Part I Overview Information


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

Components of Participating Organizations
Center for Delivery, Organizations, and Markets (CDOM), (http://www.ahrq.gov)

Title:  ARRA OS:  Recovery Act 2009 Limited Competition: Enhanced State Data for Analysis and Tracking of Comparative Effectiveness Impact: Improved Clinical Content and Race-Ethnicity Data (R01)

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 RFA. 

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

Request for Applications (RFA) Number: RFA-HS-10-010  

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)
93.715

Key Dates
Release/Posted Date: February 19, 2010
Opening Date:  February 28, 2010 (Earliest date an application may be submitted to Grants.gov)
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): March 29, 2010
Peer Review Date(s): Generally three months after receipt date 
Earliest Anticipated Start Date(s): August 31, 2010
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: March 30, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose. This AHRQ Funding Opportunity Announcement (FOA), supported by funds provided to AHRQ under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5, invites infrastructure development research grant (R01) applications from organizations seeking to either 1) enhance the clinical content of statewide, all-payer, hospital-based encounter-level data to support comparative effectiveness research, or 2) improve the reliability and validity of information in hospital-based encounter-level data related to race and ethnicity. 

Enhancing clinical content.  This project will make resources available to organizations that collect statewide all-payer, hospital-based encounter-level data (inpatient, emergency department, and ambulatory surgery) and that have the capacity to significantly broaden and supplement their existing population-based data for the purpose of both producing the evidence base for comparative effectiveness and evaluating efforts to implement comparative effectiveness.  Data organizations will link their existing core data to a choice of additional data base enhancements, including but not limited to: hospital-based electronic pharmacy data, electronic clinical data, electronic pre-hospital emergency care data, clinical registries, and vital record birth and death certificates.  Because the cost of augmenting an existing, encounter-level, statewide, administrative hospital data base varies considerably depending on the specific clinical data elements to be added, the application should inventory and discuss the reasons for selecting the specific clinical data elements that are to be added to the statewide, encounter-level, hospital-based administrative data set. 

Applicants will be required to use the resultant, enhanced data set for comparative effectiveness analyses that will either produce the evidence in an area where evidence is lacking, or  evaluate efforts where existing comparative effectiveness evidence has been implemented in a population.  The analyses will demonstrate the feasibility and usefulness of the data enhancement.

Improving race and ethnicity data:  This project will also make resources available to state data organizations to improve the validity and reliability of data on a patient’s race and ethnicity.  Information generated by comparative effectiveness research may be used to improve healthcare outcomes and one important element of this improvement is the lessening of disparities in these outcomes for different racial and ethnic groups.  One helpful source of information to assess disparities in the outcomes experienced by racial and ethnic groups is hospital administrative data collected by statewide data organizations. 

Applicants under this section will be required to complete an evaluation of the improvement of the validity and reliability of the race/ethnicity data, including a detailed description of how the program improved the quality of race/ethnicity data as well as concrete measures that other organizations may use to implement a similar program.

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

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description

Section II. Award Information

Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1.  Research Objectives

Health and Human Services (HHS) Definition of Comparative Effectiveness Research (CER)

HHS will use the definition of CER used in the Federal Coordinating Council’s Report to Congress to guide the HHS operational plan with regard to OS ARRA funds. The definition is as follows:

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

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

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

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

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

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

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

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

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

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

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

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

5)  Potential for multiplicative effect.

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

1)  One of the 100 IOM topic recommendations;

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

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

The current list of conditions includes:

The overall objective of this FOA is to provide organizations that collect statewide all-payer, hospital-based encounter-level data (inpatient, emergency department, and ambulatory surgery) the capacity to significantly broaden and supplement their database for the purpose of both producing the evidence base for comparative effectiveness and evaluating efforts to implement comparative effectiveness where the evidence already exists.  They can do this by 1) enhancing the clinical content of encounter-level hospital data, or 2) implementing a program to improve the validity and reliability of race and ethnicity data. 

Background

This initiative endeavors to enhance the utility of hospital-based encounter level data for improving CER and outcomes.  First, it will support efforts to link encounter-level data from hospitals within states to other clinical data in order to build a data infrastructure that will enable the generation and synthesis of evidence that permits the comparison of the benefits and harms of alternative methods to treat a clinical condition.  In particular, it will provide organizations that collect statewide all-payer, hospital-based encounter-level data (inpatient, emergency department, and ambulatory surgery) the capacity to significantly broaden and supplement existing population-based data for the purpose of both producing the evidence base for comparative effectiveness and evaluating efforts to implement comparative effectiveness where the evidence already exists.

A recent IOM report (1) offers recommendations to support an infrastructure that could sustain a long-term, national effort in CER.  One of the recommendations addresses the need to link multiple databases and it states that, “The CER Program should help to develop large-scale, clinical and administrative data networks to facilitate better use of data and more efficient ways to collect new data to inform CER.” 

Moreover, a related IOM report (2) states that:

A large public-private CER enterprise will re­quire a supporting infrastructure to efficiently move the science forward. In addition to the capacity to support high-efficiency, pragmatic randomized trials, the program will require large-scale clinical and administrative data networks that enable observational studies of patient care while protecting patient privacy and data security. New meth­ods for linking patient-level data from multiple health care organizations will promote inclusion of populations frequently omitted from clinical trials.

This funding initiative places particular emphasis on care for priority populations such as the elderly, people with multiple chronic conditions, racial and ethnic minorities, and children. 

Over 40 states have statewide data organizations that collect all-payer encounter level data from hospitals in their state.  In some states, the organization is part of state government; in others it is the state hospital association or another private data organization.  AHRQ participates in a unique voluntary partnership with 40 such statewide data organizations across the U.S. to produce the Healthcare Cost and Utilization Project (HCUP).  Through this partnership, AHRQ is aware of the data capacities of these organizations, as well as the potential data enhancements and data collections that could substantially improve the Department’s ability to produce comparative effectiveness evidence as well as evaluate implementation of established comparative effectiveness results.  The statewide data organizations often have authority and access to additional data resources, both within hospitals and to data sources collected by entities outside of the hospital.  These organizations also hold secure the identities of patients to enable deterministic linking to additional data resources.  However, given the current economic environment, the funding for these additional data resources and infrastructure improvements is lacking.  

This FOA solicits proposals for efforts to build the state data infrastructure for CER and CER evaluation by utilizing available state data on hospitalized patients and more extensive clinical data from other sources.

This FOA also solicits proposals to implement a program to improve the validity and reliability of data on race and ethnicity.  It is important to be able to evaluate and improve care received by priority populations such racial and ethnic minorities.  Yet, in order to evaluate and improve the care received by racial and ethnic minorities it is essential that there be valid and reliable information about the assignment of patients to these categories.

Generally, hospital staff collect information about race and ethnicity during the registration process.  However, there is often no good protocol for hospital staff to rely on when collecting information about race and ethnicity, and in most situations it is unclear whether hospital staff have asked patients directly about their race and ethnicity or whether hospital staff have supplied this information from visual observation.  Important obstacles to obtaining good information about patient race and ethnicity are the lack of time allotted to this activity and uncomfortableness on the part of hospital staff and patients about asking about patient race and ethnicity

Hospitals may improve their collection of data on race and ethnicity by providing formal  training and educational resources about the most appropriate and sensitive methods to ask patients about their race and ethnicity as well as by providing tools that hospital staff may use when a patient has not self-identified his/her racial and ethnic status. These resources may include direct classroom instruction, interactive web-based training, instruction booklets, and teaching videotapes.

Almost all states have statewide hospital administrative data sets, and almost all also include racial and ethnic identifiers. While some states do much better than others, numerous studies have detected enduring undercounting and misclassification problems associated with the designation of ethnic and racial groups in hospital administrative data sets, and these studies have engendered apprehension about the consistency and quality of hospital data on patient race and ethnicity. Indeed, difficulties in obtaining accurate data about the race and ethnicity of hospital patients are manifestations of problems associated with the hospital admission process where information about a patient’s race and ethnicity may have simply been assumed by the admission official or may not have been requested properly. 

An additional issue for the utility of the data relates to the coding categories used.  Only about half the statewide data sets use the OMB 1997 standard for race and ethnicity categories (3) with most of the remainder using the 1977 OMB standard.(4)  A few state data sets use neither standard.  The use of national standards is important for states to compare themselves to other areas and to examine national trends.  In addition, coding of multiple racial and ethnic backgrounds is rarely included in the state data sets.  The IOM Subcommittee on Standardized Collection of Race/Ethnicity Data for Healthcare Quality Improvement recently recommended that in addition to using the OMB 1997 standard for racial and ethnicity categories local areas collect more detailed categories that are of relevance to their local areas (but also use a national code set to do this)(5).  There are only three statewide data systems that include more detailed categories.

Specific Objectives

The goal of this research program is to provide funds to statewide data organizations and associated research teams in order to build an enduring infrastructure that will advance knowledge about the comparative effectiveness of important methods, strategies, and treatment regimens to prevent and treat important clinical conditions.  Projects can seek to achieve this goal by either 1) enhancing the clinical content of statewide, all-payer, hospital-based encounter-level data to support comparative effectiveness research, or 2) improving the reliability and validity of information in hospital-based encounter-level data related to race and ethnicity. 

There are two main objectives for this research program:

1.  Expand the clinical robustness and utility of statewide all-payer, hospital-based encounter-level data sets as a resource for future research and policy analysis.  Some examples of appropriate ways to expand statewide all-payer, hospital-based encounter-level data systems are for relevant state data organizations to link core, encounter-level hospital data to hospital-based electronic pharmacy data, electronic clinical data, electronic pre-hospital emergency care data, clinical registries, and/or vital record birth and death certificates.  As part of this effort, applicants will use their improved dataset to create new scientific evidence that fills important knowledge gaps and generates critical insights into the comparative clinical effectiveness of health care interventions using clinically-enhanced state data.  Specifically, the applicant for awards to enhance the clinical content of the statewide data will be required to supplement encounter-level, statewide, administrative hospital data with specific clinical data elements and to employ the augmented data set to conduct comparative effectiveness analyses.  As a consequence of the comparative effectiveness analyses, this undertaking must either produce the evidence in an area where evidence is lacking, or evaluate efforts where existing comparative effectiveness evidence has been implemented in a population. 

2.  Improve the quality of data on patient race and ethnicity data, so that the datasets can be used to understand and reduce disparities in outcomes. Applicants will be required to explain in detail how the collection of information about patient race and ethnicity will be improved and they will also be required to provide evidence that the quality of race and ethnicity data has improved as a result of the implementation of the new program.

Specific Instructions

While the exact steps will vary depending on whether the data effort involves expansion of clinical robustness or enhancement of race and ethnicity data, all applications will need to show evidence of a similar set of steps.  Specifically, each applicant will be expected to accomplish (and specifically document their plan for accomplishing) the following:

1.   Assemble and Organize Study Team

AHRQ strongly encourages applicants to bring together expertise in medical care, health services research and data collection and management. 

Provisions to review possible conflicts of interest for research personnel should also be included as well as a timeline (Gantt chart) showing the major scheduled milestones (events, activities, and data gathering, and reporting) for the project.  Provide the number of hours (or percent of time) that key project personnel will devote to each task shown on the timeline; justify the proposed levels of effort.

2.  Create Data Set      

A.  Create an expanded or linked data set (For awards involving enhancing the clinical content)

The application should include a detailed plan for creating a new or expanded data set that is derived by augmenting statewide, encounter-level, hospital data. Moreover, the application should include the following:

A description of each individual data set that will be linked to form a new or expanded data set including all applicable details, for example: 

B.  Implement program to improve validity and reliability of race/ethnicity data (For awards involving improvement of race and ethnicity data)

This program will initiate the collection of standardized race and ethnicity data or improve the quality and standardized coding of existing race/ethnicity data by employing methods that have been found to be effective elsewhere.

These methods might include, for example:  Adaptation or development of written material for hospital staff that may be used to address common problems inherent in the collection of race and ethnicity data as well as information about the importance of collecting accurate race and ethnicity data; development and implementation of guidelines for standardized collection and coding procedures as well as the presentation of methods of asking questions about race and ethnicity in a culturally appropriate and sensitive manner; development of training manuals and conduct of educational seminars and for the translation of these tools and resources into other languages. Several resources might be useful in this effort.  Examples include:

Improving race and ethnicity data in these ways is consistent with the goals of other efforts including Your Voice/Communities-of-Practice/Data for Equity, on improving race, ethnicity and language data collection (http://www.diversityrxconference.org/Your-Voice/Communities-of-Practice/Data-for-Equity/150/); and the NQF cultural competence framework http://www.qualityforum.org/projects/cultural_competency.aspx

.3.  Create Documentation for the Improved Dataset

Applicants must create documentation for the improved dataset.  Documentation should include: a data dictionary, codebooks describing the tables, variables and the primary and foreign keys, if any, in each table.

4.  Display Utility of the Dataset 

A.  Complete a comparative effectiveness analysis (For awards involving enhancing the clinical content)

Applicants must propose in brief the background, methods and analysis plan for a comparative effectiveness research (CER) study.  (See the CER definition being used by HHS, described in Section I.)

B.  Complete an evaluation of the improvement of the validity and reliability of race/ethnicity data (For awards involving improvement of race and ethnicity data). 

This evaluation must include a detailed description of how the program improved the quality of race/ethnicity data as well as concrete measures that other organizations may use to implement a similar program.

5.  Provide a Dissemination Plan

Include activities such as how the enhanced data will be made available to researchers, policy-makers and other users of the data; publishing in peer-reviewed and trade journals on the study findings; preparation of briefings, visual materials, guides, and tools for data users and policy makers; disseminating findings and tools through professional and other associations; and preparation of web-based materials.  The plan should describe the types of tools, activities, and products envisioned.  Where applicable, it should also identify stakeholders or policy-makers in the state who are interested users of the enhanced data for improving outcomes and/or reducing disparities.

6.   Report Periodically on Progress and Results

Research progress and interim research findings will be reported to AHRQ.  Monthly conference calls with the AHRQ program official and other individuals deemed necessary by the program official, are required.  These calls will report on project progress, as well as any project-specific issues that need to be resolved or brought to the program official’s attention.  Other calls, as needed, will be held at the discretion of the AHRQ and the program official. 

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 Project (R01) grant mechanism.  The individual researcher sponsored by each organizational grantee will be solely responsible for planning, directing, and executing his or her proposed projects.

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

2. Funds Available

This initiative is supported by funds provided to AHRQ under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5. A total of $10,000,000 is available to fund applications under this announcement. AHRQ anticipates making between 7 and 15 awards.

Of this amount, it is expected that approximately $7,000,000 total costs will be used to fund clinical enhancements of statewide all-payer, hospital-based encounter-level data sets that are used to conduct a comparative effectiveness study, and that approximately $3,000,000 total costs will be used to fund initiatives to improve the accuracy, standardization and local relevance of data on the race and ethnicity of inpatient and outpatient hospital patients. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Because the nature and scope of the proposed research projects will vary from application to application, it is anticipated that the size and duration of each award will also vary. The amount awarded to any given application, and the total number of awards issued will depend upon the quality, duration, and costs of the applications received.  Similarly, the precise distribution between the two types of award will depend on the quality of all applications received.  AHRQ also will seek to achieve programmatic and geographic balance in the awards.

Budget and Project Period:  The total costs for any grant awarded under this FOA must not exceed $1.5 million for the entire project period. The project period may not exceed 3 years.  Typical costs in a single year are expected to range from $200,000 total costs to $400,000 total costs.  Applicants may request varying levels of annual funding but must justify their request.  Funding beyond the first 12 months will be contingent upon a review and acceptance by Agency staff of the annual progress report. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation.  Applications with project periods that exceed 3 years duration or budgets that exceed $1.5 million over the 3-year period, will not be reviewed. 

Larger total cost awards will be reserved for projects requiring complex and expensive research methodologies, for example those involving development and analysis of clinically-enhanced state data or enhanced race and ethnicity data from several states.  These larger projects should also be likely to generate findings that are of great importance to improving medical practice, health care delivery and policy.

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

You may submit an application(s) if you are a state data organization (units of state government, state hospital association, or private not-for-profit entity which collects statewide hospital encounter data (inpatient, emergency department, and/or ambulatory surgery), or if you are an organization working collaboratively with a state data organization, provided 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.  Foreign institutions may participate in projects as members of consortia or as subcontractors only.  Applications submitted by for-profit organizations or foreign institutions will not be reviewed.  Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed data enhancement and research as the PD/PI is invited to work with his/her applicant organization/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.

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 that plan to provide support should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project.  This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be included in the detailed budget.

3. Other-Special Eligibility Criteria

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

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

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

Section IV. Application and Submission Information


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

Registration:

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

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

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

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

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

2) Organizational/Institutional Registration in the eRA Commons

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

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

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 301-435-0714; 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 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. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

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

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

SPECIAL INSTRUCTIONS  

Applications Involving a Single Institution

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

Applications Involving Multiple Institutions 

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

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:  February 28, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s):
Application Due Date(s):
March 29, 2010
Peer Review Date(s): Generally three months after receipt date
Earliest Anticipated Start Date(s): August 31, 2010    

3.A.1. Technical Assistance

Applicants may submit questions to AHRQ via email at Dawn.French@ahrq.hhs.gov.  AHRQ will respond to questions via email only.  In addition, based on inquiries received, AHRQ will post a list of Frequently Asked Questions (FAQs) and responses to these questions approximately 4 weeks after the release of this FOA at http://www.AHRQ.gov/fund/grantix.htm. 

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.  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.

In order to expedite the review, applicants are requested to notify the AHRQ Referral Office by email Gerald.Calderone@ahrq.hhs.gov when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

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”:

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 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons.  The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays.  All errors must be corrected to successfully complete the submission process.  Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3 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 for further processing.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and AHRQ. Incomplete 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 their application status in the Commons.

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

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

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

Use of CMS Data

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

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

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

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

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements and Information

Applications should provide a URL for access to any critical publications or supporting information (e.g., narrative or chronology of delivery system’s prior quality improvement activities) that is not included in an appendix.

The sites studied under this announcement should be located within the United States.  Applicants should make explicit the relevance to the aims and research design of the study of any sites or participating organizations from outside of the United States. Eligible domestic (United States) institutions/organizations who are planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested total costs or $25,000 total costs (aggregate total for a subcontract or multiple subcontracts), whichever is less.

Applications must justify any supplies and equipment requested in the project budget.  All items must be allowable, reasonable, necessary, and allocable to the project. 

For each year of funding, the budget must include funding to allow the Principal Investigator and up to two other key members of the project to attend at least three days of the AHRQ annual meeting or another appropriate AHRQ meeting – as determined by the program official. The meetings will take place in the Washington DC area.

The budget should include funds for an appropriate member of the team to work remotely (i.e., via telephone, e-mail, or Internet), for a total of at least 2 days with AHRQ’s knowledge transfer staff and/or with AHRQ contractors – including the Health Care Innovations Exchange.

Sufficient funds should be budgeted to ensure compliance with requirements for section 508 compatibility http://www.section508.gov for documents to be posted on federal government web sites.

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

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

Organizational DUNS

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

PHS398 Research Plan Component Sections

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:

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. 

Special Instructions for Modular Grant applications

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

Appendix Materials

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

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

No supplemental/update information will be accepted.

Priority Populations

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

Publication Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ-supported activities are accepted for publication in the professional literature.  Grantees should also discuss any ideas about other dissemination and marketing efforts with OCKT staff.  The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers.  This is critical when outreach to the general and trade press is involved.  Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions.  In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a brief plan describing how the product will be publicized.  An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media. The grantee shall be responsible for ensuring that content from any documents, slides or other deliverables to be posted on the AHRQ (or other Federal) website is compliant with Section 508 of the amended Rehabilitation Act (http://www.section508.gov/)

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), the Nationwide Emergency Department Sample (NEDS), and three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD).  More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.

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

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

Health Literacy

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

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

Consumer Products

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

Plan for Sharing Research Data

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

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

Section V. Application Review Information


1. Criteria 

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

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

2. Review and Selection Process

Review Process

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

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

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 in response to this FOA will be 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 research 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:  Given the goals of this project, does the main theme of the application address an area of comparative effectiveness data and research of priority to AHRQ? Given the current capacity of the institution, if the aims of the overall plan are achieved, will there be a significant impact on the institution’s capacity for engaging in and sustaining data enhancements to support comparative effectiveness research activities that are relevant at the local, state or national level? Will there be a significant impact on the quality and availability of data available to the field for conducting comparative effectiveness research, improving outcomes, and/or reducing disparities in outcomes?    

Investigators:  Are the PD/PI and other key personnel appropriately trained and well suited to carry out this work? Is the lead for the pilot or primary research project well suited to carry out the work?  Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Do the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)? Given that the PD/PI is critical to the sustainability of research efforts at the institution, how well does the PD/PI demonstrate commitment to continued enhancements of statewide administrative data and/or comparative effectiveness research?  Are there clear indicators of institutional support and evident availability to lead the effort? How adequate is the letter of institutional commitment, and does it address protected time for the proposed staff to engage in data enhancements and the research proposed? How well can the PD/PI provide direction and leadership in the data enhancements and research proposed? 

Innovation:  What is the special value of the clinically-enhanced statewide, encounter-level, hospital-based data set in creating new opportunities for research, outcomes improvement, and/or disparities reduction that have not been possible before?  Regarding the individual research project or analysis, does the project address important problems in a creative way? 

Approach:  In the context of the development of an enhanced statewide, encounter-level, hospital-based data set, how will the overall program be tested by the performance of the included research project, both from a formative and a summative perspective?  Does the applicant acknowledge potential problem areas and consider alternative tactics for the data infrastructure development?  Have potential barriers to building the improved data structures or models been identified and addressed? Have potential barriers or threats to sustainability of the developed infrastructure been identified and addressed?

In the context of the implementation of processes designed to improve the validity and reliability of racial and ethnic information, how does the project propose to improve the collection of this information? What resources will be provided to those who are responsible for affixing these designations? And, does the project specify reasonable criteria for ascertaining whether or not information on race and ethnicity has been improved as a result of the implementation of the project? Indeed, in a nontrivial number of cases individuals may identify with several categories and interviewers will be required to assign the individual to only one category.  Projects designed to improve the validity and reliability of racial and ethnic information must specify precisely how this information will be collected and how such problems will be resolved, and what they will do to provide lessons from their approach for use by others.

What is the quality of the design in the individual research project or analysis?  Does the applicant address both the benefits and the limitations of the research project?  Is the project firmly grounded in the current literature?  How will the research project or analysis contribute to the field?  If pilot in nature, does the project seek to establish feasibility, or the merit of a particular area of inquiry?  What is the appropriateness of the approach in the research project?  Are there stakeholders with an interest in the findings?  Does the dissemination plan reflect careful thought and consideration of appropriate venues?

Environment:  To what extent will the proposed data initiative and research change/alter the environment, facilitate the field’s ability to conduct, expand, and improve health services research and health outcomes, and/or reduce disparities?  Are research administration, collaborative arrangements, and data management and analysis support adequate? Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success?  Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements?  Is there evidence of institutional support?  What is the quality of the available resources at the institution, including data capacity, equipment and research space?   What is the probable long-term impact of the program?

2.A. Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

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).

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

Budget: Is the proposed budget reasonable and is the requested period of support appropriate to the proposed research? Does the budget account for all resources and expenditures needed to carry out the data enhancements and research, including travel to AHRQ meetings and cooperation with AHRQ staff and contractors? Will participating institutions make in-kind contributions?

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.

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?

In addition, the review criteria listed in the “Priority-Setting Process and Inputs for Use of ARRA OS Funds” section will also be used.

2.B. Additional Review Considerations

Not applicable

2.C. Resource Sharing Plan(s)

Data Confidentiality

Pursuant to 42 USC 299c-3(c), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data.  There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute, 42 USC 299c-3(d).  In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected.  The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded.  Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164. These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers.  Thus, health care plans ordinarily will require either patient authorization for disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators.  The 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, unless otherwise provided in grant awards, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ funds, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses.  Such copyrights and patents are subject to a worldwide irrevocable AHRQ license to use and permit others to use these products and materials for government purposes.  In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers.  In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits.  Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products.  AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities.  Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html).

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:

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

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons

If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant.  Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative issues, and certification of IRB approval of the project's proposed use of human subjects.  For details, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). 

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

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

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

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

2. Administrative and National Policy Requirements

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

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

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 annual progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm.  If instructions on the AHRQ website are different from the PHS form 2590 instructions, follow the instructions on the AHRQ website.

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

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

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

Section 1512 of the Recovery Act requires prime recipients of the ARRA funds to submit quarterly reports.  Future updates to recipient reporting guidance from OMB are likely and recipients will be expected to follow the most current OMB guidance for such reporting.  Accordingly, in addition to the standard AHRQ terms of award, all funding provided under the Recovery Act must comply with the statutory reporting requirements and will be subject to the HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (ARRA) as described above and found on the AHRQ Website at http://www.ahrq.gov/fund/arraterms.htm.

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

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

Section VII. Agency Contacts


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

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

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

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:

Fred J. Hellinger, Ph.D.
Center for Delivery, Organization, and Markets
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1407
Fax: (301) 427-1430
E-mail address: Fred.Hellinger@ahrq.hhs.gov

2. Peer Review Contact(s):

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

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

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to: 

Al Deal
Office of Performance Accountability, Resources and Technology
Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1806
Fax: (301) 427-1462
E-mail address:  Al.Deal@ahrq.hhs.gov

Section VIII. Other Information


Required Federal Citations

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

Standard Terms and Conditions for Recovery Act Awards:

The full text of these terms approved for AHRQ awards can be found in the following document: http://www.ahrq.gov/fund/arraterms.htm  

Inclusion of Women and Minorities in Research Study Populations:

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

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

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

Human Subjects Protection:

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

Standards for Privacy of Individually Identifiable Health Information:

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

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

Healthy People 2010:

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

Authority and Regulations:

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

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

References

1  Initial National Priorities for Comparative Effectiveness Research. Committee on Comparative Effectiveness Research Prioritization. Institute of Medicine. The National Academies Press. , Washington, DC: The National Academy Press, 2009, p. S-14. (Available at: http://nap.edu/catalog/12648.html)

2. Initial National Priorities for Comparative Effectiveness Research, Report Brief, June 2009. Institute of Medicine of the National Academies.  Washington DC, p. 3. Available at

http://www.iom.edu/~/media/Files/Report%20Files/2009/ComparativeEffectivenessResearchPriorities/CER%20report%20brief%2008-13-09.ashx

3.  Office of Management and Budget. Revisions to the Standards for the Classification of Federal Data on Race and Ethnicity. Federal Register.

1997;62:58781–58790. http://www.whitehouse.gov/omb/fedreg/1997standards.html.

4.  Office of Management and Budget.  Statistical Policy Directive No. 15, Race and Ethnic Standards for Federal Statistics and Administrative Reporting, 1977.

5. Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement.  August 31, 2009.  Board on Health Care Services. IOM Subcommittee on Standardized Collection of Race/Ethnicity Data for Healthcare Quality Improvement (http://www.iom.edu/Reports/2009/RaceEthnicityData.aspx)

6.  “Massachusetts Hospital Discharge Data:Hospital Race and Ethnicity Data Collection”; presentation at NAHDO Annual Meeting,October 15, 2009, Judy Parlato, Clinical Advisor, Massachusetts Division of Health Care Finance and Policy. http://www.nahdo.org/LinkClick.aspx?fileticket=nI22Ds3qnH0%3d&tabid=151

7. Weinick, Robin M., Jacquelyn M. Caglia, Elisa Friedman, and Katherine Flaherty, "Measuring Racial and Ethnic Disparities in Health Care in Massachusetts: Lessons from Implementing a Publicly-Mandated Data Collection Program", Health Affairs, 26(5) 1293-1302, 2007.


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