Part I Overview Information

Department of Health and Human Services

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

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).

Title: Infrastructure for Maintaining Primary Care Transformation (IMPaCT) Support for Models of Multi-sector, State-level Excellence (U18)

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

Announcement Type
This Funding Opportunity Announcement (FOA) is a new FOA.

Request for Applications (RFA) Number: RFA-HS-11-002

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/Posted Date: November 8, 2010
Opening Date: January 15, 2011 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): January 7, 2011
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): February 15, 2011
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration Date: February 16, 2011

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

• Purpose. This new FOA is for Research Demonstration and Dissemination Projects to expand current state-level, multi-sector efforts to transform primary care practices and develop sustainable infrastructure for quality improvement in small and medium-sized primary care practices. The goal of the FOA is to foster the advancement and evaluation of leading state-level primary care practice support efforts that may become models for a potential national primary care extension service. Successful applicants must demonstrate existing successful collaborative efforts and significant existing infrastructure and activities. Grant supported efforts are to be directed towards 1) enhancing current efforts and filling identified programmatic gaps and 2) program evaluation and sustainability planning. Additionally, a minimum of 25% of grant funds must be applied to dissemination activities targeted to other states. All applications must include a plan for packaging their efforts, including lessons learned and a plan for sharing their experience with a minimum of three other state-level coalitions.
• Mechanism of Support. This FOA will use the AHRQ Cooperative Agreement Research Demonstration and Dissemination Projects (U18) grant mechanism.
• Funds Available and Anticipated Number of Awards. AHRQ intends to make three awards totaling up to $1.5 million in 2011. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
• Budget and Project Period. The total costs awarded to a grant under this FOA will not exceed $500,000 annually or $1,000,000 over a period of two years. Facilities and Administrative (F&A) costs are included in the total cost limitation. An application with a budget that exceeds $500,000 total costs in any given year or a project period that exceeds two years will not be reviewed. Funding beyond the first year will be contingent upon a review and acceptance by Agency staff of the annual progress report.
• Application Research Strategy Length: The Research Strategy section may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts.
• Eligible Institutions/Organizations: Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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 PD/PI is expected to devote a minimum of 20% effort annually to this project. Applicants that propose less than 20% annual effort for the PD/PI must include a justification.
• Number of PDs/PIs: Only one PD/PI may be designated on the application.
• Number of Applications: Applicants may submit more than one application, provided each application is scientifically distinct.
• Resubmissions: Resubmission applications are not permitted in response to this FOA.
• Renewals: Renewal applications are not permitted in response to this FOA
• 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:
  • SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
  • General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Hearing Impaired: Telecommunications for the hearing impaired are available at: TTY 301-451-5936.

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

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
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. Receipt, 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
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. AHRQ Responsibilities
3. Collaborative Responsibilities
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

The overarching goal of this funding opportunity is to support model state-level initiatives that provide infrastructure to small (including solo) and medium sized independent primary care practices in order to support practice transformation and ongoing quality improvement. While many states and organizations are beginning to implement such projects, this effort is targeted to support successful, established programs that are willing to serve as models to other states and the federal government.

Funding from this initiative may be used for enhancing current efforts and filling identified programmatic gaps. Applicants must demonstrate that they are conducting meaningful program evaluation and are planning for program sustainability. Funds from this initiative may be used for evaluation and sustainability planning, however, if these efforts are already underway, funds from this grant do not have to be dedicated to these purposes. Given the goal of disseminating best practices and lessons learned, a minimum of 25% of grant funds over the course of the two-year project period must be applied to dissemination activities targeted to other states. Applicants are required to present a plan for creating dissemination materials and a plan for sharing their experience with coalitions from a minimum of at least three other states. Dissemination efforts may include, but are not limited to, mentoring relationships, building learning collaboratives, state-to-state visitations, and on-line resource development.

Background

AHRQ believes that a robust primary care system is the foundation for an American health care system that delivers high-quality, affordable health care to all Americans. There is growing recognition, however, that our current primary care health system is struggling. Payment reform, functional health information technology (health IT), and a well-trained, motivated, and adequate-sized workforce are all needed in order to revitalize primary care. This initiative focuses on another complementary building block for revitalizing primary care an infrastructure for practice transformation and quality improvement. (Meyers, 2009)

The dominant model for quality improvement in health care has been based on hospitals and large integrated health systems. Small and medium sized primary care practices typically do not have the quality improvement coaches, chief information officers, data entry clerks and other dedicated staff members used by these larger organizations to develop and refine systems and conduct quality improvement. Additionally, the clinical and operational staff of most primary care practices do not have training and skills in practice redesign and quality improvement. This missing infrastructure has been identified as critical if the nation is to build the primary care system it needs using the practices and clinicians it already has. (Meyers, 2009)

Over the last decade, many solutions have been proposed to meet the challenges of transforming primary care. The patient-centered medical home, with its focus on delivering high-quality primary care utilizing advanced health IT and financed through new payment approaches, is being tested, refined, and implemented across the country in small and large demonstration projects. The successful experiences of early adopters confirm that in order to adopt this model, primary care practices require significant external facilitation, support, and training. (Nutting, 2010)

In response, the concept of a primary care extension service utilizing local primary care extension agents has emerged (Grumbach, 2009). Many states and state-level coalitions have begun implementing this model, often as part of larger initiatives to transform the health care system in their communities. In 2010, Section 5405 of the Affordable Care Act, Pub. L. 111-148 authorized the Agency for Healthcare Research and Quality (AHRQ) to organize a national primary care health extension program.

This FOA is a first step towards building a national primary care health extension program. Through its support of experienced state-level programs, and by requiring evaluation, the FOA will provide AHRQ with multiple examples of how a national program could be built. Additionally this FOA is designed to further the expansion of existing programs, allowing primary care practices and the communities they serve to benefit immediately. Finally, and as importantly, this effort aims to facilitate states teaching and learning from other states.

The statutory authority for the initiative that is the subject of this FOA is 42 USC 299a(a), which authorizes AHRQ to conduct and support research, support demonstration projects, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to clinical practice, including primary care and practice-oriented research. See 42 USC 299a(a)(4).

Definitions

For the purposes of this FOA, the following terms are defined:

Primary Care: The provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, including prevention and health promotion, developing a sustained partnership with patients of all ages including men, women, children, and the elderly, and practicing in the context of family and community.

Primary Care Clinicians: Health care professionals who provide primary care who are recognized by a State licensing or regulatory authority. In general primary care clinicians include physicians, advanced practice nurses, and physician assistants practicing in the fields of family medicine, general internal medicine, and pediatrics. Women’s health clinicians and geriatricians also practice primary care.

Primary Care Practices: Health care organizations that are dedicated to the provision of primary care.

Quality Improvement: Quality improvement is a systematic form of ongoing effort to make performance better. In medical practice it often focuses on improving health outcomes, improving efficiency, and improving patient and staff experience.

Multi-Sector: For the purposes of this FOA, at a minimum initiatives must include, within the project leadership or governance structure, the State Department of Health, the State agency that administers the Medicaid program (which may or may not be the State Department of Health), and an academic department of primary care. Broader coalitions are highly encouraged. Additional information is provided below in the section on multi-sector, state-level collaborations.

Multi-Sector, State-level Collaborations

As is the case with the primary care health extension program envisioned by the Affordable Care Act, this FOA requires that programs be organized at the state level. Specifically, applicants must demonstrate the active involvement of the following entities in the project:

• State Department of Health
• State entity responsible for administering the State Medicaid program (if other than the State health department)
• A primary care department or departments of one or more health professions schools in the state that train primary care professionals

The project should also involve a variety of other stakeholders such as:

• Primary care professional societies
• The State Medicare Quality Improvement Organization (QIO)
• The Area Health Education Center
• Consumer groups
• The State Primary Care Association

It is not required that a state government be the lead agency for this application. Any eligible organization (see Section III 1 A) may submit the application on behalf of the program. Applications must describe the program leadership, including the governance structure and the meaningful involvement of key stakeholder organizations and should include letters of support from participating organizations in the appendix.

Applications should discuss the relationship between this effort and any federally-recognized Regional Extension Centers for Health IT in the state. (For a more information on the federal Health Information Technology Extension Program, please see: http://healthit.hhs.gov/portal/server.pt?open=512&objID=1495&parentname=CommunityPage&parentid=58&mode=2&in_hi_userid=11113&cached=true)

Existing Efforts

As discussed above (see Research Objectives), this FOA seeks to identify vanguard state-level programs in order to inform future federal planning and to allow active dissemination of lessons learned to state programs that are in an earlier stage in their development or those in the planning phase.

Applicants must describe their existing efforts to facilitate the transformation of primary care practices into patient centered medical homes and to support quality improvement (including the use of evidence based medicine) in primary care. Applications should include the theoretical and organizational models that underlie the work of the state-level program and describe the model or models the program helps primary care practices adopt. Applicants must describe how they work directly with individual practices across the entire state or how the program has been designed to be scalable so that all practices within the state can be reached. AHRQ is committed to improving health equity and believes programs should explicitly consider how minority clinicians and practices that serve large numbers of minority and vulnerable patients will be served. AHRQ is particularly interested in the use of practice facilitators or coaches. Applications should discuss how program goals are established and how stakeholder feedback, including the experiences of primary care professionals and consumers, is incorporated.

Applications must include evidence of the success of the program in achieving its goals.

Demonstration Components

Applications must include discussion of two demonstration components: 1) program enhancements and 2) program evaluation and sustainability planning.

Program Enhancements:

Recognizing that even successful established programs are likely to have identified areas for enhancement and gaps that require filling, applicants may request funds as part of this grant to refine their program. The application should describe what if any specific enhancement activities will be conducted, how they were identified, and how they are expected to contribute to the larger program and its goals.

Program Evaluation and Sustainability Planning:

All applications must describe how the program will be evaluated during the performance period. Applications will be evaluated on the creativity, sophistication, rigor and value of proposed evaluations. Evaluations should be able to inform future planning for both local and federal initiatives and contribute to dissemination efforts. Applications may request, but are not required, to use grant funding to support the proposed evaluation.

All applications must either describe an existing plan for program sustainability or describe a plan for developing one during the grant period. Funds may be requested to support sustainability planning.

Dissemination Components

A major aim of this funding opportunity is to allow experienced state-level teams to disseminate their knowledge and experience to teams in other states who are earlier in the process of developing their own initiatives to support primary care transformation and quality improvement.

Applicants must describe a plan for packaging their efforts and lessons learned. They must also describe an outreach effort that will result in a minimum of three other states or state coalitions receiving training about the applicant’s program and about how to develop their own programs. Outreach efforts may include developing ongoing mentoring relationships, building a regional learning collaborative, arranging in-person site visits, and developing online resources. A minimum of 25% of requested funds over the two-year grant period must be devoted to dissemination activities. (It is not required that 25% of funds in each year be devoted to dissemination as long as the proposed total expenditure over the course of the full grant period is equal to or greater than 25%.)

Involvement of Federal Program Officials under this Cooperative Agreement

As this grant utilizes a cooperative agreement mechanism, applicants should plan to include a federal program official as a member of their project leadership team and to conduct at least quarterly teleconferences with the program official. The goal of this increased engagement is for AHRQ to learn from the experience of grantees in order to improve planning and design for a national primary care extension service. AHRQ staff will be particularly interested in the design and results of on-going evaluation efforts and sustainability planning. Additionally, the AHRQ program official will coordinate the efforts of the multiple grantees under this initiative to reduce duplicative efforts and ensure that multiple projects are not targeting dissemination activity to the same additional states.

Application Format

The Research Strategy section of the application is limited to 25 pages. Applications must include the following sections (The suggested page limits shown below are provided as guidance only. Applicants may divide the 25 pages in whatever way best describes their program and plans.):

• Introduction and Background (2-3 pages)
• Existing State-level Program (4-7 pages)
  • This section must demonstrate Multi-Sector involvement, as described above
  • This section must include a brief discussion of current or planned efforts to ensure support is provided to minority clinicians and practices serving minority communities.
• Demonstration Plan (include description of proposed program enhancements and proposed evaluation and sustainability planning) (7-12 pages)
• Dissemination Plan (6-10 pages)

The Demonstration and Dissemination Plan sections of the Research Strategy should include project timelines.

As this grant uses the cooperative agreement mechanism, applications should describe how they will incorporate federal program officials in demonstration and dissemination activity planning, execution, and evaluation.

Applications should include as an Appendix a specific budget breakdown related to the dissemination plan that demonstrates that a minimum of 25% of the total requested funds will be directed at this activity.

It is expected that the PI/PD will devote a minimum of 20% effort to this project. If an applicant proposes the PI/PD will spend less than 20% effort on this project, a specific justification that addresses project leadership, management, and coordination, must be included.

While primary care practices and the communities they serve may benefit greatly from shared community-based practice resources such as care coordinators, patient educators, social workers, and mental and oral health professionals, the development of these types of practice resources is not the focus of this funding opportunity announcement. Applications that focus on the state-level initiatives to provide practice support other than for practice transformation and quality improvement would not be responsive to the goal of this FOA.

While in the future, the federal government may explore creating a national primary care extension service based on multi-state or regional hubs or having multiple hubs in single states, this FOA targets single, whole state-level initiatives. If appropriate, applicants are encouraged to discuss how local centers are supported and coordinated as part of a state-wide initiative.

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 Research Demonstration and Dissemination Projects Cooperative Agreement Grant (U18) award mechanism. The Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with AHRQ staff being substantially involved with the PD/PI, as described within Section VI.2, Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

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

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.

AHRQ intends to commit up to $1.5 million in FY 2011 and up to $1.5 million in FY2012 to fund up to three projects in response to this FOA. Applications may be up to two years in duration with a budget supported by AHRQ not to exceed $500,000 per year in total costs to the government. Facilities and administrative (F&A) costs are included in the total cost limitation. Applications with project periods that exceed two years or budgets that exceed $500,000 total costs in any given year will not be reviewed.

Funding beyond the first year will be contingent upon a review by Agency staff of the annual non-competing continuation report/progress report.

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:

• Public or non-profit private institution, such as a university, college, or a faith-based or community-based organization;
• For-profit private institution
• 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.

Tribal-focused initiatives are encouraged to respond to the FOA with the understanding that tribal-level organizations replace state-level organizations in the above descriptions and requirements.

Because the purpose of this program is to improve healthcare in the United States, foreign institutions may not submit applications, however they may participate in projects as members of consortia or as subcontractors only. Applications submitted by 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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support. The PI/PD is expected to commit at least 20% effort to this project.

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, applications must demonstrate on-going support for the currently established program that is proposed to be enhanced, evaluated, and disseminated through this FOA. Institutional support from the applicant and the collaborating institutions indicate a greater potential of success and future sustainability of the program.

• The Existing State-level Program section of the research plan should include information about the available resources supporting the program during the grant period.
• The budget section may include details about institutional support, including such examples as donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions that plan to provide support should indicate institutional support by outlining specific contributions to the project, and providing assurances that their organization and any collaborators are committed to providing these resources to the project. This can be included at the end of the budget justification section of the application, but any institutional support dollars are not to be included in the detailed budget request.
• Applications should include detailed existing program budget information as an Appendix.

3. Other-Special Eligibility Criteria

Diversity of Awards: While AHRQ will accept more than one application related to the work in a single state, AHRQ intends to make no more than one award to any given state. AHRQ strongly encourages organizations in individual states to work collaboratively.

Number of Applications. 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.

Resubmissions. Applicants are not permitted to submit a resubmission application in response to this FOA.

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

Section IV. Application and Submission Information

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

Registration:

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

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

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

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

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email [email protected]

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

• The individual designated as PD/PI on the application must be registered also in the NIH eRA Commons.
• The PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an NIH Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
• The PD/PI at the applicant organization must be affiliated with that organization. A PD/PI located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons.
• This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

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

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

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 301-710-0267; Email: [email protected].

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 for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

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
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Research & Related Budget
(See Section IV.6, Special Instructions, regarding appropriate required budget component.)

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

SPECIAL INSTRUCTIONS

Applications Involving a Single Institution

When a single institution is involved, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

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

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: January 15, 2011 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): January 7, 2011
Application Due Date(s): February 15, 2011
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date

3.A.1. Letter of Intent

To allow AHRQ staff to estimate the potential peer review workload and plan the review (e.g., anticipate the nature of reviewer expertise to be required), prospective applicants may submit a letter of intent that includes an acknowledgement of interest in this funding opportunity (please include the number and title of this funding opportunity in the letter of intent), 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.

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

Leilani Liggins
Center for Primary Care, Prevention, and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1500
[email protected]

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

3.A.2. Technical Assistance

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 December 2, 2010 at 2:00 p.m. Eastern time. To register to participate in the conference call, please send an e-mail request to [email protected] by November 26, 2010. All registrants will be sent an e-mail reply which will contain information on the call, including call-in information, by COB November 30, 2010. 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 Leilani Liggins by November 24, 2010. 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.

3.B. Submitting an Application Electronically to AHRQ

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

In order to expedite the review, applicants are requested to notify the AHRQ Referral Office by email [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

3.C.1 Submitting On-Time

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

• All registrations must be complete prior to the submission deadline
• The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Viewing an Application in the eRA Commons

Once any eRA identified 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 assembled application before it automatically moves forward to NIH and AHRQ for further processing.

• If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12 of the SF 424 (R&R) application guide, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
• If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two weekdays.

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

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

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

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

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

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

Use of CMS Data

Purchase of Centers for Medicare 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. The applicant should obtain an estimate for the costs of the requested data, if possible. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made.

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

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

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

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements

As discussed above, applications are encouraged to include letters of support demonstrating all of the required and any additional coalition partnerships.

All applications should include an appendix that details the central budget for the ongoing program. This ongoing program budget is not part of the grant budget request.

As discussed above, applications should include as an Appendix a specific budget breakdown related to the dissemination plan that demonstrates that a minimum of 25% of the total requested funds will be directed at this activity.

Applicants should budget for at least two senior team members to attend at least one three-day AHRQ conference in the Washington, DC area during the course of the grant.

Grantees must agree to the Cooperative Agreement Terms and Conditions of Award in Section VI.2.A Award Administration Information .

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

All application instructions outlined in the SF424 (R&R) Application Guide that are not otherwise specified within this Funding Opportunity Announcement are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

• Specific Aims is limited to 1 page.
• Research Strategy, including tables, graphs, figures, diagrams, and charts is limited to 25 pages.

Budget Component

Special Instructions for Modular Grant applications

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

Warning: Please be sure that you observe the total 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.

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

Publication Transmittal: General AHRQ Requirements

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

Assessment of AHRQ Grant Programs

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

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

HCUP & MEPS

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

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

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

Health Literacy

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

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

Consumer Products

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

Section V. Application Review Information

1. Criteria

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

Merit Review Criteria: Merit Review Criteria, as 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:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score
• Receive a written critique

The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. As part of this mission, applications submitted to AHRQ to support health services research are evaluated for scientific and technical merit through the AHRQ peer review system.

Overall Impact:

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria:

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Does this proposal build on an established, successful state-level initiative that supports primary care transformation and quality improvement? Is the existing program a potential national model? What are the likely effects of proposed project enhancements? Is a rigorous and useful evaluation plan in place or proposed? Is a sustainability plan in place or a meaningful plan for establishing one proposed? Is the proposed dissemination plan likely to significantly benefit a minimum of three additional states?

Investigators. Are the PD/PI and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience levels of the principal investigator and other staff? Does the PD/PI and team bring complementary and integrated expertise to the project? Does the team include experts in state-level planning, policy development, and program implementation as part of the dissemination activity?

Innovation. Is the existing project original and innovative? Do the proposed program enhancements respond to a demonstrated need? Are the proposed program enhancements and proposed dissemination plan innovative? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?

Approach. Are the conceptual or clinical framework, design, methods, and evaluation of the existing program, proposed enhancements, evaluation plan, and dissemination plan adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the program provide direct support to individual primary care practices? Does the program have plans to ensure that minority clinicians and practices that serve minority and vulnerable communities are supported? Does the program utilize practice facilitators/extension agents? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Environment. Does the proposal demonstrate a functioning and productive multi-sector collaboration? Does the application provide evidence that the existing program is well supported and will continue throughout the project period? Is there a favorable state-policy environment? Are primary care professionals and consumers supportive of the program and involved in program planning and evaluation?

Additional Review Criteria

In addition to the above criteria, the following items will be addressed and considered in the determination of scientific merit and the rating.

Degree of Responsiveness: How well does the application address the purpose and objectives of this FOA? Will this program provide AHRQ and the federal government with experience and evidence that will contribute to the development of a larger national grant initiative to establish a primary care extension service? How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?

Budget and Period of Support: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research? Is an appropriate amount of the budget (greater than or equal to 25% of the total cost) dedicated to the dissemination component of the application?

Inclusion: Does the program and proposed plan include support for the full range of primary care practices and primary care professionals represented in the state? Does the program and proposed plan address the needs of both genders and racial and ethnic minorities (and subgroups)? Does the proposal adequately attend 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.

Selection Process

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:

• Scientific and technical merit of the proposed project as determined by peer review
• Availability of funds
• Responsiveness to goals and objectives of the FOA
• Relevance to program priorities
• Programmatic balance
• Programmatic needs of AHRQ and DHHS

Additional Review Considerations

AHRQ intends to award no more than one award per state in response to this FOA.

AHRQ reserves the right to fund proposals that represent a diversity of approaches from among applications rated as meritorious.

Resource Sharing Plan(s)

Data Confidentiality

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

Sharing Research Resources

Rights in Data

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

3. Anticipated Announcement and Award Dates

Generally, applicants should anticipate eight 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, any additional information necessary to address administrative issues, and certification of IRB approval of the project's proposed use of human subjects. For details, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

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

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the as noted on the AHRQ web site at http://www.ahrq.gov/fund/postawrd.htm#terms.

2. Administrative and National Policy Requirements

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

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

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to otherwise applicable OMB administrative guidelines: DHHS grant administration regulations at 45 CFR Parts 74 or 92 (Part 92 is applicable for State and local Governments), and other DHHS, PHS, and AHRQ grant administration policy statements. AHRQ will use these procedures in evaluating and administering the cooperative agreements under this FOA.

The administrative and funding instrument used for this program is the cooperative agreement U18, an "assistance" mechanism (rather than an "acquisition mechanism), in which substantial AHRQ programmatic involvement with the grantee is anticipated during the performance of the activities. Under the cooperative agreement, the AHRQ purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the PD/PI for the project as a whole, although specific tasks and activities may be shared between the grantee and AHRQ as described in this subsection of the FOA. Cooperative activities are intended to strengthen the individual grantee activities through the facilitation of data sharing, data access and communications.

All cooperative activities that include significant government involvement will require prior approval by the AHRQ Program Officer.

2. A.1. Awardee Rights and Responsibilities

Awardees will have primary and lead responsibility for the project as a whole, including directing proposed program enhancements, conducting program evaluation, assuring development of a program sustainability plan, and implementing the proposed dissemination plan

Awardees are expected to schedule and lead quarterly (or more frequent) conference calls with AHRQ program officials, submit quarterly progress reports, and if requested, host a site visit by AHRQ program officials. In addition, two senior awardee team members must attend an AHRQ annual meeting in Washington, DC.

Awardees should collaborate with AHRQ Project Scientists (see below) on the development and implementation of their dissemination plans. Awardees will be responsible for cooperating and collaborating with other AHRQ awardees working under this FOA with assistance from the AHRQ program officials.

Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current DHHS, Public Health Services (PHS), and AHRQ policies.

2.A.2. AHRQ Staff Responsibilities

The AHRQ Program Officials for this program include program officials (POs) for the funded cooperative agreements and staff working in AHRQ’s Prevention/Care Management Portfolio. They will have programmatic involvement in guiding grant activities to inform AHRQ’s on-going work in this field and to assure coordination of dissemination activities among awardees.

For these cooperative agreements, AHRQ program officials are responsible for participating in quarterly conference calls, reviewing quarterly progress reports and providing input as needed, conducting site visits if deemed necessary and preparing site visit reports, and participating in the development and implementation of dissemination activities. Program officials will also attend the AHRQ annual meeting and may organize a session relating to best practices and lessons learned.

Under the cooperative agreement, AHRQ’s purpose is to support and stimulate the recipient's activity by involvement in and otherwise working with the awardees in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Cooperative activities are intended to strengthen individual projects and at the same time generate collaboration across projects. AHRQ program officials may provide expertise/technical assistance to the awardees and assist them in coordinating the activities of different grantees (e.g. author or co-author articles that compare two or more models of practice support). AHRQ program officials, individually and in partnership with awardee staff, may publish analyses and syntheses of aggregated findings from the partnerships.

Additionally, AHRQ program officials will be responsible for the normal programmatic stewardship of the award and will be named in the award notice.

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

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

Additionally, grantees will be required to submit quarterly progress reports to communicate project progress to AHRQ. The progress report will follow a format to be prescribed by AHRQ, and will include not only completed activities but also plans for the remainder of that year and any changes foreseen in the future. AHRQ information on project progress on a quarterly basis,

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

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

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

Section VII. Agency Contacts

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

1. Scientific/Research Contact(s):

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

Leilani Liggins
Center for Primary Care, Prevention and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1500
E-mail address: [email protected]

2. Peer Review Contact(s):

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

Nghia Vo
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) 427-1191
E-mail address: [email protected]

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to:

Nicole Williams
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1015
Fax: (301) 427-1792
E-mail address: [email protected]

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 HIPAA Privacy Rule, 45 CFR Parts 160 and 164, governs the protection of individually identifiable health information. It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory. Decisions about applicability and implementation of the Privacy Rule reside with covered entities. Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.

Access to Research Data through the Freedom of Information Act:

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

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

Healthy People 2010:

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

Authority and Regulations:

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

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

References:

Meyers DS and Clancy CM. Primary Care: Too Important to Fail. Ann Internal Med. 2009 Feb 17; 150(4): 272-4.

Nutting PA, Crabtree BF, Miller WL, et al. Journey to the Patient-Centered Medical Home. Ann Fam Med. 2010; 8 Suppl. 1: S45-56.

Grumbach K, Mold JW. A Health Care Cooperative Extension Service: Transforming Primary Care and Community Health. JAMA. 2009 Jun 24; 301(24): 2589-91.