifiable Health Information" regulation was mandated by the Health Insurance Portability and Accountability Act  of 1996 (HIPAA) which governs the protection of individually identifiable health information.  It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory.  Decisions about applicability and implementation of the Privacy Rule reside with covered entities.  Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.

Access to Research Data through the Freedom of Information Act:

OMB Circular A-110 provides access to certain research data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain circumstances.  Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation or administrative order) may be accessed through FOIA.  If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement.  Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data under FOIA, disclosure of confidential identifiable data from such study is statutorily protected under 42 USC 299c-3(c), and thus is exempted from disclosure under "the (b)(3) exemption” in FOIA, 5 USC 552(b)(3).  It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support.  Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption," 5 USC 552(b)(4), for example, if it constitutes trade secrets or commercial information.  NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.

Should applicants wish to place data collected under this FOA in a public archive, which can provide protections for the data (e.g., as required by confidentiality provisions of the statute applicable to AHRQ-supported projects, 42 USC 299c-3(c) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted.

Healthy People 2010:

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authority of 42 USC 299 et seq. and, 42 CFR Part 67 and in accordance with 45 CFR Parts 74 or 92 and other referenced applicable statutes and regulations.  All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the Public Health Service mission to protect and advance the physical and mental health of the American people.

References

1.     Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW.  Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: implications for pay for performance.  JAMA. 2005;294(6):716-24.

2.     Walter LC, Davidowitz NP, Heineken PA, Covinsky KE.  Pitfalls of converting practice guidelines into quality measures: lessons learned from a VA performance measure.  JAMA. 2004;291(20):2466-70.

3.     Werner RM, Greenfield S, Fung C, Turner BJ.  Measuring quality of care in patients with multiple clinical conditions: summary of a conference conducted by the Society of General Internal Medicine.  J Gen Intern Med. 2007; 22(8):1206-11.

4.     Weinstein MC, Siegel JE, Gold MR, Kamlet MS, Russell LB.  Recommendations of the Panel on Cost-effectiveness in Health and Medicine.  JAMA. 1996;276(15):1253-8.


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