Part I Overview Information


Department of Health and Human Services

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:  Optimizing 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
New

Update: The following update relating to this announcement has been issued:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (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 weeks prior to the grant submission date. See Section IV.

Request For Applications (RFA) Number: RFA-HS-08-003

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date:  September 20, 2007
Opening Date:  October 28, 2007
Letters of Intent Receipt Date(s):  November 2, 2007
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 Submission/Receipt Date(s):  November 28, 2007
Peer Review Date(s):  approximately March, 2008
Earliest Anticipated Start Date(s):  approximately June, 2008
Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date:  November 29, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

This funding opportunity announcement (FOA) solicits Exploratory/ Developmental (R21) grant applications from applicant organizations that propose to expand the understanding of how to optimize decisions about preventive care and management of chronic diseases in complex patients especially in primary care.  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 which interventions provide the greatest benefit 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 policy makers identify better ways to measure and promote quality care for complex patients.

Foreign organizations are eligible under this FOA but they must provide clear explanations of any clinical data sources or modeling assumptions to confirm that population disease or severity estimates are derived from U.S. data or match those observed in the U.S. population.

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to be the primary beneficiary of a grant under this research mechanism.  Thus, for the purpose of this FOA, AHRQ will make grants only to non-profit organizations.  For-profit organizations may participate in projects as members of consortia or as subcontractors only. 

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 to 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
1. Research Objectives


Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
        1. Letter of Intent
         2. Technical Assistance
    B. Submitting an Application Electronically to AHRQ
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Background

Americans are growing older today in a way unlike any preceding generation.  The demographic swell of the post-war baby boom combined with the near abolition in the 20th century of premature death due to infectious causes in the United States will result in an unprecedented number of older Americans with chronic illnesses.  The primary 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 (JNC) 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. (Boyd CM, et al., 2005)  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. (Walter LC, et al., 2004; Werner RM, et al., 2007)

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 compared to otherwise healthy individuals.  Medical specialists may not focus on how medical conditions outside of their area of expertise may impact the goals and management of the condition for which they are treating the patient.  Primary care clinicians are positioned to integrate the competing needs of complex patients within the context of the patients own values. (Beal AC, et al., 2007)  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.

Objective of this FOA 

The goals of this FOA are to:

We expect 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 goals, 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 particular 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:

While many types of projects and approaches may be responsive to this announcement, AHRQ has particular interest in funding three types of projects: 

Combination studies that propose to do both secondary data analysis as described above to provide accurate estimates to include as assumptions in models, followed by the modeling itself, are expected to have larger budgets and longer time frames.  However, all projects must fit within the total cost limit of $300,000 and total project period limit of two years.  

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 a physical, rather than mental, illness or impairment.

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/or ideally 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.  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.

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 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 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 Funding Opportunity Announcement (FOA) will use the AHRQ Exploratory/Developmental Research Grant (R21) award mechanism. 

The individual researcher sponsored by each organizational awardee 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 be returned without review.

2. Funds Available

AHRQ intends to commit up to $3,706,000 in FY 2008 to fund 15-20 applications in response to this FOA.   Applications may be up to two years in duration with a budget supported by AHRQ not to exceed $300,000 over a two year period with no more than $200,000 in any one year in total costs to the government.  Applications with project periods that exceed two years, or budgets that exceed $200,000 total costs in any one year, or budgets that exceed $300,000 in total funding over the entire grant period, will be returned without review.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. 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.  Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation.

AHRQ plans to offer additional funding through limited competition to further the dissemination of important findings and activities that result from these projects.  Dissemination supplements will be considered should future funds become available.

Funding beyond the first year will be contingent upon a review by AHRQ staff of the non-competing continuation application.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

Foreign organizations are eligible under this FOA but they must provide clear explanations of any clinical data sources or modeling assumptions to confirm that population disease or severity estimates are derived from U.S. data or match those observed in the U.S. population.

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to be the primary beneficiary of a grant under this research mechanism.  Thus, for the purpose of this FOA, AHRQ will make grants only to non-profit organizations.  For-profit organizations may participate in projects as members of consortia or as subcontractors only.  Applications submitted by for-profit organizations will be returned without review.  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 with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.

The Project Director/Principal Investigator should devote at least 20% time to the project over the course of the award.  If the Project Director/Principal Investigator devotes less than 20% of his/her time to the project, an explicit justification must be provided.

2. 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 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.

3. Other-Special Eligibility Criteria

Applicants may submit more than one application, provided each application is scientifically distinct.  However, AHRQ will not accept similar grant applications with essentially the same research focus from the same applicant organization.

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, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

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

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

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

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

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.

Note that if a PD/PI is also an AHRQ peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

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 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 (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to AHRQ. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required (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. Some components are required, others are optional. 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
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
(See Section IV.6., “Special Instructions,” regarding required budget component.)  

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

3. Submission Dates and Times

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:  October 28, 2007
Letters of Intent Receipt Date(s):  November 2, 2007
Application Submission/Receipt Date(s):  November 28, 2007    
Peer Review Date(s):  approximately March, 2008
Earliest Anticipated Start Date(s):  approximately June, 2008

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 and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1590
FAX: (301) 427-1597
E-mail address: complexpatientFOA@ahrq.hhs.gov

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

Section 3.A.2  Technical Assistance

AHRQ encourages applicants to take advantage of a technical assistance conference call sponsored by AHRQ program staff.  The purpose of the conference call is to provide potential applicants with background information and respond to questions about the preparation of an application in response to this FOA.  The conference call will take place on Monday October 15, 2007 at 12:00 p.m.  To register to participate in the conference call, please send an e-mail request to complexpatientFOA@ahrq.hhs.gov) by October 8, 2007.  All registrants will be sent an e-mail reply which will contain information on the call, including call-in information, by COB October 11, 2007.  Potential applicants are encouraged to contact AHRQ staff with any questions (see Section VII, Agency Contacts, below).

The conference call is open to any individual or organization intending to apply.  Participation is not a prerequisite to applying.  Participants are encouraged to submit questions via email prior to the conference call.  Please submit up to five questions with your name and the name of your institution to Ms Washington by October 11, 2007.  Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff.  Notes from the conference call will be posted on the AHRQ web site.  If interested applicants are not able to participate in the call, please send requests for a copy of the notes to complexpatientFOA@ahrq.hhs.gov.

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/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

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 submission/receipt date(s). (See Section IV.3.A. for all dates)  If an application is not submitted by the receipt 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 business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH and AHRQ.  Incomplete or non-responsive applications will be returned without review.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives the Grants.gov acknowledgments. The AOR 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 applicants to check periodically on their application status in the Commons.

AHRQ will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application.  This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” (three pages maximum) addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

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 and 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 provisions of AHRQ’s governing statute at 42 USC 299c-3(c), the Privacy rules 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, included in the DUA is the requirement that the 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 the 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 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)

AHRQ requires the PD/PI 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.”

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

PHS398 Research Plan Component Sections

Items 2-5 of the PHS398 Research Plan component are limited to 15 pages. 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:

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 be returned without review.

APPENDIX MATERIALS

AHRQ has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

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).

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

Note: While each section of the PHS398 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 monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the PHS 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, which 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 also 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, the 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 inpatient 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 databases include two nationwide databases, the Nationwide Inpatient Sample (NIS) with inpatient data from a national sample of approximately 1,000 hospitals and the Kids’ Inpatient Database (KID), 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 comprised 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.

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 be returned to the applicant without further consideration. 

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 R-21 mechanism are distinct from the more common R-01 mechanism.  The R-21 mechanism is an exploratory/developmental grant application and there is a 15-page limitation for Research Plan component.  This R-21 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 R-01 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:

§         The condition is relatively common;

§         It is frequently accompanied by other important co-morbidities;

§         There are effective treatments (especially if there are quality metrics built around these treatments);

§         The appropriate use of those treatments is likely to be influenced by the co-morbidities.

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?  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?

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?

2.A. Additional Review Criteria

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

Inclusion: The 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 item 7 of the Research Plan component of the SF 424 (R&R)).

2.B. Additional Review Considerations

Not Applicable.

2.C. Sharing Research Data

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 now civil monetary penalties for violation of this 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 45 CFR Parts 160 and 164, the Federal Privacy Rule developed by the Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  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 of disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an Institutional Review Board (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 DHHS 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 awardee 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 websites 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.

2.D. Sharing Research Resources

Rights in Data

AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents for, as appropriate, final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. 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; and 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 the 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

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

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 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).  AHRQ will also conduct an administrative and budgetary review of the application and request additional information, if necessary, from the applicant.

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

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).

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement, found at

http://www.ahrq.gov/fund/hhspolicy.htm.

The Progress Report must include Sections a through f as described on pages 10-14 in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the 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.  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.

A final Progress Report, Financial Status Report, and Final Invention Statement are required at the end of the project.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

AHRQ welcomes the opportunity to clarify any issues or questions from potential applicants who have read the FOA.  Written and telephone inquiries concerning this FOA are encouraged.

Direct your questions about general FOA issues, including information on the Inclusion of Women, Minorities and Children, and other priority populations to:

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
E-mail address: complexpatientFOA@ahrq.hhs.gov

OR

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

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to: 

Sherry Cochran
Office of Performance Accountability, Resources and Technology
Division of Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone:  (301) 427-1458
Fax: (301) 427-1462
E-mail address: sherry.cochran@ahrq.hhs.gov

Section VIII. Other Information


Required Federal Citations

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 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 Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 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:

The OMB Circular A-110 has been revised to provide access to research data developed with Federal support through the Freedom of Information Act (FOIA) 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) 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, 5 USC 552(b), disclosure of confidential identifiable data from such study, statutorily protected under 42 USC 299c-3(c), is exempted from disclosure under "the (b)(3) exemption” in FOIA.  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", for example, if they constitute 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 the 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 authorization of 42 USC 299 et seq. and under Federal Regulations 42 CFR 67 and 45 CFR Parts 74 and 92 and applicable authorizing 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 PHS mission to protect and advance the physical and mental health of the American people.

References

Beal AC, Doty MM, Hernandez MM, Shea KK, and Davis K.  (2007).  Closing the divide: how medical homes promote equity in health care: results from The Commonwealth Fund 2006 Health Care Quality Survey, The Commonwealth Fund. 

Boyd CM, Darer J, Boult C, Fried LP, Boult L and Wu AW.  (2005).  Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: Implications for pay for performance.  JAMA; 294(6): 716-724.

Walter LC, Davidowitz NP, Heineken PA and Covinsky KE.  (2004). Pitfalls of converting practice guidelines into quality measures: Lessons from a VA performance measure.  JAMA; 291(20): 2466-2470.

Weinstein MC, Siegel JE, Gold MR, Kamlet MS and Russell LB.  (1996).  Recommendation of the panel on cost-effectiveness in health medicine.  JAMA; 280(23): 1992-3.

Werner RM, Greenfield S, Fung C, and Turner BJ.  (2007).  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;  22(8):1206-11. Epub 2007 May 22.


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