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 Quality Improvement and Patient Safety (CQUIPS), ( http://www.ahrq.gov)

Title:  Risk Informed Intervention Development and Implementation of Safe Practices in Ambulatory Care (R18)

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

Announcement Type
New

Request for Applications (RFA) Number: RFA-HS-08-004 

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 (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release Date: February 29, 2008
Opening Date: March 24, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s):
March 19, 2008
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):  April 24, 2008
Peer Review Date(s):  July-August 2008
Earliest Anticipated Start Date(s):  September 2008
Expiration/Closing Date:  April 25, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

This FOA is a limited competition.  Only those institutions who are already currently receiving AHRQ funding under RFA-HS-07-003, Ambulatory Care Patient Safety Proactive Risk Assessment (see http://grants1.nih.gov/grants/guide/rfa-files/RFA-HS-07-003.html) projects, and those who have demonstrated the skills, abilities and capacity to comply with the requirements of the current FOA, are eligible to apply.  This FOA builds upon the risk assessments already developed or being developed under RFA-HS-07-003, therefore only institutions currently receiving funding under HS-07-003 are eligible to apply for the current FOA.

The purpose of this FOA is to support risk informed development and implementation of safe practice interventions that have the potential of eliminating or reducing medical errors, risks, hazards, and harms associated with the process of care in the ambulatory setting.  The objectives of these demonstration and dissemination projects are to:  (1) identify, develop, test, and implement safe practice interventions in ambulatory care settings; and (2) share the findings and lessons learned about the challenges and barriers to developing and implementing these interventions through toolkits.  These safe practice interventions will be informed by the previously conducted proactive risk assessments projects supported by AHRQ.  The interventions and resulting implementation toolkits shall be made publicly available to be adapted to and/or adopted by other healthcare organizations.  These projects will inform AHRQ, providers, patients, payers, policy makers, and the public about how safe practice interventions can be successfully implemented in ambulatory care settings and lead to safer and better health care for all Americans.   Characteristics of these applications include:

Applicants that are not health care provider organizations must have a provider organization which is actively engaged in the delivery of ambulatory health care as a participating partner in the proposed project.

There is no cost sharing requirement in this FOA.  However, AHRQ encourages applicant institutions to provide institutional support for the proposed project.  The applicant institutions, including collaborators, are encouraged to devote organizational resources to this effort to demonstrate commitment to system improvements.

Purpose. The purpose of this FOA is to support demonstration and dissemination projects to:  (1) identify, develop, test, and implement safe practice interventions in ambulatory care settings; and (2) share the findings and lessons learned about the challenges and barriers to developing and implementing these interventions through toolkits.  The interventions and resulting implementation toolkits shall be made publicly available to be adapted and/or adopted by other healthcare organizations. 

Mechanism of Support. This FOA will use the Research Demonstration and Dissemination Projects (R18) grant mechanism.

Funds Available and Anticipated Number of Awards. AHRQ intends to commit $4.0 million in total costs in FY 08 to fund 10-15 new projects in response to this FOA.  Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for a planning project.  While the financial plans of AHRQ provide support for this program, awards pursuant to this FOA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Budget and Project Period:  The total costs awarded under this FOA for each project will not exceed $300,000 annually.  An application with a budget that exceeds $300,000 total costs per year will be returned without review.  Funding beyond the first year will be contingent upon a review by Agency staff of the non-competing continuation reports.

Eligible Organizations:  You may only submit (an) application(s) if your organization is currently receiving funding under RFA-HS-07-003.

Institutions who meet the first criteria must be Public or non-profit private institution, such as a university, college, or a faith-based or community-based organization; Units of local or State government; eligible agencies of the Federal government; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); Indian/Native American Tribally Designated Organizations.

Eligible PIs: Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution 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.

Because this FOA builds on previous work, the PIs previously awarded funding under RFA-HS-07-003 are invited to work with the applicant organization to develop an application for support.  If it is more appropriate for another individual to serve as PI, it should be clearly stated and the application must include a specific rationale explaining the reasons why a new PI is required for this demonstration and dissemination project.  Specifically, the new PI should be an experienced senior level individual familiar with ambulatory care delivery, patient safety, and with the use of risk informed intervention development and implementation, or the PI should have such expertise available as part of the project team.  The PI should spend a minimum of 20% effort annually on the project.

Number of Applications:  Eligible organizations may submit more than one application, up to a maximum of two, provided each application is distinct and the proposed projects would each be able to meet the FOA requirements, including distinct implementation toolkits.  In addition, organizations can only submit applications that involve safe practice interventions resulting from their previously funded Proactive Risk Assessment projects.  If an organization submits more than one application, it must include a discussion in the applications of how the projects are distinct and how the organization has the appropriate resources for these intensive implementation projects.

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

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

Special Date(s): This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.

Application Materials. See Section IV.1 for application materials.

General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:

Hearing Impaired: Telecommunications for the hearing impaired are available at: TTY 301-451-5936. 

While grant awards are made to organizations rather than individuals, this announcement and its instructions are written to inform individual researchers at organizations already receiving funding under RFA-HS-07-003 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
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
    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


Research Objectives

The purpose of this FOA is to support risk informed development and implementation of safe practice interventions that have the potential of eliminating or reducing medical errors, risks, hazards, and harms associated with the process of care in the ambulatory setting.  The objectives of these projects are to:  (1) identify, develop, test, and implement safe practice interventions in ambulatory care settings; and (2) share the findings and lessons learned about the challenges and barriers to developing and implementing these interventions through toolkits. 

Because there are limited data on the nature of risks and hazards to patients and threats to quality in the ambulatory care setting and few safe practices have been identified, in FY2007 AHRQ funded planning projects to identify the risks and hazards imbedded in the process and structure of ambulatory care through the funding opportunity entitled Ambulatory Care Patient Safety Proactive Risk Assessment (RFA-HS-07-003).  These planning projects are intended to provide well documented risk assessment reports and suggested approaches for eliminating identified risks in diverse ambulatory care settings.  For further information on proactive risk assessment and the goals and objectives of the planning projects, please see RFA-HS-07-033 http://grants1.nih.gov/grants/guide/rfa-files/RFA-HS-07-003.html).

It is now time to apply what has been learned in these proactive risk assessments to improve safety and quality in ambulatory care through risk informed design.  Knowing where the risks and hazards are informs the development of appropriate interventions that can eliminate or minimize risks and hazards.  By using proven proactive risk assessment and modeling methods, AHRQ expects to begin to move the process of ambulatory care to the implementation of risk informed safe practice interventions.   

Building on those proactive risk assessment projects, this FOA is focused on projects that will: (1) demonstrate safe practice intervention strategies using risk informed approaches to improve the processes of care and (2) disseminate information about the interventions through publicly available implementation toolkits which can be adapted and/or adopted by other healthcare organizations.  These new projects must use interventions that are intended to eliminate, reduce, and/or mitigate the risks and hazards identified in the proactive risk assessment project.  This FOA provides an opportunity for AHRQ to work with the grantees and their partners to improve the implementation of risk informed patient safety practices.  These partnerships may facilitate opportunities for collaboration and coordinated efforts in response to new, emerging, or ongoing issues related to patient safety.

For the purpose of this FOA, ambulatory care refers to all types of health services provided by healthcare professionals on an outpatient basis, in contrast to services provided in the home or to persons who are inpatients. While many inpatients may be ambulatory, the term ambulatory care usually implies that the patient must travel to a location to receive services which do not require an overnight stay.  This program will specifically focus on the following settings: healthcare clinician offices and practices, both large and small, outpatient clinics, community health centers, emergency departments, urgent care centers, and ambulatory surgery centers. Non-ambulatory settings with a strong interest in fostering high quality ambulatory care and transitions are welcome to apply in partnership with an ambulatory organization. In particular, a focus on transitions between ambulatory care, home care, and nursing homes are critical to the success of ambulatory care for many elderly and chronically ill populations.

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 Research Demonstration and Dissemination Projects Grant (R18) award mechanism.  The individual researcher sponsored by each organizational grantee will be solely responsible for planning, directing, and executing his or her proposed projects.  The AHRQ R18 provides support for projects designed to develop, test, and evaluate health service 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. 

AHRQ is not using the Modular Grant Application and Award Process. Applications submitted in modular format will be returned without review.

2. Funds Available

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 intends to commit up to $4,000,000 in FY 2008 to fund 10-15 applications in response to this RFA.  Applications may be up to 3 years in duration with a budget supported by AHRQ not to exceed $300,000 per year including direct costs and indirect total costs to the government.  Applications with project periods that exceed 3 years or budgets that exceed $300,000 in total costs in any year will be returned without review.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may only submit (an) application(s) if your organization is currently funded under RFA-HS-07-003 (see http://grants1.nih.gov/grants/guide/rfa-files/RFA-HS-07-003.html).

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.  For-profit organizations may participate in projects as members of consortia or as subcontractors only.  Because the purpose of this program is to improve the safety and quality of ambulatory care in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only.  Applications submitted by for-profit organizations and foreign institutions 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

Because funding for this FOA is building on previous work, PIs previously awarded funding under RFA-HS-07-003 are invited to develop an application for support. If it is more appropriate for another individual from the institution to serve as PI for this project, a specific justification explaining the reasons why a new PI is required for this implementation project must be included in the application.  The PI should be an experienced senior level individual familiar with ambulatory care delivery, patient safety, and with the use of risk assessment methods and approach or the PI should have such expertise available as part of the project.  The PI should spend a minimum of 20% effort annually on the project.  If the PI devotes less than 20% effort annually, an explicit justification must be provided in the application. 

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

Because the FOA is intended to support the risk informed development and implementation of safe practices in the delivery of ambulatory health care, organizational entities that are not ambulatory health care provider organizations must have a provider organization which is actively engaged in the delivery of health care as a participating partner in the proposed project.  For purposes of this FOA, a health care provider organization is defined as any organization engaged in the direct delivery of ambulatory care to patients in any setting including, out patient or ambulatory, emergency departments, EMS services, urgent care centers, or home care including ambulatory surgery centers, diagnostic and therapeutic clinics including dialysis units.   Also included under this definition of health care provider organizations are those organizations that dispense or directly collect specimens, or engage in diagnostic processes (i.e., blood and urine collection, blood centers, laboratories or organizations such as pharmacies that dispense therapeutics).  Ambulatory care units that are part of inpatient care facilities or hospitals are eligible if the focus of the project is on the ambulatory services rather than in-patient services.

Grantees funded under this FOA must participate in quarterly conference calls and must submit quarterly progress reports.  Information about the calls and templates for quarterly reports will be provided by AHRQ at the time of or after grant award. In addition, the grantees will participate in a site visit conducted by the AHRQ project officer (PO); the purpose of the site visit is to review project progress and to assess the level of institutional support and commitment.  The PO travel costs for the site visit are the responsibility of AHRQ; the timing of and the agenda for the site visit will be determined after grant award.  

In addition, the PI and at least one other project member must participate in AHRQ’s annual conference.  Therefore, applicant institutions must include an allocation of projected travel funding for two conference attendees each year to attend one meeting in the Washington, DC area in each proposed budget period.  In addition, applicant institutions may use no more than 15% of the Federal grant funds for purchasing equipment, hardware, or software.  Applications which propose more than 15% for such purchases will be returned without review.

Projects funded under this FOA are part of AHRQ’s Patient Safety Initiative.  All grantees under this FOA will be required to cooperate fully with AHRQ contractors that assist AHRQ with Patient Safety Initiative activities. 

Applicant organizations may only submit applications that build upon their previously funded proactive risk assessment projects.  The applicant must address the following 12 project requirements in the narrative portion of the application.  Applications that do not address all 12 project requirements will be returned without review.

Project Requirements

1.  The applicant, or its partner(s), must be a health care provider organization capable of developing and implementing ambulatory safe practices based upon a risk informed process.

2.  The applicant must use the results of the proactive risk assessment project to identify a risk informed development and implementation project that addresses the identified risks and hazards in ambulatory care.  The applicant must have already completed the risk assessment to such a state that it can be used as part of the risk informed process to develop and implement a safe practice intervention.  The applicant must include information as to how the risk assessment/modeling has been incorporated into the planning for the safe practice intervention intended to eliminate or minimize the patient safety risk and hazards assessed and or modeled in the project.  The applicant must identify the patient population impacted by the risks and hazards and outline the expected benefit from the implementation of the safe practice.

3.  The applicant must describe in sufficient detail to render a complete understanding of the nature of the problem that is addressed and how the safe practice intervention to be developed and implemented will eliminate and/or mitigate the identified risks and hazards. This description should include not only a brief review of the salient literature with respect to the problem area, but also the anticipated benefits, limitations, and scientific significance of the proposed safe practice to be designed and implemented.  In addition, the applicant must demonstrate its understanding of the nature of the problem (past trends, need for improvement), the current problem situation, the purpose of the safe practice objectives or hypotheses to be studied, the supporting theoretical or conceptual framework, underlying assumptions, and scope or boundary conditions of the proposed research.  Finally, the application must include a discussion of the methods and approaches used for the risk informed approach, the rationale for selection of the method(s), and experience in their use.

4.  Given specification of the research objectives and taking into account practical constraints, the applicant needs to describe the methodology that will best enable the project objectives to be realized.  Information provided in the application should include the anticipated benefit to established knowledge about how to improve the safety of ambulatory healthcare delivery.  The application must include a timeline with milestones covering all major phases of the project.

5.  The applicant must describe its plans for: collecting data, including types of data; analyzing data with respect to the project objectives; and, including anticipated benefits to patient safety.  To the extent possible, applicants should discuss any anticipated limitations or cautions that will need to be exercised in the replication of results.

6.  The applicant must describe how it plans to engage and involve its partners and significant stakeholders in the project.  AHRQ fully believes that, without ownership or sharing of the perceived risks, any interventions designed to eliminate the risks will not likely succeed.

7.  The applicant must provide an implementation plan including a time line for introducing the safe practice intervention into the health care delivery process.  This plan should include the identification of barriers and problems to be overcome in introducing the safe practice intervention.  The plan should discuss the anticipated costs and benefits to the institutions of implementing the safe practice intervention, including the projected return on investment for the intervention development and implementation.

8.  The applicant must be able to anticipate the level of adoption and acceptance of the safe practice intervention by health care professionals both in their organization and any partner organizations.  The applicant should describe potential barriers to adoption and how these barriers can be overcome.

9.  The applicant must describe the tools and the implementation toolkit that will result from the project.  The applicant should specify projected impact and replicability of any tools and the toolkit developed.  The toolkit should include implementation specifications and guidelines as well as data specifications when necessary; document the lessons learned during the implementation process, including the barriers and challenges and how they were addressed;, and identify any resources (e.g., staff, costs) and other tools that facilitate adaptation and/or adoption of the safe practice intervention.  After grant award, the plan and process for developing and disseminating the implementation toolkit will be worked on by the grantees with input by AHRQ.

10.  The applicant must submit an evaluation plan.  The plan should focus on the performance and impact of the implementation of the safe practice intervention.  The applicant should describe how the safe practice intervention, including the implementation toolkit, and project outcomes, will be evaluated and assessed.  AHRQ recommends that applicants consider the use of standardized tools such as the AHRQ Medical Office Patient Safety Survey that will be publicly available in early spring 2008, be used as part of the evaluation process.  In addition, the evaluation plan should also focus on assessing the reproducibility of the safe practice intervention, including the implementation toolkit, and the resource (e.g., costs, staff) implications.

11.  The applicant must submit a dissemination plan.  The dissemination plan should describe how the applicant intends to actively promote and share the intervention tools/toolkit with other interested parties outside of the applicant organization and its partner(s).  This information should be in the form of an action plan for facilitation of the adaptation and/or adoption of the planned implementation toolkit by other healthcare organizations.  The dissemination plan may include all or some of the following:  Web, publications, conferences, CDs, DVDs.  After grant award, the dissemination plan will be refined and revised based on project progress and input from AHRQ.

12.  The applicant must describe how the project will be integrated into the mainstream or normal operations and activities of the organization for sustainability.  There is an expectation that the safe practices implemented as part of the funded activities become standard operating procedures/practices with the 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, 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.

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 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 PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

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. 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. 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

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Release Date: February 28, 2008
Opening Date: March 24, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): March 19, 2008
Application Submission/Receipt Date(s):  April 24, 2008
Peer Review Date(s):  July-August 2008
Earliest Anticipated Start Date(s):  September 2008
Expiration/Closing Date:  April 25, 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.  This letter should include 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 PI.

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:

Ms. Lisa Krever
Agency for Healthcare Research and Quality (AHRQ)
Center for Quality Improvement and Patient Safety (CQuIPS)
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1306
FAX: (301) 427-1341
Email:  Lisa.Krever@ahrq.hhs.gov

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

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 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 be returned without review.

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 FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending 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.

o 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 provision in the AHRQ statute, 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, 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 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.   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, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award without AHRQ prior approval if such costs are necessary to conduct the project and would be allowable under the grant, if awarded.  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.”

PHS398 Research Plan Component Sections

Items 2-5 of the PHS398 Research Plan component are limited to 25 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.   

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. 

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

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 comply with the required page limitations may be delayed in the review process.

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 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 follow the “AHRQ Publishing and Communications Guidelines specifications (AHRQ publication no. 07-MO20-CD) and 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.

o   HCUP & MEPS

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 include two nationwide databases, the Nationwide Inpatient Sample (NIS) 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, noninstitutionalized 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.

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 be returned to the applicant without further consideration. 

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

In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.  Each of these criteria will be addressed and considered in assigning the overall priority 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 deserve 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:  Does this study address an important problem?  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, methods, technologies, treatments, services, or preventative interventions that drive this field? 

Approach:  Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project?   Does the applicant acknowledge potential problem areas and consider alternative tactics?  Is the proposed intervention appropriate and reasonable given the risks and hazards identified in the previously funded project?   

Innovation:  Is the project original and innovative?  For example: Does the project challenge existing paradigms or clinical practice; does the project address an innovative hypothesis or critical barrier to progress in the field?  Does the proposed intervention and resulting tools and toolkit advance safety in ambulatory care?

Investigators:  Are the PI and other key personnel appropriately trained and well suited to carry out this work?  Is the work proposed appropriate to the experience level(s) of the PI and other members of the project team?  Do the PI and project team bring complementary and integrated expertise to the project as appropriate?   

Environment:  Do(es) the environment(s) in which the project will be conducted  contribute to the probability of success?  Does the proposed project benefit from unique features of the scientific environment(s) or subject populations?  Does the proposed project employ useful collaborative arrangements?  Is there evidence of institutional support and commitment from the applicant organization and collaborating partners?   

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 responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA? How well has the applicant built the proposed project upon the results of the previously funded risk assessment project?

Budget:  Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research?  Is the proposed allocation of budget appropriate for the project objectives?  Does the resource allocation allow for the effective development and implementation of the proposed intervention and the resulting tools and toolkit?

Inclusion:  Are the plans to address the needs of both genders and racial and ethnic minorities (and subgroups) adequate?  Is adequate attention given 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:

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 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 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 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 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 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.

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 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 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

Generally, applicants should anticipate approximately five to 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 score and Summary Statement (written critique) via the NIH eRA Commons

If the application is under consideration for funding, AHRQ will send an e-mail request for "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). 

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

Selection of an application for award is not an authorization to begin performance.  Any costs incurred before receipt of the NGA 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).

Activities conducted under this award that involve the collection of information e.g., conducting surveys or requesting responses to uniform questions from nine or more persons, establishments or other entities, may be required by HHS to be cleared by OMB under the Paperwork Reduction Act (PRA) (44 USC, 3501-3521).  Submissions for clearance under PRA are through AHRQ and HHS. Therefore, affected grantees should include the time in their proposed timelines to develop materials and receive necessary clearances.  It typically takes at least six months from date of initial submission to AHRQ to receive clearances, and sometimes much longer if submissions are incomplete or the justification for the proposed data collection plans are questioned during the clearance process.  Information collection that requires PRA clearance may not begin until grantees receive written notification via e-mail from AHRQ that clearance has been obtained.  Detailed information on the PRA can be found at http://www.hhs.gov/ocio/policy/collection/.

3. Reporting

When multiple years are involved, grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually.

The annual progress reports must include Sections 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.

Quarterly progress reports are to include:  descriptive and evaluative comments on 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 FSR should be submitted to the assigned grants management specialist.

At the end of the grant award period, a final progress report, final invention statement and certification, and final FSR are required to be submitted to AHRQ.  For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

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:

James B. Battles, Ph.D
Center for Quality Improvement and Patient Safety
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1332
FAX: (301) 427-1341
Email: RiskAssessment@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:

Boris Aponte, Ph.D.
Scientific Review Officer
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1396
FAX: (301) 427-1562
Email: Boris.Aponte@ahrq.hhs.gov

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to: 

Kevin Hornbeak
Grants Management Specialist
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) 427-1704
Fax: (301) 427-1462
E-mail:  Keven.Hornbeak@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 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 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 is statutorily protected under 42 USC 299c-3(c), and thus 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 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, under Federal Regulation, 42 CFR Part 67 and in accordance with 45 CFR Parts 74 or 92 and other referenced 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.



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