Part I Overview Information

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 Outcomes and Evidence (COE) and its Effective Health Care Program, (http://effectivehealthcare.ahrq.gov/index.cfm)

Title: Recovery Act 2009 Limited Competition: Innovative Adaptation and Dissemination of AHRQ Comparative Effectiveness Research Products (iADAPT) (R18)

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

Note: This is a one-time only solicitation. Resubmissions are not permitted.

Announcement Type
New

Request for Applications (RFA) Number: RFA-HS-10-004

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

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

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

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

Catalog of Federal Domestic Assistance Number(s)
93.715

Key Dates
Release/Posted Date: September 25, 2009
Opening Date: November 16, 2009
Letters of Intent Receipt Date(s): November 18, 2009
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): December 16, 2009
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: December 17, 2009

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 Research Demonstration and Dissemination grant (R18) applications from organizations to extend the reach and impact of Comparative Effectiveness Research (CER) Reviews and associated products, particularly Comparative Effectiveness Research Summary Guides (CERSGs) prepared by the John M. Eisenberg Center for Clinical Decisions and Communications Science part of the AHRQ Effective Health Care Program. (See http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=sg and http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=rr for information about CERSGs and CER Reviews respectively.) Summary guides are intended to help bridge the gap between research and practice by translating and disseminating findings on the comparative effectiveness of clinical interventions for three broad audiences patients/consumers, clinicians, and policymakers. Applicants are invited to propose innovative customizations or adaptations (as defined in this FOA under Part II Section I.1 Research Objectives subsection) to the content presentation and/or delivery mechanism(s) of one or more Comparative Effectiveness Research Review Products, such as Comparative Effectiveness Reviews, Comparative Effectiveness Review Executive Summaries, or Comparative Effectiveness Research Summary Guides (CERSGs) where additional adaptations or customizations are aimed at increasing their use, implementation, and impact among difficult-to-reach populations, including the elderly, those with limited English proficiency, limited education or insurance coverage, minority or immigrant status, health literacy problems, or other underserved populations who may have limited contact with the health care system or health information. Adaptations should aim to increase the impact and effective use of one or more CER Review Products by developing, implementing, and evaluating customizations that target important audiences, stakeholders, systems, or settings; these customizations may be in the adaptation of the original CER Review or Executive Summary contents to a specialized clinical audience of potential users (such as Formulary or Pharmaceutical and Therapeutics Committees, health care systems with electronic platforms such as electronic medical records (EMRs) that could support clinical decision support) or adaptation of CERSGs (supplemented as deemed necessary with pertinent information found solely in the CER Reviews) to underserved populations of patients/consumers whose interface with medical or Internet sources of information is limited and who may instead use health care information and advice provided through traditional means, such as neighborhood-, community-, or faith-based groups. For CER Review Products or CERSGs, adaptations may address the presentation of the content and/or the mechanisms by which the contents are delivered or used.

• Mechanism of Support. This FOA will use the AHRQ Research Demonstration and Dissemination Projects (R18) grant mechanism.
• Funds Available and Anticipated Number of Awards. A total of $29.5 million will be awarded with an anticipated 20 25 awards. 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 will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received.
• Budget and Project Period: The total costs for any grant awarded under this FOA will not exceed $1.5 million for the entire project period, which may not exceed 3 years. An application with a budget that exceeds $1.0 million in total costs in any one year, $1.5 million over 3 years, or that exceeds 3 years in duration 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.
• Research Plan Component Length: The Research Plan component may not exceed 15 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, or in collaboration or partnership with other institutions/organizations, 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. Given the focus of this FOA, participation of such groups is encouraged by AHRQ.
• 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: Because this is a one-time-only solicitation, resubmissions are not permitted.
• 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

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

AHRQ seeks Research Demonstration and Dissemination grant (R18) applications from organizations to extend the reach and impact of Comparative Effectiveness Research (CER) Reviews and associated products, particularly Comparative Effectiveness Research Summary Guides (CERSGs) prepared by the John M. Eisenberg Center for Clinical Decisions and Communications Science as part of the AHRQ Effective Health Care Program. (See http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=sg http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=rr for information on CERSGs and CER Reviews, respectively.) Summary guides are intended to bridge the gap between research and practice by translating and disseminating findings on the comparative effectiveness of clinical interventions for three broad audiences patients/consumers, clinicians, and policymakers. Applicants are invited to propose innovative customizations or adaptations (as defined within this section of the FOA) to the content presentation and/or delivery mechanism(s) of one or more Comparative Effectiveness Research Review Products, such as Comparative Effectiveness Reviews, Comparative Effectiveness Review Executive Summaries, or Comparative Effectiveness Research Summary Guides (CERSGs) where additional customizations are aimed at increasing their use, implementation, and impact among difficult-to-reach populations, including the elderly, those with limited English proficiency, limited education or insurance coverage, minority or immigrant status, health literacy problems, or other underserved populations who may have limited contact with the health care system or health information.

Adaptations should aim to increase the impact and effective use of one or more CER Review Products by developing, implementing, and evaluating customizations that target important audiences, stakeholders, systems, or settings that are not already specifically targeted or reached by the original CER review products; these customizations may be in the adaptation of the original CER Review or Executive Summary contents to a specialized clinical audience of potential users (such as Formulary or Pharmaceutical and Therapeutics Committees, health care systems with electronic platforms such as EMRs that could support clinical decision support) or adaptation of CERSGs (supplemented as deemed necessary with pertinent information found solely in the CER Reviews) to underserved populations of patients/consumers whose interface with medical or Internet sources of information is limited and who may instead use health care information and advice provided through traditional means, such as neighborhood-, community- or faith-based groups.

For CER Review Products or CERSGs, adaptations may address the presentation of the content and/or the mechanisms by which the contents are delivered or used. Applications that propose simple propagation of unchanged summary guides through printing and distribution, email, or listservs will not be considered innovative or responsive to this FOA. These applications will not undergo peer review.

Background on Comparative Effectiveness

AHRQ supports research grants and contracts focusing on comparative effectiveness of different clinical treatments and services, as authorized by Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), Pub. L. 108-173. See 42 U.S.C. 299b-7. (See http://effectivehealthcare.ahrq.gov/index.cfm) These grants and contracts support research on the synthesis, generation, and translation of new scientific evidence and analytic tools in an accelerated format and the integration of evidence into practice and decision-making in the health care system. Research projects are informed by the information needs and inputs from various stakeholders (e.g., policy-makers, clinicians, and patients/consumers) to ensure the most appropriate outcome measures for assessing the effectiveness of the interventions and outcomes of importance to stakeholders are included in the study. As mandated by Section 1013 of the MMA, research projects are organized around a set of priority conditions of importance to the Medicare, Medicaid, and CHIP programs. The current list of 14 priority conditions includes:

• Arthritis and non-traumatic joint disorders
• Cancer
• Cardiovascular disease, including stroke and hypertension
• Dementia, including Alzheimer's Disease
• Depression and other mental health disorders
• Developmental delays, attention-deficit hyperactivity disorder and autism
• Diabetes Mellitus
• Functional limitations and disability
• Infectious diseases including HIV/AIDS
• Obesity
• Peptic ulcer disease and dyspepsia
• Pregnancy including pre-term birth
• Pulmonary disease/Asthma
• Substance abuse

To address these priority conditions, AHRQ engages the research community through a variety of means, including research networks such as the Evidence-Based Practice Centers (EPCs), the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) network, and the Centers for Education and Research on Therapeutics (CERTs). Researchers within these organizations help AHRQ to identify, develop, and critically appraise the most important and relevant medical research on treatments, medications, and medical technologies for different kinds of health problems.

A key and inter-related component of AHRQ’s Effective Health Care Program is the John M. Eisenberg Center for Clinical Decisions and Communications Science, which translates the complex scientific research produced in the Effective Health Care Program into short, clear, and actionable materials and products that can be used by three broad primary audiences: (1) Patients/consumers, including family members, caregivers, and others who are not medical professionals; (2) Clinicians, including medical doctors and other health professionals who provide care to patients; and (3) Policy Makers, typically people who make regulations, guidelines, formulary, or purchasing decisions that influence how health care is provided. A key work product of the Eisenberg Center are Comparative Effectiveness Research Summary Guides (CERSGs), which are based upon extensive efforts to translate the primary scientific findings in plain, actionable language while preserving the fidelity of the more complex primary source. The Eisenberg Center creates a variety of other products for the three main audiences, including decision aids and other materials, and distributes them so that they can be available to audiences as they make their health care decisions.

In light of the substantial development and testing of content of the CERSGs to assure the clarity and fidelity of their translation, this FOA is particularly interested in applications that adapt these already-translated products to reach subpopulations underserved by the current health care system and by traditional or existing print and electronic health care information resources.

Research Objectives

AHRQ research objectives underlying this FOA include the following:

• To investigate a wide range of audiences, stakeholders, systems, and settings where targeted research and dissemination demonstration projects may show effectiveness and generalizable lessons in communication, education, translation, and/or behavioral interventions that can be applied to Comparative Effectiveness Research (CER) products for different audiences and settings
• To stimulate the development, application, and evaluation of multiple user-stakeholder-, and/or community-driven approaches that would increase the use and application of CER products by specific subpopulations of patients/consumers, clinicians, and policy-makers whose needs are not fully addressed with current CER products (particularly CERSGs), such as difficult-to-reach populations, including the elderly, those with limited English proficiency, limited education or insurance coverage, minority or immigrant status, health literacy problems, or other underserved populations who may have limited contact with the health care system or health information.
• To explore the development and evaluation of multiple mechanisms to disseminate and/or implement the use of CER findings in decision-making by diverse groups of patients/consumers, clinicians, and policymakers
• To gain and apply potentially generalizable knowledge gained from feedback and evaluation of both original and adapted CER Review Products and CERSGs in order to inform improvements in future CER products applicability to a wide range of audiences

For purposes of this FOA, adaptation is defined as one or more customizations to the content or delivery mechanism of CER Review Products, including CERSGs, to enhance their use and value in decision-making by patients/consumers, clinicians, and/or policymakers. Adapted contents should preserve the fidelity of the original’s technical contents and evidentiary criteria and assessments, so as to avoid distortions or misrepresentations. Applicants must therefore describe their means or process(es) for assuring the fidelity of their adapted product(s) to the original’s technical contents and evidentiary assessments. Examples of content adaptations include, but are not limited to: translation to a language other than English or Spanish; edited wording, length, or sequencing of information; use of alternative layouts, graphs, pictures, or formatting. Examples of delivery mechanism adaptations include, but are not limited to: use of social networking and media, videos, radio or television spots; development and in-person implementation of decision aids or clinical decision support; development of instruction, continuing medical education (CME) or continuing education (CE), and the conduct and evaluation of community, town-hall, organization, or other meetings. AHRQ is particularly interested in applying and extending useful lessons learned from other public health and social marketing initiatives.

Sample Interest Areas

For this FOA, AHRQ is seeking innovative efforts to adapt the content and/or delivery mechanism of one or more of its current or forthcoming CER Review Products, particularly CERSGs. Of particular interest are stakeholder groups or communities where the results of academic research traditionally have poor or delayed penetration into practice. Examples of interest areas include, but are not limited to, the following:

• Adaptation of the content and/or delivery mechanism of CER Review Products or CERSGs to improve their penetration and use at the policy, health systems, clinical practice, caregiver, and patient levels.
• Development/refinement demonstration, and evaluation of processes or products to incorporate CER evidence (as captured in CER Review Products, including CER Reviews, CER Executive Summaries, and CERSGs) into decision-making settings or processes for patients/consumers, clinicians, and policymakers.
• Strategies to test, via demonstration(s), the role and impact on behavior of informatics in the dissemination and application of CER evidence from CER Review Products, including CERSGs, to patients/consumers, clinicians, and policymakers.
• General public awareness campaign(s) to identify the value and contributions of CERSGs and related comparative effectiveness research products to high quality health care and shared decision-making between patients and their clinicians.
• Innovative behavioral and social sciences or information technology research to determine the best methods in patient/provider communication and decisional support, including the use and consequences of alternative information technologies for displaying or disseminating CER information such as that available in CERSGs.
• Locally-sensitive adaptation and dissemination of CERSGs (with supplemental information from CER Review Executive Summaries as deemed necessary and pertinent) that take into consideration one or more defined audiences or stakeholder groups (such as the elderly, disabled, rural, poor, rachial and ethnic minority, educationally or literacy disadvantaged, and others), whose specialized needs, communication channels, social infrastructure, or other resources can facilitate reaching them with relevant and valuable comparative effectiveness information.
• Identification and characterization of stakeholder groups where CER Review Products, especially CERSGs, have limited or no penetration with the purpose to obtain critical feedback on how to improve CERSG translation and dissemination for their use.

Targeted Stakeholder/Community Groups/Settings

Applicants should define the audience(s), stakeholder(s), system(s), and/or setting(s) that they intend to target for research and demonstration. If more than one group or setting is proposed, the feasibility of accomplishing the scope of the proposed work should be specifically addressed in the application.

In this FOA, AHRQ seeks applications that target diverse groups, address unmet needs, offer generalizable lessons, and afford the greatest possible public health impact in terms of disease burden and the quality, safety, effectiveness, and efficiency of health care. Applicants should describe the significance of their proposed target(s) in these terms for their application.

Groups and/or settings for adaptation or dissemination of CER Review Products or CERSGs may be conceptualized by geography, urban/rural/MSA residence, demographics, organizational unit(s), social or other networks, or other schema. Examples include faith-based communities, regional health information organizations, hospital chains, policymakers including governments and health departments at the state, regional, county, or Federal level, and clinicians and other providers who serve underserved populations or those with special needs. Other candidates include, but are not limited to, advocacy organizations, senior citizen centers, community health centers, or Federally- funded health centers. AHRQ welcomes and encourages applications that address the needs of priority populations, particularly groups that are underserved and difficult to reach through traditional methods.

Applicants should document their ability and experience in working with the proposed target audience(s), stakeholder group(s), system(s), and/or settings. This may be provided through robust partnerships with a variety of organizations and stakeholder groups as described in the preceding paragraph, and which also may include academic institutions serving predominantly minority populations or academic departments in social science or human behavior. For the proposed target audience(s), stakeholder(s), system(s), or setting(s), the proposed work must be based upon a needs assessment that identifies the gaps, barriers, or limitations in the use or application of currently available CER products by the proposed target(s). This needs assessment may be based upon existing research or documented experience, or developed as part of the proposed demonstration. In addition to a needs assessment, applications must provide at least preliminary evidence to support the feasibility and receptivity of the proposed target(s) for adapted CER Review Products or CERSGs; such evidence or needs assessment should show that the target(s) themselves or their leaders already seek information or recognize a need for the information available in CER Review Products or CERSGs to inform decisions by targeted individuals about their health care choices. Needs assessments may be based upon the recognition of locally high disease burden, morbidity, mortality, financial or emotional burdens, uncertainty in decisions being made in typical health care encounters, community or other types of surveys, key informant interviews, or other factors.

Methods of Adaptation or Dissemination

Applicants are invited to apply or develop new or innovative mechanisms for adaptation of CER Review Products, including CERSGs, through research, demonstration, and evaluation methods, particularly those that have been previously demonstrated to be well-suited to their defined audience(s), stakeholder(s), system(s), or setting(s). A wide range of mechanisms, media, and communication channels may be considered, including but not limited to:

• paper-based products, such as brochures, narratives, or case studies that are adapted in design, format, or language to colloquial usage or cultural sensitivities
• electronic or technology-based dissemination channels or tools, such as internet, TV, radio, cell phone, social networking sites, listservs, health avatars, and others
• adaptation to electronic health records, personal health records, electronic medical records, or clinical decision support aids attached to these systems
• Personal interactions occurring through one-on-one interactions (such as academic detailing, kitchen table meetings) or group discussions (such as focus groups, social or health care professional meetings, town hall meetings), or routine settings such as work, school, or health care clinics.

These and other mechanisms may be combined as long as their combined feasibility is addressed and supported in the application. Simple propagation of unchanged summary guides through printing and distribution, email, or listservs will not be considered innovative or responsive to this FOA. These applications will not undergo peer review.

Applicants should describe and support all proposed methods or mechanisms for adapted presentation and/or delivery of CER Review Products and CERSGs available through the Effective Health Care Program. Applications should include a clear rationale and approach for the proposed adaptation(s) of materials, such as media requirements, cultural sensitivities, literacy and numeracy, English language proficiency, visual/educational/cognitive competencies of the targeted audience or stakeholder group members, information processing and burden, conflicting health beliefs or information sources, issues with authority or trust of information provided by the government, or other considerations. Applicants are encouraged, but not required, to assess the utility of the original CER review products or CERSGs to the proposed target(s) for adaptation, so as to identify key, generalizable gaps in content presentation or formatting, acceptance, understanding, or willingness to apply the materials in actual use situations. Such assessment would provide evidence to guide subsequent adaptation or modification of the primary CER summary guides to a specific audience, system, setting, communication channel, or expanded purpose.

Evaluation Plan Requirements

All applications that will develop and implement adapted content and/or delivery of CER Review Products or CERSGs must include an evaluation of their impact on one or more pre-specified outcome measures. To this end, candidate outcome measures (or endpoints) should be specified in the application and their validity described, along with whatever data collection methods or data sources are planned for use in evaluation. Health- or patient-centered outcome measures are preferred for evaluation, but may well be difficult or infeasible to obtain. While changes in patient health outcomes (such as reduced admissions for poorly controlled chronic illnesses) or close surrogates of health outcomes (such as serum cholesterol or hemoglobin A1c) are desirable outcome measures, they are likely to be impractical or unobtainable within the scope and timeframe of efforts proposed under this FOA. Accordingly, peer reviewers and AHRQ will consider the relative strength of the applicant’s proposed outcome measures. These may include, but are not limited to: (a)changes in established or otherwise validated patient-centered measures (such as satisfaction with medical care or its processes);(b) changes in process measures (such as the number of individuals who made use of CER information in medical care: (c) changes in patient activation or improvement in locus of control in disease management; (d) changes in the target(s) knowledge, skills, or attitudes regarding CER products; or (e) changes in use parameters (such as number of visits, downloads, mentions in blogs, and others). Close surrogates of health outcomes should be sought wherever possible, but if these are infeasible, applicants are urged to seek the best possible measures of change(s) in the targeted groups (such as changes in knowledge, awareness, activation, behaviors, satisfaction with care decisions, etc.) Any process measures that are proposed as evaluation measures (such as the volume used in practice or that is distributed, requested, downloaded, or propagated through secondary channels) should describe the nature and strength of their relationship to desired health behaviors, outcomes, or surrogates.

The evaluation design (i.e. pre/post, interrupted time series, etc.) and analytic plan should be described and justified in sufficient detail to permit independent assessment of their strength and suitability for the intended evaluation. Mixed methods that include qualitative assessments of lessons learned are encouraged. Additional specific information on evaluation plan submission requirements can be found in Section IV.6. Other Submission Requirements and Information.

Reporting and Dissemination of Research Findings

Applicants must describe their plans for sharing the interim and final results of their research, findings, and product(s) with AHRQ and the public. Work products may be in the form of a peer-reviewed publication, product, tool, customer needs assessment and/or evaluation report, or other concrete deliverable that must be publicly shareable by AHRQ through its Effective Health Care Program or other sponsored Web sites; these work products are distinct from the required final progress report for the project. Applicants should anticipate and be responsive to requests from AHRQ to share preliminary findings with AHRQ’s Center for Outcomes and Effectiveness (COE) and the Office of Communications and Knowledge Transfer (OCKT) as well as other grantees funded under this FOA; if such requests are made, AHRQ or its contracted agents will provide an AHRQ-sponsored, secure electronic interface so that important findings from needs assessments, focus group testing, or other feedback can be shared and applied in a timely fashion to CER products. In particular, AHRQ is interested in the timely application of information to remediate findings about what does NOT work or what is culturally inappropriate for specific audiences.

Applicants should include plans to travel the PI and up to 2 additional key project personnel to a total of 3 meetings, each of approximately one-and-a-half days duration, to be held in the Rockville MD or greater Washington DC Metro region. One meeting will occur at the approximate midpoint of the planned period of performance, one near the end of the period of performance, and one additional time to be determined in conjunction with the AHRQ project officer. One or two of these meetings will be arranged either by AHRQ or its contracted agents and timed to include other grantees so as to allow mutual sharing of the collective findings of this research with the Effective Health Care Program or the larger community of AHRQ researchers.

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

Section II. Award Information

1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the AHRQ Research Demonstration and Dissemination Projects Grant (R18) award mechanism. The individual researcher sponsored by each organizational grantee will be solely responsible for planning, directing, and executing his or her proposed projects.

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

2. Funds Available

This initiative is supported by funds provided to AHRQ under the American Recovery & Reinvestment Act of 2009 ( Recovery Act or ARRA ), Public Law 111-5. AHRQ has designated $29.5 million in FY2010 to fund 20-25 grants of up to 3 years duration, contingent upon the submission of a sufficient number of scientifically meritorious applications. The time-limited nature of ARRA funding does not allow resubmissions under this FOA. Applicants are encouraged to accelerate and complete work in less than 3 years, when appropriate.

Budget proposals are limited to $1.0 million in total costs in any one year for a total not to exceed $1.5 million in total costs over a period of three years. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation. Applications with project periods that exceed 3 years, budgets that exceed $1.5 million in total costs over 3 years, or with a total cost that exceeds $1.0 million in any one year will not be reviewed.

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

Funding beyond the first year will be contingent upon a review and acceptance by Agency staff of the annual progress report.

Funding for this program is provided under the American Recovery and Reinvestment Act of 2009 (Recovery Act). The purposes of the Recovery Act are to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health. Consistent with these goals, eligible domestic (United States) institutions/organizations who are planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested total costs or $25,000 (aggregate total for a foreign component or multiple foreign components), whichever is less. AHRQ awards under the Recovery Act will be for up to 3 years; whenever possible, awardees are required to accelerate their work.

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 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;
• 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.

Current AHRQ contractors or grantees are eligible to apply.

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus for the purpose of this FOA, AHRQ will make grants only to non-profit organizations. For-profit organizations may participate in projects as members of consortia or as subcontractors only. Because the purpose of this program is to improve health care in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by for-profit organizations or foreign institutions will not be reviewed. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support. Given the focus of this FOA, participation of such groups is encouraged by AHRQ.

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 can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.

3. Other-Special Eligibility Criteria

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

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

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

Section IV. Application and Submission Information

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

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)

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

• 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 support@grants.gov

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 commons@od.nih.gov

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 the PD/PI on the application must be registered also in the NIH eRA Commons prior to the submission of the application.
• The PD/PI must hold a PI account in the Commons. Applicants should not share a Commons account for both a Signing Official (SO) role and a PI role; however, if they have both a PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
• A PD/PI must be affiliated with the applicant organization. PDs/PIs 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.

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

1. Request Application Information

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

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

For further assistance, contact GrantsInfo -- Telephone 301-710-0267; Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

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

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

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

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

SPECIAL INSTRUCTIONS

Applications Involving a Single Institution

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

Applications Involving Multiple Institutions

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract or multiple subcontracts 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: November 16, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): November 18, 2009
Application Due Date(s): December 16, 2009
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date(s): Generally four months after peer review date

3.A.1. Letter of Intent

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

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

The letter of intent should be sent electronically to iADAPTgrants@ahrq.hhs.gov with a subject line of Letter of Intent iADAPTgrants.

Letter of Intent iADAPTgrants

Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Email: iADAPTgrants@ahrq.hhs.gov

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

3.A.2. Technical Assistance

Not applicable.

3.B. Submitting an Application Electronically to AHRQ

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

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

3.C. Application Processing

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

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

• 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, 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 NIH 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 Commonshttps://commons.era.nih.gov/commons/. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

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

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

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

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

Use of CMS Data

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

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

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

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

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements

Responsive applications should address the following 5 items (I to V, below) in their Research Plan component as part of their proposed activities:

General Requirements

Applicants must provide the following information: 1) the fully-completed or nearly completed CER Review Product(s) or CERSG(s) that are anticipated to be adapted; 2) description of the audience(s), stakeholder(s), system(s), and/or settings being targeted and some preliminary assessment of their need/receptivity regarding the proposed CER Review Products for adaptation, 3) the needs assessment to be applied or develop to guide the proposed adaptations, 4) the principal methodologic approach to be used in adaptation (audience testing, development of clinical decision support, application of a new communication technology, etc.); 5) description of the methods and analysis for the evaluation that will be conducted on any proposed adaptation intervention; and 6) the proposed products or tools to be developed and their planned dissemination.

I. CER Review Products or Summary Guides Anticipated for Use

One or more candidate CER Review Products or CERSGs for patients/consumers, clinicians, or policymakers (see EHC website at http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=sg and http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=rr for completed and nearly-completed products) must serve as the foundation for adaptation or novel dissemination efforts.

II. Target To Be Studied

The target audience(s), stakeholder(s), system(s), or setting(s) should be well-defined and a justification provided for the significance (in terms of unmet needs, generalizability, and public health impact) of the choice(s). Applicants should present their best understanding of the target’s characteristics, (including demographics if applicable), facilitating factors, and barriers. The information needs of the target, and the barriers as well as available resources, should be understood and well-described. The portion of target to be reached by the project should be identified.

Because of its relevance to the proposed scope of the research and demonstration activities, applicants must include a needs assessment of the targeted audience(s), stakeholder(s), system(s), or setting(s). This needs assessment may be applied from existing research or experience, or developed de novo for this application. The needs assessment must demonstrate a good understanding of the following: gaps, barriers or limitations to the use of currently available CER products, stakeholders roles and incentives; factors that influence decision-making for stakeholders, implementers and target population (e.g., training, literacy, culturally sensitive adaptation); and the organizational capacity (e.g., need and fit for the proposed intervention). Broad stakeholder involvement should be outlined from the outset to include traditional and non-traditional research partners (e.g., federal/state or local government, education, community, public policy, politicians, private sector, non-profits, health systems, academics, coalitions and media). Detailed, complete and substantive plans for demonstrating and ensuring the meaningful involvement of partners and stakeholders must be included in applications responsive to this FOA.

III. Study Approach and Documentation of Scientific or Empirical Basis of Intervention

For the purpose of this FOA, an adaptation intervention is an intentional action (singular or constellation) designed for a defined population or subpopulation, a community, an organization, system of care, or a region that alters knowledge or changes a behavior related to one or more CER Review Products or CERSGs. Interventions should be evidence-based, may have a medical or behavioral focus, and may consist of a modification to the natural or built environment, engineering controls, information technologies, public heath policy, public health program, health communication, or public health law. Evidence-based means that the intervention has undergone sufficient scientific or related evaluation (i.e. commercial or social marketing evidence) to be proven to be effective in one or more relevant settings to the proposed intervention (e.g., intervention is considered valid or proven because it is strongly linked to a desirable outcome). Scientific evaluation might include but is not limited to peer reviewed publications of quantitative or qualitative research, evaluation reports, systematic reviews of the literature (e.g., meta-analysis), or descriptive or survey research. Under this FOA, it is the responsibility of the investigative team to demonstrate that sufficient evidence exists when proposing a specific intervention to adapt CER Review Products, including CERSGs.

IV. Evaluation, Assessment, and Reporting the Intervention s Translatability

Applicants must include an evaluation plan in their application, outlining outcome measures, data systems, and analytical approach they will employ in determining whether an applied adaptation of content and/or delivery mechanism of CER Review Products such as CERSGs is more effective than current practices or some other comparator. Evaluations should include a plan to estimate and report the generalizability, potential translatability and public health impact of the intervention. If appropriate, the plan should include methodology to measure the interplay between fidelity, the necessary adaptation of the intervention, and scalability. Novel evaluation models are acceptable with justification, or applicants may elect to use (but are not limited to) previously published models and frameworks. Key research questions to consider in the development and evaluation of the proposed adaptation may include, but are not limited to, the following:

• Reach What were the key factors that determined who was successfully or unsuccessfully reached in the target group(s), system(s), or setting(s)?
• Uptake (adoption) What factors influenced organizations or individuals acceptance of the intervention (e.g., organizational structure, regulation, opinion leaders, and cultural norms)?
• Feasibility What is the realistic cost, time, facility space and human resources (e.g., number of staff and type of training) needed for the targeted population or setting?
• Fidelity Describe how the fidelity of the intervention or system was compromised, deviated, or adapted from the original research setting in which it was tested.
• Adaptability What key components of the intervention or the system were modified to increase adoptability or use? Can the intervention vary, as needed, depending on the audience?
• Outcome assessment As a secondary measure, was the intervention effective in improving the quality of clinical decision-making by clinicians or patients/consumers or improving one or more health outcomes?
• Economic Cost Was cost a factor in the target’s willingness to adopt the CER Review Products such as CERSGs? What opportunity (non-fiscal) costs were incurred?
• Cultural context Did adaptation of a CER Review Product or CERSG to make it more culturally relevant result in loss of fidelity? Did this result in decreased effectiveness? What aspects of culturally sensitive adaptation(s) appeared to increase uptake, behavior change, or other positive outcomes?
• Maintenance and sustainability What is the extent to which a program or policy offers the potential to be institutionalized or part of the routine organizational practices and policies?

V. Proposed products or tools and planned dissemination

Applicants should describe the anticipated work products of their research and plans for sharing these products with AHRQ, the public, and other grantees as requested by AHRQ. Travel costs should be included for the PI and up to 2 additional key personnel for 3 meetings held in Rockville MD or the greater Washington DC metro area. Each meeting will be approximately one-and-a-half day in duration.

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

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

Items 2-5 of the PHS398 Research Plan component are limited to 15 pages. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to AHRQ in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

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

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/consumers, 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 two 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.

Plan for Sharing Research Data

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

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

Section V. Application Review Information

1. Criteria

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

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

2. Review and Selection Process

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

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

• 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

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

• Significance
• Approach
• Innovation
• Investigators
• Environment
• Budget

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

Significance: Does this study address an important problem or unmet needs? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? Does the target (audience, stakeholder, system, or setting) for adaptation or translation experience significant disparities in health care and associated health information that would be addressed by the study? What is the significance of the described gaps/limits on the use of CER products by the target group(s)? Will findings about the group(s) be generalizable to other important groups? What will be the effect of these studies on the concepts, methods, technologies, treatments, or preventative interventions in comparative effectiveness? How will these research findings improve an understanding of the gap between knowledge and application of CER evidence? Does this new understanding aid future adaptation, dissemination, diffusion, or implementation of CER evidence to promote quality, effectiveness, safety, and/or efficiency of health care delivery?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the key variables for adaptation and dissemination research included and sufficiently described? Has the applicant adequately documented that the intervention, policy, etc. is evidence-based or, at a minimum, conceptually sound, based upon other dissemination and translation activities? Has the applicant sufficiently described and justified the target audience(s), stakeholder(s), system(s), or setting(s)? Is there a plan for evaluating the intervention and estimating its translatability to other CER products or targets? How closely do the proposed outcome measures approximate actual health outcomes? What is the strength and validity of the proposed evaluation outcome measures? Is there a needs assessment for the planned target(s) that is appropriate to the aims of the project and involves key stakeholders and partners? Does the applicant address the need to disseminate the findings of their research publicly? Does the applicant include a plan to share important interim findings with AHRQ and other awardees?

Innovation: Is the project original and innovative? For example, does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area? For example, does the project extend a CERSG current format, communication channel, and dissemination by using a new outreach mechanism or technology, by targeting a special subpopulation or community, practice setting, community- or other-based setting, or by conducting an adaptation and evaluation of its impact that goes beyond process measures? Is the project non-responsive in involving solely the simple promulgation of unchanged summary guides through printing and distribution, email, or listservs?

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 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)?

Environment: 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 or partnerships with the proposed target group(s)? Is there evidence of institutional support? Is there evidence of support and commitment from the partner(s) or institution(s) proposed to be involved in the research? Is there evidence of prior effective interactions or accomplishments in any proposed partnerships?

Budget: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research?

2.A. Additional Review Criteria

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

Degree of responsiveness: How well does the application address the purpose and objectives of this FOA? How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?

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

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

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

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

• Scientific 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 in terms of target(s) and gaps that are being addressed
• Portfolio balance within AHRQ and DHHS

The AHRQ R18 provides support for projects designed to develop, test, and evaluate health service activities, and to foster the application of existing knowledge, in order to improve the quality, safety, efficiency, and effectiveness of health care for all Americans.

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

2.B. Additional Review Considerations

Not Applicable.

2.C. Resource Sharing Plan(s)

Data Confidentiality

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

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

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

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

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

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

2. Administrative and National Policy Requirements

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

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

3. Reporting

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

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

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

Financial Status Reports (FSRs; SF 269) are required annually by AHRQ for ALL grant programs 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.

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

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

A final Progress Report 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

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

1. Scientific/Research Contact(s):

Direct your questions about general scientific/research issues, including information on the inclusion of priority populations to iADAPTgrants@ahrq.hhs.gov. Due to staffing resource constraints, all scientific/research (program) inquiries pertaining to general FOA issues must be submitted, and will only be replied to, via email. A compilation of frequently asked questions and answers will be posted at http://www.ahrq.gov/fund/grantix.htm on November 2, 2009 and will include replies to inquiries received on or before October 23, 2009.

Amy Lindinha
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1600
Fax: (301) 427-1639
E-mail address: iADAPTgrants@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., M.P.H.
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 either George Gardner or Michelle Burr as described below:

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

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

Section VIII. Other Information

Required Federal Citations

The American Recovery And Reinvestment Act of 2009: 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

Funding under this program is subject to the Updated Guidance Regarding Communications with Registered Lobbyists About Recovery Act Funds that was issued by the Office of Management and Budget on July 24, 2009 to implement section 3 of the President’s March 20, 2009 Memorandum entitled Ensuring Responsible Spending of Recovery Act Funds. Many of the restrictions described in the guidance also apply to non-lobbyists after the submission of competitive applications for Recovery Act funds and before awards are made. The guidance is available at http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf.

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. 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.